Tamiflu
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 30 mg hard capsules 
Tamiflu 45 mg hard capsules 
Tamiflu 75 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Tamiflu 30 mg hard capsules 
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir.  
For the full list of excipients, see section 6.1. 
 
Tamiflu 45 mg hard capsules 
Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir.  
For the full list of excipients, see section 6.1. 
 
Tamiflu 75 mg hard capsules 
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir.  
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Tamiflu 30 mg hard capsules 
The hard capsule consists of a light yellow opaque body bearing the imprint “ROCHE” and a light 
yellow opaque cap bearing the imprint “30 mg”. Imprints are blue. 
 
Tamiflu 45 mg hard capsules 
The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap 
bearing the imprint “45 mg”. Imprints are blue. 
 
Tamiflu 75 mg hard capsules 
The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a light yellow 
opaque cap bearing the imprint “75 mg”. Imprints are blue. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of influenza  
Tamiflu is indicated in adults and children including full term neonates who present with symptoms 
typical of influenza, when influenza virus is circulating in the community. Efficacy has been 
demonstrated when treatment is initiated within two days of first onset of symptoms.  
 
Prevention of influenza 
- Post-exposure prevention in individuals 1 year of age or older following contact with a 

clinically diagnosed influenza case when influenza virus is circulating in the community. 
 
- The appropriate use of Tamiflu for prevention of influenza should be determined on a case by 

case basis by the circumstances and the population requiring protection. In exceptional 
situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a 
pandemic situation) seasonal prevention could be considered in individuals one year of age or 
older. 

 



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- Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age 
during a pandemic influenza outbreak (see section 5.2). 

 
Tamiflu is not a substitute for influenza vaccination.  
 
The use of antivirals for the treatment and prevention of influenza should be determined on the basis 
of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis 
should take into consideration what is known about the characteristics of the circulating influenza 
viruses, available information on influenza drug susceptibility patterns for each season and the impact 
of the disease in different geographical areas and patient populations (see section 5.1).  
 
4.2 Posology and method of administration 
 
Posology 
 
Tamiflu hard capsules and Tamiflu suspension are bioequivalent formulations. 75 mg doses can be 
administered as either  
- one 75 mg capsule or  
- one 30 mg capsule plus one 45 mg capsule or  
- by administering one 30 mg dose plus one 45 mg dose of suspension.  
 
Commercially manufactured Tamiflu powder for oral suspension (6 mg/ml) is the preferred product 
for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are 
needed.   
 
Adults, and adolescents 13 years and over 
 
Treatment: The recommended oral dose is 75 mg oseltamivir twice daily for 5 days for adolescents (13 
to 17 years of age) and adults.  
 

Body Weight Recommended dose for 5 days Recommended dose for 10 days* 
Immunocompromised Patients 

> 40 kg 75 mg twice daily 75 mg twice daily 
* The recommended treatment duration in immunocompromised adults and adolescents is 10 days. See Special Populations, 
Immunocompromised Patients for more information. 
 
Treatment should be initiated as soon as possible within the first two days of onset of symptoms of 
influenza.  
 
Post-exposure prevention: The recommended dose for prevention of influenza following close contact 
with an infected individual is 75 mg oseltamivir once daily for 10 days for adolescents (13 to 17 years 
of age) and adults.  
 

Body Weight Recommended dose for 10 days 
 

Recommended dose for 10 days 
Immunocompromised Patients 

> 40 kg 75 mg once daily 75 mg once daily 
 
Therapy should begin as soon as possible within two days of exposure to an infected individual. 
 
Prevention during an influenza epidemic in the community: The recommended dose for prevention of 
influenza during a community outbreak is 75 mg oseltamivir once daily for up to 6 weeks (or up to 12 
weeks in immunocompromised patients, see sections 4.4, 4.8 and 5.1). 
 



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Paediatric population 
 
Children 1 to 12 years of age  
Tamiflu 30 mg, 45 mg and 75 mg capsules and oral suspension are available for infants and children 
1 year of age or older 
 
Treatment: The following weight-adjusted dosing regimens are recommended for treatment of infants 
and children 1 year of age or older: 
 

Body Weight Recommended dose for 5 days Recommended dose for 10 days* 
Immunocompromised Patients 

10 kg to 15 kg 30 mg twice daily 30 mg twice daily 
> 15 kg to 23 kg 45 mg twice daily 45 mg twice daily 
> 23 kg to 40 kg 60 mg twice daily 60 mg twice daily 
> 40 kg 75 mg twice daily 75 mg twice daily 

*The recommended treatment duration in immunocompromised children (≥1 year old) is 10 days.  See Special Populations, 
Immunocompromised Patients for more information.  
 
Treatment should be initiated as soon as possible within the first two days of onset of symptoms of 
influenza.  
 
Post-exposure prevention: The recommended post-exposure prevention dose of Tamiflu is: 
 

Body Weight Recommended dose for 10 days Recommended dose for 10 days 
For Immunocomprmised Patients 

10 kg to 15 kg 30 mg once daily 30 mg once daily 
> 15 kg to 23 kg 45 mg once daily 45 mg once daily 
> 23 kg to 40 kg 60 mg once daily 60 mg once daily 
> 40 kg 75 mg once daily 75 mg once daily 

 
Prevention during an influenza epidemic in the community: Prevention during an influenza epidemic 
has not been studied in children below 12 years of age. 
 
Infants 0 – 12 months of age 
 
Treatment: The recommended treatment dose for infants 0 - 12 months of age is 3 mg/kg twice daily. 
This is based upon pharmacokinetic and safety data indicating that this dose in infants 0 - 12 months 
provides plasma concentrations of the pro-drug and active metabolite that are anticipated to be 
clinically efficacious with a safety profile comparable to that seen in older children and adults (see 
section 5.2). The following dosing regimen is recommended for treatment of infants 0 - 12 months of 
age: 
 

Body weight* Recommended dose for 5 days Recommended dose for 10 days** 
Immunocompromised Patients 

3 kg 9 mg twice daily 9 mg twice daily 
4 kg 12 mg twice daily 12 mg twice daily 
5 kg 15 mg twice daily 15 mg twice daily 
6 kg 18 mg twice daily 18 mg twice daily 
7 kg 21 mg twice daily 21 mg twice daily 
8 kg 24 mg twice daily 24 mg twice daily 
9 kg 27 mg twice daily 27 mg twice daily 

10 kg 30 mg twice daily 30 mg twice daily 
* This table is not intended to contain all possible weights for this population. For all patients under the age of 1 year, 

3 mg/kg should be used to determine dose regardless of the weight of the patient. 
Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza. 
** The recommended duration in immunocompromised infants (0-12 months old) is 10 days. See Special Populations, 
Immunocompromised Patients for more information. 
 



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This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual 
age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may 
be required due to the immaturity of physiological functions. 
 
Post-exposure prevention: The recommended prophylaxis dose for infants less than 1 year of age 
during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon clinical 
data in infants and children 1 year of age or older and adults showing that a prophylaxis dose 
equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza. The 
following age-adjusted dosing prophylaxis regimen is recommended for infants 0 - 12 months of age  
(see Section 5.2 for exposure simulation): 
 

Age Recommended dose for 10 days Recommended dose for 10 days 
Immunocompromised Patients 

0 - 12 months 3 mg/kg once daily 3 mg/kg once daily 
 
This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual 
age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may 
be required due to the immaturity of physiological functions. 
 
Prevention during an influenza epidemic in the community: Prevention during an influenza epidemic 
has not been studied in children 0-12 months of age. 
 
For instructions on preparing the extemporaneous formulation, see section 6.6. 
 
Special populations 
 
Hepatic impairment 
No dose adjustment is required either for treatment or for prevention in patients with hepatic 
dysfunction. No studies have been carried out in paediatric patients with hepatic disorder. 
 
Renal impairment  
Treatment of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of 
age) with moderate or severe renal impairment. Recommended doses are detailed in the table below.  
 

Creatinine clearance  Recommended dose for treatment 
> 60 (ml/min) 75 mg twice daily 

> 30 to 60 (ml/min) 30 mg (suspension or capsules) twice daily 
> 10 to 30 (ml/min) 30 mg (suspension or capsules) once daily 

£ 10 (ml/min)  Not recommended (no data available) 
Haemodialysis patients 30 mg after each haemodialysis session 

Peritoneal dialysis patients* 30 mg (suspension or capsules) single dose 
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of 

oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used. 
Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist. 

 



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Prevention of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years 
of age) with moderate or severe renal impairment as detailed in the table below. 
 

Creatinine clearance  Recommended dose for prevention 
> 60 (ml/min) 75 mg once daily 

> 30 to 60 (ml/min) 30 mg (suspension or capsules) once daily 
> 10 to 30 (ml/min) 30 mg (suspension or capsules) every second 

day 
£ 10 (ml/min)  Not recommended (no data available) 

Haemodialysis patients 30 mg after every second haemodialysis session 
Peritoneal dialysis patients* 30 mg (suspension or capsules) once weekly 

* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of 
oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used. 
Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist. 

 
There is insufficient clinical data available in infants and children (12 years of age and younger) with 
renal impairment to be able to make any dosing recommendation. 
 
Elderly 
No dose adjustment is required, unless there is evidence of moderate or severe renal impairment. 
 
Immunocompromised patients  
 
Treatment: For treatment of influenza, the recommended duration for immunocompromised patients is 
10 days (see sections 4.4, 4.8 and 5.1). No dose adjustment is necessary.   Treatment should be 
initiated as soon as possible within the first two days of onset of symptoms of influenza. 
 
Seasonal prophylaxis: Longer duration of seasonal prophylaxis up to 12 weeks has been evaluated in 
immunocompromised patients (see sections 4.4, 4.8 and 5.1). 
 
Method of administration 
 
Oral use. 
Patients who are unable to swallow capsules may receive appropriate doses of Tamiflu suspension. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for 
efficacy of oseltamivir in any illness caused by agents other than influenza viruses (see section 5.1).  
 
Tamiflu is not a substitute for influenza vaccination. Use of Tamiflu must not affect the evaluation of 
individuals for annual influenza vaccination. The protection against influenza lasts only as long as 
Tamiflu is administered. Tamiflu should be used for the treatment and prevention of influenza only 
when reliable epidemiological data indicate that influenza virus is circulating in the community. 
Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable 
(see section 5.1). Therefore, prescribers should take into account the most recent information available 
on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use 
Tamiflu. 
 
Severe concomitant condition 
No information is available regarding the safety and efficacy of oseltamivir in patients with any 
medical condition sufficiently severe or unstable to be considered at imminent risk of requiring 
hospitalisation.  



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Immunocompromised patients 
The efficacy of oseltamivir in either treatment or prophylaxis of influenza in immunocompromised 
patients has not been firmly established (see section 5.1).  
 
Cardiac / respiratory disease 
Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory 
disease has not been established. No difference in the incidence of complications was observed 
between the treatment and placebo groups in this population (see section 5.1). 
 
Paediatric population 
No data allowing a dose recommendation for premature children (< 36 weeks post-conceptual age) are 
currently available. 
 
Severe renal impairment 
Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of 
age) and adults with severe renal impairment. There is insufficient clinical data available in infants and 
children (1 year of age or older) with renal impairment to be able to make any dosing recommendation 
(see sections 4.2 and 5.2). 
 
Neuropsychiatric events 
Neuropsychiatric events have been reported during administration of Tamiflu in patients with 
influenza, especially in children and adolescents. These events are also experienced by patients with 
influenza without oseltamivir administration. Patients should be closely monitored for behavioural 
changes, and the benefits and risks of continuing treatment should be carefully evaluated for each 
patient (see section 4.8). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of 
the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant drug 
interactions via these mechanisms are unlikely. 
 
Probenecid 
No dose adjustment is required when co-administering with probenecid in patients with normal renal 
function. Co-administration of probenecid, a potent inhibitor of the anionic pathway of renal tubular 
secretion, results in an approximate 2-fold increase in exposure to the active metabolite of oseltamivir.  
 
Amoxicillin 
Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway, 
suggesting that oseltamivir interaction with this pathway is weak.  
 
Renal elimination 
Clinically important drug interactions involving competition for renal tubular secretion are unlikely, 
due to the known safety margin for most of these substances, the elimination characteristics of the 
active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of 
these pathways. However, care should be taken when prescribing oseltamivir in subjects when taking 
co-excreted agents with a narrow therapeutic margin (e.g. chlorpropamide, methotrexate, 
phenylbutazone).  
 
Additional information 
No pharmacokinetic interactions between oseltamivir or its major metabolite have been observed 
when co-administering oseltamivir with paracetamol, acetylsalicylic acid, cimetidine, antacids 
(magnesium and aluminium hydroxides and calcium carbonates), rimantadine or warfarin (in subjects 
stable on warfarin and without influenza). 
 



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4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
Influenza is associated with adverse pregnancy and foetal outcomes, with a risk of major congenital 
malformations, including congenital heart defects. A large amount of data on oseltamivir exposure of 
pregnant women from post-marketing reports and observational studies (more than 1000 exposed 
outcomes during the first trimester) indicate no malformative nor feto/neonatal toxicity by oseltamivir.  
 
However, in one observational study, while the overall malformation risk was not increased, the 
results for major congenital heart defects diagnosed within 12 months of birth were not conclusive. In 
this study, the rate of major congenital heart defects following oseltamivir exposure during the first 
trimester was 1.76% (7 infants out of 397 pregnancies) compared to 1.01% in unexposed pregnancies 
from the general population (Odds Ratio 1.75, 95% Confidence Interval 0.51 to 5.98). The clinical 
significance of this finding is not clear, as the study had limited power. Additionally, this study was 
too small to reliably assess individual types of major malformations; moreover women exposed to 
oseltamivir and women unexposed could not be made fully comparable, in particular whether or not 
they had influenza. 
 
Animal studies do not indicate reproductive toxicity (see section 5.3). 
 
The use of Tamiflu may be considered during pregnancy if necessary and after considering the 
available safety and benefit information (for data on benefit in pregnant women please refer to section 
5.1 “treatment of influenza in pregnant women”), and the pathogenicity of the circulating influenza 
virus strain. 
 
Breastfeeding 
In lactating rats, oseltamivir and the active metabolite are excreted in milk. Very limited information is 
available on children breast-fed by mothers taking oseltamivir and on excretion of oseltamivir in 
breast milk. Limited data demonstrated that oseltamivir and the active metabolite were detected in 
breast milk, however the levels were low, which would result in a subtherapeutic dose to the infant. 
Considering this information, the pathogenicity of the circulating influenza virus strain and the 
underlying condition of the breastfeeding woman, administration of oseltamivir may be considered, 
where there are clear potential benefits to breastfeeding mothers. 
 
Fertility 
Based on preclinical data, there is no evidence that Tamiflu has an effect on male or female fertility 
(see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Tamiflu has no influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The overall safety profile of Tamiflu is based on data from 6049 adult/adolescent and 1473 paediatric 
patients treated with Tamiflu or placebo for influenza, and on data from 3990 adult/adolescent and 253 
paediatric patients receiving Tamiflu or placebo/no treatment for the prophylaxis of influenza in 
clinical trials. In addition, 245 immunocompromised patients (including 7 adolescents and 39 children) 
received Tamiflu for the treatment of influenza and 475 immunocompromised patients (including 18 
children, of these 10 Tamiflu and 8 placebo) received Tamiflu or placebo for the prophylaxis of 
influenza. 
 
In adults/adolescents, the most commonly reported adverse reactions (ARs) were nausea and vomiting 
in the treatment studies, and nausea in the prevention studies. The majority of these ARs were reported 
on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 



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days. In children, the most commonly reported adverse reaction was vomiting. In the majority of 
patients, these ARs did not lead to discontinuation of Tamiflu. 
 
The following serious adverse reactions have been rarely reported since oseltamivir has been 
marketed: Anaphylactic and anaphylactoid reactions, hepatic disorders (fulminant hepatitis, hepatic 
function disorder and jaundice), angioneurotic oedema, Stevens-Johnson syndrome and toxic 
epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders.  
(Regarding neuropsychiatric disorders, see section 4.4.) 
 
Tabulated list of adverse reactions 
The ARs listed in the tables below fall into the following categories: Very common (≥ 1/10), common 
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare 
(< 1/10,000). ARs are added to the appropriate category in the tables according to the pooled analysis 
from clinical studies.  
 
Treatment and prevention of influenza in adults and adolescents:  
In adult/adolescent treatment and prevention studies, ARs that occurred the most frequently at the 
recommended dose (75  mg bid for 5  days for treatment and 75  mg od for up to 6  weeks for 
prophylaxis) are shown in Table 1. 
 
The safety profile reported in subjects who received the recommended dose of Tamiflu for prophylaxis 
(75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, 
despite a longer duration of dosing in the prophylaxis studies. 
 
Table 1 Adverse reactions in studies investigating Tamiflu for treatment and prevention of 

influenza in adults and adolescents or through post-marketing surveillance 
 
System Organ 
Class (SOC) 

Adverse reactions according to frequency 
Very common Common Uncommon Rare 

Infections and 
infestations 

 Bronchitis, 
Herpes simplex, 
Nasopharyngitis, 
Upper respiratory 
tract infections, 
Sinusitis 

  

Blood and 
lymphatic 
system disorders 

   Thrombocytopenia 

Immune system 
disorders 

  Hypersensitivity 
reaction 

Anaphylactic 
reactions, 
Anaphylactoid 
reactions 

Psychiatric 
disorders 

   Agitation,  
Abnormal behaviour, 
Anxiety,  
Confusion, 
Delusions, Delirium, 
Hallucination, 
Nightmares,  
Self-injury 

Nervous system 
disorders 

Headache Insomnia Altered level of 
consciousness, 
Convulsion 

 

Eye disorders    Visual disturbance 
Cardiac 
disorders 

  Cardiac 
arrhythmia 

 



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System Organ 
Class (SOC) 

Adverse reactions according to frequency 
Very common Common Uncommon Rare 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Cough,  
Sore throat, 
Rhinorrhea 

  

Gastrointestinal 
disorders 

Nausea Vomiting  
Abdominal pain 
(incl. upper 
abdominal pain), 
Dyspepsia 

 Gastrointestinal 
bleedings, 
Haemorrhagic 
colitis 

Hepatobiliary 
disorders 

  Elevated liver 
enzymes 

Fulminant hepatitis, 
Hepatic failure, 
Hepatitis 

Skin and 
subcutaneous 
tissue disorders 

  Eczema, 
Dermatitis,  
Rash,  
Urticaria 

Angioneurotic 
oedema,  
Erythema 
multiforme, 
Stevens-Johnson 
syndrome,  
Toxic epidermal 
necrolysis 

General 
disorders and 
administration 
site conditions 

 Pain  
Dizziness (incl. 
vertigo),  
Fatigue, 
Pyrexia, 
Pain in limb 

  

 
Treatment and prevention of influenza in children:  
 
A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic 
children aged 6-12 years old) participated in clinical studies of oseltamivir given for the treatment of 
influenza. Of those, 851 children received treatment with oseltamivir suspension. A total of 158 
children received the recommended dose of Tamiflu once daily in a post-exposure prophylaxis study 
in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12-week 
paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10). 
 
Table 2 shows the most frequently reported ARs from paediatric clinical trials.  
 



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Table 2 Adverse reactions in studies investigating Tamiflu for treatment and prevention of 
influenza in children (age/weight-based dosing [30 mg to 75 mg o.d.]) 

 
System Organ 
Class (SOC) 

Adverse reactions according to frequency 
Very common Common Uncommon Rare 

Infections and 
infestations 

 Otitis media, 
 

  

Nervous system 
disorders 

 Headache   

Eye disorders:  Conjunctivitis 
(including red 
eyes, eye 
discharge and eye 
pain) 

  

Ear and 
labyrinth 
disorders: 

 Earache Tympanic 
membrane disorder 

 

Respiratory, 
thoracic and 
mediastinal 
disorders 

Cough,  
Nasal congestion 

Rhinorrhoea   

Gastrointestinal 
disorders 

Vomiting Abdominal pain 
(incl. upper 
abdominal pain), 
Dyspepsia, 
Nausea  

  

Skin and 
subcutaneous 
tissue disorders 

  Dermatitis 
(including allergic 
and atopic 
dermatitis) 

 

 
Description of selected adverse reactions 
 
Psychiatric disorders and nervous system disorders 
Influenza can be associated with a variety of neurologic and behavioural symptoms which can include 
events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal 
outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur 
without obvious severe disease. 
 
In patients with influenza who were receiving Tamiflu, there have been postmarketing reports of 
convulsions and delirium (including symptoms such as altered level of consciousness, confusion, 
abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases 
resulting in self-injury or fatal outcomes. These events were reported primarily among paediatric and 
adolescent patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to 
those events is unknown. Such neuropsychiatric events have also been reported in patients with 
influenza who were not taking Tamiflu. 
 
Hepato-biliary disorders 
Hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with 
influenza-like illness. These cases include fatal fulminant hepatitis/hepatic failure. 
 
Other special populations 
 
Paediatric population (infants less than one year of age) 
In two studies to characterise the pharmacokinetics, pharmacodynamics and safety profile of 
oseltamivir therapy in 135 influenza infected children less than one year of age, the safety profile was 
similar among age cohorts with vomiting, diarrohea and diaper rash being the most frequently reported 



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adverse events (see section 5.2). Insufficient data are available for infants who have a post-conceptual 
age of less than 36 weeks. 
 
Safety information available on oseltamivir administered for treatment of influenza in infants less than 
one year of age from prospective and retrospective observational studies (comprising together more 
than 2,400 infants of that age class), epidemiological databases research and postmarketing reports 
suggest that the safety profile in infants less than one year of age is similar to the established safety 
profile of children aged one year and older. 
 
Older people and patients with chronic cardiac and/or respiratory disease 
The population included in the influenza treatment studies is comprised of otherwise healthy 
adults/adolescents and patients “at risk” (patients at higher risk of developing complications associated 
with influenza, e.g. older people and patients with chronic cardiac or respiratory disease). In general, 
the safety profile in the patients “at risk” was qualitatively similar to that in otherwise healthy 
adults/adolescents. 
 
Immunocompromised patients 
 
The treatment of influenza in immunocompromised patients were evaluated in two studies receiving 
standard dose or high dose regimens (double dose or triple dose) of Tamiflu (see section 5.1). The 
safety profile of Tamiflu observed in these studies was consistent with that observed in previous 
clinical trials where Tamiflu was administered for treatment of influenza in non-immunocompromised 
patients across all age groups (otherwise healthy patients or “at risk” patients [i.e., those with 
respiratory and/or cardiac co-morbidities]). The most frequent adverse reaction reported in 
immunocompromised children was vomiting (28%).  
 
In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to 
12 years of age and older, the safety profile in the 238 patients who received oseltamivir was 
consistent with that previously observed in Tamiflu prophylaxis clinical studies. 
 
Children with pre-existing bronchial asthma 
In general, the adverse reaction profile in children with pre-existing bronchial asthma was qualitatively 
similar to that of otherwise healthy children. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Reports of overdoses with Tamiflu have been received from clinical trials and during post-marketing 
experience. In the majority of cases reporting overdose, no adverse events were reported. 
 
Adverse events reported following overdose were similar in nature and distribution to those observed 
with therapeutic doses of Tamiflu, described in section 4.8 Undesirable effects. 
 
No specific antidote is known. 
 
Paediatric population 
Overdose has been reported more frequently for children than adults and adolescents. Caution should 
be exercised when preparing Tamiflu oral suspension and when administering Tamiflu products to 
children. 
 
 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


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5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: 
J05AH02 
 
Oseltamivir phosphate is a pro-drug of the active metabolite (oseltamivir carboxylate). The active 
metabolite is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins 
found on the virion surface. Viral neuraminidase enzyme activity is important both for viral entry into 
uninfected cells and for the release of recently formed virus particles from infected cells, and for the 
further spread of infectious virus in the body. 
 
Oseltamivir carboxylate inhibits influenza A and B neuraminidases in vitro. Oseltamivir phosphate 
inhibits influenza virus infection and replication in vitro. Oseltamivir given orally inhibits influenza A 
and B virus replication and pathogenicity in vivo in animal models of influenza infection at antiviral 
exposures similar to that achieved in man with 75 mg twice daily. 
 
Antiviral activity of oseltamivir was supported for influenza A and B by experimental challenge 
studies in healthy volunteers.  
 
Neuraminidase enzyme IC50 values for oseltamivir for clinically isolated influenza A ranged from 
0.1 nM to 1.3 nM, and for influenza B was 2.6 nM. Higher IC50 values for influenza B, up to a 
median of 8.5 nM, have been observed in published studies. 
 
Clinical studies 
 
Treatment of influenza infection 
 
The indication is based on clinical studies of naturally occurring influenza in which the predominant 
infection was influenza A. 
 
Oseltamivir is effective only against illnesses caused by influenza virus. Statistical analyses are 
therefore presented only for influenza-infected subjects. In the pooled treatment study population, 
which included both influenza-positive and -negative subjects (ITT), primary efficacy was reduced 
proportionally to the number of influenza-negative individuals. In the overall treatment population, 
influenza infection was confirmed in 67 % (range 46 % to 74 %) of the recruited patients. Of the older 
subjects, 64 % were influenza-positive and of those with chronic cardiac and/or respiratory disease 
62 % were influenza-positive. In all phase III treatment studies, patients were recruited only during the 
period in which influenza was circulating in the local community.   
 
Adults and adolescents 13 years of age and older: Patients were eligible if they reported within 
36 hours of onset of symptoms, had fever ≥ 37.8 ∞C, accompanied by at least one respiratory symptom 
(cough, nasal symptoms or sore throat) and at least one systemic symptom (myalgia, chills/sweats, 
malaise, fatigue or headache). In a pooled analysis of all influenza-positive adults and adolescents 
(N = 2,413) enrolled into treatment studies, oseltamivir 75 mg twice daily for 5 days reduced the 
median duration of influenza illness by approximately one day from 5.2 days (95 % CI 4.9 – 5.5 days) 
in the placebo group to 4.2 days (95 % CI 4.0 – 4.4 days; p ≤ 0.0001).  
 
The proportion of subjects who developed specified lower respiratory tract complications (mainly 
bronchitis) treated with antibiotics was reduced from 12.7 % (135/1,063) in the placebo group to 
8.6 % (116/1,350) in the oseltamivir treated population (p = 0.0012).  
 
Treatment of influenza in high risk populations: The median duration of influenza illness in older 
subjects (≥ 65 years) and in subjects with chronic cardiac and/or respiratory disease receiving 
oseltamivir 75 mg twice daily for 5 days was not reduced significantly. The total duration of fever was 
reduced by one day in the groups treated with oseltamivir. In influenza-positive older people , 



14 

oseltamivir significantly reduced the incidence of specified lower respiratory tract complications 
(mainly bronchitis) treated with antibiotics from 19 % (52/268) in the placebo group to 12 % (29/250) 
in the oseltamivir treated population (p = 0.0156).  
 
In influenza-positive patients with chronic cardiac and/or respiratory disease, the combined incidence 
of lower respiratory tract complications (mainly bronchitis) treated with antibiotics was 17 % (22/133) 
in the placebo group and 14 % (16/118) in the oseltamivir treated population (p = 0.5976).  
 
Treatment of influenza in pregnant women: No controlled clinical studies have been conducted on the 
use of oseltamivir in pregnant women, however, there is evidence from post-marketing and 
retrospective observational studies showing benefit of the current dosing regimen in this patient 
population in terms of lower morbidity/mortality. Results from pharmacokinetic analyses indicate a 
lower exposure to the active metabolite, however dose adjustments are not recommended for pregnant 
women in the treatment or prophylaxis of influenza (see section 5.2, Pharmacokinetics, Special 
Population). 
 
Treatment of influenza in children: In a study of otherwise healthy children (65 % influenza-positive) 
aged 1 to 12 years (mean age 5.3 years) who had fever (≥ 37.8 °C) plus either cough or coryza, 67 % 
of influenza-positive patients were infected with influenza A and 33 % with influenza B. Oseltamivir 
treatment, started within 48 hours of onset of symptoms, significantly reduced the time to freedom 
from illness (defined as the simultaneous return to normal health and activity and alleviation of fever, 
cough and coryza) by 1.5 days (95 % CI 0.6 – 2.2 days; p < 0.0001) compared to placebo. Oseltamivir 
reduced the incidence of acute otitis media from 26.5 % (53/200) in the placebo group to 16 % 
(29/183) in the oseltamivir treated children (p = 0.013). 
 
A second study was completed in 334 asthmatic children aged 6 to 12 years old of which 53.6 % were 
influenza-positive. In the oseltamivir treated group, the median duration of illness was not reduced 
significantly. By day 6 (the last day of treatment) FEV1 had increased by 10.8 % in the oseltamivir 
treated group compared to 4.7 % on placebo (p = 0.0148) in this population. 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Tamiflu in one or more subsets of the paediatric population in influenza. See section 4.2 for 
information on paediatric use. 
 
The indication in infants below the age of 1 is based upon extrapolation of efficacy data from older 
children and the recommended posology is based upon pharmacokinetic modelling data (see Section 
5.2). 
  
Treatment of influenza B infection: Overall, 15 % of the influenza-positive population were infected by 
influenza B, proportions ranging from 1 to 33 % in individual studies. The median duration of illness 
in influenza B infected subjects did not differ significantly between the treatment groups in individual 
studies. Data from 504 influenza B infected subjects were pooled across all studies for analysis. 
Oseltamivir reduced the time to alleviation of all symptoms by 0.7 days (95 % CI 0.1 – 1.6 days; 
p = 0.022) and the duration of fever (≥ 37.8 °C), cough and coryza by one day (95 % CI 0.4 – 
1.7 days; p < 0.001) compared to placebo.  
 
Treatment of influenza in immunocompromised patients: A randomized, double blind study, to 
evaluate safety and characterize the effects of oseltamivir on the development of resistant influenza 
virus (primary analysis) in influenza-infected immunocompromised patients, included 151 adult 
patients, 7 adolescents and 9 children evaluable for efficacy of oseltamivir (secondary analysis, not 
powered). The study included solid organ transplant [SOT] patients, haematopoietic stem cell 
transplant [HSCT] patients, HIV positive patients with a CD4+ cell count <500 cells/mm3, patients on 
systemic immunosuppressive therapy, and those with haematological malignancy. These patients were 
randomized to be treated, within 96 hours of symptoms onset for a duration of 10 days. The treatment 
regimens were: standard dose (75mg or weight adjusted dose for children) twice daily (73 adult 
patients, 4 adolescent patients and 4 children) or double dose (150 mg or weight-adjusted dose for 
children) twice daily (78 adult patients, 3 adolescent patients and 5 children) of oseltamivir.  



15 

 
The median time to resolution of symptoms (TTRS) for adults and adolescents was similar between 
the standard dose group (103.4 hours [95% CI 75.4-122.7]) and double dose group (107.2 hours [95% 
CI 63.9-140.0]).  The TTRS for children was variable and the interpretation is limited by the small 
sample size. The proportion of adult patients with secondary infections in the standard dose group and 
double dose group was comparable (8.2% vs 5.1%). For adolescents and children, only one patient (an 
adolescent) in the standard dose group experienced a secondary infection (bacterial sinusitis). 
 
A pharmacokinetics and pharmacodynamics study was conducted in severely immunocompromised 
children (≤12 years of age, n=30) receiving standard (75 mg or weight adjusted twice daily) vs. triple 
dose (225 mg or weight adjusted twice daily) oseltamivir for an adaptive dosing period of 5 to 20 days 
dependant on duration of viral shedding (mean treatment duration: 9 days). No patients in the standard 
dose group and 2 patients in the triple dose group reported secondary bacterial infections (bronchitis 
and sinusitis). 
 
Prevention of influenza 
The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated 
in a post-exposure prevention study in households and two seasonal prevention studies. The primary 
efficacy parameter for all of these studies was the incidence of laboratory-confirmed influenza. The 
virulence of influenza epidemics is not predictable and varies within a region and from season to 
season, therefore the number needed to treat (NNT) in order to prevent one case of influenza illness 
varies. 
 
Post-exposure prevention: In a study in contacts (12.6 % vaccinated against influenza) of an index 
case of influenza, oseltamivir 75 mg once daily was started within 2 days of onset of symptoms in the 
index case and continued for seven days. Influenza was confirmed in 163 out of 377 index cases. 
Oseltamivir significantly reduced the incidence of clinical influenza illness occurring in the contacts of 
confirmed influenza cases from 24/200 (12 %) in the placebo group to 2/205 (1 %) in the oseltamivir 
group (92 % reduction [95 % CI 6 – 16; p ≤ 0.0001]). The number needed to treat (NNT) in contacts 
of true influenza cases was 10 (95 % CI 9 – 12) and was 16 (95 % CI 15 – 19) in the whole population 
(ITT) regardless of infection status in the index case.  
 
The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated 
in a post-exposure prevention study in households that included adults, adolescents, and children aged 
1 to 12 years, both as index cases and as family contacts. The primary efficacy parameter for this study 
was the incidence of laboratory-confirmed clinical influenza in the households. Oseltamivir 
prophylaxis lasted for 10 days. In the total population, there was a reduction in the incidence of 
laboratory-confirmed clinical influenza in households from 20 % (27/136) in the group not receiving 
prevention to 7 % (10/135) in the group receiving prevention (62.7 % reduction [95 % CI 26.0 – 81.2; 
p = 0.0042]). In households of influenza-infected index cases, there was a reduction in the incidence of 
influenza from 26 % (23/89) in the group not receiving prevention to 11 % (9/84) in the group 
receiving prevention (58.5 % reduction [95 % CI 15.6 – 79.6; p = 0.0114]). 
According to subgroup analysis in children at 1 to 12 years of age, the incidence of laboratory-
confirmed clinical influenza among children was significantly reduced from 19 % (21/111) in the 
group not receiving prevention to 7 % (7/104) in the group receiving prevention (64.4 % reduction 
[95 % CI 15.8 – 85.0; p = 0.0188]). Among children who were not already shedding virus at baseline, 
the incidence of laboratory-confirmed clinical influenza was reduced from 21 % (15/70) in the group 
not receiving prevention to 4 % (2/47) in the group receiving prevention (80.1 % reduction [95 % CI 
22.0 – 94.9; p = 0.0206]). The NNT for the total paediatric population was 9 (95 % CI 7 – 24) and 
8 (95 % CI 6, upper limit not estimable) in the whole population (ITT) and in paediatric contacts of 
infected index cases (ITTII), respectively. 
 
Post-exposure prevention of influenza in infants less than 1 year of age during a pandemic: 
Prevention during an influenza pandemic has not been studied in controlled clinical studies in children 
0-12 months of age. See Section 5.2 for exposure simulation details. 
 



16 

Prevention during an influenza epidemic in the community: In a pooled analysis of two other studies 
conducted in unvaccinated otherwise healthy adults, oseltamivir 75 mg once daily given for 6 weeks 
significantly reduced the incidence of clinical influenza illness from 25/519 (4.8 %) in the placebo 
group to 6/520 (1.2 %) in the oseltamivir group (76 % reduction [95 % CI 1.6 – 5.7; p = 0.0006]) 
during a community outbreak of influenza. The NNT in this study was 28 (95 % CI 24 – 50). 
A study in older people in nursing homes, where 80 % of participants received vaccine in the season 
of the study, oseltamivir 75 mg once daily given for 6 weeks significantly reduced the incidence of 
clinical influenza illness from 12/272 (4.4 %) in the placebo group to 1/276 (0.4 %) in the oseltamivir 
group (92 % reduction [95 % CI 1.5 – 6.6; p = 0.0015]). The NNT in this study was 25 (95 % CI 23 – 
62).  
 
Prophylaxis of influenza in immunocompromised patients: A double-blind, placebo-controlled, 
randomised study was conducted for seasonal prophylaxis of influenza in 475 immunocompromised 
patients (388 patients with solid organ transplantation [195 placebo; 193 oseltamivir], 87 patients with 
haemopoetic stem cell transplantation [43 placebo; 44 oseltamivir], no patient with other 
immunosuppressant conditions), including 18 children 1 to 12 years of age. The primary endpoint in 
this study was the incidence of laboratory-confirmed clinical influenza as determined by viral culture 
and/or a four-fold rise in HAI antibodies. The incidence of laboratory-confirmed clinical influenza was 
2.9 % (7/238) in the placebo group and 2.1 % (5/237) in the oseltamivir group (95 % CI -2.3 % – 
4.1 %; p = 0.772). 
 
Specific studies have not been conducted to assess the reduction in the risk of complications. 
 
Oseltamivir resistance 
Clinical studies: The risk of emergence of influenza viruses with reduced susceptibility or frank 
resistance to oseltamivir has been examined during Roche-sponsored clinical studies. Developing 
oseltamivir-resistant virus during treatment was more frequent in children than adults, ranging from 
less than 1% in adults to 18% in infants aged below 1 year. Children who were found to carry 
oseltamivir-resistant virus in general shed the virus for a prolonged period compared with subjects 
with susceptible virus. However, treatment-emergent resistance to oseltamivir did not affect treatment 
response and caused no prolongation of influenza symptoms.  
 
An overall higher incidence of oseltamivir-resistance was observed in adult and adolescent 
immunocompromised patients treated with standard dose or double dose of oseltamivir for a duration 
of 10 days [14.5% (10/69) in standard dose group and 2.7% (2/74) in double dose group], compared to 
data from studies with oseltamivir-treated otherwise healthy adult and adolescent patients. The 
majority of adult patients that developed resistance were transplant recipients (8/10 patients in the 
standard dose group and 2/2 patients in the double dose group). Most of the patients with oseltamivir-
resistant virus were infected with influenza type A and had prolonged viral shedding. 
 
The incidence of oseltamivir-resistance observed in immunocompromised children (≤12 years of age) 
treated with Tamiflu across the two studies and evaluated for resistance was 20.7% (6/29). Of the six 
immunocompromised children found with treatment-emergent resistance to oseltamivir, 3 patients 
received standard dose and 3 patients high dose (double or triple dose). The majority had acute 
lymphoid leukemia and were ≤ 5 years of age.  
 
Incidence of Oseltamivir Resistance in Clinical Studies 
 

Patient Population 
Patients with Resistance Mutations (%) 

Phenotyping* Geno- and Phenotyping* 
Adults and adolescents 0.88% (21/2382) 

 
1.13% (27/2396) 

 
Children (1-12 years) 4.11% (71/1726) 4.52% (78/1727) 
Infants (<1year) 18.31% (13/71) 18.31% (13/71) 

* Full genotyping was not performed in all studies. 
 



17 

Prophylaxis of Influenza 
There has been no evidence for emergence of drug resistance associated with the use of Tamiflu in 
clinical studies conducted to date in post-exposure (7 days), post-exposure within household groups 
(10 days) and seasonal (42 days) prevention of influenza in immunocompetent patients. There was no 
resistance observed during a 12-week prophylaxis study in immunocompromised patients.  
 
Clinical and surveillance data: Natural mutations associated with reduced susceptibility to oseltamivir 
in vitro have been detected in influenza A and B viruses isolated from patients without exposure to 
oseltamivir. Resistant strains selected during oseltamivir treatment have been isolated from both 
immunocompetent and immunocompromised patients. Immunocompromised patients and young 
children are at a higher risk of developing oseltamivir-resistant virus during treatment. 
 
Oseltamivir-resistant viruses isolated from oseltamivir-treated patients and oseltamivir-resistant 
laboratory strains of influenza viruses have been found to contain mutations in N1 and N2 
neuraminidases. Resistance mutations tend to be viral sub-type specific. Since 2007 naturally 
occurring resistance associated with the H275Y mutation in seasonal H1N1 strains has been 
sporadically detected. The susceptibility to oseltamivir and the prevalence of such viruses appear to 
vary seasonally and geographically. In 2008, H275Y was found in > 99 % of circulating H1N1 
influenza isolates in Europe. The 2009 H1N1 influenza (“swine flu”) was almost uniformly 
susceptible to oseltamivir, with only sporadic reports of resistance in connection with both therapeutic 
and prophylactic regimens. 
 
5.2 Pharmacokinetic properties 
 
General Information 
 
Absorption 
Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of oseltamivir 
phosphate (pro-drug) and is extensively converted by predominantly hepatic esterases to the active 
metabolite (oseltamivir carboxylate). At least 75 % of an oral dose reaches the systemic circulation as 
the active metabolite. Exposure to the pro-drug is less than 5 % relative to the active metabolite. 
Plasma concentrations of both pro-drug and active metabolite are proportional to dose and are 
unaffected by co-administration with food. 
 
Distribution 
The mean volume of distribution at steady state of the oseltamivir carboxylate is approximately 
23 litres in humans, a volume equivalent to extracellular body fluid. Since neuraminidase activity is 
extracellular, oseltamivir carboxylate distributes to all sites of influenza virus spread. 
 
The binding of the oseltamivir carboxylate to human plasma protein is negligible (approximately 3 %). 
 
Biotransformation 
Oseltamivir is extensively converted to oseltamivir carboxylate by esterases located predominantly in 
the liver. In vitro studies demonstrated that neither oseltamivir nor the active metabolite is a substrate 
for, or an inhibitor of, the major cytochrome P450 isoforms. No phase 2 conjugates of either 
compound have been identified in vivo. 
 
Elimination 
Absorbed oseltamivir is primarily (> 90 %) eliminated by conversion to oseltamivir carboxylate. It is 
not further metabolised and is eliminated in the urine. Peak plasma concentrations of oseltamivir 
carboxylate decline with a half-life of 6 to 10 hours in most subjects. The active metabolite is 
eliminated entirely by renal excretion. Renal clearance (18.8 l/h) exceeds glomerular filtration rate 
(7.5 l/h) indicating that tubular secretion occurs in addition to glomerular filtration. Less than 20 % of 
an oral radiolabelled dose is eliminated in faeces. 
 



18 

Other special populations 
 
Paediatric population 
 
Infants less than 1 year of age:  The pharmacokinetics, pharmacodynamics and safety of Tamiflu have 
been evaluated in two uncontrolled open-label studies including influenza infected children less than 
one year of age (n=135). The rate of clearance of the active metabolite, corrected for body-weight, 
decreases with ages below one year. Metabolite exposures are also more variable in the youngest 
infants. The available data indicates that the exposure following a 3 mg/kg dose in infants 0 -
 12 months of age provides pro-drug and metabolite exposures anticipated to be efficacious with a 
safety profile comparable to that seen in older children and adults using the approved dose (see 
sections 4.1 and 4.2).The reported adverse events were consistent with the established safety profile in 
older children.  
 
There are no data available for infants below 1 year of age for post exposure prevention of influenza. 
Prevention during an influenza epidemic in the community has not been studied in children below 12 
years of age. 
 
Post-exposure prevention of influenza in infants less than 1 year of age during a pandemic:  
Simulation of once daily dosing of 3mg/kg in infants <1 year shows an exposure in the same range or 
higher than for once daily dosing of 75 mg in adults. Exposure does not exceed that for treatment of 
infants < 1 year (3 mg/kg twice daily) and is anticipated to result in a comparable safety profile (see 
Section 4.8). No clinical studies of prophylaxis in infants aged <1 have been performed.     
 
Infants and children 1 year of age or older: The pharmacokinetics of oseltamivir have been evaluated 
in single-dose pharmacokinetic studies in infants, children and adolescents 1 to 16 years of age. 
Multiple-dose pharmacokinetics were studied in a small number of children enrolled in a clinical 
efficacy study. Younger children cleared both the pro-drug and its active metabolite faster than adults, 
resulting in a lower exposure for a given mg/kg dose. Doses of 2 mg/kg give oseltamivir carboxylate 
exposures comparable to those achieved in adults receiving a single 75 mg dose (approximately 
1 mg/kg). The pharmacokinetics of oseltamivir in children and adolescents 12 years of age or older are 
similar to those in adults. 
 
Elderly 
Exposure to the active metabolite at steady state was 25 to 35 % higher in older people (age 65 to 78 
years) compared to adults less than 65 years of age given comparable doses of oseltamivir. Half-lives 
observed in older people were similar to those seen in young adults. On the basis of drug exposure and 
tolerability, dosage adjustments are not required for older people unless there is evidence of moderate 
or severe renal impairment (creatinine clearance below 60 ml /min) (see section 4.2). 
 
Renal impairment 
Administration of 100 mg oseltamivir phosphate twice daily for 5 days to patients with various 
degrees of renal impairment showed that exposure to oseltamivir carboxylate is inversely proportional 
to declining renal function. For dosing, see section 4.2. 
 
Hepatic impairment 
In vitro studies have concluded that exposure to oseltamivir is not expected to be increased 
significantly nor is exposure to the active metabolite expected to be significantly decreased in patients 
with hepatic impairment (see section 4.2). 
 
Pregnant Women 
A pooled population pharmacokinetic analysis indicates that the Tamiflu dosage regimen described in 
Section 4.2 Posology and method of administration results in lower exposure (30% on average across 
all trimesters) to the active metabolite in pregnant women compared to non-pregnant women. The 
lower predicted exposure however, remains above inhibitoy concentrations (IC95 values) and at a 
therapeutic level for a range of influenza virus strains. In addition, there is evidence from 



19 

observational studies showing benefit of the current dosing regimen in this patient population. 
Therefore, dose adjustments are not recommended for pregnant women in the treatment  
or prophylaxis of influenza (see section 4.6 Fertility, pregnancy and lactation). 
 
Immunocompromised Patients 
Population pharmacokinetic analyses indicate that treatment of adult and paediatric (<18 years old) 
immunocompromised patients with oseltamivir (as described in Section 4.2. Posology and method of 
administration) results in an increased predicted exposure (from approximately 5% up to 50%) to the 
active metabolite when compared to non-immunocompromised patients with comparable creatinine 
clearance. Due to the wide safety margin of the active metabolite, no dose adjustments are required in 
patients due to their immunocompromised status. However, for immunocompromised patients with 
renal impairment, doses should be adjusted as outlined in section 4.2. Posology and method of 
administration.  
 
Pharmacokinetic and pharmacodynamic analyses from two studies in immunocompromised patients 
indicated that there was no meaningful additional benefit in exposures higher than those achieved after 
the administration of the standard dose.  
 
5.3 Preclinical safety data 
 
Preclinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated-dose toxicity and genotoxicity. Results of the conventional rodent 
carcinogenicity studies showed a trend towards a dose-dependent increase in the incidence of some 
tumours that are typical for the rodent strains used. Considering the margins of exposure in relation to 
the expected exposure in the human use, these findings do not change the benefit-risk of Tamiflu in its 
adopted therapeutic indications.  
 
Teratology studies have been conducted in rats and rabbits at doses of up to 1,500 mg/kg/day and 
500 mg/kg/day, respectively. No effects on foetal development were observed. A rat fertility study up 
to a dose of 1,500 mg/kg/day demonstrated no adverse reactions on either sex. In pre- and post-natal 
rat studies, prolonged parturition was noted at 1,500 mg/kg/day: the safety margin between human 
exposure and the highest no-effect dose (500 mg/kg/day) in rats is 480-fold for oseltamivir and 44-fold 
for the active metabolite, respectively. Foetal exposure in the rats and rabbits was approximately 15 to 
20 % of that of the mother. 
 
In lactating rats, oseltamivir and the active metabolite are excreted in the milk. Limited data indicate 
that oseltamivir and the active metabolite are excreted in human milk. Extrapolation of the animal data 
provides estimates of 0.01 mg/day and 0.3 mg/day for the respective compounds.  
 
A potential for skin sensitisation to oseltamivir was observed in a "maximisation" test in guinea pigs. 
Approximately 50 % of the animals treated with the unformulated active substance showed erythema 
after challenging the induced animals. Reversible irritancy of rabbits' eyes was detected.  
 
Whereas very high oral single doses of oseltamivir phosphate salt, up to the highest dose tested 
(1,310 mg/kg), had no adverse reactions in adult rats, such doses resulted in toxicity in juvenile 7-day-
old rat pups, including death. These reactions were seen at doses of 657 mg/kg and higher. At 
500 mg/kg, no adverse reactions were seen, including upon chronic treatment (500 mg/kg/day 
administered from 7 to 21 days post partum). 
 
 



20 

6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tamiflu 30 mg hard capsules 
Capsule core 
Pregelatinised starch (derived from maize starch) 
Talc 
Povidone 
Croscarmellose sodium 
Sodium stearyl fumarate 
 
Capsule shell 
Gelatin 
Yellow iron oxide (E172) 
Red iron oxide (E172) 
Titanium dioxide (E171) 
 
Printing ink 
Shellac 
Titanium dioxide (E171) 
FD and C Blue 2 (indigo carmine, E132) 
 
Tamiflu 45 mg hard capsules 
Capsule core 
Pregelatinised starch (derived from maize starch) 
Talc 
Povidone 
Croscarmellose sodium 
Sodium stearyl fumarate 
 
Capsule shell 
Gelatin 
Black iron oxide (E172) 
Titanium dioxide (E171) 
 
Printing ink 
Shellac 
Titanium dioxide (E171) 
FD and C Blue 2 (indigo carmine, E132) 
 
Tamiflu 75 mg hard capsules 
Capsule core 
Pregelatinised starch (derived from maize starch) 
Talc 
Povidone 
Croscarmellose sodium 
Sodium stearyl fumarate 
 
Capsule shell 
Gelatin 
Yellow iron oxide (E172) 
Red iron oxide (E172) 
Black iron oxide (E172) 
Titanium dioxide (E171) 
 



21 

Printing ink 
Shellac 
Titanium dioxide (E171) 
FD and C Blue 2 (indigo carmine, E132) 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
Tamiflu 30 mg hard capsules 
10 years 
 
Tamiflu 45 mg hard capsules 
10 years 
 
Tamiflu 75 mg hard capsules 
10 years 
 
Storage of the pharmacy compounded suspension 
Shelf life of 10 days when stored below 25 °C. 
 
6.4 Special precautions for storage 
 
Do not store above 25 ∞C. 
 
For storage conditions of the pharmacy compounded suspension, see section 6.3. 
 
6.5 Nature and contents of container 
 
Triplex blister pack (PVC/PE/PVDC, sealed with aluminium foil). 
Pack-size 10 capsules. 
 
6.6 Special precautions for disposal and other handling 
 
Any unused product or waste material should be disposed of in accordance with local requirements.  
 
Extemporaneous formulation 
 
When Tamiflu powder for oral suspension is not available 
Commercially manufactured Tamiflu for oral suspension (6 mg/ml) is the preferred product for 
paediatric and adult patients who have difficulties swallowing capsules or where lower doses are 
needed.  In the event that commercially manufactured Tamiflu powder for oral suspension is not 
available, the pharmacist may compound a suspension (6 mg/ml) from Tamiflu capsules or patients 
can prepare the suspension from capsules at home. 
 
The pharmacy preparation should be preferred to home preparation. Detailed information on the home 
preparation can be found in the package leaflet of Tamiflu capsules under “Making liquid Tamiflu at 
home”. 
 
Syringes of appropriate volume and grading should be provided for administering the pharmacy 
compounded suspension as well as for the procedures involved in the home preparation. In both cases, 
the correct volumes should preferably be marked on the syringes. 
 



22 

Pharmacy compounding 
 
Pharmacy compounded 6 mg/ml suspension prepared from capsules  
 
Adults, adolescents and infants and children 1 year of age or older who are unable to swallow intact 
capsules 
This procedure describes the preparation of a 6 mg/ml suspension that will provide one patient with 
enough medicine for a 5-day course of treatment or a 10-day course of prophylaxis. For 
immunocompromised patients, a 10-day course of treatment is needed. 
 
The pharmacist may compound a 6 mg/ml suspension from Tamiflu 30 mg, 45 mg or 75 mg capsules 
using water containing 0.05 % w/v sodium benzoate added as a preservative. 
 
First, calculate the total volume needed to be compounded and dispensed to provide a 5-day course of 
treatment or a 10-day course of prophylaxis for the patient. The total volume required is determined by 
the weight of the patient according to the recommendation in the table below. To allow for accurate 
volume withdrawal of up to 10 doses (2 withdrawals per daily treatment dose for 5 days), the column 
indicating measurement loss is to be considered for compounding. 
 
For immunocompromised patients, calculate the total volume needed to be compounded and dispensed 
to provide a 10-day course of treatment for the patient. The total volume needed is indicated in the 
table below for immunocompromised patients and is determined by the patient’s weight. To allow for 
accurate volume withdrawal of up to 20 doses (2 withdrawals per daily treatment dose for 10 days), 
the column indicating measurement loss is to be considered for compounding. 
 
Volume of pharmacy compounded 6 mg/ml suspension prepared based upon the patient’s 
weight for 5-day treatmentor 10-day prophylaxis course  
 

Body 
weight 

(kg) 

Total volume to compound  
per patient weight 

(ml) 
Measurement loss not considered 

Total volume to compound  
per patient weight 

(ml) 
Measurement loss considered 

 
10 kg to 15 

kg 
50 ml 60 ml or 75 ml* 

> 15 kg to 
23 kg 

75 ml 90 ml or 100 ml* 

> 23 kg to 
40 kg 

100 ml 125 ml 

> 40 kg 125 ml 137.5 ml (or 150 ml)* 
* Depending on the capsule strength used. 



23 

 
Volume of pharmacy compounded 6 mg/ml suspension prepared based upon the patient’s 
weight for 10-days of treatment for immunocompromised patients 
 

Body 
weight 

(kg) 

Total volume to compound  
per patient weight 

(ml) 
Measurement loss not considered 

Total volume to compound  
per patient weight 

(ml) 
Measurement loss considered 

 
10 kg to 15 

kg 
100 ml 125 ml 

> 15 kg to 
23 kg 

150 ml 187.5 ml 

> 23 kg to 
40 kg 

200 ml 250 ml 

> 40 kg 250 ml 300 ml 
 
Second, determine the number of capsules and the amount of vehicle (water containing 0.05 % w/v 
sodium benzoate added as a preservative) that is needed to prepare the total volume (calculated from 
the table above) of pharmacy compounded 6 mg/ml suspension as shown in the table below:  
 
Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy 
compounded 6 mg/ml suspension (for 5 days of treatment or 10-days of prophylaxis) 
 

Total volume 
of compounded 

suspension 
to be prepared 

Required number of Tamiflu capsules 
(mg of oseltamivir) 

Required volume 
of vehicle 75 mg 45 mg 30 mg 

60 ml Please use 
alternative 

capsule 
strength* 

8 capsules 
(360 mg) 

12 capsules 
(360 mg) 

59.5 ml 

75 ml 6 capsules 
(450 mg) 

10 capsules 
(450 mg) 

15 capsules 
(450 mg) 

74 ml 

90 ml Please use 
alternative 

capsule 
strength* 

12 capsules 
(540 mg) 

18 capsules 
(540 mg) 

89 ml 

100 ml 8 capsules 
(600 mg) 

Please use 
alternative 

capsule 
strength* 

20 capsules 
(600 mg) 

98.5 ml 

125 ml 10 capsules 
(750 mg) 

Please use 
alternative 

capsule 
strength* 

25 capsules 
(750 mg) 

123.5 ml 

137.5 ml 11 capsules 
(825 mg) 

Please use 
alternative 

capsule 
strength* 

Please use 
alternative 

capsule 
strength* 

136 ml 

* There is no combination of this capsule strength that can be used to achieve the target concentration; therefore, 
please use an alternative capsule strength. 

 



24 

Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy 
compounded 6 mg/ml suspension (for 10 days of treatment in immunocompromised patients) 
 

Total volume 
of compounded 

suspension 
to be prepared 

Required number of Tamiflu capsules 
(mg of oseltamivir) 

Required volume 
of vehicle 75 mg 45 mg 30 mg 

125ml 10 capsules 
(750 mg) 

Please use 
alternative 

capsule 
strength* 

25 capsules 
(750 mg) 

123.5 ml 

187.5ml 15 capsules 
(1120 mg) 

25 capsules 
(1120 mg) 

Please use 
alternative 

capsule 
strength* 

185 ml 

250ml 20 capsules 
(1500 mg) 

Please use 
alternative 

capsule 
strength* 

50 capsules 
(1500 mg) 

246.5 ml 

300ml 24 capsules 
(1800 mg) 

40 capsules 
(1800 mg) 

60 capsules 
(1800 mg) 

296 ml 

* There is no combination of this capsule strength that can be used to achieve the target concentration; therefore, 
please use an alternative capsule strength. 

 
Third, follow the procedure below for compounding the 6 mg/ml suspension from Tamiflu capsules: 
1. In a glass beaker of suitable size place the stated amount of water containing 0.05 % w/v 

sodium benzoate added as a preservative. 
2. Open the stated amount of Tamiflu capsules and transfer the content of each capsule directly to 

the preserved water in the glass beaker.  
3. With a suitable stirring device, stir for 2 minutes. 
 (Note: The drug substance, oseltamivir phosphate, readily dissolves in water. The suspension is 

caused by some of the excipients of Tamiflu capsules, which are insoluble.) 
4. Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle. 

A funnel may be used to eliminate any spillage. 
5. Close the bottle using a child-resistant cap. 
6. Put an ancillary label on the bottle indicating “Shake Gently Before Use”. 
 (Note: This compounded suspension should be gently shaken prior to administration to 

minimise the tendency for air entrapment.) 
7. Instruct the parent or caregiver that any remaining material following completion of therapy 

must be discarded. It is recommended that this information be provided by either affixing an 
ancillary label to the bottle or adding a statement to the pharmacy label instructions. 

8. Place an appropriate expiration date label according to storage condition (see section 6.3).  
 
Place a pharmacy label on the bottle that includes the patient’s name, dosing instructions, use by date, 
name of medicinal product and any other required information to be in compliance with local 
pharmacy regulations. Refer to the table below for the proper dosing instructions. 
 



25 

Dosing chart for pharmacy-compounded 6 mg/ml suspension prepared from Tamiflu capsules 
for patients 1 year of age or older 
 

Body 
weight 

(kg) 
Dose 
(mg) 

Volume per 
dose 

6 mg/ml 
Treatment dose 

(for 5 days) 

Treatment dose 
(for 10 days*) 

Immunocompromised 
patients 

Prophylaxis dose 
(for 10 days) 

10 kg to 15 
kg 

30 mg 5 ml 5 ml twice daily 5 ml twice daily 5 ml once daily 

> 15 kg to 
23 kg 

45 mg 7.5 ml 7.5 ml twice daily 7.5 ml twice daily 7.5 ml once daily 

> 23 kg to 
40 kg 

60 mg 10 ml 10 ml twice daily 10 ml twice daily 10 ml once daily 

> 40 kg  75 mg 12.5 ml 12.5 ml twice daily 12.5 ml twice daily 12.5 ml once daily 
*The recommended duration in immunocompromised patients (≥1 year of age) is 10 days.   See Special Populations, 
Immunocompromised Patients for more information. 
 
Dispense the pharmacy compounded suspension with a graduated oral syringe for measuring small 
amounts of suspension. If possible, mark or highlight the graduation corresponding to the appropriate 
dose (according to the dosing table above) on the oral syringe for each patient. 
 
The appropriate dose must be mixed by the caregiver with an equal quantity of sweet liquid food, such 
as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce) to mask 
the bitter taste. 
 
Infants less than 1 year of age 
This procedure describes the preparation of a 6 mg/ml suspension that will provide one patient with 
enough medication for a 5-day course of treatment or a 10-day course of prophylaxis.  For 
immunocompromised patients, a 10-day course of treatment for the patient is needed. 
 
The pharmacist may compound a 6 mg/ml suspension from Tamiflu 30 mg, 45 mg or 75 mg capsules 
using water containing 0.05 % w/v sodium benzoate added as a preservative. 
 
First, calculate the total volume needed to be compounded and dispensed for each patient. The total 
volume required is determined by the weight of the patient according to the recommendation in the 
table below. To allow for accurate volume withdrawal of up to 10 doses (2 withdrawals per daily 
treatment dose for 5 days), the column indicating measurement loss is to be considered for 
compounding. 
 
For immunocompromised patients, calculate the total volume needed to be compounded and dispensed 
to provide a 10-day course of treatment for the patient. The total volume needed is indicated in the 
table below and is determined by the patient’s weight. To allow for accurate volume withdrawal of up 
to 20 doses (2 withdrawals per daily treatment dose for 10 days), the column indicating measurement 
loss is to be considered for compounding. 
 
Volume of pharmacy compounded 6 mg/ml suspension prepared based upon the patient’s 
weight (for 5 days of treatment or 10-days of prophylaxis) 
 

Body weight 
(kg) 

Total volume to compound  
per patient weight 

(ml) 
Measurement loss not considered 

Total volume to compound  
per patient weight 

(ml) 
Measurement loss considered 

£ 7 kg up to 40 ml 50 ml 
> 7 kg to 10 kg 50 ml 60 ml or 75 ml* 

* Depending on the capsule strength used. 
 



26 

Volume of pharmacy compounded 6 mg/ml suspension prepared based upon the patient’s 
weight (for 10-days of treatment in immunocompromised patients) 
 

Body weight 
(kg) 

Total volume to compound  
per patient weight 

(ml) 
Measurement loss not considered 

Total volume to compound  
per patient weight 

(ml) 
Measurement loss considered 

£ 7 kg up to 80 ml 100 ml 
> 7 kg to 10 kg 100 ml 125 ml 

 
Second, determine the number of capsules and the amount of vehicle (water containing 0.05 % w/v 
sodium benzoate added as a preservative) that is needed to prepare the total volume (calculated from 
the table above) of pharmacy compounded 6 mg/ml suspension as shown in the table below:  
 
Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy 
compounded 6 mg/ml suspension (for 5 days of treatment or 10-days of prophylaxis) 
 

Total volume 
of compounded 

suspension 
to be prepared 

Required number of Tamiflu capsules 
(mg of oseltamivir) 

Required volume 
of vehicle 75 mg 45 mg 30 mg 

50 ml 4 capsules 
(300 mg) 

Please use 
alternative 

capsule 
strength* 

10 capsules 
(300 mg) 

49.5 ml 

60 ml Please use 
alternative 

capsule 
strength* 

8 capsules 
(360 mg) 

12 capsules 
(360 mg) 

59.5 ml 

75 ml 6 capsules 
(450 mg) 

10 capsules 
(450 mg) 

15 capsules 
(450 mg) 

74 ml 

* There is no combination of this capsule strength that can be used to achieve the target concentration; therefore, 
please use an alternative capsule strength. 

 
Number of capsules and amount of vehicle needed to prepare the total volume of a pharmacy 
compounded 6 mg/ml suspension (for 10-days of treatment in immunocompromised patients) 
 

Total volume 
of compounded 

suspension 
to be prepared 

Required number of Tamiflu capsules 
(mg of oseltamivir) 

Required volume 
of vehicle 75 mg 45 mg 30 mg 

100 ml 8 capsules 
(600 mg) 

Please use 
alternative 

capsule 
strength* 

20 capsules 
(600 mg) 

98.5 ml 

125 ml 10 capsules 
(750 mg) 

Please use 
alternative 

capsule 
strength* 

25 capsules 
(750 mg) 

123.5 ml 

* There is no combination of this capsule strength that can be used to achieve the target concentration; therefore, 
please use an alternative capsule strength. 

 



27 

Third, follow the procedure below for compounding the 6 mg/ml suspension from Tamiflu capsules: 
1. In a glass beaker of suitable size place the stated amount of water containing 0.05 % w/v 

sodium benzoate added as a preservative. 
2. Open the stated amount of Tamiflu capsules and transfer the content of each capsule directly to 

the preserved water in the glass beaker.  
3. With a suitable stirring device, stir for 2 minutes. 
 (Note: The drug substance, oseltamivir phosphate, readily dissolves in water. The suspension is 

caused by some of the excipients of Tamiflu capsules, which are insoluble.) 
4. Transfer the suspension to an amber glass or amber polyethyleneterephthalate (PET) bottle. 

A funnel may be used to eliminate any spillage. 
5. Close the bottle using a child-resistant cap. 
6. Put an ancillary label on the bottle indicating “Shake Gently Before Use”. 
 (Note: This compounded suspension should be gently shaken prior to administration to 

minimise the tendency for air entrapment.) 
7. Instruct the parent or caregiver that any remaining material following completion of therapy 

must be discarded. It is recommended that this information be provided by either affixing an 
ancillary label to the bottle or adding a statement to the pharmacy label instructions. 

8. Place an appropriate expiration date label according to storage condition (see section 6.3).  
 
Place a pharmacy label on the bottle that includes the patient’s name, dosing instructions, use by date, 
name of medicinal product and any other required information to be in compliance with local 
pharmacy regulations. Refer to the table below for the proper dosing instructions. 
 
Dosing chart for pharmacy compounded 6 mg/ml suspension prepared from Tamiflu capsules 
for infants less than 1 year of age  
 

Body 
Weight 

(rounded to 
the nearest 

0.5 kg) 
Dose 
(mg) 

Volume 
per dose 

(6 mg/ml) 
Treatment Dose 

(for 5 days) 

Treatment Dose 
(for 10 days*) 

Immunocompromised 
patients 

Prophylaxis Dose 
(for 10 days) 

Dispenser size 
to use 

(grading 0.1 
ml) 

3 kg 9 mg  1.5 ml 1.5 ml twice daily 1.5 ml twice daily 1.5 ml once daily 2.0 ml or 3.0 ml 
3.5 kg 10.5 mg  1.8 ml 1.8 ml twice daily 1.8 ml twice daily 1.8 ml once daily 2.0 ml or 3.0 ml 
4 kg 12 mg  2.0 ml 2.0 ml twice daily 2.0 ml twice daily 2.0 ml once daily 3.0 ml 

4.5 kg 13.5 mg  2.3 ml 2.3 ml twice daily 2.3 ml twice daily 2.3 ml once daily 3.0 ml 
5 kg 15 mg  2.5 ml 2.5 ml twice daily 2.5 ml twice daily 2.5 ml once daily 3.0 ml 

5.5 kg 16.5 mg  2.8 ml 2.8 ml twice daily 2.8 ml twice daily 2.8 ml once daily 3.0 ml 
6 kg 

18 mg 3.0 ml 3.0 ml twice daily 3.0 ml twice daily 3.0 ml once daily 
3.0 ml (or 5.0 

ml) 
6.5 kg 19.5 mg 3.3 ml 3.3 ml twice daily 3.3 ml twice daily 3.3 ml once daily 5.0 ml 
7 kg 21 mg 3.5 ml 3.5ml twice daily 3.5ml twice daily 3.5 ml once daily 5.0 ml 

7.5 kg 22.5 mg 3.8 ml 3.8 ml twice daily 3.8 ml twice daily 3.8 ml once daily 5.0 ml 
8 kg 24 mg 4.0 ml 4.0 ml twice daily 4.0 ml twice daily 4.0 ml once daily 5.0 ml 

8.5 kg 25.5 mg 4.3 ml 4.3 ml twice daily 4.3 ml twice daily 4.3 ml once daily 5.0 ml 
9 kg 27 mg 4.5 ml 4.5 ml twice daily 4.5 ml twice daily 4.5 ml once daily 5.0 ml 

9.5 kg 28.5 mg 4.8 ml 4.8 ml twice daily 4.8 ml twice daily 4.8 ml once daily 5.0 ml 
10 kg 30 mg 5.0 ml 5.0 ml twice daily 5.0 ml twice daily 5.0 ml once daily 5.0 ml 

* The recommended duration in immunocompromised infants (0-12 months old) is 10 days.  See Special Populations, 
Immunocompromised Patients for more information. 
 
Dispense the pharmacy compounded suspension with a graduated oral syringe for measuring small 
amounts of suspension. If possible, mark or highlight the graduation corresponding to the appropriate 
dose (according to the dosing tables above) on the oral syringe for each patient. 
 
The appropriate dose must be mixed by the caregiver with an equal quantity of sweet liquid food, such 
as sugar water, chocolate syrup, cherry syrup, dessert toppings (like caramel or fudge sauce) to mask 
the bitter taste. 



28 

 
Home preparation 
 
When commercially manufactured Tamiflu oral suspension is not available, a pharmacy compounded 
suspension prepared from Tamiflu capsules must be used (see detailed instructions above). If the 
commercially manufactured Tamiflu oral suspension and the pharmacy compounded suspension is 
also not available, Tamiflu suspension may be prepared at home.  
 
When appropriate capsule strengths are available for the dose needed, the dose is given by opening the 
capsule and mixing its contents with no more than one teaspoon of a suitable sweetened food product. 
The bitter taste can be masked by products such as sugar water, chocolate syrup, cherry syrup, dessert 
toppings (like caramel or fudge sauce). The mixture should be stirred and given entirely to the patient. 
The mixture must be swallowed immediately after its preparation. 
 
When only 75 mg capsules are available, and doses of 30 mg or 45 mg are needed, the preparation of 
Tamiflu suspension involves additional steps. Detailed instructions can be found in the package leaflet 
of Tamiflu capsules under “Making liquid Tamiflu at home”. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
Tamiflu 30 mg hard capsules 
EU/1/02/222/003 
 
Tamiflu 45 mg hard capsules 
EU/1/02/222/004 
 
Tamiflu 75 mg hard capsules 
EU/1/02/222/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 June 2002 
Date of last renewal: 22 May 2012 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
 



29 

1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 6 mg/ml powder for oral suspension 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml of reconstituted suspension contains oseltamivir phosphate equivalent to 6 mg of oseltamivir. 
One bottle of reconstituted suspension (65 ml) contains 390 mg of oseltamivir. 
 
Excipients with known effect: 
5 ml oseltamivir suspension delivers 0.9 g of sorbitol. 
7.5 ml oseltamivir suspension delivers 1.3 g of sorbitol. 
10 ml oseltamivir suspension delivers 1.7 g of sorbitol. 
12.5 ml oseltamivir suspension delivers 2.1 g of sorbitol. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder for oral suspension 
The powder is a granulate or clumped granulate with a white to light yellow colour. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment of influenza 
Tamiflu is indicated in adults and children including full term neonates who present with symptoms 
typical of influenza, when influenza virus is circulating in the community. Efficacy has been 
demonstrated when treatment is initiated within two days of first onset of symptoms.  
 
Prevention of influenza  
- Post-exposure prevention in individuals 1 year of age or older following contact with a 

clinically diagnosed influenza case when influenza virus is circulating in the community. 
 
- The appropriate use of Tamiflu for prevention of influenza should be determined on a case by 

case basis by the circumstances and the population requiring protection. In exceptional 
situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a 
pandemic situation) seasonal prevention could be considered in individuals one year of age or 
older.  

 
- Tamiflu is indicated for post-exposure prevention of influenza in infants less than 1 year of age 

during a pandemic influenza outbreak (see section 5.2). 
 
Tamiflu is not a substitute for influenza vaccination. 
 
The use of antivirals for the treatment and prevention of influenza should be determined on the basis 
of official recommendations. Decisions regarding the use of oseltamivir for treatment and prophylaxis 
should take into consideration what is known about the characteristics of the circulating influenza 
viruses, available information on influenza drug susceptibility patterns for each season and the impact 
of the disease in different geographical areas and patient populations (see section 5.1). 
 



30 

4.2 Posology and method of administration 
 
Posology 
 
Tamiflu suspension and Tamiflu hard capsules are bioequivalent formulations. 75 mg doses can be 
administered as either  
- one 75 mg capsule or  
- one 30 mg capsule plus one 45 mg capsule or  
- by administering one 30 mg dose plus one 45 mg dose of suspension.  
 
Adults, adolescents or children (> 40 kg) who are able to swallow capsules may receive appropriate 
doses of Tamiflu capsules.  
 
Treatment 
Treatment should be initiated as soon as possible within the first two days of onset of symptoms of 
influenza.  
 
For adolescents (13 to 17 years of age) and adults: The recommended oral dose is 75 mg oseltamivir 
twice daily for 5 days (or 10 days in immunocompromised patients). 
 
Paediatric population 
 
For infants and children1 year of age or older: The recommended dose of Tamiflu 6 mg/ml oral 
suspension is indicated in the table below. Tamiflu 30 mg and 45 mg capsules are available as an 
alternative to the recommended dose of Tamiflu 6 mg/ml suspension.  
 
The following weight-adjusted dosing regimens are recommended for infants and children 1 year of 
age or older: 
 

Body weight 
Recommended dose for 

5 days 

Recommended dose for 
10 days* 

Immunocompromised 
Patients 

Amount of oral 
suspension to withdraw 

10 kg to 15 kg 30 mg twice daily 30 mg twice daily 5 ml twice daily 
> 15 kg to 23 kg 45 mg twice daily 45 mg twice daily 7.5 ml twice daily 
> 23 kg to 40 kg 60 mg twice daily 60 mg twice daily 10 ml twice daily 
> 40 kg 75 mg twice daily 75 mg twice daily 12.5 ml twice daily 

*The recommended duration in immunocompromised patients (≥1 year old) is 10 days.  See Special Populations, 
Immunocompromised Patients for more information. 
 
Children weighing > 40 kg and who are able to swallow capsules may receive treatment with the adult 
dosage of 75 mg capsules twice daily for 5 days as an alternative to the recommended dose of Tamiflu 
suspension. 
 
For infants less than 1 year of age: The recommended treatment dose for infants 0 - 12 months of age 
is 3 mg/kg twice daily. This is based upon pharmacokinetic and safety data indicating that this dose in 
infants 0 - 12 months provides plasma concentrations of the pro-drug and active metabolite that are 
anticipated to be clinically efficacious with a safety profile comparable to that seen in older children 
and adults (see section 5.2). 
 



31 

A 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing children 0 - 12 months of 
age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension. For higher doses the 10 ml syringe 
should be used. The following dosing regimen is recommended for treatment of infants below 1 year 
of age: 
 
Dosing table of oseltamivir for children less than 1 year of age : 3 mg/kg twice daily 
 

Body 
Weight*  

Recommended dose 
for 5 days 

Recommended dose for 
10 days** 

Immunocompromised 
patients 

Amount of oral 
suspension to 

withdraw 

Dispenser size 
to use 

3 kg 9 mg twice daily 9 mg twice daily 1.5 ml twice daily 3 ml 
3.5 kg 10.5 mg twice daily 10.5 mg twice daily 1.8 ml twice daily 3 ml 
4 kg 12 mg twice daily 12 mg twice daily 2.0 ml twice daily 3 ml 

4.5 kg 13.5 mg twice daily 13.5 mg twice daily 2.3 ml twice daily 3 ml 
5 kg 15 mg twice daily 15 mg twice daily 2.5 ml twice daily 3 ml 

5.5 kg 16.5 mg twice daily 16.5 mg twice daily 2.8 ml twice daily 3 ml 
6 kg 18 mg twice daily 18 mg twice daily 3.0 ml twice daily 3 ml 

> 6 - 7 kg 21 mg twice daily 21 mg twice daily 3.5 ml twice daily 10 ml 
> 7 - 8 kg 24 mg twice daily 24 mg twice daily 4.0 ml twice daily 10 ml 
> 8 - 9 kg 27 mg twice daily 27 mg twice daily 4.5 ml twice daily 10 ml 

> 9 - 10 kg 30 mg twice daily 30 mg twice daily 5.0 ml twice daily 10 ml 
* This table is not intended to contain all possible weights for this population.  
**The recommended duration in immunocompromised infants (0-12 months old) is 10 days.  See Special Populations, 
Immunocompromised Patients for more information. 
 
This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual 
age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may 
be required due to the immaturity of physiological functions. 
 
Prevention 
Post-exposure prevention 
For adolescents (13 to 17 years of age) and adults: The recommended dose for prevention of influenza 
following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days. 
Therapy should begin as soon as possible within two days of exposure to an infected individual.  
 
For infants and children 1 year of age or older: Tamiflu 30 mg and 45 mg capsules are available as an 
alternative to the recommended dose of Tamiflu 6 mg/ml suspension.  
 
The recommended post-exposure prevention dose of Tamiflu is: 
 

Body weight Recommended dose for 
10 days 

Immunocompromised 
Patients  

Recommended dose for 
10 days 

 

Amount of oral 
suspension to withdraw   

10 kg to 15 kg 30 mg once daily 30 mg once daily 5 ml once daily 
> 15 kg to 23 kg 45 mg once daily 45 mg once daily 7.5 ml once daily 
> 23 kg to 40 kg 60 mg once daily 60 mg once daily 10 ml once daily 
> 40 kg 75 mg once daily 75 mg once daily 12.5 ml once daily 

 
Children weighing > 40 kg and who are able to swallow capsules may receive prophylaxis with a 
75 mg capsule once daily for 10 days as an alternative to the recommended dose of Tamiflu 
suspension. 
 
For infants less than 1 year of age: The recommended prophylaxis dose for infants less than 12 months 
during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon clinical 



32 

data in children > 1 year of age and adults showing that a prophylaxis dose equivalent to half the daily 
treatment dose is clinically efficacious for the prevention of influenza (see Section 5.2 for exposure 
simulation).  
 
In case of a pandemic, a 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing 
children below 1 year of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension. For higher 
doses the 10 ml syringe should be used.   
 
The following dosing regimen is recommended for infants less than 1 year of age: 
 
Dosing table of oseltamivir for children below one year of age: 3 mg/kg once daily 
 

Body 
Weight*  

Recommended dose 
for 10 days 

Immunocompromised 
Patients  

Recommended dose for 10 
days 

 

Amount of oral 
suspension to 

withdraw 

Dispenser size 
to use 

3 kg 9 mg once daily 9 mg once daily 1.5 ml once daily 3 ml 
3.5 kg 10.5 mg once daily 10.5 mg once daily 1.8 ml once daily 3 ml 
4 kg 12 mg once daily 12 mg once daily 2.0 ml once daily 3 ml 

4.5 kg 13.5 mg once daily 13.5 mg once daily 2.3 ml once daily 3 ml 
5 kg 15 mg once daily 15 mg once daily 2.5 ml once daily 3 ml 

5.5 kg 16.5 mg once daily 16.5 mg once daily 2.8 ml once daily 3 ml 
6 kg 18 mg once daily 18 mg once daily 3.0 ml once daily 3 ml 

> 6 - 7 kg 21 mg once daily 21 mg once daily 3.5 ml once daily 10 ml 
> 7 - 8 kg 24 mg once daily 24 mg once daily 4.0 ml once daily 10 ml 
> 8 - 9 kg 27 mg once daily 27 mg once daily 4.5 ml once daily 10 ml 

> 9 - 10 kg 30 mg once daily 30 mg once daily 5.0 ml once daily  10 ml 
* This table is not intended to contain all possible weights for this population.  
 
This dosing recommendation is not intended for premature infants, i.e. those with a post-conceptual 
age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may 
be required due to the immaturity of physiological functions. 
 
Prevention during an influenza epidemic in the community 
Prevention during an influenza epidemic has not been studied in children below 12 years of age. The 
recommended dose for adults and adolescents for prevention of influenza during a community 
outbreak is 75 mg oseltamivir once daily for up to 6 weeks (or up to 12 weeks in 
immunocompromised patients).  
 
Special populations 
 
Hepatic impairment 
No dose adjustment is required either for treatment or for prevention in patients with hepatic 
dysfunction. No studies have been carried out in paediatric patients with hepatic disorder. 
 



33 

Renal impairment  
Treatment of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years of 
age) with moderate or severe renal impairment. Recommended doses are detailed in the table below. 
 

Creatinine clearance  Recommended dose for treatment 
> 60 (ml/min) 75 mg twice daily 

> 30 to 60 (ml/min) 30 mg (suspension or capsules) twice daily 
> 10 to 30 (ml/min) 30 mg (suspension or capsules) once daily 

£ 10 (ml/min)  Not recommended (no data available) 
Haemodialysis patients 30 mg after each haemodialysis session 

Peritoneal dialysis patients* 30 mg (suspension or capsules) single dose 
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of 

oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used. 
Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist. 

 
Prevention of influenza: Dose adjustment is recommended for adults and adolescents (13 to 17 years 
of age) with moderate or severe renal impairment as detailed in the table below. 
 

Creatinine clearance  Recommended dose for prevention 
> 60 (ml/min) 75 mg once daily 

> 30 to 60 (ml/min) 30 mg (suspension or capsules) once daily 
> 10 to 30 (ml/min) 30 mg (suspension or capsules) every second day 

£ 10 (ml/min)  Not recommended (no data available) 
Haemodialysis patients 30 mg after every second haemodialysis session 

Peritoneal dialysis patients* 30 mg (suspension or capsules) once weekly 
* Data derived from studies in continuous ambulatory peritoneal dialysis (CAPD) patients; the clearance of 

oseltamivir carboxylate is expected to be higher when automated peritoneal dialysis (APD) mode is used. 
Treatment mode can be switched from APD to CAPD if considered necessary by a nephrologist. 

 
There is insufficient clinical data available in infants and children (12 years of age and younger) with 
renal impairment to be able to make any dosing recommendation. 
 
Elderly 
No dose adjustment is required, unless there is evidence of moderate or severe renal impairment. 
 
Immunocompromised patients  
Treatment:   For treatment of influenza, the recommended duration for immunocompromised patients 
is 10 days (see sections 4.4, 4.8, 5.1).  No dose adjustment is necessary. Treatment should be initiated 
as soon as possible within the first two days of onset of symptoms of influenza. 
 
Seasonal prophylaxis: Longer duration of seasonal prophylaxis up to 12 weeks has been evaluated in 
immunocompromised patients (see sections 4.4, 4.8 and 5.1). 
 
Method of administration 
For dosing, a 3 ml and 10 ml oral dispenser is provided in the box.  
It is recommended that Tamiflu powder for oral suspension be constituted by a pharmacist prior to 
dispensing to the patient (see section 6.6). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for 
efficacy of oseltamivir in any illness caused by agents other than influenza viruses (see section 5.1).  
 



34 

Tamiflu is not a substitute for influenza vaccination. Use of Tamiflu must not affect the evaluation of 
individuals for annual influenza vaccination. The protection against influenza lasts only as long as 
Tamiflu is administered. Tamiflu should be used for the treatment and prevention of influenza only 
when reliable epidemiological data indicate that influenza virus is circulating in the community. 
Susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable 
(see section 5.1). Therefore, prescribers should take into account the most recent information available 
on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use 
Tamiflu. 
 
Severe concomitant condition 
No information is available regarding the safety and efficacy of oseltamivir in patients with any 
medical condition sufficiently severe or unstable to be considered at imminent risk of requiring 
hospitalisation.  
 
Immunocompromised patients 
The efficacy of oseltamivir in either treatment or prophylaxis of influenza in immunocompromised 
patients has not been firmly established(see section 5.1).  
 
Cardiac / respiratory disease 
Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory 
disease has not been established. No difference in the incidence of complications was observed 
between the treatment and placebo groups in this population (see section 5.1). 
 
Paediatric population 
No data allowing a dose recommendation for premature children (<36 weeks post-conceptual age) are 
currently available. 
 
Severe renal impairment 
Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of 
age) and adults with severe renal impairment. There is insufficient clinical data available in infants and 
children (1 year of age or older) with renal impairment to be able to make any dosing recommendation 
(see sections 4.2 and 5.2). 
 
Neuropsychiatric events 
Neuropsychiatric events have been reported during administration of Tamiflu in patients with 
influenza, especially in children and adolescents. These events are also experienced by patients with 
influenza without oseltamivir administration. Patients should be closely monitored for behavioural 
changes, and the benefits and risks of continuing treatment should be carefully evaluated for each 
patient (see section 4.8). 
 
This medicinal product contains sorbitol. Patients with rare hereditary problems of fructose intolerance 
should not take this medicine. 
Sorbitol can have a mild laxative effect. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of 
the CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant drug 
interactions via these mechanisms are unlikely. 
 
Probenecid 
No dose adjustment is required when co-administering with probenecid in patients with normal renal 
function. Co-administration of probenecid, a potent inhibitor of the anionic pathway of renal tubular 
secretion, results in an approximate 2-fold increase in exposure to the active metabolite of oseltamivir.  
 



35 

Amoxicillin 
Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway, 
suggesting that oseltamivir interaction with this pathway is weak.  
 
Renal elimination 
Clinically important drug interactions involving competition for renal tubular secretion are unlikely, 
due to the known safety margin for most of these substances, the elimination characteristics of the 
active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of 
these pathways. However, care should be taken when prescribing oseltamivir in subjects when taking 
co-excreted agents with a narrow therapeutic margin (e.g. chlorpropamide, methotrexate, 
phenylbutazone). 
 
Additional information 
No pharmacokinetic interactions between oseltamivir or its major metabolite have been observed 
when co-administering oseltamivir with paracetamol, acetylsalicylic acid, cimetidine, antacids 
(magnesium and aluminium hydroxides and calcium carbonates), rimantadine or warfarin (in subjects 
stable on warfarin and without influenza). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
Influenza is associated with adverse pregnancy and foetal outcomes, with a risk of major congenital 
malformations, including congenital heart defects. A large amount of data on oseltamivir exposure of 
pregnant women from post-marketing reports and observational studies (more than 1000 exposed 
outcomes during the first trimester) indicate no malformative nor feto/neonatal toxicity by oseltamivir.  
 
However, in one observational study, while the overall malformation risk was not increased, the 
results for major congenital heart defects diagnosed within 12 months of birth were not conclusive. In 
this study, the rate of major congenital heart defects following oseltamivir exposure during the first 
trimester was 1.76% (7 infants out of 397 pregnancies) compared to 1.01% in unexposed pregnancies 
from the general population (Odds Ratio 1.75, 95% Confidence Interval 0.51 to 5.98). The clinical 
significance of this finding is not clear, as the study had limited power. Additionally, this study was 
too small to reliably assess individual types of major malformations; moreover women exposed to 
oseltamivir and women unexposed could not be made fully comparable, in particular whether or not 
they had influenza. 
 
Animal studies do not indicate reproductive toxicity (see section 5.3). 
 
The use of Tamiflu may be considered during pregnancy if necessary and after considering the 
available safety and benefit information (for data on benefit in pregnant women please refer to section 
5.1 “Treatment of influenza in pregnant women”), and the pathogenicity of the circulating influenza 
virus strain. 
 
Breastfeeding 
In lactating rats, oseltamivir and the active metabolite are excreted in milk. Very limited information is 
available on children breast-fed by mothers taking oseltamivir and on excretion of oseltamivir in 
breast milk. Limited data demonstrated that oseltamivir and the active metabolite were detected in 
breast milk, however the levels were low, which would result in a subtherapeutic dose to the infant. 
Considering this information, the pathogenicity of the circulating influenza virus strain and the 
underlying condition of the breastfeeding woman, administration of oseltamivir may be considered, 
where there are clear potential benefits to breastfeeding mothers. 
 
Fertility 
Based on preclinical data, there is no evidence that Tamiflu has an effect on male or female fertility 
(see section 5.3). 
 



36 

4.7 Effects on ability to drive and use machines 
 
Tamiflu has no influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The overall safety profile of Tamiflu is based on data from 6049 adult/adolescent and 1473 paediatric 
patients treated with Tamiflu or placebo for influenza, and on data from 3990 adult/adolescent and 253 
paediatric patients receiving Tamiflu or placebo/no treatment for the prophylaxis of influenza in 
clinical trials. In addition, 245 immunocompromised patients (including 7 adolescents and 39 children) 
received Tamiflu for the treatment of influenza and 475 immunocompromised patients (including 18 
children, of these 10 Tamiflu and 8 placebo) received Tamiflu or placebo for the prophylaxis of 
influenza. 
 
In adults/adolescents, the most commonly reported adverse reactions (ARs) were nausea and vomiting 
in the treatment studies, and nausea in the prevention studies. The majority of these ARs were reported 
on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 
days. In children, the most commonly reported adverse reaction was vomiting. In the majority of 
patients, these ARs did not lead to discontinuation of Tamiflu. 
 
The following serious adverse reactions have been rarely reported since oseltamivir has been 
marketed: Anaphylactic and anaphylactoid reactions, hepatic disorders (fulminant hepatitis, hepatic 
function disorder and jaundice), angioneurotic oedema, Stevens-Johnson syndrome and toxic 
epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders.  
(Regarding neuropsychiatric disorders, see section 4.4.) 
 
Tabulated list of adverse reactions 
The ARs listed in the tables below fall into the following categories: Very common (≥ 1/10), common 
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare 
(< 1/10,000). ARs are added to the appropriate category in the tables according to the pooled analysis 
from clinical studies.  
 
Treatment and prevention of influenza in adults and adolescents:  
In adult/adolescent treatment and prevention studies, ARs that occurred the most frequently at the 
recommended dose (75  mg bid for 5  days for treatment and 75  mg od for up to 6  weeks for 
prophylaxis) are shown in Table 1. 
 
The safety profile reported in subjects who received the recommended dose of Tamiflu for prophylaxis 
(75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, 
despite a longer duration of dosing in the prophylaxis studies. 
 



37 

Table 1 Adverse reactions in studies investigating Tamiflu for treatment and prevention of 
influenza in adults and adolescents or through post-marketing surveillance 

 
System Organ 
Class (SOC) 

Adverse reactions according to frequency 
Very common Common Uncommon Rare 

Infections and 
infestations 

 Bronchitis, 
Herpes simplex, 
Nasopharyngitis, 
Upper respiratory 
tract infections, 
Sinusitis 

  

Blood and 
lymphatic 
system disorders 

   Thrombocytopenia 

Immune system 
disorders 

  Hypersensitivity 
reaction 

Anaphylactic 
reactions, 
Anaphylactoid 
reactions 

Psychiatric 
disorders 

   Agitation,  
Abnormal behaviour, 
Anxiety,  
Confusion, 
Delusions, Delirium, 
Hallucination, 
Nightmares,  
Self-injury 

Nervous system 
disorders 

Headache Insomnia Altered level of 
consciousness, 
Convulsion 

 

Eye disorders    Visual disturbance 
Cardiac 
disorders 

  Cardiac 
arrhythmia 

 

Respiratory, 
thoracic and 
mediastinal 
disorders 

 Cough,  
Sore throat, 
Rhinorrhea 

  

Gastrointestinal 
disorders 

Nausea Vomiting  
Abdominal pain 
(incl. upper 
abdominal pain), 
Dyspepsia 

 Gastrointestinal 
bleedings, 
Haemorrhagic 
colitis 

Hepatobiliary 
disorders 

  Elevated liver 
enzymes 

Fulminant hepatitis, 
Hepatic failure, 
Hepatitis 

Skin and 
subcutaneous 
tissue disorders 

  Eczema, 
Dermatitis,  
Rash,  
Urticaria 

Angioneurotic 
oedema,  
Erythema 
multiforme, 
Stevens-Johnson 
syndrome,  
Toxic epidermal 
necrolysis 

General 
disorders and 
administration 
site conditions 

 Pain  
Dizziness (incl. 
vertigo),  
Fatigue, 
Pyrexia, 
Pain in limb 

  



38 

 
Treatment and prevention of influenza in children:  
 
A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic 
children aged 6-12 years old) participated in clinical studies of oseltamivir given for the treatment of 
influenza. Of those, 851 children received treatment with oseltamivir suspension. A total of 158 
children received the recommended dose of Tamiflu once daily in a post-exposure prophylaxis study 
in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12-week 
paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10). 
 
Table 2 shows the most frequently reported ARs from paediatric clinical trials.  
 
Table 2 Adverse reactions in studies investigating Tamiflu for treatment and prevention of 

influenza in children (age/weight-based dosing [30 mg to 75 mg o.d.]) 
 
System Organ 
Class (SOC) 

Adverse reactions according to frequency 
Very common Common Uncommon Rare 

Infections and 
infestations 

 Otitis media, 
 

  

Nervous system 
disorders 

 Headache   

Eye disorders:  Conjunctivitis 
(including red 
eyes, eye 
discharge and eye 
pain) 

  

Ear and 
labyrinth 
disorders: 

 Earache Tympanic membrane 
disorder 

 

Respiratory, 
thoracic and 
mediastinal 
disorders 

Cough,  
Nasal congestion 

Rhinorrhoea   

Gastrointestinal 
disorders 

Vomiting Abdominal pain 
(incl. upper 
abdominal pain), 
Dyspepsia, 
Nausea  

  

Skin and 
subcutaneous 
tissue disorders 

  Dermatitis (including 
allergic and atopic 
dermatitis) 

 

 
Description of selected adverse reactions 
 
Psychiatric disorders and nervous system disorders 
Influenza can be associated with a variety of neurologic and behavioural symptoms which can include 
events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal 
outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur 
without obvious severe disease. 
 
In patients with influenza who were receiving Tamiflu, there have been postmarketing reports of 
convulsions and delirium (including symptoms such as altered level of consciousness, confusion, 
abnormal behaviour, delusions, hallucinations, agitation, anxiety, nightmares), in a very few cases 
resulting in self-injury or fatal outcomes. These events were reported primarily among paediatric and 
adolescent patients and often had an abrupt onset and rapid resolution. The contribution of Tamiflu to 
those events is unknown. Such neuropsychiatric events have also been reported in patients with 
influenza who were not taking Tamiflu. 



39 

 
Hepato-biliary disorders 
Hepato-biliary system disorders, including hepatitis and elevated liver enzymes in patients with 
influenza-like illness. These cases include fatal fulminant hepatitis/hepatic failure. 
 
Other special populations 
 
Paediatric population (infants less than one year of age) 
In two studies to characterise the pharmacokinetics, pharmacodynamics and safety profile of 
oseltamivir therapy in 135 influenza infected children less than one year of age, the safety profile was 
similar among age cohorts with vomiting, diarrohea and diaper rash being the most frequently reported 
adverse events (see section 5.2). Insufficient data are available for infants who have a post-conceptual 
age of less than 36 weeks. 
 
Safety information available on oseltamivir administered for treatment of influenza in infants less than 
one year of age from prospective and retrospective observational studies (comprising together more 
than 2,400 infants of that age class), epidemiological databases research and postmarketing reports 
suggest that the safety profile in infants less than one year of age is similar to the established safety 
profile of children aged one year and older. 
 
Older people and patients with chronic cardiac and/or respiratory disease 
The population included in the influenza treatment studies is comprised of otherwise healthy 
adults/adolescents and patients “at risk” (patients at higher risk of developing complications associated 
with influenza, e.g. older people and patients with chronic cardiac or respiratory disease). In general, 
the safety profile in the patients “at risk” was qualitatively similar to that in otherwise healthy 
adults/adolescents. 
 
Immunocompromised patients 
 
The treatment of influenza in immunocompromised patients were evaluated in two studies receiving 
standard dose or high dose regimens (double dose or triple dose) of Tamiflu (see section 5.1). The 
safety profile of Tamiflu observed in these studies was consistent with that observed in previous 
clinical trials where Tamiflu was administered for treatment of influenza in non-immunocompromised 
patients across all age groups (otherwise healthy patients or “at risk” patients [i.e., those with 
respiratory and/or cardiac co-morbidities]). The most frequent adverse reaction reported in 
immunocompromised children was vomiting (28%).  
 
In a 12-week prophylaxis study in 475 immunocompromised patients, including 18 children 1 to 
12 years of age and older, the safety profile in the 238 patients who received oseltamivir was 
consistent with that previously observed in Tamiflu prophylaxis clinical studies. 
 
Children with pre-existing bronchial asthma 
In general, the adverse reaction profile in children with pre-existing bronchial asthma was qualitatively 
similar to that of otherwise healthy children. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Reports of overdoses with Tamiflu have been received from clinical trials and during post-marketing 
experience. In the majority of cases reporting overdose, no adverse events were reported. 
 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


40 

Adverse events reported following overdose were similar in nature and distribution to those observed 
with therapeutic doses of Tamiflu, described in section 4.8 Undesirable effects. 
 
No specific antidote is known. 
 
Paediatric population 
Overdose has been reported more frequently for children than adults and adolescents. Caution should 
be exercised when preparing Tamiflu oral suspension and when administering Tamiflu products to 
children. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: 
J05AH02 
 
Oseltamivir phosphate is a pro-drug of the active metabolite (oseltamivir carboxylate). The active 
metabolite is a selective inhibitor of influenza virus neuraminidase enzymes, which are glycoproteins 
found on the virion surface. Viral neuraminidase enzyme activity is important both for viral entry into 
uninfected cells and for the release of recently formed virus particles from infected cells, and for the 
further spread of infectious virus in the body. 
 
Oseltamivir carboxylate inhibits influenza A and B neuraminidases in vitro. Oseltamivir phosphate 
inhibits influenza virus infection and replication in vitro. Oseltamivir given orally inhibits influenza A 
and B virus replication and pathogenicity in vivo in animal models of influenza infection at antiviral 
exposures similar to that achieved in man with 75 mg twice daily. 
 
Antiviral activity of oseltamivir was supported for influenza A and B by experimental challenge 
studies in healthy volunteers.  
 
Neuraminidase enzyme IC50 values for oseltamivir for clinically isolated influenza A ranged from 
0.1 nM to 1.3 nM, and for influenza B was 2.6 nM. Higher IC50 values for influenza B, up to a 
median of 8.5 nM, have been observed in published studies. 
 
Clinical studies 
Treatment of influenza infection 
The indication is based on clinical studies of naturally occurring influenza in which the predominant 
infection was influenza A.Oseltamivir is effective only against illnesses caused by influenza virus. 
Statistical analyses are therefore presented only for influenza-infected subjects. In the pooled 
treatment study population, which included both influenza-positive and -negative subjects (ITT), 
primary efficacy was reduced proportionally to the number of influenza-negative individuals. In the 
overall treatment population, influenza infection was confirmed in 67 % (range 46 % to 74 %) of the 
recruited patients. Of the older subjects, 64 % were influenza-positive and of those with chronic 
cardiac and/or respiratory disease 62 % were influenza-positive. In all phase III treatment studies, 
patients were recruited only during the period in which influenza was circulating in the local 
community.  
 
Adults and adolescents 13 years of age and older: Patients were eligible if they reported within 
36 hours of onset of symptoms, had fever ≥ 37.8 ∞C, accompanied by at least one respiratory symptom 
(cough, nasal symptoms or sore throat) and at least one systemic symptom (myalgia, chills/sweats, 
malaise, fatigue or headache). In a pooled analysis of all influenza-positive adults and adolescents 
(N = 2,413) enrolled into treatment studies, oseltamivir 75 mg twice daily for 5 days reduced the 
median duration of influenza illness by approximately one day from 5.2 days (95 % CI 4.9 – 5.5 days) 
in the placebo group to 4.2 days (95 % CI 4.0 – 4.4 days; p ≤ 0.0001).  
 



41 

The proportion of subjects who developed specified lower respiratory tract complications (mainly 
bronchitis) treated with antibiotics was reduced from 12.7 % (135/1,063) in the placebo group to 
8.6 % (116/1,350) in the oseltamivir treated population (p = 0.0012).  
 
Treatment of influenza in high risk populations: The median duration of influenza illness in older 
subjects (≥ 65 years) and in subjects with chronic cardiac and/or respiratory disease receiving 
oseltamivir 75 mg twice daily for 5 days was not reduced significantly. The total duration of fever was 
reduced by one day in the groups treated with oseltamivir. In  influenza-positive older people, 
oseltamivir significantly reduced the incidence of specified lower respiratory tract complications 
(mainly bronchitis) treated with antibiotics from 19 % (52/268) in the placebo group to 12 % (29/250) 
in the oseltamivir treated population (p = 0.0156).  
 
In influenza-positive patients with chronic cardiac and/or respiratory disease, the combined incidence 
of lower respiratory tract complications (mainly bronchitis) treated with antibiotics was 17 % (22/133) 
in the placebo group and 14 % (16/118) in the oseltamivir treated population (p = 0.5976).  
 
Treatment of influenza in pregnant women: No controlled clinical studies have been conducted on the 
use of oseltamivir in pregnant women, however, there is evidence from post-marketing and 
retrospective observational studies showing benefit of the current dosing regimen in this patient 
population in terms of lower morbidity/mortality. Results from pharmacokinetic analyses indicate a 
lower exposure to the active metabolite, however dose adjustments are not recommended for pregnant 
women in the treatment or prophylaxis of influenza (see section 5.2, Pharmacokinetics, Special 
Population). 
 
Treatment of influenza in children: In a study of otherwise healthy children (65 % influenza-positive) 
aged 1 to 12 years (mean age 5.3 years) who had fever (≥ 37.8 °C) plus either cough or coryza, 67 % 
of influenza-positive patients were infected with influenza A and 33 % with influenza B. Oseltamivir 
treatment, started within 48 hours of onset of symptoms, significantly reduced the time to freedom 
from illness (defined as the simultaneous return to normal health and activity and alleviation of fever, 
cough and coryza) by 1.5 days (95 % CI 0.6 – 2.2 days; p < 0.0001) compared to placebo. Oseltamivir 
reduced the incidence of acute otitis media from 26.5 % (53/200) in the placebo group to 16 % 
(29/183) in the oseltamivir treated children (p = 0.013). 
 
A second study was completed in 334 asthmatic children aged 6 to 12 years old of which 53.6 % were 
influenza-positive. In the oseltamivir treated group, the median duration of illness was not reduced 
significantly. By day 6 (the last day of treatment) FEV1 had increased by 10.8 % in the oseltamivir 
treated group compared to 4.7 % on placebo (p = 0.0148) in this population. 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Tamiflu in one or more subsets of the paediatric population in influenza. See section 4.2 for 
information on paediatric use. 
The indication in infants below the age of 1 is based upon extrapolation of efficacy data from older 
children and the recommended posology is based upon pharmacokinetic modelling data (see Section 
5.2). 
 
Treatment of influenza B infection: Overall, 15 % of the influenza-positive population were infected by 
influenza B, proportions ranging from 1 to 33 % in individual studies. The median duration of illness 
in influenza B infected subjects did not differ significantly between the treatment groups in individual 
studies. Data from 504 influenza B infected subjects were pooled across all studies for analysis. 
Oseltamivir reduced the time to alleviation of all symptoms by 0.7 days (95 % CI 0.1 – 1.6 days; 
p = 0.022) and the duration of fever (≥ 37.8 °C), cough and coryza by one day (95 % CI 0.4 – 
1.7 days; p < 0.001) compared to placebo.  
 
Treatment of influenza in immunocompromised patients: A randomized, double blind study, to 
evaluate safety and characterize the effects of oseltamivir on the development of resistant influenza 
virus (primary analysis) in influenza-infected immunocompromised patients, included 151 adult 
patients, 7 adolescents and 9 children evaluable for efficacy of oseltamivir (secondary analysis, not 



42 

powered). The study included solid organ transplant [SOT] patients, haematopoietic stem cell 
transplant [HSCT] patients, HIV positive patients with a CD4+ cell count <500 cells/mm3, patients on 
systemic immunosuppressive therapy, and those with haematological malignancy. These patients were 
randomized to be treated, within 96 hours of symptoms onset for a duration of 10 days. The treatment 
regimens were: standard dose (75mg or weight-adjusted dose for children) twice daily (73 adult 
patients, 4 adolescent patients and 4 children) or double dose (150mg or weight-adjusted dose for 
children) twice daily (78 adult patients, 3 adolescent patients and 5 children) of oseltamivir.  
 
The median time to resolution of symptoms (TTRS) for adults and adolescents was similar between 
the standard dose group (103.4 hours [95% CI 75.4-122.7]) and double dose group (107.2 hours [95% 
CI 63.9-140.0]).  The TTRS for children was variable and the interpretation is limited by the small 
sample size.The proportion of adult patients with secondary infections in the standard dose group and 
double dose group was comparable (8.2% vs 5.1%). For adolescents and children, only one patient (an 
adolescent) in the standard dose group experienced a secondary infection (bacterial sinusitis). 
 
A pharmacokinetics and pharmacodynamics study was conducted in severely immunocompromised 
children (≤12 years of age, n=30) receiving standard (75mg or weight adjusted twice daily) vs. triple 
dose (225mg or weight-adjusted dose twice daily) oseltamivir for an adaptive dosing period of 5 to 20 
days dependent on duration of viral shedding (mean treatment duration: 9 days). No patients in the 
standard dose group and 2 patients in the triple dose group reported secondary bacterial infections 
(bronchitis and sinusitis). 
 
Prevention of influenza 
The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated 
in a post-exposure prevention study in households and two seasonal prevention studies. The primary 
efficacy parameter for all of these studies was the incidence of laboratory-confirmed influenza. The 
virulence of influenza epidemics is not predictable and varies within a region and from season to 
season, therefore the number needed to treat (NNT) in order to prevent one case of influenza illness 
varies. 
 
Post-exposure prevention: In a study in contacts (12.6 % vaccinated against influenza) of an index 
case of influenza, oseltamivir 75 mg once daily was started within 2 days of onset of symptoms in the 
index case and continued for seven days. Influenza was confirmed in 163 out of 377 index cases. 
Oseltamivir significantly reduced the incidence of clinical influenza illness occurring in the contacts of 
confirmed influenza cases from 24/200 (12 %) in the placebo group to 2/205 (1 %) in the oseltamivir 
group (92 % reduction [95 % CI 6 – 16; p ≤ 0.0001]). The number needed to treat (NNT) in contacts 
of true influenza cases was 10 (95 % CI 9 – 12) and was 16 (95 % CI 15 – 19) in the whole population 
(ITT) regardless of infection status in the index case.  
 
The efficacy of oseltamivir in preventing naturally occurring influenza illness has been demonstrated 
in a post-exposure prevention study in households that included adults, adolescents, and children aged 
1 to 12 years, both as index cases and as family contacts. The primary efficacy parameter for this study 
was the incidence of laboratory-confirmed clinical influenza in the households. Oseltamivir 
prophylaxis lasted for 10 days. In the total population, there was a reduction in the incidence of 
laboratory-confirmed clinical influenza in households from 20 % (27/136) in the group not receiving 
prevention to 7 % (10/135) in the group receiving prevention (62.7 % reduction [95 % CI 26.0 – 81.2; 
p = 0.0042]). In households of influenza-infected index cases, there was a reduction in the incidence of 
influenza from 26 % (23/89) in the group not receiving prevention to 11 % (9/84) in the group 
receiving prevention (58.5 % reduction [95 % CI 15.6 – 79.6; p = 0.0114]). 
According to subgroup analysis in children at 1 to 12 years of age, the incidence of laboratory-
confirmed clinical influenza among children was significantly reduced from 19 % (21/111) in the 
group not receiving prevention to 7 % (7/104) in the group receiving prevention (64.4 % reduction 
[95 % CI 15.8 – 85.0; p = 0.0188]). Among children who were not already shedding virus at baseline, 
the incidence of laboratory-confirmed clinical influenza was reduced from 21 % (15/70) in the group 
not receiving prevention to 4 % (2/47) in the group receiving prevention (80.1 % reduction [95 % CI 
22.0 – 94.9; p = 0.0206]). The NNT for the total paediatric population was 9 (95 % CI 7 – 24) and 



43 

8 (95 % CI 6, upper limit not estimable) in the whole population (ITT) and in paediatric contacts of 
infected index cases (ITTII), respectively. 
 
Post-exposure prevention of influenza in infants less than 1 year of age during a pandemic: 
Prevention during an influenza pandemic has not been studied in controlled clinical studies in children 
0-12 months of age. See Section 5.2 for exposure simulation details. 
 
Prevention during an influenza epidemic in the community: In a pooled analysis of two other studies 
conducted in unvaccinated otherwise healthy adults, oseltamivir 75 mg once daily given for 6 weeks 
significantly reduced the incidence of clinical influenza illness from 25/519 (4.8 %) in the placebo 
group to 6/520 (1.2 %) in the oseltamivir group (76 % reduction [95 % CI 1.6 – 5.7; p = 0.0006]) 
during a community outbreak of influenza. The NNT in this study was 28 (95 % CI 24 – 50). 
A study in older people in nursing homes, where 80 % of participants received vaccine in the season 
of the study, oseltamivir 75 mg once daily given for 6 weeks significantly reduced the incidence of 
clinical influenza illness from 12/272 (4.4 %) in the placebo group to 1/276 (0.4 %) in the oseltamivir 
group (92 % reduction [95 % CI 1.5 – 6.6; p = 0.0015]). The NNT in this study was 25 (95 % CI 23 – 
62).  
 
Prophylaxis of influenza in immunocompromised patients: A double-blind, placebo-controlled, 
randomised study was conducted for seasonal prophylaxis of influenza in 475 immunocompromised 
patients (388 patients with solid organ transplantation [195 placebo; 193 oseltamivir], 87 patients with 
haemopoetic stem cell transplantation [43 placebo; 44 oseltamivir], no patient with other 
immunosuppressant conditions), including 18 children 1 to 12 years of age. The primary endpoint in 
this study was the incidence of laboratory-confirmed clinical influenza as determined by viral culture 
and/or a four-fold rise in HAI antibodies. The incidence of laboratory-confirmed clinical influenza was 
2.9 % (7/238) in the placebo group and 2.1 % (5/237) in the oseltamivir group (95 % CI -2.3 % – 
4.1 %; p = 0.772). 
 
Specific studies have not been conducted to assess the reduction in the risk of complications. 
 
Oseltamivir resistance 
Clinical studies: The risk of emergence of influenza viruses with reduced susceptibility or frank 
resistance to oseltamivir has been examined during Roche-sponsored clinical studies. Developing 
oseltamivir-resistant virus during treatment was more frequent in children than adults, ranging from 
less than 1% in adults to 18% in infants aged below 1 year.  Children who were found to carry 
oseltamivir-resistant virus in general shed the virus for a prolonged period compared with subjects 
with susceptible virus.  However treatment-emergent resistance to oseltamivir did not affect treatment 
response and caused no prolongation of influenza symptoms. 
 
An overall higher incidence of oseltamivir resistance was observed in adult and adolescent 
immunocompromised patients treated with standard dose or double dose of oseltamivir for a duration 
of 10 days [14.5% (10/69) in standard dose group and 2.7% (2/74) in double dose group], compared to 
data from studies with oseltamivir-treated otherwise healthy adult and adolescent patients. The 
majority of adult patients that developed resistance were transplant recipients (8/10 patients in the 
standard dose group and 2/2 patients in the double dose group). Most of the patients with oseltamivir-
resistant virus were infected with influenza type A and had prolonged viral shedding. 
 
The incidence of oseltamivir-resistance observed in immunocompromised children (≤12 years of age) 
treated with Tamiflu across the two studies and evaluated for resistance was 20.7% (6/29). Of the six 
immunocompromised children found with treatment-emergent resistance to oseltamivir, 3 patients 
received standard dose and 3 patients high dose (double or triple dose). The majority had acute 
lymphoid leukemia and were ≤ 5 years of age. 
 



44 

Incidence of Oseltamivir Resistance in Clinical Studies 
 

Patient Population 
Patients with Resistance Mutations (%) 

Phenotyping* Geno- and Phenotyping* 
Adults and adolescents 0.88% (21/2382) 1.13% (27/2396) 
Children (1-12 years) 4.11% (71/1726) 4.52% (78/1727) 
Infant (<1 year) 18.31% (13/71) 18.31 (13/71) 

* Full genotyping was not performed in all studies. 
 
Prophylaxis of Influenza 
There has been no evidence for emergence of drug resistance associated with the use of Tamiflu in 
clinical studies conducted to date in post-exposure (7 days), post-exposure within household groups 
(10 days) and seasonal (42 days) prevention of influenza in immunocompetent patients. There was no 
resistance observed during a 12-week prophylaxis study in immunocompromised patients.  
 
Clinical and surveillance data: Natural mutations associated with reduced susceptibility to oseltamivir 
in vitro have been detected in influenza A and B viruses isolated from patients without exposure to 
oseltamivir. Resistant strains selected during oseltamivir treatment have been isolated from both 
immunocompetent and immunocompromised patients. Immunocompromised patients and young 
children are at a higher risk of developing oseltamivir-resistant virus during treatment. 
 
Oseltamivir-resistant viruses isolated from oseltamivir-treated patients and oseltamivir-resistant 
laboratory strains of influenza viruses have been found to contain mutations in N1 and N2 
neuraminidases. Resistance mutations tend to be viral sub-type specific. Since 2007 naturally 
occurring resistance associated with the H275Y mutation in seasonal H1N1 strains has been 
sporadically detected. The susceptibility to oseltamivir and the prevalence of such viruses appear to 
vary seasonally and geographically. In 2008, H275Y was found in > 99 % of circulating H1N1 
influenza isolates in Europe. The 2009 H1N1 influenza (“swine flu”) was almost uniformly 
susceptible to oseltamivir, with only sporadic reports of resistance in connection with both therapeutic 
and prophylactic regimens. 
 
5.2 Pharmacokinetic properties 
 
General Information 
 
Absorption 
Oseltamivir is readily absorbed from the gastrointestinal tract after oral administration of oseltamivir 
phosphate (pro-drug) and is extensively converted by predominantly hepatic esterases to the active 
metabolite (oseltamivir carboxylate). At least 75 % of an oral dose reaches the systemic circulation as 
the active metabolite. Exposure to the pro-drug is less than 5 % relative to the active metabolite. 
Plasma concentrations of both pro-drug and active metabolite are proportional to dose and are 
unaffected by co-administration with food. 
 
Distribution 
The mean volume of distribution at steady state of the oseltamivir carboxylate is approximately 
23 litres in humans, a volume equivalent to extracellular body fluid. Since neuraminidase activity is 
extracellular, oseltamivir carboxylate distributes to all sites of influenza virus spread. 
 
The binding of the oseltamivir carboxylate to human plasma protein is negligible (approximately 3 %). 
 
Biotransformation 
Oseltamivir is extensively converted to oseltamivir carboxylate by esterases located predominantly in 
the liver. In vitro studies demonstrated that neither oseltamivir nor the active metabolite is a substrate 
for, or an inhibitor of, the major cytochrome P450 isoforms. No phase 2 conjugates of either 
compound have been identified in vivo. 
 



45 

Elimination 
Absorbed oseltamivir is primarily (> 90 %) eliminated by conversion to oseltamivir carboxylate. It is 
not further metabolised and is eliminated in the urine. Peak plasma concentrations of oseltamivir 
carboxylate decline with a half-life of 6 to 10 hours in most subjects. The active metabolite is 
eliminated entirely by renal excretion. Renal clearance (18.8 l/h) exceeds glomerular filtration rate 
(7.5 l/h) indicating that tubular secretion occurs in addition to glomerular filtration. Less than 20 % of 
an oral radiolabelled dose is eliminated in faeces. 
 
Other special populations 
 
Paediatric population 
Infants less than 1 year of age: The pharmacokinetics, pharmacodynamics and safety of Tamiflu have 
been evaluated in two uncontrolled open-label studies including influenza infected children less than 
one year of age (n=135). The rate of clearance of the active metabolite, corrected for body-weight, 
decreases with ages below one year. Metabolite exposures are also more variable in the youngest 
infants. The available data indicates that the exposure following a 3 mg/kg dose in infants 0-12 months 
of age provides pro-drug and metabolite exposures anticipated to be efficacious with a safety profile 
comparable to that seen in older children and adults using the approved dose (see sections 4.1 and 
4.2).The reported adverse events were consistent with the established safety profile in older children.  
 
There are no data available for infants below 1 year of age for post exposure prevention of influenza. 
Prevention during an influenza epidemic in the community has not been studied in children below 12 
years of age. 
 
Post-exposure prevention of influenza in infants less than 1 year of age during a pandemic: 
Simulation of once daily dosing of 3mg/kg in infants <1 year shows an exposure in the same range or 
higher than for once daily dosing of 75 mg in adults. Exposure does not exceed that for treatment of 
infants < 1 year (3 mg/kg twice daily) and is anticipated to result in a comparable safety profile (see 
Section 4.8). No clinical studies of prophylaxis in infants aged <1 have been performed.     
 
Infants and children 1 year of age or older: The pharmacokinetics of oseltamivir have been evaluated 
in single-dose pharmacokinetic studies in infants, children and adolescents 1 to 16 years of age. 
Multiple-dose pharmacokinetics were studied in a small number of children enrolled in a clinical 
efficacy study. Younger children cleared both the pro-drug and its active metabolite faster than adults, 
resulting in a lower exposure for a given mg/kg dose. Doses of 2 mg/kg give oseltamivir carboxylate 
exposures comparable to those achieved in adults receiving a single 75 mg dose (approximately 
1 mg/kg). The pharmacokinetics of oseltamivir in children and adolescents 12 years of age or older are 
similar to those in adults. 
  
Elderly 
Exposure to the active metabolite at steady state was 25 to 35 % higher in older people (age 65 to 78 
years) compared to adults less than 65 years of age given comparable doses of oseltamivir. Half-lives 
observed in older people were similar to those seen in young adults. On the basis of drug exposure and 
tolerability, dosage adjustments are not required for older people unless there is evidence of moderate 
or severe renal impairment (creatinine clearance below 60 ml /min) (see section 4.2). 
 
Renal impairment 
Administration of 100 mg oseltamivir phosphate twice daily for 5 days to patients with various 
degrees of renal impairment showed that exposure to oseltamivir carboxylate is inversely proportional 
to declining renal function. For dosing, see section 4.2. 
 
Hepatic impairment 
In vitro studies have concluded that exposure to oseltamivir is not expected to be increased 
significantly nor is exposure to the active metabolite expected to be significantly decreased in patients 
with hepatic impairment (see section 4.2). 
 



46 

Pregnant Women 
A pooled population pharmacokinetic analysis indicates that the Tamiflu dosage regimen described in 
Section 4.2 Posology and method of administration results in lower exposure (30% on average across 
all trimesters) to the active metabolite in pregnant women compared to non-pregnant women. The 
lower predicted exposure however, remains above inhibitoy concentrations (IC95 values) and at a 
therapeutic level for a range of influenza virus strains. In addition, there is evidence from 
observational studies showing benefit of the current dosing regimen in this patient population. 
Therefore, dose adjustments are not recommended for pregnant women in the treatment  
or prophylaxis of influenza (see section 4.6 Fertility, pregnancy and lactation). 
 
Immunocompromised Patients 
Population pharmacokinetic analyses indicate that treatment of adult and paediatric (<18 years old) 
immunocompromised patients with oseltamivir (as described in Section 4.2. Posology and method of 
administration) results in an increased predicted exposure (from approximately 5% up to 50%) to the 
active metabolite when compared to non-immunocompromised patients with comparable creatinine 
clearance. Due to the wide safety margin of the active metabolite, no dose adjustments are required in 
patients due to their immunocompromised status. However, for immunocompromised patients with 
renal impairment, doses should be adjusted as outlined in section 4.2. Posology and method of 
administration.  
 
Pharmacokinetics and pharmacodynamics analyses from two studies in immunocompromised patients 
indicated that there was no meaningful additional benefit in exposures higher than those achieved after 
the administration of the standard dose. 
 
5.3 Preclinical safety data 
 
Preclinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated-dose toxicity and genotoxicity. Results of the conventional rodent 
carcinogenicity studies showed a trend towards a dose-dependent increase in the incidence of some 
tumours that are typical for the rodent strains used. Considering the margins of exposure in relation to 
the expected exposure in the human use, these findings do not change the benefit-risk of Tamiflu in its 
adopted therapeutic indications.  
 
Teratology studies have been conducted in rats and rabbits at doses of up to 1,500 mg/kg/day and 
500 mg/kg/day, respectively. No effects on foetal development were observed. A rat fertility study up 
to a dose of 1,500 mg/kg/day demonstrated no adverse reactions on either sex. In pre- and post-natal 
rat studies, prolonged parturition was noted at 1,500 mg/kg/day: the safety margin between human 
exposure and the highest no-effect dose (500 mg/kg/day) in rats is 480-fold for oseltamivir and 44-fold 
for the active metabolite, respectively. Foetal exposure in the rats and rabbits was approximately 15 to 
20 % of that of the mother. 
 
In lactating rats, oseltamivir and the active metabolite are excreted in the milk. Limited data indicate 
that oseltamivir and the active metabolite are excreted in human milk. Extrapolation of the animal data 
provides estimates of 0.01 mg/day and 0.3 mg/day for the respective compounds.  
 
A potential for skin sensitisation to oseltamivir was observed in a "maximisation" test in guinea pigs. 
Approximately 50 % of the animals treated with the unformulated active substance showed erythema 
after challenging the induced animals. Reversible irritancy of rabbits' eyes was detected.  
 
Whereas very high oral single doses of oseltamivir phosphate salt, up to the highest dose tested 
(1,310 mg/kg), had no adverse reactions in adult rats, such doses resulted in toxicity in juvenile 7-day-
old rat pups, including death. These reactions were seen at doses of 657 mg/kg and higher. At 
500 mg/kg, no adverse reactions were seen, including upon chronic treatment (500 mg/kg/day 
administered from 7 to 21 days post partum). 
 
 



47 

6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sorbitol (E420),  
Sodium dihydrogen citrate (E331[a]) 
Xanthan gum (E415) 
Sodium benzoate (E211) 
Saccharin sodium (E954) 
Titanium dioxide (E171) 
Tutti frutti flavour (including maltodextrins [maize], propylene glycol, arabic gum E414 and natural 
identical flavouring substances [mainly consisting of banana, pineapple and peach flavour]). 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
4 years 
 
After reconstitution, store below 25 °C for 10 days. 
 
6.4 Special precautions for storage 
 
Do not store above 30∞C.  
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
100 ml amber glass bottle (with child-resistant polypropylene screw cap, outer part: polyethylene; 
inner part: polypropylene; liner: polyethylene) with 13 g of powder for oral suspension, a plastic 
adapter (low density polyethylene) , plastic 3 ml  oral dispenser (0.1 ml graduation) and 10 ml oral 
dispenser (0.5 ml graduation)  (barrel and plunger: polypropylene, silicon based seal ring) and a plastic 
measuring cup (polypropylene). 
 
Pack-size of one bottle. 
 
6.6 Special precautions for disposal and other handling 
 
It is recommended that Tamiflu oral suspension should be reconstituted by the pharmacist prior to 
being dispensed to the patient. 
 
After reconstitution with 55 ml of water, the usable volume of oral suspension allows for the retrieval 
of a total of 10 doses of 30 mg oseltamivir. 
 
Preparation of oral suspension 
1. Tap the closed bottle gently several times to loosen the powder. 
2. Measure 55 ml of water by filling the measuring cup to the indicated level (measuring cup 

included in the box). 
3. Add all 55 ml of water into the bottle, recap the bottle and shake the closed bottle well for 15 

seconds. 
4. Remove the cap and push the bottle adapter into the neck of the bottle.  
5. Close the bottle tightly with the cap (on the top of the bottle adapter). This will make sure that 

the bottle adapter fits in the bottle in the right position. 
 



48 

Tamiflu powder for suspension will appear as an opaque and white to light yellow suspension after 
reconstitution. 
 
Any unused product or waste material should be disposed of in accordance with local requirements.  
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/02/222/005 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 28 November 2011 
Date of last renewal: 22 May 2012 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
  



49 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 



50 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Roche Pharma AG 
Emil-Barell-Str. 1 
D- 79639 Grenzach –Wyhlen 
Germany 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
∑ Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
∑ Conditions or Restrictions with Regard to the Safe and Effective Use of the 

Medicinal Product 
 
The MAH shall ensure that at the launch of Tamiflu 6 mg/ml powder for oral suspension, all 
physicians who are expected to prescribe or use Tamiflu are provided with a Direct Healthcare 
Professional Communication letter, the text of which is appended to the CHMP assessment report. The 
MAH shall agree the communication plan for the DHPC letter with the National Competent Authority 
in the Member States where the letter will be distributed. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   
 
∑ Risk Management Plan (RMP) 
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in 
the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed 
subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

∑ At the request of the European Medicines Agency; 
∑ Whenever the risk management system is modified, especially as the result of new 

information being received that may lead to a significant change to the benefit/risk 
profile or as the result of an important (pharmacovigilance or risk minimisation) 
milestone being reached. 

 
  



51 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



52 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



53 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 30 mg hard capsules 
Oseltamivir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read package leaflet before use 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 ∞C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



54 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/222/003 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
tamiflu 30 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
  



55 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blisters 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 30 mg capsules 
Oseltamivir 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH. 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



56 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 45 mg hard capsules 
Oseltamivir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read package leaflet before use 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 ∞C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



57 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/222/004 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
tamiflu 45 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
  



58 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blisters 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 45 mg capsules 
Oseltamivir 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH. 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



59 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 75 mg hard capsules 
Oseltamivir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read package leaflet before use 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25 ∞C 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



60 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/222/001 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
tamiflu 75 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
  



61 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
Blisters 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 75 mg capsules 
Oseltamivir 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH. 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
  



62 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
Outer carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 6 mg/ml powder for oral suspension  
Oseltamivir 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 bottle contains 390 mg of oseltamivir. Final volume of the bottle after reconstitution is 65 ml. Each 
ml of suspension contains 6 mg oseltamivir. 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains sorbitol. 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
1 bottle 
Also contains 1 plastic bottle adapter, 1 plastic measuring cup (55 ml), 1 plastic 3 ml oral dispenser 
and 1 plastic 10 ml oral dispenser.  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
For oral use after reconstitution 
Shake bottle well before use 
Caution: dispenser graduated in millilitre (ml) 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Powder: Do not store above 30∞C 
After reconstitution, store below 25 °C for 10 days 



63 

 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/02/222/005 
 
 
13. BATCH NUMBER 
 
Batch 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
tamiflu 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
<2D barcode carrying the unique identifier included.> 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
  



64 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for bottle 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Tamiflu 6 mg/ml powder for oral suspension  
Oseltamivir 
 
 
2. METHOD OF ADMINISTRATION 
 
For oral use after reconstitution 
Shake bottle well before use 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Batch  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
The volume of the reconstituted suspension is 65 ml 
1 ml contains 6 mg oseltamivir 
 
 
6. OTHER 
 
Powder: Do not store above 30 ºC  
Oral suspension: Store below 25 °C for 10 days 
 
  



65 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



66 

Package Leaflet: Information for the user 
 

Tamiflu 30 mg hard capsules  
oseltamivir 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
∑ Keep this leaflet. You may need to read it again. 
∑ If you have further questions, ask your doctor or pharmacist. 
∑ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
∑ If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Tamiflu is and what it is used for 
2. What you need to know before you take Tamiflu  
3. How to take Tamiflu  
4. Possible side effects 
5. How to store Tamiflu  
6. Contents of the pack and other information 
 
 
1. What Tamiflu is and what it is used for 
 
∑ Tamiflu is used for adults, adolescents, children and infants (including full-term newborn 

babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu 
virus is known to be going round in your community. 

∑ Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age 
for preventing flu, on a case-by-case basis – for instance, if you have been in contact with 
someone who has flu.  

∑ Tamiflu may be prescribed for adults, adolescents, children and  infant (including full-term  
newborn babies) as preventive treatment in exceptional circumstances – for example, if there 
is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide 
sufficient protection.  

 
Tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. 
These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the 
symptoms of the flu virus infection. 
 
Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden 
fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme 
tiredness. These symptoms can also be caused by other infections. True influenza infection only 
occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. 
Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.  
 
 
2. What you need to know before you take Tamiflu 
 
Do not take Tamiflu: 
∑ if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu 

listed in section 6.  
Talk to your doctor if this applies to you. Do not take Tamiflu. 
 



67 

Warnings and precautions: 
Before you take Tamiflu, make sure the prescribing doctor knows 
∑ if you are allergic to other medicines 
∑ if you have problems with your kidneys. If so, your dose may need adjustment 
∑ if you have a severe medical condition, which may require immediate hospitalisation 
∑ if your immune system is not working 
∑ if you have chronic heart disease or respiratory disease. 
 
During treatment with Tamiflu, tell a doctor immediately: 
∑ if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and 

adolescents). These may be signs of rare but serious side effects.  
 
Tamiflu is not a flu vaccine 
Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you 
antibodies against the virus. Tamiflu will not change the effectiveness of a flu vaccine, and you might 
be prescribed both by your doctor.  
 
Other medicines and Tamiflu 
Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. This 
includes medicines obtained without a prescription. The following medicines are particularly 
important: 

∑ chlorpropamide (used to treat diabetes) 
∑ methotrexate (used to treat e.g. rheumatoid arthritis) 
∑ phenylbutazone (used to treat pain and inflammation) 
∑ probenecid (used to treat gout) 

 
Pregnancy and breast-feeding 
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get 
pregnant so that your doctor can decide if Tamiflu is right for you. 
 
The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so 
that your doctor can decide if Tamiflu is right for you. 
 
Ask your doctor or pharmacist for advice before taking this medicine. 
 
Driving and using machines 
Tamiflu has no effect on your ability to drive or use machines. 
 
 
3. How to take Tamiflu 
 
Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure. 
 
Take Tamiflu as soon as possible, ideally within two days of the flu symptoms starting. 
 
The recommended doses 
 
For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and 
one in the evening. It is important to complete the whole 5-day course, even if you start to feel 
better quickly. 
 
For patients with a weak immune system, treatment will continue for 10 days. 
 
For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It 
is best to take this in the mornings with breakfast. 
 



68 

In special situations, such as widespread flu or for patients with a weak immune system, treatment will 
continue for up to 6 or 12 weeks. 
 
The recommended dose is based on the patient’s body weight.You must use the amount of oral 
capsules or suspension prescribed by the doctor.  
 
Adults, and adolescents 13 years and over  
 
Body weight Treating flu:  

dose  
for 5 days 

Treating flu 
(Immunocompromised 
Patients):  
dose  
for 10 days*  

Preventing flu:  
dose  
for 10 days 

40 kg or more 75 mg** twice daily 75 mg** twice daily 75 mg** once daily 
* For patients with a weak immune system, treatment is for 10 days 
**75 mg can be made up of a 30 mg capsule plus a 45 mg capsule 
 
Children 1 to 12 years  
 
Body weight Treating flu:  

dose  
for 5 days  

Treating flu 
(Immunocompromised 
Patients): 
dose  
for 10 days*  

Preventing flu:  
dose  
for 10 days 

10 to 15 kg 30 mg twice daily 30 mg twice daily 30 mg once daily 
More than 15 kg and up 
to 23 kg 

45 mg twice daily 45 mg twice daily 45 mg once daily 

More than 23 kg and up 
to 40 kg 

60 mg twice daily 60 mg twice daily 60 mg once daily 

More than 40 kg 75 mg** twice daily 75 mg** twice daily 75 mg** once daily 
* For children with a weak immune system, treatment is for 10 days**75 mg can be made up of a 30 mg capsule 
plus a 45 mg capsule 
 
Infants less than 1 year (0 to 12 months) 
Giving Tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based 
upon the judgment of a doctor after considering the potential benefit versus any potential risk to the 
infant.  
 
Body weight Treating flu:  

dose  
for 5 days 

Treating flu 
(Immunocompromised 
Patients): 
dose  
for 10 days* 

Preventing flu:  
dose  
for 10 days 

3 kg to 10+ kg, 
 

3 mg per kg body  
weight**, twice daily 

3 mg per kg body  
weight**, twice daily 

3 mg per kg**, once 
daily 

* For infants with a weak immune system, treatment is for 10 days. 
** mg per kg = mg for each kilogram of the infant’s body weight. For example: 
If a 6-month-old weighs 8 kg, the dose is 
8 kg x 3mg per kg = 24 mg 
 
Method of administration 
Swallow the capsules whole with water. Do not break or chew the capsules. 
 
Tamiflu can be taken with or without food, although taking it with food can reduce the chance of 
feeling or being sick (nausea or vomiting). 
 



69 

People who find it hard to take capsules can use a liquid medicine, Tamiflu oral suspension. If you 
need Tamiflu oral suspension, but it’s not available from your pharmacy, you can make a liquid form 
of Tamiflu from these capsules. See Making liquid Tamiflu at home, over the page. 
 
If you take more Tamiflu than you should  
Stop taking Tamiflu and contact a doctor or pharmacist immediately. 
In most cases of overdose, people have not reported any side effects. When side effects were reported, 
they were similar to those from normal doses, as listed in section 4. 
Overdose has been reported to have occurred more frequently when Tamiflu was given to children 
than to adults and adolescents. Caution should be exercised when preparing liquid Tamiflu for 
children and when administering Tamiflu capsules or liquid Tamiflu to children. 
 
If you forget to take Tamiflu 
Do not take a double dose to make up for a forgotten capsule. 
 
If you stop taking Tamiflu 
There are no side effects when you stop Tamiflu. But if Tamiflu is stopped earlier than your doctor 
told you, the symptoms of flu may come back. Always complete the course that your doctor 
prescribed. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of 
the side effects listed below may also be caused by influenza. 
 
The following serious side effects have been rarely reported since oseltamivir has been marketed: 

∑ Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin 
swelling, itchy rashes, low blood pressure and breathing difficulties 

∑ Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of 
the skin and white of the eyes, change in stool color, changes in behaviour 

∑ Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head 
and neck area, including eyes and tongue, with difficulties breathing 

∑ Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life-
threatening allergic reaction, severe inflammation of the outer and possibly inner skin, 
initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding 
of larger areas of skin, possible breathing difficulties and low blood pressure 

∑ Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood 
∑ Neuropsychiatric disorders, as described below. 
 

If you notice any of these symptoms, get medical help immediately. 
 
The most frequently (very common and common) reported side effects of Tamiflu are feeling or being 
sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly 
occur after the first dose of the medicine and will usually stop as treatment continues. The frequency 
of these effects is reduced if the medicinal product is taken with food. 
 
Rare but serious effects: get medical help at once 
(These may affect up to 1 in 1,000 people)  
During Tamiflu treatment, rare events have been reported that include 

∑ Convulsions and delirium, including altered level of consciousness 
∑ Confusion, abnormal behaviour 
∑ Delusions, hallucinations, agitation, anxiety, nightmares 



70 

These are reported primarily among children and adolescents and often started suddenly and resolved 
rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events 
have also been reported in patients with influenza who were not taking Tamiflu. 

∑ Patients, especially children and adolescents, should be closely monitored for the 
behavioural changes described above. 

If you notice any of these symptoms, especially in younger people, get medical help immediately. 
 
Adults and adolescents 13 and over 
 
Very common side effects 
(may affect more than 1 in 10 people) 

∑ Headache 
∑ Nausea. 

 
Common side effects 
(may affect up to 1 in 10 people) 

∑ Bronchitis  
∑ Cold sore virus 
∑ Cough 
∑ Dizziness 
∑ Fever 
∑ Pain 
∑ Pain in limb 
∑ Runny nose 
∑ Sleeping difficulties 
∑ Sore throat 
∑ Stomach ache  
∑ Tiredness 
∑ Upper abdominal fullness  
∑ Upper respiratory tract infections (inflammation of the nose, throat and sinuses) 
∑ Upset stomach 
∑ Vomiting. 

 
Uncommon side effects 
(may affect up to 1 in 100 people) 

∑ Allergic reactions 
∑ Altered level of consciousness 
∑ Convulsion 
∑ Heart rhythm abnormalities 
∑ Mild to severe liver function disorders 
∑ Skin reactions (inflammation of the skin, red and itchy rash, scaling skin). 

 
Rare side effects 
(may affect up to 1 in 1,000 people) 

∑ Thrombocytopenia (low platelet count) 
∑ Visual disturbances. 

 
Children 1 to 12 years  
 
Very common side effects 
(may affect more than 1 in 10 people) 

∑ Cough 
∑ Nasal congestion 
∑ Vomiting. 

 



71 

Common side effects 
(may affect up to 1 in 10 people) 

∑ Conjunctivitis (red eyes and discharge or pain in the eye) 
∑ Ear inflammation and other ear disorders 
∑ Headache 
∑ Nausea 
∑ Runny nose 
∑ Stomach ache 
∑ Upper abdominal fullness  
∑ Upset stomach. 

 
Uncommon side effects 
(may affect up to 1 in 100 people) 

∑ Inflammation of the skin 
∑ Tympanic membrane (eardrum) disorder. 

 
Infants less than 1 year  
The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported 
for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been reported.. 
 
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your 
doctor or pharmacist. However, 

∑ if you or your child are repeatedly sick, or 
∑ if the influenza symptoms get worse or the fever continues 

Tell your doctor as soon as possible. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this 
leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 
By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store Tamiflu 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 25 ∞C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Tamiflu contains 
∑ Each hard capsule contains oseltamivir equivalent to 30 mg of oseltamivir  
∑ The other ingredients are: 

capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium 
stearyl fumarate 
capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172) and titanium dioxide 
(E171)  
printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigo carmine 
E132). 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


72 

 
What Tamiflu looks like and contents of the pack 
The 30 mg hard capsule consists of a light yellow opaque body bearing the imprint “ROCHE” and a 
light yellow opaque cap bearing the imprint “30 mg”. Imprints are blue. 
 
Tamiflu 30 mg hard capsules are available in blister packs of 10. 
 
Marketing Authorisation Holder and Manufacturer 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
Roche Pharma AG 
Emil-Barell-Str. 1,  
D-79639 Grenzach-Wyhlen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Malta 
(See Ireland) 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

France 
Roche 
Tél: +33 (0) 1 47 61 40 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 



73 

Hrvatska 
Roche d.o.o 
Tel:  +385 1 4722 333 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταμάτης & Σια Λτδ. 
Τηλ: +357 - 22 76 62 76 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
  



74 

--------------------------------------------------------------------------------------------------------------------------- 
 
Information for the user 
 
For people who find it hard to take capsules, including very young children, there’s a liquid 
medicine, Tamiflu oral suspension.  
 
If you need a liquid medicine, but it’s not available, a suspension can be made up at the pharmacy 
from Tamiflu capsules (see Information for healthcare professionals). This pharmacy preparation is 
the preferred option. 
 
If the pharmacy preparation is not available either, you can make liquid Tamiflu from these capsules at 
home. 
 
The dose is the same for treating or preventing flu. The difference is how often it is given. 
 
Making liquid Tamiflu at home 
 
∑ If you have the right capsule for the dose needed (a 30 mg or a 60 mg dose), you will open the 

capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product. 
This is usually suitable for children over 1 year. See the upper set of instructions. 

 
∑ If you need smaller doses, making liquid Tamiflu from capsules involves extra steps. This is 

suitable for younger children and babies: they usually need a Tamiflu dose of less than 30 mg. 
See the lower set of instructions. 

 
Children 1 to 12 years 
 
To make a 30 mg or a 60 mg dose, 
you need: 

∑ One or two 30 mg Tamiflu capsule(s) 
∑ Sharp scissors 
∑ One small bowl 
∑ Teaspoon (5 ml spoon) 
∑ Water 
∑ Sweet food to hide the bitter taste of the powder. 
 Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge 

sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a 
teaspoon of sugar. 

 
Step 1: Check the dose is correct 
 

To find the correct amount to use, find the patient’s weight on the left of the table. 
Look at the right column to check the number of capsules you will need to give the patient for a 
single dose. The amount is the same whether treating or preventing flu. 
 

30 mg dose 
 

60 mg dose 
 

 
You should use only 30 mg capsules for 30 mg and 60 mg doses. Do not try to make a 45 mg or 
75 mg dose by using the contents of 30 mg capsules. Use the appropriate size capsule instead.  



75 

 
Weight Dose of Tamiflu Number of capsules 
Up to 15 kg 30 mg 1 capsule 
15 kg up to 23 kg 45 mg Do not use 30 mg capsules 
23 kg up to 40 kg 60 mg 2 capsules 

 
Step 2: Pour all the powder into a bowl 
 

Hold a 30 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.   
Pour all of the powder into the bowl. 
Open a second capsule for a 60 mg dose. Pour all of the powder into the bowl.   
Be careful with the powder, because it may irritate your skin and eyes. 

 

   
 
Step 3: Sweeten the powder and give the dose 
 

Add a small amount – no more than one teaspoonful – of sweet food to the powder in the bowl.  
This is to hide the bitter taste of the Tamiflu powder. 
Stir the mixture well.  

 

   
 

Give the whole contents of the bowl to the patient straight away.  
 
If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get 
the patient to drink it all. 
 
Repeat this procedure every time you need to give the medicine. 

 
Infants less than 1 year  
 
To make a smaller single dose, you need: 

∑ One 30 mg Tamiflu capsule 
∑ Sharp scissors 
∑ Two small bowls (use separate pairs of bowls for each child) 
∑ One large oral dose dispenser to measure out water – a 5 or 10 ml dispenser 
∑ One small oral dose dispenser showing measurements of 0.1 ml, to give the dose 
∑ Teaspoon (5 ml spoon) 
∑ Water 
∑ Sweet food to hide the bitter taste of the Tamiflu. 

Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge 
sauce.  
Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a 
teaspoon of sugar. 

 



76 

Step 1: Pour all the powder into a bowl 
 
Hold a 30 mg capsule upright over one of the bowls and carefully snip off the rounded tip with 
scissors. Be careful with the powder: it may irritate your skin and eyes. 
Pour all of the powder into the bowl, whatever the dose you are making. 
The amount is the same whether you are treating or preventing flu. 

 

    
 
Step 2: Add water to dilute the medicine 
 

Use the larger dispenser 
to draw up 5 ml water. 
 
Add the water to the 
powder in the bowl. 

 
 

Stir the mixture with 
the teaspoon for 
about 2 minutes. 

 
 
Don’t worry if not all of the powder dissolves. The undissolved powder is just inactive 
ingredients. 

 
Step 3: Choose the correct amount for your child’s weight 

Look up the child’s weight on the left side of the table.  
The column on the right of the table shows how much of the liquid mixture you will need to 
draw up.  

 
Infants less than 1 year (including full-term newborn babies) 
 

Child’s weight 
(nearest) 

How much mixture  
to draw up 

3 kg 1.5 ml 
3.5 kg 1.8 ml 
4 kg 2.0 ml 
4.5 kg 2.3 ml  
5 kg 2.5 ml 
5.5 kg 2.8 ml   
6 kg 3.0 ml 
6.5 kg 3.3 ml 
7 kg 3.5 ml 
7.5 kg 3.8 ml 
8 kg 4.0 ml 
8.5 kg 4.3 ml 
9 kg 4.5 ml 
9.5 kg 4.8 ml 
10 kg or more 5.0 ml 



77 

 
Step 4: Draw up the liquid mixture 
 

Make sure you have the right size dispenser.  
Draw up the correct amount of liquid mixture from the first bowl.  
Draw it up carefully so as not to include air bubbles. 
Gently squirt the correct dose into the second bowl.  

 

   
 
Step 5: Sweeten and give to the child 
 

Add a small amount – no more than one teaspoonful – of a sweet food to the second bowl. 
This is to hide the bitter taste of the Tamiflu. 
Mix the sweet food and Tamiflu liquid well.  

 

   
 

Give the whole contents of the second bowl (Tamiflu liquid mixture with sweet food added) to 
the child straight away. 
 
If there is anything left in the second bowl, rinse the bowl with a small amount of water and 
get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle 
to feed the child the remaining liquid. 
 
Give the child something to drink. 
 
Throw away any unused liquid left in the first bowl. 

 
 Repeat this procedure every time you need to give the medicine. 
  



78 

--------------------------------------------------------------------------------------------------------------------------- 
 
Information for healthcare professionals only 
 
Patients who are unable to swallow capsules:   
Commercially manufactured Tamiflu for oral suspension (6mg/ml) is the preferred product for 
paediatric and adult patients who have difficulties swallowing capsules or where lower doses are 
needed.  In the event thatTamiflu powder for oral suspension is not available, the pharmacist may 
compound a suspension (6 mg/ml) from Tamiflu capsules. If the pharmacy compounded suspension is 
also not available, patients may prepare the suspension from capsules at home. 
 
Oral dose dispensers (oral syringes) of appropriate volume and grading should be provided for 
administering the pharmacy compounded suspension, and for the procedures involved in the home 
preparation. In both cases, the correct volumes should preferably be marked on the dispensers. For 
home preparation, separate dispensers should be provided for taking the correct volume of water and 
for measuring the Tamiflu-water mixture. For measuring 5.0 ml of water, dispensers of 5 ml or 10 ml 
should be used. 
 
The appropriate dispenser sizes for taking the correct volume of Tamiflu suspension (6 mg/ml) are 
shown below. 
 
Infants less than 1 year (including full term new born babies):  
 

Dose of Tamiflu 
Amount of Tamiflu 

suspension 
Dispenser size to use 

(grading 0.1 ml) 
9 mg 1.5 ml 2.0 ml (or 3.0 ml) 

10 mg 1.7 ml 2.0 ml (or 3.0 ml) 
11.25 mg 1.9 ml 2.0 ml (or 3.0 ml) 
12.5 mg 2.1 ml 3.0 ml 
13.75 mg 2.3 ml 3.0 ml 

15 mg 2.5 ml 3.0 ml 
16.25 mg 2.7 ml 3.0 ml 

18 mg 3.0 ml 3.0 ml (or 5.0 ml) 
19.5 mg 3.3 ml 5.0 ml 
21 mg 3.5 ml 5.0 ml 

22.5 mg 3.8 ml 5.0 ml 
24 mg 4.0 ml 5.0 ml 

25.5 mg 4.3 ml 5.0 ml 
27 mg 4.5 ml 5.0 ml 

28.5 mg 4.8 ml 5.0 ml 
30 mg 5.0 ml 5.0 ml 

 
  



79 

Package Leaflet: Information for the user 
 

Tamiflu 45 mg hard capsules 
oseltamivir 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
∑ Keep this leaflet. You may need to read it again. 
∑ If you have further questions, ask your doctor or pharmacist. 
∑ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
∑ If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Tamiflu is and what it is used for 
2. What you need to know before you take Tamiflu  
3. How to take Tamiflu  
4. Possible side effects 
5. How to store Tamiflu  
6. Contents of the pack and other information 
 
 
1. What Tamiflu is and what it is used for 
 
∑ Tamiflu is used for adults, adolescents, children and infants (including full-term newborn 

babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu 
virus is known to be going round in your community. 

∑ Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age 
for preventing flu, on a case-by-case basis – for instance, if you have been in contact with 
someone who has flu.  

∑ Tamiflu may be prescribed for adults, adolescents, children and infants (including full-term 
newborn babies) as preventive treatment in exceptional circumstances – for example, if there 
is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide 
sufficient protection.  

 
Tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. 
These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the 
symptoms of the flu virus infection. 
 
Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden 
fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme 
tiredness. These symptoms can also be caused by other infections. True influenza infection only 
occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. 
Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.  
 
 
2. What you need to know before you take Tamiflu 
 
Do not take Tamiflu: 
∑ if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu 

listed in section 6.  
Talk to your doctor if this applies to you. Do not take Tamiflu. 
 



80 

Warnings and precautions: 
Before you take Tamiflu, make sure the prescribing doctor knows 
∑ if you are allergic to other medicines 
∑ if you have problems with your kidneys. If so, your dose may need adjustment 
∑ if you have a severe medical condition, which may require immediate hospitalisation 
∑ if your immune system is not working 
∑ if you have chronic heart disease or respiratory disease. 
 
During treatment with Tamiflu, tell a doctor immediately: 
∑ if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and 

adolescents). These may be signs of rare but serious side effects.  
 
Tamiflu is not a flu vaccine 
Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you 
antibodies against the virus. Tamiflu will not change the effectiveness of a flu vaccine, and you might 
be prescribed both by your doctor.  
 
Other medicines and Tamiflu 
Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. This 
includes medicines obtained without a prescription. The following medicines are particularly 
important: 

∑ chlorpropamide (used to treat diabetes) 
∑ methotrexate (used to treat e.g. rheumatoid arthritis) 
∑ phenylbutazone (used to treat pain and inflammation) 
∑ probenecid (used to treat gout) 

 
Pregnancy and breast-feeding 
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get 
pregnant so that your doctor can decide if Tamiflu is right for you. 
 
The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so 
that your doctor can decide if Tamiflu is right for you. 
 
Ask your doctor or pharmacist for advice before taking this medicine. 
 
Driving and using machines 
Tamiflu has no effect on your ability to drive or use machines. 
 
 
3. How to take Tamiflu 
 
Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure. 
 
Take Tamiflu as soon as possible, ideally within two days of the flu symptoms starting. 
 
The recommended doses  
 
For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and 
one in the evening. It is important to complete the whole 5-day course, even if you start to feel 
better quickly. 
 
For patients with a weak immune system, treatment will continue for 10 days. 
 
For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It 
is best to take this in the mornings with breakfast. 
 



81 

In special situations, such as widespread flu or for patients with a weak immune system, treatment will 
continue for up to 6 or 12 weeks. 
 
The recommended dose is based on the patient’s body weight.You must use the amount of oral 
capsules or suspension prescribed by the doctor.  
 
Adults, and adolescents 13 years and over  
 
Body weight Treating flu:  

dose  
for 5 days 

Treating flu 
(Immunocompromised 
Patients):  
dose  
for 10 days* 

Preventing flu:  
dose  
for 10 days 

40 kg or more 75 mg** twice daily 75 mg** twice daily 75 mg** once daily 
* For patients with a weak immune system, treatment is for 10 days. 
**75 mg can be made up of a 30 mg capsule plus a 45 mg capsule 
 
Children 1 to 12 years  
 
Body weight Treating flu:  

dose  
for 5 days 

Treating flu 
(Immunocompromised 
Patients):  
dose  
for 10 days* 

Preventing flu:  
dose  
for 10 days 

10 to 15 kg 30 mg twice daily 30 mg twice daily 30 mg once daily 
More than 15 kg and up 
to 23 kg 

45 mg twice daily 45 mg twice daily 45 mg once daily 

More than 23 kg and up 
to 40 kg 

60 mg twice daily 60 mg twice daily 60 mg once daily 

More than 40 kg 75 mg** twice daily 75 mg** twice daily 75 mg** once daily 
* For children with a weak immune system, treatment is for 10 days. 
** 75 mg can be made up of a 30 mg capsule plus a 45 mg capsule 
 
Infants less than 1 year (0 to 12 months) 
Giving Tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based 
upon the judgment of a doctor after considering the potential benefit versus any potential risk to the 
infant.  
 
Body weight Treating flu:  

dose  
for 5 days 

Treating flu 
(Immunocompromised 
Patients):  
dose  
for 10 days* 

Preventing flu:  
dose  
for 10 days 

3 kg to 10+ kg, 
 

3 mg per kg body  
weight**, twice daily 

3 mg per kg body  
weight**, twice daily 

3 mg per kg**,  
once daily 

* For infants with a weak immune system, treatment is for 10 days. 
**mg per kg = mg for each kilogram of the infant’s body weight. For example: 
If a 6-month-old weighs 8 kg, the dose is 
8 kg x 3mg per kg = 24 mg 
 
Method of administration 
Swallow the capsules whole with water. Do not break or chew the capsules. 
 
Tamiflu can be taken with or without food, although taking it with food can reduce the chance of 
feeling or being sick (nausea or vomiting). 
 



82 

People who find it hard to take capsules can use a liquid medicine, Tamiflu oral suspension. If you 
need Tamiflu oral suspension, but it’s not available from your pharmacy, you can make a liquid form 
of Tamiflu from these capsules. See Making liquid Tamiflu at home, over the page. 
 
If you take more Tamiflu than you should  
Stop taking Tamiflu and contact a doctor or pharmacist immediately. 
In most cases of overdose, people have not reported any side effects. When side effects were reported, 
they were similar to those from normal doses, as listed in section 4. 
Overdose has been reported to have occurred more frequently when Tamiflu was given to children 
than to adults and adolescents. Caution should be exercised when preparing liquid Tamiflu for 
children and when administering Tamiflu capsules or liquid Tamiflu to children. 
 
If you forget to take Tamiflu 
Do not take a double dose to make up for a forgotten capsule. 
 
If you stop taking Tamiflu 
There are no side effects when you stop Tamiflu. But if Tamiflu is stopped earlier than your doctor 
told you, the symptoms of flu may come back. Always complete the course that your doctor 
prescribed. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of 
the side effects listed below may also be caused by influenza. 
 
The following serious side effects have been rarely reported since oseltamivir has been marketed: 

∑ Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin 
swelling, itchy rashes, low blood pressure and breathing difficulties 

∑ Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of 
the skin and white of the eyes, change in stool color, changes in behaviour 

∑ Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head 
and neck area, including eyes and tongue, with difficulties breathing 

∑ Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life-
threatening allergic reaction, severe inflammation of the outer and possibly inner skin, 
initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding 
of larger areas of skin, possible breathing difficulties and low blood pressure 

∑ Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood 
∑ Neuropsychiatric disorders, as described below. 
 

If you notice any of these symptoms, get medical help immediately. 
 
The most frequently (very common and common) reported side effects of Tamiflu are feeling or being 
sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly 
occur after the first dose of the medicine and will usually stop as treatment continues. The frequency 
of these effects is reduced if the medicinal product is taken with food. 
 
Rare but serious effects: get medical help at once 
(These may affect up to 1 in 1,000 people)  
During Tamiflu treatment, rare events have been reported that include 

∑ Convulsions and delirium, including altered level of consciousness 
∑ Confusion, abnormal behaviour 
∑ Delusions, hallucinations, agitation, anxiety, nightmares 



83 

These are reported primarily among children and adolescents and often started suddenly and resolved 
rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events 
have also been reported in patients with influenza who were not taking Tamiflu. 

∑ Patients, especially children and adolescents, should be closely monitored for the 
behavioural changes described above. 

If you notice any of these symptoms, especially in younger people, get medical help immediately. 
 
Adults and adolescents 13 and over 
 
Very common side effects 
(may affect more than 1 in 10 people) 

∑ Headache 
∑ Nausea. 

 
Common side effects 
(may affect up to 1 in 10 people) 

∑ Bronchitis  
∑ Cold sore virus 
∑ Cough 
∑ Dizziness 
∑ Fever 
∑ Pain 
∑ Pain in limb 
∑ Runny nose 
∑ Sleeping difficulties 
∑ Sore throat 
∑ Stomach ache  
∑ Tiredness 
∑ Upper abdominal fullness  
∑ Upper respiratory tract infections (inflammation of the nose, throat and sinuses) 
∑ Upset stomach 
∑ Vomiting. 

 
Uncommon side effects 
(may affect up to 1 in 100 people) 

∑ Allergic reactions 
∑ Altered level of consciousness 
∑ Convulsion 
∑ Heart rhythm abnormalities 
∑ Mild to severe liver function disorders 
∑ Skin reactions (inflammation of the skin, red and itchy rash, scaling skin). 

 
Rare side effects 
(may affect up to 1 in 1,000 people) 

∑ Thrombocytopenia (low platelet count) 
∑ Visual disturbances. 

 
Children 1 to 12 years  
 
Very common side effects 
(may affect more than 1 in 10 people) 

∑ Cough 
∑ Nasal congestion 
∑ Vomiting. 

 



84 

Common side effects 
(may affect up to 1 in 10 people) 

∑ Conjunctivitis (red eyes and discharge or pain in the eye) 
∑ Ear inflammation and other ear disorders 
∑ Headache 
∑ Nausea 
∑ Runny nose 
∑ Stomach ache 
∑ Upper abdominal fullness  
∑ Upset stomach. 

 
Uncommon side effects 
(may affect up to 1 in 100 people) 

∑ Inflammation of the skin 
∑ Tympanic membrane (eardrum) disorder. 

 
Infants less than 1 year  
The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported 
for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been  reported. 
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your 
doctor or pharmacist. However, 

∑ if you or your child are repeatedly sick, or 
∑ if the influenza symptoms get worse or the fever continues 

Tell your doctor as soon as possible. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this 
leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 
By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store Tamiflu 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 25 ∞C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Tamiflu contains 
∑ Each hard capsule contains oseltamivir equivalent to 45 mg of oseltamivir  
∑ The other ingredients are: 

capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium 
stearyl fumarate 
capsule shell: gelatin, black iron oxide (E172) and titanium dioxide (E171) 
printing ink: shellac (E904), titanium dioxide (E171) and FD and C Blue 2 (indigo carmine 
E132). 

 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


85 

What Tamiflu looks like and contents of the pack 
The 45 mg hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey 
opaque cap bearing the imprint “45 mg”. Imprints are blue. 
 
Tamiflu 45 mg hard capsules are available in blister packs of 10. 
 
Marketing Authorisation Holder and Manufacturer 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
Roche Pharma AG 
Emil-Barell-Str. 1,  
D-79639 Grenzach-Wyhlen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Malta 
(See Ireland) 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

France 
Roche 
Tél: +33 (0) 1 47 61 40 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 



86 

Hrvatska 
Roche d.o.o 
Tel:  +385 1 4722 333 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταμάτης & Σια Λτδ. 
Τηλ: +357 - 22 76 62 76 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
  



87 

--------------------------------------------------------------------------------------------------------------------------- 
 
Information for the user 
 
For people who find it hard to take capsules, including very young children, there’s a liquid 
medicine, Tamiflu oral suspension.  
 
If you need a liquid medicine, but it’s not available, a suspension can be made up at the pharmacy 
from Tamiflu capsules (see Information for healthcare professionals). This pharmacy preparation is 
the preferred option. 
 
If the pharmacy preparation is not available either, you can make liquid Tamiflu from these capsules at 
home. 
 
The dose is the same for treating or preventing flu. The difference is how often it is given. 
 
Making liquid Tamiflu at home 
 

∑ If you have the right capsule for the dose needed (a 45 mg dose), you will open the capsule 
and stir its contents into one teaspoon (or less) of a suitable sweetened food product. This is 
usually suitable for children over 1 year. See the upper set of instructions. 

 
∑ If you need smaller doses, making liquid Tamiflu from capsules involves extra steps. This 

is suitable for younger, lighter children and babies: they usually need a Tamiflu dose of less 
than 45 mg. See the lower set of instructions.  

 
Children 1 to 12 years 
 
To make a 45 mg dose, you need:  

∑ One 45 mg Tamiflu capsule 
∑ Sharp scissors 
∑ One small bowl  
∑ Teaspoon (5 ml spoon)  
∑ Water 
∑ Sweet food to hide the bitter taste of the powder.  

Examples are chocolate or cherry syrup, and dessert toppings such as caramel or fudge 
sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a 
teaspoon of sugar. 

 
Step 1: Check the dose is correct 
 

To find the correct amount to use, find the patient’s weight on the left of the table.   
Look at the right column to check the number of capsules you will need to give the patient for a 
single dose. The amount is the same whether treating or preventing flu.  
 

45 mg dose  

 
You should use only 45 mg capsules for 45 mg doses. Do not try to make a 30 mg, 60 mg or 
75 mg dose by using the contents of 45 mg capsules. Use the appropriate size capsule instead.  

 
Weight Dose of Tamiflu Number of capsules 
Up to 15 kg 30 mg Do not use 45 mg capsules 
15 kg up to 23 kg 45 mg 1 capsule 
23 kg up to 40 kg 60 mg Do not use 45 mg capsules 



88 

 
Step 2: Pour all the powder into a bowl 
 

Hold a 45 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.   
Pour all of the powder into the bowl.   
Be careful with the powder, because it may irritate your skin and eyes. 

 

   
 
Step 3: Sweeten the powder and give the dose 
 

Add a small amount – no more than one teaspoonful – of sweet food to the powder in the bowl.  
This is to hide the bitter taste of the Tamiflu powder. 
Stir the mixture well.  

 

   
 

Give the whole contents of the bowl to the patient straight away.  
 
If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get 
the patient to drink it all. 
 
Repeat this procedure every time you need to give the medicine. 

 
Infants less than 1 year 
 
To make a smaller single dose, you need: 

∑ One 45 mg Tamiflu capsule 
∑ Sharp scissors 

∑ Two small bowls (use separate pairs of bowls for each child) 
∑ One large oral dose dispenser to measure out water – a 5 ml dispenser or 10 ml dispenser 
∑ One small oral dose dispenser showing measurements of 0.1 ml, to give the dose 
∑ Teaspoon (5 ml spoon) 
∑ Water 
∑ Sweet food to hide the bitter taste of the Tamiflu. 

Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge 
sauce.  
Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a 
teaspoon of sugar. 

 
Step 1: Pour all the powder into a bowl 
 

Hold a 45 mg capsule upright over one of the bowls and carefully snip off the rounded tip with 
scissors. Be careful with the powder: it may irritate your skin and eyes. 
Pour all of the powder into the bowl, whatever the dose you are making.  
The amount is the same whether you are treating or preventing flu. 
 



89 

     
 
Step 2: Add water to dilute the medicine 
 

Use the larger dispenser 
draw up 7.5 ml water. 
 
Add the water to the 
powder in the bowl. 

 
 

Stir the mixture with 
the teaspoon for 
about 2 minutes. 

 
 
Don’t worry if not all of the powder dissolves. The undissolved powder is just inactive 
ingredients. 

 
Step 3: Choose the correct amount for your child’s weight 

Look up the child’s weight on the left side of the table.  
The column on the right of the table shows how much of the liquid mixture you will need to 
draw up.  

 
Infants less than 1 year (including full term newborn babies) 
 

Child’s weight 
(nearest) 

How much mixture  
to draw up 

3 kg 1.5 ml 
3.5 kg 1.8 ml 
4 kg 2.0 ml 
4.5 kg 2.3 ml 
5 kg 2.5 ml 
5.5 kg 2.8 ml 
6 kg 3.0 ml 
6.5 kg 3.3 ml 
7 kg 3.5 ml 
7.5 kg 3.8 ml 
8 kg 4.0 ml 
8.5 kg 4.3 ml 
9 kg 4.5 ml 
9.5 kg 4.8 ml 
10 kg or more 5.0 ml 

 



90 

Step 4: Draw up the liquid mixture 
 

Make sure you have the right size dispenser.  
Draw up the correct amount of liquid mixture from the first bowl.  
Draw it up carefully so as not to include air bubbles. 
Gently squirt the correct dose into the second bowl.  

 

     
 
Step 5: Sweeten and give to the child 
 

Add a small amount – no more than one teaspoonful – of a sweet food to the second bowl. 
This is to hide the bitter taste of the Tamiflu. 
Mix the sweet food and Tamiflu liquid well.  

 

   
 

Give the whole contents of the second bowl (Tamiflu liquid mixture with sweet food added) to 
the child straight away. 
 
If there is anything left in the second bowl, rinse the bowl with a small amount of water and 
get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle 
to feed the child the remaining liquid. 
 
Give the child something to drink. 
 
Throw away any unused liquid left in the first bowl. 

 
 Repeat this procedure every time you need to give the medicine. 

 
  



91 

--------------------------------------------------------------------------------------------------------------------------- 
 
Information for healthcare professionals only 
 
Patients who are unable to swallow capsules 
Commercially manufactured Tamiflu for oral suspension (6mg/ml) is the preferred product for 
paediatric and adult patients who have difficulties swallowing capsules or where lower doses are 
needed.  In the event thatTamiflu powder for oral suspension is not available, the pharmacist may 
compound a suspension (6 mg/ml) from Tamiflu capsules. If the pharmacy compounded suspension is 
also not available, patients may prepare the suspension from capsules at home. 
 
Oral dose dispensers (oral syringes) of appropriate volume and grading should be provided for 
administering the pharmacy compounded suspension, and for the procedures involved in the home 
preparation. In both cases, the correct volumes should preferably be marked on the dispensers. For 
home preparation, separate dispensers should be provided for taking the correct volume of water and 
for measuring the Tamiflu-water mixture. For measuring 5.0 ml of water, dispensers of 5 ml or 10 ml 
should be used. 
 
The appropriate dispenser sizes for taking the correct volume of Tamiflu suspension (6 mg/ml) are 
shown below. 
 
Infants less than 1 year (including full term new born babies):  
 

Dose of Tamiflu 
Amount of Tamiflu 

suspension 
Dispenser size to use 

(grading 0.1 ml) 
9 mg 1.5 ml 2.0 ml (or 3.0 ml) 

10 mg 1.7 ml 2.0 ml (or 3.0 ml) 
11.25 mg 1.9 ml 2.0 ml (or 3.0 ml) 
12.5 mg 2.1 ml 3.0 ml 
13.75 mg 2.3 ml 3.0 ml 

15 mg 2.5 ml 3.0 ml 
16.25 mg 2.7 ml 3.0 ml 

18 mg 3.0 ml 3.0 ml (or 5.0 ml) 
19.5 mg 3.3 ml 5.0 ml 
21 mg 3.5 ml 5.0 ml 

22.5 mg 3.8 ml 5.0 ml 
24 mg 4.0 ml 5.0 ml 

25.5 mg 4.3 ml 5.0 ml 
27 mg 4.5 ml 5.0 ml 

28.5 mg 4.8 ml 5.0 ml 
30 mg 5.0 ml 5.0 ml 

 
  



92 

Package Leaflet: Information for the user 
 

Tamiflu 75 mg hard capsules 
oseltamivir 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
∑ Keep this leaflet. You may need to read it again. 
∑ If you have further questions, ask your doctor or pharmacist. 
∑ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
∑ If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Tamiflu is and what it is used for 
2. What you need to know before you take Tamiflu  
3. How to take Tamiflu  
4. Possible side effects 
5. How to store Tamiflu  
6. Contents of the pack and other information 
 
 
1. What Tamiflu is and what it is used for 
 
∑ Tamiflu is used for adults, adolescents, children and infants (including full-term newborn 

babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu 
virus is known to be going round in your community. 

∑ Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age 
for preventing flu, on a case-by-case basis – for instance, if you have been in contact with 
someone who has flu.  

∑ Tamiflu may be prescribed for adults, adolescents, children and infants (including full-term 
newborn babies) as preventive treatment in exceptional circumstances – for example, if there 
is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide 
sufficient protection.  

 
Tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. 
These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the 
symptoms of the flu virus infection. 
 
Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden 
fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme 
tiredness. These symptoms can also be caused by other infections. True influenza infection only 
occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. 
Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.  
 
 
2. What you need to know before you take Tamiflu 
 
Do not take Tamiflu: 
∑ if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu 

listed in section 6.  
Talk to your doctor if this applies to you. Do not take Tamiflu. 
 



93 

Warnings and precautions: 
Before you take Tamiflu, make sure the prescribing doctor knows 
∑ if you are allergic to other medicines 
∑ if you have problems with your kidneys. If so, your dose may need adjustment 
∑ if you have a severe medical condition, which may require immediate hospitalisation 
∑ if your immune system is not working 
∑ if you have chronic heart disease or respiratory disease. 
 
During treatment with Tamiflu, tell a doctor immediately: 
∑ if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and 

adolescents). These may be signs of rare but serious side effects.  
 
Tamiflu is not a flu vaccine 
Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you 
antibodies against the virus. Tamiflu will not change the effectiveness of a flu vaccine, and you might 
be prescribed both by your doctor.  
 
Other medicines and Tamiflu 
Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. This 
includes medicines obtained without a prescription. The following medicines are particularly 
important: 

∑ chlorpropamide (used to treat diabetes) 
∑ methotrexate (used to treat e.g. rheumatoid arthritis) 
∑ phenylbutazone (used to treat pain and inflammation) 
∑ probenecid (used to treat gout) 

 
Pregnancy and breast-feeding 
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get 
pregnant so that your doctor can decide if Tamiflu is right for you. 
 
The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so 
that your doctor can decide if Tamiflu is right for you. 
 
Ask your doctor or pharmacist for advice before taking this medicine. 
 
Driving and using machines 
Tamiflu has no effect on your ability to drive or use machines. 
 
 
3. How to take Tamiflu 
 
Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure. 
 
Take Tamiflu as soon as possible, ideally within two days of the flu symptoms starting. 
 
The recommended doses 
 
For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and 
one in the evening. It is important to complete the whole 5-day course, even if you start to feel 
better quickly. 
 
For patients with a weak immune system, treatment will continue for 10 days. 
 
For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It 
is best to take this in the mornings with breakfast. 
 



94 

In special situations, such as widespread flu or for patients with a weak immune system, treatment will 
continue for up to 6 or 12 weeks. 
 
The recommended dose is based on the patient’s body weight.You must use the amount of oral 
capsules or suspension prescribed by the doctor.  
 
Adults, and adolescents 13 years and over  
 
Body weight Treating flu:  

dose  
for 5 days  

Treating flu 
(Immunocompromised 
Patients):  
dose  
for 10 days * 

Preventing flu:  
dose  
for 10 days 

40 kg or more 75 mg** twice daily 75 mg** twice daily 75 mg** once daily 
* For patients with a weak immune system, treatment is for 10 days. 
**75 mg can be made up of a 30 mg capsule plus a 45 mg capsule 
 
Children 1 to 12 years  
 
Body weight Treating flu:  

dose  
for 5 days 

Treating flu 
(Immunocompromised 
Patients):  
dose  
for 10 days* 

Preventing flu:  
dose  
for 10 days 

10 to 15 kg 30 mg twice daily 30 mg twice daily 30 mg once daily 
More than 15 kg and up 
to 23 kg 

45 mg twice daily 45 mg twice daily 45 mg once daily 

More than 23 kg and up 
to 40 kg 

60 mg twice daily 60 mg twice daily 60 mg once daily 

More than 40 kg 75 mg** twice daily 75 mg** twice daily 75 mg** once daily 
* For children with a weak immune system, treatment is for 10 days. 
**75 mg can be made up of a 30 mg capsule plus a 45 mg capsule 
 
Infants less than 1 year (0 to 12 months) 
Giving Tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based 
upon the judgment of a doctor after considering the potential benefit versus any potential risk to the 
infant.  
 
Body weight Treating flu:  

dose  
for 5 days 

Treating flu 
(Immunocompromised 
Patients):  
dose  
for 10 days* 

Preventing flu:  
dose  
for 10 days 

3 kg to 10+ kg, 
 

3 mg per kg body  
weight**, twice daily 

3 mg per kg body  
weight**, twice daily 

3 mg per kg**,  
once daily 

* For infants with a weak immune system, treatment is for 10 days. 
**mg per kg = mg for each kilogram of the infant’s body weight. For example: 
If a 6-month-old weighs 8 kg, the dose is 
8 kg x 3mg per kg = 24 mg 
 
Method of administration 
Swallow the capsules whole with water. Do not break or chew the capsules. 
 
Tamiflu can be taken with or without food, although taking it with food can reduce the chance of 
feeling or being sick (nausea or vomiting). 
 



95 

People who find it hard to take capsules can use a liquid medicine, Tamiflu oral suspension. If you 
need Tamiflu oral suspension, but it’s not available from your pharmacy, you can make a liquid form 
of Tamiflu from these capsules. See Making liquid Tamiflu at home, over the page. 
 
If you take more Tamiflu than you should  
Stop taking Tamiflu and contact a doctor or pharmacist immediately. 
In most cases of overdose, people have not reported any side effects. When side effects were reported, 
they were similar to those from normal doses, as listed in section 4. 
Overdose has been reported to have occurred more frequently when Tamiflu was given to children 
than to adults and adolescents. Caution should be exercised when preparing liquid Tamiflu for 
children and when administering Tamiflu capsules or liquid Tamiflu to children. 
 
If you forget to take Tamiflu 
Do not take a double dose to make up for a forgotten capsule. 
 
If you stop taking Tamiflu 
There are no side effects when you stop Tamiflu. But if Tamiflu is stopped earlier than your doctor 
told you, the symptoms of flu may come back. Always complete the course that your doctor 
prescribed. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of 
the side effects listed below may also be caused by influenza. 
 
The following serious side effects have been rarely reported since oseltamivir has been marketed: 

∑ Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin 
swelling, itchy rashes, low blood pressure and breathing difficulties 

∑ Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of 
the skin and white of the eyes, change in stool color, changes in behaviour 

∑ Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head 
and neck area, including eyes and tongue, with difficulties breathing 

∑ Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life-
threatening allergic reaction, severe inflammation of the outer and possibly inner skin, 
initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding 
of larger areas of skin, possible breathing difficulties and low blood pressure 

∑ Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood 
∑ Neuropsychiatric disorders, as described below. 
 

If you notice any of these symptoms, get medical help immediately. 
 
The most frequently (very common and common) reported side effects of Tamiflu are feeling or being 
sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly 
occur after the first dose of the medicine and will usually stop as treatment continues. The frequency 
of these effects is reduced if the medicinal product is taken with food. 
 
Rare but serious effects: get medical help at once 
(These may affect up to 1 in 1,000 people)  
During Tamiflu treatment, rare events have been reported that include 

∑ Convulsions and delirium, including altered level of consciousness 
∑ Confusion, abnormal behaviour 
∑ Delusions, hallucinations, agitation, anxiety, nightmares 



96 

These are reported primarily among children and adolescents and often started suddenly and resolved 
rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events 
have also been reported in patients with influenza who were not taking Tamiflu. 

∑ Patients, especially children and adolescents, should be closely monitored for the 
behavioural changes described above. 

If you notice any of these symptoms, especially in younger people, get medical help immediately. 
 
Adults and adolescents 13 and over 
 
Very common side effects 
(may affect more than 1 in 10 people) 

∑ Headache 
∑ Nausea. 

 
Common side effects 
(may affect up to 1 in 10 people) 

∑ Bronchitis  
∑ Cold sore virus 
∑ Cough 
∑ Dizziness 
∑ Fever 
∑ Pain 
∑ Pain in limb 
∑ Runny nose 
∑ Sleeping difficulties 
∑ Sore throat 
∑ Stomach ache  
∑ Tiredness 
∑ Upper abdominal fullness  
∑ Upper respiratory tract infections (inflammation of the nose, throat and sinuses) 
∑ Upset stomach 
∑ Vomiting. 

 
Uncommon side effects 
(may affect up to 1 in 100 people) 

∑ Allergic reactions 
∑ Altered level of consciousness 
∑ Convulsion 
∑ Heart rhythm abnormalities 
∑ Mild to severe liver function disorders 
∑ Skin reactions (inflammation of the skin, red and itchy rash, scaling skin). 

 
Rare side effects 
(may affect up to 1 in 1,000 people) 

∑ Thrombocytopenia (low platelet count) 
∑ Visual disturbances. 

 
Children 1 to 12 years  
 
Very common side effects 
(may affect more than 1 in 10 people) 

∑ Cough 
∑ Nasal congestion 
∑ Vomiting. 

 



97 

Common side effects 
(may affect up to 1 in 10 people) 

∑ Conjunctivitis (red eyes and discharge or pain in the eye) 
∑ Ear inflammation and other ear disorders 
∑ Headache 
∑ Nausea 
∑ Runny nose 
∑ Stomach ache 
∑ Upper abdominal fullness  
∑ Upset stomach. 

 
Uncommon side effects 
(may affect up to 1 in 100 people) 

∑ Inflammation of the skin 
∑ Tympanic membrane (eardrum) disorder. 

 
Infants less than 1 year  
The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported 
for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been  reported.. 
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your 
doctor or pharmacist. However, 

∑ if you or your child are repeatedly sick, or 
∑ if the influenza symptoms get worse or the fever continues 

Tell your doctor as soon as possible. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this 
leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 
By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store Tamiflu 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The 
expiry date refers to the last day of that month. 
 
Do not store above 25 ∞C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Tamiflu contains 
∑ Each hard capsule contains oseltamivir equivalent to 75 mg of oseltamivir  
∑ The other ingredients are: 

capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium 
stearyl fumarate 
capsule shell: gelatin, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) 
and titanium dioxide (E171)  
printing ink: shellac (E904), titanium dioxide (E171) FD and C Blue 2 (indigo carmine E132). 

 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


98 

What Tamiflu looks like and contents of the pack 
The 75 mg hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a light 
yellow opaque cap bearing the imprint “75 mg”. Imprints are blue. 
 
Tamiflu 75 mg hard capsules are available in blister packs of 10. 
 
Marketing Authorisation Holder and Manufacturer 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
Roche Pharma AG 
Emil-Barell-Str. 1,  
D-79639 Grenzach-Wyhlen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Malta 
(See Ireland) 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

France 
Roche 
Tél: +33 (0) 1 47 61 40 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 



99 

Hrvatska 
Roche d.o.o 
Tel:  +385 1 4722 333 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταμάτης & Σια Λτδ. 
Τηλ: +357 - 22 76 62 76 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency  web site: 
http://www.ema.europa.eu 
  



100 

--------------------------------------------------------------------------------------------------------------------------- 
 
Information for the user 
 
For people who find it hard to take capsules, including very young children, there’s a liquid 
medicine, Tamiflu oral suspension.  
 
If you need a liquid medicine, but it’s not available, a suspension can be made up at the pharmacy 
from Tamiflu capsules (see Information for healthcare professionals). This pharmacy preparation is 
the preferred option. 
 
If the pharmacy preparation is not available either, you can make liquid Tamiflu from these capsules at 
home. 
 
The dose is the same for treating or preventing flu. The difference is how often it is given. 
 
Making liquid Tamiflu at home 
 
∑ If you have the right capsule strength for the dose needed (a 75 mg dose), you will open the 

capsule and stir its contents into one teaspoon (or less) of a suitable sweetened food product. 
This is usually suitable for children over 1 year. See the upper set of instructions. 

 
∑ If you need smaller doses, making liquid Tamiflu from capsules involves extra steps. This is 

suitable for younger children and babies: they usually need a Tamiflu dose of less than 30 mg. 
See the lower set of instructions. 

 
Adults, adolescents 13 years and over, and children weighing 40 kg and over 
 
To make a 75 mg dose, you need: 

∑ One 75 mg Tamiflu capsule 
∑ Sharp scissors 
∑ One small bowl  
∑ Teaspoon (5 ml spoon) 
∑ Water 
∑ Sweet food to hide the bitter taste of the powder. 
 Examples are: chocolate or cherry syrup, and dessert toppings such as caramel or fudge 

sauce. Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a 
teaspoon of sugar. 

 
Step 1: Check the dose is correct 
 

To find the correct amount to use, find the patient’s weight on the left of the table. 
Look at the right column to check the number of capsules you will need to give the patient for a 
single dose. The amount is the same whether treating or preventing flu. 
 

75 mg dose  

 
You should use only 75 mg capsules for 75 mg doses. Do not try to make a 75 mg dose by using 
the contents of 30 mg or 45 mg capsules.  

 
Weight 
 

Dose of Tamiflu Number of capsules 

40 kg and over 75 mg 1 capsule 
 



101 

Not for children who weigh less than 40 kg 
You will need to prepare a dose of less than 75 mg for children who weigh less than 40 kg. See 
below.   

 
Step 2: Pour all the powder into a bowl 
 

Hold a 75 mg capsule upright over a bowl and carefully snip off the rounded tip with scissors.   
Pour all of the powder into the bowl. 
Be careful with the powder, because it may irritate your skin and eyes. 

 

   
 
Step 3: Sweeten the powder and give the dose 
 

Add a small amount – no more than one teaspoonful – of sweet food to the powder in the bowl.  
This is to hide the bitter taste of the Tamiflu powder. 
Stir the mixture well.  

 

   
 

Give the whole contents of the bowl to the patient straight away.  
 
If there is some mixture left in the bowl, rinse the bowl with a small amount of water and get 
the patient to drink it all. 
 
Repeat this procedure every time you need to give the medicine. 

 
Infants less than 1 year, and children weighing less than 40 kg 
 
To make a smaller single dose, you need: 

∑ One 75 mg Tamiflu capsule 
∑ Sharp scissors 
∑ Two small bowls  
∑ One large oral dose dispenser to measure out water – a 5 or 10 ml dispenser 
∑ One small oral dose dispenser showing measurements of 0.1 ml, to give the dose  
∑ Teaspoon (5 ml spoon) 
∑ Water 
∑ Sweet food to hide the bitter taste of the Tamiflu. 

Examples are: chocolate or cherry syrup and dessert toppings such as caramel or fudge 
sauce.  
Or you can make sugar water: mix a teaspoon of water with three-quarters (3/4) of a 
teaspoon of sugar. 

 
Step 1: Pour all the powder into a bowl 

 
Hold a 75 mg capsule upright over one of the bowls and carefully snip off the rounded tip with 
scissors. Be careful with the powder: it may irritate your skin and eyes. 



102 

Pour all of the powder into the bowl, whatever the dose you are making. 
The amount is the same whether you are treating or preventing flu. 

 

    
 
Step 2: Add water to dilute the medicine 
 

Use the larger dispenser 
to draw up 12.5 ml water.  
 
Add the water to the 
powder in the bowl. 

 
 

Stir the mixture with 
the teaspoon for 
about 2 minutes. 

 
 
Don’t worry if not all of the powder dissolves. The undissolved powder is just inactive 
ingredients. 

 
Step 3: Choose the correct amount for your child’s weight 
 

Look up the child’s weight on the left side of the table.  
The column on the right of the table shows how much of the liquid mixture you will need to 
draw up.  

 
Infants less than 1 year (including full-term newborn babies)  

Child’s weight 
(nearest) 

How much mixture  
to draw up 

3 kg 1.5 ml 
3.5 kg 1.8 ml 
4 kg 2.0 ml 
4.5 kg 2.3 ml 
5 kg 2.5 ml 
5.5 kg 2.8 ml 
6 kg 3.0 ml 
6.5 kg 3.3 ml 
7 kg 3.5 ml 
7.5 kg 3.8 ml 
8 kg 4.0 ml 
8.5 kg 4.3 ml 
9 kg 4.5 ml 
9.5 kg 4.8 ml 
10 kg or more 5.0 ml 

 



103 

Children 1 year or older, weighing less than 40 kg 
Child’s weight 
(nearest) 

How much mixture  
to draw up 

Up to 15 kg 5.0 ml 
15 to 23 kg 7.5 ml 
23 to 40 kg 10.0 ml 

 
Step 4: Draw up the liquid mixture 
 

Make sure you have the right size dispenser.  
Draw up the correct amount of liquid mixture from the first bowl.  
Draw it up carefully so as not to include air bubbles. 
Gently squirt the correct dose into the second bowl.  

 

    
 
Step 5: Sweeten and give to the child 
 

Add a small amount – no more than one teaspoonful – of a sweet food to the second bowl. 
This is to hide the bitter taste of the Tamiflu. 
Mix the sweet food and Tamiflu liquid well.  

 

   
 

Give the whole contents of the second bowl (Tamiflu liquid mixture with sweet food added) to 
the child straight away. 
 
If there is anything left in the second bowl, rinse the bowl with a small amount of water and 
get the child to drink it all. For children unable to drink from a bowl, spoon-feed or use a bottle 
to feed the child the remaining liquid. 
 
Give the child something to drink.  
 
Throw away any unused liquid left in the first bowl. 
 
Repeat this procedure every time you need to give the medicine. 

  



104 

--------------------------------------------------------------------------------------------------------------------------- 
 
Information for healthcare professionals only 
 
Patients who are unable to swallow capsules:  
Commercially manufactured Tamiflu for oral suspension (6mg/ml) is the preferred product for 
paediatric and adult patients who have difficulties swallowing capsules or where lower doses are 
needed.  In the event thatTamiflu powder for oral suspension is not available, the pharmacist may 
compound a suspension (6 mg/ml) from Tamiflu capsules. If the pharmacy compounded suspension is 
also not available, patients may prepare the suspension from capsules at home. 
 
Oral dose dispensers (oral syringes) of appropriate volume and grading should be provided for 
administering the pharmacy compounded suspension, and for the procedures involved in the home 
preparation. In both cases, the correct volumes should preferably be marked on the dispensers. For 
home preparation, separate dispensers should be provided for taking the correct volume of water and 
for measuring the Tamiflu-water mixture. For measuring 12.5 ml of water a 10 ml dispenser should be 
used. 
 
The appropriate dispenser sizes for taking the correct volume of Tamiflu suspension (6 mg/ml) are 
shown below. 
 
Infants less than 1 year (including full-term new born babies):  
 

Dose of Tamiflu 
Amount of Tamiflu 

suspension 
Dispenser size to use 

(grading 0.1 ml) 
9 mg 1.5 ml 2.0 ml (or 3.0 ml) 

10 mg 1.7 ml 2.0 ml (or 3.0 ml) 
11.25 mg 1.9 ml 2.0 ml (or 3.0 ml) 
12.5 mg 2.1 ml 3.0 ml 
13.75 mg 2.3 ml 3.0 ml 

15 mg 2.5 ml 3.0 ml 
16.25 mg 2.7 ml 3.0 ml 

18 mg 3.0 ml 3.0 ml (or 5.0 ml) 
19.5 mg 3.3 ml 5.0 ml 
21 mg 3.5 ml 5.0 ml 

22.5 mg 3.8 ml 5.0 ml 
24 mg 4.0 ml 5.0 ml 

25.5 mg 4.3 ml 5.0 ml 
27 mg 4.5 ml 5.0 ml 

28.5 mg 4.8 ml 5.0 ml 
30 mg 5.0 ml 5.0 ml 

 
Children 1 year or older, weighing less than 40 kg: 
 

Dose of Tamiflu 
Amount of Tamiflu 

suspension 
Dispenser size to use 

(grading 0.1 ml) 
30 mg 5.0 ml 5.0 ml (or 10.0 ml) 
45 mg 7.5 ml 10.0 ml 
60 mg 10.0 ml  10.0 ml 

 
  



105 

Package Leaflet: Information for the user 
 

Tamiflu 6 mg/ml powder for oral suspension 
oseltamivir 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
∑ Keep this leaflet. You may need to read it again. 
∑ If you have further questions, ask your doctor or pharmacist. 
∑ This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
∑ If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible 

side effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Tamiflu is and what it is used for 
2. What you need to know before you take Tamiflu  
3. How to take Tamiflu  
4. Possible side effects 
5. How to store Tamiflu  
6. Contents of the pack and other information 
 
 
1. What Tamiflu is and what it is used for 
 
∑ Tamiflu is used for adults, adolescents, children and infants (including full-term newborn 

babies) for treating flu (influenza). It can be used when you have flu symptoms, and the flu 
virus is known to be going round in your community. 

∑ Tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age 
for preventing flu, on a case-by-case basis – for instance, if you have been in contact with 
someone who has flu.  

∑ Tamiflu may be prescribed for adults, adolescents, children and infants (including full-term 
newborn babies) as preventive treatment in exceptional circumstances – for example, if there 
is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide 
sufficient protection.  

 
Tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. 
These medicines prevent the flu virus from spreading inside the body. They help to ease or prevent the 
symptoms of the flu virus infection. 
 
Influenza, usually called flu, is an infection caused by a virus. The signs of flu often include a sudden 
fever (more than 37.8 °C), cough, runny or stuffy nose, headaches, muscle aches and extreme 
tiredness. These symptoms can also be caused by other infections. True influenza infection only 
occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. 
Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.  
 
 
2. What you need to know before you take Tamiflu 
 
Do not take Tamiflu: 
∑ if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of Tamiflu 

listed in section 6.  
Talk to your doctor if this applies to you. Do not take Tamiflu. 
 



106 

Warnings and precautions: 
Before you take Tamiflu, make sure the prescribing doctor knows 
∑ if you are allergic to other medicines 
∑ if you have problems with your kidneys. If so, your dose may need adjustment 
∑ if you have a severe medical condition, which may require immediate hospitalisation 
∑ if your immune system is not working 
∑ if you have chronic heart disease or respiratory disease. 
 
During treatment with Tamiflu, tell a doctor immediately: 
∑ if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and 

adolescents). These may be signs of rare but serious side effects.  
 
Tamiflu is not a flu vaccine 
Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you 
antibodies against the virus. Tamiflu will not change the effectiveness of a flu vaccine, and you might 
be prescribed both by your doctor.  
 
Other medicines and Tamiflu 
Tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. This 
includes medicines obtained without a prescription. The following medicines are particularly 
important: 

∑ chlorpropamide (used to treat diabetes) 
∑ methotrexate (used to treat e.g. rheumatoid arthritis) 
∑ phenylbutazone (used to treat pain and inflammation) 
∑ probenecid (used to treat gout) 

 
Pregnancy and breast-feeding 
You must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get 
pregnant so that your doctor can decide if Tamiflu is right for you. 
 
The effects on breast-fed infants are unknown. You must tell your doctor if you are breast-feeding so 
that your doctor can decide if Tamiflu is right for you. 
 
Ask your doctor or pharmacist for advice before taking this medicine. 
 
Driving and using machines 
Tamiflu has no effect on your ability to drive or use machines. 
 
Tamiflu contains fructose 
Before you take Tamiflu, make sure your prescribing doctor knows if you have hereditary fructose 
intolerance. This medicine contains sorbitol, which is a form of fructose.  
Sorbitol can have a mild laxative effect. 
 
 
3. How to take Tamiflu 
 
Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure. 
 
Always use the oral dispenser that is provided in the box and has markings indicating the dose in 
millilitres (ml). 
 
Take Tamiflu as soon as possible, ideally within two days of the flu symptoms starting. 
 



107 

The recommended doses 
 
For treating flu, take two doses daily. It is usually convenient to take one dose in the morning and 
one in the evening. It is important to complete the whole 5-day course, even if you start to feel 
better quickly. 
 
For patients with a weak immune system, treatment will continue for 10 days. 
 
For preventing flu or after being exposed to an infected person, take one dose daily for 10 days. It 
is best to take this in the mornings with breakfast. 
 
In special situations, such as widespread flu, or for patients with a weak immune system, treatment 
will continue for up to 6 or 12 weeks. 
 
The recommended dose is based on the patient’s body weight. You must use the amount of 
Tamiflu prescribed by the doctor. The oral suspension can be used by people who find it hard to take 
capsules. See the instructions overleaf to make up and give a dose. 
 
Adults, and adolescents 13 years and over 
 
Body weight Treating flu:  

dose  
for 5 days 

Treating flu 
(Immunocompromised 
Patients):  
dose  
for 10 days* 

Preventing flu: 
dose  
for 10 days 

40 kg or more 12.5 ml** twice daily 12.5 ml** twice daily 12.5 ml** once 
daily 

*For patients with a weak immune system, treatment is for 10 days. 
**12.5 ml is made up of a 5 ml dose plus a 7.5 ml dose 
 
Children 1 to 12 years  
 
Body weight Treating flu: 

dose  
for 5 days 

Treating flu 
(Immunocompromised 
Patients): 
dose  
for 10 days* 

Preventing flu: 
dose  
for 10 days 

10 kg to 15 kg 5.0 ml twice daily 5.0 ml twice daily 5.0 ml once daily 
More than 15 kg,  
up to 23 kg 

7.5 ml twice daily 7.5 ml twice daily 7.5 ml once daily 

More than 23 kg,  
up to 40 kg 

10.0 ml twice daily 10.0 ml twice daily 10.0 ml once daily 

More than 40 kg 12.5 ml** twice daily 12.5 ml** twice daily 12.5 ml** once 
daily 

*For children with a weak immune system, treatment is for 10 days. 
**12.5 ml is made up of a 5 ml dose plus a 7.5 ml dose 
 
Infants less than 1 year (0 to 12 months) 
Giving Tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based 
upon the judgment of a doctor after considering the potential benefit versus any potential risk to the 
infant.  
A 3 ml oral dispenser (graduated in 0.1 ml steps) should be used for dosing infants less than 1 year old 
requiring 1 to 3 ml of Tamiflu oral suspension.  
 



108 

Body weight Treating flu: 
dose 
for 5 days 

Treating flu 
(Immunocompromised 
Patients): 
dose 
for 10 days* 

Preventing flu: 
dose  
for 10 days 

Dispenser size 
to use 

3 kg 1.5 ml twice daily 1.5 ml twice daily 1.5 ml once daily 3 ml 
3.5 kg 1.8 ml twice daily 1.8 ml twice daily 1.8 ml once daily 3 ml 
4 kg 2.0 ml twice daily 2.0 ml twice daily 2.0 ml once daily 3 ml 
4.5 kg 2.3 ml twice daily 2.3 ml twice daily 2.3 ml once daily 3 ml 
5 kg 2.5 ml twice daily 2.5 ml twice daily 2.5 ml once daily 3 ml 
5.5 kg 2.8 ml twice daily 2.8 ml twice daily 2.8 ml once daily 3 ml 
6 kg 3.0 ml twice daily 3.0 ml twice daily 3.0 ml once daily 3 ml 
> 6 to 7 kg 3.5 ml twice daily 3.5 ml twice daily 3.5 ml once daily 10 ml 
> 7 to 8 kg 4.0 ml twice daily 4.0 ml twice daily 4.0 ml once daily 10 ml 
> 8 to 9 kg 4.5 ml twice daily 4.5 ml twice daily 4.5 ml once daily 10 ml 
> 9 to 10 kg 5.0 ml twice daily 5.0 ml twice daily 5.0 ml once daily 10 ml 

*For patients with a weak immune system, treatment is for 10 days. 
 
If you take more Tamiflu than you should 
Stop taking Tamiflu and contact a doctor or pharmacist immediately. 
In most cases of overdose, people have not reported any side effects. When side effects were reported, 
they were similar to those from normal doses, as listed in section 4. 
Overdose has been reported to have occurred more frequently when Tamiflu was given to children 
than to adults and adolescents. Caution should be exercised when preparing liquid Tamiflu for 
children and when administering Tamiflu capsules or liquid Tamiflu to children. 
 
If you forget to take Tamiflu 
Do not take a double dose to make up for a forgotten dose. 
 
If you stop taking Tamiflu 
There are no side effects when you stop Tamiflu. But if Tamiflu is stopped earlier than your doctor 
told you, the symptoms of flu may come back. Always complete the course that your doctor 
prescribed. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of 
the side effects listed below may also be caused by influenza. 
 
The following serious side effects have been rarely reported since oseltamivir has been marketed: 

∑ Anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin 
swelling, itchy rashes, low blood pressure and breathing difficulties 

∑ Hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of 
the skin and white of the eyes, change in stool color, changes in behaviour 

∑ Angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head 
and neck area, including eyes and tongue, with difficulties breathing 

∑ Stevens-Johnson syndrome and toxic epidermal necrolysis: complicated, possibly life-
threatening allergic reaction, severe inflammation of the outer and possibly inner skin, 
initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding 
of larger areas of skin, possible breathing difficulties and low blood pressure 

∑ Gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood 
∑ Neuropsychiatric disorders, as described below. 



109 

If you notice any of these symptoms, get medical help immediately. 
 
The most frequently (very common and common) reported side effects of Tamiflu are feeling or being 
sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. These side effects mostly 
occur after the first dose of the medicine and will usually stop as treatment continues. The frequency 
of these effects is reduced if the medicinal product is taken with food. 
 
Rare but serious effects: get medical help at once 
(These may affect up to 1 in 1,000 people)  
During Tamiflu treatment, rare events have been reported that include 

∑ Convulsions and delirium, including altered level of consciousness 
∑ Confusion, abnormal behaviour 
∑ Delusions, hallucinations, agitation, anxiety, nightmares 

These are reported primarily among children and adolescents and often started suddenly and resolved 
rapidly. A few cases resulted in self-injury, some with fatal outcome. Such neuropsychiatric events 
have also been reported in patients with influenza who were not taking Tamiflu. 

∑ Patients, especially children and adolescents, should be closely monitored for the 
behavioural changes described above. 

If you notice any of these symptoms, especially in younger people, get medical help immediately. 
 
Adults and adolescents 13 and over 
 
Very common side effects 
(may affect more than 1 in 10 people) 

∑ Headache 
∑ Nausea. 

 
Common side effects 
(may affect up to 1 in 10 people) 

∑ Bronchitis  
∑ Cold sore virus 
∑ Cough 
∑ Dizziness 
∑ Fever 
∑ Pain 
∑ Pain in limb 
∑ Runny nose 
∑ Sleeping difficulties 
∑ Sore throat 
∑ Stomach ache  
∑ Tiredness 
∑ Upper abdominal fullness  
∑ Upper respiratory tract infections (inflammation of the nose, throat and sinuses) 
∑ Upset stomach 
∑ Vomiting. 

 
Uncommon side effects 
(may affect up to 1 in 100 people) 

∑ Allergic reactions 
∑ Altered level of consciousness 
∑ Convulsion 
∑ Heart rhythm abnormalities 
∑ Mild to severe liver function disorders 
∑ Skin reactions (inflammation of the skin, red and itchy rash, scaling skin). 

 



110 

Rare side effects 
(may affect up to 1 in 1,000 people) 

∑ Thrombocytopenia (low platelet count) 
∑ Visual disturbances. 

 
Children 1 to 12 years  
 
Very common side effects 
(may affect more than 1 in 10 people) 

∑ Cough 
∑ Nasal congestion 
∑ Vomiting. 

 
Common side effects 
(may affect up to 1 in 10 people) 

∑ Conjunctivitis (red eyes and discharge or pain in the eye) 
∑ Ear inflammation and other ear disorders 
∑ Headache 
∑ Nausea 
∑ Runny nose 
∑ Stomach ache 
∑ Upper abdominal fullness  
∑ Upset stomach. 

 
Uncommon side effects 
(may affect up to 1 in 100 people) 

∑ Inflammation of the skin 
∑ Tympanic membrane (eardrum) disorder. 

 
Infants less than 1 year  
The reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported 
for older children (1 year old or older). Additionally, diarrhoea and diaper rash have been reported. 
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your 
doctor or pharmacist. However, 

∑ if you or your child are repeatedly sick, or 
∑ if the influenza symptoms get worse or the fever continues 

Tell your doctor as soon as possible. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this 
leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 
By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store Tamiflu 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The 
expiry date refers to the last day of that month. 
 
Powder: Do not store above 30∞C. 
After reconstitution, store below 25 °C for 10 days. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 

https://www.ema.europa.eu/documents/template-form/appendix-v-adverse-drug-reaction-reporting-details_en.doc


111 

 
 
6. Contents of the pack and other information 
 
What Tamiflu contains 
 
∑ The active substance is oseltamivir (6 mg/ml oseltamivir after reconstitution). 
∑ The other ingredients are sorbitol (E420), sodium dihydrogen citrate (E331[a]), xanthan gum 

(E415), sodium benzoate (E211), saccharin sodium (E954), titanium dioxide (E171) and tutti 
frutti flavour (including maltodextrins [maize], propylene glycol, arabic gum E414 and natural 
identical flavouring substances [mainly consisting of banana, pineapple and peach flavour]). 

 
What Tamiflu looks like and contents of the pack 
 
Powder for oral suspension 
 
The powder is a granulate or clumped granulate with a white to light yellow colour. 
 
Tamiflu 6 mg/ml powder for oral suspension is available in a bottle containing 13 g powder for mixing 
with 55 ml of water.  
 
The box also contains 1 plastic measuring jug (55 ml), 1 plastic bottle adapter (to help get the drug 
into the dispenser),1 plastic 3 ml oral dispenser and 1 plastic 10 ml oral dispenser (to give the correct 
amount of medicine via the mouth). Shown on the oral dispenser are millilitre (ml) markings of the 
medicine (see figures in Instructions for the user). 
 
For details on how to prepare the oral suspension and how to measure and take the medicine, read 
Instructions for the user, over the page. 
 
Marketing Authorisation Holder and Manufacturer 
Roche Registration GmbH  
Emil-Barell-Strasse 1 
79639 Grenzach-Wyhlen 
Germany 
 
Roche Pharma AG 
Emil-Barell-Str. 1,  
D-79639 Grenzach-Wyhlen 
Germany 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
N.V. Roche S.A. 
Tél/Tel: +32 (0) 2 525 82 11 
 

Lietuva 
UAB “Roche Lietuva” 
Tel: +370 5 2546799 
 

България 
Рош България ЕООД 
Тел: +359 2 818 44 44 
 

Luxembourg/Luxemburg 
(Voir/siehe Belgique/Belgien) 
 

Česká republika 
Roche s. r. o. 
Tel: +420 - 2 20382111 

Magyarország 
Roche (Magyarország) Kft. 
Tel: +36 - 23 446 800 
 



112 

Danmark 
Roche a/s 
Tlf: +45 - 36 39 99 99 
 

Malta 
(See Ireland) 
 

Deutschland 
Roche Pharma AG 
Tel: +49 (0) 7624 140 
 

Nederland 
Roche Nederland B.V. 
Tel: +31 (0) 348 438050 
 

Eesti 
Roche Eesti OÜ 
Tel: + 372 - 6 177 380 
 

Norge 
Roche Norge AS 
Tlf: +47 - 22 78 90 00 
 

Ελλάδα 
Roche (Hellas) A.E.  
Τηλ: +30 210 61 66 100 
 

Österreich 
Roche Austria GmbH 
Tel: +43 (0) 1 27739 
 

España 
Roche Farma S.A. 
Tel: +34 - 91 324 81 00 
 

Polska 
Roche Polska Sp.z o.o. 
Tel: +48 - 22 345 18 88 
 

France 
Roche 
Tél: +33 (0) 1 47 61 40 00 
 

Portugal 
Roche Farmacêutica Química, Lda 
Tel: +351 - 21 425 70 00 
 

Hrvatska 
Roche d.o.o 
Tel:  +385 1 4722 333 
 

România 
Roche România S.R.L. 
Tel: +40 21 206 47 01 
 

Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700 
 

Slovenija 
Roche farmacevtska družba d.o.o. 
Tel: +386 - 1 360 26 00 
 

Ísland  
Roche a/s 
c/o Icepharma hf 
Sími: +354 540 8000 
 

Slovenská republika  
Roche Slovensko, s.r.o. 
Tel: +421 - 2 52638201 
 

Italia 
Roche S.p.A. 
Tel: +39 - 039 2471 

Suomi/Finland 
Roche Oy  
Puh/Tel: +358 (0) 10 554 500 
 

Kύπρος  
Γ.Α.Σταμάτης & Σια Λτδ. 
Τηλ: +357 - 22 76 62 76 
 

Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200 
 

Latvija 
Roche Latvija SIA 
Tel: +371 - 6 7039831 
 

United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000 
 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 



113 

Instructions for the user 
 
There are two stages to taking Tamiflu oral suspension.  
 
Stage 1 Prepare a new bottle of the medicine 

Your pharmacist may have prepared the medicine for you when you collected your prescription. 
If not, you can do it easily yourself.  See the first set of instructions. You only need to do this 
once, at the beginning of your course.  

 
Stage 2 Measure and give the correct dose 

Shake the suspension well and draw the appropriate recommended dose into the dispenser. See 
the second set of instructions. You will need to do this every time you need a dose. 

 
Stage 1: Prepare a new bottle of the medicine 
 
You will need: 

∑ The bottle, containing Tamiflu powder (in the medicine pack) 
∑ The bottle cap (in the medicine pack) 
∑ A plastic measuring jug (in the medicine pack) 
∑ The plastic bottle adapter (in the medicine pack) 
∑ Water 

 

  
 
∑ Tap the bottle to loosen the powder  

Tap the closed bottle gently several times to loosen the powder. 
 
∑ Use the jug to measure 55 ml of water  

The measuring jug in the pack has a line marked to show you an exact amount.  
Fill it with water to the indicated level.  

 
∑ Add all the water, close and shake  

Pour all of the water from the jug into the bottle, onto the powder.  
Always use 55 ml of water, whatever the dose you need. 
Put the cap back on the bottle. Shake the bottle well for 15 seconds. 

 
∑ Press in the adapter 

Open the bottle and press the bottle adapter hard into the neck of the bottle.  
 

∑ Close the bottle again 
Screw the cap tightly onto the top of the bottle, which now includes the adapter.  
This will make sure that the bottle adapter fits in the bottle in the right position. 

 
You now have a bottle of Tamiflu oral suspension ready to measure out a dose. You will not need to 
prepare it again unless you start a new bottle.  
 



114 

 
Stage 2: Measure and give the correct dose 
 
You will need:  

∑ A bottle of prepared Tamiflu oral suspension 
∑ Depending on the required dose you will need the 3 ml oral dispenser (orange plunger, 

0.1 ml graduation) or the 10 ml oral dispenser (transparent plunger 0.5 ml graduation) 
from the medicine pack.  

∑ For doses from 1.0  ml to 3.0 ml, the 3 ml oral dispenser should be used. For doses above 3.0 
ml to 10 ml, 10 ml oral dispenser should be used. 

 
Always use the oral dispenser provided with your medicine to measure a correct dose.  

                   
 
∑ Shake the bottle 

Check the cap is secure, and then shake the bottle of Tamiflu oral suspension. 
Always shake well before use. 

 
∑ Prepare the oral dispenser 

Depending on the required dose, use the 3 ml dispenser (orange plunger) or the 10 ml oral 
dispenser (transparent plunger) provided in the pack.  
Push the plunger completely down toward the tip of the dispenser.  

 

  
 
∑ Fill the dispenser with the correct dose 

Unscrew the cap from the bottle. 
Push the tip of the dispenser into the bottle adapter.  
Then turn the whole unit upside down (bottle and dispenser together).  
 



115 

 
 
Slowly pull out the plunger to draw medicine into the dispenser.  
Stop at the mark that shows the dose you need.  
Turn the whole unit upright. 
Remove the dispenser from the bottle.  
 

∑ Give the medicine into the mouth 
Deliver the suspension directly into the mouth by pushing down the plunger of the dispenser. 
Make sure the medicine is swallowed.  
You may drink and eat something after taking the medicine. 
 

∑ Close the bottle, keep it safe 
Put the cap back on the bottle. Keep it out of sight and reach of children. 
 
Store the medicine below 25 º C for up to 10 days. See 5 How to store Tamiflu, overleaf. 

 
Take the dispenser apart straight after dosing, and rinse both parts of the dispenser under running tap 
water. 

 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT  
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what tamiflu is and what it is used for', 'Section_Content': '∑ tamiflu is used for adults, adolescents, children and infants (including full-term newborn babies) for treating flu (influenza). it can be used when you have flu symptoms, and the flu virus is known to be going round in your community. ∑ tamiflu can also be prescribed for adults, adolescents, children and infants above 1 year of age for preventing flu, on a case-by-case basis for instance, if you have been in contact with someone who has flu. ∑ tamiflu may be prescribed for adults, adolescents, children and infant (including full-term newborn babies) as preventive treatment in exceptional circumstances for example, if there is a global epidemic of flu (a flu pandemic) and the seasonal flu vaccine may not provide sufficient protection. tamiflu contains oseltamivir, which belongs to a group of medicines named neuraminidase inhibitors. these medicines prevent the flu virus from spreading inside the body. they help to ease or prevent the symptoms of the flu virus infection. influenza, usually called flu, is an infection caused by a virus. the signs of flu often include a sudden fever (more than 37.8 ), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. these symptoms can also be caused by other infections. true influenza infection only occurs during annual outbreaks (epidemics) when flu viruses are spreading in the local community. outside epidemic periods, flu-like symptoms are usually caused by a different type of illness.', 'Entity_Recognition': [{'Text': 'tamiflu', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 2, 'BeginOffset': 2, 'EndOffset': 9, 'Score': 0.9655587077140808, 'Text': 'tamiflu', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'full-term newborn babies', 'Type': 'TREATMENT', 'BeginOffset': 75, 'EndOffset': 99}, {'Id': 10, 'BeginOffset': 114, 'EndOffset': 117, 'Score': 0.6941039562225342, 'Text': 'flu', 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{'Title': '2. what you need to know before you take tamiflu', 'Section_Content': 'do not take tamiflu: ∑ if you are allergic (hypersensitive) to oseltamivir or any of the other ingredients of tamiflu listed in section 6. talk to your doctor if this applies to you. do not take tamiflu. warnings and precautions: before you take tamiflu, make sure the prescribing doctor knows ∑ if you are allergic to other medicines ∑ if you have problems with your kidneys. if so, your dose may need adjustment ∑ if you have a severe medical condition, which may require immediate hospitalisation ∑ if your immune system is not working ∑ if you have chronic heart disease or respiratory disease. during treatment with tamiflu, tell a doctor immediately: ∑ if you notice changes in behaviour or mood (neuropsychiatric events), especially in children and adolescents). these may be signs of rare but serious side effects. tamiflu is not a flu vaccine tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading. a vaccine gives you antibodies against the virus. tamiflu will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor. other medicines and tamiflu tell your doctor or pharmacist if you are taking any other medicines, or have recently taken any. this includes medicines obtained without a prescription. the following medicines are particularly important: ∑ chlorpropamide (used to treat diabetes) ∑ methotrexate (used to treat e.g. rheumatoid arthritis) ∑ phenylbutazone (used to treat pain and inflammation) ∑ probenecid (used to treat gout) pregnancy and breast-feeding you must tell your doctor if you are pregnant, if you think you are pregnant or if you are trying to get pregnant so that your doctor can decide if tamiflu is right for you. the effects on breast-fed infants are unknown. you must tell your doctor if you are breast-feeding so that your doctor can decide if tamiflu is right for you. ask your doctor or pharmacist for advice before taking this medicine. driving and using machines tamiflu has no effect on your ability to drive or use machines.', 'Entity_Recognition': [{'Text': 'tamiflu', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 3, 'BeginOffset': 12, 'EndOffset': 19, 'Score': 0.9796357154846191, 'Text': 'tamiflu', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.5860006213188171}]}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 34, 'EndOffset': 42}, {'Id': 22, 'BeginOffset': 44, 'EndOffset': 58, 'Score': 0.6962851881980896, 'Text': 'hypersensitive', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': []}, {'Id': 4, 'BeginOffset': 63, 'EndOffset': 74, 'Score': 0.9979464411735535, 'Text': 'oseltamivir', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 110, 'EndOffset': 117, 'Score': 0.9647571444511414, 'Text': 'tamiflu', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': 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{'Title': '3. how to take tamiflu', 'Section_Content': "take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure. take tamiflu as soon as possible, ideally within two days of the flu symptoms starting. the recommended doses for treating flu, take two doses daily. it is usually convenient to take one dose in the morning and one in the evening. it is important to complete the whole 5-day course, even if you start to feel better quickly. for patients with a weak immune system, treatment will continue for 10 days. for preventing flu or after being exposed to an infected person, take one dose daily for 10 days. it is best to take this in the mornings with breakfast. in special situations, such as widespread flu or for patients with a weak immune system, treatment will continue for up to 6 or 12 weeks. the recommended dose is based on the patient's body weight.you must use the amount of oral capsules or suspension prescribed by the doctor. adults, and adolescents 13 years and over body weight treating flu: dose for 5 days treating flu (immunocompromised patients): dose for 10 days* preventing flu: dose for 10 days 40 kg or more 75 mg** twice daily 75 mg** twice daily 75 mg** once daily * for patients with a weak immune system, treatment is for 10 days **75 mg can be made up of a 30 mg capsule plus a 45 mg capsule children 1 to 12 years body weight treating flu: dose for 5 days treating flu (immunocompromised patients): dose for 10 days* preventing flu: dose for 10 days 10 to 15 kg 30 mg twice daily 30 mg twice daily 30 mg once daily more than 15 kg and up to 23 kg 45 mg twice daily 45 mg twice daily 45 mg once daily more than 23 kg and up to 40 kg 60 mg twice daily 60 mg twice daily 60 mg once daily more than 40 kg 75 mg** twice daily 75 mg** twice daily 75 mg** once daily * for children with a weak immune system, treatment is for 10 days**75 mg can be made up of a 30 mg capsule plus a 45 mg capsule infants less than 1 year (0 to 12 months) giving tamiflu to infants less than 1 year old for preventing flu during flu pandemic should be based upon the judgment of a doctor after considering the potential benefit versus any potential risk to the infant. body weight treating flu: dose for 5 days treating flu (immunocompromised patients): dose for 10 days* preventing flu: dose for 10 days 3 kg to 10+ kg, 3 mg per kg body weight**, twice daily 3 mg per kg body weight**, twice daily 3 mg per kg**, once daily * for infants with a weak immune system, treatment is for 10 days. ** mg per kg = mg for each kilogram of the infant's body weight. for example: if a 6-month-old weighs 8 kg, the dose is 8 kg x 3mg per kg = 24 mg method of administration swallow the capsules whole with water. do not break or chew the capsules. tamiflu can be taken with or without food, although taking it with food can reduce the chance of feeling or being sick (nausea or vomiting). people who find it hard to take capsules can use a liquid medicine, tamiflu oral suspension. if you need tamiflu oral suspension, but it's not available from your pharmacy, you can make a liquid form of tamiflu from these capsules. see making liquid tamiflu at home, over the page. if you take more tamiflu than you should stop taking tamiflu and contact a doctor or pharmacist immediately. in most cases of overdose, people have not reported any side effects. when side effects were reported, they were similar to those from normal doses, as listed in section 4. overdose has been reported to have occurred more frequently when tamiflu was given to children than to adults and adolescents. caution should be exercised when preparing liquid tamiflu for children and when administering tamiflu capsules or liquid tamiflu to children. if you forget to take tamiflu do not take a double dose to make up for a forgotten capsule. if you stop taking tamiflu there are no side effects when you stop tamiflu. but if tamiflu is stopped earlier than your 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. many of the side effects listed below may also be caused by influenza. the following serious side effects have been rarely reported since oseltamivir has been marketed: ∑ anaphylactic and anaphylactoid reactions: severe allergic reactions, with face and skin swelling, itchy rashes, low blood pressure and breathing difficulties ∑ hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice): yellowing of the skin and white of the eyes, change in stool color, changes in behaviour ∑ angioneurotic oedema: sudden onset of severe swelling of the skin mainly around the head and neck area, including eyes and tongue, with difficulties breathing ∑ stevens-johnson syndrome and toxic epidermal necrolysis: complicated, possibly life- threatening allergic reaction, severe inflammation of the outer and possibly inner skin, initially with fever, sore throat, and fatigue, skin rashes, leading to blisters, peeling, shedding of larger areas of skin, possible breathing difficulties and low blood pressure ∑ gastrointestinal bleeding: prolonged bleeding from the large bowel or spitting up blood ∑ neuropsychiatric disorders, as described below. if you notice any of these symptoms, get medical help immediately. the most frequently (very common and common) reported side effects of tamiflu are feeling or being sick (nausea, vomiting), stomach ache, stomach upset, headache and pain. these side effects mostly occur after the first dose of the medicine and will usually stop as treatment continues. the frequency of these effects is reduced if the medicinal product is taken with food. rare but serious effects: get medical help at once (these may affect up to 1 in 1,000 people) during tamiflu treatment, rare events have been reported that include ∑ convulsions and delirium, including altered level of consciousness ∑ confusion, abnormal behaviour ∑ delusions, hallucinations, agitation, anxiety, nightmares 70 these are reported primarily among children and adolescents and often started suddenly and resolved rapidly. a few cases resulted in self-injury, some with fatal outcome. such neuropsychiatric events have also been reported in patients with influenza who were not taking tamiflu. ∑ patients, especially children and adolescents, should be closely monitored for the behavioural changes described above. if you notice any of these symptoms, especially in younger people, get medical help immediately. adults and adolescents 13 and over very common side effects (may affect more than 1 in 10 people) ∑ headache ∑ nausea. common side effects (may affect up to 1 in 10 people) ∑ bronchitis ∑ cold sore virus ∑ cough ∑ dizziness ∑ fever ∑ pain ∑ pain in limb ∑ runny nose ∑ sleeping difficulties ∑ sore throat ∑ stomach ache ∑ tiredness ∑ upper abdominal fullness ∑ upper respiratory tract infections (inflammation of the nose, throat and sinuses) ∑ upset stomach ∑ vomiting. uncommon side effects (may affect up to 1 in 100 people) ∑ allergic reactions ∑ altered level of consciousness ∑ convulsion ∑ heart rhythm abnormalities ∑ mild to severe liver function disorders ∑ skin reactions (inflammation of the skin, red and itchy rash, scaling skin). rare side effects (may affect up to 1 in 1,000 people) ∑ thrombocytopenia (low platelet count) ∑ visual disturbances. children 1 to 12 years very common side effects (may affect more than 1 in 10 people) ∑ cough ∑ nasal congestion ∑ vomiting. common side effects (may affect up to 1 in 10 people) ∑ conjunctivitis (red eyes and discharge or pain in the eye) ∑ ear inflammation and other ear disorders ∑ headache ∑ nausea ∑ runny nose ∑ stomach ache ∑ upper abdominal fullness ∑ upset stomach. uncommon side effects (may affect up to 1 in 100 people) ∑ inflammation of the skin ∑ tympanic membrane (eardrum) disorder. infants less than 1 year the reported side effects in infants 0 to 12 months old are mostly similar to the side effects reported for older children (1 year old or older). additionally, diarrhoea and diaper rash have been reported.. if any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. however, ∑ if you or your child are repeatedly sick, or ∑ if the influenza symptoms get worse or the fever continues tell your doctor as soon as possible. reporting of side effects if you get any side effects, talk to your doctor. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'tamiflu', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 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{'Title': '5. how to store tamiflu', 'Section_Content': 'keep out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton and blister after exp. the expiry date refers to the last day of that month. do not store above 25 ∞c. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help to protect the environment.', 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what tamiflu contains ∑ each hard capsule contains oseltamivir equivalent to 30 mg of oseltamivir ∑ the other ingredients are: capsule contents: pregelatinised starch, talc, povidone, croscarmellose sodium and sodium stearyl fumarate capsule shell: gelatin, yellow iron oxide (e172), red iron oxide (e172) and titanium dioxide (e171) printing ink: shellac (e904), titanium dioxide (e171) and fd and c blue 2 (indigo carmine e132). what tamiflu looks like and contents of the pack the 30 mg hard capsule consists of a light yellow opaque body bearing the imprint "roche" and a light yellow opaque cap bearing the imprint "30 mg". imprints are blue. tamiflu 30 mg hard capsules are available in blister packs of 10.', 'Entity_Recognition': [{'Text': 'tamiflu', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 5, 'EndOffset': 12, 'Score': 0.9337902665138245, 'Text': 'tamiflu', 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