Epivir
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 150 mg film-coated tablets 
 
Epivir 300 mg film-coated tablets 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Epivir 150 mg film-coated tablets 
 
Each film-coated tablet contains 150 mg lamivudine.  
 
Epivir 300 mg film-coated tablets 
 
Each film-coated tablet contains 300 mg lamivudine 
 
Excipient(s) with known effect:  
Each 150 mg tablet contains 0.378 mg sodium.  
Each 300 mg tablet contains 0.756 mg sodium.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Epivir 150 mg film-coated tablets 
 
Film-coated tablet 
 
White, diamond shaped scored tablets engraved with “GX CJ7” on both faces. 
 
Epivir 300 mg film-coated tablets 
 
Film-coated tablet 
 
Grey, diamond shaped and engraved with “GX EJ7” on one face 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human 
Immunodeficiency Virus (HIV) infected adults and children.  
 
4.2 Posology and method of administration 
 
The therapy should be initiated by a physician experienced in the management of HIV infection. 
 
Epivir may be administered with or without food. 
To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without 
crushing.   
 
Epivir is also available as an oral solution for children over three months of age and who weigh less 
than 14 kg or for patients who are unable to swallow tablets (see section 4.4). 
Patients changing between lamivudine oral solution and lamivudine tablets should follow the dosing 
recommendations that are specific for the formulation (see section 5.2) 



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Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added 
to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see 
section 5.2). 
 
Adults, adolescents and children (weighing at least 25 kg):  
 
The recommended dose of Epivir is 300 mg daily. This may be administered as either 150 mg twice 
daily or 300 mg once daily (see section 4.4).  
 
The 300 mg tablet is only suitable for the once a day regimen.  
 
Children (weighing less than 25 kg): 
 
Dosing according to weight bands is recommended for Epivir tablets.  
 
Children weighing ≥ 20 kg to <25 kg: The recommended dose is 225 mg daily. This may be 
administered as either 75 mg (one-half of a 150 mg tablet) taken in the morning and 150 mg (one 
whole 150 mg tablet) taken in the evening, or 225 mg (one and a half 150 mg tablets) taken once daily. 
 
Children weighing 14 to < 20 kg: The recommended dose is 150 mg daily. This may be administered 
as 75 mg (one-half of a 150 mg tablet) taken twice daily, or 150 mg (one whole 150 mg tablet) taken 
once daily.   
 
Children from three months of age: As an accurate dosage cannot be achieved with the 300 mg non-
scored tablet formulation in this patient population, it is recommended that the Epivir 150 mg scored 
tablet formulation is used and the corresponding recommended dosage instructions are followed. 
 
Children less than three months of age: The limited data available are insufficient to propose specific 
dosage recommendations (see section 5.2). 
 
Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take 
the recommended once daily dose (as described above) approximately 12 hours after the last twice 
daily dose, and then continue to take the recommended once daily dose (as described above) 
approximately every 24 hours. When changing back to a twice daily regimen, patients should take the 
recommended twice daily dose approximately 24 hours after the last once daily dose. 
 
Special populations: 
 
Older people: No specific data are available; however, special care is advised in this age group due to 
age-associated changes such as the decrease in renal function and alteration of haematological 
parameters. 
 
Renal impairment: Lamivudine concentrations are increased in patients with moderate - severe renal 
impairment due to decreased clearance.  The dose should therefore be adjusted, using oral solution 
presentation of Epivir for patients whose creatinine clearance falls below 30 ml/min (see tables). 
 
Dosing recommendations – Adults, adolescents and children (weighing at least 25 kg): 
 

 
Creatinine clearance  
(ml/min) 

First dose Maintenance dose 

≥50 300 mg 
or 

150 mg 

300 mg once daily 
or 
150 mg twice daily 

30-<50 150 mg 150 mg once daily 



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<30 As doses below 150 mg are needed the use of the oral solution is recommended 
 
15 to <30 150 mg 100 mg once daily 
5 to <15 150 mg 50 mg once daily 
<5 50 mg 25 mg once daily 

 
There are no data available on the use of lamivudine in children with renal impairment.  Based on the 
assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in 
adults; it is recommended that the dosage in children with renal impairment be reduced according to 
their creatinine clearance by the same proportion as in adults. The Epivir 10 mg/mL oral solution may 
be the most appropriate formulation to achieve the recommended dose in children with renal 
impairment aged at least 3 months and weighing less than 25kg.  
 
Dosing recommendations – Children aged at least 3 months and weighing less than 25 kg: 
 
Creatinine clearance 
(ml/min) 

First dose Maintenance dose 

≥50 10 mg/kg 
or 

5 mg/kg 

10 mg/kg once daily 
or 
5 mg/kg twice daily 

30 to<50 5 mg/kg 5 mg/kg once daily 
15 to <30 5 mg/kg 3.3 mg/kg once daily 
5 to <15 5 mg/kg 1.6 mg/kg once daily 
<5 1.6 mg/kg 0.9 mg/kg once daily 

 
Hepatic impairment: Data obtained in patients with moderate to severe hepatic impairment shows that 
lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction. Based on these 
data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless 
accompanied by renal impairment. 
 
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 
 
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce 
the risk of sexual transmission, a residual risk cannot be excluded.  Precautions to prevent 
transmission should be taken in accordance with national guidelines. 
 
Epivir is not recommended for use as monotherapy. 
 
Renal impairment: In patients with moderate to severe renal impairment, the terminal plasma half-life 
of lamivudine is increased due to decreased clearance, therefore the dose should be adjusted (see 
section 4.2). 
 
Triple nucleoside therapy: There have been reports of a high rate of virological failure and of 
emergence of resistance at an early stage when lamivudine was combined with tenofovir disoproxil 
fumarate and abacavir as well as with tenofovir disoproxil fumarate and didanosine as a once daily 
regimen. 
 
Opportunistic infections: Patients receiving Epivir or any other antiretroviral therapy may continue to 
develop opportunistic infections and other complications of HIV infection, and therefore should 
remain under close clinical observation by physicians experienced in the treatment of patients with 
associated HIV diseases. 
 



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Pancreatitis: Cases of pancreatitis have occurred rarely.  However it is not clear whether these cases 
were due to the antiretroviral treatment or to the underlying HIV disease.  Treatment with Epivir 
should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of 
pancreatitis occur. 
 
Mitochondrial dysfunction following exposure in utero: Nucleoside and nucleotide analogues may 
impact mitochondrial function to a variable degree, which is most pronounced with stavudine, 
didanosine and zidovudine. There have been reports of mitochondrial dysfunction in HIV-negative 
infants exposed in utero and/or post-natally to nucleoside analogues; these have predominantly 
concerned treatment with regimens containing zidovudine. The main adverse reactions reported are 
haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, 
hyperlipasemia). These events have often been transitory. Late-onset neurological disorders have been 
reported rarely (hypertonia, convulsion, abnormal behaviour). Whether such neurological disorders are 
transient or permanent is currently unknown. These findings should be considered for any child 
exposed in utero to nucleoside and nucleotide analogues, who presents with severe clinical findings of 
unknown etiology, particularly neurologic findings. These findings do not affect current national 
recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of 
HIV. 
 
Weight and metabolic parameters: An increase in weight and in levels of blood lipids and glucose 
may occur during antiretroviral therapy. Such changes may in part be linked to disease control and life 
style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is 
no strong evidence relating this to any particular treatment. For monitoring of blood lipids and glucose 
reference is made to established HIV treatment guidelines. Lipid disorders should be managed as 
clinically appropriate. 
 
Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time 
of institution of combination antiretroviral therapy (CART), an inflammatory reaction to 
asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or 
aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or 
months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or 
focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP). 
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.  
Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to 
occur in the setting of immune reactivation; however, the reported time to onset is more variable and 
these events can occur many months after initiation of treatment. 
 
Liver disease: If lamivudine is being used concomitantly for the treatment of HIV and HBV, 
additional information relating to the use of lamivudine in the treatment of hepatitis B infection is 
available in the Zeffix SPC. 
 
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an 
increased risk of severe and potentially fatal hepatic adverse events. In case of concomitant antiviral 
therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal 
products. 
 
If Epivir is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver 
function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may 
result in an acute exacerbation of hepatitis (see Zeffix SPC). 
 
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased 
frequency of liver function abnormalities during combination antiretroviral therapy, and should be 
monitored according to standard practice.  If there is evidence of worsening liver disease in such 
patients, interruption or discontinuation of treatment must be considered (see section 4.8). 
 
Paediatric population: In a study performed in paediatric patients (see section 5.1 ARROW study), 
lower rates of virologic suppression and more frequent viral resistance were reported in children 



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receiving the oral solution of Epivir as compared to those receiving the tablet formulation. Whenever 
possible in children, Epivir as tablet formulation should preferably be used.  
 
Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, 
alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis 
have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to 
combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they 
experience joint aches and pain, joint stiffness or difficulty in movement. 
 
Drug Interactions: Epivir should not be taken with any other medicinal products containing 
lamivudine or medicinal products containing emtricitabine (see section 4.5). 
 
The combination of lamivudine with cladribine is not-recommended (see section 4.5). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Interaction studies have only been performed in adults. 
 
The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding 
and almost complete renal clearance. 
 
Administration of trimethoprim/sulfamethoxazole 160 mg/800 mg results in a 40 % increase in 
lamivudine exposure, because of the trimethoprim component; the sulfamethoxazole component did 
not interact. However, unless the patient has renal impairment, no dosage adjustment of lamivudine is 
necessary (see section 4.2).  Lamivudine has no effect on the pharmacokinetics of trimethoprim or 
sulfamethoxazole.  When concomitant administration is warranted, patients should be monitored 
clinically. Co-administration of lamivudine with high doses of co-trimoxazole for the treatment of 
Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis should be avoided. 
 
The possibility of interactions with other medicinal products administered concurrently should be 
considered, particularly when the main route of elimination is active renal secretion via the organic 
cationic transport system e.g. trimethoprim. Other medicinal products (e.g. ranitidine, cimetidine) are 
eliminated only in part by this mechanism and were shown not to interact with lamivudine.  The 
nucleoside analogues (e.g. didanosine) like zidovudine, are not eliminated by this mechanism and are 
unlikely to interact with lamivudine. 
 
A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, 
however overall exposure (AUC) is not significantly altered. Zidovudine has no effect on the 
pharmacokinetics of lamivudine (see section 5.2). 
 
Due to similarities, Epivir should not be administered concomitantly with other cytidine analogues, 
such as emtricitabine. Moreover, Epivir should not be taken with any other medicinal products 
containing lamivudine (see section 4.4). 
In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of 
cladribine loss of efficacy in case of combination in the clinical setting. Some clinical findings also 
support a possible interaction between lamivudine and cladribine. Therefore, the concomitant use of 
lamivudine with cladribine is not recommended (see section 4.4). 
 
Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products 
metabolised by this system (e.g. PIs) unlikely. 
 
Coadministration of sorbitol solution (3.2 g, 10.2 g, 13.4 g) with a single 300 mg dose of lamivudine 
oral solution resulted in dose-dependent decreases of 14%, 32%, and 36% in lamivudine exposure 
(AUC∞) and 28%, 52%, and 55% in the Cmax of lamivudine in adults. When possible, avoid chronic 
coadministration of Epivir with medicinal products containing sorbitol or other osmotic acting poly-
alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol). Consider more frequent 
monitoring of HIV-1 viral load when chronic coadministration cannot be avoided. 



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4.6 Fertility, Pregnancy and lactation 
 
Pregnancy 
 
As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in 
pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, 
the animal data as well as the clinical experience in pregnant women should be taken into account.  
Animal studies with lamivudine showed an increase in early embryonic deaths in rabbits but not in rats 
(see section 5.3). Placental transfer of lamivudine has been shown to occur in humans.  
 
More than 1000 outcomes from first trimester and more than 1000 outcomes from second and third 
trimester exposure in pregnant women indicate no malformative and foeto/neonatal effect. Epivir can 
be used during pregnancy if clinically needed. The malformative risk is unlikely in humans based on 
those data. 
 
For patients co-infected with hepatitis who are being treated with lamivudine and subsequently 
become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on 
discontinuation of lamivudine. 
 
Mitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and 
in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial 
dysfunction in infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4). 
 
Breast-feeding 
 
Following oral administration lamivudine was excreted in breast milk at similar concentrations to 
those found in serum. Based on more than 200 mother/child pairs treated for HIV, serum 
concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of 
maternal serum concentrations) and progressively decrease to undetectable levels when breastfed 
infants reach 24 weeks of age. There are no data available on the safety of lamivudine when 
administered to babies less than three months old.  It is recommended that HIV infected women do not 
breast-feed their infants under any circumstances in order to avoid transmission of HIV. 
 
Fertility 
 
Studies in animals showed that lamivudine had no effect on fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. 
 
4.8 Undesirable effects 
 
The following adverse reactions have been reported during therapy for HIV disease with Epivir.   
 
The adverse reactions considered at least possibly related to the treatment are listed below by body 
system, organ class and absolute frequency. Frequencies are defined as 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), very rare 
(<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing 
seriousness. 
 
Blood and lymphatic systems disorders 
Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia 
Very rare: Pure red cell aplasia 
 



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Metabolism and nutrition disorders 
Very rare: Lactic acidosis 
 
Nervous system disorders 
Common: Headache, insomnia  
Very rare: Peripheral neuropathy (or paraesthesia)  
 
Respiratory, Thoracic and mediastinal disorders 
Common: Cough, nasal symptoms 
 
Gastrointestinal disorders 
Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea 
Rare: Pancreatitis, elevations in serum amylase 
 
Hepatobiliary disorders 
Uncommon: Transient elevations in liver enzymes (AST, ALT) 
Rare: Hepatitis 
 
Skin and subcutaneous tissue disorders 
Common: Rash, alopecia 
Rare: Angioedema 
 
Musculoskeletal and connective tissue disorders 
Common: Arthralgia, muscle disorders  
Rare: Rhabdomyolysis 
 
General disorders and administration site conditions 
Common: Fatigue, malaise, fever 
 
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 
4.4) 
 
In HIV-infected patients with severe immune deficiency at the time of initiation of combination 
antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic 
infections may arise.  Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have 
also been reported to occur in the setting of immune reactivation; however, the reported time to onset 
is more variable and these events can occur many months after initiation of treatment (see section 4.4). 
 
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk 
factors, advanced HIV disease or long-term combined antiretroviral exposure (CART). The frequency 
of which is unknown (see section 4.4). 
 
Paediatric population 
 
1206 HIV-infected paediatric patients aged 3 months to 17 years were enrolled in the ARROW Trial 
(COL105677), 669 of whom received abacavir and lamivudine either once or twice daily (see section 
5.1). No additional safety issues have been identified in paediatric subjects receiving either once or 
twice daily dosing compared to adults. 
 
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 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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Administration of lamivudine at very high dose levels in acute animal studies did not result in any 
organ toxicity.  Limited data are available on the consequences of ingestion of acute overdoses in 
humans.  No fatalities occurred, and the patients recovered.  No specific signs or symptoms have been 
identified following such overdose. 
 
If overdosage occurs the patient should be monitored, and standard supportive treatment applied as 
required.  Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of 
overdosage, although this has not been studied. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: nucleoside analogue, ATC Code: J05AF05. 
 
Mechanism of action 
 
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) 
and hepatitis B virus (HBV).  It is metabolised intracellularly to the active moiety, lamivudine 5’-
triphosphate. Its main mode of action is as a chain terminator of viral reverse transcription. The 
triphosphate has selective inhibitory activity against HIV-1 and HIV-2 replication in vitro, it is also 
active against zidovudine-resistant clinical isolates of HIV. No antagonistic effects in vitro were seen 
with lamivudine and other anti retrovirals (tested agents: abacavir, didanosine, nevirapine and 
zidovudine). 
 
Resistance 
 
HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the 
active site of the viral reverse transcriptase (RT). This variant arises both in vitro and in HIV-1 
infected patients treated with lamivudine-containing antiretroviral therapy.  M184V mutants display 
greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro. In 
vitro studies indicate that zidovudine-resistant virus isolates can become zidovudine sensitive when 
they simultaneously acquire resistance to lamivudine.  The clinical relevance of such findings remains, 
however, not well defined. 
 
In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the 
development of M184V might provide residual anti-retroviral activity (likely through impaired viral 
fitness).  The clinical relevance of these findings is not established.  Indeed, the available clinical data 
are very limited and preclude any reliable conclusion in the field.  In any case, initiation of susceptible 
NRTI’s should always be preferred to maintenance of lamivudine therapy.  Therefore, maintaining 
lamivudine therapy despite emergence of M184V mutation should only be considered in cases where 
no other active NRTI’s are available.  
 
Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of 
antiretroviral agents. Zidovudine and stavudine maintain their antiretroviral activities against 
lamivudine-resistant HIV-1. Abacavir maintains its antiretroviral activities against lamivudine-
resistant HIV-1 harbouring only the M184V mutation.  The M184V RT mutant shows a <4-fold 
decrease in susceptibility to didanosine; the clinical significance of these findings is unknown. In vitro 
susceptibility testing has not been standardised and results may vary according to methodological 
factors. 
 
Lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established 
lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells in 
vitro.  
 



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Clinical efficacy and safety 
 
In clinical trials, lamivudine in combination with zidovudine has been shown to reduce HIV-1 viral 
load and increase CD4 cell count.  Clinical end-point data indicate that lamivudine in combination 
with zidovudine, results in a significant reduction in the risk of disease progression and mortality. 
 
Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of 
zidovudine resistant isolates in individuals with no prior antiretroviral therapy. 
 
Lamivudine has been widely used as a component of antiretroviral combination therapy with other 
antiretroviral agents of the same class (NRTIs) or different classes (PIs, non-nucleoside reverse 
transcriptase inhibitors).   
 
Clinical trial evidence from paediatric patients receiving lamivudine with other antiretroviral drugs 
(abacavir, nevirapine/efavirenz or zidovudine) has shown that the resistance profile observed in 
paediatric patients is similar to that observed in adults, in terms of the genotypic substitutions detected 
and their relative frequency. 
 
Children receiving lamivudine oral solution concomitantly with other antiretroviral oral solutions in 
clinical trials developed viral resistance more frequently than children receiving tablets (see the 
description of the clinical experience in paediatric population (ARROW study) and section 5.2). 
 
Multiple drug antiretroviral therapy containing lamivudine has been shown to be effective in 
antiretrovirally-naive patients as well as in patients presenting with viruses containing the M184V 
mutations.   
 
The relationship between in vitro susceptibility of HIV to lamivudine and clinical response to 
lamivudine-containing therapy remains under investigation. 
 
Lamivudine at a dose of 100 mg once daily has also been shown to be effective for the treatment of 
adult patients with chronic HBV infection (for details of clinical studies, see the prescribing 
information for Zeffix).  However, for the treatment of HIV infection only a 300 mg daily dose of 
lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious. 
 
Lamivudine has not been specifically investigated in HIV patients co-infected with HBV. 
 
Once daily dosing (300 mg once a day): a clinical study has demonstrated the non inferiority between 
Epivir once a day and Epivir twice a day containing regimens. These results were obtained in an 
antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC 
stage A). 
 
Paediatric population: a randomised comparison of a regimen including once daily vs twice daily 
dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study 
of HIV-infected, paediatric patients. 1206 paediatric patients aged 3 months to 17 years enrolled in the 
ARROW Trial (COL105677) and were dosed according to the weight - band dosing recommendations 
in the World Health Organisation treatment guidelines (Antiretroviral therapy of HIV infection in 
infants and children, 2006). After 36 weeks on a regimen including twice daily abacavir and 
lamivudine, 669 eligible subjects were randomised to either continue twice daily dosing or switch to 
once daily abacavir and lamivudine for at least 96 weeks. Of note, from this study clinical data were 
not available for children under one year old. The results are summarised in the table below: 
 
Virological Response Based on Plasma HIV-1 RNA less than 80 copies/ml at Week 48 and Week 
96 in the Once Daily versus Twice Daily abacavir + lamivudine randomisation of ARROW 
(Observed Analysis) 
 

 Twice Daily 
N (%) 

Once Daily 
N (%) 



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Week 0 (After ≥36 Weeks on Treatment) 
Plasma HIV-1 RNA 

<80 c/ml 
250/331 (76) 237/335 (71) 

Risk difference (once 
daily-twice daily) 

-4.8% (95% CI -11.5% to +1.9%), p=0.16 

Week 48 
Plasma HIV-1 RNA 

<80 c/ml 
242/331 (73) 236/330 (72) 

Risk difference (once 
daily-twice daily) 

-1.6% (95% CI -8.4% to +5.2%), p=0.65 

Week 96 
Plasma HIV-1 RNA 

<80 c/ml 
234/326 (72) 230/331 (69) 

Risk difference (once 
daily-twice daily) 

-2.3% (95% CI -9.3% to +4.7%), p=0.52 

 
In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of 
age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen. Three 
subjects had undetectable viral load and one had plasmatic HIV-RNA of 900 copies/ml at Week 48. 
No safety concerns were observed in these subjects. 
 
The abacavir + lamivudine once daily dosing group was demonstrated to be non-inferior to the twice 
daily group according to the pre-specified non-inferiority margin of -12%, for the primary endpoint of 
<80 c/ml at Week 48 as well as at Week 96 (secondary endpoint) and all other thresholds tested 
(<200c/ml, <400c/ml, <1000c/ml), which all fell well within this non-inferiority margin. Subgroup 
analyses testing for heterogeneity of once vs twice daily demonstrated no significant effect of sex, age, 
or viral load at randomisation. Conclusions supported non-inferiority regardless of analysis method. 
 
At the time of randomization to once daily vs twice daily dosing (Week 0), those patients who had 
received tablet formulations had a higher rate of viral load suppression than those who had received 
any solution formulations at any time. These differences were observed in each different age group 
studied. This difference in suppression rates between tablets and solutions remained through Week 96 
with once daily dosing.  
 
Proportions of Subjects in the Once Daily versus Twice Daily Abacavir+Lamivudine 
Randomisation of ARROW with Plasma HIV-1 RNA <80 copies/ml: Subgroup Analysis by 
Formulation 
 

 Twice Daily 
Plasma HIV-1 RNA 
<80 c/ml:  
n/N (%) 

Once Daily 
Plasma HIV-1 RNA 
<80 c/ml:  
n/N (%) 

Week 0 (after 36 weeks on Treatment)   
Any solution regimen at any time 14/26 (54) 15/30 (50) 
All tablet based regimen throughouts 236/305 (77) 222/305 (73) 
Week 96   
Any solution regimen at any time 13/26 (50) 17/30 (57) 
All tablet based regimen throughouts 221/300 (74) 213/301 (71) 
 

 
Genotypic resistance analyses were conducted on samples with plasma HIV-1 RNA >1000 copies/ml. 
More cases of resistance were detected among patients who had received lamivudine solution, in 
combination with other antiretroviral solutions, compared with those who received similar doses of 
tablet formulation. This is consistent with the lower rates of antiviral suppression observed in these 
patients. 
 



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5.2 Pharmacokinetic properties 
 
Absorption 
 
Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine 
in adults is normally between 80 and 85%.  Following oral administration, the mean time (tmax) to 
maximal serum concentrations (Cmax) is about an hour. Based on data derived from a study in healthy 
volunteers, at a therapeutic dose of 150 mg twice daily, mean (CV) steady-state Cmax and Cmin of 
lamivudine in plasma are 1.2 µg/ml (24%) and 0.09 µg/ml (27%), respectively.  The mean (CV) AUC 
over a dosing interval of 12 hours is 4.7 µg.h/ml (18%).  At a therapeutic dose of 300 mg once daily, 
the mean (CV) steady-state Cmax, Cmin and 24h AUC are 2.0 µg/ml (26%), 0.04 µg/ml (34%) and 8.9 
µg.h/ml (21%), respectively. 
 
The 150 mg tablet is bioequivalent and dose proportional to the 300 mg tablet with respect to AUC∞, 
Cmax, and tmax. Administration of Epivir tablets is bioequivalent to Epivir oral solution with respect to 
AUC∞ and Cmax in adults. Absorption differences have been observed between adult and paediatric 
populations (see Special populations). 
 
Co-administration of lamivudine with food results in a delay of tmax and a lower C max (decreased by 
47%). However, the extent (based on the AUC) of lamivudine absorbed is not influenced.   
 
Administration of crushed tablets with a small amount of semi-solid food or liquid would not be 
expected to have an impact on the pharmaceutical quality, and would therefore not be expected to alter 
the clinical effect.  This conclusion is based on the physiochemical and pharmacokinetic data 
assuming that the patient crushes and transfers 100% of the tablet and ingests immediately. 
 
Co-administration of zidovudine results in a 13% increase in zidovudine exposure and a 28 % increase 
in peak plasma levels.  This is not considered to be of significance to patient safety and therefore no 
dosage adjustments are necessary.  
 
Distribution 
 
From intravenous studies, the mean volume of distribution is 1.3 l/kg.  The observed half-life of 
elimination is 5 to 7 hours.  The mean systemic clearance of lamivudine is approximately  
0.32 l/h/kg, with predominantly renal clearance (> 70%) via the organic cationic transport system. 
 
Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited 
binding to the major plasma protein albumin (< 16% - 36% to serum albumin in in vitro studies).  
 
Limited data show that lamivudine penetrates the central nervous system and reaches the cerebro-
spinal fluid (CSF).  The mean ratio CSF/serum lamivudine concentration 2-4 hours after oral 
administration was approximately 0.12.  The true extent of penetration or relationship with any clinical 
efficacy is unknown. 
 
Biotransformation 
 
The active moiety, intracellular lamivudine triphosphate, has a prolonged terminal half-life in the cell 
(16 to 19 hours) compared to the plasma lamivudine half-life (5 to 7 hours).  In 60 healthy adult 
volunteers, Epivir 300 mg once daily has been demonstrated to be pharmacokinetically equivalent at 
steady-state to Epivir 150 mg twice daily with respect to intracellular triphosphate AUC24 and Cmax.  
 
Lamivudine is predominately cleared unchanged by renal excretion. The likelihood of metabolic 
interactions of lamivudine with other medicinal products is low due to the small extent of hepatic 
metabolism (5-10%) and low plasma protein binding. 
 
Elimination 
 



13 
 

Studies in patients with renal impairment show lamivudine elimination is affected by renal 
dysfunction. A recommended dosage regimen for patients with creatinine clearance below 50 ml/min 
is shown in the dosage section (see section 4.2).  
 
An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40% increase in 
lamivudine exposure at therapeutic doses.  This does not require dose adjustment unless the patient 
also has renal impairment (see sections 4.5 and 4.2).  Administration of co-trimoxazole with 
lamivudine in patients with renal impairment should be carefully assessed. 
 
Special populations 
 
Children: The absolute bioavailability of lamivudine (approximately 58-66%) was reduced in 
paediatric patients below 12 years of age.  In children, administration of tablets given concomitantly 
with other antiretroviral tablets delivered higher plasma lamivudine AUC∞ and Cmax than oral solution 
given concomitantly with other antiretroviral oral solutions. Children receiving lamivudine oral 
solution according to the recommended dosage regimen achieve plasma lamivudine exposure within 
the range of values observed in adults.  Children receiving lamivudine oral tablets according to the 
recommended dosage regimen achieve higher plasma lamivudine exposure than children receiving 
oral solution because higher mg/kg doses are administered with the tablet formulation and the tablet 
formulation has higher bioavailability (see section 4.2). Paediatric pharmacokinetic studies with both 
oral solution and tablet formulations have demonstrated that once daily dosing provides equivalent 
AUC0-24 to twice daily dosing of the same total daily dose. 
  
There are limited pharmacokinetic data for patients less than three months of age. In neonates one 
week of age, lamivudine oral clearance was reduced when compared to paediatric patients and is likely 
to be due to immature renal function and variable absorption.  Therefore to achieve similar adult and 
paediatric exposure, an appropriate dose for neonates is 4 mg/kg/day. Glomerular filtration estimates 
suggests that to achieve similar adult and paediatric exposure, an appropriate dose for children aged 
six weeks and older could be 8 mg/kg/day. 
 
Pharmacokinetic data were derived from 3 pharmacokinetic studies (PENTA 13, PENTA 15 and 
ARROW PK substudy) enrolling children under 12 years of age. The data are displayed in the table 
below: 
 
Summary of Stead-State Plasma Lamivudine AUC (0-24) (µg.h/ml) and Statistical Comparisons 
for Once and Twice-Daily Oral Administration Across Studies 

 
Study 

 
Age Group 

Lamivudine  
8mg/kg Once-
Daily Dosing 

Geometric Mean 
(95% Cl) 

Lamivudine 
4 mg/kg Twice-

Daily Dosing 
Geometric Mean 

(95% Cl) 

Once-Versus 
Twice-Daily 
Comparison 

GLS Mean Ratio 
(90% Cl) 

ARROW PK 
Substudy 

Part 1 

3 to 12 years 
(N=35) 

13.0 
(11.4,14.9) 

12.0 
(10.7, 13.4) 

1.09 
(0.979, 1.20) 

PENTA 13 2 to 12 years 
(N=19) 

9.80 
(8.64, 11.1) 

8.88 
(7.67, 10.3) 

1.12 
(1.03, 1.21) 

PENTA 15 3 to 36 months 
(N=17) 

8.66 
(7.46, 10.1) 

9.48 
(7.89, 11.40) 

0.91 
(0.79, 1.06) 

 
In PENTA 15 study, the geometric mean plasma lamivudine AUC(0-24) (95% CI) of the four subjects 
under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 
10.31 (6.26, 17.0) µg.h/ml in the once-daily dosing and 9.24 (4.66, 18.3) µg.h/ml in the twice-daily 
dosing. 
 



14 
 

Pregnancy: Following oral administration, lamivudine pharmacokinetics in late-pregnancy were 
similar to non-pregnant women.  
 
5.3 Preclinical safety data 
 
Administration of lamivudine in animal toxicity studies at high doses was not associated with any 
major organ toxicity.  At the highest dosage levels, minor effects on indicators of liver and kidney 
function were seen together with occasional reductions in liver weight.  The clinically relevant effects 
noted were a reduction in red blood cell count and neutropenia. 
 
Lamivudine was not mutagenic in bacterial tests but, like many nucleoside analogues, showed activity 
in an in vitro cytogenetic assay and the mouse lymphoma assay.  Lamivudine was not genotoxic in 
vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical 
plasma levels. As the in vitro mutagenic activity of lamivudine could not be confirmed in in vivo tests, 
it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing 
treatment. 
 
A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the 
combination of zidovudine and lamivudine at human-equivalent exposures.  The study demonstrated 
that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue-
DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening 
than in those exposed to zidovudine alone. The clinical significance of these findings is unknown. 
 
The results of long-term carcinogenicity studies in rats and mice did not show any carcinogenic 
potential relevant for humans. 
 
A fertility study in rats has shown that lamivudine had no effect on male or female fertility. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Epivir 150 mg Film-coated tablets 
 
Tablet core: 
Microcrystalline cellulose (E460),  
Sodium starch glycollate  
Magnesium stearate  
 
Tablet film-coat: 
Hypromellose (E464) 
Titanium dioxide (E171),  
Macrogol,  
Polysorbate 80 
 
Epivir 300 mg Film-coated tablets 
 
Tablet core: 
Microcrystalline cellulose (E460),  
Sodium starch glycollate  
Magnesium stearate  
 
Tablet film-coat: 
Hypromellose (E464),  
Titanium dioxide (E171),  
Black iron oxide (E172),  



15 
 

Macrogol, Polysorbate 80 
 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
Epivir 150 mg Film-coated tablets 
 
HDPE bottles:    5 years  
 
PVC/aluminium foil blister packs: 2 years 
 
Epivir 300 mg Film-coated tablets 
 
HDPE bottles :    3 years  
 
PVC/aluminium foil blister packs: 2 years 
 
 
6.4 Special precautions for storage 
 
Do not store above 30°C 
 
6.5 Nature and contents of container 
 
Epivir 150 mg Film-coated tablets 
 
Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 60 tablets. 
 
Epivir 300 mg Film-coated tablets 
 
Child resistant HDPE bottles or PVC/aluminium foil blister packs each containing 30 tablets 
 
6.6 Special precautions for disposal 
 
No special requirements for disposal 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER 
 
Epivir 150 mg Film-coated tablets 
 
EU/1/96/015/001 (Bottle) 
EU/1/96/015/004 (Blister pack) 
 
Epivir 300 mg Film-coated tablets 



16 
 

 
EU/1/96/015/003 (Bottle) 
EU/1/96/015/005 (Blister pack) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Epivir 150 mg Film-coated tablets 
 
Date of first authorisation: 8 August 1996 
Date of last renewal: 28 July 2006 
 
Epivir 300 mg Film-coated tablets 
 
Date of first authorisation: 15 November 2001 
Date of last renewal: 28 July 2006 
 
 
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. 

http://www.ema./
http://www.ema./


17 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 10 mg/ml oral solution 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml of oral solution contains 10 mg of lamivudine.  
 
Excipient(s) with known effect: 
 
Each 15 ml dose contains 3 g sucrose (20% w/v). 
Methyl parahydroxybenzoate 
Propyl parahydroxybenzoate 
Each 15 ml dose contains 300 mg propylene glycol. 
Each 15 ml dose contains 44.1 mg sodium.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Oral solution 
 
Clear, colourless to pale yellow solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Epivir is indicated as part of antiretroviral combination therapy for the treatment of Human 
Immunodeficiency Virus (HIV) infected adults and children.  
 
4.2 Posology and method of administration 
 
The therapy should be initiated by a physician experienced in the management of HIV infection. 
 
Epivir may be administered with or without food. 
 
Epivir is also available as a tablet formulation for patients who weigh at least 14 kg (see section 4.4). 
 
Patients changing between lamivudine tablets and lamivudine oral solution should follow the dosing 
recommendations that are specific for the formulation (see section 5.2). 
 
For patients who are unable to swallow  tablets, the tablet(s) may be crushed and added to a small 
amount of semi-solid food or liquid, all of which should be consumed immediately (see section 5.2). 
 
 
Adults, adolescents and children (weighing at least 25 kg):  
 
The recommended dose of Epivir is 300 mg daily. This may be administered as either 150 mg (15 ml) 
twice daily or 300 mg (30 ml) once daily (see section 4.4).  
 
Children (weighing less than 25 kg): 
 
Children from one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice daily, or 1 
mL/kg (10 mg/kg) once daily (see sections 4.4 and 4.5). 



18 
 

 
Children from three months to one year of age: The recommended dose is 0.5 mL/kg (5 mg/kg) twice 
daily. If a twice daily regimen is not feasible, a once daily regimen (10 mg/kg/day) could be 
considered. It should be taken into account that data for the once daily regimen are very limited in this 
population (see sections 4.4, 5.1 and 5.2). 
 
Children less than three months of age: The limited data available are insufficient to propose specific 
dosage recommendations (see section 5.2). 
 
Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take 
the recommended once daily dose (as described above) approximately 12 hours after the last twice 
daily dose, and then continue to take the recommended once daily dose (as described above) 
approximately every 24 hours. When changing back to a twice daily regimen, patients should take the 
recommended twice daily dose approximately 24 hours after the last once daily dose. 
 
Special populations: 
 
Older people: No specific data are available; however, special care is advised in this age group due to 
age-associated changes such as the decrease in renal function and alteration of haematological 
parameters. 
 
Renal impairment: Lamivudine concentrations are increased in patients with moderate - severe renal 
impairment due to decreased clearance.  The dose should therefore be adjusted (see tables). 
 
Dosing recommendations – Adults, adolescents and children (weighing at least 25 kg): 
 

Creatinine clearance 
(ml/min) 
 

First dose Maintenance dose 

≥50 300 mg (30 ml) 
or 

150 mg  (15 ml) 

300 mg (30 ml) once daily 
or 
150 mg  (15 ml) twice daily 

30 to<50 150 mg  (15 ml) 150 mg  (15 ml) once daily 
15 to <30 150 mg  (15 ml) 100 mg  (10 ml) once daily 
5 to <15 150 mg  (15 ml) 50 mg  (5 ml) once daily 
<5 50 mg  (5 ml) 25 mg  (2.5 ml) once daily 

 
There are no data available on the use of lamivudine in children with renal impairment.  Based on the 
assumption that creatinine clearance and lamivudine clearance are correlated similarly in children as in 
adults; it is recommended that the dosage in children with renal impairment be reduced according to 
their creatinine clearance by the same proportion as in adults. The Epivir 10 mg/mL oral solution may 
be the most appropriate formulation to achieve the recommended dose in children with renal 
impairment aged at least 3 months and weighing less than 25kg. 
 
Dosing recommendations – Children aged at least 3 months and weighing less than 25 kg: 
 
Creatinine clearance  
(ml/min) 

First dose Maintenance dose 

≥50 10 mg/kg 
or 

5 mg/kg 

10 mg/kg once daily  
or 
5 mg/kg twice daily 

30 to<50 5 mg/kg 5 mg/kg once daily 
15 to <30 5 mg/kg 3.3 mg/kg once daily 
5 to <15 5 mg/kg 1.6 mg/kg once daily 
<5 1.6 mg/kg 0.9 mg/kg once daily 

 



19 
 

Hepatic impairment: Data obtained in patients with moderate to severe hepatic impairment shows that 
lamivudine pharmacokinetics are not significantly affected by hepatic dysfunction. Based on these 
data, no dose adjustment is necessary in patients with moderate or severe hepatic impairment unless 
accompanied by renal impairment. 
 
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 
 
While effective viral suppression with antiretroviral therapy has been proven to substantially reduce 
the risk of sexual transmission, a residual risk cannot be excluded.  Precautions to prevent 
transmission should be taken in accordance with national guidelines. 
 
Epivir is not recommended for use as monotherapy. 
 
Renal impairment: In patients with moderate –to- severe renal impairment, the terminal plasma half-
life of lamivudine is increased due to decreased clearance, therefore the dose should be adjusted (see 
section 4.2). 
 
Triple nucleoside therapy: There have been reports of a high rate of virological failure and of 
emergence of resistance at an early stage when lamivudine was combined with tenofovir disoproxil 
fumarate and abacavir as well as with tenofovir disoproxil fumarate and didanosine as a once daily 
regimen. 
 
Opportunistic infections: Patients receiving Epivir or any other antiretroviral therapy may continue to 
develop opportunistic infections and other complications of HIV infection, and therefore should 
remain under close clinical observation by physicians experienced in the treatment of patients with 
associated HIV diseases. 
 
Pancreatitis: Cases of pancreatitis have occurred rarely.  However it is not clear whether these cases 
were due to the antiretroviral treatment or to the underlying HIV disease.  Treatment with Epivir 
should be stopped immediately if clinical signs, symptoms or laboratory abnormalities suggestive of 
pancreatitis occur. 
 
Mitochondrial dysfunction following exposure in utero: Nucleoside and nucleotide analogues may 
impact mitochondrial function to a variable degree, which is most pronounced with stavudine, 
didanosine and zidovudine. There have been reports of mitochondrial dysfunction in HIV-negative 
infants exposed in utero and/or post-natally to nucleoside analogues, these have predominantly 
concerned treatment with regimens containing zidovudine. The main adverse reactions reported are 
haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, 
hyperlipasemia). These events have often been transitory. Late-onset neurological disorders have been 
reported rarely (hypertonia, convulsion, abnormal behaviour). Whether such neurological disorders are 
transient or permanent is currently unknown. These findings should be considered for any child 
exposed in utero to nucleoside and nucleotide analogues, who presents with severe clinical findings of 
unknown etiology, particularly neurologic findings. These findings do not affect current national 
recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of 
HIV. 
 
Weight and metabolic parameters: An increase in weight and in levels of blood lipids and glucose 
may occur during antiretroviral therapy. Such changes may in part be linked to disease control and life 
style. For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is 
no strong evidence relating this to any particular treatment. For monitoring of blood lipids and glucose 
reference is made to established HIV treatment guidelines. Lipid disorders should be managed as 
clinically appropriate. 
 



20 
 

Immune Reactivation Syndrome: In HIV-infected patients with severe immune deficiency at the time 
of institution of combination antiretroviral therapy (CART), an inflammatory reaction to 
asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or 
aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or 
months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or 
focal mycobacterium infections, and Pneumocystis jirovecii pneumonia (often referred to as PCP). 
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.  
Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to 
occur in the setting of immune reactivation; however, the reported time to onset is more variable and 
these events can occur many months after initiation of treatment. 
 
Liver disease: If lamivudine is being used concomitantly for the treatment of HIV and HBV, 
additional information relating to the use of lamivudine in the treatment of hepatitis B infection is 
available in the Zeffix SPC. 
 
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an 
increased risk of severe and potentially fatal hepatic adverse events. In case of concomitant antiviral 
therapy for hepatitis B or C, please refer also to the relevant product information for these medicinal 
products. 
 
If Epivir is discontinued in patients co-infected with hepatitis B virus, periodic monitoring of liver 
function tests and markers of HBV replication is recommended, as withdrawal of lamivudine may 
result in an acute exacerbation of hepatitis (see Zeffix SPC). 
 
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased 
frequency of liver function abnormalities during combination antiretroviral therapy, and should be 
monitored according to standard practice.  If there is evidence of worsening liver disease in such 
patients, interruption or discontinuation of treatment must be considered (see section 4.8). 
 
Excipients: Diabetic patients should be advised that each dose (150 mg = 15 ml) contains 3 g of 
sucrose. 
 
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or 
sucrase-isomaltase insufficiency should not take this medicine. 
 
Epivir contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. These may cause 
allergic reactions (possibly delayed). 
 
Paediatric Population: In a study performed in paediatric patients (see section 5.1 ARROW study), 
lower rates of virologic suppression and more frequent viral resistance were reported in children 
receiving the oral solution of Epivir as compared to those receiving the tablet formulation.  
 
Whenever possible in children, an all-tablet regimen should preferably be used. Epivir oral solution 
given concomitantly with sorbitol-containing medicines should be used only when an all-tablet 
regimen cannot be used and the benefits of treatment outweigh possible risks including lower 
virological suppression. Consider more frequent monitoring of HIV-1 viral load when Epivir is used 
with chronically-administered, sorbitol-containing medicines [e.g. Ziagen oral solution]. Although not 
studied, the same effect would be expected with other osmotic acting poly-alcohols or monosaccharide 
alcohols (e.g. xylitol, mannitol, lactitol, maltitol (see section 4.5)). 
 
Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, 
alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis 
have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to 
combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they 
experience joint aches and pain, joint stiffness or difficulty in movement. 
 



21 
 

Drug Interactions: Epivir should not be taken with any other medicinal products containing 
lamivudine or medicinal products containing emtricitabine (see section 4.5). 
 
The combination of lamivudine with cladribine is not-recommended (see section 4.5). 
 
4.5  Interaction with other medicinal products and other forms of interaction 
 
Interaction studies have only been performed in adults. 
 
The likelihood of metabolic interactions is low due to limited metabolism and plasma protein binding 
and almost complete renal clearance. 
 
Administration of trimethoprim/sulfamethoxazole 160 mg/800 mg results in a 40 % increase in 
lamivudine exposure, because of the trimethoprim component; the sulfamethoxazole component did 
not interact. However, unless the patient has renal impairment, no dosage adjustment of lamivudine is 
necessary (see section 4.2).  Lamivudine has no effect on the pharmacokinetics of trimethoprim or 
sulfamethoxazole.  When concomitant administration is warranted, patients should be monitored 
clinically. Co-administration of lamivudine with high doses of co-trimoxazole for the treatment of 
Pneumocystis jirovecii pneumonia (PCP) and toxoplasmosis should be avoided. 
 
The possibility of interactions with other medicinal products administered concurrently should be 
considered, particularly when the main route of elimination is active renal secretion via the organic 
cationic transport system e.g. trimethoprim. Other medicinal products (e.g. ranitidine, cimetidine) are 
eliminated only in part by this mechanism and were shown not to interact with lamivudine.  The 
nucleoside analogues (e.g. didanosine) like zidovudine, are not eliminated by this mechanism and are 
unlikely to interact with lamivudine. 
 
A modest increase in Cmax (28 %) was observed for zidovudine when administered with lamivudine, 
however overall exposure (AUC) is not significantly altered. Zidovudine has no effect on the 
pharmacokinetics of lamivudine (see section 5.2). 
 
Due to similarities, Epivir should not be administered concomitantly with other cytidine analogues, 
such as emtricitabine. Moreover, Epivir should not be taken with any other medicinal products 
containing lamivudine (see section 4.4). 
 
In vitro lamivudine inhibits the intracellular phosphorylation of cladribine leading to a potential risk of 
cladribine loss of efficacy in case of combination in the clinical setting. Some clinical findings also 
support a possible interaction between lamivudine and cladribine. Therefore, the concomitant use of 
lamivudine with cladribine is not recommended (see section 4.4). 
 
Lamivudine metabolism does not involve CYP3A, making interactions with medicinal products 
metabolised by this system (e.g. PIs) unlikely. 
 
Coadministration of sorbitol solution (3.2 g, 10.2 g, 13.4 g) with a single 300 mg dose of lamivudine 
oral solution resulted in dose-dependent decreases of 14%, 32%, and 36% in lamivudine exposure 
(AUC∞) and 28%, 52%, and 55% in the Cmax of lamivudine in adults. When possible, avoid chronic 
coadministration of Epivir with medicinal products containing sorbitol or other osmotic acting poly-
alcohols or monosaccharide alcohols (e.g. xylitol, mannitol, lactitol, maltitol). Consider more frequent 
monitoring of HIV-1 viral load when chronic coadministration cannot be avoided (see section 4.4). 
 
 
4.6 Fertility Pregnancy and lactation 
 
Pregnancy 
 



22 
 

As a general rule, when deciding to use antiretroviral agents for the treatment of HIV infection in 
pregnant women and consequently for reducing the risk of HIV vertical transmission to the newborn, 
the animal data as well as the clinical experience in pregnant women should be taken into account.  
Animal studies with lamivudine showed an increase in early embryonic deaths in rabbits but not in rats 
(see section 5.3). Placental transfer of lamivudine has been shown to occur in humans.  
 
More than 1000 outcomes from first trimester and more than 1000 outcomes from second and third 
trimester exposure in pregnant women indicate no malformative and foeto/neonatal effect. Epivir can 
be used during pregnancy if clinically needed. The malformative risk is unlikely in humans based on 
those data. 
 
For patients co-infected with hepatitis who are being treated with lamivudine and subsequently 
become pregnant, consideration should be given to the possibility of a recurrence of hepatitis on 
discontinuation of lamivudine. 
 
Mitochondrial dysfunction: Nucleoside and nucleotide analogues have been demonstrated in vitro and 
in vivo to cause a variable degree of mitochondrial damage. There have been reports of mitochondrial 
dysfunction in infants exposed in utero and/or post-natally to nucleoside analogues (see section 4.4). 
 
Breast-feeding 
 
Following oral administration lamivudine was excreted in breast milk at similar concentrations to 
those found in serum. Based on more than 200 mother/child pairs treated for HIV, serum 
concentrations of lamivudine in breastfed infants of mothers treated for HIV are very low (< 4% of 
maternal serum concentrations) and progressively decrease to undetectable levels when breastfed 
infants reach 24 weeks of age. There are no data available on the safety of lamivudine when 
administered to babies less than three months old.  It is recommended that HIV infected women do not 
breast-feed their infants under any circumstances in order to avoid transmission of HIV. 
 
Fertility 
Studies in animals showed that lamivudine had no effect on fertility (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. 
 
4.8 Undesirable effects 
 
The following adverse reactions have been reported during therapy for HIV disease with Epivir.   
 
The adverse reactions considered at least possibly related to the treatment are listed below by body 
system, organ class and absolute frequency. Frequencies are defined as 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), very rare 
(<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing 
seriousness. 
 
Blood and lymphatic systems disorders 
Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia 
Very rare: Pure red cell aplasia 
 
Metabolism and nutrition disorders 
Very rare: Lactic acidosis 
 
Nervous system disorders 
Common: Headache, insomnia  
Very rare: Peripheral neuropathy (or paraesthesia) 
 



23 
 

Respiratory, Thoracic and mediastinal disorders 
Common: Cough, nasal symptoms 
 
Gastrointestinal disorders 
Common: Nausea, vomiting, abdominal pain or cramps, diarrhoea 
Rare: Pancreatitis, elevations in serum amylase 
 
Hepatobiliary disorders 
Uncommon: Transient elevations in liver enzymes (AST, ALT) 
Rare: Hepatitis 
 
Skin and subcutaneous tissue disorders 
Common: Rash, alopecia 
Rare: Angioedema 
 
Musculoskeletal and connective tissue disorders 
Common: Arthralgia, muscle disorders  
Rare: Rhabdomyolysis 
 
General disorders and administration site conditions 
Common: Fatigue, malaise, fever 
 
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 
4.4) 
 
In HIV-infected patients with severe immune deficiency at the time of initiation of combination 
antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic 
infections may arise.  Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have 
also been reported to occur in the setting of immune reactivation; however, the reported time to onset 
is more variable and these events can occur many months after initiation of treatment (see section 4.4). 
 
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk 
factors, advanced HIV disease or long-term combined antiretroviral exposure (CART). The frequency 
of which is unknown (see section 4.4). 
 
Paediatric population 
 
1206 HIV-infected paediatric patients aged 3 months to 17 years were enrolled in the ARROW Trial 
(COL105677), 669 of whom received abacavir and lamivudine either once or twice daily (see section 
5.1). No additional safety issues have been identified in paediatric subjects receiving either once or 
twice daily dosing compared to adults. 
 
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 
 
Administration of lamivudine at very high dose levels in acute animal studies did not result in any 
organ toxicity. Limited data are available on the consequences of ingestion of acute overdoses in 
humans. No fatalities occurred, and the patients recovered.  No specific signs or symptoms have been 
identified following such overdose. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
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24 
 

If overdosage occurs the patient should be monitored, and standard supportive treatment applied as 
required.  Since lamivudine is dialysable, continuous haemodialysis could be used in the treatment of 
overdosage, although this has not been studied. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: nucleoside analogue, ATC Code: J05AF05. 
 
Mechanism of action 
 
Lamivudine is a nucleoside analogue which has activity against human immunodeficiency virus (HIV) 
and hepatitis B virus (HBV).  It is metabolised intracellularly to the active moiety, lamivudine 
5’- triphosphate. Its main mode of action is as a chain terminator of viral reverse transcription. The 
triphosphate has selective inhibitory activity against HIV-1 and HIV-2 replication in vitro; it is also 
active against zidovudine-resistant clinical isolates of HIV. No antagonistic effects in vitro were seen 
with lamivudine and other anti retrovirals (tested agents: abacavir, didanosine, nevirapine and 
zidovudine).  
 
Resistance 
 
HIV-1 resistance to lamivudine involves the development of a M184V amino acid change close to the 
active site of the viral reverse transcriptase (RT). This variant arises both in vitro and in HIV-1 
infected patients treated with lamivudine-containing antiretroviral therapy.  M184V mutants display 
greatly reduced susceptibility to lamivudine and show diminished viral replicative capacity in vitro. In 
vitro studies indicate that zidovudine-resistant virus isolates can become zidovudine sensitive when 
they simultaneously acquire resistance to lamivudine.  The clinical relevance of such findings remains, 
however, not well defined. 
 
In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the 
development of M184V might provide residual anti-retroviral activity (likely through impaired viral 
fitness).  The clinical relevance of these findings is not established.  Indeed, the available clinical data 
are very limited and preclude any reliable conclusion in the field.  In any case, initiation of susceptible 
NRTI’s should always be preferred to maintenance of lamivudine therapy.  Therefore, maintaining 
lamivudine therapy despite emergence of M184V mutation should only be considered in cases where 
no other active NRTI’s are available.  
 
Cross-resistance conferred by the M184V RT is limited within the nucleoside inhibitor class of 
antiretroviral agents. Zidovudine and stavudine maintain their antiretroviral activities against 
lamivudine-resistant HIV-1. Abacavir maintains its antiretroviral activities against lamivudine-
resistant HIV-1 harbouring only the M184V mutation.  The M184V RT mutant shows a <4-fold 
decrease in susceptibility to didanosine; the clinical significance of these findings is unknown. In vitro 
susceptibility testing has not been standardised and results may vary according to methodological 
factors. 
 
Lamivudine demonstrates low cytotoxicity to peripheral blood lymphocytes, to established 
lymphocyte and monocyte-macrophage cell lines, and to a variety of bone marrow progenitor cells in 
vitro.  
 
Clinical efficacy and safety 
 
In clinical trials, lamivudine in combination with zidovudine has been shown to reduce HIV-1 viral 
load and increase CD4 cell count.  Clinical end-point data indicate that lamivudine in combination 
with zidovudine, results in a significant reduction in the risk of disease progression and mortality. 
 



25 
 

Evidence from clinical studies shows that lamivudine plus zidovudine delays the emergence of 
zidovudine resistant isolates in individuals with no prior antiretroviral therapy. 
 
Lamivudine has been widely used as a component of antiretroviral combination therapy with other 
antiretroviral agents of the same class (NRTIs) or different classes (PIs, non-nucleoside reverse 
transcriptase inhibitors).   
 
Clinical trial evidence from paediatric patients receiving lamivudine with other antiretroviral drugs 
(abacavir, nevirapine/efavirenz or zidovudine) has shown that the resistance profile observed in 
paediatric patients is similar to that observed in adults, in terms of the genotypic substitutions detected 
and their relative frequency.  
 
Children receiving lamivudine oral solution concomitantly with other antiretroviral oral solutions in 
clinical trials developed viral resistance more frequently than children receiving tablets (see the 
description of the clinical experience in paediatric population (ARROW study) and section 5.2). 
 
Multiple drug antiretroviral therapy containing lamivudine has been shown to be effective in 
antiretrovirally-naive patients as well as in patients presenting with viruses containing the M184V 
mutations.   
 
The relationship between in vitro susceptibility of HIV to lamivudine and clinical response to 
lamivudine-containing therapy remains under investigation.  
 
Lamivudine at a dose of 100 mg once daily has also been shown to be effective for the treatment of 
adult patients with chronic HBV infection (for details of clinical studies, see the prescribing 
information for Zeffix).  However, for the treatment of HIV infection, only a 300 mg daily dose of 
lamivudine (in combination with other antiretroviral agents) has been shown to be efficacious. 
 
Lamivudine has not been specifically investigated in HIV patients co-infected with HBV. 
 
Once daily dosing (300 mg once a day): a clinical study has demonstrated the non inferiority between 
Epivir once a day and Epivir twice a day containing regimens. These results were obtained in an 
antiretroviral naïve-population, primarily consisting of asymptomatic HIV infected patients (CDC 
stage A). 
 
Paediatric population:a randomised comparison of a regimen including once daily vs twice daily 
dosing of abacavir and lamivudine was undertaken within a randomised, multicentre, controlled study 
of HIV-infected, paediatric patients. 1206 paediatric patients aged 3 months to 17 years enrolled in the 
ARROW Trial (COL105677) and were dosed according to the weight - band dosing recommendations 
in the World Health Organisation treatment guidelines (Antiretroviral therapy of HIV infection in 
infants and children, 2006). After 36 weeks on a regimen including twice daily abacavir and 
lamivudine, 669 eligible subjects were randomised to either continue twice daily dosing or switch to 
once daily abacavir and lamivudine for at least 96 weeks. Of note, from this study clinical data were 
not available for children under one year old.  The results are summarised in the table below: 
 



26 
 

Virological Response Based on Plasma HIV-1 RNA less than 80 copies/ml at Week 48 and Week 
96 in the Once Daily versus Twice Daily abacavir + lamivudine randomisation of ARROW 
(Observed Analysis) 
 

 Twice Daily 
N (%) 

Once Daily 
N (%) 

Week 0 (After ≥36 Weeks on Treatment) 
Plasma HIV-1 RNA 

<80 c/ml 
250/331 (76) 237/335 (71) 

Risk difference (once 
daily-twice daily) 

-4.8% (95% CI -11.5% to +1.9%), p=0.16 

Week 48 
Plasma HIV-1 RNA 

<80 c/ml 
242/331 (73) 236/330 (72) 

Risk difference (once 
daily-twice daily) 

-1.6% (95% CI -8.4% to +5.2%), p=0.65 

Week 96 
Plasma HIV-1 RNA 

<80 c/ml 
234/326 (72) 230/331 (69) 

Risk difference (once 
daily-twice daily) 

-2.3% (95% CI -9.3% to +4.7%), p=0.52 

 
In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of 
age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen. Three 
subjects had undetectable viral load and one had plasmatic HIV-RNA of 900 copies/ml at Week 48. 
No safety concerns were observed in these subjects. 
 
The abacavir + lamivudine once daily dosing group was demonstrated to be non-inferior to the twice 
daily group according to the pre-specified non-inferiority margin of -12%, for the primary endpoint of 
<80 c/ml at Week 48 as well as at Week 96 (secondary endpoint) and all other thresholds tested 
(<200c/ml, <400c/ml, <1000c/ml), which all fell well within this non-inferiority margin. Subgroup 
analyses testing for heterogeneity of once vs twice daily demonstrated no significant effect of sex, age, 
or viral load at randomisation. Conclusions supported non-inferiority regardless of analysis method. 
 
At the time of randomization to once daily vs twice daily dosing (Week 0), those patients who had 
received tablet formulations had a higher rate of viral load suppression than those who had received 
any solution formulations at any time. These differences were observed in each different age group 
studied. This difference in suppression rates between tablets and solutions remained through Week 96 
with once daily dosing.  
 
Proportions of Subjects in the Once Daily versus Twice Daily Abacavir+Lamivudine 
Randomisation of ARROW with Plasma HIV-1 RNA <80 copies/ml: Subgroup Analysis by 
Formulation 
 

 Twice Daily 
Plasma HIV-1 RNA 
<80 c/ml:  
n/N (%) 

Once Daily 
Plasma HIV-1 RNA 
<80 c/ml:  
n/N (%) 

Week 0 (after 36 weeks on Treatment)   
Any solution regimen at any time 14/26 (54) 15/30 (50) 
All tablet based regimen throughouts 236/305 (77) 222/305 (73) 
Week 96   
Any solution regimen at any time 13/26 (50) 17/30 (57) 
All tablet based regimen throughouts 221/300 (74) 213/301 (71) 
 

 



27 
 

Genotypic resistance analyses were conducted on samples with plasma HIV-1 RNA >1000 copies/ml. 
More cases of resistance were detected among patients who had received lamivudine solution, in 
combination with other antiretroviral solutions, compared with those who received similar doses of 
tablet formulation. This is consistent with the lower rates of antiviral suppression observed in these 
patients. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Lamivudine is well absorbed from the gastrointestinal tract, and the bioavailability of oral lamivudine 
in adults is normally between 80 and 85%.  Following oral administration, the mean time (tmax) to 
maximal serum concentrations (Cmax) is about an hour. Based on data derived from a study in healthy 
volunteers, at a therapeutic dose of 150 mg twice daily, mean (CV) steady-state Cmax and Cmin of 
lamivudine in plasma are 1.2 µg/ml (24%) and 0.09 µg/ml (27%), respectively.  The mean (CV) AUC 
over a dosing interval of 12 hours is 4.7 µg.h/ml (18%).  At a therapeutic dose of 300 mg once daily, 
the mean (CV) steady-state Cmax, Cmin and 24h AUC are 2.0 µg/ml (26%), 0.04 µg/ml (34%) and 8.9 
µg.h/ml (21%), respectively. 
 
Co-administration of lamivudine with food results in a delay of tmax and a lower C max (decreased by 
47 %). However, the extent (based on the AUC) of lamivudine absorbed is not influenced.   
 
Administration of crushed tablets with a small amount of semi-solid food or liquid would not be 
expected to have an impact on the pharmaceutical quality, and would therefore not be expected to alter 
the clinical effect.  This conclusion is based on the physiochemical and pharmacokinetic data 
assuming that the patient crushes and transfers 100% of the tablet and ingests immediately. 
 
Co-administration of zidovudine results in a 13% increase in zidovudine exposure and a 28% increase 
in peak plasma levels.  This is not considered to be of significance to patient safety and therefore no 
dosage adjustments are necessary.  
 
Distribution 
 
From intravenous studies, the mean volume of distribution is 1.3 l/kg.  The observed half-life of 
elimination is 5 to 7 hours.  The mean systemic clearance of lamivudine is approximately  
0.32 l/h/kg, with predominantly renal clearance (>70 %) via the organic cationic transport system. 
 
Lamivudine exhibits linear pharmacokinetics over the therapeutic dose range and displays limited 
binding to the major plasma protein albumin (< 16% - 36% to serum albumin in in vitro studies).  
 
Limited data show that lamivudine penetrates the central nervous system and reaches the cerebro-
spinal fluid (CSF).  The mean ratio CSF/serum lamivudine concentration 2-4 hours after oral 
administration was approximately 0.12.  The true extent of penetration or relationship with any clinical 
efficacy is unknown. 
 
Biotransformation 
 
The active moiety, intracellular lamivudine triphosphate, has a prolonged terminal half-life in the cell 
(16 to 19 hours) compared to the plasma lamivudine half-life (5 to 7 hours).  In 60 healthy adult 
volunteers, Epivir 300 mg once daily has been demonstrated to be pharmacokinetically equivalent at 
steady-state to Epivir 150 mg twice daily with respect to intracellular triphosphate AUC24 and Cmax.  
 
Lamivudine is predominately cleared unchanged by renal excretion. The likelihood of metabolic 
interactions of lamivudine with other medicinal products is low due to the small extent of hepatic 
metabolism (5-10%) and low plasma protein binding. 
 
Elimination 



28 
 

 
Studies in patients with renal impairment show lamivudine elimination is affected by renal 
dysfunction. A recommended dosage regimen for patients with creatinine clearance below 50 ml/min 
is shown in the dosage section (see section 4.2).  
 
An interaction with trimethoprim, a constituent of co-trimoxazole, causes a 40 % increase in 
lamivudine exposure at therapeutic doses.  This does not require dose adjustment unless the patient 
also has renal impairment (see sections 4.5 and 4.2).  Administration of co-trimoxazole with 
lamivudine in patients with renal impairment should be carefully assessed. 
 
Special populations  
 
Children: The absolute bioavailability of lamivudine (approximately 58-66%) was reduced in 
paediatric patients below 12 years of age.  In children, administration of tablets given concomitantly 
with other antiretroviral tablets delivered higher plasma lamivudine AUC∞ and Cmax than oral solution 
given concomitantly with other antiretroviral oral solutions. Children receiving lamivudine oral 
solution according to the recommended dosage regimen achieve plasma lamivudine exposure within 
the range of values observed in adults.  Children receiving lamivudine oral tablets according to the 
recommended dosage regimen achieve higher plasma lamivudine exposure than children receiving 
oral solution because higher mg/kg doses are administered with the tablet formulation and the tablet 
formulation has higher bioavailability (see section 4.2). Paediatric pharmacokinetic studies with both 
oral solution and tablet formulations have demonstrated that once daily dosing provides equivalent 
AUC0-24 to twice daily dosing of the same total daily dose. 
 
There are limited pharmacokinetic data for patients less than three months of age. In neonates one 
week of age, lamivudine oral clearance was reduced when compared to paediatric patients and is likely 
to be due to immature renal function and variable absorption.  Therefore to achieve similar adult and 
paediatric exposure, an appropriate dose for neonates is 4 mg/kg/day. Glomerular filtration estimates 
suggests that to achieve similar adult and paediatric exposure, an appropriate dose for children aged 
six weeks and older could be 8 mg/kg/day. 
 
Pharmacokinetic data were derived from 3 pharmacokinetic studies (PENTA 13, PENTA 15 and 
ARROW PK substudy) enrolling children under 12 years of age. The data are displayed in the table 
below: 
 
Summary of Stead-State Plasma Lamivudine AUC (0-24) (µg.h/ml) and Statistical Comparisons 
for Once and Twice-Daily Oral Administration Across Studies 

 
Study 

 
Age Group 

Lamivudine  
8mg/kg Once-
Daily Dosing 

Geometric Mean 
(95% Cl) 

Lamivudine 
4 mg/kg Twice-

Daily Dosing 
Geometric Mean 

(95% Cl) 

Once-Versus 
Twice-Daily 
Comparison 

GLS Mean Ratio 
(90% Cl) 

ARROW PK 
Substudy 

Part 1 

3 to 12 years 
(N=35) 

13.0 
(11.4,14.9) 

12.0 
(10.7, 13.4) 

1.09 
(0.979, 1.20) 

PENTA 13 2 to 12 years 
(N=19) 

9.80 
(8.64, 11.1) 

8.88 
(7.67, 10.3) 

1.12 
(1.03, 1.21) 

PENTA 15 3 to 36 months 
(N=17) 

8.66 
(7.46, 10.1) 

9.48 
(7.89, 11.40) 

0.91 
(0.79, 1.06) 

 
In PENTA 15 study, the geometric mean plasma lamivudine AUC(0-24) (95% CI) of the four subjects 
under 12 months of age who switch from a twice daily to a once daily regimen (see section 5.1) are 
10.31 (6.26, 17.0) µg.h/ml in the once-daily dosing and 9.24 (4.66, 18.3) µg.h/mL in the twice-daily 
dosing. 



29 
 

 
Pregnancy: Following oral administration, lamivudine pharmacokinetics in late-pregnancy were 
similar to non-pregnant women.  
 
5.3 Preclinical safety data 
 
Administration of lamivudine in animal toxicity studies at high doses was not associated with any 
major organ toxicity.  At the highest dosage levels, minor effects on indicators of liver and kidney 
function were seen together with occasional reductions in liver weight.  The clinically relevant effects 
noted were a reduction in red blood cell count and neutropenia. 
 
Lamivudine was not mutagenic in bacterial tests but, like many nucleoside analogues, showed activity 
in an in vitro cytogenetic assay and the mouse lymphoma assay.  Lamivudine was not genotoxic in 
vivo at doses that gave plasma concentrations around 40-50 times higher than the anticipated clinical 
plasma levels.  As the in vitro mutagenic activity of lamivudine could not be confirmed in in vivo tests, 
it is concluded that lamivudine should not represent a genotoxic hazard to patients undergoing 
treatment. 
 
A transplacental genotoxicity study conducted in monkeys compared zidovudine alone with the 
combination of zidovudine and lamivudine at human-equivalent exposures.  The study demonstrated 
that foetuses exposed in utero to the combination sustained a higher level of nucleoside analogue-
DNA incorporation into multiple foetal organs, and showed evidence of more telomere shortening 
than in those exposed to zidovudine alone. The clinical significance of these findings is unknown. 
 
The results of long-term carcinogenicity studies in rats and mice did not show any carcinogenic 
potential relevant for humans. 
 
A fertility study in rats has shown that lamivudine had no effect on male or female fertility. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Sucrose 20 % w/v (3 g/15 ml) 
Methyl parahydroxybenzoate  
Propyl parahydroxybenzoate  
Citric acid Anhydrous 
Propylene glycol  
Sodium citrate  
Artificial strawberry flavour 
Artificial banana flavour 
Purified water  
 
6.2 Incompatibilities 
 
Not applicable 
 
6.3 Shelf life 
 
2 years 
 
Discard the oral solution one month after first opening. 
 



30 
 

6.4 Special precautions for storage 
 
Do not store above 25°C. 
 
6.5 Nature and contents of container 
 
Cartons containing 240 ml oral solution in a white high density polyethylene (HDPE) bottle, with a 
child resistant closure.  The pack also includes a polyethylene syringe-adapter, and a 10 ml oral dosing 
syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger. 
 
The oral dosing syringe is provided for accurate measurement of the prescribed dose of the oral 
solution. Instructions for use are included in the pack. 
 
 
6.6 Special precautions for disposal 
 
No special requirements for disposal. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/015/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 8 August 1996 
Date of last renewal: 28 July 2006 
 
 
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. 
  

http://www.ema.e/
http://www.ema.e/


31 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX II 

 
A.  MANUFACTURER(S) 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 



32 
 

A.  MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Film-coated tablets: 
 
Glaxo Operations UK Limited 
(trading as Glaxo Wellcome Operations) 
Priory Street, Ware 
Hertfordshire 
SG12 0DJ 
United Kingdom. 
 
or 
 
GlaxoSmithKline Pharmaceuticals S.A. 
ul. Grunwaldzka 189 
60-322 Poznan 
Poland 
 
Oral solution: 
 
Glaxo Operations UK Ltd (trading as GlaxoWellcome Operations), Harmire Road, Barnard Castle, 
Co. Durham DL12 8DT, United Kingdom 
 
ViiV Healthcare Trading Services UK Limited  
12 Riverwalk,  
Citywest Business Campus  
Dublin 24, 
Ireland 
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch. 
 
 
B.  CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE   
 

 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2) 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION  
 
Periodic Safety Update Reports 

 
The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE 
AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
  



33 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX III 

 
LABELLING AND PACKAGE LEAFLET 

  



34 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
A. LABELLING 

 
 
  



35 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE CARTON X 60 FILM-COATED TABLETS (150 mg) 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 150 mg film-coated tablets 
Lamivudine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains lamivudine 150 mg 
 
 

3. LIST OF EXCIPIENTS 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
60 film-coated tablets 
Scored tablets 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Read the package leaflet before 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 {MM/YYYY} 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
 
  



36 
 

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 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/015/001 
 
 

13. BATCH NUMBER 
 
LOT 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
epivir 150 mg 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included.  
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
 
PC: 
SN: 
NN:  
 
                                                                                                                                                                                       



37 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL X 60 FILM-COATED TABLETS (150 mg) 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 150 mg film-coated tablets 
Lamivudine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains lamivudine 150 mg 
 
 

3. LIST OF EXCIPIENTS 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
60 film-coated tablets 
Scored tablets 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Read the package leaflet before 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 {MM/YYYY} 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
 
  



38 
 

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 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/015/001 
 
 

13. BATCH NUMBER 
 
LOT 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BLISTER CARTON X 60 FILM-COATED TABLETS (150 mg) 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 150 mg film-coated tablets 
Lamivudine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains  
lamivudine 150 mg 
 



39 
 

 
3. LIST OF EXCIPIENTS 

 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
60 film-coated tablets 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Read the package leaflet before 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 {MM/YYYY} 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
 
  



40 
 

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 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/015/004 
 
 

13. BATCH NUMBER 
 
LOT 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
epivir 150 mg 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included.  
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
 
PC: 
SN: 
NN:  
 



41 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 150 mg tablets 
 
lamivudine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
ViiV Healthcare BV 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
LOT 
 
 
5. OTHER 
 
  



42 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE CARTON FOR ORAL SOLUTION 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 10 mg/ml oral solution 
Lamivudine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml of oral solution contains 10 mg lamivudine  
 
 

3. LIST OF EXCIPIENTS 
 
This product also contains sugar, preservatives: methyl parahydroxybenzoate and propyl 
parahydroxybenzoate 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Bottle contents: 
240 ml oral solution  
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Read the package leaflet before 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 {MM/YYYY} 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C 
 
Discard one month after first opening 
 



43 
 

 
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 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/015/002 
 
 

13. BATCH NUMBER 
 
LOT 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
epivir 10 mg/ml 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included.  
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
 
PC: 
SN: 
NN:  
  



44 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL FOR ORAL SOLUTION 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 10 mg/ml oral solution 
Lamivudine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each ml of oral solution contains 10 mg lamivudine  
 
 

3. LIST OF EXCIPIENTS 
 
This product also contains sugar, preservatives: methyl parahydroxybenzoate and propyl 
parahydroxybenzoate 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Bottle contents: 
240 ml oral solution  
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Read the package leaflet before 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 {MM/YYYY} 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 25°C 
 
Discard one month after first opening 
 



45 
 

 
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 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/015/002 
 
 

13. BATCH NUMBER 
 
LOT 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
  



46 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE CARTON X 30 FILM-COATED TABLETS (300 mg ) 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 300 mg film-coated tablets 
Lamivudine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains  
Lamivudine 300 mg 
 
 

3. LIST OF EXCIPIENTS 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Read the package leaflet before 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 {MM/YYYY} 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
 
  



47 
 

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 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/015/003 
 
 

13. BATCH NUMBER 
 
LOT 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
epivir 300 mg 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included.  
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
 
PC: 
SN: 
NN:  
  



48 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
BOTTLE LABEL X 30 FILM-COATED TABLETS (300 mg ) 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 300 mg film-coated tablets 
Lamivudine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains  
Lamivudine 300 mg 
 
 

3. LIST OF EXCIPIENTS 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Read the package leaflet before 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 {MM/YYYY} 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
 
  



49 
 

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 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/015/003 
 
 

13. BATCH NUMBER 
 
LOT 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
  



50 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BLISTER CARTON X 30 FILM-COATED TABLETS (300 mg ) 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 300 mg film-coated tablets 
Lamivudine 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains  
lamivudine 300 mg 
 
 

3. LIST OF EXCIPIENTS 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
30 film-coated tablets 
 
 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
 
Read the package leaflet before 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 {MM/YYYY} 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C 
 
 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 



51 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 
 

12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/96/015/005 
 
 

13. BATCH NUMBER 
 
LOT 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
epivir 300 mg 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included.  
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA  
 
PC: 
SN: 
NN:  
  



52 
 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Epivir 300 mg tablet 
 
lamivudine 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
ViiV Healthcare BV 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
LOT 
 
 
5. OTHER 
 
  



53 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
B. PACKAGE LEAFLET 

 
 



54 
 

Package leaflet: Information for the user 
 

Epivir 150 mg film-coated tablets 
lamivudine 

 
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 any 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 Epivir is and what it is used for 
2. What you need to know before you take Epivir 
3. How to take Epivir 
4. Possible side effects 
5. How to store Epivir 
6. Contents of the pack and other information 
 
 
1. What Epivir is and what it is used for 
 
Epivir is used to treat HIV (human immunodeficiency virus) infection in adults and children. 

The active ingredient in Epivir is lamivudine. Epivir is a type of medicine known as an anti-retroviral. 
It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors 
(NRTIs). 
 
Epivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps 
it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood 
cells that are important in helping your body to fight infection. 
 
Not everyone responds to treatment with Epivir in the same way. Your doctor will monitor the 
effectiveness of your treatment. 
 
 
2. What you need to know before you take Epivir 
 
Do not take Epivir: 

• if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in Section 
6). 

 
Check with your doctor if you think this applies to you. 

 
Take special care with Epivir 

Some people taking Epivir or other combination treatments for HIV are more at risk of serious side 
effects. You need to be aware of the extra risks: 
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, 

do not stop Epivir without your doctor’s advice, as your hepatitis may come back) 
• if you are seriously overweight (especially if you are a woman) 
• if you or your child has a kidney problem, your dose may be altered. 



55 
 

Talk to your doctor if any of these apply to you. You may need extra check-ups, including 
blood tests, while you are taking your medicine. See Section 4 for more information.  

 
Look out for important symptoms 

Some people taking medicines for HIV infection develop other conditions, which can be serious. You 
need to know about important signs and symptoms to look out for while you are taking Epivir. 

Read the information ‘Other possible side effects of combination therapy for HIV’ in 
Section 4 of this leaflet. 

 
Protect other people 

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of 
infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this 
medicine, although the risk is lowered by effective antiretroviral therapy.  

Discuss with your doctor the precautions needed to avoid infecting other people. 
 
Other medicines and Epivir 

Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any 
recently, including herbal medicines or other medicines you bought without a prescription.  

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking 
Epivir. 
 
These medicines should not be used with Epivir: 

•  medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, 
mannitol, lactitol or maltitol), if taken regularly 

• other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection) 

• emtricitabine (used to treat HIV infection) 
• high doses of co-trimoxazole, an antibiotic 

• cladribine (used to treat hairy cell leukaemia). 

Tell your doctor if you are being treated with any of these. 
 
Pregnancy  

If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor 
about the risks and benefits to you and your baby of taking Epivir.  
 
Epivir and similar medicines may cause side effects in unborn babies. If you have taken Epivir during 
your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the 
development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from 
the protection against HIV outweighed the risk of side effects. 
 
Breast-feeding 

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the 
baby in breast milk. 

A small amount of the ingredients in Epivir can also pass into your breast milk. 

If you are breast-feeding, or thinking about breast-feeding: 

Talk to your doctor immediately. 
 



56 
 

Driving and using machines 

Epivir is unlikely to affect your ability to drive or use machines. 
 
 
3.  How to take Epivir  
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your 
doctor or pharmacist if you are not sure. 
 
Swallow the tablets, with some water. Epivir can be taken with or without food. 
 
If you cannot swallow the tablets whole, you may crush and combine them with a small amount of 
food or drink, and take all the dose immediately. 
 
Stay in regular contact with your doctor 

Epivir helps to control your condition. You need to keep taking it every day to stop your illness getting 
worse. You may still develop other infections and illnesses linked to HIV infection. 

Keep in touch with your doctor, and do not stop taking Epivir without your doctor’s advice. 
 
How much to take 

Adults, adolescents and children who weigh at least 25 kg: 

The usual dose of Epivir is 300 mg a day. This can be taken as either one 150 mg tablet twice a day 
(leaving approximately 12 hours between each dose), or two 150 mg tablets once a day as advised by 
your doctor. 
 
Children weighing at least 20 kg and less than 25 kg: 

The usual dose of Epivir is 225 mg a day. This can be given as 75 mg (half a 150 mg tablet) in the 
morning and 150 mg (one whole 150 mg tablet) in the evening, or 225 mg (one and a half 150 mg 
tablets) once a day as advised by your doctor. 
 
Children weighing at least 14 kg and less than 20 kg: 

The usual dose of Epivir is 150 mg a day. This can be given as 75 mg (half a 150 mg tablet) twice a 
day (leaving approximately 12 hours between each dose), or 150 mg (one 150 mg tablet) once a day as 
advised by your doctor. 
 
An oral solution is also available for the treatment of children over 3 months of age, or for people 
who need a lower dose than usual, or who cannot take tablets. 
 
If you or your child has a kidney problem, your dose may be altered.   

Talk to your doctor if this applies to you or your child. 
 
If you take more Epivir than you should  

Accidentally taking too much Epivir is unlikely to cause any serious problems.  If you take too much, 
tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further 
advice. 
 
If you forget to take Epivir 

If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. 
Do not take a double dose to make up for a forgotten dose. 
 
 
4. Possible side effects 



57 
 

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This 
is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV 
medicines themselves. Your doctor will test for these changes.  
 
Like all medicines, this medicine can cause side effects, but not everyone gets them.  
 
When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Epivir 
or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to 
talk to your doctor about any changes in your health. 
 
As well as the side effects listed below for Epivir, other conditions can develop during combination 
therapy for HIV.  

It is important to read the information later in this section under ‘Other possible side effects of 
combination therapy for HIV’. 

 
Common side effects 
These may affect up to 1 in 10 people: 
• headache 
• feeling sick (nausea) 
• being sick (vomiting) 
• diarrhoea 
• stomach pains 
• tiredness, lack of energy 
• fever (high temperature) 
• general feeling of being unwell 
• muscle pain and discomfort 
• joint pain 
• difficulty in sleeping (insomnia) 
• cough 
• irritated or runny nose 
• rash 
• hair loss (alopecia). 
 
Uncommon side effects 
These may affect up to 1 in 100 people: 
 
Uncommon side effects that may show up in blood tests are: 
• a decrease in the number of cells involved in blood clotting (thrombocytopenia)  
• a low red blood cell count (anaemia) or low white blood cell count (neutropenia)  
• an increase in the level of liver enzymes. 
 
Rare side effects 
These may affect up to 1 in 1000 people: 
• serious allergic reaction causing swelling of the face, tongue or throat which may cause 

difficulty in swallowing or breathing 
• inflammation of the pancreas (pancreatitis) 
• breakdown of muscle tissue 
• liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis). 
 
A rare side effect that may show up in blood tests is: 
• an increase in an enzyme called amylase. 
 



58 
 

Very rare side effects 
These may affect up to 1 in 10,000 people: 
• Lactic acidosis (excess lactic acid in the blood) 
• tingling or numbness of the arms, legs, hands or feet. 
 
A very rare side effect that may show up in blood tests is: 
• a failure of the bone marrow to produce new red blood cells (pure red cell aplasia). 
 
If you get side effects 

Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you 
notice any side effects not listed in this leaflet. 

 
Other possible side effects of combination therapy for HIV 

Combination therapy including Epivir may cause other conditions to develop during HIV treatment. 
 
Old infections may flare up 

People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to 
develop serious infections (opportunistic infections). When these people start treatment, they may find 
that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are 
probably caused by the body’s immune system becoming stronger, so that the body starts to fight these 
infections. 
 
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the 
immune system attacks healthy body tissue) may also occur after you start taking medicines for the 
treatment of your HIV infection. Autoimmune disorders may occur many months after the start of 
treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, 
weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, 
tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. 
 
If you get any symptoms of infection while you are taking Epivir: 

Tell your doctor immediately. Do not take other medicines for the infection without your 
doctor’s advice. 

 
You may have problems with your bones 

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this 
condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be 
more likely to get this condition: 
• if they have been taking combination therapy for a long time 
• if they are also taking anti-inflammatory medicines called corticosteroids 
• if they drink alcohol 
• if their immune systems are very weak 
• if they are overweight. 
Signs of osteonecrosis include: 
• stiffness in the joints 
• aches and pains (especially in the hip, knee or shoulder) 
• difficulty moving. 
If you notice any of these symptoms: 

Tell your doctor. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 



59 
 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
5. How to store Epivir 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton. 
 
Do not store Epivir above 30oC.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away the medicines you no longer use. These measures will help to protect the environment. 
 
 
6 Contents of the pack and other information 
 
What Epivir contains 
The active substance is lamivudine.  
The tablets also contain the following other ingredients: 
Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate  
Film-coat: hypromellose, titanium dioxide, macrogol, polysorbate 80 
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 
‘sodium-free’. 
 
What Epivir looks like and the contents of the pack 
Epivir 150 mg film-coated tablets are supplied in white polyethylene bottles or blister packs 
containing 60 tablets. They are white, diamond shaped, scored, film-coated tablets, marked with the 
code ‘GXCJ7’ on both sides.   

 
Marketing Authorisation Holder and Manufacturer 
 

Manufacturer Marketing Authorisation Holder 
 

Glaxo Operations UK Limited 
(trading as Glaxo Wellcome 
Operations)  
Priory Street  
Ware  
Herts SG12 0DJ  
United Kingdom 
 
or 
 
GlaxoSmithKline 
Pharmaceuticals S.A. 
ul. Grunwaldzka 189 
60-322 Poznan 
Poland 

ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 

 
  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


60 
 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
ViiV Healthcare srl/bv  
Tél/Tel: + 32 (0)10 85 65 00 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 
 

България 
ГлаксоСмитКлайн ЕООД 
Teл.: + 359 2 953 10 34 
 

Luxembourg/Luxemburg 
ViiV Healthcare srl/bv  
Belgique/Belgien 
Tél/Tel: + 32 (0)10 85 65 00 
 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 222 001 111 
cz.info@gsk.com 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Malta 
GlaxoSmithKline (Malta) Limited 
Tel: + 356 21 238131 

Deutschland 
ViiV Healthcare GmbH  
Tel.: + 49 (0)89 203 0038-10 
viiv.med.info@viivhealthcare.com  
 

Nederland 
ViiV Healthcare BV  
Tel: + 31 (0)33 2081199 
 

Eesti 
GlaxoSmithKline Eesti OÜ 
Tel: + 372 6676 900 
estonia@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
 

Ελλάδα 
GlaxoSmithKline Μονοπρόσωπη 
A.E.B.E. 
Τηλ: + 30 210 68 82 100 

Österreich 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 
 

España 
Laboratorios ViiV Healthcare, S.L.  
Tel: + 34 900 923 501  
es-ci@viivhealthcare.com 
 

Polska 
GSK Services Sp. z o.o. 
Tel.: + 48 (0)22 576 9000 
 

France 
ViiV Healthcare SAS  
Tél.: + 33 (0)1 39 17 6969 
Infomed@viivhealthcare.com 
 
 

Portugal 
VIIVHIV HEALTHCARE, UNIPESSOAL, 
LDA. 
Tel: + 351 21 094 08 01 
viiv.fi.pt@viivhealthcare.com 
 

Hrvatska 
GlaxoSmithKline d.o.o. 
Tel: +385 1 6051 999 
 

România 
GlaxoSmithKline (GSK) S.R.L.  
Tel: + 4021 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 

mailto:dk-info@gsk.com
mailto:dk-info@gsk.com
mailto:viiv.med.info@viivhealthcare.com
mailto:viiv.med.info@viivhealthcare.com
mailto:es-ci@viivhealthcare.com
mailto:es-ci@viivhealthcare.com
mailto:Infomed@viivhealthcare.com
mailto:Infomed@viivhealthcare.com
mailto:viiv.fi.pt@viivhealthcare.com
mailto:viiv.fi.pt@viivhealthcare.com


61 
 

 
Ísland 
Vistor hf.  
Sími: +354 535 7000 

Slovenská republika 
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 

Italia 
ViiV Healthcare S.r.l.  
Tel: + 39 (0)45 9212611 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
Finland.tuoteinfo@gsk.com 
 

Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com  
 

United Kingdom 
ViiV Healthcare UK Limited 
Tel: + 44 (0)800 221441 
customercontactuk@gsk.com  
  

  
 
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. 

  

mailto:gskcyprus@gsk.com
mailto:gskcyprus@gsk.com
http://www.ema.e/
http://www.ema.e/


62 
 

Package leaflet: Information for the user 
 

Epivir 10 mg/ml oral solution 
lamivudine 

 
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 any further questions, ask your doctor or pharmacist. 
− This medicine has been prescribed for you or for your child. 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. This includes any possible side effects not 

listed in this leaflet. See section 4. 
 
What is in this leaflet: 
 
1. What Epivir is and what it is used for 
2. What you need to know before you take Epivir 
3. How to take Epivir 
4. Possible side effects 
5. How to store Epivir 
6. Contents of the pack and other information 
 
 
1. What Epivir is and what it is used for 
 
Epivir is used to treat HIV (human immunodeficiency virus) infection in adults and children. 
 
The active ingredient in Epivir is lamivudine. Epivir is a type of medicine known as an anti-retroviral. 
It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors 
(NRTIs). 
 
Epivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps 
it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood 
cells that are important in helping your body to fight infection. 
 
Not everyone responds to treatment with Epivir in the same way. Your doctor will monitor the 
effectiveness of your treatment. 
 
 
2. What you need to know before you take Epivir 
 
Do not take Epivir: 

• if you are allergic to lamivudine or any of the other ingredients  of this medicine (listed in Section 
6). 

 
Check with your doctor if you think this applies to you.  

 
Take special care with Epivir 

Some people taking Epivir or other combination treatments for HIV are more at risk of serious side 
effects. You need to be aware of the extra risks: 
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, 

do not stop Epivir without your doctor’s advice, as your hepatitis may come back) 
• if you are seriously overweight (especially if you are a woman) 
• if you or your child has a kidney problem, your dose may be altered. 



63 
 

Talk to your doctor if any of these apply to you. You may need extra check-ups, including 
blood tests, while you are taking your medicine. See Section 4 for more information.  

 
Look out for important symptoms 

Some people taking medicines for HIV infection develop other conditions, which can be serious. You 
need to know about important signs and symptoms to look out for while you are taking Epivir. 

Read the information ‘Other possible side effects of combination therapy for HIV’ in 
Section 4 of this leaflet. 

 
Protect other people 

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of 
infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this 
medicine, although the risk is lowered by effective antiretroviral therapy.   

Discuss with your doctor the precautions needed to avoid infecting other people. 
 
Other medicines and Epivir 

Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any 
recently, including herbal medicines or other medicines you bought without a prescription.  

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking 
Epivir. 

 
These medicines should not be used with Epivir: 

• medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, 
mannitol, lactitol or maltitol), if taken regularly 

• other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection) 
• emtricitabine (used to treat HIV infection) 
• high doses of co-trimoxazole, an antibiotic 

• cladribine (used to treat hairy cell leukaemia). 

Tell your doctor if you are being treated with any of these. 
 
Pregnancy 

If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor 
about the risks and benefits to you and your baby of taking Epivir. 
 
Epivir and similar medicines may cause side effects in unborn babies. If you have taken Epivir during 
your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the 
development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from 
the protection against HIV outweighed the risk of side effects. 
 
Breast-feeding 

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the 
baby in breast milk. 
A small amount of the ingredients in Epivir can also pass into your breast milk. 

If you are breast-feeding, or thinking about breast-feeding: 

Talk to your doctor immediately. 



64 
 

 
Driving and using machines 

Epivir is unlikely to affect your ability to drive or use machines. 
 
Important information about some of the ingredients of Epivir 
 
If you are a diabetic, please note that each dose (150 mg = 15 ml) contains 3 g sugar.   
Epivir contains sucrose. If you have been told by your doctor that you have an intolerance to some 
sugars, contact your doctor before taking Epivir. Sucrose may be harmful to the teeth. 
 
Epivir also contains preservatives (parahydroxybenzoates) which may cause allergic reactions 
(possibly delayed). 
 
 
3.  How to take Epivir 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your 
doctor or pharmacist if you are not sure.  
 
Epivir can be taken with or without food. 
 
Stay in regular contact with your doctor 

Epivir helps to control your condition. You need to keep taking it every day to stop your illness getting 
worse. You may still develop other infections and illnesses linked to HIV infection. 

Keep in touch with your doctor, and do not stop taking Epivir without your doctor’s advice. 
 
How much to take 
 
Adults, adolescents and children weighing at least 25 kg 

The usual dose of Epivir is 30 ml (300 mg) a day. This can be taken either as 15 ml (150 mg) twice a 
day (leaving approximately 12 hours between each dose), or as 30 ml (300 mg) once a day. 
 
Children from 3 months of age weighing less than 25 kg 

The dose depends on the child’s body weight. The usual dose of Epivir is 0.5 mL/kg (5 mg/kg) 
twice daily (leaving approximately 12 hours between each dose), or 1 mL/kg (10 mg/kg) once daily.   
 
Use the oral dosing syringe supplied with the pack to measure your dose accurately.  
 
1. Remove the bottle cap. Keep it safely 
2. Hold the bottle firmly. Push the plastic adapter into the neck of the bottle.  
3. Insert the syringe firmly into the adapter. 
4.  Turn the bottle upside down. 
5. Pull out syringe plunger until the syringe contains the first part of your full dose.  
6. Turn the bottle the correct way up. Remove the syringe from the adapter. 
7. Put the syringe into your mouth, placing the tip of the syringe against the inside of your 

cheek. Slowly push the plunger in, allowing time to swallow. Do not push too hard and squirt 
the liquid into the back of your throat or you may choke.  

8. Repeat steps 3 to 7 in the same way until you have taken your whole dose. For example, if your 
dose is 15 ml, you need to take one and a half syringe-fulls of medicine. 

9. Take the syringe out of the bottle and wash it thoroughly in clean water. Let it dry completely 
before you use it again. 

10. Close the bottle tightly with the cap, leaving the adaptor in place. 
 
If you or your child has a kidney problem, the dose may be altered.   

Talk to your doctor if this applies to you or your child. 



65 
 

 
If you take more Epivir than you should 

Accidentally taking too much Epivir is unlikely to cause any serious problems. If you take too much, 
tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further 
advice. 
 
If you forget to take Epivir 

If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. 
Do not take a double dose to make up for a forgotten dose. 
 
 
4. Possible side effects  
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This 
is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV 
medicines themselves. Your doctor will test for these changes.  
 
Like all medicines, this medicine can cause side effects, but not everyone gets them.  
 
When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Epivir 
or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to 
talk to your doctor about any changes in your health. 
 
As well as the side effects listed below for Epivir, other conditions can develop during combination 
therapy for HIV.  

It is important to read the information later in this section under ‘Other possible side effects of 
combination therapy for HIV’. 

 
Common side effects 
These may affect up to 1 in 10 people: 
• headache 
• feeling sick (nausea) 
• being sick (vomiting) 
• diarrhoea 
• stomach pains 
• tiredness, lack of energy 
• fever (high temperature) 
• general feeling of being unwell 
• muscle pain and discomfort 
• joint pain 
• difficulty in sleeping (insomnia) 
• cough 
• irritated or runny nose 
• rash 
• hair loss (alopecia). 
 
Uncommon side effects 
These may affect up to 1 in 100 people: 
 
Uncommon side effects that may show up in blood tests are: 



66 
 

• a decrease in the number of cells involved in blood clotting (thrombocytopenia)  
• a low red blood cell count (anaemia) or low white blood cell count (neutropenia)  
• an increase in the level of liver enzymes. 
 
Rare side effects 
These may affect up to 1 in 1000 people: 
• serious allergic reaction causing swelling of the face, tongue or throat which may cause 

difficulty in swallowing or breathing 
• inflammation of the pancreas (pancreatitis) 
• breakdown of muscle tissue 
• liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis). 
 
A rare side effect that may show up in blood tests is: 
• increase in an enzyme called amylase. 
 
Very rare side effects 
These may affect up to 1 in 10,000 people: 
• Lactic acidosis (excess lactic acid in the blood) 
• tingling or numbness of the arms, legs, hands or feet. 
 
A very rare side effect that may show up in blood tests is: 
• a failure of the bone marrow to produce new red blood cells (pure red cell aplasia). 
 
If you get side effects 

Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you 
notice any side effects not listed in this leaflet. 

 
Other possible side effects of combination therapy for HIV 
Combination therapy such as Epivir may cause other conditions to develop during HIV treatment. 
 
Old infections may flare up 
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to 
develop serious infections (opportunistic infections). When these people start treatment, they may find 
that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are 
probably caused by the body’s immune system becoming stronger, so that the body starts to fight these 
infections. 
 
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the 
immune system attacks healthy body tissue) may also occur after you start taking medicines for the 
treatment of your HIV infection. Autoimmune disorders may occur many months after the start of 
treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, 
weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, 
tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. 
 
If you get any symptoms of infection while you are taking Epivir: 

Tell your doctor immediately. Do not take other medicines for the infection without your 
doctor’s advice. 

 
You may have problems with your bones 
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this 
condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be 
more likely to get this condition: 
• if they have been taking combination therapy for a long time 
• if they are also taking anti-inflammatory medicines called corticosteroids 
• if they drink alcohol 



67 
 

• if their immune systems are very weak 
• if they are overweight. 
Signs of osteonecrosis include: 
• stiffness in the joints 
• aches and pains (especially in the hip, knee or shoulder) 
• difficulty moving. 
If you notice any of these symptoms: 

Tell your doctor. 
 

Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. 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 Epivir 
 
Keep this medicine out of the sight and reach of children 
 
Do not use this medicine after the expiry date which is stated on the container.  
 
Discard one month after first opening. 
 
Do not store above 25oC.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away the medicines you no longer use. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Epivir contains 
The active substance is lamivudine.  
The oral solution also contains the following other ingredients: sugar (sucrose 3 g/15 ml), methyl 
parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene 
glycol, water, artificial strawberry and banana flavourings. 
 
This medicine contains 300 mg propylene glycol in each 15ml. 
 
This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium-
free’. 
 
What Epivir looks like and the contents of the pack 
Epivir oral solution is supplied in a white polyethylene bottle containing 240 ml of solution. An oral 
dosing syringe and a plastic adapter for the bottle is included in the pack. 
 
Marketing Authorisation Holder and Manufacturer 
 
Manufacturer Marketing Authorisation Holder 

 
Glaxo Operations UK Ltd 
(trading as GlaxoWellcome 
Operations) 
Harmire Road 
Barnard Castle 

ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


68 
 

Co. Durham DL12 8DT 
United Kingdom 
 
  

ViiV Healthcare Trading Services UK Limited  
12 Riverwalk,  
Citywest Business Campus  
Dublin 24, 
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
ViiV Healthcare srl/bv  
Tél/Tel: + 32 (0)10 85 65 00 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 
 

България 
ГлаксоСмитКлайн ЕООД 
Teл.: + 359 2 953 10 34 
 

Luxembourg/Luxemburg 
ViiV Healthcare srl/bv  
Belgique/Belgien 
Tél/Tel: + 32 (0)10 85 65 00 
 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 222 001 111 
cz.info@gsk.com 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Malta 
GlaxoSmithKline (Malta) Limited 
Tel: + 356 21 238131 

Deutschland 
ViiV Healthcare GmbH  
Tel.: + 49 (0)89 203 0038-10  
viiv.med.info@viivhealthcare.com  
 

Nederland 
ViiV Healthcare BV  
Tel: + 31 (0)33 2081199 
 

Eesti 
GlaxoSmithKline Eesti OÜ 
Tel: + 372 6676 900 
estonia@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
 

Ελλάδα 
GlaxoSmithKline Μονοπρόσωπη 
A.E.B.E. 
Τηλ: + 30 210 68 82 100 

Österreich 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 
 

España 
Laboratorios ViiV Healthcare, S.L.  
Tel: + 34 900 923 501 
es-ci@viivhealthcare.com 
 

Polska 
GSK Services Sp. z o.o. 
Tel.: + 48 (0)22 576 9000 
 

France 
ViiV Healthcare SAS  
Tél.: + 33 (0)1 39 17 6969 
Infomed@viivhealthcare.com 

Portugal 
VIIVHIV HEALTHCARE, UNIPESSOAL, 
LDA. 
Tel: + 351 21 094 08 01  

mailto:dk-info@gsk.com
mailto:dk-info@gsk.com
mailto:viiv.med.info@viivhealthcare.com
mailto:viiv.med.info@viivhealthcare.com
mailto:es-ci@viivhealthcare.com
mailto:es-ci@viivhealthcare.com
mailto:Infomed@viivhealthcare.com
mailto:Infomed@viivhealthcare.com


69 
 

 viiv.fi.pt@viivhealthcare.com 
 

Hrvatska 
GlaxoSmithKline d.o.o. 
Tel: +385 1 6051 999 
 

România 
GlaxoSmithKline (GSK) S.R.L.  
Tel: + 4021 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
Vistor hf.  
Sími: +354 535 7000 
 

Slovenská republika 
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 

Italia 
ViiV Healthcare S.r.l. 
Tel: + 39 (0)45 9212611 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
Finland.tuoteinfo@gsk.com 
 

Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com 

United Kingdom 
ViiV Healthcare UK Limited 
Tel: + 44 (0)800 221441 
customercontactuk@gsk.com  
  

 
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. 

 

mailto:viiv.fi.pt@viivhealthcare.com
mailto:gskcyprus@gsk.com
mailto:gskcyprus@gsk.com
http://www.ema.e/
http://www.ema.e/


70 
 

Package leaflet: Information for the user 
 

Epivir 300 mg film-coated tablets 
lamivudine 

 
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 any 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. This includes any side effects not listed in this 
leaflet. See section 4. 
 
In this leaflet: 
 
1. What Epivir is and what it is used for 
2. What you need to know before you take Epivir 
3. How to take Epivir 
4. Possible side effects 
5. How to store Epivir 
6. Contents of the pack and other information 
 
1. What Epivir is and what it is used for 
 
Epivir is used to treat HIV (human immunodeficiency virus) infection in adults and children. 

The active ingredient in Epivir is lamivudine. Epivir is a type of medicine known as an anti-retroviral. 
It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors 
(NRTIs). 
 
Epivir does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps 
it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood 
cells that are important in helping your body to fight infection. 
 
Not everyone responds to treatment with Epivir in the same way. Your doctor will monitor the 
effectiveness of your treatment. 
 
2. What you need to know before you take Epivir 
 
Do not take Epivir: 

• if you are allergic to lamivudine or any of the other ingredients in this medicine (listed in Section 
6). 

Check with your doctor if you think this applies to you.  

 
Take special care with Epivir 

Some people taking Epivir or other combination treatments for HIV are more at risk of serious side 
effects. You need to be aware of the extra risks: 
• if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, 

do not stop Epivir without your doctor’s advice, as your hepatitis may come back) 
• if you are seriously overweight (especially if you are a woman) 
• if you have a kidney problem, your dose may be altered. 

Talk to your doctor if any of these apply to you. You may need extra check-ups, including 
blood tests, while you are taking your medicine. See Section 4 for more information.  



71 
 

 
Look out for important symptoms 

Some people taking medicines for HIV infection develop other conditions, which can be serious. You 
need to know about important signs and symptoms to look out for while you are taking Epivir. 

Read the information ‘Other possible side effects of combination therapy for HIV’ in 
Section 4 of this leaflet. 

 
Protect other people 

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of 
infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this 
medicine, although the risk is lowered by effective antiretroviral therapy.  

Discuss with your doctor the precautions needed to avoid infecting other people. 
 
Other medicines and Epivir 

Tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any 
recently, including herbal medicines or other medicines you bought without a prescription.  

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking 
Epivir. 

 
These medicines should not be used with Epivir: 

•  medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, 
mannitol, lactitol or maltitol), if taken regularly 

• other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection) 

• emtricitabine (used to treat HIV infection) 
• high doses of co-trimoxazole, an antibiotic.  

• cladribine (used to treat hairy cell leukaemia). 

Tell your doctor if you are being treated with any of these. 

 
Pregnancy  

If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor 
about the risks and benefits to you and your baby of taking Epivir.  
 
Epivir and similar medicines may cause side effects in unborn babies. If you have taken Epivir during 
your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the 
development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from 
the protection against HIV outweighed the risk of side effects. 
 
Breast-feeding 

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the 
baby in breast milk. 

A small amount of the ingredients in Epivir can also pass into your breast milk. 

If you are breast-feeding, or thinking about breast-feeding: 
Talk to your doctor immediately. 

 
Driving and using machines 

Epivir is unlikely to affect your ability to drive or use machines. 
 
3.  How to take Epivir 



72 
 

 
Always take this medicine exactly as your doctor has told you. Check with your doctor or 
pharmacist if you are not sure.  
 
Swallow the tablet with some water. Epivir can be taken with or without food. 
 
If you cannot swallow the tablet whole, you may crush and combine it with a small amount of food or 
drink, and take all the dose immediately. 
 
Stay in regular contact with your doctor 

Epivir helps to control your condition. You need to keep taking it every day to stop your illness getting 
worse. You may still develop other infections and illnesses linked to HIV infection. 

Keep in touch with your doctor, and do not stop taking Epivir without your doctor’s advice. 
 
How much to take 

Adults, adolescents and children who weigh at least 25 kg: 

The usual dose is one 300 mg tablet once a day.  
 
A 150 mg strength Epivir tablet is also available for the treatment of children from 3 months of age 
who weigh less than 25 kg: 
 
An oral solution is also available for the treatment of children over 3 months of age, or for people who 
need a lower dose than usual, or who cannot take tablets. 
 
If you have a kidney problem, your dose may be altered.   

Talk to your doctor if this applies to you. 
 
If you take more Epivir than you should 

Accidentally taking too much Epivir is unlikely to cause any serious problems. If you take too much, 
tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further 
advice. 
 
If you forget to take Epivir 

If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. 
Do not take a double dose to make up for a forgotten dose. 
 
 
4. Possible side effects  
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This 
is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV 
medicines themselves. Your doctor will test for these changes.  

 
Like all medicines, this medicine can cause side effects, but not everyone gets them.  
 
When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Epivir 
or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to 
talk to your doctor about any changes in your health. 
 
As well as the side effects listed below for Epivir, other conditions can develop during combination 
therapy for HIV.  

It is important to read the information later in this section under ‘Other possible side effects of 
combination therapy for HIV’. 

 



73 
 

Common side effects 
These may affect up to 1 in 10 people: 
• headache 
• feeling sick (nausea) 
• being sick (vomiting) 
• diarrhoea 
• stomach pains 
• tiredness, lack of energy 
• fever (high temperature) 
• general feeling of being unwell 
• muscle pain and discomfort 
• joint pain 
• difficulty in sleeping (insomnia) 
• cough 
• irritated or runny nose 
• rash 
• hair loss (alopecia). 
 
Uncommon side effects 
These may affect up to 1 in 100 people: 
 
Uncommon side effects that may show up in blood tests are: 
• a decrease in the number of cells involved in blood clotting (thrombocytopenia)  
• a low red blood cell count (anaemia) or low white blood cell count (neutropenia)  
• an increase in the level of liver enzymes. 
 
Rare side effects 
These may affect up to 1 in 1000 people: 
• serious allergic reaction causing swelling of the face, tongue or throat which may cause 

difficulty in swallowing or breathing 
• inflammation of the pancreas (pancreatitis) 
• breakdown of muscle tissue 
• liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis). 
 
A rare side effect that may show up in blood tests is: 
• increase in an enzyme called amylase. 
 
Very rare side effects 
These may affect up to 1 in 10,000 people: 
• Lactic acidosis (excess lactic acid in the blood) 
• tingling or numbness of the arms, legs, hands or feet. 
 
A very rare side effect that may show up in blood tests is: 
• a failure of the bone marrow to produce new red blood cells (pure red cell aplasia). 
 
If you get side effects 

Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you 
notice any side effects not listed in this leaflet. 

 
Other possible side effects of combination therapy for HIV 

Combination therapy including Epivir may cause other conditions to develop during HIV treatment. 
 
Old infections may flare up 



74 
 

People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to 
develop serious infections (opportunistic infections). When these people start treatment, they may find 
that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are 
probably caused by the body’s immune system becoming stronger, so that the body starts to fight these 
infections. 
 
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the 
immune system attacks healthy body tissue) may also occur after you start taking medicines for the 
treatment of your HIV infection. Autoimmune disorders may occur many months after the start of 
treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, 
weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, 
tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. 
 
If you get any symptoms of infection while you are taking Epivir: 

Tell your doctor immediately. Do not take other medicines for the infection without your 
doctor’s advice. 

 
You may have problems with your bones 

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this 
condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be 
more likely to get this condition: 
• if they have been taking combination therapy for a long time 
• if they are also taking anti-inflammatory medicines called corticosteroids 
• if they drink alcohol 
• if their immune systems are very weak 
• if they are overweight. 
Signs of osteonecrosis include: 
• stiffness in the joints 
• aches and pains (especially in the hip, knee or shoulder) 
• difficulty moving. 
If you notice any of these symptoms: 

Tell your doctor. 
 
Reporting of side effects 
• If you get any side effects, talk to your doctor or pharmacist. 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 Epivir 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton.  
Do not store Epivir above 30oC.  
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away the medicines you no longer use. These measures will help to protect the environment. 
 
 
6 Contents of the pack and other information 
 
What Epivir contains 
The active substance is lamivudine.  

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


75 
 

The tablets also contain the following other ingredients: 
Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate  
Film-coat: hypromellose, titanium dioxide, black iron oxide (E172), macrogol, polysorbate 80 
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 
‘sodium-free’. 
 
What Epivir looks like and the contents of the pack 
Epivir 300 mg film-coated tablets are supplied in white polyethylene bottles or blister packs 
containing 30 tablets. They are grey, diamond shaped film-coated tablets, marked with the code 
‘GXEJ7’ on one side.   
 
Marketing Authorisation Holder and Manufacturer 
 

Manufacturer Marketing Authorisation Holder 
 

Glaxo Operations UK Limited 
(trading as Glaxo Wellcome 
Operations)  
Priory Street  
Ware  
Herts SG12 0DJ  
United Kingdom 
 
or 
 
GlaxoSmithKline 
Pharmaceuticals S.A. 
ul. Grunwaldzka 189 
60-322 Poznan 
Poland 

ViiV Healthcare BV 
Van Asch van Wijckstraat 55H 
3811 LP Amersfoort 
Netherlands 
 

 
  



76 
 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
 
België/Belgique/Belgien 
ViiV Healthcare srl/bv  
Tél/Tel: + 32 (0)10 85 65 00 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 
 

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77 
 

 
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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. 
 
 
 

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mailto:gskcyprus@gsk.com
http://www.ema.europa.eu/
http://www.ema.europa.eu/

	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) 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 epivir is and what it is used for', 'Section_Content': 'epivir is used to treat hiv (human immunodeficiency virus) infection in adults and children. the active ingredient in epivir is lamivudine. epivir is a type of medicine known as an anti-retroviral. it belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (nrtis). epivir does not completely cure hiv infection; it reduces the amount of virus in your body, and keeps it at a low level. it also increases the cd4 cell count in your blood. cd4 cells are a type of white blood cells that are important in helping your body to fight infection. not everyone responds to treatment with epivir in the same way. your doctor will monitor the effectiveness of your treatment.', 'Entity_Recognition': [{'Text': 'epivir', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 0, 'EndOffset': 6, 'Score': 0.3455481231212616, 'Text': 'epivir', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'hiv (human immunodeficiency virus) infection', 'Type': 'PROBLEM', 'BeginOffset': 24, 'EndOffset': 68}, {'Id': 1, 'BeginOffset': 118, 'EndOffset': 124, 'Score': 0.2826763093471527, 'Text': 'epivir', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 2, 'BeginOffset': 128, 'EndOffset': 138, 'Score': 0.9967551827430725, 'Text': 'lamivudine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 3, 'BeginOffset': 140, 'EndOffset': 146, 'Score': 0.5778348445892334, 'Text': 'epivir', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'an anti-retroviral', 'Type': 'TREATMENT', 'BeginOffset': 178, 'EndOffset': 196}, {'Text': 'a group of medicines', 'Type': 'TREATMENT', 'BeginOffset': 212, 'EndOffset': 232}, {'Id': 12, 'BeginOffset': 240, 'EndOffset': 292, 'Score': 0.7639033198356628, 'Text': 'nucleoside analogue reverse transcriptase inhibitors', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 302, 'EndOffset': 308, 'Score': 0.3751348853111267, 'Text': 'epivir', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 10, 'BeginOffset': 334, 'EndOffset': 347, 'Score': 0.824788510799408, 'Text': 'hiv infection', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9006764888763428}, {'Name': 'NEGATION', 'Score': 0.4623987376689911}]}, {'Text': 'the cd4 cell count', 'Type': 'TEST', 'BeginOffset': 441, 'EndOffset': 459}, {'Text': 'your blood', 'Type': 'TEST', 'BeginOffset': 463, 'EndOffset': 473}, {'Id': 13, 'BeginOffset': 475, 'EndOffset': 484, 'Score': 0.5000689625740051, 'Text': 'cd4 cells', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Id': 14, 'BeginOffset': 499, 'EndOffset': 516, 'Score': 0.621914803981781, 'Text': 'white blood cells', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Text': 'fight infection', 'Type': 'PROBLEM', 'BeginOffset': 560, 'EndOffset': 575}, {'Text': 'treatment', 'Type': 'TREATMENT', 'BeginOffset': 602, 'EndOffset': 611}, {'Id': 6, 'BeginOffset': 617, 'EndOffset': 623, 'Score': 0.5407949090003967, 'Text': 'epivir', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'your treatment', 'Type': 'TREATMENT', 'BeginOffset': 687, 'EndOffset': 701}]}
{'Title': '2. what you need to know before you take epivir', 'Section_Content': "do not take epivir: if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in section 6). check with your doctor if you think this applies to you. take special care with epivir some people taking epivir or other combination treatments for hiv are more at risk of serious side effects. you need to be aware of the extra risks: if you have ever had liver disease, including hepatitis b or c (if you have hepatitis b infection, do not stop epivir without your doctor's advice, as your hepatitis may come back) if you are seriously overweight (especially if you are a woman) if you or your child has a kidney problem, your dose may be altered. talk to your doctor if any of these apply to you. you may need extra check-ups, including blood tests, while you are taking your medicine. see section 4 for more information. look out for important symptoms some people taking medicines for hiv infection develop other conditions, which can be serious. you need to know about important signs and symptoms to look out for while you are taking epivir. read the information 'other possible side effects of combination therapy for hiv' in section 4 of this leaflet. protect other people hiv infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). you can still pass on hiv when taking this medicine, although the risk is lowered by effective antiretroviral therapy. discuss with your doctor the precautions needed to avoid infecting other people. other medicines and epivir tell your doctor or pharmacist if you are taking any other medicines, or if you have taken any recently, including herbal medicines or other medicines you bought without a prescription. remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking epivir. these medicines should not be used with epivir: medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly other medicines containing lamivudine, (used to treat hiv infection or hepatitis b infection) emtricitabine (used to treat hiv infection) high doses of co-trimoxazole, an antibiotic cladribine (used to treat hairy cell leukaemia). tell your doctor if you are being treated with any of these. pregnancy if you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits to you and your baby of taking epivir. epivir and similar medicines may cause side effects in unborn babies. if you have taken epivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. in children whose mothers took nrtis during pregnancy, the benefit from the protection against hiv outweighed the risk of side effects. breast-feeding women who are hiv-positive must not breast-feed, because hiv infection can be passed on to the baby in breast milk. a small amount of the ingredients in epivir can also pass into your breast milk. if you are breast-feeding, or thinking about breast-feeding: talk to your doctor immediately. driving and using machines epivir is unlikely to affect your ability to drive or use machines.", 'Entity_Recognition': [{'Text': 'epivir', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 2, 'BeginOffset': 12, 'EndOffset': 18, 'Score': 0.44089725613594055, 'Text': 'epivir', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.5459949970245361}]}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 31, 'EndOffset': 39}, {'Id': 3, 'BeginOffset': 43, 'EndOffset': 53, 'Score': 0.9921059608459473, 'Text': 'lamivudine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 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{'Title': '3. how to take epivir', 'Section_Content': "always take this medicine exactly as your doctor or pharmacist has told you. check with your doctor or pharmacist if you are not sure. swallow the tablets, with some water. epivir can be taken with or without food. if you cannot swallow the tablets whole, you may crush and combine them with a small amount of food or drink, and take all the dose immediately. stay in regular contact with your doctor epivir helps to control your condition. you need to keep taking it every day to stop your illness getting worse. you may still develop other infections and illnesses linked to hiv infection. keep in touch with your doctor, and do not stop taking epivir without your doctor's advice. how much to take adults, adolescents and children who weigh at least 25 kg: the usual dose of epivir is 300 mg a day. this can be taken as either one 150 mg tablet twice a day (leaving approximately 12 hours between each dose), or two 150 mg tablets once a day as advised by your doctor. children weighing at least 20 kg and less than 25 kg: the usual dose of epivir is 225 mg a day. this can be given as 75 mg (half a 150 mg tablet) in the morning and 150 mg (one whole 150 mg tablet) in the evening, or 225 mg (one and a half 150 mg tablets) once a day as advised by your doctor. children weighing at least 14 kg and less than 20 kg: the usual dose of epivir is 150 mg a day. this can be given as 75 mg (half a 150 mg tablet) twice a day (leaving approximately 12 hours between each dose), or 150 mg (one 150 mg tablet) once a day as advised by your doctor. an oral solution is also available for the treatment of children over 3 months of age, or for people who need a lower dose than usual, or who cannot take tablets. if you or your child has a kidney problem, your dose may be altered. talk to your doctor if this applies to you or your child. if you take more epivir than you should accidentally taking too much epivir is unlikely to cause any serious 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{'Title': '4. possible side effects', 'Section_Content': "during hiv therapy there may be an increase in weight and in levels of blood lipids and glucose. this is partly linked to restored health and life style, and in the case of blood lipids sometimes to the hiv medicines themselves. your doctor will test for these changes. like all medicines, this medicine can cause side effects, but not everyone gets them. when you are being treated for hiv, it can be hard to tell whether a symptom is a side effect of epivir or other medicines you are taking, or an effect of the hiv disease itself. so it is very important to talk to your doctor about any changes in your health. as well as the side effects listed below for epivir, other conditions can develop during combination therapy for hiv. it is important to read the information later in this section under 'other possible side effects of combination therapy for hiv'. common side effects these may affect up to 1 in 10 people: headache feeling sick (nausea) being sick (vomiting) diarrhoea stomach pains tiredness, lack of energy fever (high temperature) general feeling of being unwell muscle pain and discomfort joint pain difficulty in sleeping (insomnia) cough irritated or runny nose rash hair loss (alopecia). uncommon side effects these may affect up to 1 in 100 people: uncommon side effects that may show up in blood tests are: a decrease in the number of cells involved in blood clotting (thrombocytopenia) a low red blood cell count (anaemia) or low white blood cell count (neutropenia) an increase in the level of liver enzymes. rare side effects these may affect up to 1 in 1000 people: serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing inflammation of the pancreas (pancreatitis) breakdown of muscle tissue liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis). a rare side effect that may show up in blood tests is: an increase in an enzyme called amylase. very rare side effects these may affect up to 1 in 10,000 people: lactic acidosis (excess lactic acid in the blood) tingling or numbness of the arms, legs, hands or feet. a very rare side effect that may show up in blood tests is: a failure of the bone marrow to produce new red blood cells (pure red cell aplasia). if you get side effects tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet. other possible side effects of combination therapy for hiv combination therapy including epivir may cause other conditions to develop during hiv treatment. old infections may flare up people with advanced hiv infection (aids) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). when these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. these symptoms are probably caused by the body's immune system becoming stronger, so that the body starts to fight these infections. in addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your hiv infection. autoimmune disorders may occur many months after the start of treatment. if you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment. if you get any symptoms of infection while you are taking epivir: tell your doctor immediately. do not take other medicines for the infection without your doctor's advice. you may have problems with your bones some people taking combination therapy for hiv develop a condition called osteonecrosis. with this condition, parts of the bone tissue die because of reduced blood supply to the bone. people may be more likely to get this condition: if they have been taking combination therapy for a long time if they are also taking anti-inflammatory medicines called corticosteroids if they drink alcohol if their immune systems are very weak if they are overweight. signs of osteonecrosis include: stiffness in the joints aches and pains (especially in the hip, knee or shoulder) difficulty moving. if you notice any of these symptoms: tell your doctor. reporting of side effects if you get any side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system 59 listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.", 'Entity_Recognition': [{'Text': 'epivir', 'Type': 'PRODUCT_NAME', 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4753, 'Score': 0.3767179846763611, 'Text': 'appendix v.', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.553373396396637}, {'Name': 'DIAGNOSIS', 'Score': 0.4440743625164032}]}, {'Id': 168, 'BeginOffset': 4767, 'EndOffset': 4779, 'Score': 0.8661080598831177, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7258061170578003}]}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 4835, 'EndOffset': 4848}]}
{'Title': '5. how to store epivir', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the carton. do not store epivir above 30oc. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away the 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 epivir contains the active substance is lamivudine. the tablets also contain the following other ingredients: tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate film-coat: hypromellose, titanium dioxide, macrogol, polysorbate 80 this medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'. what epivir looks like and the contents of the pack epivir 150 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 60 tablets. they are white, diamond shaped, scored, film-coated tablets, marked with the code 'gxcj7' on both sides.", 'Entity_Recognition': [{'Text': 'epivir', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 1, 'BeginOffset': 45, 'EndOffset': 55, 'Score': 0.9960557222366333, 'Text': 'lamivudine', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.3489597737789154, 'RelationshipScore': 0.9999121427536011, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 61, 'EndOffset': 68, 'Text': 'tablets', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': 'the tablets', 'Type': 'TREATMENT', 'BeginOffset': 57, 'EndOffset': 68}, {'Id': 3, 'BeginOffset': 128, 'EndOffset': 154, 'Score': 0.9668685793876648, 'Text': 'microcrystalline cellulose', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.3489597737789154, 'RelationshipScore': 0.7454135417938232, 'RelationshipType': 'FORM', 'Id': 2, 'BeginOffset': 61, 'EndOffset': 68, 'Text': 'tablets', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 4, 'BeginOffset': 156, 'EndOffset': 180, 'Score': 0.9728299975395203, 'Text': 'sodium starch glycollate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'magnesium stearate film', 'Type': 'TEST', 'BeginOffset': 196, 'EndOffset': 219}, {'Id': 7, 'BeginOffset': 226, 'EndOffset': 238, 'Score': 0.98482346534729, 'Text': 'hypromellose', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 240, 'EndOffset': 256, 'Score': 0.9979345798492432, 'Text': 'titanium dioxide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 9, 'BeginOffset': 258, 'EndOffset': 266, 'Score': 0.8148099184036255, 'Text': 'macrogol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 10, 'BeginOffset': 268, 'EndOffset': 279, 'Score': 0.47505465149879456, 'Text': 'polysorbate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'STRENGTH', 'Score': 0.3654305040836334, 'RelationshipScore': 0.9995095729827881, 'RelationshipType': 'STRENGTH', 'Id': 11, 'BeginOffset': 280, 'EndOffset': 282, 'Text': '80', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.6059784293174744, 'RelationshipScore': 0.9959949254989624, 'RelationshipType': 'DOSAGE', 'Id': 14, 'BeginOffset': 331, 'EndOffset': 336, 'Text': '23 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '80', 'Type': 'NUMBER', 'BeginOffset': 280, 'EndOffset': 282}, {'Text': '1 mmol sodium', 'Type': 'TREATMENT', 'BeginOffset': 316, 'EndOffset': 329}, {'Text': 'the pack epivir', 'Type': 'TREATMENT', 'BeginOffset': 440, 'EndOffset': 455}, {'Text': '150', 'Type': 'NUMBER', 'BeginOffset': 456, 'EndOffset': 459}, {'Text': 'film-coated tablets', 'Type': 'TREATMENT', 'BeginOffset': 463, 'EndOffset': 482}, {'Text': 'white polyethylene bottles', 'Type': 'TREATMENT', 'BeginOffset': 499, 'EndOffset': 525}, {'Text': 'blister packs', 'Type': 'TREATMENT', 'BeginOffset': 529, 'EndOffset': 542}, {'Text': '60', 'Type': 'NUMBER', 'BeginOffset': 554, 'EndOffset': 556}, {'Text': 'film-coated tablets', 'Type': 'TREATMENT', 'BeginOffset': 606, 'EndOffset': 625}, {'Id': 0, 'BeginOffset': 664, 'EndOffset': 669, 'Score': 0.48741471767425537, 'Text': 'sides', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}]}