Levviax
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Levviax 400 mg film-coated tablets. 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each film-coated tablet contains 400 mg of telithromycin. 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Film-coated tablet. 
Light orange, oblong, biconvex tablet, imprinted with H3647 on one side and 400 on the other. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
When prescribing Levviax, consideration should be given to official guidance on the appropriate use 
of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1). 
 
Levviax is indicated for the treatment of the following infections: 
 
In patients of 18 years and older: 

• Community-acquired pneumonia, mild or moderate (see section 4.4). 
 
• When treating infections caused by known or suspected beta-lactam and/or macrolide resistant 
strains (according to history of patients or national and/or regional resistance data) covered by 
the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1): 

- Acute exacerbation of chronic bronchitis, 
- Acute sinusitis 

 
In patients of 12 years and older: 

•Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam 
antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide 
resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1). 

 
4.2 Posology and method of administration 
 
The recommended dose is 800 mg once a day i.e. two 400 mg tablets once a day. The tablets should be 
swallowed whole with a sufficient amount of water. The tablets may be taken with or without food. 
Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual 
disturbances and loss of consciousness (see section 4.4). 
 
In patients of 18 years and older, according to the indication, the treatment regimen will be: 
- Community-acquired pneumonia: 800 mg once a day for 7 to 10 days, 
- Acute exacerbation of chronic bronchitis: 800 mg once a day for 5 days, 
- Acute sinusitis: 800 mg once a day for 5 days, 
- Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days. 
 
In patients of 12 to 18 years old, the treatment regimen will be: 
- Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days. 
 
In the elderly: 



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No dosage adjustment is required in elderly patients based on age alone. 
 
In children: 
Levviax is not recommended for use in children below 12 years of age due to lack of data on safety 
and efficacy (see section 5.2).  
 
Impaired renal function: 
No dosage adjustment is necessary in patients with mild or moderate renal impairment. Levviax is not 
recommended as first choice in patients with severe renal impairment (creatinine clearance 
<30ml/min) or patients with both severe renal impairment and co-existing hepatic impairment, as an 
optimal dosage format (600 mg) is not available. If telithromycin treatment is deemed necessary, these 
patients may be treated with alternating daily doses of 800 mg and 400 mg, starting with the 800 mg 
dose. 
In haemodialysed patients, the posology should be adjusted so that Levviax 800 mg is given after the 
dialysis session (see also section 5.2). 
 
Impaired hepatic function: 
No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, 
unless renal function is severely impaired, however the experience in patients with impaired hepatic 
function is limited. Hence, Levviax should be used with caution (see also section 4.4 and 5.2). 
 
4.3 Contraindications 
 
Levviax is contraindicated in patients with myasthenia gravis (see section 4.4). 
 
Hypersensitivity to the active substance, to any of the macrolide antibacterial agents, or to any of the 
excipients. 
 
Levviax must not be used in patients with previous history of hepatitis and/or jaundice associated with 
the use of telithromycin. 
 
Concomitant administration of Levviax and any of the following substances is contraindicated: 
cisapride, ergot alkaloid derivatives (such as ergotamine and dihydroergotamine), pimozide, 
astemizole and terfenadine (see section 4.5). 
 
Levviax should not be used concomitantly with simvastatin, atorvastatin and lovastastin. Treatment 
with these agents should be interrupted during Levviax treatment (see section 4.5). 
 
Levviax is contraindicated in patients with a history of congenital or a family history of long QT 
syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.  
 
In patients with severely impaired renal and/or hepatic function, concomitant administration of 
Levviax and strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole, is 
contraindicated. 
 
4.4 Special warnings and precautions for use 
 
As with macrolides, due to a potential to increase QT interval, Levviax should be used with care in 
patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia 
and or hypomagnesaemia, bradycardia (<50 bpm), or during concomitant administration of Levviax 
with QT interval prolonging agents or potent CYP 3A4 inhibitors such as protease inhibitors and 
ketoconazole. 
 
As with nearly all antibacterial agents, diarrhoea, particularly if severe, persistent and /or bloody, 
during or after treatment with Levviax may be caused by pseudomembranous colitis. If 
pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients 
should be treated with supportive measures and/or specific therapy. 



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Exacerbations of myasthenia gravis have been reported in patients treated with telithromycin and 
sometimes occurred within a few hours of the first dose.Reports have included death and life 
threatening acute respiratory failure with rapid onset (see section 4.8). 
Alterations in hepatic enzymes have been commonly observed in clinical studies with telithromycin.  
Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally 
been associated with serious underlying diseases or concomitant medications), have been reported (see 
section 4.8). These hepatic reactions were observed during or immediately after treatment, and in most 
cases were reversible after discontinuation of telithromycin. 
Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic 
disease develop such as anorexia, jaundice, dark urine, pruritus or tender abdomen. 
 
Due to limited experience, Levviax should be used with caution in patients with liver impairment (see 
section 5.2). 
 
Levviax may cause visual disturbances particularly in slowing the ability to accommodate and the 
ability to release accommodation. Visual disturbances included blurred vision, difficulty focusing, and 
diplopia. Most events were mild to moderate; however, severe cases have been reported. (see sections 
4.7 and 4.8). 
 
There have been post-marketing adverse event reports of transient loss of consciousness including 
some cases associated with vagal syndrome (see sections 4.7 and 4.8). 
 
Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual 
disturbances and loss of consciousness. 
 
Levviax should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as 
rifampicin, phenytoin, carbamazepine, phenobarbital, St John’s wort). Concomitant treatment with 
these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore 
encompass a risk of treatment failure (see section 4.5). 
 
Levviax is an inhibitor of CYP3A4 and should only be used under specific circumstances during 
treatment with other medicinal products that are metabolised by CYP3A4.  
 
In areas with a high incidence of erythromycin A resistance, it is especially important to take into 
consideration the evolution of the pattern of susceptibility to telithromycin and other antibiotics. 
 
In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients 
with risk factors such as pneumococcal bacteraemia or age higher than 65 years. 
 
Experience of treatment of infections caused by penicillin/or erythromycin resistant S. pneumoniae is 
limited, but so far, clinical efficacy and eradication rates have been similar compared with the 
treatment of susceptible S. pneumoniae.  Caution should be taken when S. aureus is the suspected 
pathogen and there is a likelihood of erythromycin resistance based on local epidemiology.  
 
L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the 
treatment of pneumonia caused by legionella is limited.  
 
As for macrolides, H. influenzae is classified as intermediately susceptible. This should be taken into 
account when treating infections caused by H. influenzae. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
  
Interaction studies have only been performed in adults. 
 
• Effect of Levviax on other medicinal product 
 



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Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6. In vivo studies with 
simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and 
a moderate inhibition of hepatic CYP3A4. The degree of inhibition with different CYP3A4 substrates 
is difficult to predict. Hence, Levviax should not be used during treatment with medicinal products 
that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or 
adverse events can be closely monitored. Alternatively, interruption in the treatment with the CYP3A4 
substrate should be made during treatment with Levviax. 
 
Medicinal products with a potential to prolong QT interval 
Levviax is expected to increase the plasma levels of cisapride, pimozide, astemizole and terfenadine. 
This could result in QT interval prolongation and cardiac arrhythmias including ventricular 
tachycardia, ventricular fibrillation and torsades de pointes. Concomitant administration of Levviax 
and any of these medicinal products is contraindicated (see section 4.3). 
 
Caution is warranted when Levviax is administered to patients taking other medicinal products with 
the potential to prolong QT interval (see section 4.4). 
 
Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) 
By extrapolation from erythromycin A and josamycin, concomitant medication of Levviax and 
alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the 
extremities. The combination is contraindicated (see section 4.3). 
 
Statins 
When simvastatin was coadministered with Levviax, there was a 5.3 fold increase in simvastatin Cmax, 
an 8.9 fold increase in simvastatin AUC, a 15-fold increase in simvastatin acid Cmax and an 11-fold 
increase in simvastatine acid AUC. In vivo interaction studies with other statins have not been 
performed, but Levviax may produce a similar interaction with lovastatin and atorvastatin, a lesser 
interaction with cerivastatin and little or no interaction with pravastatin and fluvastatin. Levviax 
should not be used concomitantly with simvastatin, atorvastastin and lovastatin. Treatment with these 
agents should be interrupted during Levviax treatment. Cerivastatin should be used with caution and 
patients should be carefully monitored for signs and symptoms of myopathy. 
 
Benzodiazepins 
When midazolam was coadministered with Levviax, midazolam AUC was increased 2.2-fold after 
intravenous administration of midazolam and 6.1-fold after oral administration. The midazolam half-
life was increased about 2.5-fold. Oral administration of midazolam concomitantly with Levviax 
should be avoided. Intravenous dosage of midazolam should be adjusted as necessary and monitoring 
of the patient be undertaken. The same precautions should also apply to the other benzodiazepins 
which are metabolized by CYP3A4, (especially triazolam but also to a lesser extent alprazolam).  For 
those benzodiazepins which are not metabolized by CYP3A4 (temazepam, nitrazepam, lorazepam) an 
interaction with Levviax is unlikely. 
 
Cyclosporin, tacrolimus, sirolimus 
Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these 
CYP34A4 substrates. Thus, when initiating telithromycin in patients already receiving any of theses 
immunosuppressive agents, cyclosporin, tacrolimus or sirolimus levels must be carefully monitored 
and their doses decreased as necessary. When telithromycin is discontinued, cyclosporin, tacrolimus or 
sirolimus levels must be again carefully monitored and their dose increased as necessary. 
 
Metoprolol 
When metoprolol (a CYP2D6 substrate) was coadministered with Levviax, metropolol Cmax and 
AUC were increased by approximately 38%, however, there was no effect on the elimination half-life 
of metoprolol.  The increase exposure to metoprolol may be of clinical importance in patients with 
heart failure treated with metoprolol.  In these patients, co-administration of Levviax and metoprolol, a 
CYP2D6 substrate, should be considered with caution. 
 
Digoxin  



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Levviax has been shown to increase the plasma concentrations of digoxin. The plasma trough levels, 
Cmax, AUC and renal clearance were increased by 20 %, 73 %, 37 % and 27% respectively, in healthy 
volunteers. There were no significant changes in ECG parameters and no signs of digoxin toxicity 
were observed. Nevertheless, monitoring of serum digoxin level should be considered during 
concomitant administration of digoxin and Levviax. 
 
Theophylline 
There is no clinically relevant pharmacokinetic interaction of Levviax and theophylline administered 
as extended release formulation. However, the co-administration of both medicinal products should be 
separated by one hour in order to avoid possible digestive side effects such as nausea and vomiting. 
 
Oral anticoagulants  
Increased anticoagulant activity has been reported in patients simultaneously treated with 
anticoagulants and antibiotics, including telithromycin.  The mechanisms are incompletely known. 
Although Levviax has no clinically relevant pharmacokinetic or pharmacodynamic interaction with 
warfarin after single dose administration, more frequent monitoring of prothrombin time/INR 
(International Normalised Ratio) values should be considered during concomitant treatment. 
 
Oral contraceptives 
There is no pharmacodynamic or clinically relevant pharmacokinetic interaction with low-dose 
triphasic oral contraceptives in healthy subjects. 
 
• Effect of other medicinal products on Levviax 
 
During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC 
of telithromycin were on average decreased by 79% and 86% respectively. Therefore, concomitant 
administration of CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St 
John’s wort) is likely to result in subtherapeutic levels of telithromycin and loss of effect. The 
induction gradually decreases during 2 weeks after cessation of treatment with CYP3A4 inducers. 
Levviax should not be used during and 2 weeks after treatment with CYP3A4 inducers. 
 
Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that 
maximum plasma concentrations of telithromycin were increased respectively by 1.22 and 1.51 fold 
and AUC by respectively 1.54 fold and 2.0 fold. These changes in the pharmacokinetics of 
telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well 
tolerated range. The effect of ritonavir on telithromycin has not been studied and could lead to larger 
increase in telithromycin exposure. The combination should be used with caution. 
 
Ranitidine (taken 1 hour before Levviax) and antacid containing aluminium and magnesium hydroxide 
has no clinically relevant influence on telithromycin pharmacokinetics. 
 
4.6 Pregnancy and lactation 
 
There are no adequate data from the use of Levviax in pregnant women. Studies in animals have 
shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Levviax 
should not be used during pregnancy unless clearly necessary. 
 
Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of 
maternal plasma. Corresponding data for humans is not available. Levviax should not be used by 
breast-feeding women. 
 
4.7 Effects on ability to drive and use machines 
 
Levviax may cause undesirable effects such as visual disturbances which may reduce the capacity for 
the completion of certain tasks. In addition, rare cases of transient loss of consciousness, which may be 
preceded by vagal symptoms, have been reported (see section 4.8). Because of potential visual 
difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a 



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motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment 
with Levviax. If patients experience visual disorders or loss of consciousness while taking Levviax 
patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous 
activities (see sections 4.4 and 4.8). 
Patients should be informed that these undesirable effects may occur as early as after the first dose of 
medication. Patients should be cautioned about the potential effects of these events on the ability to 
drive or operate machinery. 
 
4.8 Undesirable effects 
 
In 2461 patients treated by Levviax in phase III clinical trials, the following undesirable effects 
possibly or probably related to telithromycin have been reported. This is shown below. 
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
System organ 
class 

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)  

Blood and the 
lymphatic system 
disorders 

  Eosinophilia   

Nervous system 
disorders 

 Dizziness, 
headache, 
disturbance of 
taste 

Vertigo 
somnolence, 
nervousness, 
insomnia,  

Transient loss 
of 
consciousness, 
paraesthesia 
 

Parosmia 

Eye disorders   Blurred vision Diplopia  
Cardiovascular 
disorders 

  Flush 
Palpitations 

Atrial 
arrhythmia, 
hypotension, 
bradycardia 

 

Gastro-intestinal 
disorders 

Diarrhoea Nausea, 
vomiting, 
gastrointestinal 
pain, flatulence 

Oral Candida 
infection, 
stomatitis 
anorexia, 
constipation, ,  

 Pseudomembranous 
colitis 

Hepato-biliary 
disorders 

 Increase in liver 
enzymes (AST, 
ALT, alkaline 
phosphatase) 

Hepatitis Cholestatic 
jaundice 

 

Skin and 
subcutaneous 
tissue disorders 

  Rash, urticaria, 
pruritus 

Eczema Erythema 
multiforme 

Musculoskeletal, 
connective tissue  

    Muscle cramps 

Reproductive 
system disorders 

 Vaginal Candida 
infection  

   

 
Visual disturbances (<1%) associated with the use of Levviax, including blurred vision, difficulty 
focusing and diplopia, were mostly mild to moderate. They typically occurred within a few hours after 
the first or second dose, recurred upon subsequent dosing, lasted several hours and were fully 
reversible either during therapy or following the end of treatment. These events have not been 
associated with signs of ocular abnormality (see sections 4.4 and 4.7). 
In clinical trials the effect on QTc was small (mean of approximately 1 msec). In comparative trials, 
similar effects to those observed with clarithromycin were seen with an on-therapy ∆QTc >30 msec in 
7.6% and 7.0% of cases, respectively. No patient in either group developed a ∆QTc >60 msec. There 



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were no reports of TdP or other serious ventricular arrhythmias or related syncope in the clinical 
program and no subgroups at risk were identified. 
 
During post-marketing experience the following reactions have been reported (frequency unknown): 
-Immune system disorders: Angioneurotic oedema, anaphylactic reactions including anaphylactic 
shock 
-Cardiac disorders: QT/QTc interval prolongation 
-Gastrointestinal disorders: Pancreatitis, 
-Hepato-biliary disorders: Severe hepatitis and liver failure (see section 4.4) 
-Nervous system disorders: Cases of rapid onset of exacerbation of myasthenia gravis have been 
reported (see sections 4.3 and 4.4). 
 
4.9 Overdose 
 
In the event of acute overdose the stomach should be emptied. The patients should be carefully 
observed and given symptomatic and supportive treatment. Adequate hydration should be maintained. 
Blood electrolytes (especially potassium) must be controlled. Due to the potential for the prolongation 
of the QT interval and increased risk of arrhythmia, ECG monitoring must take place 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: macrolides, lincosamides and streptogramins, ATC Code: J01FA15. 
 
Telithromycin is a semisynthetic derivative of erythromycin A belonging to the ketolides, a class of 
antibacterial agents related to macrolides. 
 
Mode of action 
 
Telithromycin inhibits protein synthesis by acting at the ribosome level. 
 
The affinity of telithromycin for the 50S bacterial subunit of ribosome is 10 fold higher than that of 
erythromycin A when the strain is susceptible to erythromycin A. Against erythromycin A resistant 
strains, due to an MLSB mechanism of resistance, telithromycin shows a more than 20 fold affinity 
compared to erythromycin A in the 50S bacterial subunit. 
 
Telithromycin interferes with the ribosome translation at the 23S ribosomal RNA level, where it 
interacts with domain V and II. Furthermore, telithromycin is able to block the formation of the 50S 
and 30S ribosomal subunits. 
 
Breakpoints 
 
The recommended MIC breakpoints for telithromycin, separating susceptible organisms from 
intermediately susceptible organisms and intermediately susceptible organisms from resistant 
organisms, are: susceptible ≤0.5 mg/l, resistant >2mg/l. 
 
Antibacterial spectrum 
 
The prevalence of resistance may vary geographically and with time for selected species and local 
information on resistance is desirable, particularly when treating severe infections. As necessary, 
expert advice should be sought when the local prevalence of resistance is such that the utility of the 
agent in at least some types of infections is questionable. 
This information provides only an approximate guidance on probabilities as to whether 
microorganisms will be susceptible to telithromycin. 
 



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Commonly susceptible species 

Aerobic Gram-positive bacteria 

Staphylococcus aureus  methicillin susceptible (MSSA)*  

Lancefield group C and G ( ß haemolytic ) streptococci  
Streptococcus agalactiae 
Streptococcus pneumoniae * 
Viridans group streptococci 
Aerobic Gram- negative bacteria 
 
Legionella pneumophila 
Moraxella catarrhalis* 
Other 

Chlamydophila pneumoniae* 
Chlamydia psittaci 
Mycoplasma pneumoniae* 

Species for which acquired resistance may be a problem 
Aerobic Gram-positive bacteria  
Staphylococcus aureus methicillin resistant (MRSA)+ 
Streptococcus pyogenes* 
Aerobic Gram- negative bacteria 
Haemophilus influenzae$* 
Haemophilus parainfluenzae$ 
Inherantly resistant organisms 
Aerobic Gram- negative bacteria 
Acinetobacter  
Enterobacteriaceae 
Pseudomonas 

∗ Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications. 
$ natural intermediate susceptibility 
+Among MRSA the rate of MLSBc resistant strains is more than 80%, telithromycin is not active 
against MLSBc. 
 
Resistance 
 
Telithromycin does not induce MLSB resistance in vitro to Staphylococcus aureus, Streptococcus 
pneumoniae, and Streptococcus pyogenes, an attribute related to its 3 keto function. Development of in 
vitro resistance to telithromycin due to spontaneous mutation is rare. The majority of MRSA are 
resistant to erythromycin A by a constitutive MLSB mechanism.  
 
In vitro results have shown that telithromycin is affected by the erythromycin ermB or mefA related 
resistance mechanisms but to lesser extent than erythromycin. While exposure to telithromycin did 
select for pneumococcal mutants with increased MICs, the MICs remained within the proposed 
susceptibility range.  
 
For Streptococcus pneumoniae, there is no cross- or co-resistance between telithromycin and other 
antibacterial classes including erythromycin A and/or penicillin resistance.  
 
For Streptococcus pyogenes, cross-resistance occurs for high-level erythromycin A resistant strains.   
 



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Effect on oral and faecal flora 
 
In a comparative study in healthy human volunteers, telithromycin 800 mg daily and clarithromycin 
500 mg twice daily for 10 days showed a similar and reversible reduction of oral and faecal flora. 
However, in contrast to clarithromycin, no resistant strains of alpha streptococci emerged in saliva on 
treatment with telithromycin. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
 
Following oral administration, telithromycin is fairly rapidly absorbed. A mean maximum plasma 
concentration of about 2 mg/l is reached within 1-3 hour after dose with once-daily dosing of 
telithromycin 800 mg. The absolute bioavailability is about 57 % after a single dose of 800 mg. The 
rate and extent of absorption is unaffected by food intake, and thus Levviax tablets can be given 
without regard to food. 
 
Mean steady-state trough plasma concentrations of between 0.04 and 0.07 mg/l are reached within 3 to 
4 days with once-daily dosing of telithromycin 800 mg. At steady-state AUC is approximately 1.5 fold 
increased compared to the single dose. 
 
Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/l (range 0.02-
7.6 mg/l) and 0.2±0.2 mg/l (range 0.010 to 1.29 mg/l), during a therapeutic 800 mg once-daily dose 
regimen. 
 
Distribution 
 
The in vitro protein binding is approximately 60 % to 70 %. Telithromycin is widely distributed 
throughout the body. The volume of distribution is 2.9±1.0 l/kg. Rapid distribution of telithromycin 
into tissues results in significantly higher telithromycin concentrations in most target tissues than in 
plasma. The maximum total tissue concentration in epithelial lining fluid, alveolar macrophages, 
bronchial mucosa, tonsils and sinus tissue were 14.9±11.4 mg/l, 318.1±231 mg/l, 3.88±1.87 mg/kg, 
3.95±0.53 mg/kg and 6.96±1.58 mg/kg, respectively. The total tissue concentration 24 h after dose in 
epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 
0.84±0.65 mg/l, 162±96 mg/l, 0.78±0.39 mg/kg, 0.72±0.29 mg/kg and 1.58±1.68 mg/kg, respectively. 
The mean maximum white blood cell concentration of telithromycin was 83±25 mg/l. 
 
Metabolism 
 
Telithromycin is metabolized primarily by the liver. After oral administration, two-thirds of the dose is 
eliminated as metabolites and one-third unchanged. The main circulating compound in plasma is 
telithromycin. Its principal circulating metabolite represents approximately 13 % of telithromycin 
AUC, and has little antimicrobial activity compared with the parent medicinal product. Other 
metabolites were detected in plasma, urine and faeces and represent less or equal than 3 % of plasma 
AUC. 
 
Telithromycin is metabolized both by CYP450 isoenzymes and non-CYP enzymes. The major 
CYP450 enzyme involved in the metabolism of telithromycin is CYP3A4. Telithromycin is an 
inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9, 
2C19 and 2E1. 
 
Elimination 
 
After oral administration of radiolabelled telithromycin, 76 % of the radioactivity was recovered from 
faeces, and 17 % from the urine. Approximately one-third of telithromycin was eliminated unchanged; 
20 % in faeces and 12 % in urine. Telithromycin displays moderate non-linear pharmacokinetics. The 
non-renal clearance is decreased as the dose is increased. The total clearance (mean ±SD) is 



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approximately 58±5 l/h after an intravenous administration with renal clearance accounting for about 
22 % of this. Telithromycin displays a tri-exponential decay from plasma, with a rapid distribution 
half-life of 0.17 h. The main elimination half-life of telithromycin is 2-3 h and the terminal, less 
important, half-life is about 10 h at the dose 800 mg once daily. 
 
Special populations 
 
-Renal impairment 
In a multiple-dose study, 36 subjects with varying degrees of renal impairment, a 1.4-fold increase in 
Cmax,ss, and a 2-fold increase in AUC (0-24)ss at 800 mg multiple doses in the severe renally impaired 
group (CLCR < 30 mL/min) compared to healthy volunteers were observed and a reduced dosage of 
Levviax is recommended (See Section 4.2.). Based on observed data, a 600 mg daily dose is 
approximately equivalent with the target exposure observed in healthy subjects. Based on simulation 
data, an alternating daily dosing regimen of 800 mg and 400 mg in patients with severe renal 
impairment can approximate the AUC (0-48h) in healthy subjects receiving 800 mg once daily.  
 
The effect of dialysis on the elimination of telithromycin has not been assessed.  
 
-Hepatic impairment 
In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with 
mild to severe hepatic insufficiency (Child Pugh Class A, B and C), the Cmax, AUC and t1/2 of 
telithromycin were similar compared to those obtained in age- and sex-matched healthy subjects. In 
both studies, higher renal elimination was observed in the hepatically impaired patients. Due to limited 
experience in patients with decreased metabolic capacity of the liver, Levviax should be used with 
caution in patients with hepatic impairment (see also section 4.4). 
 
-Elderly subjects  
In subjects over 65 (median 75 years), the maximum plasma concentration and AUC of telithromycin 
were increased approximately 2 fold compared with those achieved in young healthy adults. These 
changes in pharmacokinetics do not necessitate dosage adjustment. 
 
-Paediatric patients  
The pharmacokinetics of telithromycin in paediatric population less than 12 years old have not yet 
been studied. Limited data, obtained in paediatric patients 13 to 17 years of age, showed that 
telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 
years of age. 
 
-Gender 
The pharmacokinetics of telithromycin are similar between males and females. 
 
5.3 Preclinical safety data 
 
Repeated dose toxicity studies of 1, 3 and 6 months duration with telithromycin conducted in rat, dog 
and monkey showed that the liver was the principal target for toxicity with elevations of liver 
enzymes, and histological evidence of damage. These effects showed a tendency to regress after 
cessation of treatment. Plasma exposures based on free fraction of active substance, at the no observed 
adverse effect levels ranged from 1.6 to 13 times the expected clinical exposure.  
 
Phospholipidosis (intracellular phospholipid accumulation) affecting a number of organs and tissues 
(e.g., liver, kidney, lung, thymus, spleen, gall bladder, mesenteric lymph nodes, GI-tract) has been 
observed in rats and dogs administered telithromycin at repeated doses of 150 mg/kg/day or more for 1 
month and 20 mg/kg/day or more for 3-6 months. This administration corresponds to free active 
substance systemic exposure levels of at least 9 times the expected levels in human after 1 month and 
less than the expected level in humans after 6 months, respectively. There was evidence of 
reversibility upon cessation of treatment. The significance of these findings for humans is unknown. 
 



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In similarity to some macrolides, telithromycin caused a prolongation of Qtc interval in dogs and on 
action potential duration in rabbit Purkinje fibers in vitro. Effects were evident at plasma levels of free 
drug 8 to 13 times the expected clinical level. Hypokalaemia and quinidine had additive/supra-additive 
effects in vitro while potentiation was evident with sotalol. Telithromycin, but not its major human 
metabolites, had inhibitory activity on HERG and Kv1.5 channels.  
 
Reproduction toxicity studies showed reduced gamete maturation in rat and adverse effects on 
fertilization. At high doses embryotoxicity was apparent and an increase in incomplete ossification and 
in skeletal anomalies was seen. Studies in rats and rabbits were inconclusive with respect to potential 
for teratogenicity, there was equivocal evidence of adverse effects on foetal development at high 
doses. 
 
Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in 
vitro and in vivo. No carcinogenicity studies have been conducted with telithromycin. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Tablet core: 
 
Microcrystalline cellulose  
Povidone K25 
Croscarmellose sodium 
Magnesium stearate 
 
Tablet coating: 
 
Talc 
Macrogol 8000 
Hypromellose 6 cp 
Titanium dioxide E171 
Yellow iron oxide E172 
Red iron oxide E172 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
No special precautions for storage. 
 
6.5 Nature and contents of container 
 
Two tablets are contained in each blister cavity. 
 
Available as packs of 10, 14, 20 and 100 tablets. 
Opaque PVC/Aluminium blisters 
 
Available as pack of 5 x 2 tablets. 



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Opaque PVC/Aluminium perforated unit dose blisters. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Aventis Pharma S.A. 
20, Avenue Raymond Aron 
F-92160 ANTONY 
France 
 
 
8. MARKETING AUTHORISATION NUMBERS  
 
EU/1/01/192/001-005 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first  authorisation: 9 July 2001 
Date of first renewal: 9 July 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 



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14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 
A. MANUFACTURING AUTHORISATION HOLDER 

RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 



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A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE  

 
Name and address of the manufacturer responsible for batch release: 
 
Aventis Pharma S.p.A. 
Strada Statale No 17, km22 
67019 Scoppito (L’Aquila) 
Italy 
 
 
B CONDITIONS OF THE MARKETING AUTHORISATION 
 
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to medical prescription 
 
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable  
 
• OTHER CONDITIONS  
 
The holder of this marketing Authorisation will have to submit PSURs every 6 months. 
 
 



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16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



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A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
Carton 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levviax 400 mg film-coated tablets 
Telithromycin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each film-coated tablet contains 400 mg of telithromycin 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
10 film-coated tablets 
14 film-coated tablets 
20 film-coated tablets 
100 film-coated tablets 
5 x 2 film-coated tablets 
 
 
5. METHOD AND, ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use 
 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP {month/year} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 



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11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Aventis Pharma S.A. 
20, Avenue Raymond Aron 
F-92160 ANTONY 
France 
 
 
12. MARKETING AUTORISATION NUMBER(S) 
 
EU/1/01/192/001 10 tablets 
EU/1/01/192/002 14 tablets 
EU/1/01/192/003 20 tablets 
EU/1/01/192/004 100 tablets 
EU/1/01/192/005 5x2 tablets 
 
 
13. BATCH NUMBER 
 
Batch {number} 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Levviax 



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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Levviax 400 mg film-coated tablets 
Telithromycin  
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Aventis Pharma S.A. 
 
 
3. EXPIRY DATE 
 
EXP {month/year} 
 
 
4. BATCH NUMBER 
 
Batch {number} 
 
 



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B. PACKAGE LEAFLET 



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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Levviax 400 mg film-coated tablets 
Telithromycin 

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

if their symptoms are the same as yours. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
In this leaflet:  
1. What Levviax is and what it is used for 
2. Before you take Levviax. 
3. How to take Levviax. 
4. Possible side effects 
5. How to store Levviax 
6. Further Information 
 
 
1.  WHAT LEVVIAX IS AND WHAT IT IS USED FOR 
 
Levviax belongs to one of a group of medicines called ketolides, a new class of antibiotics related to 
macrolides. Antibiotics stop the growth of bacteria which cause infections. 
 
Levviax is used in adults and adolescents of 12 years and older to treat infections due to bacteria 
against which the medicine is active. In adolescents of 12 years and older, Levviax can be used to 
treat: infections of the throat. In adults, Levviax can be used to treat infections of the throat, infections 
of the sinuses, chest infections in patients with long standing breathing difficulties and pneumonia. 
 
 
2. BEFORE YOU TAKE LEVVIAX 
 
Do not take Levviax: 
 
- if you suffer from myasthenia gravis, a rare disease which causes muscle weakness. 
- if you are allergic (hypersensitive) to telithromycin, to any of the macrolide antibiotics or to any of 

the other ingredients of Levviax. If in doubt, talk to your doctor or pharmacist. 
if you have had a hepatitis and/or jaundice while taking Levviax in the past. 

 - if you are taking certain medicinal products to control the blood level of cholesterol or other lipids. 
- if you or someone in your family are known to have an abnormality of electrocardiogram (ECG) 

called “long QT syndrome”. 
- while taking other medicines containing any of the following active substances: 

• ergotamine or dihydroergotamine (tablets or inhaler for migraine) 
• terfenadine or astemizole (allergic problems) 
• cisapride (digestive problems) 
• pimozide (psychiatric problems) 

- if you have severely impaired renal function and/or severely impaired hepatic function, do not take 
Levviax while taking other medicines containing any of the following active substances: 
• ketoconazole (anti fungal treatment) 
• a medicine called protease inhibitor (HIV treatment) 

Refer also to section “Taking other medicines”. 
 
Take special care with Levviax: 



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- if you have had certain heart problems such as coronary heart disease, ventricular arrhythmias, 
bradycardia or if you have had certain abnormal blood tests due to medical conditions such as 
hypokalaemia, hypomagnesaemia. 

- if you develop severe or prolonged or bloody diarrhoea during or after taking Levviax tablets, 
consult your doctor immediately since it may be necessary to interrupt the treatment. This may be 
a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment 
with antibiotics. 

- if you have liver disease. 
- if you experience visual disturbances (blurred vision, difficulty in focusing, double vision) 
- if you experience transient loss of consciousness (fainting). 
- Levviax tablets are not recommended for use in children and adolescents less than 12 years old. 
 
Refer also to sections “Do not take Levviax”, “Taking other medicines” and “Driving and using 
machines”. 
 
Taking other medicines 
Please tell your doctor if you are taking or have recently taken any other medecines, including 
medicines obtained without a prescription, as some of them could have an interaction with Levviax. 
 
You should not use Levviax with medicines containing ergotamine or dihydroergotamine tablets or 
ergotamine inhalers for migraine, terfenadine or astemizole for allergic problems, cisapride for 
digestive problems and pimozide for psychiatric problems. You should not use Levviax if you are 
taking certain medicinal products to control the blood level of cholesterol or other lipids, like 
simvastatin. 
Refer also to section “Do not take Levviax”. 
 
It is particularly important for your doctor to know if you are taking medicines containing phenytoin, 
and carbamazepine (for epilepsy), rifampicin (antibiotic), phenobarbital or St John’s wort, medicines 
like tacrolimus, cyclosporin and sirolimus (for organ transplantation), or metoprolol (against heart 
disorder) or the anti HIV medicine ritonavir.  
 
Taking Levviax with food and drink 
Levviax may be taken with or without food. 
 
Pregnancy and Breast-feeding 
If you are pregnant do not take Levviax tablets as the safety of Levviax in pregnancy is insufficiently 
established. If you are breast-feeding do not take Levviax tablets. 
 
Driving and using machines 
Limit driving or other hazardous activities while taking Levviax. If you have vision problems or faint 
while taking Levviax do not drive, operate heavy machinery, or engage in dangerous activities. 
Taking Levviax tablets may cause side effects such as visual disturbances, which may reduce the 
capacity to carry out certain tasks. Rare cases of transient loss of consciousness (fainting), which may 
be preceded by vagal symptoms (malaise, gastrointestinal distress), have been reported. These 
symptoms may appear as early as after the first dose of Levviax. 
 
 
3. HOW TO TAKE LEVVIAX 
 
Your doctor will tell you how many Levviax tablets to take, at what time and for how long. 
 
The usual duration of treatment is 5 days for infections of the throat, infections of the sinuses, chest 
infections in patients with long standing breathing difficulties and 7 to 10 days for pneumonia. 
 
The recommended dose of Levviax for adults and children of 12 years and older is two tablets of 400 
mg once daily (800 mg once daily).  



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If you have severe renal insufficiency you should take alternating daily doses of 800 mg (two tablets of 
400 mg) and 400 mg (one tablet of 400 mg), starting with the 800 mg dose. 
 
Swallow the tablets whole with a glass of water. 
It is best to take tablets at the same time each day. If possible take the tablets before going to bed, to 
reduce the potential impact of visual disturbances and loss of consciousness. 
 
If you take more Levviax than you should 
If you accidentally take one tablet too many, nothing is likely to happen. If you accidentally take 
several tablets too many, contact your doctor or pharmacist. If possible, take your tablets or the box 
with you to show the doctor or pharmacist. 
 
If you forget to take Levviax 
If you forget to take a dose, take it as soon as possible. However, if it is nearly time for your next dose 
skip the missed dose and take the next tablet at the usual time. 
 
If you stop taking Levviax 
Take the complete course of tablets prescribed by your doctor, even if you begin to feel better before 
you have finished them all. If you stop taking the tablets too soon, the infection may return, or your 
condition may get worse.  
If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine. 
If you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking 
the next dose. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 

 
Like all medicines Levviax can cause side effects, although not everybody gets them. Most of them are 
mild and transient, but very rare cases of serious adverse liver reactions and liver failure, including 
fatal cases, have been reported. So, if any of the following happens, stop taking Levviax and tell your 
doctor immediately: 
- Allergic or skin reactions such as face swelling, general allergic reactions including allergic 

shock, or serious skin conditions associated with red spots, blisters. 
- Severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a 

sign of serious bowel inflammation which may occur very rarely following treatment with 
antibiotics. 

- Signs and symptoms of hepatitis (liver disease) such as yellowing of skin and eyes, dark urine, 
itching, loss of appetite or abdominal pain. 

- Worsening of a condition called myasthenia gravis, a rare disease which causes muscle 
weakness. 
 
The above serious side effects are uncommon (1 out of 1000 to less than 1 out of 100), rare (1 out of 
10,000 to less than 1 out of 1000 patients) or very rare (less than 1/10,000 patients including isolated 
report), but may require urgent medical attention. 
 
The other side effects listed below are given with an estimation of the frequency with which they may 
occur. 
 
The most common side effect (10 or more out of 100 patients) which may occur with Levviax is 
diarrhoea, usually mild and temporary. 
 
Other side effects which may commonly (1 to 10 out of 100 patients) occur with Levviax are: 



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Nausea, vomiting, abdominal pain, flatulence (excess wind), dizziness, headaches, disturbance of 
taste, vaginal Candida infection (fungal infection associated with local itching, burning and white 
discharge), increase in liver enzymes (detected by blood test). 
 
Uncommon or rare side effects (1 out of 10,000 to less than 1 out of 100 patients) which may occur 
with Levviax are: 
Constipation, anorexia (loss of appetite), stomatitis (inflammation in themouth), oral Candida 
infection (fungal infection), hepatitis, rash, urticaria (hives), pruritus (itching), eczema, somnolence, 
insomnia, nervousness, vertigo, paraesthesia (tingling of the hands or feet), , visual disturbances 
(blurred vision, difficulty in focusing, double vision), , flushes, transient loss of consciousness 
(fainting), arrhythmia, bradycardia or palpitations (changes in heart rate or in ECG), hypotension (low 
blood pressure), eosinophilia (increase of certain white blood cells, detected by blood test). 
Very rare side effects(less than 1 out of 10,000 patients) which may occur with Levviax are : 
Disturbance of smell, muscle cramps. 
 
Additional side effects which may occur with Levviax are: 
abnormality of electrocardiogram (ECG) called prolongation of QT interval and inflamed pancreas 
(pancreatitis).  
During post-marketing experience, liver failure has been reported (frequency unknown). 
 
If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on, tell 
your doctor.  
 
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 
 
 
5. HOW TO STORE  LEVVIAX 
 
Keep out of the reach and sight of children. 
 
Do not use Levviax after the expiry date which is stated on the pack. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. FURTHER INFORMATION 
 
What Levviax contains 

 
- The active substance is telithromycin 
- The other ingredients are microcrystalline cellulose, povidone K25, croscarmellose sodium, 

magnesium stearate in the tablet core as well as talc, macrogol 8000 , hypromellose 6 cp, 
titanium dioxide E171, yellow iron oxide E172, red iron oxide E172 in the film-coating. 

 
 
What Levviax looks like and contents of the pack 
 
Levviax 400 mg tablets are light orange, oblong, biconvex, film-coated tablet imprinted with “H3647” 
on one side and “400” on the other. 
 
Levviax tablets are presented in blister packs. Two tablets are contained in each blister cavity. 
They are available in packs of 10, 5x2, 14, 20 and 100 tablets.  Not all pack sizes may be marketed. 
 



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Marketing Authorisation Holder and Manufacturer 
 
The marketing authorisation holder of Levviax is: 
Aventis Pharma S.A. 
20 Avenue Raymond Aron 
F-92160 ANTONY 
France 
 
The manufacturer of Levviax is: 
Aventis Pharma S.p.A. 
Strada Statale No 17, km 22 
I-67019 Scoppito (L’Aquila), Italy 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder. 
 
Belgique/België/Belgien 
sanofi-aventis Belgium 
Tél/Tel: +32 (0)2 710 54 00 
 

Luxembourg/Luxemburg 
sanofi-aventis Belgium  
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) 

България 
sanofi-aventis Bulgaria EOOD 
Тел: +359 (0)2 970 53 00 
 

Magyarország 
sanofi-aventis zrt., Magyarország 
Tel: +36 1 505 0050 

Česká republika 
sanofi-aventis, s.r.o. 
Tel: +420 233 086 111 
 

Malta 
sanofi-aventis Malta Ltd. 
Tel: +356 21493022 

Danmark 
sanofi-aventis Denmark A/S 
Tlf: +45 45 16 70 00 
 

Nederland 
sanofi-aventis Netherlands B.V. 
Tel: +31 (0)182 557 755 

Deutschland 
Sanofi-Aventis Deutschland GmbH 
Tel: +49 (0)180 2 222010 
 

Norge 
Aventis Pharma AS 
Tlf: +47 67 10 71 00 

Eesti 
sanofi-aventis Estonia OÜ 
Tel: +372 627 34 88 
 

Österreich 
sanofi-aventis GmbH 
Tel: +43 1 80 185 – 0 

Ελλάδα 
sanofi-aventis AEBE 
Τηλ.: +30 210 900 16 00 
 

Polska 
sanofi-aventis Sp. z o.o. 
Tel: +48 22 541 46 00 

España 
sanofi-aventis, S.A.U. 
Tel: +34 93 485 94 00 
 

Portugal 
sanofi-aventis - Produtos Farmacêuticos, S.A. 
Tel: +351 21 35 89 400 

France 
sanofi-aventis france 
Tél : 0 800 222 555 
Appel depuis l’étranger : +33 1 57 63 23 23 
 

România 
sanofi-aventis România S.R.L. 
Tel: +40 (0)21 317 31 36 

Ireland 
sanofi-aventis Ltd. 
Tel: +353 (0) 1 403 56 00 
 

Slovenija 
sanofi-aventis d.o.o. 
Tel: +386 1 560 48 00 



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Ísland 
Vistor hf. 
Sími: +354 535 7000 
 

Slovenská republika 
sanofi-aventis Pharma Slovakia s.r.o. 
Tel: +421 2 57 103 777 

Italia 
sanofi-aventis S.p.A. 
Tel. +39 02 393 91 
 

Suomi/Finland 
sanofi-aventis Oy 
Puh/Tel: +358 (0) 201 200 300 

Κύπρος 
sanofi-aventis Cyprus Ltd. 
Τηλ.: +357 22 871600 
 

Sverige 
sanofi-aventis AB 
Tel: +46 (0)8 634 50 00 

Latvija 
sanofi-aventis Latvia SIA 
Tel.: +371 7 33 24 51 
 

United Kingdom 
sanofi-aventis 
Tel: +44 (0) 1483 505 515 

Lietuva 
UAB sanofi-aventis Lietuva 
Tel: +370 5 2755224 
 

 

 
This leaflet was last approved in 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
	CONDITIONS OF THE MARKETING AUTHORISATION
	LABELLING
	PACKAGE LEAFLET
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likely to happen. if you accidentally take several tablets too many, contact your doctor or pharmacist. if possible, take your tablets or the box with you to show the doctor or pharmacist. if you forget to take levviax if you forget to take a dose, take it as soon as possible. however, if it is nearly time for your next dose skip the missed dose and take the next tablet at the usual time. if you stop taking levviax take the complete course of tablets prescribed by your doctor, even if you begin to feel better before you have finished them all. if you stop taking the tablets too soon, the infection may return, or your condition may get worse. if you stop taking the tablets too soon you may also create a bacterial resistance to the medicine. if you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking the next dose. if you have any further questions on the use of this product, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines levviax can cause side effects, although not everybody gets them. most of them are mild and transient, but very rare cases of serious adverse liver reactions and liver failure, including fatal cases, have been reported. so, if any of the following happens, stop taking levviax and tell your doctor immediately: - allergic or skin reactions such as face swelling, general allergic reactions including allergic shock, or serious skin conditions associated with red spots, blisters. - severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation which may occur very rarely following treatment with antibiotics. - signs and symptoms of hepatitis (liver disease) such as yellowing of skin and eyes, dark urine, itching, loss of appetite or abdominal pain. - worsening of a condition called myasthenia gravis, a rare disease which causes muscle weakness. the above serious side effects are uncommon (1 out of 1000 to less than 1 out of 100), rare (1 out of 10,000 to less than 1 out of 1000 patients) or very rare (less than 1/10,000 patients including isolated report), but may require urgent medical attention. the other side effects listed below are given with an estimation of the frequency with which they may occur. the most common side effect (10 or more out of 100 patients) which may occur with levviax is diarrhoea, usually mild and temporary. other side effects which may commonly (1 to 10 out of 100 patients) occur with levviax are: 25 nausea, vomiting, abdominal pain, flatulence (excess wind), dizziness, headaches, disturbance of taste, vaginal candida infection (fungal infection associated with local itching, burning and white discharge), increase in liver enzymes (detected by blood test). uncommon or rare side effects (1 out of 10,000 to less than 1 out of 100 patients) which may occur with levviax are: constipation, anorexia (loss of appetite), stomatitis (inflammation in themouth), oral candida infection (fungal infection), hepatitis, rash, urticaria (hives), pruritus (itching), eczema, somnolence, insomnia, nervousness, vertigo, paraesthesia (tingling of the hands or feet), , visual disturbances (blurred vision, difficulty in focusing, double vision), , flushes, transient loss of consciousness (fainting), arrhythmia, bradycardia or palpitations (changes in heart rate or in ecg), hypotension (low blood pressure), eosinophilia (increase of certain white blood cells, detected by blood test). very rare side effects(less than 1 out of 10,000 patients) which may occur with levviax are : disturbance of smell, muscle cramps. additional side effects which may occur with levviax are: abnormality of electrocardiogram (ecg) called prolongation of qt interval and inflamed pancreas (pancreatitis). during post-marketing experience, liver failure has been reported (frequency unknown). if any of these undesirable effects are 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{'Title': '5. how to store levviax', 'Section_Content': 'keep out of the reach and sight of children. do not use levviax after the expiry date which is stated on the pack. medicines should not be disposed of via wastewater or household waste. ask your pharmacist how to dispose of medicines no longer required. these measures will help to protect the environment.', 'Entity_Recognition': [{'Text': 'levviax', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 56, 'EndOffset': 63, 'Score': 0.926194429397583, 'Text': 'levviax', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.40279844403266907}]}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 115, 'EndOffset': 124}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 224, 'EndOffset': 233}, {'Text': 'these measures', 'Type': 'TREATMENT', 'BeginOffset': 254, 'EndOffset': 268}]}
{'Title': '6. further information', 'Section_Content': 'what levviax contains - the active substance is telithromycin - the other ingredients are microcrystalline cellulose, povidone k25, croscarmellose sodium, magnesium stearate in the tablet core as well as talc, macrogol 8000 , hypromellose 6 cp, titanium dioxide e171, yellow iron oxide e172, red iron oxide e172 in the film-coating. what levviax looks like and contents of the pack levviax 400 mg tablets are light orange, oblong, biconvex, film-coated tablet imprinted with "h3647" on one side and "400" on the other. levviax tablets are presented in blister packs. two tablets are contained in each blister cavity. they are available in packs of 10, 5x2, 14, 20 and 100 tablets. not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'levviax', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 3, 'BeginOffset': 5, 'EndOffset': 12, 'Score': 0.5370705127716064, 'Text': 'levviax', 'Category': 'MEDICATION', 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