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AstraZeneca

Levviax
telithromycin

Medicinal Product no longer authorised

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.


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:

    Medicinal Product no longer authorised

    • 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).

    Medicinal Product no longer authorised

    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:

    Medicinal Product no longer authorised

    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


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.

Medicinal Product no longer authorised

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

Medicinal Product no longer authorised

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