Ketek 400 mg film-coated tablets

Ketek is an antibiotic of the type macrolides. Antibiotics stop the growth of bacteria which cause infections.

Ketek is used to treat infections due to bacteria against which the medicine is active.

• In adults, Ketek is used to treat infections of the throat, infections of the sinuses (hollow cavities in the bones around the nose) and chest infections in patients with long standing breathing difficulties and lung infection (pneumonia).
• In adolescents of 12 years and older, Ketek is used to treat infections of the throat.

Do not take Ketek:

• 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 Ketek. If in doubt, talk to your doctor or pharmacist.
• if you have had a liver disease ( hepatitis and/or jaundice) while taking Ketek in the past.
• if you are taking certain medicinal products to control the blood level of cholesterol or other lipids like simvastatin, lovastatin, or atorvastatin, as the side effects of these medicinal products could be increased.
• 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 kidney problems (severely impaired renal function) and/or liver problems (severely impaired hepatic function), do not take Ketek while taking other medicines containing any of the following active substances: - ketoconazole (anti-fungal treatment) - a medicine called protease inhibitor (anti-HIV treatment).

Take special care with Ketek:

• if you have had certain heart problems such as coronary heart disease, ventricular arrhythmias, bradycardia (changes in heart rate or electrocardiogram) or if you have had certain abnormal blood tests due to medical conditions such as low levels of potassium (hypokalaemia), low levels of magnesium (hypomagnesaemia).
• if you have liver disease.
• if you experience visual disturbances (blurred vision, difficulty in focusing, double vision)
• if you experience fainting (transient loss of consciousness)

If any of these apply to you, or if you are not sure, tell your doctor before taking Ketek. If you develop severe or prolonged or bloody diarrhoea during or after taking Ketek tablets, consult your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation which can occur following treatment with antibiotics.

Ketek is not recommended for use in children and adolescents less than 12 years old.

Refer also to sections ?Do not take Ketek?, ?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 medicines, including medicines obtained without a prescription, as some of them could affect or be affected by Ketek.

These medicinesmust not be taken with Ketek:

• medicinal products to control the blood level of cholesterol or other lipids like simvastatin, atorvastatin, or lovastatin, as the side effects of the medicinal products could be increased.
• 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 kidney problems (severely impaired renal function) and/or liver problems (severely impaired hepatic function), other medicines containing any of the following active substances: - ketoconazole (anti-fungal treatment) - a medicine called protease inhibitor (anti-HIV treatment).

It is important to tell your doctor if you are taking:

• medicines containing phenytoin, and carbamazepine (for epilepsy)
• rifampicin (antibiotic)
• phenobarbital or St John?s wort, (herbal medicine used to treat mild depression)
• medicines like tacrolimus, cyclosporin and sirolimus (for organ transplantation)
• metoprolol (for heart disorders)
• ritonavir (anti-HIV medicine).

TakingKetek with food and drink
Ketek may be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant do not take Ketek as the safety of this medicine in pregnancy is insufficiently established. If you are breast-feeding do not take Ketek.

Driving and using machines
Limit driving or other hazardous activities while taking Ketek. If you have vision problems, faint or experience confusion or hallucination while taking Ketek, do not drive, operate heavy machinery, or engage in dangerous activities.

Taking Ketek may cause side effects such as visual disturbances, confusion or hallucination, which may reduce the capacity to carry out certain tasks. Rare cases of fainting (transient loss of consciousness), which may be preceded by a general feeling of being sick (e.g. nausea, stomach upsets) have been reported. These symptoms may appear as early as after the first dose of Ketek.

Your doctor will tell you how many Ketek 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 Ketek for adults and children of 12 years and older is two tablets of 400 mg once daily (800 mg once daily).

If you have kidney problems (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 moreKetek 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 Ketek
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 Ketek

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.

Like all medicines Ketek 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.

The side effects are described into the following frequencies
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000

If you notice any of the following, stop taking Ketek 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 (frequency not known).
• Severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation which may occur following treatment with antibiotics (very rare).
• Signs and symptoms of liver disease (hepatitis) such as yellowing of skin and eyes, dark urine, itching, loss of appetite or abdominal pain (uncommon).
• Worsening of a condition called myasthenia gravis, a rare disease which causes muscle weakness (frequency unknown).

The above serious side effects may require urgent medical attention.

The other side effects listed below are given with an estimation of the frequency with which they may occur with Ketek:

Very common side effects

• diarrhoea, usually mild and temporary.

Common side effects

• 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

• constipation, loss of appetite (anorexia)
• inflammation in the mouth, fungal infection in the mouth ( Candida infection)
• liver problem (hepatitis)
• rash, hives (urticaria), itching, eczema
• drowsiness, difficulties in falling asleep (insomnia), nervousness, vertigo
• tingling of the hands or feet (paraesthesia)
• visual disturbances (blurred vision, difficulty in focusing, double vision)
• flushes, fainting (transient loss of consciousness)
• changes in heart rate (e.g. slow beating) or abnormality of electrocardiogram (ECG)
• low blood pressure (hypotension)
• increase of certain white blood cells, detected by blood test (eosinophilia).

Very rare side effects

• disturbance of smell, muscle cramps.

Additional side effects (frequency unknown) which may occur with Ketek are:

• abnormality of electrocardiogram (ECG), called prolongation of QT interval
• inflamed pancreas
• joint and muscle pain
• confusion
• hallucination (seeing or hearing things that are not there)
• loss of taste and smell
• liver failure.

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.

Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Ketek 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.

What Ketek contains

• The active substance is telithromycin 400 mg
• 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 Ketek looks like and contents of the pack

Ketek 400 mg tablets are light orange, oblong, biconvex, film-coated tablets imprinted with ?H3647? on one side and ?400? on the other.

Ketek 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.

Marketing Authorisation Holder and Manufacturer

The marketing authorisation holder of Ketek is:Aventis Pharma S.A.
20 Avenue Raymond Aron
F-92160 ANTONY
France

The manufacturer ofKetek is:sanofi-aventis S.p.A.
Strada Statale No 17, km 22
I-67019 Scoppito (L?Aquila), Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien sanofi-aventis Belgium TélTel 32 02 710 54 00 LuxembourgLuxemburg sanofi-aventis Belgium TélTel 32 02 710 54 00 BelgiqueBelgien

sanofi-aventis Bulgaria EOOD . 359 02 970 53 00 Magyarország sanofi-aventis zrt., Magyarország Tel. 36 1 505 0050

eská republika sanofi-aventis, s.r.o. Tel 420 233 086 111 Malta sanofi-aventis Malta Ltd. Tel 356 21493022

Danmark sanofi-aventis Denmark AS Tlf 45 45 16 70 00 Nederland sanofi-aventis Netherlands B.V. Tel 31 0182 557 755

Deutschland Sanofi-Aventis Deutschland GmbH Tel 49 0180 2 222010 Norge sanofi-aventis Norge 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

sanofi-aventis AEBE 30 210 900 16 00 Polska sanofi-aventis Sp. z o.o. Tel. 48 22 280 00 00

España sanofi-aventis, S.A. Tel 34 93 485 94 00 Portugal sanofi-aventis - Produtos Farmacêuticos, Lda Tel 351 21 35 89 400

România sanofi-aventis România S.R.L. Tel 40 021 317 31 36 France sanofi-aventis France Tél 0 800 222 555 Appel depuis létranger 33 1 57 63 23 23

Ireland sanofi-aventis Ireland Ltd. Tel 353 0 1 403 56 00 Slovenija sanofi-aventis d.o.o. Tel 386 1 560 48 00

Ísland Vistor hf. Sími 354 535 7000 Slovenská republika sanofi-aventis Pharma Slovakia s.r.o. Tel 421 2 33 100 100

Italia sanofi-aventis S.p.A. Tel 39 02 393 91 SuomiFinland sanofi-aventis Oy PuhTel 358 0 201 200 300

sanofi-aventis Cyprus Ltd. 357 22 871600 Sverige sanofi-aventis AB Tel 46 08 634 50 00

Latvija sanofi-aventis Latvia SIA Tel 371 67 33 24 51 United Kingdom sanofi-aventis Tel 44 0 1483 505 515

Lietuva

UAB sanofi-aventis Lietuva
Tel: +370 5 2755224

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