Ketek
telithromycin
Telithromycin
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
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 side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
What Ketek is and what it is used for
What you need to know before you take Ketek
How to take Ketek
Possible side effects
How to store Ketek
Contents of the pack and other information
Ketek contains the active substance telithromycin.
Medicinal product no longer authorised
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.
if you are allergic to telithromycin, to any of the macrolide antibiotics or to any of the other ingredients of this medicine (listed in section 6). If in doubt, talk to your doctor or pharmacist.
if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
if you have had a liver disease (hepatitis and/or jaundice) while taking Ketek in the past.
if you are taking other medicines that can prolong the QT interval of the electrocardiogram (ECG), such as:
terfenadine or astemizole (allergic problems)
cisapride (digestive problems)
pimozide (psychiatric problems)
dronedarone (for atrial fibrillation)
saquinavir (anti-HIV treatment)
if you are taking other medicines containing any of the following active substances:
ergotamine or dihydroergotamine (tablets or inhaler for migraine)
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”.
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 or fluconazole (anti-fungal treatment)
a medicine called protease inhibitor (anti-HIV treatment)
colchicine (for gout)
Talk to your doctor, pharmacist or nurse before taking 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 fainting (transient loss of consciousness)
Talk to your doctor, pharmacist or nurse if you experience irregular heartbeat.
Medicinal product no longer authorised
Talk to your doctor, pharmacist or nurse if you experience visual disturbances (blurred vision, difficulty focusing, double vision). These visual disturbances may happen suddenly and last several hours. You may experience this within a few hours of taking your daily dose of Ketek the first or second time. It may happen again when you take the next dose of Ketek. These effects usually disappear during treatment or after completion of treatment with Ketek.
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.
To reduce the potential impact of visual disturbances take the tablets before going to bed (see also section 3).
Ketek is not recommended for use in children less than 12 years old.
Refer also to sections “Do not take Ketek”, “Other medicines and Ketek” and “Driving and using machines”.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, as some of them could affect or be affected by Ketek.
These medicines must 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 that can prolong the QT interval of the electrocardiogram (ECG), such as:
terfenadine or astemizole (allergic problems)
cisapride (digestive problems)
pimozide (psychiatric problems)
dronedarone (for atrial fibrillation)
saquinavir (anti-HIV treatment)
other medicines containing any of the following active substances:
ergotamine or dihydroergotamine (tablets or inhaler for migraine)
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 or fluconazole (anti-fungal treatment)
a medicine called protease inhibitor (anti-HIV treatment)
colchicine (for gout).
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)
sotalol (for heart disorders)
ritonavir (anti-HIV medicine).
medicines known to affect the way your heart beats (drugs that prolong the QT interval).
These include medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, amiodarone), for depression (citalopram, tricyclic antidepressants), methadone, some antipsychotics (phenothiazines), some antibiotics (fluoroquinolones such as moxifloxacin), some antifungals (fluconazole, pentamidine), and some antiviral drugs (telaprevir).
medicines containing digoxin (for heart disorders) or dabigatran (for prevention of blood clots)
colchicine (for gout)
some calcium channel blockers (e.g. verapamil, nifedipine, felodipine) (for heart disorders).
Medicinal product no longer authorised
Ketek may be taken with or without food.
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.
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. Always take this medicine exactly as your doctor or pharmacist has told you. Check with you doctor or pharmacist if you are not sure.
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 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 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. Do not take a double dose to make up for a forgotten dose.
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.
Medicinal product no longer authorised
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 medicine, ask your doctor, pharmacist or nurse.
Like all medicines this medicine 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.
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).
Irregular heartbeat
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:
diarrhoea, usually mild and temporary.
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).
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)(please read section 2)
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).
disturbance of smell, muscle cramps.
Medicinal product no longer authorised
Additional side effects (frequency not known – frequency cannot be estimated from available data) which may occur with Ketek are:
tremors, convulsions
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 you get any side effects, talk to your doctor, pharmacist or nurse. 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.
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 pack. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is telithromycin. Each tablet contains 400 mg of 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.
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, 14, 20 and 100 tablets. Not all pack sizes may be marketed.
The marketing authorisation holder of Ketek is:
Aventis Pharma S.A.
Medicinal product no longer authorised
20 Avenue Raymond Aron F-92160 ANTONY
France
The manufacturer of Ketek is:
S.C. Zentiva S.A.
B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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