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Ketek 400 mg film-coated tabletsPatient’s LeafletSummary for
2013-11-25 14:40:06 来源: 作者: 【 】 浏览:440次 评论:0

For doctors

 

What is it and how is it used?

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.

What do you have to consider before using it?

Do not take Ketek:

Take special care 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.

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 medicines must not be taken with Ketek:

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

Taking Ketek 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.

How is it used?

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 more Ketek 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.

What are possible side effects?

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:

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

Common side effects

Uncommon or rare side effects

Very rare side effects

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

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.

How should it be stored?

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.

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For doctors

What is it?

Ketek is a medicine that contains the active substance telithromycin. It is available as orange, oblong tablets (400 mg).

What is it used for?

Ketek is used to treat adults with mild or moderate community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).

It is also used to treat adults with the following infections when they are caused by bacteria that are or could be resistant (insensitive) to beta-lactams or macrolides (types of antibiotic):

acute exacerbation flare-up of chronic bronchitis long-lasting inflammation of the airways in the lungs

acute sinusitis short-lived infection of the sinuses, air-filled passageways in the bones around the nose and eyes.

Ketek is also used to treat patients aged 12 years or over who have tonsillitis or pharyngitis (infections of the tonsils or throat) caused by the bacterium Streptococcus pyogenes. It is used when beta-lactams are not appropriate, in countries or regions where there are high levels of resistance to macrolides.

Prescribers should consider official guidance on the use of antibacterial agents and local levels of resistance to antibiotics.

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Ketek is 800 mg (two tablets) once a day. The tablets should be swallowed whole with water. Taking Ketek at bedtime may reduce the potential impact of side effects such as visual disturbances and loss of consciousness. For pneumonia, the tablets should be taken for seven to 10 days. For the other infections, they are taken for five days.

A lower dose may be needed in patients who have severe kidney problems. For more information, see the package leaflet.

How does it work?

The active substance in Ketek, telithromycin, is an antibiotic belonging to the class ‘ketolides’. These are closely related to the macrolides. Telithromycin works by blocking the bacteria’s ribosomes (the parts of the cells where proteins are produced), inhibiting the growth of the bacteria. The full list of bacteria against which Ketek is active can be found in the summary of product characteristics (also part of the EPAR).

How has it been studied?

Ketek has been studied in 10 main studies involving a total of over 4,000 patients. Four studies looked at its effects in mild to moderate community-acquired pneumonia, two looked at acute sinusitis, two looked at acute exacerbations of chronic bronchitis and two looked at tonsillitis or pharyngitis. All but two of the studies compared Ketek with other antibiotics. The main measure of effectiveness was the proportion of patients who were cured at the end of treatment as determined by a reduction in symptoms, or who had ‘satisfactory’ reductions in the amount of bacteria detected in samples taken from the throat.

What benefits has it shown during the studies?

Ketek was as effective as the comparator antibiotics. For pneumonia and chronic bronchitis, Ketek was as effective as amoxicillin, clarithromycin, trovafloxacin, amoxicillin/clavulanic acid and cefuroxime axetil, with between 82 and 95% of the patients having no symptoms at the end of treatment. In patients with acute sinusitis, five- and 10-day courses of Ketek led to similar cure rates, which were similar to that seen with amoxicillin/clavulanic acid. For tonsillitis or pharyngitis, between 84 and 92% of the patients taking Ketek, penicillin or clarithromycin had a satisfactory reduction in bacterial levels in samples taken from the throat.

What is the risk associated?

The most common side effect with Ketek (seen in more than 1 patient in 10) is diarrhoea. For the full list of all side effects reported with Ketek, see the package leaflet.

Ketek should not be used in people who may be hypersensitive (allergic) to telithromycin, any macrolides, or any of the other ingredients. It must not be used in patients with myasthenia gravis (a disease of the nerves causing muscle weakness), or who have had hepatitis (inflammation of the liver)

Page or jaundice when they have taken telithromycin in the past. Ketek must also not be used in patients who are taking any of the following medicines:

pimozide used to treat mental illness

astemizole or terfenadine commonly used to treat allergy symptoms - these medicines may be available without prescription

simvastatin, atorvastatin or lovastastin used to lower cholesterol in the blood.

Ketek must not be taken by patients with a history or a family history of ‘long QT syndrome’ or with ‘acquired QT interval prolongation’ (disruption of the heartbeat). In patients with severe kidney or liver problems, Ketek must not be used with some medicines that may affect the way that telithromycin is broken down, including protease inhibitors (used in HIV infection) and ketoconazole (an antifungal medicine).

Why has it been approved?

The CHMP concluded that Ketek’s benefits are greater than its risks and recommended that it be given marketing authorisation. However, the Committee noted that Ketek is associated with a greater risk of certain side effects than other antibiotics. Some of these side effects can be serious, including a worsening of myasthenia gravis, transient loss of consciousness and temporary disturbances to vision. Therefore, the Committee decided that its use should be reserved to the treatment of community-acquired pneumonia, to the treatment of bronchitis and sinusitis when caused by bacteria that are resistant to beta-lactam or macrolide antibiotics, and to tonsillitis/pharyngitis when these antibiotics cannot be used.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Ketek to Aventis Pharma S.A. on 9 July 2001. The marketing authorisation is valid for an unlimited period. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Ketek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2011. Ketek Page

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Name

Ketek 400 mg film-coated tablets

Composition

Each film coated tablet contains 400 mg of telithromycin.

For a full list of excipients, see section 6.1.

Pharmaceutical Form

Film-coated tablet.
Light orange, oblong, biconvex tablet, imprinted with ‘H3647’ on one side and ‘400’ on the other.

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