MULTAQ 400 mg film-coated tablets

MULTAQ contains an active substance named dronedarone. It belongs to a group of medicines called anti-arrhythmics that help regulate your heart beat.

MULTAQ is used if you have had or are currently experiencing a problem with your heart beat (your heart beats out of time - atrial fibrillation).
MULTAQ prevents repetition of your problem of irregular heart beat and slows down your heart rate.

Do not take MULTAQ if:

• you are allergic (hypersensitive) to dronedarone or to any of the other ingredients of MULTAQ (listed in section 6),
• you have a problem with the nerves in your heart (heart block). Your heart might beat very slowly or you may feel dizzy. If you have had a pacemaker fitted for this problem, you can use MULTAQ,
• you have a very slow heart beat (less than 50 beats a minute),
• your ECG (electrocardiogram), shows a heart problem called ?prolonged QT corrected interval? (this interval is more than 500 milliseconds),
• you have a problem where you heart cannot pump the blood round your body as well as it should (severe heart failure) and your problem is not controlled. You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when moving around,
• you take medicines for infection (including fungal infection or AIDS), allergies, heart beat problems, depression, after a transplant (see section below on ?Taking other medicines?. This will give you more details on exactly what medicines you cannot take with MULTAQ),
• you have a severe liver problem,
• you have a severe kidney problem.

If any of the above apply to you, do not take MULTAQ.

Take special care with MULTAQ if:

• you have a problem that gives you a low level of potassium or magnesium in your blood. This problem should be corrected before starting treatment with MULTAQ
• you have a problem where your heart does not adequately pump the blood round your body as well as it should (heart failure). You may have swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase but your problem is controlled and your symptoms do not change.

If this applies to you (or you are not sure), please talk to your doctor or pharmacist before taking MULTAQ.

MULTAQ is not recommended in children and adolescents below 18 years of age.

Heart and blood tests
While you are taking MULTAQ, your doctor may perform tests to check your medical condition and how the medicine is working for you.

• Your doctor may look at your heart?s electrical activity using an ECG (electrocardiogram) machine.
• Your doctor may also do blood tests. The results of one of the blood tests (blood creatinine levels) may be changed by MULTAQ. Your doctor will take this into account when checking your blood levels and will use another reference of the ?normal? value of blood creatinine.

Please tell any other person who checks your blood that you are taking MULTAQ.

Taking other medicines
MULTAQ and some other medicines can affect each other and cause serious side effects. Your doctor may change the dose of any other medicines you are taking.

You must not take any of the following with MULTAQ:

• other medicines used to control an irregular or fast heart beat such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• some medicines for fungal infections such as ketoconazole, voricanozole, itraconazole or posaconazole,
• some medicines for infections called macrolides,
• some medicines for depression called tricyclic antidepressants,
• some tranquilising medicines called phenothiazines,
• bepridil for chest pain caused by heart disease,
• telithromycin or clarithromycin (antibiotics for infections),
• terfenadine - for allergies,
• nefazodone - for depression,
• cisapride - for food and acid reflux from your stomach to your mouth,
• ritonavir - for AIDS infection,

You must tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines for high blood pressure, for chest pain caused by heart disease, or other heart problems, such as verapamil, diltiazem, nifedipine, metoprolol, propranolol or digoxin,
• some medicines for reducing the cholesterol in your blood (such as simvastatin, lovastatin, atorvastatin or pravastatin),
• some medicines for epilepsy called phenobarbital, carbamazepine or phenytoin ,
• sirolimus and tacrolimus (used after a transplant ),
• St John?s Wort - a herbal medicine for depression,
• rifampicin - for tuberculosis.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription or herbal medicines.

Taking MULTAQ with food and drink
Take one tablet during your morning meal and one tablet during your evening meal. Do not drink grapefruit juice while taking MULTAQ. It can interfere with the usual effect of your medicine.

Pregnancy and breast-feeding

• MULTAQ is not recommended if you are pregnant or you think you may be pregnant.
• Do not take MULTAQ if you are a woman able to have children and you are not using a reliable contraceptive method.
• Stop taking your tablets and talk to your doctor straight away if you get pregnant while taking MULTAQ.
• If you are a mother breast feeding a baby, you should discuss with your doctor before taking MULTAQ.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
No studies on the effects on the ability to drive and use machines have been performed.

Important information about some of the ingredients of MULTAQ

MULTAQ contains lactose, which is a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking MULTAQ.

Always take MULTAQ exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How much to take
The usual dose is one 400 mg tablet twice a day. Take:

• one tablet during your morning meal and
• one tablet during your evening meal.

If you think that your medicine is too strong or too weak, talk to your doctor or pharmacist.

Taking this medicine

Swallow the tablets whole with a drink of water during a meal.

If you take more MULTAQthan you should
Contact immediately your doctor or the nearest emergency department or hospital. Take the medicine pack with you.

If you forget to take MULTAQ
Do not take a double dose to make up for a forgotten tablet. Take the next dose when you are normally due to take it.

If you stop taking MULTAQ
Do not stop taking this medicine without first talking to your doctor or pharmacist.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, MULTAQ can cause side effects, although not everybody gets them.

The following side effects have been reported with this medicine:

The frequency of possible side effects listed below is defined using the following convention:

• 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)
• not known (frequency cannot be estimated from the available data).

Very Common

• changes in the results of one blood test: your blood creatinine level,
• changes in your ECG (electrocardiogram).

Common

• problems with your digestion such as diarrhoea, nausea, vomiting and stomach pain
• feeling tired,
• slow heart beat ,
• skin problems such as rash or itching.

Uncommon

• other skin problems such as redness of the skin or eczema (redness, itching, burning or blistering),
• your skin being more sensitive to the sun,
• change in how things taste.

Rare

• losing your sense of taste.

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.

Do not use MULTAQ after the expiry date, which is stated on the carton after ?EXP.? The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not use MULTAQ if you notice any visible sign of deterioration (see in section 6 ?What MULTAQ looks like and content of 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 MULTAQ contains

• The active substance is dronedarone. Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
• The other ingredients in the film-coated tablet core are hypromellose, maize starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal anhydrous silica, magnesium stearate.
• The other ingredients in the coating of the film-coated tablets are hypromellose, macrogol 6000, titanium dioxide (E171), carnauba wax.

What MULTAQ looks like and content of the pack

MULTAQ is a white, oval, film-coated tablet (tablet) with a double wave marking on one side and ?4142? on the other side.

MULTAQ film-coated tablets are supplied in packs of 20, 50, 60 tablets in opaque PVC and aluminium blisters and 100x1 tablets in opaque PVC and aluminium perforated unit dose blisters. Not all pack size may be marketed.

Marketing Authorisation Holder

sanofi-aventis
174, avenue de France
75013 Paris ? France

Manufacturer

Sanofi Winthrop Industrie
1 rue de la Vierge, Ambarès & Lagrave,
F-33565 Carbon Blanc Cedex - France

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

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