dronedarone: package leaflet

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 a problem with your heart rhythm (your heart beats out of time - atrial fibrillation) and through a treatment called cardioversion has changed your heartbeat back to normal rhythm.
MULTAQ prevents repetition of your problem of irregular heart rhythm. MULTAQ is used only in adults.

Your doctor will consider all available treatment options before prescribing MULTAQ to you.

Do not take MULTAQ:

• if you are allergic to dronedarone or to any of the other ingredients of this medicine (listed in section 6),
• if 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,
• if you have a very slow heart beat (less than 50 beats a minute),
• if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” (this interval is more than 500 milliseconds),
• if you have a type of atrial fibrillation called permanent atrial fibrillation (AF). In permanent AF, the AF has been present for a long time (at least during 6 months) and a decision has been made not to change back your heart rhythm to atrial normal rhythm with a treatment called cardioversion,
• if you have instability (drops) in your blood pressure which can lead to inadequate arterial blood flow to your organs,

• if you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure). You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when moving around,
• if the percentage of blood leaving your heart each time it contracts is too low (condition called left ventricular dysfunction),
• if you took amiodarone (another antiarrhythmic medicine) previously and experienced lung or liver problems,
• if you take medicines for infection (including fungal infection or AIDS), allergies, heart beat problems, depression, after a transplant (see section below on “Other medicines and MULTAQ”. This will give you more details on exactly what medicines you cannot take with MULTAQ),
• if you have a severe liver problem,
• if you have a severe kidney problem,
• if you take dabigatran (see section below on “Other medicines and MULTAQ”).

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

Warnings and precautions
Talk to your doctor or pharmacist before taking 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 are more than 75 years old,
- you have a condition when the vessel that supplies blood to heart muscle becomes hardened and narrowed (coronary artery disease).

While taking MULTAQ, tell your doctor if
- your atrial fibrillation becomes permanent while you are taking MULTAQ. You should stop taking MULTAQ,
- you have swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase (which are signs and symptoms of heart failure),
- tell your doctor immediately if you develop any of these signs and symptoms of liver problems:
stomach (abdominal) area pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other symptoms listed above), itching,
- you have breathlessness or non-productive cough. Tell your doctor, he/she will check your lung.

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

Heart, lung 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 will order blood tests to check your liver function before you start taking MULTAQ and during treatment.
- If you are taking some medicines against blood clot formation such as warfarin, your doctor will order a blood test called INR to check how well your medicine is working.
- Your doctor may also do other blood tests. The results of one of the blood tests to check kidney function (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.
- Your doctor may check your lungs.
In some cases, MULTAQ treatment may need to be stopped.

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

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

Other medicines and MULTAQ
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may recommend that you use a medicine against blood clot formation according to your condition.

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, voriconazole, itraconazole or posaconazole,
- some medicines for depression called tricyclic antidepressants,
- some tranquilising medicines called phenothiazines,
- bepridil for chest pain caused by heart disease,
- telithromycin, erythromycin, or clarithromycin (antibiotics for infections),
- terfenadine (a medicine for allergies),
- nefazodone (a medicine for depression),
- cisapride (a medicine for food and acid reflux from your stomach to your mouth),
- ritonavir (a medicine for AIDS infection),
- dabigatran (a medicine for prevention of blood clot formation).

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 rosuvastatin),
- some medicines against blood clot formation such as warfarin, rivaroxaban, edoxaban and apixaban.
- some medicines for epilepsy called phenobarbital, carbamazepine or phenytoin,
- sirolimus, tacrolimus, everolimus and cyclosporine (used after a transplant),
- St John’s Wort - a herbal medicine for depression,
- rifampicin - for tuberculosis.

MULTAQ with food and drink
Do not drink grapefruit juice while taking MULTAQ. It can increase the blood levels of dronedarone and may increase your chance of getting side effects.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
- If you are a woman able to have children, the doctor will do a pregnancy test before you start the treatment with MULTAQ.
- 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.
- Use effective birth control (contraception) during treatment and for 7 days after the final dose of MULTAQ.

• Stop taking your tablets and talk to your doctor straight away if you get pregnant while taking MULTAQ.
• It is not known if MULTAQ passes into your breast milk. You and your doctor should decide if you will take MULTAQ or breastfeed. Do not breastfeed during treatment with MULTAQ and for 7 days after the final dose.

Driving and using machines
MULTAQ does not usually affect your ability to drive or use machine. However, your ability to drive and use machines may be affected by side effects such as tiredness.

MULTAQ contains lactose
Lactose 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 this medicine.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Treatment with MULTAQ will be overseen by a doctor who is experienced in the treatment of heart disease.

If you need to change from amiodarone (another medicine for irregular heart beat) to MULTAQ, your doctor can provide special recommendations, for example pausing amiodarone before switching. Tell your doctor about all the medicines you take.

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 tablet whole with a drink of water during a meal. The tablet cannot be divided into equal doses.

If you take more MULTAQ than 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 medicine, ask your doctor or pharmacist.

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

The following side effects have been reported with this medicine:

Talk to your doctor straight away, if you notice any of the following serious side effects – you may need urgent medical assistance Very common (may affect more than 1 in 10 people)
- Problem where your heart does not adequately pump the blood round your body as well as it should (congestive heart failure) In clinical studies, this side effect was observed at a similar rate in patients receiving MULTAQ and in patients receiving placebo. Signs include swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase.

Common (may affect up to 1 in 10 people)
- Diarrhoea, vomiting when excessive as it can lead to kidney problems.
- Slow heart beat.

Uncommon (may affect up to 1 in 100 people)
- Inflammation of the lungs (including scarring and thickening of the lungs). Signs include breathlessness or non-productive cough.

Rare (may affect up to 1 in 1,000 people)
- Liver problems including life threatening liver failure. Signs include stomach (abdominal) area pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other symptoms listed above), itching.
- Allergic reactions, including swelling of the face, lips, mouth, tongue or throat.

Other side effects include:
Very Common
- changes in the results of one blood test: your blood creatinine level,
- changes in your ECG (electrocardiogram) called QTc Bazett prolonged.

Common
- problems with your digestive system such as indigestion, diarrhoea, nausea, vomiting and stomach pain,
- feeling tired,
- skin problems such as rash or itching,
- change in the results of blood tests used to check your liver function.

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,
- inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 blister and 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 this medicine if you notice any visible sign of deterioration (see section 6).

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.

What MULTAQ contains
- The active substance is dronedarone.
Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
- The other ingredients in the tablet core are hypromellose (E464), maize starch, crospovidone (E1202), poloxamer 407, lactose monohydrate (see section 2 under ‘MULTAQ contains lactose’), colloidal anhydrous silica, magnesium stearate (E572).
- The other ingredients in the tablet coat are hypromellose (E464), macrogol 6000, titanium dioxide (E171), carnauba wax (E903).

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 Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

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

Sanofi-Aventis Deutschland GmbH
Brüningstrasse 50
Industriepark Höchst,
D-65926 Frankfurt
Germany

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

België/Belgique/Belgien
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00

Lietuva
Swixx Biopharma UAB
Tel: +370 5 236 91 40

България
Swixx Biopharma EOOD
Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg
Sanofi Belgium
Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika
Sanofi s.r.o.
Tel: +420 233 086 111

Magyarország
SANOFI-AVENTIS Zrt.
Tel.: +36 1 505 0050

Danmark
Sanofi A/S
Tlf: +45 45 16 70 00

Malta
Sanofi S.r.l.
Tel: +39 02 39394275
Deutschland
Sanofi-Aventis Deutschland GmbH
Tel.: 0800 52 52 010
Tel. aus dem Ausland: +49 69 305 21 131

Nederland
Sanofi B.V.
Tel: +31 20 245 4000

Eesti
Swixx Biopharma OÜ
Tel: +372 640 10 30

Norge sanofi-aventis Norge AS
Tlf: +47 67 10 71 00

Ελλάδα
Sanofi-Aventis Μονοπρόσωπη AEBE
Τηλ: +30 210 900 16 00

Österreich sanofi-aventis GmbH
Tel: +43 1 80 185 – 0

España sanofi-aventis, S.A.
Tel: +34 93 485 94 00

Polska
Sanofi Sp. z o.o.
Tel.: +48 22 280 00 00

France
Sanofi Winthrop Industrie
Tél: 0 800 222 555
Appel depuis l’étranger : +33 1 57 63 23 23
Portugal
Sanofi - Produtos Farmacêuticos, Lda.
Tel: +351 21 35 89 400

Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 1 2078 500
România
Sanofi Romania SRL
Tel: +40 (0) 21 317 31 36

Ireland sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +353 (0) 1 403 56 00

Slovenija
Swixx Biopharma d.o.o.
Tel: +386 1 235 51 00

Ísland
Vistor ehf.
Sími: +354 535 7000

Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 2 208 33 600

Italia
Sanofi S.r.l.
Tel: 800.536389

Suomi/Finland
Sanofi Oy
Puh/Tel: +358 (0) 201 200 300

Κύπρος
C.A. Papaellinas Ltd.
Τηλ: +357 22 741741

Sverige
Sanofi AB
Tel: +46 (0)8 634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

This leaflet was last revised in

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.