Multaq

Patient Information Leaflet: Information for the patient

MULTAQ 400 mg film-coated tablets

dronedarone
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist (See section 4).

Contents of this leaflet:

1. What MULTAQ is and what it is used for
2. What you need to know before taking MULTAQ
3. How to take MULTAQ
4. Possible side effects
5. How to store MULTAQ
6. Contents of the pack and other information

1. What MULTAQ is and what it is used for

MULTAQ contains an active substance called dronedarone. It belongs to a group of medicines known as antiarrhythmics, which help regulate the heartbeat.
MULTAQ is used if you have a heart rhythm problem such as irregular heartbeat (atrial fibrillation) and have spontaneously or with a treatment called cardioversion returned to a normal heart rhythm.
MULTAQ prevents the recurrence of irregular heart rhythm problems. MULTAQ is used only in adults.
Your doctor will consider all available treatment options before prescribing MULTAQ.

2. What you need to know before taking MULTAQ

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 heart nerve condition (heart block). Your heart may beat very slowly or you may feel dizzy. If you have had a pacemaker implanted for this condition, you may take MULTAQ,
• if you have a very slow heart rate (less than 50 beats per minute),
• if your ECG (electrocardiogram) has shown a heart problem called "prolonged QTc interval" (this interval is longer than 500 milliseconds),
• if you have a type of atrial fibrillation (AF) known as permanent atrial fibrillation. In permanent atrial fibrillation, AF has been present for a long time (at least 6 months), and your doctor has decided not to restore normal heart rhythm using a treatment called cardioversion,
• if you have instability (drops) in blood pressure that may lead to inadequate blood flow to organs,
• if you have or have had a condition that prevents the heart from pumping blood properly throughout the body (a condition called heart failure). You may experience swelling in your feet or legs, breathing difficulties when lying down or sleeping, or shortness of breath during physical activity,
• if the percentage of blood pumped by your heart with each contraction is too low (a condition called left ventricular dysfunction),
• if you have previously taken amiodarone (another antiarrhythmic medicine) and experienced lung or liver problems,
• if you are taking medicines for infections (including fungal infections or AIDS), allergies, heart rhythm disorders, depression, or after an organ transplant (see the section below “Other medicines and MULTAQ”. This will provide further details on the types of medicines you must not take with MULTAQ),
• if you have severe liver disease,
• if you have severe kidney disease,
• if you are taking dabigatran (see the section below “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 condition causing low levels of potassium or magnesium in your blood. This condition must be corrected before starting treatment with MULTAQ,
• you are over 75 years old,
• you have a condition in which the coronary arteries supplying blood to the heart become hardened and narrowed (coronary artery disease).

While taking MULTAQ, inform your doctor if:

• your atrial fibrillation becomes permanent while you are taking MULTAQ. You must stop taking MULTAQ,
• you develop swelling in your feet or legs, breathing difficulties when lying down or sleeping, shortness of breath during physical activity, or weight gain (which are signs and symptoms of heart failure),
• you experience any of the following signs or symptoms of liver problems: pain or discomfort in the stomach (abdominal) area, loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), unusually dark-colored urine, fatigue (especially in combination with the other symptoms listed above), or itching. Inform your doctor immediately,
• you develop shortness of breath or a dry cough. Inform your doctor, who will check your lungs.

If any of the above apply to you (or if you are unsure), talk to your doctor or pharmacist before taking MULTAQ.
Heart, lung, and blood tests
Your doctor may perform tests while you are taking MULTAQ to monitor your health and how the medicine is working.

• Your doctor may check your heart's electrical activity using an ECG (electrocardiogram).
• Your doctor will order blood tests to monitor liver function before you start taking MULTAQ and during treatment.
• If you are taking certain medicines that prevent blood clots, such as warfarin, your doctor will order a blood test called INR to ensure the medicine is working properly.
• Your doctor may also perform other blood tests. One of the blood tests used to monitor kidney function (blood creatinine levels) may be affected by MULTAQ. Your doctor will take this into account when interpreting blood test results and will use an adjusted reference value for normal blood creatinine levels.
• Your doctor may perform a clinical assessment of your lungs.

In some cases, treatment with MULTAQ may need to be stopped.
Inform any healthcare professional performing blood tests that you are taking MULTAQ.
Children and adolescents
MULTAQ is not recommended for children and adolescents under 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.
Depending on your condition, your doctor may recommend that you take an anticoagulant medicine to prevent blood clots.
MULTAQ and certain other medicines may interact, causing serious side effects. Your doctor may decide to adjust the dose of any other medicine you are taking.
You must not take any of the following medicines with MULTAQ:

• other medicines used to control irregular or fast heartbeat, such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• certain antifungal medicines, such as ketoconazole, voriconazole, itraconazole, or posaconazole,
• certain antidepressants called tricyclic antidepressants,
• certain tranquilizers called phenothiazines,
• bepridil for chest pain caused by heart disease,
• telithromycin, erythromycin, or clarithromycin (antibiotics for infections),
• terfenadine (an allergy medicine),
• nefazodone (a medicine for depression),
• cisapride (a medicine for acid reflux or regurgitation of food or acid from the stomach to the mouth),
• ritonavir (a medicine for AIDS),
• dabigatran (a medicine to prevent blood clots).

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

• other medicines for high blood pressure, chest pain due to heart disease, or other heart conditions, such as verapamil, diltiazem, nifedipine, metoprolol, propranolol, or digoxin,
• certain medicines used to lower cholesterol levels in the blood (such as simvastatin, lovastatin, atorvastatin, or rosuvastatin),
• certain anticoagulant medicines, such as warfarin, rivaroxaban, edoxaban, and apixaban,
• certain medicines for epilepsy called phenobarbital, carbamazepine, or phenytoin,
• sirolimus, tacrolimus, everolimus, and cyclosporine (used after organ transplant),
• St. John’s wort (Hypericum perforatum) – a herbal remedy for depression,
• rifampicin – for tuberculosis.

MULTAQ with food and drink
Do not drink grapefruit juice while taking MULTAQ. This beverage can increase the levels of dronedarone in your blood and increase the risk of side effects.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.

• If you are a woman of childbearing potential, your doctor will ask you to take a pregnancy test before starting treatment with MULTAQ.
• MULTAQ is not recommended during pregnancy or if you suspect you are pregnant.
• Do not take MULTAQ if you are a woman of childbearing potential and are not using an effective method of contraception.
• Use an effective method of birth control (contraception) during treatment and for 7 days after the last dose of MULTAQ.
• Stop taking the tablets and contact your doctor immediately if you become pregnant while taking MULTAQ.
• It is not known whether MULTAQ passes into breast milk. You and your doctor must decide whether to take MULTAQ or breastfeed. Do not breastfeed during treatment with MULTAQ and for 7 days after the last dose.

Driving and using machines
MULTAQ usually does not affect your ability to drive or operate machinery. However, your ability to drive or use machinery may be impaired by side effects such as fatigue.
MULTAQ contains lactose
Lactose is a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take MULTAQ

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Treatment with MULTAQ will be carried out under the supervision of a doctor experienced in the treatment
of heart diseases.
If it is necessary to switch from amiodarone (another medicine for irregular heartbeat) to
MULTAQ, your doctor may provide specific recommendations, for example stopping amiodarone
before the switch. Inform your doctor about all medicines you are taking.
How much medicine to take
The usual dose is one 400 mg tablet twice daily. Take:

• one tablet during breakfast and
• one tablet during dinner.

If you think that the effect of the medicine is too strong or too weak, inform your doctor or
pharmacist.
How to take this medicine
Swallow the tablet whole with a glass of water during a meal. The tablet must not be divided into equal doses.
If you take more MULTAQ than you should:
Contact your doctor or the nearest emergency department or hospital immediately. Take the
medicine pack with you.
If you forget to take MULTAQ:
Do not take a double dose to make up for the missed tablet. Take the next dose at the usual time of day.
If you stop taking MULTAQ:
Do not stop treatment with this medicine without first consulting your doctor or
pharmacist.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects have been reported with the use of this medicine:
Tell your doctor immediately if you notice any of the following serious side effects – you
may need urgent medical attention.

Very common (occurs in more than 1 in 10 people)

• Heart disorder in which the heart does not pump blood around the body as well as it should (congestive heart failure). In clinical studies, this side effect was observed with similar frequency in patients treated with MULTAQ and in untreated patients. Signs of this disorder include swelling of the feet or legs, breathing difficulties when lying down or sleeping, shortness of breath during physical activity, or weight gain.

Common (occurs in up to 1 in 10 people)

• Diarrhoea, vomiting when excessive, as it may lead to kidney problems.
• Slow heart rate.

Uncommon (occurs in up to 1 in 100 people)

• Inflammation of the lungs (including scarring and thickening of the lungs). Signs include shortness of breath or dry cough.

Rare (occurs in up to 1 in 1,000 people)

• Liver problems, including life-threatening liver failure. Signs include pain or discomfort in the stomach (abdominal area), loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), abnormally dark-coloured urine, tiredness (especially when associated 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 blood test results: your blood creatinine levels,
• Changes in ECG (electrocardiogram), known as QTc prolongation according to Bazett.

Common

• Gastrointestinal problems such as indigestion, diarrhoea, nausea, vomiting and stomach ache,
• Feeling tired,
• Skin problems such as rash or itching,
• Changes in blood test results used to monitor liver function.

Uncommon

• Other skin problems such as redness of the skin or eczema (redness, itching, burning or blisters),
• Increased sensitivity of the skin to sunlight,
• Altered taste.

Rare

• Loss of taste,
• Inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MULTAQ

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the packaging after "Exp.". The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration (see section 6 "Description of the appearance of MULTAQ and contents of the pack").
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MULTAQ contains

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

Description of the appearance of MULTAQ and contents of the pack
MULTAQ is a white, oval, film-coated tablet (tablet) with a double wave symbol engraved on one side and the number “4142” on the other.
Film-coated MULTAQ tablets are supplied in opaque PVC/aluminum blisters containing 20, 50, or 60 tablets, and in a pack of 100x1 tablets in unit-dose divisible opaque PVC/aluminum blisters.
Not all pack sizes may be marketed.

Marketing Authorization 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 further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma UAB
Tél/Tel: +32 (0)2 710 54 00 Tel: +370 5 236 91 40

България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Тел.: +359 (0)2 4942 480 Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika Magyarország
Sanofi s.r.o. SANOFI-AVENTIS Zrt.
Tel: +420 233 086 111 Tel: +36 1 505 0050

Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 45 16 70 00 Tel: +39 02 39394275

Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel.: 0800 52 52 010 Tel: +31 20 245 4000
Tel. aus dem Ausland: +49 69 305 21 131

Eesti Norge
Swixx Biopharma OÜ sanofi-aventis Norge AS
Tel: +372 640 10 30 Tlf: +47 67 10 71 00

Ελλάδα Österreich
Sanofi-Aventis Μονοπρόσωπη AEBE sanofi-aventis GmbH
Τηλ.: +30 210 900 16 00 Tel: +43 1 80 185 – 0

España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel: +48 22 280 00 00

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

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

Ireland Slovenija
sanofi-aventis Ireland Ltd. T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 403 56 00 Tel: +386 1 235 51 00

Ísland Slovenská republika
Vistor hf. Swixx Biopharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 208 33 600

Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel. 800.536389 Puh/Tel: +358 (0) 201 200 300

Κύπρος Sverige
C.A. Papaellinas Ltd. Sanofi AB
Τηλ: +357 22 741741 Tel: +46 (0)8 634 50 00

Latvija United Kingdom (Northern Ireland)
Swixx Biopharma SIA sanofi-aventis Ireland Ltd. T/A SANOFI
Tel: +371 6 616 47 50 Tel: +44 (0) 800 035 2525

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.