MULTAQ 400 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

MULTAQ 400 mg Film-Coated Tablets

dronedarone

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is MULTAQ and what is it used for

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

MULTAQ is used if you have a problem with your heart rhythm (atrial fibrillation: your heart beats irregularly) and it has spontaneously returned to your normal heart rhythm, or through a treatment called cardioversion.

MULTAQ prevents your irregular heart rhythm problem from coming back. MULTAQ is only used in adults.

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

2. What you need to know before you take MULTAQ

Do not take MULTAQ:

• if you are allergic to dronedarone or 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 may beat very slowly or you may feel dizzy. If you have had a pacemaker for this problem, you may use MULTAQ,
• if you have a very slow heart rate (less than 50 beats per minute),
• if your ECG (electrocardiogram) shows a heart problem called "prolonged QT interval" (this interval is more than 500 milliseconds),
• if you have a type of atrial fibrillation called permanent atrial fibrillation. In permanent atrial fibrillation, the atrial fibrillation has been present for a long time (at least 6 months) and the decision has been made not to return your heart rhythm to normal with a treatment called cardioversion,
• if you have instability (drops) in your blood pressure that may cause inadequate blood flow to your organs,
• if you have or have had a problem where your heart cannot pump blood throughout your body as it should (a condition called heart failure). You may have swollen feet or legs, breathing problems when lying down or sleeping, or shortness of breath when moving,
• if the percentage of blood that leaves your heart each time it contracts is too low (a condition called left ventricular dysfunction),
• if you previously took amiodarone (another anti-arrhythmic medicine) and had lung or liver problems,

• if you are taking medicines for infections (including fungal or HIV infections), allergies, heart rhythm problems, depression, after a transplant (see section "Taking MULTAQ with other medicines". This will give you more details on which medicines you cannot take with MULTAQ),
• if you have severe liver problems,
• if you have severe kidney problems.
• if you are taking dabigatran (see section "Taking MULTAQ with other medicines").

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take MULTAQ if

• you have a problem that causes your potassium or magnesium levels in the blood to drop. This problem must be corrected before starting treatment with MULTAQ,

• you are over 75 years old,
• you have a disease in which the blood vessels that supply blood to the heart become hardened and narrowed (coronary artery disease).

While taking MULTAQ, tell your doctor if:

• your atrial fibrillation while taking MULTAQ becomes permanent. You must stop taking MULTAQ,
• you have swollen feet or legs, breathing problems when lying down or sleeping, shortness of breath when moving, or weight gain (signs and symptoms of heart failure),
• immediately inform your doctor if you develop any of these signs and symptoms related to liver problems: discomfort or pain in the stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), darkening of the urine, fatigue (especially associated with the above-mentioned symptoms), itching,
• you have difficulty breathing or non-productive cough. Contact your doctor, they will check your lungs.

If any of the above situations apply to you (or you are not sure), consult your doctor or pharmacist before taking MULTAQ.

Blood tests, heart tests, and lung tests

While taking MULTAQ, your doctor may perform tests to check your health and the effect of the medicine on you.

• Your doctor may look at the electrical activity of your heart with an ECG (electrocardiogram).
• Your doctor will ask for blood tests to check your liver function before starting treatment with MULTAQ and during treatment.
• If you are taking certain medicines that prevent blood clots, such as warfarin, your doctor will ask for a blood test called INR to check if your medicine is working properly.
• Your doctor may also perform other blood tests. The results of one of the blood tests to check your kidney function (creatinine levels in the blood) may be altered with MULTAQ. Your doctor will take this into account when checking your blood levels and will use another reference value for "normal" creatinine levels in the blood.
• Your doctor may check your lungs.

In some cases, it may be necessary to interrupt treatment with MULTAQ.

Tell any other person who analyzes your blood that you are taking MULTAQ.

Use in 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.

Your doctor may recommend a medicine to prevent blood clots based on your clinical condition.

MULTAQ and other medicines may interact and cause serious side effects. Your doctor may change the dose of other medicines you are taking.

Do not take any of the following medicines with MULTAQ:

• other medicines used to control fast or irregular heartbeats, such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• certain medicines for fungal infections, such as ketoconazole, voriconazole, itraconazole, or posaconazole,
• certain medicines for depression called tricyclic antidepressants,
• certain sedatives 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 stomach problems and acid reflux),
• ritonavir (a medicine for HIV infection).
• dabigatran (a medicine to prevent blood clots).

You should consult your doctor or pharmacist if you are taking any of the following medicines:

• other medicines for high blood pressure, chest pain caused by heart disease, or other heart problems, such as verapamil, diltiazem, nifedipine, metoprolol, propranolol, or digoxin,
• certain medicines that lower cholesterol levels in your blood, such as simvastatin, lovastatin, atorvastatin, or rosuvastatin,
• certain medicines that prevent blood clots, such as warfarin, rivaroxaban, edoxaban, and apixaban,
• certain medicines for epilepsy, such as phenobarbital, carbamazepine, or phenytoin,
• sirolimus, tacrolimus, everolimus, and cyclosporin (used after a transplant),
• St. John's Wort - a herbal medicine for depression,
• rifampicin - for tuberculosis.

Taking MULTAQ with food and drinks

Do not drink grapefruit juice while taking MULTAQ. It may increase the levels of dronedarone in your blood and increase the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 of childbearing potential, your doctor will perform a pregnancy test before starting treatment with MULTAQ.
• MULTAQ is not recommended if you are pregnant or think you may be pregnant.
• Do not take MULTAQ if you are a woman who can become pregnant and are not using a reliable contraceptive method.
• Use a reliable contraceptive method during treatment and for 7 days after the last dose of MULTAQ.
• Stop taking your tablets and talk to your doctor immediately if you become pregnant during treatment with 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 normally does not affect your ability to drive or use machines. However, your ability to drive or use machines may be affected 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 some sugars, consult your doctor before taking this medicine.

3. How to take MULTAQ

Follow exactly the instructions of administration of this medicine given by your doctor. If you are not sure, ask your doctor or pharmacist.

Treatment with MULTAQ will be supervised by a doctor with experience in the treatment of heart disease.

If you need to switch from amiodarone (another medicine for irregular heartbeat) to MULTAQ, your doctor may provide special recommendations, such as pausing amiodarone before switching. Tell your doctor about all the medicines you are taking.

How much to take

The normal dose is one 400 mg tablet twice a day. Take:

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

If you think that the action of your medicine is too strong or too weak, consult your doctor or pharmacist.

How to take this medicine

Swallow the tablet whole with water during a meal. The tablet cannot be divided into equal doses.

If you take more MULTAQ than you should

Contact your doctor or the nearest emergency service or hospital immediately. Bring the package of this medicine with you.

If you forget to take MULTAQ

Do not take a double dose to make up for forgotten doses. Take the next dose when you normally would.

If you stop taking MULTAQ

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

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

4. Possible side effects

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

The following side effects have been reported with this medicine:

Tell your doctor immediately if you notice any of the following serious side effects - you may need urgent medical attention

Very common(may affect more than 1 in 10 people)

• problems where your heart does not pump blood properly throughout your body as it should (congestive heart failure). In clinical studies, this side effect was observed with a similar frequency in patients who took MULTAQ and those who received placebo. The signs include swollen feet or legs, breathing problems when lying down or sleeping, shortness of breath when moving, or weight gain.

Common(may affect up to 1 in 10 people)

• diarrhea, vomiting that can lead to kidney problems.
• slow heartbeats.

Uncommon(may affect up to 1 in 100 people)

• inflammation of the lungs (including scarring and thickening of the lungs). The signs include breathing problems or non-productive cough.

Rare(may affect up to 1 in 1,000 people)

• liver problems, including potentially life-threatening liver failure. The signs include discomfort or pain in the stomach area (abdomen), loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), darkening of the urine, fatigue (especially associated with the above-mentioned symptoms), itching,
• allergic reactions, including swelling of the face, lips, mouth, tongue, or throat.

Other side effects

Very common

• changes in the results of a blood test: your creatinine level in the blood,
• changes in your ECG (electrocardiogram) called QTc Bazett prolongation.

Common

• problems with your digestive system, such as indigestion, diarrhea, nausea, vomiting, and stomach pain,
• fatigue,
• skin problems, such as rash or itching,
• changes in the results of blood tests performed to check your liver function.

Uncommon

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

Rare

• loss of taste,
• inflammation of the blood vessels (vasculitis, including leucocytoclastic vasculitis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly to 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. Storage of MULTAQ

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 on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

MULTAQ Composition

• The active ingredient is dronedarone.

Each tablet contains 400 mg of dronedarone (as hydrochloride).

• The other components of the tablet core are hypromellose (E464), corn starch, crospovidone (E1202), poloxamer 407, lactose monohydrate (see section 2 "MULTAQ contains lactose"), colloidal anhydrous silica, magnesium stearate (E572).
• The other components of the coating are hypromellose (E464), macrogol 6000, titanium dioxide (E171), carnauba wax (E903).

Product Appearance and Package Contents

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

MULTAQ film-coated tablets are available in packages of 20, 50, 60 tablets in aluminum and opaque PVC blisters and 100 x 1 tablets in monodose perforated aluminum and opaque PVC blisters.

Only some package 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus: July 2024

Other Sources of Information

Detailed information about this medication is available on the European Medicines Agency website http://www.ema.europa.eu/.