Prospect: information for the patient

MULTAQ 400 mg film-coated tablets

dronedarone

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• Ifyouexperienceadverse effects, consult your doctor or pharmacist,eveniftheydo notappearin this prospect. See section 4.

MULTAQ contains an active ingredient called dronedarone. It belongs to a group of medications known as antiarrhythmics that help regulate your heart rhythm.

MULTAQ is used if you have a heart rhythm problem (atrial fibrillation: your heart beats irregularly) andeither occurs spontaneously, or is returned to a normal heart rhythmthrough a treatment called cardioversion.

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

Your doctor will consider all possible treatment options before prescribing 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 heart rhythm problem (heart block). Your heart may beat very slowly or you may feel dizzy. If you have had a pacemaker for this problem, you may be able to take 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 corrected QT interval" (this interval is more than 500 milliseconds),
• if you have a type of atrial fibrillation (AF) called permanent atrial fibrillation. In permanent AF, AF has been present for a long time (at least 6 months) and the decision has been made not to restore your heart rhythm to normal sinus rhythm with a treatment called cardioversion,
• if you have instability (falls) 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, problems breathing when lying down or sleeping, or shortness of breath when moving,
• if the percentage of blood that leaves your heart with each contraction is too low (a condition called left ventricular dysfunction),
• if you have previously taken amiodarone (another antiarrhythmic medication) and had problems with your lungs or liver,

-if you take medications 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 a severe liver problem,
• if you have a severe kidney problem.
• if you take dabigatran (see section "Taking MULTAQ with other medicines").

If you can attribute any of the above situations, do not take MULTAQ.

Warnings and precautions

Consult your doctor or pharmacist before starting to take MULTAQ if

• you have a condition that causes a decrease in your potassium or magnesium levels in the blood. This condition 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, inform 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),
• inform your doctor immediately if you develop any of these signs and symptoms related to liver problems: discomfort or pain in the abdominal area, loss of appetite, nausea, vomiting, yellowing of the skin or white of the eyes (jaundice), dark urine, fatigue (especially associated with the above symptoms), itching,
• you have difficulty breathing or non-productive cough. Contact your doctor, they will review your lungs.

If you can attribute any of the above situations (or are unsure), consult your doctor or pharmacist before taking MULTAQ.

Blood tests, cardiac and pulmonary tests

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

• Your doctor may look at the electrical activity of your heart using an ECG (electrocardiogram).
• Your doctor will ask you to have blood tests to check liver function before starting treatment with MULTAQ and during treatment.
• If you are taking some medications that act against the formation of blood clots in the blood, such as warfarin, your doctor will ask you to have a blood test called INR to check if your medication 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 the "normal" level of creatinine in the blood.
• Your doctor may check your lungs.

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

Inform 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 old.

Other medicines and MULTAQ

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Your doctor may recommend a medication to prevent blood clots in the blood, depending on your clinical condition.

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

You should not take any of the following medications with MULTAQ:

• other medications used to control rapid or irregular heartbeats, such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• some medications for fungal infections, such as ketoconazole, voriconazole, itraconazole, or posaconazole,
• some antidepressant medications called tricyclic antidepressants,
• some tranquilizers called phenothiazines,
• bepridil for chest pain caused by heart disease,
• telithromycin, erythromycin, or clarithromycin (antibiotics for infections),
• terfenadine (an allergy medication),
• nefazodone (a depression medication),
• cisapride (a medication for food and acid reflux in your stomach to your mouth),
• ritonavir (a medication for HIV infection).
• dabigatran (a medication to prevent blood clots in the blood).

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

• other medications 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 medications that reduce cholesterol in your blood (such as simvastatin, lovastatin, atorvastatin, or rosuvastatin),
• some medications that prevent blood clots in the blood, such as warfarin, rivaroxaban, edoxaban, and apixaban,
• some medications for epilepsy, called phenobarbital, carbamazepine, or phenytoin,
• sirolimus, tacrolimus, everolimus, and cyclosporine (used after a transplant),
• St. John's Wort - a medicinal herb 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, or think you may be pregnant, consult your doctor before taking this medication.

• If you are a woman of childbearing age, 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 safe contraceptive method.
• Use a safe and effective 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.
• You do not know if MULTAQ passes into breast milk. You and your doctor must decide whether to take MULTAQ or breastfeed. Do not breastfeed during treatment with MULTAQ or for 7 days after the last dose.

Driving and operating machinery

MULTAQ usually does not affect your ability to drive and operate machinery. However, your ability to drive and operate machinery 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 certain sugars, consult your doctor before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor. If you are unsure, ask your doctor or pharmacist.

Treatment with MULTAQ will be supervised by a doctor with experience in treating heart disease.

If you need to switch from amiodarone (another medication for irregular heartbeat) to MULTAQ, your doctor may provide special recommendations, such as pausing amiodarone before switching. Inform your doctor of all medications you are taking.

How much to take

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

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

If you think your medication may be too strong or too weak, consult with your doctor or pharmacist.

Taking this medication

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 immediately, or the nearest emergency service or hospital. Bring the packaging of this medication.

If you forget to take MULTAQ

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

If you interrupt treatment with MULTAQ

Do not stop taking this medication without first speaking with your doctor or pharmacist.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, MULTAQ can cause side effects, although not everyone will experience them.

The following side effects have been reported with this medicine:

Contact your doctor immediately if you notice any of the following serious side effects – as you may need urgent medical assistance

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

• Problems where your heart does not pump blood 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 a placebo. Symptoms include swollen feet or legs, difficulty breathing 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)

• Pneumonia (including scarring and thickening of the lungs). Symptoms include respiratory problems or non-productive cough.

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

• Liver problems including potentially fatal liver failure. Symptoms include discomfort or pain in the abdominal area, loss of appetite, nausea, vomiting, yellowing of the skin or white of the eyes (jaundice), dark-colored urine, fatigue (especially associated with the previously mentioned symptoms), itching.
• Allergic reactions including swelling of the face, lips, mouth, tongue, or throat.

Other side effects

Very common

• Changes in your blood test results: your blood creatinine level,
• Changes in your ECG (electrocardiogram) calledprolongation of the QTc Bazett.

Common

• Problems with your digestive system such as indigestion, diarrhea, nausea, vomiting, and stomach pain,
• Fatigue,
• Problems with your skin such as rash or itching,
• Changes in your blood test results 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 blood vessels (vasculitis including leucocytoclastic vasculitis).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAnexo V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister and on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Do not use this medication if you observe visible signs of deterioration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of MULTAQ

• The active ingredient is dronedarone.

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

• The other components of the tablet core are hypromellose (E464), cornstarch, 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).

Appearance of the product and contents of the pack

MULTAQ is an oval-shaped, white, film-coated tablet with a double wave embossing on one side and “4142” on the other side.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Responsible Person

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 about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet: July 2024

Other sources of information

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