400 mg film-coated tablets
dronedarone
What MULTAQ is and what it is used for
MULTAQ contains an active substance called dronedarone. It belongs to a group of medicines called antiarrhythmics that help regulate your heart rhythm.
MULTAQ is used if you have problems with your heart rhythm (your heart beats irregularly – so-called atrial fibrillation ) and spontaneously or through a treatment called conversion has restored your heart rhythm to normal rhythm.
MULTAQ prevents your problems with an irregular heartbeat from recurring. MULTAQ is only used for adults.
Your doctor will consider all available treatment options before prescribing MULTAQ.
What you need to know before taking 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 problems with conduction disturbances in the heart (heart block), which can cause very slow heart rhythm or dizziness. If you have a pacemaker for such symptoms, you can use MULTAQ.
- if you have a very slow heartbeat (less than 50 beats per minute),
- if your ECG ( electrocardiogram ) indicates that you have a heart problem called “prolonged QTc time” (this interval is over 500 milliseconds),
- if you have a type of irregular heartbeat called permanent atrial fibrillation . In the case of permanent atrial fibrillation , the flicker has been present for a long time (for at least 6 months) and a decision has been made not to restore your heart rhythm to a normal rhythm by means of conversion.
- if you have unstable blood pressure (including recurrent drops in blood pressure) which may lead to insufficient arterial blood flow to your organs.
- if you have or have had problems where your heart can not pump around the blood in the body as well as it should ( heart failure ). You may have swollen feet or legs, difficulty breathing when lying down or sleeping, or shortness of breath when moving.
- if the amount of blood that leaves your heart each time it contracts is too small (left ventricular dysfunction),
- if you have previously used amiodarone (another antiarrhythmic ) and experienced lung or liver problems,
- if you are taking medicines for infections (including fungal infections or AIDS ), allergies , heart problems, depression or medicines given after a transplant (see section below “Other medicines and MULTAQ”). This section gives you more information about which medicines you can not bring MULTAQ).
- if you have severe liver problems,
- if you have severe kidney problems,
- if you are taking dabigatran (see section below “Other medicines and MULTAQ”).
If any of the above apply to you, do not take MULTAQ.
Warnings and cautions
Talk to your doctor or pharmacist before taking MULTAQ
- if you have a problem that causes you to have low levels of potassium or magnesium in your blood. This problem should be treated before starting treatment with MULTAQ.
- if you are older than 75 years,
- if you have a condition in which your blood vessels, which supply the heart muscle with blood, become hardened and narrower (coronary heart disease).
While taking MULTAQ, talk to your doctor
- your atrial fibrillation becomes permanent while you are being treated with MULTAQ. If this happens, stop using MULTAQ.
- you have swollen feet or legs, difficulty breathing when you lie down or sleep, become short of breath when you move or gain weight (which are signs and symptoms of heart failure ).
- Tell your doctor immediately if you develop any of these signs and symptoms of liver problems: abdominal pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), abnormal dark urine, fatigue (especially in connection with other symptoms such as indicated above), itching .
- you are short of breath or have a dry cough. Talk to your doctor who will examine your lungs.
If this applies to you (or you are not sure) talk to your doctor or pharmacist before taking MULTAQ.
Tests on the heart, lungs, and blood
When you are being treated with MULTAQ, your doctor may perform tests to check your medical condition and how the medicine works for you.
- Your doctor can monitor your heart’s electrical activity using an ECG ( electrocardiogram ).
- Your doctor will order blood tests to check your liver function before you start taking MULTAQ and also during treatment.
- If you are taking certain blood-thinning drugs such as warfarin , your doctor will order a blood test called PK (INR) to check how well your drug is working.
- Your doctor may also take other blood samples. The results of one of these blood tests, which check kidney function (blood creatinine levels), may be altered by MULTAQ. Your doctor will keep this in mind when testing your blood levels and will use a different limit on the normal value of blood creatinine.
- Your doctor may examine your lungs.
In some cases, treatment with MULTAQ may need to be stopped.
Tell other people who control your blood that you are taking MULTAQ.
Children and young people
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 that you use a blood thinner as part of your treatment.
MULTAQ and some other medicines can affect each other and lead to serious side effects. Your doctor may change the dosage of any of the other medicines you use.
You must not take any of the following with MULTAQ:
- other drugs used to control irregular or rapid heartbeat such as flecainide , propafenone , quinidine , disopyramide , dofetilide, sotalol, amiodarone ,
- certain medicines for fungal infections such as ketoconazole , voriconazole, itraconazole or posaconazole,
- certain antidepressants called tricyclic antidepressants ,
- certain sedatives called phentiazines,
- bepridil for chest pain caused by heart disease,
- telithromycin, erythromycin or clarithromycin ( antibiotics for infection ),
- terfenadine (an anti- allergy drug ),
- nefazodone (an antidepressant),
- cisapride (a medicine for reflux of food and acid reflux from the stomach to the mouth),
- ritonavir (an anti- AIDS drug ) ,
- dabigatran (a medicine that counteracts the formation of blood clots).
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 ,
- certain blood cholesterol lowering medicines (such as simvastatin , lovastatin, atorvastatin or rosuvastatin),
- certain drugs that counteract the formation of blood clots such as warfarin , rivaroxaban, edoxaban and apixaban,
- certain medicines for epilepsy called phenobarbital, carbamazepine or phenytoin ,
- sirolimus, tacrolimus, everolimus and ciclosporin (used after transplantation),
- St. John’s wort (herbal medicine for depression),
- rifampicin (for tuberculosis ).
MULTAQ with food and drink
Do not drink grapefruit juice while taking MULTAQ, as it may raise the blood levels of dronedarone and thus 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 using this medicine.
- MULTAQ is not recommended if you are pregnant or think you may be pregnant.
- Do not take MULTAQ if you can have children and do not use a reliable method of contraception.
- Stop taking your tablets and contact your doctor immediately if you become pregnant while taking MULTAQ.
- It is not known if MULTAQ is transferred to your breast milk. You and your doctor should decide whether to take MULTAQ or breast-feed. You should not do both.
Driving and using machines
MULTAQ does not usually affect your ability to drive and use machines. However, the ability to drive and use machines may be affected by side effects such as fatigue.
MULTAQ contains lactose
Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take MULTAQ
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
MULTAQ treatment will be supervised by a doctor who has experience in the treatment of heart disease.
If you need to change treatment from amiodarone (another medicine for the treatment of atrial fibrillation ) to MULTAQ, your doctor may give you special recommendations, such as that you should stop taking amiodarone before changing. Tell your doctor about all the medicines you use.
Dosage The
usual dose is one 400 mg tablet twice a day. Take:
- a tablet with breakfast and
- one tablet with the evening meal.
If you have the impression that the medicine is too strong or too weak, talk to your doctor or pharmacist.
Taking this medicine
Swallow the tablet whole with water with a meal. The tablet can not be divided into equal doses.
If you take more MULTAQ than you should
Contact your doctor or 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 a forgotten tablet. Take the next dose as you normally would.
If you stop taking MULTAQ
Do not stop treatment without first contacting a doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
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 a 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 is not pumping around enough blood in the body, as good as it should be ( heart failure ). In clinical trials , these adverse reactions were observed at similar frequencies in patients receiving MULTAQ and in patients receiving placebo . Symptoms of this 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, persistent vomiting, as it can lead to kidney problems.
- Slow heartbeat.
Uncommon (may affect up to 1 in 100 people)
- Pneumonia (with scarring and thickening of the lungs). Symptoms of this include shortness of breath and dry cough.
Rare (may affect up to 1 in 1,000 people)
- Liver problems including life-threatening liver failure. Symptoms of this include abdominal pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice), abnormal dark urine, fatigue (especially in connection with other symptoms listed above), itching .
- Allergic reactions including swelling of the face, lips, tongue or throat.
Other side effects include:
Very common
- changes in the results of a blood test (your blood creatinine level),
- changes in your ECG ( electrocardiogram ) called QTc (Bazett) extension.
Usual
- problems with your digestive system such as indigestion, diarrhea, nausea, vomiting and abdominal pain,
- fatigue,
- skin problems such as rash or itching ,
- changes in the results of blood tests used to check your liver function.
Less common
- other skin problems such as redness or eczema ( redness , itching , burning sensation or blisters),
- increased sensitivity to sunlight,
- taste disorders,
Rare
- lost taste,
- inflammation of a blood vessel ( vasculitis including leukocytoclastic vasculitis ).
How to store 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 carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Do not use this medicine if you notice any visible signs of deterioration (see section 6 “What the medicine looks like and contents of the pack”).
The medicine 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.
Contents of the pack and other information
Content declaration
- The active substance is dronedarone.
Each film-coated tablet contains 400 mg 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”), anhydrous colloidal silica, magnesium stearate (E572).
- The other ingredients in the tablet coating are hypromellose (E464), macrogol 6000, titanium dioxide (E171), carnauba wax (E903).
What the medicine looks like and contents of the pack
MULTAQ is a white, oblong film-coated tablet, marked with a double scale on one side and “4142” on the other side.
MULTAQ film-coated tablets are supplied in packs of 20, 50, and 60 tablets in opaque blisters of PVC and aluminum and 100×1 tablets in opaque perforated single-dose blisters of PVC and aluminum.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
sanofi-aventis groupe
54, rue La Boétie
F-75008 Paris – France
Manufacturer
Sanofi Winthrop Industrie
1 rue de la Vierge, Ambarès & Lagrave,
F-33565 Carbon Blanc Cedex – France
Chino in Pharmaceutical and Chemical Works Private Co.Ltd
Manufacturing site Veresegyhaz
2112 Veresegyhaz Lévai u.5
Hungary
Sanofi-Aventis Deutschland GmbH
Brüningstrasse 50
Industrial Park Höchst,
D-65926 Frankfurt
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
Sanofi AB
Tel: +46 (0) 8 634 50 00