MULTAQ 400 mg Film-Coated Tablets

Зміст інструкції

1. MULTAQ 400 mg film-coated tablets
   1. What is MULTAQ 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. Package contents and other information

MULTAQ 400 mg film-coated tablets

dronedarone

Read this leaflet carefully before you start taking this medicine as 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is MULTAQ and what it is used for

MULTAQ contains an active substance called dronedarone. It belongs to the group of
medicines called antiarrhythmics that help to regulate the heartbeat.
MULTAQ is used if you have a problem concerning your heart rhythm such as an irregular heartbeat (atrial fibrillation) and spontaneously or through a treatment called
cardioversion, your heartbeat has returned to a normal rhythm.
MULTAQ prevents the recurrence of the irregular heart rhythm problem. MULTAQ is only used in
adults.
The 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 any of the other ingredients of this medicine (listed in section 6),
• if you have a problem that affects the heart's electrical conduction system (heart block). Your heart may beat very slowly or you may feel dizzy. If you have had a pacemaker implanted for this type of problem, you can take MULTAQ,
• if you have a very slow heartbeat (less than 50 beats per minute),
• if the ECG (electrocardiogram) has shown a problem with the heart called “prolonged QTc interval” (this interval is greater than 500 milliseconds),
• if you have a type of atrial fibrillation (AF) called permanent atrial fibrillation. In permanent atrial fibrillation, the AF has been present for a long time (at least 6 months) and the doctor has decided not to restore the heart rhythm to normal sinus rhythm with a treatment called cardioversion,
• if you have instability (drops) in blood pressure that can lead to inadequate blood flow to the organs,
• if you have or have had a problem that prevents the heart from pumping blood throughout the body as it should (a condition called heart failure). You may experience swelling of the feet or legs, breathing problems when lying down or sleeping, or shortness of breath while moving,
• if the percentage of blood that the heart pumps each time it contracts is too low (a condition called left ventricular dysfunction),
• if you have previously taken amiodarone (another antiarrhythmic medicine) and have had problems with the lungs or liver,
• if you are taking medicines for an infection (including fungal infections or AIDS), for allergies, for heart rhythm problems, for depression, or after a transplant (see below “Other medicines and MULTAQ”. This will allow you to get more details on the types of medicines that you should not take with MULTAQ),
• if you have a severe liver problem,
• if you have a severe kidney problem,
• if you are taking dabigatran (see below “Other medicines and MULTAQ”).

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

Warnings and precautions
Talk to your doctor or pharmacist before taking MULTAQ if

• you have a problem that causes low levels of potassium or magnesium in the blood. This problem must be corrected before starting treatment with MULTAQ,
• you are over 75 years old,
• you have a condition in which the coronary arteries that supply blood to the heart become hardened and narrowed (coronary artery disease).

While you are being treated with MULTAQ, tell your doctor if

• the atrial fibrillation becomes permanent while you are taking MULTAQ. You should stop taking MULTAQ,
• you experience swelling of the feet or legs, breathing problems when lying down or sleeping, shortness of breath while moving, or weight gain (which are signs and symptoms of heart failure),
• immediately inform your doctor if you develop any of these signs and symptoms of liver problems: pain or discomfort in the stomach (abdominal), loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusually dark urine, fatigue (especially in association with other symptoms described above), itching,
• you have shortness of breath or a dry cough. Tell your doctor, who will check your lungs.

If any of the above applies to you (or if you are not sure), 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 check your health and how the medicine is working on you.

• Your doctor may check the electrical activity of the heart using an ECG (electrocardiogram).
• Your doctor will prescribe blood tests to check liver function before you start taking MULTAQ and during therapy.
• If you are taking some medicines that prevent blood clots from forming, such as warfarin, your doctor will prescribe a blood test called INR to check if the medicine is working properly.
• Your doctor may also perform other blood tests. The results of a blood test to check kidney function (blood creatinine levels) may be altered following the administration of MULTAQ. Your doctor will take this into account when checking blood tests and will use another reference parameter for the “normal” levels of creatinine in the blood.
• Your doctor may perform a clinical assessment of your lungs.

In some cases, it may be necessary to stop treatment with MULTAQ.
Inform anyone who is checking your blood tests that you are taking MULTAQ.

Children and adolescents
MULTAQ is not recommended in 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 the use of a medicine against the formation of
blood clots (anticoagulant).
MULTAQ and some other medicines can interact with each other and cause serious side effects. Your doctor may decide to change the dose of any other medicine you are taking.
You should 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,
• some medicines used to treat fungal infections such as ketoconazole, voriconazole, itraconazole or posaconazole,
• some medicines for depression called tricyclic antidepressants,
• some tranquillizer 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 heartburn or acid reflux),
• ritonavir (a medicine for AIDS),
• dabigatran (a medicine for preventing blood clots).

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

• other medicines used for high blood pressure, chest pain caused by heart disease or other heart problems, such as verapamil, diltiazem, nifedipine, metoprolol, propranolol, or digoxin,
• some medicines used to reduce cholesterol levels in the blood (such as simvastatin, lovastatin, atorvastatin or rosuvastatin),
• some medicines against the formation of blood clots, 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 (hypericum) - a herbal medicine for depression,
• rifampicin - for tuberculosis.

MULTAQ with food and drink
Do not drink grapefruit juice while taking MULTAQ. This drink can increase the levels of
dronedarone in the blood and the likelihood of having side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.

• If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before starting treatment with MULTAQ.
• MULTAQ is not recommended if you are pregnant or think you might be.
• Do not take MULTAQ if you are a woman who can become pregnant and are not using effective contraception.
• Use an effective method of contraception (contraception) during treatment and for 7 days after the last dose of MULTAQ.
• Stop taking the tablets and consult 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 to breastfeed. Do not breastfeed during treatment with MULTAQ and for 7 days after the last dose.

Driving and using machines
MULTAQ usually does not impair the ability to drive or operate machinery. However, your
ability to drive or operate 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 some types of
sugars, contact your doctor before taking this medicine.

3. How to take MULTAQ

Always take this medicine exactly as your doctor has instructed. If you have any doubts, ask 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, such as stopping amiodarone
before the change. Tell your doctor about all the medicines you are taking.

How much medicine 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 feel that the effect of the medicine is too strong or too weak, tell your doctor or
pharmacist.

How to take this medicine
Swallow the tablet whole with a sip 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 room or hospital immediately. Bring the
package of the medicine 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 time of day you usually take it.

If you stop taking MULTAQ:
Do not stop treatment with this medicine without first consulting your doctor or
pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. 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 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(affects more than 1 in 10 people)

• heart condition that does not pump enough blood around the body as it should (congestive heart failure). In clinical studies, this side effect was observed with similar frequency in patients treated with MULTAQ and in patients not treated. Signs of the condition include swelling of the feet or legs, breathing problems when lying down or sleeping, shortness of breath while moving, or weight gain. Common(affects up to 1 in 10 people)
• Diarrhea, vomiting when excessive as it can lead to kidney problems.
• Slow heartbeat.

Uncommon(affects 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(affects up to 1 in 1,000 people)

• Liver problems, including liver failure which is life-threatening. 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 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 a blood test: your blood creatinine levels,
• changes in the ECG (electrocardiogram), called prolonged QTc interval according to Bazett.

Common

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

Uncommon

• other skin problems such as skin redness or eczema (redness, itching, burning or blisters),
• skin more sensitive to the sun,
• altered taste.

Rare

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist .
You can also report side effects directly through the national reporting system referred to in
Appendix 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 which is stated on the blister and the packaging after
“Exp.”. The expiry date refers to the last day of the month indicated.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice visible signs of deterioration (see section 6
“Description of MULTAQ and contents of the pack”).
Do not dispose of any medicine in waste water 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 ingredient is dronedarone. Each film-coated tablet contains 400 mg of dronedarone (as hydrochloride).
• The other components contained in the tablet core are: hypromellose (E464), corn starch, crospovidone (E1202), poloxamer 407, lactose monohydrate (see section 2 in “MULTAQ contains lactose”), anhydrous colloidal silica, magnesium stearate (E572).
• The other components contained in the tablet coating are: hypromellose (E464), macrogol 6000, titanium dioxide (E171), carnauba wax (E903).

Description of the appearance of MULTAQ and package contents
MULTAQ is a white, oval-shaped, film-coated tablet (tablet) with a double wave engraved on one
side and the number “4142” on the other side.
MULTAQ film-coated tablets are supplied in opaque PVC and
aluminium blister packs of 20, 50, 60 tablets and in packs of 100x1 tablets in opaque PVC and
aluminium unit-dose blister packs.
Not all pack sizes 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 further information on this medicinal product, 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 S.R.L.
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 hf.
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

United Kingdom (Northern Ireland)
sanofi-aventis Ireland Ltd. T/A SANOFI
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/.