Dronedarone 400 mg film-coated tablets

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

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

• if you are allergic to dronedarone or to 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 might beat very slowly or you may feel dizzy. If you have had a pacemaker fitted for this problem, you can use Dronedarone,
• if you have a very slow heart beat (less than 50 beats a minute),
• if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” (this interval is more than 500 milliseconds),
• if you have a type of atrial fibrillation called permanent atrial fibrillation (AF). In permanent AF, the AF has been present for a long time (at least during 6 months) and a decision has been made not to change back your heart rhythm to atrial normal rhythm with a treatment called cardioversion,
• if you have instability (drops) in your blood pressure which can lead to inadequate arterial blood flow to your organs,
• if you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure). You may have swollen feet or legs, trouble breathing when lying down or sleeping, or shortness of breath when moving around,
• if the percentage of blood leaving your heart each time it contracts is too low (condition called left ventricular dysfunction),
• if you took amiodarone (another antiarrhythmic medicine) previously and experienced lung or liver problems,
• if you take medicines for infection (including fungal infection or AIDS), allergies, heart beat problems, depression, after a transplant (see section below on “Other medicines and Dronedarone”. This will give you more details on exactly what medicines you cannot take with Dronedarone),
• if you have a severe liver problem,
• if you have a severe kidney problem
• if you take dabigatran (see section below on “Other medicines and Dronedarone”).

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

Talk to your doctor or pharmacist before taking Dronedarone if

• you have a problem that gives you a low level of potassium or magnesium in your blood. This problem should be corrected before starting treatment with Dronedarone,
• you are more than 75 years old,
• you have a condition when the vessel that supplies blood to heart muscle becomes hardened and narrowed (coronary artery disease).

While taking Dronedarone, tell your doctor if

• your atrial fibrillation becomes permanent while you are taking Dronedarone.
  You should stop taking Dronedarone,
• you have swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase (which are signs and symptoms of heart failure),
• tell your doctor immediately if you develop any of these signs and symptoms of liver problems: stomach (abdominal) area pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other symptoms listed above), itching,
• you have breathlessness or non-productive cough. Tell your doctor, he/she will check your lung.

If this applies to you (or you are not sure), please talk to your doctor or pharmacist before taking Dronedarone.

While you are taking Dronedarone, your doctor may perform tests to check your medical condition and how the medicine is working for you.

• Your doctor may look at your heart’s electrical activity using an ECG (electrocardiogram) machine.
• Your doctor will order blood tests to check your liver function before you start taking Dronedarone and during treatment.
• If you are taking some medicines against blood clot formation such as warfarin, your doctor will order a blood test called INR to check how well your medicine is working.
• Your doctor may also do other blood tests. The results of one of the blood tests to check kidney function (blood creatinine levels) may be changed by Dronedarone. Your doctor will take this into account when checking your blood levels and will use another reference of the “normal” value of blood creatinine.
• Your doctor may check your lungs.

In some cases, Dronedarone treatment may need to be stopped.

Please tell any other person who checks your blood that you are taking Dronedarone.

Dronedarone is not recommended in children and adolescents below 18 years of age.

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 medicine against blood clot formation according to your condition.

Dronedarone and some other medicines can affect each other and cause serious side effects. Your doctor may change the dose of any other medicines you are taking.

You must not take any of the following with Dronedarone:

• other medicines used to control an irregular or fast heart beat such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone,
• some medicines for fungal infections such as ketoconazole, voriconazole, itraconazole or posaconazole,
• some medicines for depression called tricyclic antidepressants,
• some tranquilising 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 food and acid reflux from your stomach to your mouth),
• ritonavir (a medicine for AIDS infection),
• dabigatran (a medicine for prevention of blood clot formation).

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,
• some medicines for reducing the cholesterol in your blood (such as simvastatin, lovastatin, atorvastatin, or rosuvastatin),
• some medicines against blood clot formation 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 - a herbal medicine for depression,
• rifampicin - for tuberculosis.

Do not drink grapefruit juice while taking Dronedarone. It can increase the blood levels of dronedarone and may increase your chance of getting side effects.

If you are pregnant or breast-feeding, 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 able to have children, the doctor will do a pregnancy test before you start the treatment with Dronedarone.
• Dronedarone is not recommended if you are pregnant or you think you may be pregnant.
• Do not take Dronedarone if you are a woman able to have children and you are not using a reliable contraceptive method.
• Use effective birth control (contraception) during treatment and for 7 days after the final dose of Dronedarone.
• Stop taking your tablets and talk to your doctor straight away if you get pregnant while taking Dronedarone.
• It is not known if Dronedarone passes into your breast milk. You and your doctor should decide if you will take Dronedarone or breastfeed. Do not breastfeed during treatment with Dronedarone and for 7 days after the final dose.

Dronedarone does not usually affect your ability to drive or use machine. However, your ability to drive and use machines may be affected by side effects such as tiredness.

Dronedarone film-coated tablets contain lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

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

• one tablet during your morning meal and
• one tablet during your evening meal.

If you think that your medicine is too strong or too weak, talk to your doctor or pharmacist.

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

Contact immediately your doctor or the nearest emergency department or hospital. Take the medicine pack with you.

Do not take a double dose to make up for a forgotten tablet. Take the next dose when you are normally due to take it.

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

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

• Problem where your heart does not adequately pump the blood round your body as well as it should (congestive heart failure) In clinical studies, this side effect was observed at a similar rate in patients receiving dronedarone and in patients receiving placebo. Signs include swollen feet or legs, trouble breathing when lying down or sleeping, shortness of breath when moving around, or weight increase.

Common (may affect up to 1 in 10 people)

• Diarrhoea, vomiting when excessive as it can lead to kidney problems.
• Slow heart beat.

Uncommon (may affect up to 1 in 100 people)

• Inflammation of the lungs (including scarring and thickening of the lungs). Signs include breathlessness or non-productive cough.

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

• Liver problems including life threatening liver failure. Signs include stomach (abdominal) area pain or discomfort, loss of appetite, nausea, vomiting, yellowing of the skin or the whites of the eyes (jaundice), unusual darkening of the urine, fatigue (especially in association with other symptoms listed above), itching.
• Allergic reactions, including swelling of the face, lips, mouth, tongue or throat.

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

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

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• losing your sense of taste,
• inflammation of blood vessels (vasculitis including leukocytoclastic vasculitis).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substance is dronedarone.
  Each film-coated tablet contains 400 mg dronedarone (as hydrochloride).
• The other ingredients are:
  Tablet core:
  Lactose Monohydrate, maize starch, crospovidone Type-A (E1202), hypromellose 2910 (E464), silica colloidal anhydrous, poloxamer (Type 407) and magnesium stearate.
  Tablet coating:
  Hypromellose 2910, titanium dioxide (E171) and macrogol 6000.

White to off-white, oblong-shaped, film-coated tablets, debossed with “E” on one side and “400” on the other side.

Dronedarone film-coated tablets are available in blister packs.

Pack sizes

Blister packs: 20 and 60 film-coated tablets.

Not all pack sizes may be marketed.

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