Dronedarone - Oral

Dronedarone is used in the management of certain types of atrial fibrillation (an irregular or abnormal heart rhythm that begins in the heart's upper chambers).

Take Dronedarone exactly as directed by your doctor or according to the instructions on the label. Do not take more or less than instructed by your doctor.

Take this medicine with your morning and evening meals. Try to take it at the same time each day.

Swallow the tablet whole with a glass of water. Do not divide or crush the tablet.

Dronedarone must be taken regularly for it to be effective. Continue taking this medicine even when you feel better. Do not stop taking it unless instructed by the doctor.

Skip the missed dose and return to your normal dosing schedule.

DO NOT double a dose under any circumstances.

If you often forget to take your medicine, let your doctor and pharmacist know.

Alert your doctor if you have the following conditions:

• permanent atrial fibrillation (irregular or abnormal heart rhythm has been present for a long time) that cannot be restored
• current or history of heart failure (weakness and inability of the heart to pump blood)
• heart block or sick sinus syndrome (abnormal heart rhythms due to problems with your heart's natural pacemaker), unless a pacemaker (a device implanted in the chest that helps control your heartbeat) is present
• very slow heartbeat
• prolonged QT interval (heart rhythm disorder)
• liver and lung problems due to previous use of amiodarone (medicine for irregular or abnormal heartbeat)
• severe liver disease
• severe kidney disease

as Dronedarone may not be suitable for you.

Do not take Dronedarone with medicines used to treat fungal infections, depression, HIV infection, heartburn (burning pain in your chest caused by food or acid from your stomach that backs up into your mouth), cold or allergy, certain antibiotics, certain blood-thinning medicine and other medicines for irregular or abnormal heartbeat. Please see the section "Can I take this with other medicines?" below for more information.

Inform your doctor if you have the following conditions:

• coronary artery disease (narrowing of the blood vessels of the heart)
• hypokalaemia (low potassium level in the blood)
• hypomagnesaemia (low magnesium level in the blood)
• mild to moderate liver disease

Let your doctor know if you are pregnant.

It is important that you do not get pregnant while being treated with this medicine. You must use proven birth control methods during Dronedarone therapy and for 7 days after the last dose. You may wish to discuss birth control methods with your doctor or pharmacist.

Inform your doctor if you are breastfeeding. Breastfeeding is not recommended during treatment with this medicine and for 7 days after the last dose.

Be sure to check with your doctor or pharmacist before giving this medicine to the elderly. Elderly people may be more sensitive to the side effects.

Why is it important to keep my appointments with the doctor?

Keep your appointments with your doctor. Your doctor needs to monitor your condition and check your response to the medication regularly.

• Pregnancy tests must be done before treatment to know if this medicine is suited for you to take.
• Routine tests (e.g. liver and kidney function, ECG [test used to record the electrical activity of the heart], electrolyte levels) may be done while you are being treated with Dronedarone. Your doctor will advise you about how often you need to have these tests.
• Regular monitoring of blood pressure and heart rate and for signs and symptoms of heart failure, liver injury and lung problems may also be needed.

Dronedarone may cause any of the following side effects: diarrhoea, vomiting, nausea, indigestion, rash, itching, and generalised weakness.

Some side effects may need immediate medical help. Alert your doctor quickly if you experience any of the following:

• yellowing of the skin or eyes, stomach pain, dark coloured urine, tiredness, swelling in the legs and ankles, loss of appetite
• signs and symptoms of heart failure e.g. breathlessness, swelling in the hands, feet or legs, big weight gain
• signs and symptoms of lung problems e.g. shortness of breath, dry cough
• pain or difficulty in passing urine, change in how much urine is passed, blood in the urine
• fast or slow heartbeat that is new or worse, passing out

Inform your doctor if any of these side effects do not go away or are severe, or if you experience other side effects.

Do not take Dronedarone with the following medicines:

• certain antibiotics e.g. telithromycin, clarithromycin, oral erythromycin
• medicines to treat depression e.g. nefazodone
• other medicines for irregular or abnormal heartbeat e.g. flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone
• medicines to treat fungal infection e.g. ketoconazole, voriconazole, itraconazole, posaconazole
• certain medicines for mood disorders
• ritonavir (medicine for HIV infection)
• ciclosporin (medicine used in organ transplants or certain immune disorders)
• cisapride (medicine used to treat heartburn)
• bepridil (medicine for chest pain)
• terfenadine (medicine for cold or allergy)
• dabigatran (blood-thinning medicine)

Inform your doctor and pharmacist if you are taking any of these medicines:

• other medicines used in organ transplants or certain immune disorders e.g. tacrolimus, sirolimus, everolimus
• cholesterol-lowering medicines e.g. simvastatin, atorvastatin, lovastatin
• other blood-thinning medicines e.g. apixaban, rivaroxaban, warfarin
• medicines for high blood pressure e.g. verapamil, diltiazem, nifedipine, metoprolol, propranolol
• medicines for epilepsy (fits or seizures) e.g. phenobarbital, carbamazepine, phenytoin
• rifampicin (medicine to treat TB [lung infection known as tuberculosis])
• digoxin (medicine for irregular heart rhythm)
• St. John's wort (herbal medicine)

This list does not include all medicines that may interact with Dronedarone.

Always notify your doctor and pharmacist if you are taking any other medicines, including herbal tonics such as traditional Chinese medicines, supplements, and medicines that you buy without a prescription.

Avoid alcohol and grapefruit juice.

Store in a cool, dry place away from the reach of children.

Medicines must not be used past the expiry date.