When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to dronedarone, if you are pregnant or breastfeeding, or if you had liver or lung problems caused by amiodarone (another heart rhythm medicine).

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Always take this medicine with food. Take 1 tablet with the morning meal and 1 tablet with the evening meal.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Skip the missed dose and take your next dose at the regular time. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using any of the following:
  
  • Cyclosporine
  • Ritonavir
  • Medicine for depression (such as nefazodone or a TCA)
  • Other medicine for heart rhythm problems (such as amiodarone, disopyramide, dofetilide, flecainide, propafenone, quinidine, sotalol)
  • Medicine to treat infections (such as clarithromycin, erythromycin, itraconazole, ketoconazole, telithromycin, voriconazole)
  • Phenothiazine medicine (such as chlorpromazine, prochlorperazine, thioridazine)
• Some foods and medicines can affect how dronedarone works. Tell your doctor if you are using any of the following:
  
  • Carbamazepine, dabigatran, digoxin, phenobarbital, phenytoin, rifampin, simvastatin, sirolimus, tacrolimus, or St John's wort
  • A diuretic (water pill), a beta-blocker or calcium channel blocker medicine to lower blood pressure, or a blood thinner (such as warfarin)
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you have liver disease, lung disease, heart failure, a slow heartbeat, or other heart or heart rhythm problems.
• This medicine may cause the following problems:
  
  • Heart failure
  • Liver, lung, or kidney problems
  • A heart rhythm problem called QT prolongation
• Do not stop taking this medicine without talking to your doctor first.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Chest pain, cough, trouble breathing
• Dark urine or pale stools, nausea, vomiting, stomach pain, loss of appetite, yellow skin or eyes
• Dry mouth, increased thirst, muscle cramps, nausea, or vomiting
• Fast, slow, pounding, or uneven heartbeat
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual tiredness or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088