Dronedarone (By mouth)

Introduction

Dronedarone (droe-NE-da-rone)

Treats heart rhythm problems in patients who have a history of atrial fibrillation.

Brand Name(s)

Multaq

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

Do not use this medicine if you have had an allergic reaction to dronedarone or if you are pregnant or breastfeeding. You should not use this medicine if you have severe heart failure, heart failure that has recently become worse, or permanent atrial fibrillation. You should not use this medicine if you have certain other heart rhythm problems, slow heartbeat, or severe liver disease, or if you have had liver problems caused by amiodarone (another heart rhythm medicine). Do not use this medicine if you also use cyclosporine, ritonavir, medicine for depression, medicine for heart rhythm problems, medicine for infections, or a phenothiazine medicine. Please see the Drugs and Foods to Avoid section for more information on these medicines.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• 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. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose of this medicine, wait and take your next dose at your regular dosing time. Do not take more than one dose at a time.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

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 also use cyclosporine (Gengraf®, Neoral®, Sandimmune®), ritonavir (Norvir®), medicine for depression (such as amitriptyline, nefazodone, nortriptyline, Elavil®, Pamelor®, Serzone®, or Vivactil®), other medicine for heart rhythm problems (such as amiodarone, disopyramide, dofetilide, flecainide, propafenone, quinidine, sotalol, Cardioquin®, Cordarone®, Norpace®, Rhythmol®, or Tikosyn®), medicine for infections (such as clarithromycin, erythromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Biaxin®, Ery-tab®, Ketek®, Nizoral®, Sporanox®, or Vfend®), or a phenothiazine medicine (such as chlorpromazine, prochlorperazine, thioridazine, Compazine®, Mellaril®, Thorazine®, or Trilafon®).
• Make sure your doctor knows if you also use carbamazepine (Tegretol®), dabigatran (Pradaxa®), digoxin (Lanoxin®), phenobarbital (Luminal®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), simvastatin (Zocor®), sirolimus (Rapamune®), tacrolimus (Prograf®), or St John's wort. Tell your doctor if you also use a diuretic or "water pill" (such as amiloride, spironolactone, triamterene, Aldactone®, Dyrenium®, or Midamor®), blood pressure medicine (such as atenolol, diltiazem, labetalol, metoprolol, nifedipine, propranolol, timolol, verapamil, Cardizem®, Inderal®, Lotrel®, Norvasc®, Plendil®, or Toprol®), or a blood thinner (such as warfarin, Coumadin®).
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have kidney disease, liver disease, other heart problems, or low potassium or magnesium in the blood.
• Tell your doctor right away if you have chest pain, trouble breathing, swelling, or weight gain. These may be symptoms of heart failure, and you should not take this medicine if you have severe heart failure.
• Check with your doctor right away if you have stomach pain, light-colored stools or dark urine, loss of appetite, or nausea and vomiting. These could be signs of a serious liver problem.
• This medicine can cause heart rhythm problems. Tell your doctor right away if you have fast or uneven heartbeat, fainting, or dizziness.
• Do not stop taking this medicine without first checking with your doctor.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

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
• Dark-colored urine or pale stools
• Dry mouth, increased thirst, muscle cramps, nausea, or vomiting
• Fast, slow, pounding, or uneven heartbeat
• Loss of appetite or stomach pain
• Rapid weight gain
• Swelling in your hands, ankles, or feet
• Trouble breathing
• Unusual tiredness or weakness
• Yellow skin or eyes

If you notice these less serious side effects, talk with your doctor:

• Diarrhea
• Lack or loss of strength

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