Dronedarone (droe-NE-da-rone)

Treats serious heart rhythm problems in patients with a history of atrial fibrillation or atrial flutter.

Brand Name(s):

There may be other brand names for this medicine.

When This Medicine Should Not Be Used:

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. This medicine should be taken one tablet with the morning meal and one tablet with the evening meal.
• It is best to take this medicine with food or milk.
• 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. Your doctor might ask you to sign some forms to show that you understand this information.

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 double doses.

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 leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• 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.

• Make sure your doctor knows if you are also using 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 are also using a diuretic or "water pill" (such as amiloride, spironolactone, triamterene, or 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, a history of heart failure, or low potassium or magnesium in the blood.
• Stop using this medicine and tell your doctor right away if you develop any of the following: chest pain; shortness of breath; swelling of your hands, ankles, or feet; or weight gain. These may be symptoms of heart failure.
• Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness; light-colored stools; dark urine; decreased or loss of appetite; fever; itching; nausea and vomiting; skin rash; unusual tiredness or weakness; or yellow eyes or skin. These could be signs of a serious liver problem.
• This medicine can cause changes in your heart rhythm, such as a condition called QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding or uneven heartbeats.
• This medicine may increase risk for heart attack, stroke, or other serious side effects. Talk to your doctor about whether you should continue to take this medicine for paroxysmal or persistent atrial fibrillation.
• Do not stop taking this medicine without first checking with your doctor.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood and urine tests may be needed to check for unwanted effects.

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.
• Coughing up a frothy sputum.
• 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 pain in your upper stomach.
• Rapid weight gain.
• Shortness of breath or trouble breathing.
• Swelling in your hands, ankles, or feet.
• Trouble with sleeping.
• Yellowing of your skin or the whites of your eyes.

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

• Lack or loss of strength.
• Mild nausea, vomiting, diarrhea, indigestion, stomach pain, or upset stomach.
• Rash or itching skin.
• Unpleasant taste in your mouth.

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