Dronedarone (droe-NE-da-rone)

Treats heart rhythm problems.

Brand Name(s):

Multaq

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk. Take it in the morning and evening.
• 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 cyclosporine, ritonavir, medicine for depression (including nefazodone, TCAs), medicine to treat infections (including clarithromycin, erythromycin, itraconazole, ketoconazole, telithromycin, voriconazole), phenothiazine medicine, or other medicine for heart rhythm problems (including amiodarone, disopyramide, dofetilide, flecainide, propafenone, quinidine, sotalol).
• Some medicines can affect how dronedarone works. Tell your doctor if you are using any of the following:
  • Carbamazepine, digoxin, phenobarbital, phenytoin, rifampin, simvastatin, sirolimus, tacrolimus, St John's wort
  • Blood pressure medicine (including beta-blockers, calcium channel blockers)
  • Blood thinner (including dabigatran, warfarin)
  • Diuretic (water pill)
  • Medicine for depression (including SSRIs)
• 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. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment and for 5 days after the last dose.
• Do not breastfeed during treatment and for 5 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, lung disease, heart or blood vessel disease, electrolyte problems, or if you have a history of stroke.
• This medicine may cause the following problems:
  • Increased risk for heart failure or stroke
  • Liver problems
  • Lung problems, including interstitial lung disease, pneumonitis, and pulmonary fibrosis
  • Heart rhythm problem, including QT prolongation
  • Kidney problems
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• 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
• Fainting, dizziness, lightheadedness
• Fast, slow, pounding, or uneven heartbeat
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual tiredness or weakness

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

• Diarrhea
• Itching, skin rash

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