Multaq is a heart rhythm medicine that helps maintain normal heartbeats in certain people with life-threatening rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart).

Multaq helps lower your risk of needing to be hospitalized for a heart rhythm disorder called atrial fibrillation.

Multaq is for adults who have had this disorder in the past, but now have normal heart rhythm.

You should not use Multaq if you have severe liver disease, if you are pregnant or breast-feeding, or if you have ever used amiodarone and then had liver or lung problems. You should not use Multaq if you have a serious heart condition such as very slow heartbeats, "sick sinus syndrome," or "AV block" (unless you have a pacemaker).

Multaq can double your risk of death if you have certain heart conditions. You should not use this medicine if you have severe heart failure, if you were recently hospitalized for worsening heart failure symptoms, or if you have a "permanent" type of atrial fibrillation (this will be determined by your doctor).

Check your pulse often, and tell your doctor right away if you notice an irregular rhythm.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with dronedarone, and some drugs should not be used together.

Multaq can cause liver problems. Call your doctor at once if you have symptoms such as nausea, loss of appetite, unusual tiredness, dark urine, or yellowing of your skin or eyes.

Take Multaq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Multaq is usually taken with morning and evening meals.

Your heart function may need to be checked every 3 months to help determine if you still need Multaq. Do not stop taking Multaq without your doctor's advice.

Check your pulse often, and call your doctor if you notice an irregular rhythm.

Store at room temperature away from heat and moisture.

Usual Adult Dose for Atrial Fibrillation:

400 mg orally 2 times a day with a meal

Use: To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age greater than 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or more, or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be cardioverted.

Usual Adult Dose for Atrial Flutter:

400 mg orally 2 times a day with a meal

Use: To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age greater than 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or more, or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be cardioverted.

You should not use Multaq if you are allergic to dronedarone, or if you have:

• severe liver disease;

• a serious heart condition such as "sick sinus syndrome," "AV block" (unless you have a pacemaker), or very slow heartbeats that have caused you to faint;

• if you are pregnant or breastfeeding; or

• if you used a medicine called amiodarone and then had lung problems or liver problems.

Dronedarone can double your risk of death if you have certain heart conditions. You should not use this medicine if:

• you have severe heart failure;

• you were recently hospitalized for worsening heart failure symptoms (shortness of breath, chest tightness, night-time breathing problems, swelling, rapid weight gain); or

• you have a "permanent" atrial fibrillation that cannot be changed back to a normal rhythm (this will be determined by your doctor).

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Multaq. Your doctor may change your treatment plan if you also use:

• other heart rhythm medicines;

• cyclosporine;

• ritonavir or other antiviral medicine;

• an antibiotic such as clarithromycin or telithromycin;

• an antidepressant such as amitriptyline, clomipramine, doxepin, imipramine, nefazodone, and others;

• antifungal medicine such as itraconazole, ketoconazole, or voriconazole; or

• antipsychotic medicine such as chlorpromazine, fluphenazine, promethazine, thioridazine, and others.

Tell your doctor if you have other heart problems.

Dronedarone may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

You should not breastfeed while using Multaq.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with dronedarone and cause side effects. Avoid consuming grapefruit while taking Multaq.

Get emergency medical help if you have signs of an allergic reaction to Multaq: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• dry cough, shortness of breath;

• little or no urination;

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• heart problems - swelling, rapid weight gain, feeling short of breath;

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or

• low magnesium or potassium levels - dizziness, numbness or tingling, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle cramps or limp feeling.

Common Multaq side effects may include:

• stomach pain, indigestion, nausea, vomiting, diarrhea;

• feeling weak or tired; or

• skin rash, itching, or redness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Multaq can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your current medicines. Many drugs can interact with dronedarone, especially:

• digoxin;

• St. John's wort;

• a blood thinner (warfarin, Coumadin, Jantoven);

• a diuretic or "water pill";

• medicines to treat tuberculosis;

• medicine to prevent organ transplant rejection;

• seizure medicine; or

• "statin" cholesterol medication (Lipitor, Zocor, Vytorin, and others).

This list is not complete and many other drugs may interact with dronedarone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.