Multaq 400mg Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DRONEDARONE - ORAL

(DROE-NE-da-rone)

COMMON BRAND NAME(S): Multaq

WARNING: This medication should not be used by people with certain kinds of heart failure (such as people with NYHA Class IV heart failure, people with recent worsening of heart failure) or a certain kind of irregular heartbeat (permanent atrial fibrillation). Consult your doctor for more details. Tell your doctor immediately if you have new or worsening symptoms of heart failure, including shortness of breath, wheezing, unusual tiredness, swelling ankles/feet, unusual weight gain. Talk to your doctor about the risks and benefits of dronedarone.

USES: This medication is used by people with a history of certain types of irregular heartbeat (paroxysmal or persistent atrial fibrillation). It helps to reduce the risk of going to the hospital for atrial fibrillation. Dronedarone is known as an antiarrhythmic drug. This medication should not be used by people with a certain type of irregular heartbeat (permanent atrial fibrillation) due to the increased risk of serious side effects.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using dronedarone and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth, usually twice daily, once with your morning meal and once with your evening meal, or as directed by your doctor. Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. Your doctor may also direct you to take another medication ("blood thinner") along with this medication. Follow your doctor's instructions carefully. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details. Tell your doctor if your condition persists or worsens (such as your pulse becomes irregular).

SIDE EFFECTS: See also Warning section. Nausea or diarrhea may occur. If any of these effects persist or worsen, tell your doctor promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: symptoms of liver disease (such as dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin). Seek immediate medical attention if any of these rare but serious side effects occur: unusually fast/slow/irregular heartbeat, severe dizziness, fainting. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section. Before taking dronedarone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, certain types of irregular heartbeat (sick sinus syndrome, second- or third-degree atrioventricular block), serious side effects (such as liver/lung disease) from taking the medication amiodarone. Dronedarone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using dronedarone, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death). Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dronedarone safely. Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: fingolimod. Many drugs besides dronedarone may affect the heart rhythm (QT prolongation). Examples include amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, among others. Other medications can affect the removal of dronedarone from your body, which may affect how dronedarone works. Examples include azole antifungals (such as ketoconazole, itraconazole, voriconazole), cyclosporine, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as lopinavir, ritonavir), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), telithromycin, among others. Dronedarone can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include certain "statin" drugs (atorvastatin, lovastatin, simvastatin), warfarin, tacrolimus, sirolimus, digoxin, dabigatran, among others.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as EKG, kidney/liver function, blood mineral levels including potassium) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Keep all laboratory and medical appointments.

MISSED DOSE: If you miss a dose, skip the missed dose and take your next dose at your regular scheduled time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (US), or 1-800-668-1507 (Canada).

Information last revised July 2012. Copyright(c) 2012 First Databank, Inc.