Do not take this medication if you have severe heart failure that makes you short of breath during light activity or even while resting, or if you recently had to stay in a hospital because your heart failure got worse. Also, do not take this medication if you have a certain kind of irregular heartbeat (permanent atrial fibrillation) that will not or cannot be changed back to a normal heart rhythm. Dronedarone may increase your risk of death, stroke, or the need to be treated in the hospital for heart failure if you have any of these conditions. Consult your doctor for more details and to discuss the risks and benefits of dronedarone. Tell your doctor right away if you have new or worsening symptoms of heart failure such as shortness of breath, wheezing, unusual tiredness, swelling ankles/feet, unusual weight gain.Who should not take dronedarone?
This medication is used if you have had certain types of irregular heartbeat (paroxysmal or persistent atrial fibrillation) in the past but now have a normal heart rhythm. It helps you keep a normal heart rhythm and lowers your chance of having to go to the hospital for atrial fibrillation. Dronedarone is known as an antiarrhythmic drug.
This medication should not be used if you have permanent atrial fibrillation because of the increased risk of very serious side effects. See also Warning section.
Read the Medication Guide provided by your pharmacist before you start taking dronedarone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with food as directed by your doctor, usually twice daily (once with your morning meal and once with your evening meal).
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking dronedarone without asking your doctor first, even if you feel well. Your doctor may direct you to also take another medication ("blood thinner"/anticoagulant) to lower the risk of getting serious blood clots. Follow your doctor's instructions carefully.
Get medical help right away if your heartbeat or pulse becomes fast or irregular.
See also Warning section.
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 right away if you have any serious side effects, including: symptoms of liver disease (such as persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), symptoms of lung problems (such as persistent dry cough, shortness of breath), change in the amount of urine.
A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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 (second- or third-degree atrioventricular block or sick sinus syndrome, unless you have a heart pacemaker), 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 rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.
The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using dronedarone, tell your doctor or pharmacist of all the drugs you take and 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 doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).
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 right away.
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.
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, disopyramide, dofetilide, flecainide, pimozide, procainamide, propafenone, 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), rifampin, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, 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 dabigatran, digoxin, among others.
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
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.
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.
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 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised October 2015. Copyright(c) 2015 First Databank, Inc.
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