Dronedarone

You should not take dronedarone if you have severe heart failure. Dronedarone may increase the risk of death in people who have severe heart failure. Tell your doctor if you have heart failure that is severe enough to cause shortness of breath while you are at rest, after a small amount of exercise, or after any physical activity. Also tell your doctor if you have been hospitalized for heart failure during the past month even if you are feeling better. Your doctor will not prescribe dronedarone for you.

You should not take dronedarone if you have atrial fibrillation (a heart rhythm disorder that may cause the heartbeat to be fast and irregular) that will not or cannot be converted back to a normal heart rhythm. Dronedarone may increase the risk of death, stroke, and the need to be hospitalized in people with permanent atrial fibrillation. Your doctor will check your heart rhythm at least every 3 months while you are taking dronedarone. Call your doctor immediately if your heartbeat becomes fast or irregular while you are taking dronedarone.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with dronedarone and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Dronedarone is used to treat people who currently have normal heart rhythm, but have had atrial fibrillation in the past. Dronedarone decreases the risk that people who have this condition will need to be hospitalized to treat atrial fibrillation. Dronedarone is in a class of medications called antiarrhythmics. It works by helping the heart to beat normally.

Dronedarone comes as a tablet to take by mouth. It is usually taken twice a day, with the morning meal and the evening meal. Take dronedarone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dronedarone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may prescribe certain medications to decrease the risk of stroke while you are taking dronedarone. Take this medication exactly as directed during your treatment.

Dronedarone will help control your heartbeat only as long as you continue to take it. Continue to take dronedarone even if you feel well and have felt well for a long time. Do not stop taking dronedarone without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking dronedarone,

• tell your doctor and pharmacist if you are allergic to dronedarone, any other medications, or any of the ingredients in dronedarone tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• some medications should not be taken with dronedarone. Other medications may cause dosing changes or extra monitoring when taken with dronedarone. Make sure you have discussed any medications you are currently taking or plan to take before starting dronedarone with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking dronedarone, please get the advice of your doctor or pharmacist.
• the following herbal product may interact with dronedarone: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking dronedarone. Do not start this medication while taking dronedarone without discussing with your healthcare provider.
• tell your doctor if you have any other heart problems such as a fast or slow heartbeat, a long QT interval (a heart problem that may cause irregular heartbeat, fainting, or sudden death), liver disease, or if you have had liver or lung problems that developed after taking amiodarone (Pacerone). Your doctor may tell you not to take dronedarone.
• tell your doctor if you have or have ever had any other medical conditions.
• tell your doctor if you are pregnant or plan to become pregnant. You must use effective birth control during your treatment with dronedarone. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking dronedarone, call your doctor immediately. Dronedarone may harm the fetus.
• you should not breast-feed during your treatment with dronedarone.
• talk to your doctor about the risks and benefits of taking dronedarone if you are 65 years of age or older. Some older adults should not take dronedarone because it is not as safe or effective as other medications that can be used to treat the same condition.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

Skip the missed dose and continue your regular dosing schedule. Do not try to make up for a missed dose or take a double dose to make up for a missed one.

Dronedarone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• heartburn
• weakness
• rash
• redness

Some side effects can be serious. If you experience any of these symptoms, or those listed in the IMPORTANT WARNING section, stop taking dronedarone and call your doctor immediately or get emergency medical treatment:

• shortness of breath
• difficulty swallowing or breathing
• wheezing
• chest tightness
• dry cough
• coughing up frothy mucus
• difficulty sleeping due to breathing problems
• need to prop yourself up with extra pillows in order to breathe at night
• weight gain (of 5 or more pounds) in a short period of time
• swelling of the eyes, face, lips, throat, hands, feet or legs
• slowed heartbeat
• fainting
• fever
• flu-like symptoms
• yellowing of the skin or eyes
• itching
• unusual bruising or bleeding
• nausea
• vomiting
• loss of appetite
• pain in the upper right part of the stomach
• tiredness or lack of energy
• unusual darkening of the urine
• light colored stools
• sudden severe headache
• sudden complete or partial loss of vision
• weakness or numbness of an arm or leg
• difficulty thinking clearly, remembering, or learning new things

Dronedarone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dronedarone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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