Dronedarone Oral tablet

What is this medicine?

DRONEDARONE is an antiarrhythmic drug. It helps make your heart beat regularly.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• heart failure
• liver disease
• low levels of magnesium in the blood
• low levels of potassium in the blood
• other heart disease
• an unusual or allergic reaction to dronedarone, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take one tablet with the morning meal and one tablet with the evening meal. Do not take your medicine more often than directed. Do not stop taking except on the advice of your doctor or health care professional.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take thi medicine with any of the following medications:

• arsenic trioxide
• certain antibiotics like clarithromycin, erythromycin, telithromycin
• cyclosporine
• droperidol
• haloperidol
• medicines for depression called tricyclic antidepressants
• medicines for fungal infections like itraconazole, ketoconazole, voriconazole
• medicines for malaria like chloroquine and halofantrine
• medicines to control heart rhythm like amiodarone, disopyramide, dofetilide, flecainide, ibutilide, quinidine, propafenone, sotalol
• methadone
• pentamidine
• pimozide
• nefazodone
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• ritonavir
• troleandomycin
• ziprasidone

This medicine may also interact with the following medications:

• beta-blockers like metoprolol and propranolol
• calcium channel blockers like diltiazem and verapamil
• digoxin
• grapefruit juice
• medicines for cholesterol like atorvastatin, lovastatin, simvastatin
• medicines for seizures like carbamazepine, phenobarbital, phenytoin
• rifampin
• sirolimus
• St. John's Wort
• tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Your condition will be monitored closely when you first begin therapy. Often, this drug is first started in a hospital or other monitored health care setting. Once you are on maintenance therapy, visit your doctor or health care professional for regular checks on your progress. Because your condition and use of this medicine carry some risk, it is a good idea to carry an identification card, necklace or bracelet with details of your condition, medications, and doctor or health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• fast, irregular heartbeat
• slow heartbeat
• stomach pain
• unusually weak or tired

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• nausea
• vomiting
• stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.