Dronedarone Tablets

What is this medication?

DRONEDARONE (droe NE da rone) treats a fast or irregular heartbeat (arrhythmia). It works by slowing down overactive electric signals in the heart, which stabilizes your heart rhythm. It belongs to a group of medications called antiarrhythmics.

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

COMMON BRAND NAME(S): Multaq

What should I tell my care team before I take this medication?

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

• Heart failure
• History of irregular heartbeat
• Liver disease
• Liver or lung problems with the past use of amiodarone
• 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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication 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 medication more often than directed. Do not stop taking except on the advice of your care team.

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 care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have 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 medication?

Do not take this medication with any of the following:

• Arsenic trioxide
• Certain antibiotics like clarithromycin, erythromycin, pentamidine, telithromycin, troleandomycin
• Certain medications for depression like tricyclic antidepressants
• Certain medications for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for irregular heart beat like amiodarone, disopyramide, flecainide, ibutilide, quinidine, propafenone, sotalol
• Certain medications for malaria like chloroquine, halofantrine
• Cisapride
• Cyclosporine
• Droperidol
• Haloperidol
• Methadone
• Other medications that prolong the QT interval (cause an abnormal heart rhythm) like degarelix, encorafenib, entrectinib, eribulin, goserelin, lapatinib
• Pimozide
• Nefazodone
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Ritonavir
• Ziprasidone

This medication may also interact with the following:

• Certain medications for blood pressure, heart disease, or irregular heart beat like diltiazem, metoprolol, propranolol, verapamil
• Certain medications for cholesterol like atorvastatin, lovastatin, simvastatin
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin
• Dabigatran
• Digoxin
• Dofetilide
• Grapefruit juice
• Rifampin
• Sirolimus
• St. John's Wort
• Tacrolimus
• Warfarin

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 medication?

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

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication 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 medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Lung injury—shortness of breath or trouble breathing, cough, spitting up blood, chest pain, fever

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Diarrhea
• Nausea
• Stomach pain
• Vomiting

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 medication?

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 medication 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.