Indication and Important Safety Information for MULTAQ^® (dronedarone)

Indication

MULTAQ is a prescription medicine used to lower the chance you would need to go into the hospital for an irregular heart rhythm called atrial fibrillation (AFib).

It is meant for people who have had AFib in the past but are now in normal heart rhythm.

Important Safety Information

What is the most important safety information I should know about MULTAQ?
Do not take MULTAQ if you have symptoms of heart failure that recently worsened and you were hospitalized, or if you have severe heart failure. MULTAQ doubles your risk of dying if you have these conditions.

Do not take MULTAQ if you have a type of atrial fibrillation (AFib) called permanent AFib. You should not take MULTAQ if you are in AFib and your doctor is not planning to change you back into normal rhythm. People with permanent AFib who take MULTAQ have a higher risk of death, stroke, and needing to be treated in a hospital for heart failure.

MULTAQ may cause liver problems, including life-threatening liver failure. Call your doctor right away if you are taking MULTAQ and develop any of these signs and symptoms of liver problems: loss of appetite; nausea; vomiting; fever; feeling unwell; unusual tiredness; itching; yellowing of the skin or the whites of the eyes; unusual darkening of the urine; right upper stomach area pain or discomfort.

When should I call the doctor?
Call your doctor right away if you're taking MULTAQ and have any signs and symptoms of heart failure. These may include shortness of breath or wheezing at rest; wheezing, chest tightness, or coughing up frothy sputum at rest, nighttime, or after minor exercise; trouble sleeping or waking up at night or using more pillows to prop yourself at night because of breathing problems; weight gain; or foot or leg swelling.

Call your doctor right away if you notice that your heartbeat or pulse is irregular. This is a sign that you are in AFib.

Call your doctor if you develop shortness of breath or a dry cough during treatment with MULTAQ.

Call your doctor if you experience an allergic reaction, such as itchy rash, low blood pressure, or rapid swelling of the throat or skin, especially around the lips or eyes.

Who else shouldn't take MULTAQ?
You should not take MULTAQ if you are allergic to dronedarone or any of the other ingredients in MULTAQ.

You should not take MULTAQ if you have severe liver problems or if you had liver or lung problems after using amiodarone.

You should not take MULTAQ if you have a certain type of heart problem called heart block, and you do not have an implanted pacemaker.

You should not take MULTAQ if you are breastfeeding, pregnant, or plan to become pregnant as it is not known if it may pass to or harm your baby. Women who may become pregnant should use effective birth control while taking MULTAQ. Talk to your doctor about the best birth control methods for you.

Are there any medications I should avoid while taking MULTAQ?
MULTAQ can interact with certain medications. Do not use the following medications with MULTAQ:

• Nefazodone
• Voriconazole
• Ritonavir
• Telithromycin

• Ketoconazole
• Clarithromycin
• Itraconazole
• Cyclosporine

Are there other medicines that would be harmful when taken with MULTAQ?
The following medicines can lead to a dangerous abnormal heart rhythm if taken with MULTAQ:

• Phenothiazines
• Tricyclic antidepressants
• Certain antibiotics

• Certain medicines used to treat an abnormal heart rhythm or fast heartbeat

What are possible serious side effects from taking MULTAQ?
MULTAQ may cause serious side effects including slowed heartbeat, inflammation of the lungs (including scarring and thickening), low potassium and magnesium levels in your blood, and changes in kidney function blood tests.

What are the most common side effects?
The most common side effects when taking MULTAQ include stomach problems such as diarrhea, nausea, vomiting, stomach area pain, and indigestion; feeling tired and weak; skin problems such as redness, rash, and itching. Tell your doctor about any side effect that bothers you or that does not go away.

Are there other things I should avoid while taking MULTAQ?
Do not drink grapefruit juice while taking MULTAQ, as this can increase the likelihood that you will have a side effect of MULTAQ.

What else should I tell my doctor?
Tell your doctor about all medications, vitamins, and herbal remedies (including St. John's wort) you take to help avoid serious drug interactions.

Is it OK to take a diuretic ("water pill") while on MULTAQ?
Your potassium levels should be within the normal range prior to and while taking MULTAQ. Tell your doctor about any diuretic medications ("water pills") you are taking as some can lower the level of potassium or magnesium in your blood.

Will I need any tests while I'm on MULTAQ?
Your doctor will monitor your heart rhythm regularly to make sure your heartbeat keeps a normal rhythm. Your doctor may perform certain tests, such as heart exams and blood tests, while you're taking MULTAQ.

Click here for full Prescribing Information, including boxed WARNING

Click here for the MULTAQ Medication Guide (English)

Sign up for the MULTAQ Savings Card to receive savings on your next prescription

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Remember, your doctor is the single best source of information regarding your health. Please consult your doctor if you have any questions about your health or your medicine.

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