AMIODARONE HYDROCHLORIDE- amiodarone hydrochloride tablet 
Mylan Institutional Inc.

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MEDICATION GUIDE

AMIODARONE HYDROCHLORIDE TABLETS

Rx only

Read the Medication Guide that comes with amiodarone hydrochloride tablets before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information I should know about amiodarone hydrochloride tablets?

Amiodarone hydrochloride tablets can cause serious side effects that can lead to death including:

Call your doctor or get medical help right away if you have any symptoms such as the following:

Because of these possible side effects, amiodarone hydrochloride tablets should only be used in adults with life-threatening heartbeat problems called ventricular arrhythmias, for which other treatments did not work or were not tolerated.

Amiodarone hydrochloride tablets can cause other serious side effects. See “What are the possible or reasonably likely side effects of amiodarone hydrochloride tablets?” for more information.

If you get serious side effects during treatment with amiodarone hydrochloride tablets you may need to stop amiodarone hydrochloride tablets, have your dose changed, or get medical treatment. Talk with your doctor before you stop taking amiodarone hydrochloride tablets.

You may still have side effects after stopping amiodarone hydrochloride tablets because the medicine stays in your body months after treatment is stopped.

Tell all your healthcare providers that you take or took amiodarone hydrochloride tablets. This information is very important for other medical treatments or surgeries you may have.

What are amiodarone hydrochloride tablets?

Amiodarone hydrochloride tablets are a medicine used in adults to treat life-threatening heartbeat problems called ventricular arrhythmias, for which other treatment did not work or was not tolerated. Amiodarone hydrochloride tablets have not been shown to help people with life-threatening heartbeat problems live longer. Treatment with amiodarone hydrochloride tablets should be started in a hospital to monitor your condition. You should have regular check-ups, blood tests, chest x-rays, and eye exams before and during treatment with amiodarone hydrochloride tablets to check for serious side effects.

Amiodarone hydrochloride tablets have not been studied in children.

Who should not take amiodarone hydrochloride tablets?

Do not take amiodarone hydrochloride tablets if you:

What should I tell my doctor before starting amiodarone hydrochloride tablets?

Tell your doctor about all of your medical conditions including if you:

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Amiodarone hydrochloride tablets and certain other medicines can interact with each other causing serious side effects. Sometimes the dose of amiodarone hydrochloride tablets or other medicines must be changed when they are used together. Especially, tell your doctor if you are taking:

Know the medicines you take. Keep a list of them with you at all times and show it to your doctor and pharmacist each time you get a new medicine. Do not take any new medicines while you are taking amiodarone hydrochloride tablets unless you have talked with your doctor.

How should I take amiodarone hydrochloride tablets?

What should I avoid while taking amiodarone hydrochloride tablets?

What are the possible or reasonably likely side effects of amiodarone hydrochloride tablets?

Amiodarone hydrochloride tablets can cause serious side effects that lead to death including lung damage, liver damage, worse heartbeat problems, and thyroid problems. See “What is the most important information I should know about amiodarone hydrochloride tablets?”

Some other serious side effects of amiodarone hydrochloride tablets include:

Other side effects of amiodarone hydrochloride tablets include nausea, vomiting, constipation, and loss of appetite.

Call your doctor about any side effect that bothers you.

These are not all the side effects with amiodarone hydrochloride tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store amiodarone hydrochloride tablets?

General information about amiodarone hydrochloride tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use amiodarone hydrochloride tablets for a condition for which it was not prescribed. Do not share amiodarone hydrochloride tablets with other people, even if they have the same symptoms that you have. It may harm them.

If you have any questions or concerns about amiodarone hydrochloride tablets, ask your doctor or healthcare provider. This Medication Guide summarizes the most important information about amiodarone hydrochloride tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about amiodarone hydrochloride tablets that was written for healthcare professionals.

This product’s Medication Guide may have been updated. For current Medication Guide, please call 1-888-838-2872, MEDICAL AFFAIRS.

What are the ingredients in amiodarone hydrochloride tablets?

Active Ingredient: amiodarone hydrochloride

Inactive Ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, povidone, corn starch, and FD&C Red 40.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured in India by:
Emcure Pharmaceuticals Ltd.
Hinjwadi, Pune, India

Manufactured for:
Teva Pharmaceuticals USA
Sellersville, PA 18960

Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.

S-11356
12/12

Revised: 12/2012
 
Mylan Institutional Inc.