AMIODARONE HCL- amiodarone hydrochloride tablet 
Libertas Pharma, Inc.

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MEDICATION GUIDE

Amiodarone HCl Tablets
a MEE oh da rone hye droe KLOR ide Tablets
Rx only

Read the Medication Guide that comes with Amiodarone HCl 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 HCl Tablets? Amiodarone HCl 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 HCl 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 HCl Tablets can cause other serious side effects. See “What are the possible or reasonably likely side effects of Amiodarone HCl Tablets?” for more information.

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

You may still have side effects after stopping Amiodarone HCl Tablets because the medicine stays in your body months after treatment is stopped.

Tell all your healthcare providers that you take or took Amiodarone HCl Tablets. This information is very important for other medical treatments or surgeries you may have.

What are Amiodarone HCl Tablets?
Amiodarone HCl is 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 HCl Tablets have not been shown to help people with life-threatening heartbeat problems live longer. Treatment with Amiodarone HCl 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 HCl Tablets to check for serious side effects.

Amiodarone HCl Tablets have not been studied in children.

Who should not take Amiodarone HCl Tablets?
Do not take Amiodarone HCl Tablets if you:

What should I tell my doctor before starting Amiodarone HCl 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 HCl Tablets and certain other medicines can interact with each other causing serious side effects. Sometimes the dose of Amiodarone HCl 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 HCl Tablets unless you have talked with your doctor.

How should I take Amiodarone HCl Tablets?

     

What should I avoid while taking Amiodarone HCl Tablets?

What are the possible or reasonably likely side effects of Amiodarone HCl Tablets?
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Amiodarone HCl 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 HCl Tablets?”

Some other serious side effects of Amiodarone HCl Tablets include:

     

Other side effects of Amiodarone HCl 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 HCl Tablets. For more information, ask your doctor or pharmacist.

How should I store Amiodarone HCl Tablets?

General information about Amiodarone HCl Tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Amiodarone HCl Tablets for a condition for which it was not prescribed. Do not share Amiodarone HCl 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 HCl Tablets, ask your doctor or healthcare provider. This Medication Guide summarizes the most important information about Amiodarone HCl Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Amiodarone HCl Tablets that was written for healthcare professionals.

This product’s Medication Guide may have been revised after this copy was produced. For more information about the current Medication Guide, please visit www.libertaspharma.com.

What are the ingredients in Amiodarone HCl Tablets?

Active Ingredient: Amiodarone HCl

Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, povidone, sodium starch glycolate, and pigment D&C yellow 10 aluminum lake. 

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

Rx only

Tagamet is a registered trademark of SmithKline Beecham Pharmaceuticals Co.

Claritin is a registered trademark of Schering Corporation.

Alavert is a registered trademark of Wyeth.

Manufactured for:
LIBERTAS PHARMA, INC.
LAWRENCEVILLE, GA 30043

Manufactured by:
MURTY PHARMACEUTICALS, INC.
LEXINGTON, KY 40509

Issued: May 2014                                                 P069-04

Revised: 09/2014
 
Libertas Pharma, Inc.