PACERONE- amiodarone hydrochloride tablet 
Upsher-Smith Laboratories, Inc.

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Medication Guide
Pacerone® (PĀS-ər-ōn) Tablets
(Amiodarone HCl)

Read the Medication Guide that comes with Pacerone® 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 Pacerone® Tablets?

Pacerone® 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 of the following symptoms during treatment with Pacerone® Tablets:

Pacerone® Tablets should only be used in people with life-threatening heartbeat problems called ventricular arrhythmias, for which other treatments did not work or were not tolerated.

Pacerone® Tablets can cause other serious side effects. See "What are the possible side effects of Pacerone® Tablets?" If you get serious side effects during treatment you may need to stop Pacerone® Tablets, have your dose changed, or get medical treatment. Talk with your doctor before you stop taking Pacerone® Tablets.

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

Tell all your healthcare providers that you take or took Pacerone® Tablets.

What are Pacerone® Tablets?

Amiodarone is a prescription medicine used to treat life-threatening heartbeat problems called ventricular arrhythmias, for which other treatment did not work or was not tolerated. Pacerone® Tablets have not been shown to help people with life-threatening heartbeat problems live longer. Pacerone® 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 Pacerone® Tablets to check for serious side effects.

It is not known if Pacerone® Tablets is safe and effective in children.

Who should not take Pacerone® Tablets?

Do not take Pacerone® Tablets if you:

What should I tell my doctor before taking Pacerone® Tablets?

Before you take Pacerone® Tablets tell your doctor about all of your medical conditions including if you:

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take Pacerone® Tablets?

What should I avoid while taking Pacerone® Tablets?

What are the possible side effects of Pacerone® Tablets?

See "What is the most important information I should know about Pacerone® Tablets"?

The most common side effects of Pacerone® Tablets include:

  • nausea
  • vomiting
  • constipation
  • loss of appetite

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Pacerone® 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 Pacerone® Tablets?

Keep Pacerone® Tablets and all medicines out of the reach of children.

General information about the safe and effective use of Pacerone® Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Pacerone® Tablets for a condition for which it was not prescribed. Do not give Pacerone® Tablets to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Pacerone® Tablets that was written for health professionals.

This Medication Guide may have been revised after this copy was produced. For more information and the most current Medication Guide, please visit www.pacerone.com or www.upsher-smith.com or call 1-888-650-3789.

What are the ingredients in Pacerone® Tablets?

Active Ingredient: amiodarone HCl, 100 mg and 200 mg

Inactive Ingredients: lactose monohydrate, magnesium stearate, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, FD&C Red 40 (for 200 mg only) and FD&C Yellow 6.

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

For Medication Guides, please visit www.upsher-smith.com or call 1-888-650-3789.

Rx only

Manufactured by
UPSHER-SMITH LABORATORIES, INC.
Maple Grove, MN 55369

Revised 0915

Revised: 8/2016
Upsher-Smith Laboratories, Inc.