MEDICATION GUIDE

AMIODARONE HYDROCHLORIDE (A-mee-OH-da-rone HYE-droe-KLOR-ide) 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:

•

lung damage

•

liver damage

•

worse heartbeat problems

•

thyroid problems

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

•

shortness of breath, wheezing, or any other trouble breathing; coughing, chest pain, or spitting up of blood

•

nausea or vomiting; passing brown or dark-colored urine; feel more tired than usual; your skin and whites of your eyes get yellow; or have stomach pain

•

heart pounding, skipping a beat, beating very fast or very slowly; feel light-headed or faint

•

weakness, weight loss or weight gain, heat or cold intolerance, hair thinning, sweating, changes in your menses, swelling of your neck (goiter), nervousness, irritability, restlessness, decreased concentration, depression in the elderly, or tremor.

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:

•

have certain heart conditions (heart block, very slow heart rate, or slow heart rate with dizziness or lightheadedness)

•

have an allergy to amiodarone, iodine, or any of the other ingredients in amiodarone hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in amiodarone hydrochloride tablets.

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

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

•

have lung or breathing problems

•

have liver problems

•

have or had thyroid problems

•

have blood pressure problems

•

are pregnant or planning to become pregnant. Amiodarone hydrochloride tablets can harm your unborn baby. Amiodarone can stay in your body for months after treatment is stopped. Therefore, talk with your doctor before you plan to get pregnant.

•

are breastfeeding. Amiodarone passes into your milk and can harm your baby. You should not breast feed while taking amiodarone hydrochloride tablets. Also, amiodarone can stay in your body for months after treatment is stopped.

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:

•

antibiotic medicines used to treat infections

•

depression medicines

•

blood thinner medicines

•

HIV or AIDS medicines

•

cimetidine (Tagamet®), a medicine for stomach ulcers or indigestion

•

loratadine (for example: Claritin®, Alavert®), a medicine for allergy symptoms

•

seizure medicines

•

diabetes medicines

•

cyclosporine, an immunosuppressive medicine

•

dextromethorphan, a cough medicine

•

medicines for your heart, circulation, or blood pressure

•

water pills (diuretics)

•

high cholesterol or bile medicines

•

narcotic pain medicines

•

St. John’s Wort

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?

•

Take amiodarone hydrochloride tablets exactly as prescribed by your doctor.

•

The dose of amiodarone hydrochloride tablets you take has been specially chosen for you by your doctor and may change during treatment. Keep taking your medicine until your doctor tells you to stop. Do not stop taking it because you feel better. Your condition may get worse. Talk with your doctor if you have side effects.

•

Your doctor will tell you to take your dose of amiodarone hydrochloride tablets with or without meals. Make sure you take amiodarone hydrochloride tablets the same way each time.

•

Do not drink grapefruit juice during treatment with amiodarone hydrochloride tablets. Grapefruit juice affects how amiodarone is absorbed in the stomach.

•

Taking too many amiodarone hydrochloride tablets can be dangerous. If you take too many amiodarone hydrochloride tablets, call your doctor or go to the nearest hospital right away. You may need medical care right away.

•

If you miss a dose, do not take a double dose to make up for the dose you missed. Continue with your next regularly scheduled dose.

What should I avoid while taking amiodarone hydrochloride tablets?

•

Do not drink grapefruit juice during treatment with amiodarone hydrochloride tablets. Grapefruit juice affects how amiodarone is absorbed in the stomach.

•

Avoid exposing your skin to the sun or sun lamps. Amiodarone hydrochloride tablets can cause a photosensitive reaction. Wear sun-block cream or protective clothing when out in the sun.

•

Avoid pregnancy during treatment with amiodarone hydrochloride tablets. Amiodarone hydrochloride tablets can harm your unborn baby.

•

Do not breastfeed while taking amiodarone hydrochloride tablets. Amiodarone passes into your milk and can harm your baby.

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

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

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:

•

vision problems that may lead to permanent blindness. You should have regular eye exams before and during treatment with amiodarone hydrochloride tablets. Call your doctor if you have blurred vision, see halos, or your eyes become sensitive to light.

•

nerve problems. Amiodarone hydrochloride tablets can cause a feeling of “pins and needles” or numbness in the hands, legs, or feet, muscle weakness, uncontrolled movements, poor coordination, and trouble walking.

•

thyroid problems. Amiodarone hydrochloride tablets can cause thyroid problems, including low thyroid function or overactive thyroid function. Your doctor may arrange regular blood tests to check your thyroid function during treatment with amiodarone hydrochloride tablets. Call your doctor if you have weakness, weight loss or weight gain, heat or cold intolerance, hair thinning, sweating, changes in your menses, swelling of your neck (goiter), nervousness, irritability, restlessness, decreased concentration, depression in the elderly, or tremor.

•

skin problems. Amiodarone hydrochloride tablets can cause your skin to be more sensitive to the sun or to turn a bluish-gray color. In most patients, skin color slowly returns to normal after stopping amiodarone hydrochloride tablets. In some patients, skin color does not return to normal.

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.

How should I store amiodarone hydrochloride tablets?

•

Store amiodarone hydrochloride tablets at room temperature. Protect from light. Keep amiodarone hydrochloride tablets in a tightly closed container.

•

Safely dispose of amiodarone hydrochloride tablets that are out-of-date or no longer needed.

•

Keep amiodarone hydrochloride tablets and all medicines out of the reach of children.

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 they were not prescribed. Do not share amiodarone hydrochloride tablets with other people, even if they have the same symptoms that you have. They 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.

What are the ingredients in amiodarone hydrochloride tablets?

Active Ingredient: amiodarone hydrochloride

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

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

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

Manufactured for:
Teva Pharmaceutials USA, Inc.
North Wales, PA 19454

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

Repackaged By:

Cardinal Health

Zanesville, OH 43701

L36148801115

S-12093 R1
7/15