MEDICATION GUIDE

Amiodarone HCl Tablets
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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:

• lung problems 
  
• liver problems
  
• worsening heartbeat problems
  
• thyroid problems

Call your doctor or get medical help right away if you have any of the following symptoms during treatment with Amiodarone HCl Tablets:

• shortness of breath, wheezing, or any other trouble breathing; coughing, chest pain, or spitting up of blood
  
• nausea or vomiting, brown or dark-colored urine, feel more tired than usual, yellowing of your skin or the whites of your eyes (jaundice), or right upper stomach pain
  
• heart pounding, skipping a beat, beating fast or 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.

Amiodarone HCl 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.

Amiodarone HCl Tablets can cause other serious side effects. See “What are the possible side effects of Amiodarone HCl Tablets?”  

If you get serious side effects during treatment 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.

What are Amiodarone HCl 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. Amiodarone HCl Tablets have not been shown to help people with life-threatening heartbeat problems live longer. 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.

It is not known if Amiodarone HCl Tablets is safe and effective in children.

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

• have a certain heart condition called heart block with or without a slow heart rate
  
• have a slow heart rate with dizziness or lightheadedness, and you do not have an implanted pacemaker
  
• are allergic to amiodarone, iodine, or any of the other ingredients in Amiodarone HCl Tablets. See the end of this Medication Guide for a complete list of ingredients in Amiodarone HCl Tablets.

What should I tell my doctor before taking Amiodarone HCl Tablets?
Before you take Amiodarone HCl 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 plan to become pregnant. Amiodarone can harm your unborn baby. Amiodarone can stay in your body for months after treatment is stopped. Talk with your doctor before you plan to get pregnant.   
  
• are breastfeeding or plan to breastfeed. Amiodarone can pass into your breast milk and can harm your baby. Talk to your doctor about the best way to feed your baby. You should not breast feed while taking Amiodarone. 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 over-the-counter medicines, vitamins and herbal supplements. Amiodarone HCl Tablets and certain other medicines can affect (interact) with each other and cause serious side effects. You can ask your pharmacist for a list of medicines that interact with Amiodarone HCl Tablets.

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 Amiodarone HCl Tablets?

• Take Amiodarone HCl Tablets exactly as your doctor tells you to take it.
  
• Your doctor will tell you how many Amiodarone HCl Tablets to take and when to take it.
  
• Amiodarone HCl Tablets can be taken with or without food. Make sure you take Amiodarone HCl Tablets the same way each time.
  
• If you take too many Amiodarone HCl Tablets, call your doctor or go to the nearest hospital emergency room right away.
  
• If you miss a dose, wait and take your next dose at your regular time. Do not take two doses at the same time. Continue with your next regularly scheduled dose.

What should I avoid while taking Amiodarone HCl Tablets?

• Do not drink grapefruit juice during treatment with Amiodarone HCl Tablets. Grapefruit juice affects how Amiodarone is absorbed in the stomach.
  
• Avoid sunlight. Amiodarone can make your skin sensitive to sun and the light from sunlamps and tanning beds. You could get severe sunburn. Use sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn.

What are the possible side effects of Amiodarone HCl Tablets?

See “What is the most important information I should know about Amiodarone HCl Tablets?”

• vision problems that may lead to permanent blindness. You should have regular eye exams before and during treatment with Amiodarone HCl Tablets. Call your doctor if you have blurred vision, see halos, or your eyes become sensitive to light. Tell your doctor if you plan to have laser eye surgery.
  
• nerve problems. Amiodarone HCl 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.
  
• skin problems. Amiodarone HCl Tablets can cause your skin to be more sensitive to the sun or turn a bluish-gray color. In most people, skin color slowly returns to normal after stopping Amiodarone HCl Tablets. In some people, skin color does not return to normal.

The most common side effects of Amiodarone HCl 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 Amiodarone HCl 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 HCl Tablets?

• Store Amiodarone HCl Tablets at room temperature between 68°F to 77°F (20°C to 25°C).
  
• Keep Amiodarone HCl Tablets in a tightly closed container, and keep Amiodarone HCl Tablets out of the light.
  
• Keep Amiodarone HCl Tablets and all medicines out of the reach of children.

General information about the safe and effective use of 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 give Amiodarone HCl 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 Amiodarone HCl Tablets that was written for health 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.maynepharma.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

Distributed by:
MAYNE PHARMA 
GREENVILLE, NC 27834

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

Issued: October2017                                     P069-08