AMIODARONE HCL- amiodarone hydrochloride tablet
Mayne Pharma Inc.
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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 of the following symptoms during treatment with Amiodarone HCl Tablets:
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:
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:
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?
What should I avoid while taking Amiodarone HCl Tablets?
What are the possible side effects of Amiodarone HCl Tablets?
See “What is the most important information I should know about Amiodarone HCl Tablets?”
The most common side effects of Amiodarone HCl Tablets include:
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?
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