What is the most important information I should know about Cordarone? Cordarone 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 Cordarone:
- 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.
Cordarone 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.
Cordarone can cause other serious side effects. See "What are the possible side effects of Cordarone?" If you get serious side effects during treatment you may need to stop Cordarone, have your dose changed, or get medical treatment. Talk with your doctor before you stop taking Cordarone.
You may still have side effects after stopping Cordarone Tablets because the medicine stays in your body months after treatment is stopped.
Tell all your healthcare providers that you take or took Cordarone Tablets.
What is Cordarone?
Cordarone 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. Cordarone has not been shown to help people with life-threatening heartbeat problems live longer. Cordarone 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 Cordarone to check for serious side effects.
It is not known if Cordarone is safe and effective in children.
Who should not take Cordarone?
Do not take Cordarone 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 Cordarone. See the end of this Medication Guide for a complete list of ingredients in Cordarone.
What should I tell my doctor before taking Cordarone
Before you take Cordarone 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. Cordarone can harm your unborn baby. Cordarone 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. Cordarone 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 Cordarone. Also, Cordarone 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. Cordarone 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 Cordarone.
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 Cordarone?
- Take Cordarone exactly as your doctor tells you to take it.
- Your doctor will tell you how much Cordarone to take and when to take it. Cordarone can be taken with or without food. Make sure you take Cordarone the same way each time.
- If you take too much Cordarone, 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. Continue with your next regularly scheduled dose.
What should I avoid while taking Cordarone?
- Do not drink grapefruit juice during treatment with Cordarone. Grapefruit juice affects how Cordarone is absorbed in the stomach.
Avoid sunlight. Cordarone 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 you doctor if you get sunburn.
What are the possible side effects of Cordarone?
See "What is the most important information I should know about Cordarone?"
- vision problems that may lead to permanent blindness. You should have regular eye exams before and during treatment with Cordarone. 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. Cordarone 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. Cordarone 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 Cordarone. In some people, skin color does not return to normal.
The most common side effects of Cordarone include:
- 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 Cordarone. 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 Cordarone Tablets?
- Store Cordarone at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep Cordarone Tablets in a tightly closed container, and keep Cordarone out of the light.
Keep Cordarone and all medicines out of the reach of children.
General information about the safe and effective use of Cordarone
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Cordarone for a condition for which it was not prescribed. Do not give Cordarone 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 Cordarone that was written for health professionals.
For more information call 1-800-XXX-XXXX or go to www.pfizer.com.
What are the ingredients in Cordarone Tablets?
Active Ingredient: amiodarone HCl
Inactive Ingredients: colloidal silicon dioxide, lactose, magnesium stearate, povidone, starch, and FD&C Red 40.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Cordarone is a registered trademark of Sanofi-Synthelabo.
©2004, Wyeth Pharmaceuticals. All rights reserved.
Manufactured by Sanofi Winthrop Industrie
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