COUMADIN - warfarin sodium tablet 
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SPL MEDGUIDE

MEDICATION GUIDE


COUMADIN® (COU-ma-din)
(warfarin sodium)

Read this Medication Guide before you start taking COUMADIN (warfarin sodium) and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about COUMADIN when you start taking it and at regular checkups.

What is the most important information I should know about COUMADIN?

COUMADIN can cause bleeding which can be serious and sometimes lead to death. This is because COUMADIN is a blood thinner medicine that lowers the chance of blood clots forming in your body.

Tell your healthcare provider if you take any of these medicines. Ask your healthcare provider if you are not sure if your medicine is one listed above.

Many other medicines can interact with COUMADIN and affect the dose you need or increase COUMADIN side effects. Do not change or stop any of your medicines or start any new medicines before you talk to your healthcare provider.

Do not take other medicines that contain warfarin sodium while taking COUMADIN.

See "What are the possible side effects of COUMADIN?" for more information about side effects.

What is COUMADIN?

COUMADIN is prescription medicine used to treat blood clots and to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions if they form in the legs or lungs.

It is not known if COUMADIN is safe and effective in children.

Who should not take COUMADIN?

Do not take COUMADIN if:

What should I tell my healthcare provider before taking COUMADIN?

Before you take COUMADIN, tell your healthcare provider if you:

Tell all of your healthcare providers and dentists that you are taking COUMADIN. They should talk to the healthcare provider who prescribed COUMADIN for you before you have any surgery or dental procedure. Your COUMADIN may need to be stopped for a short time or you may need your dose adjusted.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way COUMADIN works. Certain medicines may increase your risk of bleeding. See "What is the most important information I should know about COUMADIN?"

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

How should I take COUMADIN?

What should I avoid while taking COUMADIN?

What are the possible side effects of COUMADIN?

COUMADIN may cause serious side effects including:

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

These are not all of the side effects of COUMADIN. For more information, ask your healthcare provider 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 COUMADIN?

Keep COUMADIN and all medicines out of the reach of children.

General Information about COUMADIN.

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

This Medication Guide summarizes the most important information about COUMADIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about COUMADIN that is written for healthcare professionals.

If you would like more information, go to www.coumadin.com or call 1-800-321-1335.

What are the ingredients in COUMADIN?

Active ingredient: Warfarin Sodium

Inactive ingredients: Lactose, starch, and magnesium stearate. The following tablets contain:

1 mg: D&C Red No. 6 Barium Lake
2 mg: FD&C Blue No. 2 Aluminum Lake and
FD&C Red No. 40 Aluminum Lake
2-1/2 mg: D&C Yellow No. 10 Aluminum Lake and
FD&C Blue No. 1 Aluminum Lake
3 mg: FD&C Yellow No. 6 Aluminum Lake,
FD&C Blue No. 2 Aluminum Lake, and
FD&C Red No. 40 Aluminum Lake
4 mg: FD&C Blue No. 1 Aluminum Lake
5 mg: FD&C Yellow No. 6 Aluminum Lake
6 mg: FD&C Yellow No. 6 Aluminum Lake and
FD&C Blue No. 1 Aluminum Lake
7-1/2 mg: D&C Yellow No. 10 Aluminum Lake and
FD&C Yellow No. 6 Aluminum Lake

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



COUMADIN is distributed by:
Bristol-Myers Squibb Company
Princeton, New Jersey 08543 USA

COUMADIN® is a registered trademark of Bristol-Myers Squibb Pharma Company.

**The brands listed (other than COUMADIN®) are registered trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company.


1258498A3 / 1215385A4 / 1205734A4 / 1205736A4
Rev October 2011

 

Revised: 02/2013
 
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