JANTOVEN - warfarin sodium tablet 
REMEDYREPACK INC.

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SPL MEDGUIDE

MEDICATION GUIDE

JANTOVEN® (JAN-to-ven) Tablets
(Warfarin Sodium Tablets, USP)

Read this Medication Guide before you start taking JANTOVEN (Warfarin Sodium Tablets, USP) 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 JANTOVEN when you start taking it and at regular checkups.

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

JANTOVEN can cause bleeding which can be serious and sometimes lead to death. This is because JANTOVEN 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 JANTOVEN and affect the dose you need or increase JANTOVEN 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 JANTOVEN.

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

What is JANTOVEN?

JANTOVEN 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 JANTOVEN is safe and effective in children.

Who should not take JANTOVEN?

Do not take JANTOVEN if:

What should I tell my healthcare provider before taking JANTOVEN?

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

Tell all of your healthcare providers and dentists that you are taking JANTOVEN. They should talk to the healthcare provider who prescribed JANTOVEN for you before you have any surgery or dental procedure. Your JANTOVEN 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 JANTOVEN works. Certain medicines may increase your risk of bleeding. See "What is the most important information I should know about JANTOVEN?"

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 JANTOVEN?

What should I avoid while taking JANTOVEN?

What are the possible side effects of JANTOVEN?

JANTOVEN 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 JANTOVEN. 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. You may also report side effects to Upsher-Smith Laboratories at 1-888-650-3789.

How should I store JANTOVEN?

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

General information about JANTOVEN.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use JANTOVEN for a condition for which it was not prescribed. Do not give JANTOVEN 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 JANTOVEN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about JANTOVEN that is written for healthcare professionals.

If you would like more information, go to www.jantoven.com or www.upsher-smith.com or call our professional services department toll free at 1-800-654-2299.

What are the ingredients in JANTOVEN?

Active ingredient: Warfarin Sodium, USP

Inactive ingredients: Lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch (corn). The following tablets contain:

1 mg: FD&C Red #40 Aluminum Lake
2 mg: FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake
2½ mg: D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake
3 mg: Brown #75 Synthetic Brown Iron Oxide
4 mg: FD&C Blue #1 Aluminum Lake
5 mg: FD&C Yellow #6 Aluminum Lake
6 mg: Yellow #10 Synthetic Yellow Iron Oxide, Black #85 Synthetic Black Iron Oxide and FD&C Blue #1 Aluminum Lake
7½ mg: D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake

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

JANTOVEN is manufactured by:
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447

**The brands listed (other than JANTOVEN®) are registered trademarks of their respective owners and are not trademarks of Upsher-Smith Laboratories, Inc.

Revised 1011

 

Revised: 03/2013
 
REMEDYREPACK INC.