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Medication Guide

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

Read this Medication Guide before you start taking Jantoven® Tablets (warfarin sodium tablets) (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. Yo u and your healthcare provider should talk about Jantoven® Tablets (warfarin sodium tablets) when you start taking it and at regular checkups.

What is the most important information I should know about Jantoven (warfarin sodium tablets) ® Tablets?

• Take your Jantoven® Tablets (warfarin sodium tablets) exactly as prescribed to lower the chance of blood clots forming in your body. (See "What are Jantoven® Tablets (warfarin sodium tablets) ?").
• Jantoven® Tablets (warfarin sodium tablets) are very important for your health, but it can cause serious and life-threatening bleeding problems. To benefit from Jantoven (warfarin sodium tablets) ® Tablets and also lower your chance for bleeding problems, you must:
  • Get your regular blood test to check for your response to Jantoven (warfarin sodium tablets) ® Tablets. This blood test is called a PT/INR test. The PT/INR test checks to see how fast your blood clots. Your healthcare provider will decide what PT/INR numbers are best for you. Your dose of Jantoven (warfarin sodium tablets) ® Tablets will be adjusted to keep your PT/INR in a target range for you.
  • Call your healthcare provider right away if you get any of the following signs or symptoms of bleeding problems:
  • pain, swelling or discomfort
  • headaches, dizziness, or weakness
  • unusual bruising (bruises that develop without known cause or grow in size)
  • nose bleeds
  • bleeding gums
  • bleeding from cuts takes a long time to stop
  • menstrual bleeding or vaginal bleeding that is heavier than normal
  • pink or brown urine
  • red or black stools
  • coughing up blood
  • vomiting blood or material that looks like coffee grounds
• Many other medicines, including prescription and non- prescription medicines, vitamins and herbal supplements can interact with Jantoven® Tablets (warfarin sodium tablets) and:
  •  affect the dose you need, or
  • increase Jantoven® Tablets (warfarin sodium tablets) side effects.

Tell your healthcare provider about all the medicines you take. Do not stop medicines or take anything new unless you have talked to your healthcare provider. Keep a list of your medicines with you at all times to show your healthcare provider and pharmacist.

• Do not take other medicines that contain warfarin. Warfarin is the active ingredient in Jantoven® Tablets (warfarin sodium tablets) .
• Some foods can interact with Jantoven® Tablets (warfarin sodium tablets) and affect your treatment and dose.
  • Eat a normal, balanced diet. Talk to your doctor before you make any diet changes. Do not eat large amounts of leafy green vegetables. Leafy green vegetables contain Vitamin K. Certain vegetable oils also contain large amounts of Vitamin K. Too much Vitamin K can lower the effect of Jantoven® Tablets (warfarin sodium tablets) .
  • Avoid drinking cranberry juice or eating cranberry products.
  • Avoid drinking alcohol.
• Always tell all of your healthcare providers that you take Jantoven (warfarin sodium tablets) ® Tablets.
• Wear or carry information that you take Jantoven® Tablets (warfarin sodium tablets) .

What are Jantoven® Tablets (warfarin sodium tablets) ?

Jantoven® Tablets (warfarin sodium tablets) are an anticoagulant medicine. They are used to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions such as blood clots in the legs or lungs.

Who should not take Jantoven® Tablets (warfarin sodium tablets) ?

Do not take Jantoven® Tablets (warfarin sodium tablets) if:

• your chance of having bleeding problems is higher than the possible benefit of treatment. Your healthcare provider will decide if Jantoven® Tablets (warfarin sodium tablets) are right for you. Talk to your healthcare provider about all of your health conditions.
• you are pregnant or plan to become pregnant. Jantoven® Tablets (warfarin sodium tablets) can cause death or birth defects to an unborn baby. Use effective birth control if you can get pregnant.
• you are allergic to warfarin or to anything else in Jantoven® Tablets (warfarin sodium tablets) .

What should I tell my healthcare provider before starting Jantoven (warfarin sodium tablets) ® Tablets?

Tell your healthcare provider about all of your health conditions, including if you:

• have bleeding problems
• fall often
• have liver or kidney problems
• have high blood pressure
• have a heart problem called congestive heart failure
• have diabetes
• drink alcohol or have problems with alcohol abuse. Alcohol can affect your Jantoven® Tablets (warfarin sodium tablets) dose and should be avoided.
• are pregnant or planning to become pregnant. See "Who should not take Jantoven® Tablets (warfarin sodium tablets) ?"
• are breastfeeding. Jantoven® Tablets (warfarin sodium tablets) may increase bleeding in your baby. Talk to your doctor about the best way to feed your baby. If you choose to breastfeed while taking Jantoven® Tablets (warfarin sodium tablets) , both you and your baby should be carefully monitored for bleeding problems.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. See "What is the most important information I should know about Jantoven (warfarin sodium tablets) ® Tablets?"

How should I take Jantoven® Tablets (warfarin sodium tablets) ?

• Take Jantoven® Tablets (warfarin sodium tablets) exactly as prescribed. Your healthcare provider will adjust your dose from time to time depending on your response to Jantoven® Tablets (warfarin sodium tablets) .
• You must have regular blood tests and visits with your healthcare provider to monitor your condition.
• Take Jantoven® Tablets (warfarin sodium tablets) at the same time every day. You can take Jantoven® Tablets (warfarin sodium tablets) either with food or on an empty stomach.
• If you miss a dose of Jantoven® Tablets (warfarin sodium tablets) , call your healthcare provider. Take the dose as soon as possible on the same day. Do not take a double dose of Jantoven® Tablets (warfarin sodium tablets) the next day to make up for a missed dose.
• Call your healthcare provider right away if you take too many Jantoven (warfarin sodium tablets) ® Tablets.
• Call your healthcare provider if you are sick with diarrhea, an infection, or have a fever.
• Tell your healthcare provider about any planned surgeries, medical or dental procedures. Your Jantoven® Tablets (warfarin sodium tablets) may have to be stopped for a short time or you may need your dose adjusted.
• Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you.

What should I avoid while taking Jantoven® Tablets (warfarin sodium tablets) ?

• Do not start, stop, or change any medicine without talking with your healthcare provider.
• Do not make changes in your diet, such as eating large amounts of green, leafy vegetables.
• Do not change your weight by dieting, without first checking with your healthcare provider.
• Avoid drinking alcohol.
• Do not do any activity or sport that may cause a serious injury.

What are the possible side effects of Jantoven® Tablets (warfarin sodium tablets) ?

• Jantoven® Tablets (warfarin sodium tablets) are very important for your health, but it can cause serious and life- threatening bleeding problems. See "What is the most important information I should know about Jantoven® Tablets (warfarin sodium tablets) ?"
• Serious side effects of Jantoven® Tablets (warfarin sodium tablets) also include:
• death of skin tissue (skin necrosis or gangrene). This can happen soon after starting Jantoven® Tablets (warfarin sodium tablets) . It happens because blood clots form and block blood flow to an area of your body. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body. You may need medical care right away to prevent death or loss (amputation) of your affected body part.
• "purple toes syndrome." Call your healthcare provider right away if you have pain in your toes and they look purple in color or dark in color.

Other side effects with Jantoven® Tablets (warfarin sodium tablets) include allergic reactions, liver problems, low blood pressure, swelling, low red blood cells, paleness, fever, and rash. Call your healthcare provider if you have any side effect that bothers you.

These are not all of the side effects of Jantoven® Tablets (warfarin sodium tablets) . For more information, ask your healthcare provider or pharmacist.

How should I store Jantoven® Tablets (warfarin sodium tablets) ?

• Store at 20-25°C (68-77°F). Excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.
• Keep Jantoven® Tablets (warfarin sodium tablets) and all medicines out of the reach of children.

General Information about Jantoven® Tablets (warfarin sodium tablets)

Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide. Do not use Jantoven® Tablets (warfarin sodium tablets) for a condition for which it was not prescribed. Do not give Jantoven® Tablets (warfarin sodium tablets) to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about Jantoven® Tablets (warfarin sodium tablets) . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Jantoven® Tablets (warfarin sodium tablets) that was written for healthcare professionals. This Medication Guide may have been revised after this copy was produced. For more information and the most current Medication Guide, please visit www.jantoven (warfarin sodium tablets) .com or www.upsher-smith.com or call our professional services department toll-free at 1-800-654-2299. This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/24/2008
This monograph has been modified to include the generic and brand name in many instances.