RIBAVIRIN- ribavirin capsule 
Teva Pharmaceuticals USA Inc

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MedICATION guide

Ribavirin (rye-bah-VYE-rin)

Capsules

Read this Medication Guide before you start taking ribavirin capsules, and each time you get a refill. There may be new information. This information does not take the place of talking to your health care provider about your medical condition or your treatment.

What is the most important information I should know about ribavirin capsules?

  1. Do Not take ribavirin capsules alone to treat chronic hepatitis C infection. Ribavirin capsules should be used in combination with interferon alfa-2b (Intron® A) to treat chronic hepatitis C infection.
  2. Ribavirin capsules may cause a significant drop in your red blood cell count and cause anemia in some cases. Anemia has been associated with worsening of Heart Problems, and in rare cases can cause a Heart Attack and Death. Tell your health care provider if you have ever had any heart problems. Ribavirin capsules may not be right for you. Seek medical attention right away if you experience chest pain.
  3. Ribavirin capsules may cause Birth Defects or the Death of your unborn baby. Do Not Take ribavirin capsules if you or your sexual partner is pregnant or plan to become pregnant. Do Not become Pregnant within 6 months after discontinuing ribavirin capsule therapy. You must use 2 forms of birth control when you take ribavirin capsules and for the 6 months after treatment.

What are ribavirin capsules?

Ribavirin capsules are a medicine used with interferon alfa-2b (Intron A) to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with liver disease.

It is not known if ribavirin capsule use for longer than 1 year is safe and will work.

It is not known if ribavirin capsule use in children younger than 3 years old is safe and will work.

Who should not take ribavirin capsules?

See “What is the most important information I should know about ribavirin capsules?”

Do not take ribavirin capsules if you have:

Talk to your health care provider before taking ribavirin capsules if you have any of these conditions.

What should I tell my health care provider before taking ribavirin capsules?

Before you take ribavirin capsules, tell your health care provider if you have or ever had:

Tell your health care provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Ribavirin capsules may affect the way other medicines work.

Especially tell your health care provider if you take didanosine (VIDEX®) or azathioprine (Imuran® and Azasan®).

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

How should I take ribavirin capsules?

What are the possible side effects of ribavirin capsules?

Ribavirin capsules may cause serious side effects, including:

See “What is the most important information I should know about ribavirin capsules?”

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

The most common side effects of ribavirin capsules include:

The most common side effects of ribavirin capsules in children include:

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

These are not all the possible side effects of ribavirin capsules. For more information ask your health care 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 ribavirin capsules?

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF RIBAVIRIN CAPSULES.

It is not known if treatment with ribavirin capsules will cure hepatitis C virus infections or prevent cirrhosis, liver failure, or liver cancer that can be caused by hepatitis C virus infections. It is not known if taking ribavirin capsules will prevent you from infecting another person with the hepatitis C virus.

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

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

What are the ingredients in ribavirin capsules?

Active ingredients: ribavirin, USP

Inactive ingredients: calcium phosphate dibasic, croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, povidone, shellac and titanium dioxide. The gelatin capsule contains gelatin and titanium dioxide.

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

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

Manufactured In Israel By:

TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. L 12/2013

Revised: 07/2014
 
Teva Pharmaceuticals USA Inc