REBETOL- ribavirin capsule 
REBETOL- ribavirin liquid 
Merck Sharp & Dohme Corp.

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MEDICATION GUIDE

REBETOL® (REB-eh-tol)

(ribavirin)

Capsules and Oral Solution

Read this Medication Guide before you start taking REBETOL, 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 REBETOL®?

1.
Do Not take REBETOL alone to treat chronic hepatitis C infection. REBETOL should be used in combination with either interferon alfa-2b (Intron® A) or peginterferon alfa-2b (PegIntron®) to treat chronic hepatitis C infection.
2.
REBETOL 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. REBETOL may not be right for you. Seek medical attention right away if you experience chest pain.
3.
REBETOL may cause Birth Defects or the Death of your unborn baby. Do Not Take REBETOL if you or your sexual partner is pregnant or plan to become pregnant. Do Not become Pregnant within 6 months after discontinuing REBETOL therapy. You must use 2 forms of birth control when you take REBETOL and for the 6 months after treatment.
  • Females must have a pregnancy test before starting REBETOL, every month while taking REBETOL, and every month for the 6 months after the last dose of REBETOL.
  • If you or your female sexual partner becomes pregnant while taking REBETOL or within 6 months after you stop taking REBETOL, tell your health care provider right away. You or your health care provider should contact the REBETOL pregnancy registry by calling 1-800-593-2214. The REBETOL pregnancy registry collects information about what happens to mothers and their babies if the mother takes REBETOL while she is pregnant.

What is REBETOL®?

REBETOL is a medicine used with either interferon alfa-2b (Intron A) or peginterferon alfa-2b (PegIntron) to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with liver disease.

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

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

Who should not take REBETOL®?

See "What is the most important information I should know about REBETOL?"

Do not take REBETOL if you have:

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

What should I tell my health care provider before taking REBETOL®?

Before you take REBETOL, 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. REBETOL 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 REBETOL®?

What are the possible side effects of REBETOL®?

REBETOL may cause serious side effects, including:

See "What is the most important information I should know about REBETOL?"

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 REBETOL include:

The most common side effects of REBETOL 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 REBETOL. 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 REBETOL®?

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

GENERAL INFORMATION ABOUT THE SAFE AND EFFECTIVE USE OF REBETOL®.

It is not known if treatment with REBETOL 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 REBETOL 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 REBETOL for a condition for which it was not prescribed. Do not give REBETOL 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 REBETOL. If you would like more information, talk with your health care provider. You can ask your pharmacist or health care provider for information about REBETOL that is written for health professionals.

What are the ingredients in REBETOL®?

Active ingredients: ribavirin

REBETOL Capsules

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. The capsule shell consists of gelatin, sodium lauryl sulfate, silicon dioxide, and titanium dioxide. The capsule is printed with edible blue pharmaceutical ink which is made of shellac, anhydrous ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, ammonium hydroxide, and FD&C Blue #2 aluminum lake.

REBETOL Oral Solution

Inactive ingredients: sucrose, glycerin, sorbitol, propylene glycol, sodium citrate, citric acid, sodium benzoate, natural and artificial flavor for bubble gum # 15864, and water.

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

Revised: 07/2014
 
Merck Sharp & Dohme Corp.