8017965/1016
MEDICATION Guide

8017965/1016

MEDICATION GUIDE

Ribavirin

(rye-ba-VYE-rin)

Capsules, USP

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 capsules therapy. You must use 2 forms of birth control when you take ribavirin capsules and for the 6 months after treatment.
4. Females must have a pregnancy test before starting ribavirin capsules, every month while taking ribavirin capsules, and every month for the 6 months after last dose of ribavirin capsules.
5. If you or your female sexual partner becomes pregnant while taking ribavirin capsules or within 6 months after you stop taking ribavirin capsules, tell your health care provider right away. You or your health care provider should contact the ribavirin capsules pregnancy registry by calling 1-800-593-2214. The ribavirin capsules pregnancy registry collects information about what happens to mothers and their babies if the mother takes ribavirin capsules while she is pregnant.

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 capsules use for longer than 1 year is safe and will work.

It is not known if ribavirin capsules 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:

• or ever had serious allergic reactions to the ingredients in ribavirin capsules. See the end of this Medication Guide for a complete list of ingredients.
• certain types of hepatitis (autoimmune hepatitis).
• certain blood disorders (hemoglobinopathies).
• severe kidney disease.
• taken or currently take didanosine (VIDEX ®).

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:

• treatment for hepatitis C that did not work for you.
• breathing problems. Ribavirin capsules may cause or worsen breathing problems you already have.
• vision problems. Ribavirin capsules may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with ribavirin capsules.
• certain blood disorders such as anemia (low red blood cell count).
• high blood pressure, heart problems, or have had a heart attack. Your health care provider should check your blood and heart before you start treatment with ribavirin capsules.
• thyroid problems.
• liver problems other than hepatitis C infection.
• human immunodeficiency virus (HIV) or any immunity problems.
• mental health problems, including depression and thoughts of hurting yourself or others.
• kidney problems.
• an organ transplant.
• diabetes. Ribavirin capsules may make your diabetes worse or harder to treat.
• any other medical condition.
• are breastfeeding. It is not known if ribavirin passes into your breast milk. You and your health care provider should decide if you will take ribavirin capsules or breastfeed.

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?

• Take ribavirin capsules exactly as your health care provider tells you. Your health care provider will tell you how much ribavirin capsules to take and when to take it.
• Take ribavirin capsules with food.
• Take ribavirin capsules whole. Do not open, break, or crush ribavirin capsules before swallowing. If you cannot swallow ribavirin capsules whole, tell your health care provider.
• If you miss a dose of ribavirin capsules, take the missed dose as soon as possible during the same day. Do not double the next dose. If you have questions about what to do, call your health care provider.
• If you take too much ribavirin capsules, call your health care provider or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

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?"

• Swelling and irritation of your pancreas (pancreatitis). You may have stomach pain, nausea, vomiting, or diarrhea.
• Serious breathing problems. Difficulty breathing may be a sign of a serious lung infection (pneumonia) that can lead to death.
• Serious eye problems that may lead to vision loss or blindness.
• Dental problems. Your mouth may be very dry, which can lead to problems with your teeth and gums.
• Severe blood disorders. An increased risk when used in combination with azathioprine.
• Growth problems in children. Weight loss and slowed growth are common in children during combination treatment with INTRON A. Most children will go through a growth spurt and gain weight after treatment stops. Some children may not reach the height that they were expected to have before treatment. Talk to your healthcare provider if you are concerned about your child's growth during treatment with ribavirin capsules and INTRON A.
• Severe depression.
• Thoughts of hurting yourself or others, and suicide attempts. Adults and children who take ribavirin capsules, especially teenagers, are more likely to have suicidal thoughts or attempt to hurt themselves while taking ribavirin capsules. Call your health care provider right away or go to the nearest hospital emergency room if you have new or worse depression or thoughts about hurting yourself or others or dying.

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:

• flu-like symptoms - feeling tired, headache, shaking along with high temperature (fever), nausea, and muscle aches.
• mood changes, feeling irritable.

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

• a decrease in the blood cells that fight infection (neutropenia).
• a decrease in appetite.
• stomach pain and vomiting.

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 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 Ribavirin capsules?

• Store ribavirin capsules between 59˚F to 86˚F (15˚C to 30˚C).

Keep ribavirin capsules and all medicines out of the reach of children.

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 it was not prescribed. Do not give ribavirin capsules 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 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, USP?
Active ingredients: ribavirin, USP
Inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, and silicon dioxide. The capsule shell consists of gelatin and titanium dioxide. It may also contain sodium lauryl sulfate. The capsule is printed with black pharmaceutical ink.

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

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

This product's label may have been updated. For current full prescribing information, please call American Health Packaging at 1-800-707-4621.

Distributed by:
American Health Packaging
Columbus, OH 43217

8017965/1016