Brand Names: Copegus, Rebetol, RibaPak, Ribasphere, RibaTab

Generic Name: ribavirin (oral) (Pronunciation: rye ba VYE rin)

• What is ribavirin (Copegus)?
• What are the possible side effects of ribavirin (Copegus)?
• What is the most important information I should know about ribavirin (Copegus)?
• What should I discuss with my healthcare provider before taking ribavirin (Copegus)?
• How should I take ribavirin (Copegus)?
• What happens if I miss a dose (Copegus)?
• What happens if I overdose (Copegus)?
• What should I avoid while taking ribavirin (Copegus)?
• What other drugs will affect ribavirin (Copegus)?
• Where can I get more information?

What is ribavirin (Copegus)?

Ribavirin is an antiviral medication.

Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.

Ribavirin may also be used for other purposes not listed in this medication guide.

Copegus 200 mg

oval, pink, imprinted with RIB 200, ROCHE

Ribavirin 200 mg-TEV

white, imprinted with 93 7227

What are the possible side effects of ribavirin (Copegus)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ribavirin and call your doctor at once if you have any of these serious side effects:

• pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness;
• severe depression, hallucinations, thoughts of suicide or hurting yourself;
• fever, chills, body aches, flu symptoms, trouble breathing;
• severe blistering, peeling, and red skin rash;
• blood diarrhea, or black tarry stools;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious side effects may include:

• feeling tired or irritable;
• dry mouth, cough;
• headache, dizziness;
• hearing or vision problems;
• hair loss, dry skin, rash, itching;
• joint or muscle pain; or
• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ribavirin (Copegus)?

Ribavirin is not effective when used alone to treat hepatitis C. Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.

This medication can cause birth defects or death in an unborn baby.

• If you are a woman, do not take ribavirin if you are pregnant.
• If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
• Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and for at least 6 months after treatment ends.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.