What is the most important information I should know about 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 copegus if you are pregnant
• If you are a man, do not take copegus if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking copegus.
• Use at least two effective forms of birth control while either sexual partner is taking copegus, 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 copegus.

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.

What is 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 purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking copegus?

Do not take this medication if you are allergic to copegus, or if you have:

• autoimmune hepatitis; or
• a hemoglobin disorder such as anemia, thalassemia (Mediterranean anemia), or sickle-cell anemia.

Before using copegus, tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart disease, high blood pressure, or a heart attack;
• cancer;
• diabetes;
• lung disease or breathing problems;
• kidney or liver disease;
• a history of depression or suicide attempt;
• sarcoidosis;
• a history of drug or alcohol addiction;
• a thyroid disorder;
• a history of a liver or other organ transplant; or
• hepatitis B virus or human immunodeficiency virus (HIV or AIDS).
• Tell your doctor if you have been treated with interferon in the past and it did not work well in treating your hepatitis C.

If you have any of these conditions, you may not be able to use copegus, or you may need a dosage adjustment or special tests during treatment.

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

• If you are a woman, do not take copegus if you are pregnant
• If you are a man, do not take copegus if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking copegus.
• Use at least two effective forms of birth control while either sexual partner is taking copegus, 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 copegus.

Your name may need to be listed on a copegus pregnancy registry if you become pregnant while you or your male sexual partner are taking this medication or during the 6 months after treatment ends. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether copegus had any effect on the baby.

It is not known whether copegus passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take copegus?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Ribavirin is not effective when used alone to treat hepatitis C. It must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C. Take the copegus tablet or capsule with a full glass of water.

Measure the liquid form of copegus with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

You may take copegus with or without food, but take it the same way every time.

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. Your liver and thyroid function may also need to be checked. 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.

It is important to use copegus regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to take this medication for many months.

Drink extra fluids while you are taking copegus to keep from getting dehydrated, especially during exercise or in hot weather.

Ribavirin can cause dry mouth, which could lead to tooth decay or gum disease. If you vomit while taking copegus, rinse your mouth out with water to prevent damage to your teeth or gums. Be sure to have regular dental exams while you are taking this medication.

Store copegus tablets and capsules at room temperature away from moisture, heat, and light. Store copegus liquid (oral solution) in the refrigerator. Do not allow it to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. If you have not taken the medication for longer than 24 hours, call your doctor for instructions. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a copegus overdose may include easy bruising or bleeding, urinating less than usual or not at all, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, or a general ill feeling.

What should I avoid while taking copegus?

Treatment with copegus does not prevent spread of the hepatitis C virus to other people. Follow your doctors instructions about how to prevent passing the disease to another person.

Do not drink alcohol while taking copegus. Alcohol can increase the risk of damage to your liver. Ribavirin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What are the possible side effects of 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 copegus and call your doctor at once if you have any of these serious side effects:

• severe depression, thoughts of suicide or hurting yourself;
• pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness;
• fever, chills, body aches, flu symptoms, trouble breathing;
• 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.

Continue taking copegus and talk to your doctor if you have any of these less serious side effects:

• dry mouth;
• nausea, vomiting, loss of appetite, weight loss;
• headache, dizziness;
• skin rash or itching;
• feeling tired or irritable;
• trouble concentrating;
• joint or muscle pain;
• sleep problems (insomnia); or
• stuffy nose.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect copegus?

Before taking copegus, tell your doctor if you are using any of the following drugs:

• didanosine (Videx);
• stavudine (Zerit); or
• zidovudine (Retrovir, AZT).

If you are using any of these drugs, you may not be able to use copegus, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect copegus. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.