RIBAVIRIN (ORAL)

(rye ba VYE rin) Brand: Copegus, Rebetol, RibaPak, Ribasphere, RibaTab

What is the most significant information I must know about ribavirin?

• Ribavirin is not effective when used alone to treat hepatitis C. It should be used together with an interferon alfa product (such as Pegasys, PegIntron, Sylatron, or Intron A) to treat chronic hepatitis C.

• You must not take ribavirin if you are allergic to it, or if you have severe liver malady, autoimmune hepatitis, a hemoglobin mess (anemia, thalassemia, and others), if you are also taking didanosine (Videx), or if you are pregnant woman, or a man whose female sexual partner is pregnant.

• This medicine can reason birth defects or death in an unborn child.

• 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 child could also be harmed if a man fathers the baby 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. Speak 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 malady or circulation problems. Your blood will need to be tested often. Your vision, liver function, and thyroid function may also need to be tested. Visit your doctor regularly.

• Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, weakness, or trouble breathing.

What is ribavirin?

• Ribavirin is an antiviral medication.

• Ribavirin should be used together with an interferon alfa product (such as Pegasys, PegIntron, Sylatron, or Intron A) to treat chronic hepatitis C.

• Ribavirin may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking ribavirin?

• You must not take ribavirin if you are allergic to it, or if you have:

· severe liver malady (especially cirrhosis);

· autoimmune hepatitis;

· a hemoglobin mess such as anemia, thalassemia (Mediterranean anemia), or sickle-cell anemia;

· if you are also taking didanosine (Videx); or

· if you are pregnant woman, or a man whose female sexual partner is pregnant.

• To create certain you can safely take ribavirin, speak your doctor if you have any of these another conditions:

· kidney or liver malady (other than hepatitis C);

· hepatitis B infection;

· a blood cell mess such as hemolytic anemia (a lack of red blood cells);

· human immunodeficiency virus (HIV or AIDS);

· diabetes;

· a pancreas disorder;

· sarcoidosis;

· breathing problems;

· a thyroid disorder;

· new or worsening eye problems (such as retinopathy);

· a history of heart malady, tall blood pressure, or a heart attack;

· a history of depression or suicide attempt;

· a history of a liver, kidney, or another organ transplant; or

· if you have ever received treatment for hepatitis C that did not work well.

• This medicine can reason birth defects or death in an unborn child.

· If you are a woman, do not take ribavirin if you are pregnant. You will need frequent pregnancy trials to create certain you are not pregnant while taking ribavirin.

· If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn child could also be harmed if a man fathers the baby while he is taking ribavirin. Your sexual partner will need frequent pregnancy trials to create certain she is not pregnant while you are 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.

· Speak your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

• Your name may need to be listed on a ribavirin pregnancy registry if you become pregnant while you or your male sexual partner are taking this medicine or during the 6 months after treatment ends. This is to track the outcome of the pregnancy and to estimate any effects of ribavirin on the baby.

• It is not known whether ribavirin passes into breast milk or if it could harm a nursing child. You must not breast-feed while you are taking ribavirin.

• Ribavirin may affect growth in children.

How must I take ribavirin?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

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

• Take this medication with food.

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

• 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 malady or circulation problems. Your blood will need to be tested often. Your vision, liver function, and thyroid function may also need to be tested. Visit your doctor regularly.

• 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.

• Use ribavirin regularly to get the most benefit. Get your prescription refilled till you run out of medication completely.

• Drink extra fluids while you are taking ribavirin to hold from getting dehydrated, especially during exercice or in hot weather.

• Ribavirin can reason dry mouth, which could lead to tooth decay or gum malady. If you vomit while taking ribavirin, rinse your mouth out with water to prevent hurt to your teeth or gums. Be certain to have regular dental exams while you are taking this medication.

• Store ribavirin tablets and capsules at room temperature away from moisture, heat, and light.

• Store ribavirin liquid (oral solution) in the refrigerator. Do not let it to freeze.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. If you have not taken the medicine for longer than 24 hours, call your doctor for instructions. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include light bruising or bleeding, urinating smaller than normal or not at all, chest pain or hard feeling, pain spreading to the hand or shoulder, nausea, sweating, or a common ill feeling.

What must I avoid while taking ribavirin?

• Treatment with ribavirin does not prevent spread of the hepatitis C virus to another people. Follow your doctor's instructions about how to prevent passing the malady to other person.

• Avoid drinking alcohol. It may magnify your risk of liver damage.

• Ribavirin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What are the possible side effects of ribavirin?

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

• Stop using ribavirin and call your doctor at once if you have a serious side effect such as:

· problems with your vision;

· fever, chills, body aches, flu symptoms;

· severe pain in your upper stomach spreading to your back, nausea and vomiting, quick heart rate;

· stabbing chest pain, wheezing, feeling short of breath;

· severe depression, hallucinations, thoughts of suicide or hurting yourself;

· chest pain or hard feeling, pain spreading to the hand or shoulder, nausea, sweating, common ill feeling; or

· pale or yellowed skin, dark colored urine, light bruising or bleeding, confusion, or unusual weakness.

• Smaller serious side effects may include:

· headache;

· muscle pain;

· dry mouth;

· nausea; vomiting, stomach pain, loss of appetite;

· weight loss;

· feeling weary or irritable;

· anxiety, mood changes; or

· pain, swelling, or irritation where the interferon injection was given.

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

What another drugs will affect ribavirin?

• Speak your doctor about all another medicines you use, especially:

· abacavir (Ziagen);

· azathiopriine (Azasan, Imuran);

· lamivudine (Combivir, Epivir, Epzicom, Trizivir);

· stavudine (Zerit);

· tenofovir (Viread);

· zalcitabine (Hivid); or

· zidovudine (Retrovir, AZT).

• This list is not complete and another drugs may interact with ribavirin. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about ribavirin.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

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