Rebetol

Rebetol is used for:

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Treating hepatitis C infection in certain patients when used in combination with interferon. It may also be used for other conditions as determined by your doctor.

Rebetol is an antiviral medicine. How Rebetol works to treat hepatitis C is not completely understood.

Do NOT use Rebetol if:

• you are pregnant
• your female sexual partner is pregnant or could become pregnant within the next 6 months
• you have certain blood disorders (eg, sickle-cell anemia, thalassemia major), a history of serious heart problems, severe kidney problems, or inflammation of the pancreas (acute pancreatitis)
• you have autoimmune hepatitis (liver problems caused by your body instead of a virus) or severely decreased liver function
• you are taking didanosine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Rebetol :

Some medical conditions may interact with Rebetol . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have female sexual partner who is of childbearing age
• if you have a history of cancer, heart problems or heart attack, high blood pressure, kidney problems, diabetes, pancreas problems, lung or breathing problems, sarcoidosis, blood problems (eg, anemia), thyroid problems, or HIV infection
• if you have liver problems (other than hepatitis C infection) such as hepatitis B infection, cirrhosis of the liver, or decreased liver function
• if you have a history of anxiety or other mood or mental disorders, thoughts of suicide, or suicidal behavior
• if you have used interferon before to treat hepatitis C and it did not work
• if you have a history of drug or alcohol abuse

Some MEDICINES MAY INTERACT with Rebetol . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Didanosine or other nucleoside reverse transcriptase inhibitors (NRTIs) (eg, lamivudine), immunosuppressants (eg, cyclosporine), or other antiretroviral medicines for HIV infection because the risk of serious side effects, including risk of infection, nerve problems (peripheral neuropathy), pancreas problems, lactic acidosis, and severe or fatal liver failure, may be increased by Rebetol
• Anticoagulants (eg, warfarin) because they may decrease Rebetol 's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Rebetol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Rebetol :

Use Rebetol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Rebetol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Rebetol refilled.
• Take Rebetol by mouth with food.
• Drinking extra fluids while you are taking Rebetol is recommended. Check with your doctor for instructions.
• Taking Rebetol at the same time each day will help you remember to take it.
• Take Rebetol on a regular schedule to get the most benefit from it.
• Continue to use Rebetol even if you feel well. Do not miss any doses.
• If you miss a dose of Rebetol , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Rebetol .

Important safety information:

• Rebetol may cause dizziness, drowsiness, tiredness, confusion, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Rebetol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Avoid drinking alcohol, including beer, wine, and liquor, because it could worsen liver disease.
• Lab tests, including pregnancy tests; blood counts; hemoglobin levels; and heart, liver, kidney, thyroid, and lung function tests, may be performed while you use Rebetol . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• At least 2 reliable forms of effective birth control must be used during treatment with Rebetol and for 6 months after treatment with Rebetol is stopped.
• Women of childbearing potential who either take Rebetol or are sexual partners of men who take Rebetol must have a pregnancy test before therapy with Rebetol is started, monthly during therapy, and monthly for 6 months after Rebetol is stopped.
• Rebetol may cause dry mouth and increase the risk of teeth and gum problems. Proper dental care is important while you are taking Rebetol . Brush and floss your teeth carefully at least twice a day and visit the dentist regularly.
• If vomiting occurs while you are taking Rebetol , be sure to rinse your mouth and clean your teeth afterwards.
• Rebetol should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
• Use Rebetol with caution in the ELDERLY; they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: Do not use Rebetol if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Rebetol is excreted in breast milk. Do not breast-feed while taking Rebetol .

Possible side effects of Rebetol :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; dizziness; dry mouth; dry skin; loss of appetite; mild headache, nausea, or vomiting; mild pain, redness, or swelling at the injection site; tiredness; upset stomach; weakness or fatigue.

Severe allergic reactions (rash; hives; itching; difficulty breathing; itching; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in hearing, taste, or vision; chest pain; dark urine; decrease in the amount of urine; fever, chills, or sore throat; hair loss; irregular heartbeat; joint pain; muscle pain or weakness; numbness or tingling of arms or legs; prolonged nausea and vomiting; rapid breathing; severe headache; severe stomach or back pain; shortness of breath; sinus problems; thoughts of suicide; trouble sleeping; unusual bruising or bleeding; unusual mental or mood changes; unusual or severe tiredness and fatigue; vomit that looks like coffee grounds; weight loss; yellowing of eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately.

Store Rebetol at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Rebetol out of the reach of children and away from pets.

General information:

• If you have any questions about Rebetol , please talk with your doctor, pharmacist, or other health care provider.
• Rebetol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Rebetol . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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