What is the most important information I should know about Rebetol?

• Rebetol should not be used alone in the treatment of hepatitis C. It should be used in combination with an interferon alfa product. When used by itself, Rebetol is not effective against the hepatitis C virus.
• Rebetol is in the FDA pregnancy category X. This means that it is known to cause birth defects in an unborn baby. Rebetol should not be used by women who are pregnant or by male partners of pregnant women. Treatment with Rebetol should not be started until a negative pregnancy test has been obtained. Extreme care must be taken to avoid pregnancy during treatment with Rebetol and for 6 months following the completion of treatment in women taking this medication and women partners of men being treated with this medication. Women who could become pregnant during treatment and men must use two reliable forms of birth control during treatment and during the 6-month period following treatment. A pregnancy test should be taken before starting treatment with Rebetol, every month during treatment, and every month for six months following treatment to make sure there is no pregnancy. Notify your doctor immediately if pregnancy occurs.
• Rebetol may cause anemia, which is a decrease in the number of red blood cells in the body. This can be dangerous, especially for patients who already have heart or circulatory problems. Your doctor will want to check your red blood cell count before starting treatment and periodically during treatment. Notify your doctor if you experience unusual tiredness, chest pain, or shortness of breath. These may be signs of low red blood cell counts.
• Combination treatment with Rebetol and interferon alfa may cause mental health problems such as depression, suicidal behavior, and psychosis (loss of contact with reality such as hearing voices or seeing things that are not there). In general, these feelings and behaviors stop after treatment is stopped. Talk to your doctor immediately if you experience any new or worsening mental health problems.

What is Rebetol?

• Rebetol is an antiviral medication. The exact way that Rebetol works is unknown.
• Rebetol is used in combination with an interferon alfa product to treat chronic hepatitis C in patients with compensated liver disease who have not previously been treated with alfa interferon or who have relapsed following alfa interferon therapy.
• Rebetol may also be used for purposes other than those listed here.

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

• Do not take Rebetol without first talking to your doctor if you have
  • a history of heart disease, high blood pressure, or a heart attack;
  • a hemoglobin disorder such as anemia (low red blood cell count), thalassemia (Mediterranean anemia), or sickle-cell anemia;
  • pancreatitis;
  • kidney problems;
  • liver problems (other than hepatitis C infection);
  • mental health problems such as depression or anxiety;
  • a history of organ transplant;
  • thyroid disease;
  • current or history of alcoholism or drug abuse or addiction;
  • cancer;
  • infection with hepatitis B virus and/ or human immunodeficiency virus (HIV or AIDS);
  • diabetes; or
  • past interferon treatment for hepatitis C virus infection that did not work for you.
• You may not be able to take Rebetol or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• Rebetol is in the FDA pregnancy category X. This means that it is known to cause birth defects in an unborn baby. Rebetol should not be used by women who are pregnant or by male partners of pregnant women. Treatment with Rebetol should not be started until a negative pregnancy test has been obtained. Extreme care must be taken to avoid pregnancy during treatment with Rebetol and for 6 months following the completion of treatment in women taking this medication and women partners of men being treated with this medication. Women who could become pregnant during treatment and men must use two reliable forms of birth control during treatment and during the 6-month period following treatment. A pregnancy test should be taken before starting treatment with Rebetol, every month during treatment, and every month for six months following treatment to make sure there is no pregnancy. Notify your doctor immediately if pregnancy occurs.
• It is not known whether Rebetol passes into breast milk. Because it may harm a nursing baby, breast-feeding is not recommended during treatment with Rebetol.
• Side effects may be more likely to occur in people over the age of 65 treated with Rebetol. A lower dose or special monitoring may be required.

How should I take Rebetol?

• Take Rebetol exactly as directed by your doctor. If you do not understand these instructions, ask your doctor, nurse, or pharmacist to explain them to you.
• Rebetol should not be used alone in the treatment of hepatitis C. It should be used in combination with an interferon alfa product. When used by itself, Rebetol is not effective against the hepatitis C virus.
• Take the Rebetol tablets and capsules with a full glass of water.
• To ensure that you get a correct dose, measure the Rebetol solution with a dose-measuring spoon, dropper, or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.
• Take the medication twice a day in the morning and evening as directed by your doctor. It is recommended that Rebetol be taken with food. However, Rebetol can be taken with or without food. It should be taken the same way every day (e.g., with food or without food).
• Maintain adequate fluid intake to prevent dehydration during treatment with Rebetol by drinking several extra glasses of fluid each day. Additional fluid may be necessary during hot weather, vigorous exercise, and illness.
• It is important to follow your dosing schedule and your health care provider's instructions on how to take your medicines.
• Take the medicine for as long as it is prescribed and do not take more than the recommended dose.
• It is important to take Rebetol regularly to get the most benefit.
• Your doctor may want you to have regularly scheduled blood tests or other medical evaluations during treatment with Rebetol to monitor progress and side effects.
• Treatment with Rebetol does not prevent spread of the hepatitis C virus to other people. Follow your healthcare provider's instructions regarding minimizing the risk of spreading the virus.
• Store Rebetol tablets and capsules at room temperature away from moisture, heat, and light.
• The Rebetol oral solution can be stored at room temperature, away heat and light, or in the refrigerator.

What happens if I miss a dose?

• If you miss a dose of Rebetol, take the missed dose as soon as possible during the same day. If an entire day has gone by, check with your health care provider about what to do. Do not double the next dose.

What happens if I overdose?

• Seek emergency medical attention if an overdose is suspected.
• Symptoms of a Rebetol overdose are not known.

What should I avoid while taking Rebetol?

• Do not drink alcohol during treatment with Rebetol unless otherwise directed by your doctor.
• Do not take other prescription or nonprescription drugs, including herbal products during treatment with Rebetol without first talking to your doctor.
• Maintain adequate fluid intake to prevent dehydration during treatment with Rebetol by drinking several extra glasses of fluid each day. Additional fluid may be necessary during hot weather, vigorous exercise, and illness.
• Use caution when driving, operating machinery, or performing other hazardous activities. Rebetol may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities.
• Treatment with Rebetol does not prevent spread of the hepatitis C virus to other people. Follow your healthcare provider's instructions regarding minimizing the risk of spreading the virus.

What are the possible side effects of Rebetol?

• Stop taking Rebetol and seek emergency medical attention or call your doctor immediately if you experience
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • chest, arm or neck pain;
  • trouble breathing or increased cough;
  • severe stomach pain or low back pain;
  • black or bloody bowel movements (may look like black tar);
  • unusual bruising or bleeding;
  • changes in vision;
  • fever greater than 100.5 degrees Fahrenheit; or
  • worsening symptoms of psoriasis.
• Rebetol may cause anemia, which is a decrease in the number of red blood cells in the body. This can be dangerous, especially for patients who already have heart or circulatory problems. Your doctor will want to check your red blood cell count before starting treatment and periodically during treatment. Notify your doctor if you experience unusual tiredness, chest pain, or shortness of breath. These may be signs of low red blood cell counts.
• Combination treatment with Rebetol and interferon alfa may cause mental health problems such as depression, suicidal behavior, and psychosis (loss of contact with reality such as hearing voices or seeing things that are not there). In general, these feelings and behaviors stop after treatment is stopped. Talk to your doctor immediately if you experience any new or worsening mental health problems.
• Other less serious side effect may be more likely to occur. Continue to take Rebetol and talk to your doctor if you experience
  • fatigue or tiredness;
  • nausea or decreased appetite;
  • thinning of the hair;
  • rash or itching; or
  • insomnia or restlessness.
• 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 Rebetol?

• Before taking Rebetol, tell your doctor if you are taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, and do not start taking any other medicines during treatment without first talking to your doctor. You may require a dosage adjustment or special monitoring during treatment.

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