Rebetol is not recommended for use in patients under the age of 3 years.
Do not take Rebetol
If any of the following apply to you or the child you are caring for, do not take Rebetol, and tell your doctor if you:
- are allergic (hypersensitive) to ribavirin or any of the other ingredients of Rebetol.
- are pregnant or planning to become pregnant (see section ?Pregnancy and breast-feeding?) .
- are breast-feeding.
- had a problem with your heart during the past 6 months.
- have severe medical conditions that leave you very weak.
- have severe kidney disease and/or are on haemodialysis.
- have a serious problem with your liver other than chronic hepatitis C.
- have any blood disorders, such as anaemia (low blood count), thalassemia, sickle-cell anaemia.
- have autoimmune hepatitis or any other problem with your immune system.
- are taking medicine that suppresses your immune system (that protects you against infection and some diseases).
Children and adolescents must not take combination therapy with Rebetol and alpha interferon when there is existence or history of serious nervous or mental problems, such as severe depression, thoughts of suicide or attempted suicide.
Reminder: Please read the ?Do not use? section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b before you begin combination treatment with Rebetol.
Take special care with Rebetol
Seek medical help immediately if you develop symptoms of a severe allergic reaction (such as difficulty in breathing, wheezing or hives) while taking this treatment.
Children and adolescents weighing less than 47 kg:
The use of Rebetol hard capsules is not recommended. An oral solution of Rebetol is available for children 3 years of age and older and adolescents weighing less than 47 kg.
You should tell your doctor if you or the child you are caring for:
- are an adult who has or had a severe nervous or mental disorder, confusion, unconsciousness, or have had thoughts of suicide or have attempted suicide.
- have ever had depression or develop symptoms associated with depression (e.g. feeling of sadness, dejection, etc.) while on treatment with Rebetol.
- are a woman of childbearing age (see section ?Pregnancy and breast-feeding?).
- are a male and your female partner is of childbearing age (see section ?Pregnancy and breast-feeding?).
- had a previous serious heart condition or have cardiac disease.
- are older than 65 years or if you have problems with your kidneys.
- have or have had any serious illness.
- have thyroid problems.
During treatment with Rebetol in combination therapy with an alpha interferon, dental and gum disorders, which may lead to loss of teeth, have been reported. In addition, dry mouth that could have a damaging effect on teeth and membranes of the mouth has been reported during long-term treatment with Rebetol in combination therapy with an alpha interferon. You should brush your teeth thoroughly twice daily and have regular dental examinations. In addition some patients may experience vomiting. If you have this reaction, be sure to rinse your mouth thoroughly afterwards.
During treatment with Rebetol in combination therapy with an alpha interferon, patients may experience eye problems, or loss of vision in rare instances. If you receive ribavirin in combination with an alpha interferon, you should have a baseline eye examination. Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination. Patients with pre-existing eye disorders (e.g., diabetic or hypertensive retinopathy) should receive periodic eye exams during combination therapy with ribavirin and an alpha interferon. Combination therapy with ribavirin and an alpha interferon should be discontinued in patients who develop new or worsening eye disorders.
Reminder: Please read the ?Take special care? section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b before you begin combination treatment.
Taking other medicines
Please tell your doctor or pharmacist if you or the child you are caring for:
- are taking or have recently taken any other medicines, including medicines obtained without a prescription.
- are receiving azathioprine in combination with ribavirin and pegylated alpha interferons and, therefore may be at an increased risk of developing severe blood disorders.
- are infected with both Human Immunodeficiency Virus (HIV-positive) and Hepatitis C Virus (HCV) and are being treated with an anti-HIV medicinal product(s) - [nucleoside reverse transcriptase inhibitor ( NRTI), and/or highly active anti-retroviral therapy ( HAART)]:
- Taking Rebetol in combination with an alpha interferon and an anti-HIV medicinal product(s) may increase the risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).
- With zidovudine or stavudine, it is not certain if Rebetol will change the way these medicines work. Therefore, your blood will be checked regularly to be sure that the HIV infection is not getting worse. If it gets worse, your doctor will decide whether or not your Rebetol treatment needs to be changed. Additionally, patients receiving zidovudine with ribavirin in combination with alpha interferons could be at increased risk of developing anaemia (low number of red blood cells). Therefore the use of zidovudine and ribavirin in combination with alpha interferons is not recommended.
- Due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis, the use of ribavirin and didanosine is not recommended and the use of ribavirin and stavudine should be avoided.
- Co-infected patients with advanced liver disease receiving HAART may be at increased risk of worsening liver function. Adding treatment with an alpha interferon alone or in combination with ribavirin may increase the risk in this patient subset.
Reminder: Please read the ?Taking other medicines? section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b before you begin combination treatment with Rebetol.
Taking Rebetol with food and drink
Rebetol must be taken with food.
Pregnancy and breast-feeding
If you are pregnant, you must not take Rebetol. Rebetol can be very damaging to your unborn baby (embryo).
Both female and male patients must take special precautions in their sexual activity if there is any possibility for pregnancy to occur:
- Girl or woman of childbearing age: You must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped. This should be discussed with your doctor.
Do not have sex with a pregnant woman unless you use a condom. This will lessen the possibility for ribavirin to be left in the woman?s body.
If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment has stopped. You and your female partner must each use an effective contraceptive during the time you are taking Rebetol and for 7 months after stopping treatment. This should be discussed with your doctor (see section ?Do not take Rebetol?).
If you are a woman who is breast-feeding, you must not take Rebetol. Discontinue breast-feeding before starting to take Rebetol.
Driving and using machines
Rebetol does not affect your ability to drive or use machines; however, peginterferon alfa-2b or interferon alfa-2b may affect your ability to drive or use machines. Therefore, do not drive or use machines if you become tired, sleepy, or confused from this treatment.
Important information about some of the ingredients of Rebetol
Each Rebetol capsule contains a small amount of lactose.
If you have been told by your doctor that you have an intolerance to some sugars, discuss with your doctor before taking this medicinal product.