Brand Name Choices
No generic medication is available for Rebetol (Ribavirin)
What Rebetol is and what it is used for
Rebetol contains the active substance ribavirin. This medicine stops the multiplication of hepatitis C virus. Rebetol must not be used alone. Depending on the genotype of the hepatitis C virus that you have, your doctor may choose to treat you with a combination of this medicine with other medicines. There may be some further treatment limitations if you have or have not been previously treated for chronic hepatitis C infection. Your doctor will recommend the best course of therapy. The combination of Rebetol and other medicines is used to treat adult patients who have chronic hepatitis C (HCV). Rebetol may be used in paediatric patients (children 3 years of age and older and adolescents) who are not previously treated and without severe liver disease.For paediatric patients (children and adolescents) weighing less than 47 kg a solution formulation is available. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
How to take Rebetol
General information about taking this medicine:
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Do not take more than the recommended dosage and take the medicine for as long as prescribed.
Your doctor has determined the correct dose of this medicine based on how much you or the child you
are caring for weighs.
The recommended dose and duration of Rebetol depends on how much the patient weighs and the
medicines that are used in combination.
Use in children and adolescents
Dosing for children above 3 years of age and adolescents depends on how much the person weighs
and the medicines that are used in combination. The recommended dose of Rebetol combined with
interferon alfa-2b or peginterferon alfa-2b, is shown in the below table.
Rebetol dose based on body weight when used in combination with interferon alfa-2b or peginterferon
alfa-2b in children above 3 years of age and adolescents
If the child/adolescent weighs
Usual daily Rebetol dose Number of 200 mg capsules
•49 600 mg 1 capsule in the morning and 2 capsules in the evening 50
•65 800 mg 2 capsules in the morning and 2 capsules in the evening > 65 See adult dose Take your prescribed dose by mouth with water and during your meal. Do not chew the hard capsules. For children or adolescents who cannot swallow a hard capsule, an oral solution of this medicine is available. Reminder: This medicine is used in combination with other medicines for hepatitis C virus infection. For complete information be sure to read the “How to use” section of the Package Leaflet for the other medicines used in combination with Rebetol. If you take more Rebetol than you should Tell your doctor or pharmacist as soon as possible. If you forget to take Rebetol Take/administer the missed dose as soon as possible during the same day. If an entire day has gone by, check with your doctor. Do not take a double dose to make up for a forgotten dose.
Possible side effects
Please read the “Possible side effects” section of the Package Leaflet for the other medicines used in
combination with Rebetol.
Like all medicines, this medicine used in combination with other medicines can cause side effects,
although not everybody gets them. Although not all of these unwanted effects may occur, they may
need medical attention if they do occur.
Contact your doctor immediately if you notice any of the following side effects occurring during
combination treatment with other medicines:
− chest pain or persistent cough; changes in the way your heart beats, fainting,
− confusion, feeling depressed; suicidal thoughts or aggressive behaviour, attempt suicide,
thoughts about threatening the life of others,
− feelings of numbness or tingling,
− trouble sleeping, thinking or concentrating,
− severe stomach pain, black or tar-like stools, blood in stool or urine, lower back or side pain,
− painful or difficult urination,
− severe bleeding from your nose,
− fever or chills beginning after a few weeks of treatment,
− problems with your eyesight or hearing,
− severe skin rash or redness.
The following side effects have been reported with the combination of this medicine hard capsules and an alpha interferon product in adults:
Very commonly reported side effects (may affect more than 1 in 10 people): − decreases in the number of red blood cells (that may cause fatigue, shortness of breath, dizziness), decrease in neutrophils (that make you more susceptible to different infections), − difficulty concentrating, feeling anxious or nervous, mood swings, feeling depressed or irritable, tired feeling, trouble falling asleep or staying asleep, − cough, dry mouth, pharyngitis (sore throat), − diarrhoea, dizziness, fever, flu-like symptoms, headache, nausea, shaking chills, virus infection, vomiting, weakness, − loss of appetite, loss of weight, stomach pain, − dry skin, irritation, hair loss, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Commonly reported side effects (may affect up to 1 in 10 people): − decrease in blood clotting cells called platelets that may result in easy bruising and spontaneous bleeding, decrease in certain white blood cells called lymphocytes that help fight infection, decrease in thyroid gland activity (which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms), excess of sugar or uric acid (as in gout) in the blood, low calcium level in the blood, severe anaemia, − fungal or bacterial infections, crying, agitation, amnesia, memory impaired, nervousness, abnormal behaviour, aggressive behaviour, anger, feeling confused, lack of interest, mental disorder, mood changes, unusual dreams, wanting to harm yourself, feeling sleepy, trouble sleeping, lack of interest in sex or inability to perform, vertigo (spinning feeling), − blurred or abnormal vision, eye irritation or pain or infection, dry or teary eyes, changes in your hearing or voice, ringing in ears, ear infection, earache, cold sores (herpes simplex), change in taste, taste loss, bleeding gums or sores in mouth, burning sensation on tongue, sore tongue, inflamed gums, tooth problem, migraine, respiratory infections, sinusitis, nose bleed, nonproductive cough, rapid or difficult breathing, stuffy or runny nose, thirst, tooth disorder, − cardiac murmur (abnormal heart beat sounds), chest pain or discomfort, feeling faint, feeling unwell, flushing, increased sweating, heat intolerance and excessive sweating, low or high blood pressure, palpitations (pounding heart beat), rapid heart rate, − bloating, constipation, indigestion, intestinal gas (flatus), increased appetite, irritated colon, irritation of prostate gland, jaundice (yellow skin), loose stools, pain on the right side around your ribs, enlarged liver, stomach upset, frequent need to urinate, passing more urine than usual, urinary tract infection, abnormal urine, − difficult, irregular, or no menstrual period, abnormally heavy and prolonged menstrual periods, painful menstruation, disorder of ovary or vagina, breast pain, erectile problem, − abnormal hair texture, acne, arthritis, bruising, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), hives, increased or decreased sensitivity to touch, nail disorder, muscle spasms, numbness or tingling feeling, limb pain, pain in joints, shaky hands, psoriasis, puffy or swollen hands and ankles, sensitivity to sunlight, rash with raised spotted lesions, redness of skin or skin disorder, swollen face, swollen glands (swollen lymph nodes), tense muscles, tumour (unspecified), unsteady when walking, water impairment.
Uncommonly reported side effects (may affect up to 1 in 100 people): − hearing or seeing images that are not present, − heart attack, panic attack, − hypersensitivity reaction to the medication, − inflammation of pancreas, pain in bone, diabetes mellitus, − muscle weakness.
Rarely reported side effects (may affect up to 1 in 1,000 people): − seizure (convulsions) − pneumonia, − rheumatoid arthritis, kidney problems, − dark or bloody stools, intense abdominal pain, − sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands), − vasculitis.
Very rarely reported side effects (may affect up to 1 in 10,000 people): − suicide, − stroke (cerebrovascular events).
Not known side effects (frequency cannot be estimated from the available data): − thoughts about threatening the life of others, − mania (excessive or unreasonable enthusiasm), − pericarditis (inflammation of the lining of the heart), pericardial effusion [a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself], − change in colour of the tongue. Side effects in children and adolescents
The following side effects have been reported with the combination of this medicine and an interferon alfa-2b product in children and adolescents:
Very commonly reported side effects (may affect more than 1 in 10 people): − decreases in the number of red blood cells (that may cause fatigue, shortness of breath, dizziness), decrease in neutrophils (that make you more susceptible to different infections), − decrease in thyroid gland activity (which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms), − feeling depressed or irritable, feeling sick to stomach, feeling unwell, mood swings, tired feeling, trouble falling asleep or staying asleep, virus infection, weakness, − diarrhoea, dizziness, fever, flu-like symptoms, headache, loss of or increase in appetite, loss of weight, decrease in the rate of growth (height and weight), pain on right side of ribs, pharyngitis (sore throat), shaking chills, stomach pain, vomiting, − dry skin, hair loss, irritation, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Commonly reported side effects (may affect up to 1 in 10 people): − decrease in blood clotting cells called platelets (that may result in easy bruising and spontaneous bleeding), − excess of triglycerides in the blood, excess of uric acid (as in gout) in the blood, increase in thyroid gland activity (which may cause nervousness, heat intolerance and excessive sweating, weight loss, palpitation, tremors), − agitation, anger, aggressive behaviour, behaviour disorder, difficulty concentrating, emotional instability, fainting, feeling anxious or nervous, feeling cold, feeling confused, feeling of restlessness, feeling sleepy, lack of interest or attention, mood changes, pain, poor quality sleep, sleepwalking, suicide attempt, trouble sleeping, unusual dreams, wanting to harm yourself, − bacterial infections, common cold, fungal infections, abnormal vision, dry or teary eyes, ear infection, eye irritation or pain or infection, change in taste, changes in your voice, cold sores, coughing, inflamed gums, nose bleed, nose irritation, oral pain, pharyngitis (sore throat), rapid breathing, respiratory infections, scaling lips and clefts in the corners of the mouth, shortness of breath, sinusitis, sneezing, sores in mouth, sore tongue, stuffy or runny nose, throat pain, toothache, tooth abscess, tooth disorder, vertigo (spinning feeling), weakness, − chest pain, flushing, palpitations (pounding heart beat), rapid heart rate, − abnormal liver function, − acid reflux, back pain, bedwetting, constipation, gastroesophageal or rectal disorder, incontinence, increased appetite, inflammation of the membrane of the stomach and intestine, stomach upset, loose stools, − urination disorders, urinary tract infection, − difficult, irregular, or no menstrual period, abnormally heavy and prolonged menstrual periods, disorder of vagina, inflammation of the vagina, testis pain, development of male body traits, − acne, bruising, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), increased or decreased sensitivity to touch, increased sweating, increase in muscle movement, tense muscle, limb pain, nail disorder, numbness or tingling feeling, pale skin, rash with raised spotted lesions, shaky hands, redness of skin or skin disorder, skin discolouration, skin sensitive to sunlight, skin wound, swelling due to a build-up of excess water, swollen glands (swollen lymph nodes), tremor, tumour (unspecified).
Uncommonly reported side effects (may affect up to 1 in 100 people): − abnormal behaviour, emotional disorder, fear, nightmare, − bleeding of the mucous membrane that lines the inner surface of the eyelids, blurred vision, drowsiness, intolerance to light, itchy eyes, facial pain, inflamed gums, − chest discomfort, difficult breathing, lung infection, nasal discomfort, pneumonia, wheezing, − low blood pressure, − enlarged liver, − painful menstruation, − itchy anal area (pinworms or ascarids), blistering rash (shingles), decreased sensitivity to touch, muscle twitching, pain in skin, paleness, peeling of skin, redness, swelling. The attempt to self-harm has also been reported in adults, children, and adolescents. This medicine in combination with an alpha interferon product may also cause: − aplastic anaemia, pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells); this causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy, − delusions, − upper and lower respiratory tract infection, − inflammation of the pancreas, − severe rashes which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes (erythema multiforme, Stevens Johnson syndrome), toxic epidermal necrolysis (blistering and peeling of the top layer of skin). The following other side effects have also been reported with the combination of this medicine and an alpha interferon product: − abnormal thoughts, hearing or seeing images that are not present, altered mental status, disorientation, − angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing), − Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), − bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction), constant cough, − eye problems including damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton wool spots (white deposits on the retina), − enlarged abdominal area, heartburn, trouble having bowel movement or painful bowel movement, − acute hypersensitivity reactions including urticaria (hives), bruises, intense pain in a limb, leg or thigh pain, loss of range of motion, stiffness, sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands). This medicine in combination with peginterferon alfa-2b or interferon alfa-2b may also cause: − dark, cloudy or abnormally coloured urine, − difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw pain, − loss of consciousness, − loss of use, drooping or loss of power of facial muscles, loss of feeling sensation, − loss of vision. You or your caregiver should call your doctor immediately if you have any of these side effects. If you are a HCV/HIV co-infected adult patient receiving anti-HIV treatment, the addition of this medicine and peginterferon alfa may increase your risk of worsening liver function (combined anti-retroviral therapy (cART)) and increase your 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) (NRTI). In HCV/HIV co-infected patients receivingcART, the following other side effects have occurred with the combination of Rebetol hard capsules and peginterferon alfa-2b (not listed above in adults side effects): − appetite decreased, − back pain, − CD4 lymphocytes decreased, − defective metabolism of fat, − hepatitis, − limb pain, − oral candidiasis (oral thrush), − various laboratory blood values abnormalities.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can also help provide more information on the safety of this
How to Store Rebetol
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not store above 30ºC. Do not use this medicine without advice of your doctor or pharmacist if you notice any change in the appearance of the hard capsules. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
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