200 mg hard capsules
ribavirin
What Rebetol is and what it is used for
Rebetol contains the active substance ribavirin. This medicine prevents the proliferation of the hepatitis C virus. Rebetol should not be used alone.
Depending on the genotype of the hepatitis C virus you have, your doctor may choose to treat you with a combination of this medicine and other medicines. Depending on whether you have been previously treated or not treated for chronic hepatitis C infection, there may be additional treatment restrictions. Your doctor will recommend the best treatment.
The combination of Rebetol and other medicines is used in the treatment of adult patients with chronic hepatitis C ( HCV ).
Rebetol can be used in children (aged 3 years and older) and adolescents who have not been treated before and who do not have severe liver disease.
For children and adolescents weighing less than 47 kg, this medicine is available in the form of an oral solution.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What you need to know before using Rebetol
Do not take Rebetol
Do not take Rebetol if any of the following apply to you or the child for whom you are responsible.
If you are not sure, talk to your doctor or pharmacist before taking Rebetol.
- is allergic to ribavirin or any of the other ingredients of this medicine (listed in section 6).
- is pregnant or planning to become pregnant (see section “Pregnancy and breastfeeding”).
- Ammar.
- has had a serious heart problem for the past six months.
- have any blood disease, such as anemia (low red blood cell count ), thalassemia, or sickle cell anemia.
Reminder: Read the “Do not take” section of the package leaflet for the other medicines used in combination with this medicine.
Warnings and cautions
There are several serious side effects associated with combination therapy with ribavirin and (peg) interferon alfa. These include:
- Mental effects and effects on the central nervous system (such as depression, suicidal thoughts, suicide attempts, aggressive behavior, etc.). Be sure to seek emergency care if you notice that you are depressed or have suicidal thoughts or that your behavior is changing. You may want to consider asking a family member or close friend for help in drawing attention to signs of depression or changes in your behavior.
- Serious eye changes
- Dental and gum problems: Dental and gum problems have been reported in patients receiving Rebetol in combination with (peg) interferon alfa ‑ 2b. You should brush your teeth thoroughly twice daily and go for regular dental checkups. In addition, some patients may vomit. If you get this reaction, rinse your mouth thoroughly afterward
- Inability to reach full length as an adult can occur in some children and adolescents
- Increase in hormones that affect the thyroid gland ( TSH ) in children and adolescents
Children and young people
If you are responsible for a child and your doctor decides not to wait for combination therapy with peginterferon alfa ‑ 2b or interferon alfa ‑ 2b until adulthood, it is important to note that this combination therapy causes growth retardation that may be permanent in some patients.
In addition, the following events have occurred in patients taking Rebetol:
Hemolysis: Rebetol can cause a breakdown of red blood cells leading to anemia which can impair your heart function or worsen the symptoms of heart disease.
Pancytopenia: Rebetol may cause a decrease in platelet counts, as well as read and white blood cells when used in combination with peginterferon.
Standard blood tests will be taken to check blood, kidney, and liver function.
- Regular blood tests will be done to help your doctor know if the treatment is working.
- Depending on the results of these tests, your doctor may change/adjust the number of hard capsules you or the child you are responsible for taking, prescribe a different pack size of this medicine, and/or change the duration of treatment.
- If you have or develop severe kidney or liver problems, treatment will be stopped.
Seek medical attention immediately if you develop symptoms of a severe allergic reaction (such as difficulty breathing, wheezing, or hives) during treatment.
Talk to a doctor about you or the child you are responsible for:
- is a woman of childbearing potential (see section “Pregnancy and breastfeeding”).
- is male and your female partner is of childbearing potential (see section “Pregnancy and breast-feeding”).
- previously had a heart condition or have heart disease.
- have any other liver problems in addition to hepatitis C infection.
- if you have kidney problems.
- have HIV ( human immunodeficiency virus) or ever had problems with the immune system.
Read the (peg) interferon alfa package leaflet for more detailed information on these safety issues.
Reminder: Read the “Warnings and Precautions” section of the Package Leaflet for the other medicines used in combination with Rebetol before starting the combination treatment.
Use for children and adolescents
If the child weighs less than 47 kg or can not swallow, Rebetol is available in the form of an oral solution.
Other medicines and Rebetol
Tell your doctor or pharmacist if you or the child you are taking, have recently taken, or might take:
- azathioprine, a drug that suppresses your immune system, which in combination with Rebetol may increase the risk of developing severe blood clots.
- anti-human immunodeficiency virus ( HIV ) ‑drug [reverse nucleoside analog transcriptase ( NRTI ) and/or combined antiretroviral therapy ( cART )]:
- Taking this drug in combination with alpha-interferon and anti – HIV drugs may increase the risk of lactic acidosis, liver failure, and the development of blood clots (decreased number of red blood cells that carry oxygen, certain white blood cells that fight infections, and platelets that coagulate the blood).
- With zidovudine or stavudine, it has not been established whether this medicine can change the way these medicines work. Your blood will therefore be tested regularly to ensure that HIV infection does not worsen. If it gets worse, your doctor will decide if your treatment with Rebetol needs to be changed. In addition, patients treated with zidovudine and ribavirin in combination with alpha-interferon may develop anemia (low red blood cell count). Therefore, the use of zidovudine and ribavirin in combination with alpha interferon is not recommended.
- Due to the risk of lactic acidosis (accumulation 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.
- For patients who are concomitantly infected with HCV / HIV, receive cART, and have advanced liver disease, there is a risk that liver function will worsen. The addition of treatment with alpha-interferon alone or in combination with ribavirin may increase that risk in this patient population.
Reminder: Read the “Other medicines” section of the package leaflet for the other medicines used in combination with Rebetol before starting combination therapy with this medicine.
Pregnancy and breastfeeding
If you are pregnant, do not use this medicine. This medicine can be very harmful to your unborn baby (fetus).
Both women and men must take special precautions in their sexual intercourse if there is a possibility that pregnancy will occur:
- Girl or woman of childbearing potential: You must show a negative pregnancy test before treatment, every month during treatment, and for 9 months after the end of treatment. You must use effective contraception during your treatment and for 9 months after the last dose. You should discuss this with your doctor.
- you should not have intercourse with a pregnant woman unless they are using a condom. This reduces the risk of ribavirin remaining in the woman’s body. If your female partner is not pregnant now but is of childbearing potential, she must have a pregnancy test every month during treatment and for 6 months after treatment has ended. You or your female partner must use an effective contraceptive while you are taking Rebetol and for 6 months after stopping treatment. You should discuss this with your doctor (see section “Do not take Rebetol”).
If you are a woman who is breastfeeding, do not use this medicine. Stop breastfeeding before you start taking this medicine.
Driving and using machines
This medicine does not affect your ability to drive or use machines. However, other medicines used in combination with Rebetol may have some effect on your ability to drive and use machines. Therefore, do not drive or use machines if you get tired, drowsy, or confused by this treatment.
Rebetol contains lactose and sodium
Lactose
Each capsule contains a small amount of lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, ie essentially ‘sodium-free’.
How to use Rebetol
General information on how to take this medicine:
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Do not take more than the recommended dose and take the medicine for the time it is prescribed.
Your doctor has determined the correct dose of one of these medicines based on how much you or the child you are responsible for weighs.
Adults
The recommended dose of Rebetol and the duration of treatment depend on the patient’s weight and the medicines used in combination.
Use for children and adolescents
Dosage for children older than 3 years and adolescents depends on how much the person weighs and on the drugs used in combination. The recommended dose of Rebetol used in combination with interferon alfa ‑ 2b or peginterferon alfa ‑ 2b is shown in the table below.
| The rebetol dose is based on body weight when combined with interferon alfa ‑ 2b or peginterferon alfa ‑ 2b in children older than 3 years and adolescents | ||
| If the child/adolescent weighs (kg) | Common daily Rebetoldos | Number of 200 mg capsules |
| 47 – 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 with your meal. Do not chew the hard capsules. For children or adolescents who are unable to swallow hard capsules, there is an oral solution to this medicine.
Reminder: This medicine is used in combination with other medicines to treat hepatitis C virus infection. For complete information, read the section “How to take” in the package leaflets of 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/miss the missed dose as soon as possible on the same day. If a full day has passed, consult your doctor. Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Although not all of these side effects occur, they may require medical attention if they do occur.
The side effects in this section were mainly observed when ribavirin was used in combination with drugs containing interferon.
When this drug was used in combination with other drugs to treat hepatitis C (also called direct-acting antivirals ) in clinical trials in adults, the most common side effects were low red blood cell count ( anemia ), nausea, vomiting, fatigue, fatigue, difficulty to fall asleep, cough, shortness of breath, itching, and rash.
Also, read the package leaflet for the other medicines used in combination with ribavirin for information on the side effects of these products.
Tell your doctor immediately if you notice any of the following side effects occurring with combination therapy with other medicines:
- chest pain or persistent cough, changes in how your heart beats, fainting,
- confusion, depression, suicidal ideation or aggressive behavior, suicide attempts, thoughts of threatening others to live,
- numbness or stinging sensation,
- difficulty sleeping or thinking or concentrating,
- severe abdominal pain, black or tar-like stools, blood in the stools or urine, pain in the lower back or side,
- painful or awkward urination,
- severe bleeding from the nose,
- fever or chills that occur after a few weeks of treatment,
- problems with your vision or hearing,
- severe skin rash or severe redness.
The following side effects have been reported with combination therapy with hard capsules of this medicine and an alpha interferon product in adults :
Very common side effects reported (may affect more than 1 user in 10):
- decreased number of red blood cells (which can cause fatigue, shortness of breath, and dizziness), decrease in some white blood cells (which makes you more susceptible to various infections ),
- difficulty concentrating, feeling anxious or nervous, mood swings, depression or irritability, feeling tired, difficulty falling asleep or sleeping,
- cough, dry mouth, inflammation of the throat (sore throat),
- diarrhea, dizziness, fever, flu-like symptoms, headache, nausea, chills, viral infection, vomiting, weakness,
- decreased appetite, weight loss, abdominal pain,
- dry skin, irritation, hair loss, itching, muscle aches, muscle aches, joint and muscle pain, and rash.
Commonly reported side effects ( may affect up to 1 in 10 people):
- Decreased platelet count (which is involved in coagulation ), which can cause bruising and spontaneous bleeding, decreased white blood cell count lymphocytes that help fight infection, decreased thyroid activity (which can make you feel tired, depressed, do that you become sensitive to cold and other symptoms), excess sugar and uric acid (as in gout ) in the blood, low calcium levels in the blood, severe anemia,
- fungal or bacterial infections, crying, upset, memory loss, memory loss, nervousness, abnormal behavior, aggressive behavior, anger, confusion, lack of interest, mental disorder, mood swings, unusual dreams, desire to hurt oneself, drowsiness, lack of sleep, absence. or ability to have sex, dizziness (feeling of rotation),
- blurred vision or abnormal vision, irritation or pain or infection in the eyes, dry or watery eyes, hearing or voice changes, tinnitus, ear infection, earache, cold sores ( herpes simplex), taste changes, loss of taste, bleeding gums or sores in the mouth, burning sensation on the tongue, sore tongue, inflamed gums, dental problems, migraines, respiratory infections, sinusitis, nosebleeds, dry cough, rapid or difficult breathing, stuffy or runny nose, thirst, dental disease
- wheezing (abnormal sounds from the heartbeat), chest pain or discomfort, fainting, malaise, swelling, increased sweating, heat intolerance and profuse sweating, low or high blood pressure, palpitations (beating heartbeat), rapid heartbeat,
- bloating, constipation, stomach upset, flatulence, increased appetite, intestinal irritation, prostate irritation, jaundice (yellowish skin), loose stools, pain on the right side of the ribs, enlarged liver, upset stomach, frequent need to urinate, urinate more than common, urinary tract infection, abnormal urine,
- severe, irregular or absent menstruation, abnormally heavy and long periods of menstruation, painful menstruation, ovarian or vaginal disorders, chest pain, erection problems,
- abnormal hair structure, acne, arthritis, bruising, eczema (inflamed, red, itchy, and dry skin possibly with exuding sores), hives, increased or decreased sensitivity to touch, nail problems, muscle twitching, numbness or tingling sensation, pain in an arm or leg, joint pain, trembling hands, psoriasis, swollen hands and ankles, sensitivity to sunlight, raised skin rashes, reddening or skin problems, facial swelling, swollen glands (swollen lymph nodes ), tense muscles, tumor (unspecified), unsteady gait, dehydration.
Uncommon reported side effects ( may affect up to 1 in 100 people):
- to hear and see images that do not exist,
- heart attack, panic attack,
- hypersensitivity reaction to the drug,
- pancreatitis, bone pain, diabetes mellitus,
- muscle weakness.
Rarely reported side effects ( may affect up to 1 in 1,000 people) :
- cramps,
- pneumonia,
- rheumatoid arthritis, kidney problems,
- dark or bloody stools, intense abdominal pain,
- sarcoidosis (a disease characterized by persistent fever, weight loss, aching and swollen joints, skin changes, and swollen glands ),
- inflammation of the vessel wall.
Very rarely reported side effects ( may affect up to 1 in 10,000 people) :
- suicide,
- stroke (cerebrovascular events).
No known frequency of side effects (affects an unknown number of users):
- thoughts of threatening others to live,
- mania (excessive or unfounded enthusiasm),
- pericarditis ( inflammation of the pericardium), pericardial effusion (fluid accumulation that develops between the pericardium and the heart itself),
- discoloration of the tongue.
Side effects are in children and adolescents
The following side effects have been reported with combination therapy with this drug and an interferon alfa-2b product in children and adolescents :
Very common side effects reported (may affect more than 1 user in 10):
- decreased number of red blood cells (which can cause fatigue, shortness of breath, and dizziness), decrease in some white blood cells (which makes you more susceptible to various infections ),
- decreased thyroid activity (which may make you feel tired, depressed, make you sensitive to colds and other symptoms),
- depression or irritability, feeling sick to the stomach, feeling sick, mood swings, feeling tired, difficulty falling asleep or sleeping viral infection, weakness,
- diarrhea, dizziness, fever, flu-like symptoms, headache, decreased or increased appetite, weight loss, decrease in growth rate (height and weight), pain on the right side of the ribs, inflammation of the throat (sore throat), chills, abdominal pain, vomiting,
- dry skin, hair loss, irritation, itching, muscle aches, muscle aches, joint and muscle pain, and rash.
Commonly reported side effects ( may affect up to 1 in 10 people) :
- decreased platelet counts, cells involved in coagulation (it can cause bruising and spontaneous bleeding),
- excess fats ( triglycerides ) in the blood, excess uric acid (as in gout ) in the blood, increased thyroid activity (which can make you nervous, intolerant of heat and sweat a lot, lose weight, have palpitations, tremble),
- agitation, anger, aggressive behavior, behavioral disorders, difficulty concentrating, emotional instability, fainting, feeling of anxiety or nervousness, feeling cold, confusion, restlessness, tiredness, lack of interest and attention, mood swings, drowsiness, drowsiness, drowsiness dreams, the desire to hurt oneself,
- bacterial infections, colds, fungal infections, abnormal vision, dry or watery eyes, ear infections, irritation or pain or infection in the eyes, taste changes, voice changes, cold sores, cough, inflamed gums, nosebleeds, irritation of the nose, pain in the mouth, inflammation of the throat (sore throat ), rapid breathing, respiratory infections, flaking lips and self-cracks in the mouth pores, shortness of breath, sinusitis, sneezing, sores in the mouth, sore tongue, stuffy or runny nose, sore throat, toothache, teeth problems (including warts), dizziness (feeling of rotation), weakness,
- chest pain, hot flashes, palpitations (beating heartbeat), rapid heartbeat,
- liver dysfunction,
- acid regurgitation, back pain, bedwetting, constipation, problems with the stomach or rectum, incontinence, increased appetite, inflammation of the gastrointestinal mucosa, upset stomach, loose stools,
- urination problems, urinary tract infection,
- severe, irregular or absent menstruation, abnormally heavy and long periods of menstruation, vaginal problems, inflammation of the vagina, pain in the testicles, development of male body features,
- acne, bruising, eczema (inflamed, red, itchy, and dry skin possibly with exuding sores), increased or decreased sensitivity to touch, increased sweating, increased muscle movements, tense muscles, pain in the extremities, nail problems, numbness or tingling sensation, pale skin, rash with raised patchy changes, trembling hands, reddening of the skin or skin problems, discoloration of the skin, skin sensitive to sunlight, skin ulcers, swelling due to accumulation of water, swollen glands (swollen lymph nodes), tremors, tumor (unspecified).
Uncommon reported side effects ( may affect up to 1 in 100 people):
- abnormal behavior, emotional disturbances, fear, nightmares,
- bleeding in the mucous membranes covering the inner surface of the eyelids, blurred vision, drowsiness, photosensitivity, itchy eyes, facial pain, inflamed gums,
- chest problems, difficulty breathing, infection of the lungs, discomfort from the nose, pneumonia, wheezing / wheezing,
- low blood pressure,
- enlarged liver,
- painful menstruation,
- itchy rectal opening (tapeworm or flushing worm), a rash with blisters ( shingles ), decreased sensitivity to touch, muscle twitching, skin pain, pallor, flaky skin, redness, swelling.
Self-harm attempts have also been reported in adults, children, and adolescents.
This medicine in combination with an alpha interferon product may also cause:
- aplastic anemia, lack of red blood cells (a condition in which the body stops or reduces the production of red blood cells ); this can cause severe anemia with symptoms that may include unusual tiredness and lack of energy,
- delusions,
- upper and lower respiratory tract infection,
- inflammation of the pancreas,
- severe skin rash that may be associated with blisters in the mouth, nose, eyes, or other mucous membranes (erythema multiforme, Stevens-Johnson syndrome ), toxic epidermal necrolysis (blisters and flaking of the upper layer of skin).
The following other side effects have also been reported when treatment with this medicine is combined with an alpha interferon product:
- abnormal thoughts, hearing or visual hallucinations, altered mental state, disorientation,
- angioedema (swollen hands, feet, ankles, face, lips, mouth, or throat which may make it difficult to swallow or breathe),
- Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disease that affects the eyes, skin, and membranes in the ears, brain, and spinal cord),
- bronchoconstriction and anaphylaxis (a severe allergic reaction throughout the body), persistent cough,
- eye problems including damage to the retina, narrowing of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton exudate (white spots on the retina),
- enlarged abdomen, heartburn, problems with bowel movements or painful bowel movements,
- Acute hypersensitivity reactions include urticaria (hives), bruising, intense pain in one extremity, leg, or thigh, loss of range of motion, stiffness, and sarcoidosis (a disease characterized by persistent fever, weight loss, joint pain and swelling, skin damage, and swollen glands ).
This medicine in combination with peginterferon alfa-2b or interferon alfa-2b may also cause:
- dark, cloudy, or abnormally colored urine,
- difficulty breathing, altered heartbeat, chest pain, pain in the lower left arm, pain in the jaw,
- loss of consciousness,
- loss of ability to use facial muscles, sagging or weakened facial muscles, loss of sensation,
- vision loss.
You or your guardian should talk to a doctor immediately if you get any of these side effects.
If you are an adult and infected with both HCV / HIV and receiving anti- HIV treatment, the addition of this medicine and peginterferon alfa may increase the risk of hepatic impairment (combined antiretroviral therapy (cART)) and increase the risk of lactic acidosis, liver failure and the development of abnormal blood counts (decrease in the number of red blood cells that carry oxygen, certain white blood cells that fight infections and blood cells that coagulate and are called platelets ) (NRTIs).
In patients with concomitant HCV and HIV infection who receive cART, the following other side effects have occurred with the combination of Rebetol hard capsules and peginterferon alfa-2b (not listed above as side effects in adults):
- decreased appetite,
- back pain,
- decrease in CD4 lymphocyte count,
- disturbed fat metabolism,
- hepatitis,
- pain in the extremity you,
- mouth infection caused by candida fungi (cod),
- abnormal laboratory values for the blood.
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 expiration date is the last day of the specified month.
Do not store above 30 ° C.
Do not use this medicine if you notice any change in the appearance of the hard capsules without consulting a doctor or pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is ribavirin 200 mg.
- The other ingredients are microcrystalline cellulose, lactose monohydrate (40 mg), croscarmellose sodium, and magnesium stearate. The capsule cover contains gelatin, and titanium dioxide (E 171). The capsule print contains shellac, propylene glycol (E 1520), ammonium hydroxide, and dye (E 132).
What the medicine looks like and the contents of the pack
This medicine is a white, opaque, hard capsule with blue ink.
This medicine is available in different pack sizes containing 84, 112, 140, or 168 200 mg capsules to be swallowed.
Not all pack sizes may be marketed.
Your doctor will prescribe the pack size that is best for you.
Marketing Authorization Holder and Manufacturer
| Marketing Authorization Holder : | Manufacturer : |
| Merck Sharp & Dohme BVWaarderweg 392031 BN HaarlemNetherlands | SP Labo NVIndustrial Park 30B-2220 Heist-op-den-BergBelgium |
Contact the representative of the marketing authorization holder to find out more about this medicine:
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