Please read the ?Possible side effects? section of the Package Leaflet for interferon alfa-2b.
Like all medicines, Ribavirin Mylan used in combination with an alpha interferon product 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.
Psychiatric and Central Nervous System:
Some people get depressed when taking Ribavirin in combination treatment with an interferon, and in some cases people had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others). Some patients have actually committed suicide. Be sure to seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour. You may want to consider asking a family member or close friend to help you stay alert to signs of depression or changes in your behaviour.
Children and adolescents are particularly prone to develop depression when being treated with ribavirin and interferon alpha. Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.
Growth and development(children and adolescents):
During the one year of treatment with Ribavirin in combination with interferon alfa-2b, some children and adolescents did not grow or gain weight as much as expected. Some children did not reach their projected height within 1-5 years after completing treatment.
Contact your doctor immediately if you notice any of the following side effects occuring during combination treatment with an alpha interferon product:
- 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.
Possible side effects listed below are grouped by frequency of occurrence Very common Common Uncommon Rare Very rare Not known affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000 affects 1 to 10 users in 10,000 affects less than 1 user in 10,000 frequency cannot be estimated from the available data.
The following side effects have been reported with the combination of Ribavirin Mylan and an alpha interferon product in adults:
Very commonly reported side effects:
- 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, pain or redness at the site of injection, hair loss, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Commonly reported side effects:
- 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 at the site of injection, 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:
- 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:
- seizure (convulsions)
- pneumonia,
- diabetes, 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:
- suicide. Not known side effects:
- 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.
The following side effects have been reported with the combination of Ribavirin Mylan and interferon alfa-2b product in children and adolescents:
Very commonly reported side effects:
- 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, pain or redness at the site of injection, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Commonly reported side effects:
- 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 corner 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, irritation or itching at the site of injection, 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
- 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 harm yourself has also been reported in adults, children, and adolescents.
Ribavirin Mylan 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 Ribavirin Mylan 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), stroke (cerebrovascular events)
- 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)
Ribavirin Mylan in combination with 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 symptoms.
For HCV/HIV co-infected patients receiving Ribavirin Mylan in combination with peginterferon alfa-2b, there is an increased risk of lactic acidosis, liver failure and blood abnormalities (reduction in red or white blood cells that fight infection, and blood clotting cells called platelets).
The following additional side effects have occurred in HCV/HIV co-infected patients receiving Ribavirin in combination with peginterferon alfa-2b: oral thrush, changes in the amount and distribution of body fat, reduction in the amount of white blood cells, decreased appetite, increase in gamma-glutamyltransferase (an enzyme produced by the liver, associated with early liver cell damage), back pain, increase amounts of amylase (an enzyme present in the blood) and lactic acid, hepatitis, increased lipase (the enzyme necessary for the absorption and digestion of nutrients in the intestines) and limb pain.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
