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- Taking this medicine in combination with an alpha and an anti-HIV medicine may increase PACKAGE LEAFLET: the risk of lactic acidosis, liver failure, and blood INFORMATION FOR THE USER abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood Ribavirin 200 mg capsules cells that fight , and blood clotting cells called ribavirin platelets). - With or stavudine, it is not certain if this medicine will change the way these medicines work. Therefore, your blood will be checked regularly to be Read all of this leaflet carefully before you start taking sure that the HIV infection is not getting worse. If it this medicine because it contains important information gets worse, your doctor will decide whether or not your for you. Ribavirin treatment needs to be changed. Additionally, - Keep this leaflet. You may need to read it again. patients receiving zidovudine with ribavirin in - If you have any further questions, ask your doctor or combination with alpha could be at pharmacist. increased risk of developing anaemia (low number of - This medicine has been prescribed for you only. Do not red blood cells). Therefore the use of zidovudine and pass it on to others. It may harm them, even if their signs ribavirin in combination with alpha interferons is not of illness are the same as yours. recommended. - If you get any side effects, talk to your doctor or - Due to the risk of lactic acidosis (a build-up of lactic pharmacist. This includes any possible side effects not acid in the body) and pancreatitis, the use of ribavirin listed in this leaflet. See section 4. and is not recommended and the use of ribavirin and stavudine should be avoided. What is in this leaflet - Co-infected patients with advanced 1. What Ribavirin is and what it is used for receiving (cART) may be at increased risk of worsening 2. What you need to know before you take Ribavirin liver function. Adding treatment with an alfa interferon 3. How to take Ribavirin alone or in combination with ribavirin may increase the 4. Possible side effects risk in this patient subset. 5. How to store Ribavirin Reminder: Please read the “Other medicines” section of the 6. Contents of the pack and other information Package Leaflet for the other medicines used in combination 1. What Ribavirin is and what it is used for with Ribavirin before you begin combination treatment with this medicine. Ribavirin contain the active substance ribavirin. This and breast-feeding and fertility medicine stops the multiplication of C . Ribavirin must not be used alone. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or Depending on the genotype of the virus that pharmacist for advice before taking this medicine. you have, your doctor may choose to treat you with a combination of this medicine with other medicines. There If you are pregnant you must not take this medicine. may be some further treatment limitations if you have or This medicine can be very damaging to your unborn baby have not been previously treated for chronic hepatitis C (embryo). infection. Your doctor will recommend the best course of Both female and male patients must take special therapy. precautions in their sexual activity if there is any possibility The combination of Ribavirin and other medicines is used to for pregnancy to occur: treat adult patients who have chronic hepatitis C (HCV), • Girl or woman of childbearing age: Ribavirin may be used in paediatric patients (children You must have a negative pregnancy test before treatment, 3 years of age and older and adolescents) who are not each month during treatment, and for the 4 months after previously treated and without severe liver disease. treatment is stopped. This should be discussed with your For paediatric patients (children and adolescents) weighing doctor. less than 47 kg a solution formulation is available. • Men: Do not have sex with a pregnant woman unless you use a 2. What you need to know before you take Ribavirin condom. This will lessen the possibility for ribavirin to be left Do not take Ribavirin in the woman’s body. Do not take Ribavirin if any of the following apply to you or If your female partner is not pregnant now but is of the child you are caring for. childbearing age, she must be tested for pregnancy each month during treatment and for the 7 months after treatment If you are not sure, talk to your doctor or pharmacist has stopped. You and your female partner must use an before taking Ribavirin. effective contraceptive during the time you are taking - If you are allergic to ribavirin or any of the other Ribavirin and for 7 months after stopping treatment. This ingredients of this medicine (listed in section 6). should be discussed with your doctor (see section “Do not - Are pregnant or planning to become pregnant. (see take Ribavirin”). section “pregnancy,breast-feeding and fertility). - Are breast-feeding. If you are a woman who is breast-feeding, you must not - Had aserious heart problemduring the past 6 months. take this medicine. Discontinue breastfeeding before starting - Have any blood disorder, such as anaemia (low blood to take this medicine. count), thalassemia or sickle-cell anaemia. Driving and using machines Children and adolescents must not take combination This medicine does not affect your ability to drive or use therapy with Ribavirin and alpha interferon when there is machines; however, other medicines used in combination existence or history of serious nervous or mental problems, with Ribavirin may affect your ability to drive or use such as severe depression, suicidal thoughts or attempted machines. suicide. Therefore, do not drive or use machines if you become tired, sleepy, or confused from this treatment. You should tell your doctor if you have suffered from any other serious illness in the past. Ribavirin contains lactose If you have been told by your doctor that you have an - Reminder: Please read the “Do not take” section of intolerance to some sugars, contact your doctor before the package leaflet for the other medicines used in taking this medicinal product. combination with this medicine. Ribavirin contains Sodium Warnings and precautions This medicine contains less than 1 mmol sodium (23 mg) Talk to your doctor or pharmacist before taking Ribavirin per capsule that is to say essentially ‘sodium free’ There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg) interferon 3. How to take Ribavirin alfa. These include: • Psychiatric and central nervous system effects (such General information about taking this medicine: as depression, suicidal thoughts, attempted suicide and Always take this medicine exactly as your doctor or aggressive behaviour, etc.). Be sure to seek emergency pharmacist has told you. Check with your doctor or care if you notice that you are becoming depressed or pharmacist, if you are not sure. have suicidal thoughts or change in your behaviour. You Do not take more than the recommended dosage and take may want to consider asking a family member or close the medicine for as long as prescribed. friend to help you stay alert to signs of depression or Your doctor has determined the correct dose of this changes in your behaviour medicine based on how much you or the child you are • Severe eye disorders caring for weighs. • Dental and periodontal disorders: Dental and gum disorders have been reported in patients receiving Adults Ribavirin in combination with (peg) -2b. The recommended dose and duration of Ribavirin depends You should brush your teeth thoroughly twice daily on how much the patient weighs and the medicines that are and have regular dental examinations. In addition used in combination. some patients may experience vomiting. If you have Use in children and adolescents this reaction, be sure to rinse your mouth thoroughly Dosing for children above 3 years of age and adolescents afterwards depends on how much the person weighs and the • Inability to achieve full adult height may occur in some medicines that are used in combination. The recommended children and adolescents dose of Ribavirin combined with interferon alfa-2b or • Increased hormone related to your thyroid (TSH) in peginterferon alfa-2b, is shown in the below table. children and adolescents Paediatric population Ribavirin based on body weight when used in combination If you are caring for a child and your doctor decides not with interferon alfa-2b or peginterferon alfa-2b in children to defer combination treatment with peginterferon alfa- above 3 years of age and adolescents 2b or interferon alfa-2b until adulthood, it is important to If the Usual daily understand that this combination therapy induces a growth child/ Ribavirin Number of 200 mg capsules inhibition that may be irreversible in some patients. adolescent dose In addition these events have occurred in patients taking weighs (kg) Ribavirin: 1 capsule in the morning and 2 47 – 49 600 mg Haemolysis: Ribavirin can cause a break down in red blood capsules in the evening cells causing anaemia which may impair your heart function 2 capsules in the morning and 2 or worsen symptoms of heart disease. 50 – 65 800 mg capsules in the evening Pancytopenia: Ribavirin can cause a decrease in your > 65 see adult dose platelet and red and white blood cell count when used in combination with peginterferon. Take your prescribed dose by mouth with water and during Standard blood tests will be taken to check your blood, your meal. Do not chew the hard capsules. For children or kidney and liver function. adolescents who cannot swallow a hard capsule, an oral - Blood tests will be done regularly to help your doctor to solution of this medicine is available. know if this treatment is working. Reminder: This medicine is used in combination with other - Depending upon the results of these tests, your doctor medicines for infection. For complete may change/adjust the number of hard capsules you or information be sure to read the “How to use” section of the the child you are caring for take, prescribe a different Package Leaflet for the other medicines used in combination pack size of this medicine, and/or change the length of with Ribavirin. time to take this treatment. If you have or develop severe kidney or liver problems, this If you take more Ribavirin than you should treatment will be stopped. Tell your doctor or pharmacist as soon as possible. Seek medical help immediately if you develop symptoms If you forget to take Ribavirin of a severe allergic reaction (such as difficulty in breathing, Take/administer the missed dose as soon as possible during wheezing or hives) while taking this treatment. 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 Talk to your doctor if you or the child you are caring for: dose. • Are a woman of childbearing age (see section If you have any further questions on the use of this “Pregnancy, breast-feeding and fertility”) medicine, ask your doctor or pharmacist. • Are a male and your female partner is of childbearing age (see section “Pregnancy, breastfeeding and fertility”) 4. Possible side effects • Had a previous serious heart condition or have heart disease Please read the “Possible side effects” section of the • Have another liver problem in addition to hepatitis C Package Leaflet for the other medicines used in combination infection. with Ribavirin. • Have problems with your kidneys Like all medicines, this medicine used in combination • Have HIV (human immunodeficiency virus) or have ever with other medicines can cause side effects, although not had any other problems with your immune system. everybody gets them. Although not all of these unwanted Please refer to the Package Leaflet of (peg) interferon alfa effects may occur, they may need medical attention if they for more detailed information on these safety issues. do occur. - Reminder: Please read the “Warnings and precautions” • Severe stomach pain section of the Package Leaflet for the other medicines • Black or tar-like stools used in combination with Ribavirin before you begin • Blood in stool or urine combination treatment. • Severe bleeding from your nose Use in children and adolescents • Fever or chills beginning after a few weeks of treatment If the child is weighing less than 47 kg or unable to swallow • Lower back or side pain an oral solution of ribavirin is available. • Painful or difficult urination • Problems with your eyesight or hearing, Other medicines and Ribavirin • Severe skin rash or redness Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Contact your doctor immediately if you notice any of the following side effects occurring during combination - Azathioprine is a medicine that suppresses your immune treatment with other medicines: system, using this medicine in combination with ribavirin - Chest pain or persistent cough; changes in the way may increase your risk of developing severe blood your heart beats, fainting, disorders. - Confusion, feeling depressed; suicidal thoughts or - Anti- Human Immunodeficiency Virus (HIV) aggressive behaviour, attempt suicide, thoughts medicines– [ reverse transcriptase inhibitor about threatening the life of others, (NRTI), and/or combined anti-retroviral therapy (cART)]:

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- Trouble sleeping, thinking or - Acid reflux, back pain, bedwetting, constipation, concentrating, gastroesophageal or rectal disorder, incontinence, - Severe stomach pain, black or tar-like increased appetite, inflammation of the membrane of the stools, blood in stool or urine, lower back stomach and intestine, stomach upset, loose stools, or side pain, - Urination disorders, urinary tract infection, - Painful or difficult urination, - Difficult, irregular or no menstrual period, abnormally - Severe bleeding from your nose, heavy and prolonged menstrual periods, disorder - Fever or chills beginning after a few of vagina, inflammation of the vagina, testis pain, weeks of treatment, development of male body traits, - Problems with your eyesight or - Acne, bruising, eczema (inflamed, red, itchy and dryness hearing, of the skin with possible oozing lesions), increased or - Severe skin rash or redness. decreased sensitivity to touch, increased sweating, increase in muscle movement, tense muscle, limb The following side effects have been reported with the pain, nail disorder, numbness or tingling feeling, pale combination of this medicine hard capsules and an alpha skin, rash with raised spotted lesions, shaky hands, interferon product in adults: redness of skin or skin disorder, skin discolouration, Very commonly reported side effects (may affect more than skin sensitive to sunlight, skin wound, swelling due to a 1 in 10 people): build-up of excess water, ,swollen glands (swollen lymph - Decreases in the number of red blood cells (that may nodes), tremor, tumour (unspecified). cause fatigue, shortness of breath, dizziness), decrease Uncommonly reported side effects (may affect up to 1 in 100 in neutrophils (that make you more susceptible to people): different ). - Abnormal behaviour, emotional disorder, fear, - Difficulty concentrating, feeling anxious or nervous, nightmare, mood swings, feeling depressed or irritable, tired feeling, - Bleeding of the mucous membrane that lines the inner trouble falling asleep or staying asleep, surface of the eyelids, blurred vision, drowsiness, - Cough, dry mouth, pharyngitis (sore throat) intolerance to light, itchy eyes, facial pain, inflamed - Diarrhoea, dizziness, fever, flu-like symptoms, gums, headache, nausea, shaking chills, virus infection, - Chest discomfort, difficult breathing, lung infection, nasal vomiting, weakness, discomfort, pneumonia, wheezing, - Loss of appetite, loss of weight, stomach pain, - Low blood pressure, - Dry skin, irritation, hair loss, itching, muscle pain, muscle - Enlarged liver, aches, pain in joints and muscles, rash. - Painful menstruation, - Itchy anal area (pinworms or ascarids), blistering rash Commonly reported side effects (may affect up to 1 in 10 (shingles), decreased sensitivity to touch, muscle people): twitching, pain in skin, paleness, peeling of skin, - Decrease in blood clotting cells called platelets that redness, swelling. may result in easy bruising and spontaneous bleeding, decrease in certain white blood cells called lymphocytes The attempt to self-harm has also been reported in adults, that help fight infection, decrease in thyroid gland activity children, and adolescents. (which may make you feel tired, depressed, increase This medicine in combination with an alpha interferon your sensitivity to cold and other symptoms) excess of product may also cause: sugar or uric acid (as in gout) in the blood, low calcium - Aplastic anaemia, pure red cell aplasia (a condition level in the blood, severe anaemia where the body stopped or reduced the production of red blood cells); this causes severe anaemia, symptoms - Fungal or bacterial infections, crying, agitation, amnesia, of which would include unusual tiredness and a lack of memory impaired, nervousness, abnormal behaviour, energy, aggressive behaviour, anger, feeling confused, lack - Delusions of interest, mental disorder, mood changes, unusual - Upper and lower respiratory tract infection, dreams, wanting to harm yourself, feeling sleepy, trouble - Inflammation of the pancreas, sleeping, lack of interest in sex or inability to perform, - Severe rashes which may be associated with blisters in vertigo (spinning feeling) the mouth, nose, eyes and other mucosal membranes - Blurred or abnormal vision, eye irritation or pain or (erythema multiforme, Stevens Johnson syndrome), infection, dry or teary eyes, changes in your hearing toxic epidermal necrolysis (blistering and peeling of the or voice, ringing in ears, ear infection, earache, cold top layer of skin), sores (herpes simplex), change in taste, taste loss, bleeding gums or sores in mouth, burning sensation The following other side effects have also been reported on tongue, sore tongue, inflamed gums, tooth problem, with the combination of this medicine and an alpha migraine, respiratory infections, sinusitis, nose bleed, interferon product: nonproductive cough, rapid or difficult breathing, stuffy or - Abnormal thoughts, hearing or seeing images that are runny nose, thirst, tooth disorder, not present, altered mental status, disorientation, - Cardiac murmur (abnormal heart beat sounds), chest - Angioedema (swelling of the hands, feet, ankles, face, pain or discomfort, feeling faint, feeling unwell, flushing, lips, mouth, or throat which may cause difficulty in increased sweating, heat intolerance and excessive swallowing or breathing), sweating, low or high blood pressure, palpitations - Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the (pounding heart beat), rapid heart rate. membranes of the ears, brain and spinal cord) - Bloating, constipation, indigestion intestinal gas (flatus), - Bronchoconstriction and anaphylaxis (a severe, whole- increased appetite, irritated colon, irritation of prostate body allergic reaction), constant cough, gland, jaundice (yellow skin), loose stools, pain on the - Eye problems including damage to the retina, obstruction right side around your ribs, enlarged liver, stomach of the retinal artery, inflammation of the optic nerve, upset, frequent need to urinate, passing more urine than swelling of the eye and cotton wool spots (white deposits usual, urinary tract infection, abnormal urine, on the retina), - Difficult, irregular, or no menstrual period, abnormally - Enlarged abdominal area, heartburn, trouble having heavy and prolonged menstrual periods, painful bowel movement or painful bowel movement, menstruation, disorder of ovary or vagina, breast pain, - Acute hypersensitivity reactions including urticaria erectile problem, (hives), bruises, intense pain in a limb, leg or thigh pain, - Abnormal hair texture, acne, arthritis, bruising, eczema loss of range of motion, stiffness, sarcoidosis, (a disease (inflamed, red, itchy and dryness of the skin with characterised by persistent fever, weight loss, joint pain possible oozing lesions),hives, increased or decreased and swelling, skin lesions and swollen glands) sensitivity to touch, nail disorder, muscle spasms, numbness or tingling feeling, limb pain, pain at the site This medicine in combination with peginterferon alfa-2b or of injection, pain in joints, shaky hands, psoriasis, puffy interferon alfa-2b may also cause: or swollen hands and ankles, sensitivity to sunlight, rash - Dark, cloudy or abnormally coloured urine. with raised spotted lesions, , redness of skin or skin - Difficulty breathing, changes in the way your heart beats, disorder, swollen face, swollen glands (swollen lymph chest pain, pain down left arm, jaw pain, nodes), tense muscles, tumour (unspecified), unsteady - Loss of consciousness, when walking, water impairment. - Loss of use, drooping or loss of power of facial muscles, loss of feeling sensation, Uncommonly reported side effects (may affect up to 1 in 100 - Loss of vision, people): You or your caregiver should call your doctor - Hearing or seeing images that are not present, immediately if you have any of these side effects. - Heart attack, panic attack, If you are a HCV/HIV co-infected adult patient receiving - Hypersensitivity reaction to the medication, anti-HIV treatment, the addition of this medicine in and - Inflammation of pancreas, pain in bone, diabetes peginterferon alfamay increase your risk of worsening liver mellitus, function (combined anti-retroviral therapy (cART)) and - Muscle weakness. increase your risk of lactic acidosis, liver failure and blood Rarely reported side effects (may affect up to 1 in 1,000 abnormalities development (reduction in number of red people): blood cells which carry oxygen, certain white blood cells - Seizure (convulsions) that fight infection, and blood clotting cells called platelets) - Pneumonia, (NRTI). - Rheumatoid arthritis, kidney problems, In HCV/HIV co-infected patients receiving cART, the - Dark or bloody stools, intense abdominal pain following other side effects have occurred with the - Sarcoidosis (a disease characterised by persistent fever, combination of ribavirin hard capsules and peginterferon weight loss, joint pain and swelling, skin lesions and alfa-2b (not listed above in adults side effects): swollen glands), - Appetite decreased , - Vasculitis. - Back pain, Very rarely reported side effects (may affect up to 1 in - CD4 lymphocytes decreased, 10,000 people): - Defective metabolism of fat, - Suicide. - Hepatitis, - Stroke (cerebrovascular events) - Limb pain, - Oral candidiasis (oral thrush), Not known side effects (frequency cannot be estimated from - Various laboratory blood values abnormalities. the available data): - Thoughts about threatening the life of others, Reporting of side effects If you get any side effects, talk to your doctor or pharmacist - Mania (excessive or unreasonable enthusiasm), or nurse. This includes any possible side effects not listed - Pericarditis (inflammation of the lining of the heart), in this leaflet. You can also report side effects directly via pericardial effusion [a fluid collection that develops the national reporting system listed in Yellow Card Scheme between the pericardium (the lining of the heart) and the Website: www.mhra.gov.uk/yellowcard. or search for MHRA heart itself. Yellow Card in the Google Play or Apple App Store By - Change in colour of the tongue reporting side effects you can help provide more information Side effects in children and adolescents on the safety of this medicine. The following side effects have been reported with the combination of this medicine and an interferon alfa-2b 5. How to store Ribavirin product in children and adolescents: Keep this medicine out of the sight and reach of children. Very commonly reported side effects (may affect more than 1 in 10 people): Do not use this medicine after the expiry date, which is - Decreases in the number of red blood cells (that may stated on the carton/blister after EXP. The expiry date refers cause fatigue, shortness of breath, dizziness) decrease to the last date of that month. in neutrophils (that make you more susceptible to This medicine does not require any special storage different infections), conditions. - Decrease in thyroid gland activity (which may make you Do not throw away any medicines via wastewater or feel tired, depressed, increase your sensitivity to cold household waste. Ask your pharmacist how to throw away and other symptoms), medicines you no longer use. These measures will help - Feeling depressed or irritable, feeling sick to stomach, protect the environment. feeling unwell, mood swings, tired feeling, trouble falling asleep or staying asleep, virus infection, weakness, 6. Contents of the pack and other information - Diarrhoea, dizziness, fever, flu-like symptoms, headache, loss of or increase in appetite, loss of weight, What Ribavirin contains decrease in the rate of growth (height and weight), pain - The active substance is ribavirin. on right side of ribs, pharyngitis (sore throat), shaking Each Ribavirin capsule contains 200 mg of ribavirin. chills, stomach pain, vomiting, - The other ingredients are cellulose, microcrystalline, - Dry skin, hair loss, irritation, itching, muscle pain, muscle lactose monohydrate, povidone, magnesium stearate. aches, pain in joints and muscles, rash. - The capsule shell contains gelatine, titanium dioxide Commonly reported side effects (may affect up to 1 in 10 (E171) and sodium lauryl sulphate. people): - The capsule shell imprint contains shellac, propylene - Decrease in blood clotting cells called platelets (that may glycol, potassium hydroxide, black iron oxide (E 172). result in easy bruising and spontaneous bleeding), What Ribavirin looks like and contents of the pack - Excess of triglycerides in the blood, excess of uric acid Capsule, hard (as in gout) in the blood, increase in thyroid gland activity White / White, size ‘1’ hard gelatin capsules filled with white (which may cause nervousness, heat intolerance and to off-white granular powder and imprinted with ‘E’ on white excessive sweating, weight loss, palpitation, tremors), cap and ‘81’ on white body with black ink. - Agitation, anger, aggressive behaviour, behaviour Ribavirin is available in PVC/PE/PVDC/Aluminium blisters disorder, difficulty concentrating, emotional instability, and HDPE containers in the pack sizes of fainting, feeling anxious or nervous, feeling cold, feeling PVC/PE/PVDC/aluminium blister: 84, 112, 140 and 168 confused, feeling of restlessness, feeling sleepy, lack of capsules interest or attention, mood changes, pain, poor quality HDPE bottle: 42 and 500 capsules sleep, sleepwalking, suicide attempt, trouble sleeping, unusual dreams, wanting to harm yourself, Not all pack sizes may be marketed. - Bacterial infections, common cold, fungal infections, Marketing Authorisation Holder abnormal vision, dry or teary eyes, ear infection, eye Milpharm Limited irritation or pain or infection, change in taste, changes in Ares, Odyssey Business Park your voice, cold sores, coughing, inflamed gums, nose West End Road bleed, nose irritation, oral pain, pharyngitis (sore throat), South Ruislip HA4 6QD rapid breathing, respiratory infections, scaling lips and United Kingdom clefts in the corners of the mouth, shortness of breath, Manufacturer sinusitis, sneezing, sores in mouth, sore tongue, stuffy or

APL Swift Services (Malta) Limited runny nose, throat pain, toothache, tooth abscess, tooth HF26, Hal Far Industrial Estate, Hal Far disorder, vertigo (spinning feeling), weakness Birzebbugia, BBG 3000 - Chest pain, flushing, palpitations (pounding heart beat), Malta rapid heart rate, This leaflet was last revised in 09/2020. - Abnormal liver function, P15XXXXX