Ribavirin Mylan (previously Ribavirin Three Rivers)
ribavirin
ribavirin
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Ribavirin Mylan is and what it is used for
What you need to know before you use Ribavirin Mylan
How to take Ribavirin Mylan
Possible side effects
How to store Ribavirin Mylan
Contents of the pack and other information
Medicinal product no longer authorised
Ribavirin Mylan contain the active substance ribavirin. Ribavirin Mylan stops the multiplication of many types of viruses, including hepatitis C virus. Ribavirin Mylan must not be used without interferon alfa-2b, i.e. Ribavirin Mylan must not be used alone.
Previouslyuntreatedpatients:
The combination of Ribavirin Mylan with interferon alfa-2b is used to treat patients 3 years of age and older who have chronic hepatitis C (HCV) infection. For children and adolescents weighing less than 47 kg a solution formulation is available.
Previouslytreatedadultpatients:
The combination of Ribavirin Mylan with interferon alfa-2b is used to treat adult patients with chronic hepatitis C, who have previously responded to treatment with an alpha interferon alone, but whose condition has recurred.
There is no safety or efficacy information on the use of Ribavirin Mylan with pegylated or other forms of interferon (i.e., not alfa-2b).
If any of the following apply to you or the child you are caring for, do not take Ribavirin Mylan, and
are allergic (hypersensitive) to ribavirin or any of the other ingredients of this medicine (listed in section 6).
are pregnant or planning to become pregnant. (see section “Pregnancy, breast-feeding and fertility”)
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 Ribavirin Mylan 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 take” section of the Package Leaflet for interferon alfa-2b before you begin combination treatment with this medicine.
Talk to your doctor or pharmacist before taking Ribavirin Mylan.
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 Ribavirin Mylan hard capsules is not recommended. An oral solution of ribavirin may be available for children 3 years of age and older and adolescents weighing less than 47 kg.
Medicinal product no longer authorised
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, or have a history of substance abuse (e.g., alcohol or drugs).
have ever had depression or develop symptoms associated with depression (e.g. feeling of sadness, dejection, etc.) while on treatment with this medicine (see section 4. “Possible side effects”).
are a woman of childbearing age (see section “Pregnancy, breast-feeding and fertility”).
are a male and your female partner is of childbearing age (see section “Pregnancy, breast- feeding and fertility”)
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 Ribavirin Mylan in combination therapy with an alfa 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 Ribavirin Mylan 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 Ribavirin Mylan 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.
The use of Ribavirin Mylan is not recommended for use in patients under the age of 3 years. An oral solution of ribavirin is available for children 3 years of age and older and adolescents weighing less than 47 kg.
Reminder: Please read the “Warnings and precautions” section of the Package Leaflet for interferon alfa-2b before you begin combination treatment.
Tell your doctor or pharmacist if you or the child you are caring for are taking, have recently taken or might take any other medicines and/or:
-
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 Ribavirin Mylan 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).
Medicinal product no longer authorised
With zidovudine or stavudine, it is not certain if Ribavirin Mylan 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 Ribavirin Mylan 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 alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Reminder: Please read the “Other medicines” section of the Package Leaflet for interferon alfa-2b before you begin combination treatment.
Ribavirin Mylan must be taken with food. See section 3
Pregnancy
If you are pregnant you must not take Ribavirin Mylan. Ribavirin Mylan 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:
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 or your female partner must use an effective contraceptive during the time you are taking ribavirin and for 7 months after stopping treatment. This should be discussed with your doctor (see “Do not take Ribavirin Mylan”).
Breast-feeding
If you are a woman who is breast-feeding, you must not take Ribavirin Mylan. Discontinue breast- feeding before starting to take Ribavirin Mylan.
Ribavirin Mylan does not affect your ability to drive or use machines; however, 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.
Each Ribavirin Mylan hard 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.
Medicinal product no longer authorised
GeneralinformationabouttakingRibavirinMylan
If the child you are caring for is under the age of 3 years, do not administer.
Always take this medicine exactly as your doctor or pharmacist 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 Ribavirin Mylan based on how much you or the child you are caring for weighs.
Blood tests will be done regularly to help your doctor to know if this treatment is working.
Depending upon the results of these tests, your doctor may change/adjust the number of hard capsules you or the child you are caring for take, prescribe a different pack size of Ribavirin Mylan, and/or change the length of time to take this treatment.
If you have or develop severe kidney or liver problems, this treatment will be stopped.
The recommendeddose, according to how much the patient weighs, is shown in the table below:
Look for the line that shows how much the adult or child/adolescent weighs.
Reminder: If the child is under the age of 3 years, do not administer.
Read across on the same line to see how many hard capsules to take.
Reminder: If your doctor’s instructions are different from the amounts in the below table, follow your doctor’s instructions.
If you have any questions about the dose, ask your doctor.
Ribavirin Mylan for oral use - dose based on body weight | ||
If the adult weighs | Usual daily Ribavirin | Number of 200 mg capsules |
(kg) | Mylan dose | |
< 65 | 800 mg | 2 capsules in the morning and 2 capsules in the evening |
65 – 80 | 1,000 mg | 2 capsules in the morning and 3 capsules in the evening |
81 - 105 | 1,200 mg | 3 capsules in the morning and 3 capsules in the evening |
> 105 | 1,400 mg | 3 capsules in the morning and 4 capsules in the evening |
If the child/adolescent weighs (kg) | Usual daily Ribavirin Mylan dose | 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 and corresponding number of hard capsules | |
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 ribavirin is available.
Reminder: Ribavirin Mylan is only to be used in combination with interferon alfa-2b for hepatitis C virus infection. For complete information be sure to read the “How to take” section of the Package Leaflet for interferon alfa-2b.
Interferon medicine that is used in combination with Ribavirin Mylan may cause unusual tiredness; if you are injecting this medicine yourself or giving it to a child, use it at bedtime.
Medicinal product no longer authorised
Tell your doctor or pharmacist as soon as possible.
If you are self-administering treatment, or if you are the caregiver of a child taking Ribavirin Mylan in combination with interferon alfa-2b, 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.
If you have any questions on the use of this medicine, ask your doctor or pharmacists.
Please read the “Possible side effects” section of the Package Leaflet for interferon alfa-2b.
Like all medicines, this medicine 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.
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.
Childrenandadolescents 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.
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 1-12 years after completing treatment.
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.
Medicinal product no longer authorised
The following side effects have been reported with the combination of Ribavirin Mylan and an alpha interferon product in adults:
Very common: 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, pain or redness at the site of injection, hair loss, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Common: 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 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.
Uncommon: 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.
Rare: may affect up to 1 in 1,000 people
Medicinal product no longer authorised
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 rare: may affect up to 1 in 10,000 people
suicide.
stroke (cerebrovascular events).
Not known: 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.
The following side effects have been reported with the combination of Ribavirin Mylan and interferon alfa-2b product in children and adolescents:
Very common: 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, pain or redness at the site of injection, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Common: 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),
Medicinal product no longer authorised
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).
Uncommon: 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 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),
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),
Medicinal product no longer authorised
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.
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.
Reporting of side effects
If you get any of the 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 viathenationalreporting
system listed in Appendix V*. By reporting side effects, you can help provide more information on the safety of this medicine.
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 bottle or blister after EXP. The expiry date refers to the last date of that month.
Do not store the bottles above 30°C.
There are no special storage conditions for capsules packed in blisters.
Do not use this medicine if you notice any change in the appearance of the 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.
The active substance is ribavirin. Each hard capsule contains 200 mg ribavirin.
Medicinal product no longer authorised
The other ingredients are croscarmellose sodium, lactose monohydrate, microcrystalline cellulose, povidone. The capsule shell contains gelatine and titanium dioxide (E171). The capsule shell imprint contains shellac, propylene glycol, strong ammonia solution, colouring agents (E172, E132, E171).
The Ribavirin Mylan hard capsule is a white, opaque, hard capsule imprinted with green ink. The Ribavirin Mylan hard capsule is available in different pack sizes:
High-density polyethylene (HDPE) bottle, closed with a child-resistant (CR) polypropylene (PP) screw cap. Pack sizes of 84, 112, 140 and 168 capsules.
Blisters:
Cardboard box containing 56 or 168 hard capsules in PVC/Aclar – Aluminium foil blisters
Unit Dose Blisters:
Cardboard box containing 56x1, 84x1, 112x1, 140x1, 168x1 hard capsules in PVC/Aclar – Aluminium foil perforated unit dose blisters
Not all pack sizes may be marketed.
Your physician will prescribe the pack size which is best for you.
Generics [UK] Limited, Station Close,
Potters Bar,
Hertfordshire, EN6 1TL
United Kingdom.
Penn Pharmaceutical Services Ltd
23-24 Tafarnaubach Industrial Estate, Tredegar,
Gwent, NP22 3AA United Kingom
McDermott Laboratories Ltd t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13 Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Mylan bvba/sprl
Tél/Tel: + 0032 02 658 61 00
Medicinal product no longer authorised
Generics [UK] Ltd Teл.: +44 1707 853000
(United Kingdom)
Mylan Pharmaceuticals s.r.o. Tel: +420 274 770 201
Mylan AB
Tlf: + 46 8-555 227 50
(Sweden) Deutschland Mylan dura GmbH
Tel: + 49-(0) 6151 9512 0
Generics [UK] Ltd Tel: +44 1707 853000
(United Kingdom)
Generics Pharma Hellas ΕΠΕ Τηλ: +30 210 9936410
Mylan Pharmaceuticals, S.L. tel: +34 93 378 6400
Mylan SAS
Tel: +33 4 37 25 75 00
(United Kingdom)
Generics [UK] Ltd Tel: +44 1707 853000
(United Kingdom) Luxembourg/Luxemburg Generics [UK] Ltd
Tél/Tel: +44 1707 853000
(United Kingdom) Magyarország Generics [UK] Ltd Tel: +44 1707 853000
(United Kingdom)
George Borg Barthet Ltd Tel: +356 21244205
Mylan B.V
Tel: + +31 (0)33 2997080
Mylan AB
Tlf: + 46 8-555 227 50
(Sweden)
Arcana Arzneimittel GmbH Tel: ++43 1 416 24 18
Mylan Sp. z o.o.
Tel: +48 22 5466400
Mylan Lda.
Tel: + 351 21 412 72 00
Generics [UK]Limited Tel: + 44 1707 853000
Mc Dermott Laboratories Ltd t/a Gerard Laboratories
Tel: 1800 272 272
or +353 (0)1 832 2250
(United Kingdom)
Generics [UK] Ltd Tél: +44 1707 853000
(United Kingdom)
Mylan AB
Sími: + 46 8-555 227 50
(Sweden)
Mylan S.p.A
Tel: + +39/02-61246921
Pharmaceutical Trading Co Ltd Τηλ: +357 24656165
Mylan s r. o
Tel: + 421 2 32 604 901
Mylan OY
Puh/Tel: + 358 9-46 60 03
Mylan AB
Tel: + 46 8-555 227 50
Generics [UK] Ltd Tel: +44 1707 853000
(United Kingdom)
Medicinal product no longer authorised
Scientific conclusions
Taking into account the PRAC Assessment Report on the PSURs for Ribavirin containing medicinal products, the scientific conclusions are as follows:
This PSUSA covers a yearly period with a Data lock point up to 24 July 2013.
The MAH submitted an evaluation of a signal on tongue hyperpigmentation, as requested in the previous PSUR of Ribavirin. The number of cases of tongue pigmentation reported to date with ribavirin and/or peginterferon alfa 2b, even though some of them are insufficiently documented, is significant. In literature case reports, a positive dechallenge (with slowly resolution of symptoms) was generally reported after stopping antiviral therapy which is in favour of drug causality. This
evaluation led to the conclusion that bitherapy with ribavirin and peginterferon can induce tongue pigmentation. PRAC therefore recommends the inclusion of this adverse reaction in section 4.8 of the SmPC of the oral formulations of ribavirin containing products. The package leaflet should be updated accordingly.
Furthermore, it was noted that the following adverse drug reactions should be included across the product information of all the ribavirin containing products: tinnitus, hypotension, vasculitis and cerebrovascular ischaemia. As such PRAC recommended that these adverse drug reactions be added to the product information of those products that do not contain them.
Medicinal product no longer authorised
The CHMP agrees with the scientific conclusions made by the PRAC.
On the basis of the scientific conclusions for Ribavirin containing medicinal products the CHMP is of the opinion that the benefit-risk balance of the medicinal products containing the active substance Ribavirin is favourable subject to the proposed changes to the product information.
The CHMP recommends that the terms of the Marketing Authorisations should be varied.