Ribavirin Teva Pharma B.V. - patient leaflet, side effects, dosage

- If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possi side effects not listed in this leaflet. See section 4.What is in this leaflet:1.2.3.4.5.6.What Ribavirin Teva Pharma B.V. is and what it is used forWhat you need to know before you use Ribavirin Teva Pharma B.V.How to use Ribavirin Teva Pharma B.V.Possible side effectsHow to store Ribavirin Teva Pharma B.V.Contents of the pack and other information1.What Ribavirin Teva Pharma B.V. is and what it is

Ribavirin Teva Pharma B.V. contains the active substance ribavirin. This medicine stops the multiplication of hepatitis C virus. Ribavirin Teva Pharma B.V. must not be used alone.

Depending on the genotype of the hepatitis C virus that you have, your doctor may choose to treat you with a combination of this medicine with other medicines. There may be some further treatment limitations if you have or have not been previously treated for chronic hepatitis C infection. Your doctor will recommend the best course of therapy.

a B.V. and other medicines is used to treat patients who

be used in paediatric patients (children 3 years of age and older and sly treated and without severe liver disease.

ildren and adolescents) weighing less than 47 kg a solution formulation is

rther questions on the use of this medicine, ask your doctor or pharmacist.

you need to know before you use Ribavirin Teva Pharma B.V.

Do not take Ribavirin Teva Pharma B.V.

Do not take Ribavirin Teva Pharma B.V. if any of the following apply to you or the child you are caring for.

Talk to your doctor or pharmacist before taking Ribavirin Teva Pharma B.V. if you:

• – are allergic 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 and breast-feeding”).

• – are breast-feeding

• – had a serious heart problem during the past 6 months

• – have any blood disorders such as anaemia (low blood count), thalassemia or sickle-cell anaemia

Reminder: Please read the “Do not take” section of the Package leaflet for the other medicines used in

combination with this medicine.

Warnings and precautions

There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa. These include:

• Psychiatric and central nervous system effects (such as depression, suicidal thoughts, attempted suicide and aggressive behaviour, etc.). 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
• Severe eye disorders
• Dental and periodontal disorders: Dental and gum disorders have been reported in patients receiving ribavirin in combination with (peg)interferon alfa-2b. 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

Increased hormone related to your thyroid (TSH) in children

Paediatric population

If you are caring for a child and your doctor decides not to defer combination treatment with peginterferon alfa-2b or interferon alfa-2b until adulthood, it is important to understand that this combination therapy induces a growth inhibition that may be irreversible in some patients.

In addition these events have occurred in patients taking Ribavirin Teva Pharma B.V.:

Haemolysis: Ribavirin Teva Pharma B.V. can cause a break down in red blood cells causing anaemia which may impair your heart function or worsen symptoms of heart disease.

can cause a decrease in your platelet and red and white with peginterferon.

Standard blood tests will be taken to check your blood, kidney and liver function.

• – 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 tablets

you or the child you are caring for take, prescribe a different pack size of this medicine, 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.

Seek medical help immediately if you develop symptoms of a severe allergic reaction (such as

reathing, wheezing or hives) while taking this treatment.

o your doctor if you or the child you are caring for:

are a woman of childbearing age (see section “Pregnancy and breast-feeding”).

are a male and your female partner is of childbearing age (see section “Pregnancy and breastfeeding”).

had a previous heart condition or have heart disease.

have another liver problem in addition to hepatitis C infection.

have problems with your kidneys.

have HIV (human immunodeficiency virus) or have ever had any other problems with your immune system.

Please refer to the Package Leaflet of (peg)interferon alfa for more detailed information on these safety issues.

Reminder: Please read the “Warnings and precautions” section of the Package Leaflet for the other medicines used in combination with Ribavirin Teva Pharma B.V. before you begin combination treatment.

Use in children and adolescents

If the child is weighing less than 47 kg or unable to swallow tablets an oral solution of ribavirin is available.

Other medicines and Ribavirin Teva Pharma B.V.

Tell your doctor or pharmacist if you or the child you are caring for, are taking, have recently might take:

• – azathioprine is a medicine that suppresses your immune system, using this medicine in

  combination with ribavirin may increase your risk of developing severe blood disorders.

  – anti-Human Immunodeficiency Virus (HIV) medicines – [nucleoside reversetranscrip­tase

  inhibitor (NRTI ), and/or combined anti-retroviral

  
  

  Taking this medicine in combination with an alpha interferon may increase the risk of lactic acidosis, liver failure, and bloo

  
  
  
  

  HIV medicine alities

  
  

  development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).

  With zidovudine 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 sure that the HIV infection is not getting worse. If it gets worse, your doctor will decide whether or not your Ribavirin Teva Pharma B.V. treatment needs to be changed. Additionally, patients receiving zidovudine with ribavirin in combination with alpha interferons could be at

  
  

  increased risk of developing anaemi of zidovudine and ribavirin in comb

  
  

  Due to the risk of lactic acidosi the use of ribavirin and didan stavudine should be avo Co-infected patients with of worsening liver functi

  
  
  
  
  
  

  combination wi

  
  

  (low number of red blood cells). Therefore the use nation with alpha interferons is not recommended. uild-up of lactic acid in the body) and pancreatitis, is not recommended and the use of ribavirin and

  
  

  ced liver disease receiving cART may be at increased risk ding treatment with an alpha interferon alone or in

  
  

  n may increase the risk in this patient subset.

  
  

  Reminder: Please read used in co treatment

  
  

her medicines” section of the Package Leaflet for the other medicines n with Ribavirin Teva Pharma B.V. before you begin combination medicine.

st-feeding

t you must not take this medicine. This medicine can be very damaging to your mbryo).

Both female and male patients must take special precautions in their sexual activity if there is any possibility for pregnancy to occur:

• Girl or woman of childbearing age:

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.

• Men

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 this medicine and for

3. How to use Ribavirin Teva Pharma B.V.

Take your prescribed dose by mouth with water and during your meal. Do not chew the film-coated tablets. For children or adolescents who cannot swallow a film-coated tablet, an oral solution of ribavirin is available.

Reminder: This medicine is only to be used in combination with other medicines for hepatitis C virus infection. For complete information be sure to read the “How to use” section of the Package Leaflet for the other medicines used in combination with Ribavirin Teva Pharma B.V..

If you take more Ribavirin Teva Pharma B.V. than you should

Tell your doctor or pharmacist as soon as possible.

If you forget to take Ribavirin Teva Pharma B.V.

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 further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Please read the “Possible side effects” section of the Package Leaflet for the other medicines used in combination with Ribavirin Teva Pharma B.V..

Like all medicines, this medicine used in combination with other medicines can cause side effects, although not everybody gets them. Although not all of these unwanted effects may occur, they may need medical attention if they do occur.

Contact your doctor immediately if you notice any of the following side effects occurring during combination treatment with other medicines:

• – chest pain or persistent cough; changes in the way your heart beats; fainting,

• – confusion, feeling depressed; suicidal thoughts or aggressive behaviour, attempt suicide, thoughts about threatening the life of others,

• – feelings of numbness or tingling,

• – trouble sleeping, thinking or concentrating,

• – severe stomach pain; black or tar-like stools; blood in stool or urine; lower back or side pain,

• – painful or difficult urination,

• – severe bleeding from your nose,

• – fever or chills beginning after a few weeks of treatment,

• – problems with your eyesight or hearing,

• – severe skin rash or redness.

  – severe skin rash or redness.

  The following side effects have been reported with the combination of this medicine and an alpha interferon product in adults :

  
  

Very commonly reported side effects (may affect more than 1 in 10 people):

• – decreases in the number of red blood cells (that may cause fatigue, shortness of breath,

dizziness), decrease in neutrophils(that make you more susceptible to different infections),

• – difficulty concentrating, feeling anxious or nervous, mood swings, feeling depressed or irritable,

tired feeling, trouble falling asleep or staying asleep, cough, dry mouth, pharyngitis (sore throat),

• – diarrhoea, dizziness, fever, flu-like symptoms, headache, nausea, shaking chills, virus infection, vomiting, weakness,

loss of appetite, loss of weight, stomach pain,

dry skin, irritation, hair loss, itching, muscle pain, muscle aches, pain in joints and muscles, rash.

Commonly reported side effects (may affect up to 1 in 10 people):

• – decrease in blood clotting cells called platelets that may result in easy bruising and spontaneous bleeding, decrease in certain white blood cells called lymphocytes that help fight infection, decrease in thyroid gland activity (which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms), excess of sugar or uric acid (as in gout) in the blood, low calcium level in the blood, severe anaemia,

• – fungal or bacterial infections, crying, agitation, amnesia, memory impaired, nervousness, abnormal behaviour, aggressive behaviour, anger, feeling confused, lack of interest, mental disorder, mood changes, unusual dreams, wanting to harm yourself, feeling sleepy, trouble sleeping, lack of interest in sex or inability to perform, vertigo (spinning feeling),

• – blurred or abnormal vision, eye irritation or pain or infection, dry or teary eyes, changes in your hearing or voice, ringing in ears, ear infection, earache, cold sores (herpes simplex), change in taste, taste loss, bleeding gums or sores in mouth, burning sensation on tongue, sore tongue, inflamed gums, tooth problem, migraine, respiratory infections, sinusitis, nose bleed, nonproductive cough, rapid or difficult breathing, stuffy or runny nose, thirst, tooth disorder,

• – cardiac murmur (abnormal heart beat sounds), chest pain or discomfort, feeling faint, feeling unwell, flushing, increased sweating, heat intolerance and excessive sweating, low or high blood pressure, palpitations (pounding heart beat), rapid heart rate,

• – bloating, constipation, indigestion, intestinal gas (flatus), increased appetite, irritated colon, irritation of prostate gland, jaundice (yellow skin), loose stools, pain on the right side around your ribs, enlarged liver, stomach upset, frequent need to urinate, passing more urine than usual, urinary tract infection, abnormal urine,

• – difficult, irregular, or no menstrual period, abnormally heavy and prolonged menstrual periods, painful menstruation, disorder of ovary or vagina, breast pain, erectile problem,

• – abnormal hair texture, acne, arthritis, bruising, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), hives, increased or decreased sensitivity to touch, nail disorder, muscle spasms, numbness or tingling feeling, limb pain, pain in joints, shaky hands, psoriasis, puffy or swollen hands and ankles, sensitivity to sunlight, rash with raised spotted lesions, redness of skin or skin disorder, swollen face, swollen glands (swollen lymph nodes), tense muscles, tumour (unspecified), unsteady when walking, water impairment.

Uncommonly reported side effects (may affect up to 1 in 100 people): – hearing or seeing images that are not present, – heart attack, panic attack, – hypersensitivity reaction to the medication

• – inflammation of pancreas, pain in bone, diabetes mellitus,

• – muscle weakness,

Rarely reported side effects (may affect up to 1 in 1,000 people):

• – seizure (convulsions)

• – pneumonia,

• – rheumatoid arthritis, kidney problems,

• – dark or bloody stools, intense abdominal pain

• – sarcoidosis (a disease characterised by persistent fever, w

  • – sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands),

  • – vasculitis.

Very rarely reported – suicide,

• – stroke (cerebrov

  ects (may affect up to 1 in 10,000 people) :

  
  

  scular events).

  
  

Not known side effects (frequency cannot be estimated from the available data): – thoughts about threatening the life of others,

• – mania (excessive or unreasonable enthusiasm),

• – pericarditis (inflammation of the lining of the heart), pericardial effusion [a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself],

• – change in colour of the tongue.

Side effects in children and adolescents

The following side effects have been reported with the combination of this medicine and an interferon

alfa-2b product in children and adolescents :

Very commonly reported side effects (may affect more than 1 in 10 people):

• – decreases in the number of red blood cells (that may cause fatigue, shortness of breath, dizziness), decrease in neutrophils (that make you more susceptible to different infections),

• – decrease in thyroid gland activity (which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms),

• – feeling depressed or irritable, feeling sick to stomach, feeling unwell, mood swings, tired feeling, trouble falling asleep or staying asleep, virus infection, weakness,

• – diarrhoea, dizziness, fever, flu-like symptoms, headache, loss of or increase in appetite, loss of weight, decrease in the rate of growth (height and weight), pain on right side of ribs, pharyngitis (sore throat), shaking chills, stomach pain, vomiting,

• – dry skin, hair loss, irritation, itching, muscle pain, muscle aches, pain in joints and muscles, rash.

Commonly reported side effects (may affect up to 1 in 10 people):

• – decrease in blood clotting cells called platelets (that may result in easy bruising and spontaneous bleeding),

• – excess of triglycerides in the blood, excess of uric acid (as in gout) in the blood, increase in thyroid gland activity (which may cause nervousness, heat intolerance and excessive sweating, weight loss, palpitation, tremors),

• – agitation, anger, aggressive behaviour, behaviour disorder, difficulty concentrating, emotional

instability, fainting, feeling anxious or nervous, feeling cold, feeling confused, feeling of restlessness, feeling sleepy, lack of interest or attention, mood changes, pain, poor quality sleep, sleepwalking, suicide attempt, trouble sleeping, unusual dreams, wanting to harm yourself,

• – bacterial infections, common cold, fungal infections, abnormal vision, dry or teary eyes, ear infection, eye irritation or pain or infection, change in taste, changes in your voice, cold sores, coughing, inflamed gums, nose bleed, nose irritation, oral pain, pharyngitis (sore throat), rapid breathing, respiratory infections, scaling lips and clefts in the corners of the mouth, shortness of breath, sinusitis, sneezing, sores in mouth, sore tongue, stuffy or runny nose, throat pain, toothache, tooth abscess, tooth disorder, vertigo (spinning feeling), weakness,

• – chest pain, flushing, palpitations (pounding heart beat), rapid heart rate,

• – abnormal liver function,

• – acid reflux, back pain, bedwetting, constipation, gastroesophageal or rectal disorder, incontinence, increased appetite, inflammation of the membrane of the stomach and intestine, stomach upset, loose stools,

• – urination disorders, urinary tract infection,

• – difficult, irregular, or no menstrual period, abnormally heavy and prolonged menstrual periods, disorder of vagina, inflammation of the vagina, testis pain, development of male body traits,

• – acne, bruising, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions),

increased or decreased sensitivity to touch, increased sweating, increase in muscle movement, tense muscle, limb pain, nail disorder, numbness or tingling feeling, pale skin, rash with raised spotted lesions, shaky hands, redness of skin or skin disorder, skin discolouration, skin sensitive to sunlight, skin wound, swelling due to a build-up of excess water, swollen glands (swollen lymph nodes), tremor, tumour (unspecified).

nly reported side effects (may affect up to 1 in 100 people):

rmal behaviour, emotional disorder, fear, nightmare,

ing of the mucous membrane that lines the inner surface of the eyelids, blurred vision, siness, intolerance to light, itchy eyes, facial pain, inflamed gums,

• – chest discomfort, difficult breathing, lung infection, nasal discomfort, pneumonia,wheezing,

• – low blood pressure,

• – enlarged liver,

• – painful menstruation,

• – itchy anal area (pinworms or ascarids), blistering rash (shingles), decreased sensitivity to touch, muscle twitching, pain in skin, paleness, peeling of skin, redness, swelling.

The attempt to self-harm has also been reported in adults, children, and adolescents.

This medicine in combination with an alpha interferon product may also cause: aplastic anaemia, pure red cell aplasia (a condition where the body stopped or reduced the production of red blood cells); this causes severe anaemia, symptoms of which would include unusual tiredness and a lack of energy,

delusions, upper and lower respiratory tract infection,

inflammation of the pancreas,

severe rashes which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes (erythema multiforme, Stevens Johnson syndrome), toxic epidermal necrolysis (blistering and peeling of the top layer of skin).

The following other side effects have also been reported with the combination of this medicine and an alpha interferon product:

• – abnormal thoughts, hearing or seeing images that are not present, altered mental status, disorientation,

• – angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing),

• – Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin

and the membranes of the ears, brain and spinal cord),

• – bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction), constant cough,

• – eye problems including damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton wool spots (white deposits on the retina),

• – enlarged abdominal area, heartburn, trouble having bowel movement or painful bowel movement,

• – acute hypersensitivity reactions including urticaria (hives), bruises, intense pain in a limb, leg or thigh pain, loss of range of motion, stiffness, sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands).

This medicine in combination with peginterferon alfa-2b or interferon alfa-2b may also cause:

• – dark, cloudy or abnormally coloured urine,

• – difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw pain,

• – loss of consciousness,

• – loss of use, drooping or loss of power of facial muscles, loss of feeling sensation, – loss of vision.

You or your caregiver should call your doctor immediately if you have any of these side effects.

If you are a HCV/HIV co-infected adult patient receiving anti-HIV treatment , the addition of this medicine and peginterferon alfa may increase your risk of worsening liver function combined antiretroviral therapy (cART) and increase your risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets) (NRTI).

In HCV/HIV co-infected patients receiving cART, the following other side effects have occurred with the combination of ribavirin and peginterferon alfa-2b (not listed above in adults side effects): – appetite decreased, – back pain,

• – CD4 lymphocytes decreased,

• – defective metabolism of fat,

• – hepatitis,

• – limb pain,

• – oral candidiasis (oral thrush),

• – various laboratory blood values abnormalities.

5. How to store Ribavirin Teva Pharma B.V.

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 and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product requires no special storage conditions.

Do not use this medicine if you notice any change in the appearance of the tablets.

Do not throw away any medicines via wastewater or household waste. Ask your pharma throw away medicines you no longer use. These measures will help to protect the enviro

6. Contents of the pack and other informationWhat Ribavirin Teva Pharma B.V. containsThe active substance is Ribavirin. Each film-coated tablet contaiThe other ingredients are

Tablet core; Calcium hydrogen phosphate, crosc ose sodium, povidone, magnesium stearate.

e and contents of the pack

will prescribe the pack size which is best for you.

Marketing Authorisation Holder

Swensweg 5 2031GA Haarlem

The Netherlands

Manufacturer

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

Debrecen H-4042

Hungary

Pharmachemie B.V.