Patient leaflet - Ribavirin Teva
What Ribavirin Teva is and what it is used for
Ribavirin Teva contains the active substance ribavirin. This medicine stops the multiplication of hepatitis C virus. Ribavirin Teva 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 o limitations if you have or have not been doctor will recommend the best course
The combination of Ribavirin Te hepatitis C (HCV).
Ribavirin Teva may be use who are not previously trea
r medicines. There may be some further treatment ly treated for chronic hepatitis C infection. Your apy.
other medicines is used to treat patients who have chronic
diatric patients (children 3 years of age and older and adolescents) without severe liver disease.
For paediatric pati available.
ren and adolescents) weighing less than 47 kg a solution formulation is
If you h
rther questions on the use of this medicine, ask your doctor or pharmacist.
hat you need to know before you use Ribavirin Teva
o not take Ribavirin Teva
Do not take Ribavirin Teva 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 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 yo are becoming depressed or have suicidal thoughts or change in your behaviour. You may w to consider asking a family member or close friend to help you stay alert to signs of depress
or changes in your behaviour
Severe eye disorders
Dental and periodontal disorders: Dental and gum disorders have been report receiving ribavirin in combination with (peg)interferon alfa-2b. You should thoroughly twice daily and have regular dental examinations. In addition s experience vomiting. If you have this reaction, be sure to rinse your m afterwards
adolescents lescents
ents ur teeth atients may
Inability to achieve full adult height may occur in some c Increased hormone related to your thyroid (TSH) in c
Paediatric population
If you are caring for a child and your doctor decides not to peginterferon alfa-2b or interferon alfa-2b until adultho combination therapy induces a growth inhibition that
In addition these events have occurred in patie Haemolysis: Ribavirin Teva can cause a br
impair your heart function or worsen sy Pancytopenia: Ribavirin Teva can cause when used in combination with pegi
ombination treatment with mportant to understand that this eversible in some patients.
Ribavirin Teva:
in red blood cells causing anaemia which may
Blood tests will be d Depending upon the capsules y medicine, If you hav
Standard blood tests will be
f heart disease.
rease in your platelet and red and white blood cell count on.
check your blood, kidney and liver function.
larly to help your doctor to know if this treatment is working. sults of these tests, your doctor may change/adjust the number of ld you are caring for take, prescribe a different pack size of this
ge the length of time to take this treatment.
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 difficu in breathing, wheezing or hives) while taking this treatment.
our 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 before you begin combination treatment.
Use in children and adolescents
If the child is weighing less than 47 kg or unable to swallow capsules an oral solution of ribavirin is available.
Other medicines and Ribavirin Teva
Tell your doctor or pharmacist if you or the child you are caring for, are taking, have recently taken o 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 disorder
-
– anti-Human Immunodeficiency Virus (HIV) medicines – [nucleoside reverse transcript
inhibitor (NRTI ), and/or combined anti-retroviral therapy (cART )]:
-
– Taking this medicine in combination with an alpha interferon and an may increase the risk of lactic acidosis, liver failure, and blood abn development (reduction in number of red blood cells which carry oxyge blood cells that fight infection, and blood clotting cells called platelets).
medicine
, certain white
With zidovudine or stavudine , it is not certain if this medi medicines work. Therefore, your blood will be checked r
infection is not getting worse. If it gets worse, your d your Ribavirin Teva treatment needs to be change zidovudine with ribavirin in combination with
e will change the way these to be sure that the HIV
l decide whether or not
itionally, patients receiving interferons could be at increased
risk of developing anaemia (low number of red b od cells). Therefore the use of zidovudine and ribavirin in combination with alpha interferons is not recommended. Due to the risk of lactic acidosis (a bui of lactic acid in the body) and pancreatitis,
the use of ribavirin and didanosine is ecommended and the use of ribavirin and
stavudine should be avoided.
Co-infected patients with advanced liver disease receiving cART may be at increased risk of worsening liver function. Adding treatment with an alpha interferon 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 the other medicines used in combination with R Teva before you begin combination treatment with this medicine.
Both femal possibility
Pregnancy and breast
If you are pregnan unborn baby (em
not take this medicine. This medicine can be very damaging to your
ale patients must take special precautions in their sexual activity if there is any nancy to occur:
l or woman of childbearing age:
ave a negative pregnancy test before treatment, each month during treatment, and for the 4 r treatment is stopped. This should be discussed with your doctor.
Men
Yo
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 7 months after stopping treatment. This should be discussed with your doctor (see section “Do not take Ribavirin Teva”).
If you are a woman who is breast-feeding , you must not take this medicine. Discontinue breastfeeding before starting to take this medicine.
Driving and using machines
This medicine does not affect your ability to drive or use machines; however, other medicines used in combination with Ribavirin Teva 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.
Ribavirin Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.
3. How to use Ribavirin Teva
General information about taking this medicine:
Always take this medicine exactly as your doctor has told you. Check with your doctor or if you are not sure.
Do not take more than the recommended dosage and take the medicine for as lon Your doctor has determined the correct dose of this medicine based on how much are caring for weighs.
bed.
child you
Adults
The recommended dose and duration of Ribavirin Teva depends on h the medicines that are used in combination.
h the patient weighs and
cist
Use in children and adolescents
Dosing for children above 3 years of age and adolescents depends on how much the person weighs and the medicines that are used in combination. The recommended dose of Ribavirin Teva combined with interferon alfa-2b or peginterferon alfa-2b, is s in the below table.
Ribavirin Teva dose based on body wei ___________peginterferon alfa-2b in chil
If the child/adolescent weighs
______________(kg)
47 – 49
en used in combination with interferon alfa-2b or wc 3 years of age and adolescents
50 – 65
> 65
800 mg
ly Ribavirin Teva
dose __________
600 mg
Number of 200 mg capsules
See adult dose
-
1 capsule in the morning and 2 capsules in the evening
-
2 capsules in the morning and 2 capsules in the evening
Take your prescribed dose by mouth with water and during your meal. Do not chew the hard capsules. For children lescents who cannot swallow a hard capsule, an oral solution of ribavirin is available.
Re
is 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.
If you take more Ribavirin Teva than you should Tell your doctor or pharmacist as soon as possible.
If you forget to take Ribavirin Teva
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.
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 durin 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 suici
ghts
r side pain
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; lowe 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.
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
decreases in the number of red blood cells
re than 1 in 10 people):
t 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 cough, dry mouth, pharyngi diarrhoea, dizziness, feve
decreas bleedin
vomiting, weakness, loss of appetite, los dry skin, irri
Commonly repo
—
e symptoms, headache, nausea, shaking chills, virus infection,
ight, stomach pain,
ir loss, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
de effects (may affect up to 1 in 10 people):
d clotting cells called platelets that may result in easy bruising and spontaneous crease 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, weight loss, joint pain and swelling, skin lesions and swollen glands), vasculitis.
t up to 1 in 10,000 people):
Very rarely reported side effects
suicide, stroke (
Not known side effects (frequency cannot be estimated from the available data):
thoughts abou atening the life of others,
mania (exces r 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,
—
colour of the tongue.
cts in children and adolescents
he following side effects have been reported with the combination of this medicine and an interferon pha-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, emoti 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 sleepwalking, suicide attempt, trouble sleeping, unusual dreams, wanting to harm y bacterial infections, common cold, fungal infections, abnormal vision, dry or te infection, eye irritation or pain or infection, change in taste, changes in your voice, sores,
coughing, inflamed gums, nose bleed, nose irritation, oral pain, pharyngitis ( roat), rapid breathing, respiratory infections, scaling lips and clefts in the corners of the th, 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 rate, abnormal liver function,
acid reflux, back pain, bedwetting, constipation, gastroesopha r rectal disorder, incontinence, increased appetite, inflammation of the membrane of omach 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, nd dryness of the skin with possible oozing lesions),
increased or decreased sensitivity to to creased 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 ( cified).
ear
low
ressure,
Uncommonly reported si
abnormal beh bleeding of drowsine chest disco
cts (may affect up to 1 in 100 people): otional disorder, fear, nightmare,
cous membrane that lines the inner surface of the eyelids, blurred vision, rance to light, itchy eyes, facial pain, inflamed gums,
rt, difficult breathing, lung infection, nasal discomfort, pneumonia, wheezing,
—
—
epnalianrged liver,
ful menstruation,
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,
etabolism of fat,
-
– oral candidiasis (oral thrush),
-
– various laboratory blood values abnormalities.
5. How to store Ribavirin Teva
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.
Do not store above 30oC
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.
6. Contents of the pack and other information
What Ribavirin Teva contains
The active substance is Ribavirin 200 mg
The other ingredients are calcium hydrogen phosphate, croscarmellose sodium, povidone, magnesium stearate. The capsule shell contains titanium dioxide (E171) and gelatin. The capsule shell imprint contains shellac, titanium dioxide (E171) and indigo carmine
What Ribavirin Teva looks like and contents of the pack
Ribavirin Teva is a white, opaque, hard capsule im Ribavirin Teva is available in different pack sizes swallowed.
2, 140 or 168 capsules to be
Not all pack sizes may be marketed.
Your physician will prescri
h is best for you.
Marketing Authorisation Holder
Teva B.V.
Swensweg 5 2031GA Haarlem The Netherlands
Ph
Private Limited Company
Teva Pharma SLU
Manufacturer
Teva Pharmaceu Pallagi út 13 Debrecen Hun
mie B.V. eg 5 GA Haarlem e Netherlands
C/C, no4
Poligono Industrial Malpica
50016 Zaragoza
Spain
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373
Lietuva
UAB Teva Baltics
Tel: +370 52660203
Efc^rapufl
TeBa OapMa EAfl
Ten: +359 24899585
Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373
Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111
Danmark
Teva Denmark A/S.
Tlf: +45 44985511
Deutschland
TEVA GmbH
Tel: +49 73140208
Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801
Magyarország
Teva Gyógyszergyár Zrt.
Tel: +36 12886400
Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +353 19127700
Nederland
Teva Nederland B
Tel: +31 8000
Norge
Teva Norway AS
Tlf: +47 66775590
sterreich
atiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070
France
Teva Santé
Tél: +33 1
España
Teva Pharma, S.L.U.
Tel: +34 913873280
EXÀàôa
Specifar A.B.E.E.
Tql: +30 2118805000
România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524
rvatska d.o.o.
85 13720000
Ireland
Teva Pharmaceuticals Ireland
Tel: +353 19127700
Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300
Portugal
Teva Pharma – Produtos Farmacêuticos, Lda.
Tel: +351 214767550
Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390
Island
Teva Finland Oy
Finnland
Smi: +358 201805900
Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911
Italia
Teva Italia S.r.l.
Tel: +39 028917981
Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900
Kùnpoç
Specifar A.B.E.E.
EZZàôa
Tql: +30 2118805000
Sverige
Teva Sweden AB
Tel: +46 42121100
Latvija
UAB Teva Baltics filiale Latvijä
Tel: +371 67323666
United Kingdom
Teva UK Limited
Tel: +44 1977628500
This leaflet was last revised in {MM/YYYY}.
Other sources of information
s Agency website:
Detailed information on this medicine is available on the European M
ines Agency website.
This leaflet is available in all EU/EEA languages on the Europ
48
NR: Non-responder defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment. Plasma HCV-RNA is measured with a research-based quantitative polymerase chain reaction assay by a central laboratory
Overall Responsea(n=118)