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RIBAVIRIN 200 MG FILM-COATED TABLETS

Active substance(s): RIBAVIRIN

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Ribavirin 200 mg film-coated tablets
Ribavirin 400 mg film-coated tablets
Ribavirin
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- 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 side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Ribavirin is and what it is used for
2. What you need to know before you take Ribavirin
3. How to take Ribavirin
4. Possible side effects
5. How to store Ribavirin
6. Contents of the pack and other information
1. What Ribavirin is and what it is used for
Ribavirin, which is the antiviral active substance of Ribavirin, inhibits the multiplication of
many types of viruses, including the hepatitis C viruses.
Ribavirin is used in combination with interferon alfa-2a to treat certain chronic forms of
hepatitis C (a viral infection of the liver). This includes previously untreated adult patients and
adult patients who have previously been treated for hepatitis C.
Ribavirin should only be used in combination with interferon alfa-2a. It should not be taken
alone.
Please read also the package leaflet for interferon alfa-2a for further information.
2. What you need to know before you take Ribavirin
Do not take Ribavirin:
• if you are allergic to ribavirin or to any of the other ingredients of this medicine (listed in
section 6).
• if you are pregnant or breast-feeding (see section “Pregnancy, breast-feeding and
fertility”).
• if you have had a heart attack or have suffered from any other severe heart disease in the
previous six months.
• if you have advanced liver disease (e.g. your skin has become yellow and you have
excess fluid in your abdomen).
• if you have a blood disorder such as sickle cell anaemia or thalassaemia.
Please read also the package leaflet for interferon alfa-2a for further information.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ribavirin
• if you are a woman of child-bearing age (see section “Pregnancy, breast-feeding and
fertility”).
• if you are a man and your female partner is of childbearing age (see section “Pregnancy,
breast-feeding and fertility”).
• if you have a heart problem. In this case you will need to be monitored carefully. A heart
recording (ECG or electrocardiogram) is recommended prior to and during treatment.
• if you develop a heart problem along with intense fatigue. This may be due to anaemia
caused by Ribavirin.
• if you have ever had anaemia (the risk of developing anaemia is higher in women
compared to men, in general).
• if you have a problem with your liver other than hepatitis C.
• if you have a problem with your kidneys. Ribavirin treatment may need to be decreased
or stopped.
• if you have had an organ transplant (such as liver or kidney) or have one planned in the
near future.
• if you develop symptoms of an allergic reaction such as difficulty in breathing, wheezing,
sudden swelling of the skin and mucous membranes, itching or rashes. Ribavirin
treatment must be stopped immediately and you should seek medical help immediately.
• if you have ever had depression or develop symptoms associated with depression (e.g.
feelings of sadness, dejection, etc) while on treatment with Ribavirin (see section 4).
• if you are an adult who has or had a history of substance abuse (e.g. alcohol or drugs).
• if you are under the age of 18. The efficacy and safety of ribavirin in combination with
peginterferon alfa-2a or interferon alfa-2a have not been sufficiently evaluated in patients
under the age of 18 years.
• if you are co-infected with HIV and are being treated with any anti HIV medicinal
products.
• if you have been withdrawn from previous therapy for hepatitis C because of anaemia or
low blood count.
Before treatment with Ribavirin, kidney function must be tested in all patients. Your doctor
must also test your blood before starting treatment with Ribavirin. The blood tests should be
repeated after 2 and 4 weeks of treatment, and thereafter as frequently as your doctor thinks
is necessary.
If you are a woman of childbearing age, you must have a pregnancy test before starting
treatment with ribavirin , every month during treatment and during the 4 months after
treatment (see section “Pregnancy, breast-feeding and fertility”).
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients
receiving Ribavirin and peginterferon alfa-2a combination therapy. In addition, dry mouth
could have a damaging effect on teeth and membranes of the mouth during long-term
treatment with the combination of ribavirin and peginterferon alfa-2a. 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.
Other medicines and Ribavirin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Patients who also have HIV infection: Tell your doctor if you are being treated for HIV.
Lactic acidosis (a buildup of lactic acid in the body, leading to the blood becoming acidic) and
worsening liver function are side effects associated with HAART (Highly Active Anti-Retroviral
Therapy), an HIV treatment regimen. If you are receiving HAART, the addition of ribavirin to
peginterferon alfa-2a or interferon alfa-2a may increase your risk of lactic acidosis or liver
failure. Your doctor will monitor you for signs and symptoms of these conditions.
If you take zidovudine or stavudine, because you are HIV positive or suffering from AIDS it is
possible that Ribavirin can decrease the effect of these medicines. Therefore your blood will
be checked regularly to make sure the HIV infection is not getting worse. If it does get worse,
your doctor may decide to stop your treatment with Ribavirin. In addition, patients receiving
zidovudine in combination with Ribavirin and alpha interferons are at increased risk of
developing anaemia.
Co-administration of Ribavirin and didanosine, (which is a treatment for HIV) is not
recommended. Certain side effects of didanosine (e.g. liver problems, tingling and painful
arms and /or feet, pancreatitis) may occur more frequently.
Patients receiving azathioprine in combination with ribavirin and peginterferon are at
increased risk of developing severe blood disorders.
Make sure you read the patient leaflet for peginterferon alfa-2a or interferon alfa-2a, to
ensure you know what medicines you can also take while you are taking either of these
medicines.
Ribavirin may remain in your body for up to 2 months, therefore you should check with your
doctor or pharmacist before starting treatment with any of the other medicines mentioned in
this leaflet.
Ribavirin with food and drink
Ribavirin film-coated tablets are normally taken at two times in the day with food (morning
and evening) and should be swallowed whole.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.

Black

P150

Ribavirin
film-coated tablets

P150

Ribavirin
film-coated tablets

Package Leaflet: Information for the patient

Ribavirin can be very harmful to the unborn child; it may cause birth defects. Therefore, if
you are a female patient, it is very important to avoid becoming pregnant during treatment
and during the 4 months after treatment. Ribavirin can damage the sperm and so harm the
embryo (unborn child). Therefore, if you are a male patient, it is very important for your
female partner to avoid becoming pregnant during your treatment and during the 7 months
after treatment.
If you are a woman of childbearing age who is taking Ribavirin, you must have a negative
pregnancy test before treatment, each month during therapy and for the 4 months after
treatment is stopped. You must use an effective contraceptive during the time you are taking
the treatment and for 4 months after stopping treatment. This can be discussed with your
doctor. If your male partner is being treated with Ribavirin, please see the section “If you are
a man”.
If you are a man who is taking Ribavirin, do not have sex with a pregnant woman unless you
use a condom. This will lessen the chance 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 partner must use an effective contraceptive during the time you are taking the
treatment and for 7 months after stopping treatment. This can be discussed with your doctor.
Please see “if you are a woman” if your female partner is treated with Ribavirin.
It is not known whether Ribavirin is excreted in human milk. Women should not breast-feed
while taking Ribavirin as this may harm the baby. If treatment with Ribavirin is necessary,
breast-feeding should be stopped.
Driving and using machines
Ribavirin has very little effect on your ability to drive or use machines.
However, peginterferon alfa-2a or interferon alfa-2a may cause sleepiness, tiredness or
confusion. Do not drive or use any tools or machines, if you develop any of these symptoms.
3. How to take Ribavirin
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure. Your doctor will decide the correct dose for you depending on
your body weight and type of virus.
The recommended dose is:
For 200 mg:
- 800 mg/day: Take 2 Ribavirin 200 mg tablets in the morning and 2 tablets in the evening
- 1000 mg/day: Take 2 Ribavirin 200 mg tablets in the morning and 3 tablets in the evening
- 1200 mg/day: Take 3 Ribavirin 200 mg tablets in the morning and 3 tablets in the evening
For 400 mg:
The recommended dose is:
- 800 mg/day: Take 1 Ribavirin 400 mg tablet in the morning and 1 tablet in the evening
- 1000 mg/day: Patients are advised to take Ribavirin 200 mg tablets
- 1200 mg/day: Patients are advised to take Ribavirin 200 mg tablets
Swallow the tablets whole and take the tablets with food.
The amount of time you have to continue taking Ribavirin film-coated tablets varies from 16
weeks to 72 weeks, depending on the type of virus you are infected with, on treatment
response and whether you have been treated before. Please check with your doctor and
follow the recommended duration of treatment.
If you have any problem with your kidneys, Ribavirin should be used carefully and under
supervision of your doctor.
If you have any problem with your liver you should consult your doctor before starting
treatment with Ribavirin.
If you are over the age of 65 you should consult your doctor before using Ribavirin.
Ribavirin is not recommended for use in patients under the age of 18.
As ribavirin is teratogenic (may cause abnormalities in the unborn child), the tablets should
be handled with care and should not be broken or crushed. If you accidentally touch
damaged tablets, wash thoroughly with soap and water any part of your body which came in
contact with the contents of the tablet. If any powder from the tablets gets in your eyes, rinse
your eyes thoroughly with sterile water, or plain water if sterile water is not available.
If you have the impression that the effect of Ribavirin is too strong or too weak, talk to your
doctor or pharmacist.
If side-effects occur during treatment, your doctor may adapt the dose or stop treatment.
Ribavirin is administered together with interferon alfa-2a.
See also the patient leaflet for interferon alfa-2a for dosing of the concerned product.
If you take more Ribavirin than you should
Contact your doctor or pharmacist as soon as possible.
If you forget to take Ribavirin
Do not take a double dose to make up for a forgotten dose.
If you miss a dose, take it as soon as you remember and take the next dose at the normal
time.
If you stop taking Ribavirin
Only your doctor can decide how your treatment should be discontinued. Never stop the
treatment yourself because the disease, for which you are being treated, can come back or
get worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some people get depressed when taking Ribavirin in combination treatment with an
interferon, and in some cases people have had suicidal thoughts or aggressive behaviour
(sometimes directed against others such as thoughts about threatening the life of the
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.
Growth and development (children and adolescents):
With up to one year of treatment with Pegasys in combination with ribavirin, some children
and adolescents did not grow or gain weight as much as expected. Some children did not
reach their projected height within two years after completing treatment, and this may
affect their final adult height.
During treatment, your doctor will take blood samples regularly to check for changes in your
white blood cells (cells that fight infection), red blood cells (cells that carry oxygen), platelets
(blood clotting cells), liver function or changes in other laboratory values.
Tell your doctor immediately if you notice any of the following side effects occur: severe
chest pain; persistent cough; irregular heartbeat; trouble breathing; confusion; depression;
severe stomach pain; blood in stools (or black, tarry stools); severe nosebleed; fever or
chills; problems with your eyesight. These side effects may all occur when taking ribavirin in
combination with peginterferon alfa-2a or interferon alfa-2a. These side effects can be
serious and you may need urgent medical attention.
Very common side effects with the combination of pegylated alfa interferon and
ribavirin (may affect more than 1 in 10 people):
Blood disorders:
Metabolic disorders:
Psychiatric disorders:
Nervous system disorders:
Respiratory disorders:
Gastrointestinal disorders:
Skin disorders:
Musculoskeletal disorders:
General disorders:

Anaemia (low red cell count)
Loss of appetite
Feeling depressed (feeling low, feeling bad
about yourself or feeling hopeless), inability to
sleep
Headache, difficulty concentrating and
dizziness
Cough, shortness of breath
Diarrhoea, nausea, abdominal pain
Loss of hair, and skin reactions (including
itching, dermatitis and dry skin).
Pain in joints and muscles
Fever, weakness, tiredness, shaking, chills,
pain, injection site irritation and irritability
(getting easily upset)

Infections:

Blood disorders:
Endocrine disorders:
Psychiatric disorders:
Nervous system disorders:

Eye Disorders:
Ear disorders:
Cardiac disorders:
Vascular disorders:
Respiratory disorders:

Gastrointestinal disorders:

Skin disorders:
Musculoskeletal disorders:
Reproductive system disorders:
General disorders:

Upper respiratory infection, bronchitis, fungal
infection of the mouth and herpes (a common
recurring viral infection affecting the lips,
mouth)
Low platelet count (affecting the clotting ability)
and enlarged lymph glands.
Overactive and underactive thyroid gland
Mood /emotion changes, anxiety, aggression,
nervousness, decreased sexual desire
Poor memory, fainting, decreased muscle
strength, migraine, numbness, tingling, burning
sensation, tremor, changes in the sense of
taste, nightmares, sleepiness
Blurry vision, eye pain, eye inflammation and
dry eyes.
Sensation of room spinning, ear pain
Rapid heart rate, pulsation of the heart beats,
swelling in the extremities.
Flushing
Shortness of breath with activity, nose bleeds,
nose and throat inflammation, infections of the
nose and sinuses (air-filled spaces found in the
bones of the head and face), runny nose, sore
throat
Vomiting, indigestion, difficulty swallowing,
mouth ulceration, bleeding gums, inflammation
of tongue and mouth, flatulence (excess
amount of air or gases), constipation, dry
mouth.
Rash, increased sweating, psoriasis, hives,
eczema, sensitivity to sunlight, night sweats
Back pain, joint inflammation, muscle
weakness, bone pain, neck pain, muscle pain,
muscle cramps
Impotence (inability to maintain an erection)
Chest pain, flu-like illness, malaise (not feeling
well), lethargy, hot flushes, thirst, weight
decreased

Uncommon side effects with the combination of pegylated alfa interferon and ribavirin
(may affect up to 1 in 100 people):
Infections:

Lower respiratory tract infections, urinary tract
infection, skin infections
Neoplasms benign and malignant disorders: Liver tumour
Immune disorders:
Sarcoidosis (areas of inflamed tissue occurring
throughout the body), inflammation of the
thyroid.
Endocrine disorders:
Diabetes (high blood sugar)
Metabolic disorders:
Dehydration
Psychiatric disorders:
Thoughts of suicide, hallucinations (abnormal
perceptions), anger
Nervous system disorder:
Peripheral neuropathy (disorder of the nerves
affecting the extremities)
Eye disorder:
Bleeding in the retina (back of the eye)
Ear and labyrinth disorders:
Hearing loss
Vascular disorder:
High blood pressure
Respiratory disorder:
Wheezing
Gastrointestinal disorders:
Gastrointestinal bleeding, inflammation of the
lips, inflammation of the gums
Liver disorders:
Poor functioning of the liver
Rare side effects with the combination of pegylated alfa interferon and ribavirin (may
affect up to 1 in 1000 people):
Infections:
Blood disorders:
Immune system disorders:

Psychiatric disorders:
Nervous system disorders:
Eye disorders:
Cardiac disorders:
Vascular disorders:
Respiratory disorders:
Gastrointestinal disorders:
Liver disorders:
Musculoskeletal disorders:
Injury or poisoning:

Infection of the heart, infection of the external
ear
Severe reduction in red blood cells, white blood
cells and platelets
Severe allergic reaction, systemic lupus
erythematosus (an illness where the body
attacks its own cells), rheumatoid arthritis (an
autoimmun disease)
Suicide, psychotic disorders (severe problems
with personality and deterioration in normal
social functioning).
Coma (a deep prolonged unconsciousness),
seizures, facial palsy
Inflammation and swelling of the optic nerve,
inflammation of the retina, ulceration of the
cornea
Heart attack, heart failure, heart pain, rapid
heart rhythm, rhythm disorders or inflammation
of the lining of the heart
Bleeding in the brain
Interstitial pneumonia (inflammation of the
lungs with fatal outcome), blood clots in the
lung
Stomach ulcer, inflammation of the pancreas
Liver failure, bile duct inflammation, fatty liver
Inflammation of the muscles
Substance overdose

Very rare side effects with the combination of pegylated alfa interferon and ribavirin
(may affect up to 1 in 10,000 people):
Blood disorders:
Immune System disorders:

Eye disorders:
Skin disorders:

Side effects with unknown frequency:
Blood disorders:

Immune System disorders:

Psychiatric disorders:

Eye disorders:
Musculoskeletal disorders:
Renal disorders:

Aplastic anaemia (failure of the bone marrow to
produce red blood cells, white blood cells and
platelets).
Idiopathic (or thrombotic) thrombocytopenic
purpura (increased bruising, bleeding,
decreased platelets, anaemia and extreme
weakness)
Loss of vision
Toxic epidermal necrolysis/ Stevens Johnson
Syndrome/ erythema multiforme (a spectrum of
rashes with varying degrees of severity which
may be associated with blisters in the mouth,
nose, eyes and other mucosal membranes),
angioedema (swelling in the skin and mucosa)
Pure red cell aplasia (a severe form of anaemia
where red blood cell production is decreased or
stopped); it can result in symptoms such as
feeling very tired with no energy.
liver and kidney transplant rejections, Vogt
Koyanagi Harada Syndrome – a rare disease
characterized by loss of vision, hearing, and
skin pigmentation.
mania (episodes of exaggerated elevation of
mood) and bipolar disorders (episodes of
exaggerated elevation of mood alternating with
sadness or hopelessness).
Rare form of retinal detachment with fluid in the
retina
Serious muscle damage and pain.
kidneys stop functioning adequately, other
complaints that suggest kidney problems.

If you are infected with both viruses, HCV and HIV, and are receiving HAART (Highly Active
Anti- Retroviral Therapy), the addition of ribavirin to peginterferon alfa-2a or interferon alfa2a therapy may cause fatal liver failure, peripheral neuropathy (numbness, tingling or pain in
hands or feet), pancreatitis (symptoms may include stomach pain, nausea and vomiting),
lactic acidosis (a build up of lactic acid in the body, leading to the blood becoming acidic),
influenza, pneumonia, affect lability (alterations in mood), apathy (lethargy), tinnitus (ringing
in the ear), pharyngolaryngeal pain (pain in the back of your mouth and throat), cheilitis (dry
and cracked lips), acquired lipodystrophy (increased amount of fat in upper back and neck)
and chromaturia (change in colour of your urine) as side effects.
See also the patient leaflet for peginterferon alfa-2a or interferon alfa-2a for additional
information regarding side effects for the concerned product.
Reporting of side effects
If you get any 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 (see details below).
By reporting side effects you can help provide more information on the safety of this medicine.
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
G¯R-1368 G¿ira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

The United Kingdom
Yellow Card Scheme
Website:
www.mhra.gov.uk/yellowcard

5. How to store Ribavirin
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 label, carton, bottle after
EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 contains
- The active substance is ribavirin.
Each film-coated tablet contains 200 mg of ribavirin.
Each film-coated tablet contains 400 mg of ribavirin.
- The other ingredients are
Tablet core: Cellulose, microcrystalline, starch, pregelatinised (Maize starch), sodium starch
glycolate (Type A), povidone (K-30), silica, colloidal anhydrous, magnesium stearate.
Film coating:
200 mg: HPMC 2910/ Hypromellose (15cP) (E464), titanium dioxide (E171), triacetin
(E1518), iron oxide red (E172), iron oxide yellow (E172), ethyl cellulose (10cP) (E462).
400 mg: Hypromellose 2910 (E464), titanium dioxide (E171), triacetin (E1518), iron oxide
red (E172), iron oxide yellow (E172), talc (E533b).
What Ribavirin looks like and contents of the pack
Film-coated tablet.
Ribavirin 200 mg:
Light pink colored, capsule shaped, film-coated tablets debossed with 'F' on one side and '10' on
the other side.
Ribavirin 400 mg:
Reddish brown colored, oval shaped, beveled biconvex, film-coated tablets debossed with 'F'
on one side and '11' on the other side.
Ribavirin film-coated tablets are available in clear PVC - Aluminium foil blister pack and HDPE
bottle packs with polypropylene closure.
Pack sizes:
Blister pack: 14, 20, 28, 42, 56, 84, 112, 140 and 168 film-coated tablets
HDPE bottle pack:
200 mg: 28, 42, 56, 112, 168 and 500 film-coated tablets
400 mg: 14, 28, 56, 84 and 500 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
UK_
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
MT_

Aurobindo Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront
Floriana FRN 1913
Malta

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
or
ARROW Génériques
26 avenue Tony Garnier
69007 Lyon - France
This medicinal product is authorised in the Member States of the EEA under the
following names:
Cyprus:
Ribavirin Aurobindo 200 mg åðéêáëõììÝíá ìå ëåðôü õìÝíéï äéóêßá
Czech Republic:
Ribavirin Aurobindo 200 mg potahované tablety
Germany:
Ribavirin Aurobindo 200 mg/ 400 mg Filmtabletten
Estonia:
Ribavirin Aurobindo 200 mg
France:
RIBAVIRINE ARROW 200 mg/400 mg, comprimé pelliculé
Lithuania:
Ribavirin Aurobindo 200 mg plëvele dengtos tabletës
Latvia:
Ribavirin Aurobindo 200 mg apvalkotâs tabletes
Malta:
Ribavirin 200 mg/ 400 mg film-coated tablets
Portugal:
Ribavirina Aurobindo
Romania:
Ribavirinã Aurobindo 200 mg comprimate filmate
Spain:
Ribavirina Aurobindo 200 mg comprimidos recubiertos con película
EFG
The united kingdom: Ribavirin 200 mg/ 400 mg film-coated tablets
This leaflet was last revised in 10/2014.

P150

Common side effects with the combination of pegylated alfa interferon and ribavirin
(may affect up to 1 in 10 people):

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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