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MODERIBA 200MG FILM-COATED TABLETS

Active substance(s): RIBAVIRIN

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PACKAGE LEAFLET

Package leaflet: Information for the user
Moderiba 200mg film-coated tablets
Moderiba 400mg film-coated tablets
Moderiba 600mg 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.
What is in this leaflet
1. What Moderiba Tablets are and what they are used for
2. What you need to know before you take Moderiba Tablets
3. How to take Moderiba Tablets
4. Possible side effects
5. How to store Moderiba Tablets
6. Contents of the pack and other information

1.

What Moderiba Tablets are and what they are used for

Ribavirin, which is the antiviral active substance in Moderiba Tablets, inhibits the multiplication of many
types of viruses, including the hepatitis C viruses.
Ribavirin is used in combination with peginterferon alfa-2a or 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. In patients who are co-infected with HIV and
HCV, ribavirin is only used in combination with peginterferon alfa-2a.
Ribavirin should only be used in combination with peginterferon alfa-2a or interferon alfa-2a. It should not
be taken alone.
Please read also the package leaflet for interferon alfa-2a or peginterferon alfa-2a for further information.

2.

What you need to know before you take you take Moderiba Tablets

Do not take Moderiba Tablets:





if you are allergic to ribavirin or any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or breast-feeding (see section ‘Pregnancy and Breast-feeding’).
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.
if the following situation is applicable; if you are co-infected with HIV and HCV and have
advanced liver disease, in some cases treatment with ribavirin in combination with peginterferon
alfa-2a should not be started. Your doctor will determine if this is the case.

Please read also the package leaflet for peginterferon alfa-2a or interferon alfa-2a for further information.
Warnings and precautions
Talk to your doctor before taking Moderiba Tablets
• if you are a woman of child-bearing age (see section “Pregnancy and breast-feeding”).
• if you are a man and your female partner is of childbearing age (see section “Pregnancy and breastfeeding”).
• 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 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 and
breast-feeding”).
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 Moderiba Tablets
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 build up 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.
Moderiba Tablets with food and drink
Ribavirin is normally taken at two times in the day with food (morning and evening) and should be
swallowed whole.
Pregnancy and breast-feeding
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.
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.
Moderiba Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3.

How to take Moderiba Tablets

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:
- 800 mg/day: Take 400mg in the morning and 400mg in the evening
- 1000 mg/day: Take 400mg in the morning and 600mg in the evening
- 1200 mg/day: Take 600mg in the morning and 600mg in the evening
The tablets should be taken twice a day with food. They should be swallowed whole and not broken or
chewed.
The amount of time you have to continue taking ribavirin 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.
For patients who are co-infected with HIV and HCV the recommended ribavirin dosage varies from 800 to
1200 mg daily in combination with 180 micrograms peginterferon alpha-2a once weekly, depending on your
body weight and on the type of virus you are infected with. 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 peginterferon alfa-2a or interferon alfa-2a.
See also the patient leaflet for peginterferon alfa-2a or interferon alfa-2a for dosing of the concerned product.
If you take more Moderiba Tablets than you should
Contact your doctor or pharmacist as soon as possible.
If you forget to take Moderiba Tablets
If you miss a dose, take it as soon as you remember and take the next dose at the normal time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Moderiba Tablets
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.
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: Anaemia (low red cell count), neutropenia (low white cell count).
Metabolic disorders: Loss of appetite
Psychiatric disorders: Feeling depressed (feeling low, feeling bad about yourself or feeling hopeless),
inability to sleep

Nervous system disorders: Headache, difficulty concentrating and dizziness
Respiratory disorders: Cough, shortness of breath
Gastrointestinal disorders: Diarrhoea, nausea, abdominal pain
Skin disorders: Loss of hair, and skin reactions (including itching, dermatitis and dry skin).
Musculoskeletal disorders: Pain in joints and muscles
General disorders: Fever, weakness, tiredness, shaking, chills, pain, injection site irritation and irritability
(getting easily upset)
Common side effects with the combination of pegylated alfa interferon and ribavirin (may affect up to 1 in
10 people):
Infections: Upper respiratory infection, bronchitis, fungal infection of the mouth and herpes (a common
recurring viral infection affecting the lips, mouth)
Blood disorders: Low platelet count (affecting the clotting ability) and enlarged lymph glands.
Endocrine disorders: Overactive and underactive thyroid gland
Psychiatric disorders: Mood /emotion changes, anxiety, aggression, nervousness, decreased sexual desire
Nervous system disorders: Poor memory, fainting, decreased muscle strength, migraine, numbness, tingling,
burning sensation, tremor, changes in the sense of taste, nightmares, sleepiness
Eye disorders: Blurry vision, eye pain, eye inflammation and dry eyes.
Ear disorders: Sensation of room spinning, ear pain
Cardiac disorders: Rapid heart rate, pulsation of the heart beats, swelling in the extremities.
Vascular disorders: Flushing
Respiratory disorders: 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
Gastrointestinal disorders: Vomiting, indigestion, difficulty swallowing, mouth ulceration, bleeding gums,
inflammation of tongue and mouth, flatulence (excess amount of air or gases), constipation, dry mouth.
Skin disorders: Rash, increased sweating, psoriasis, hives, eczema, sensitivity to sunlight, night sweats
Musculoskeletal disorders: Back pain, joint inflammation, muscle weakness, bone pain, neck pain, muscle
pain, muscle cramps
Reproductive system disorders: Impotence (inability to maintain an erection)
General disorders: 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, pneumonia, 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 1,000
people):
Infections: Infection of the heart, infection of the external ear
Blood disorders: Severe reduction in red blood cells, white blood cells and platelets
Immune system disorders: Severe allergic reaction, systemic lupus erythematosus (an illness where the body
attacks its own cells), rheumatoid arthritis (an autoimmune disease)
Psychiatric disorders: Suicide, psychotic disorders (severe problems with personality and deterioration in
normal social functioning).
Nervous system disorders: Coma (a deep prolonged unconsciousness), seizures, facial palsy
Eye disorders: Inflammation and swelling of the optic nerve, inflammation of the retina, ulceration of the
cornea
Cardiac disorders: Heart attack, heart failure, heart pain, rapid heart rhythm, rhythm disorders or
inflammation of the lining of the heart
Vascular disorders: Bleeding in the brain
Respiratory disorders: Interstitial pneumonia (inflammation of the lungs with fatal outcome), blood clots in
the lung
Gastrointestinal disorders: Stomach ulcer, inflammation of the pancreas
Liver disorders: Liver failure, bile duct inflammation, fatty liver
Musculoskeletal disorders: Inflammation of the muscles
Injury or poisoning: 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: Aplastic anaemia (failure of the bone marrow to produce red blood cells, white blood cells
and platelets)
Immune System disorders: Idiopathic (or thrombotic) thrombocytopenic purpura (increased bruising,
bleeding, decreased platelets, anaemia and extreme weakness)
Eye disorders: Loss of vision
Skin disorders: 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)
Side effects with unknown frequency:
Blood disorders: 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.
Immune System disorders: liver and kidney transplant rejections, Vogt Koyanagi Harada Syndrome – a rare
disease characterized by loss of vision, hearing, and skin pigmentation.
Psychiatric disorders: mania (episodes of exaggerated elevation of mood) and bipolar disorders (episodes of
exaggerated elevation of mood alternating with sadness or hopelessness).
Eye disorders: Rare form of retinal detachment with fluid in the retina
Gastrointestinal disorders: Ischemic colitis (inflammation of the colon from decreased blood supply),
ulcerative colitis (inflammatory disease of the colon).
Musculoskeletal disorders: Serious muscle damage and pain.
Renal disorders: 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 AntiRetroviral Therapy), the addition of ribavirin to peginterferon alfa-2a or interferon alfa-2a 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.
See also the patient leaflet for peginterferon alfa-2a or interferon alfa-2a for additional information regarding
side effects for the concerned product.

5.

How to store Moderiba Tablets

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 the bottle label, after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions. Keep the bottle tightly closed in
order to protect from moisture.
Do not use this medicine if you notice the bottle or packaging is damaged.
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 Moderiba Tablets contain
The active substance is ribavirin.
Each film-coated tablet contains 200, 400 or 600mg of ribavirin.
The other ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, Povidone
and magnesium stearate.
The film coating contains polyvinyl alcohol, titanium dioxide (E171), Macrogol 3350, talc, indigotine
aluminium lake (E132) (200mg), Brilliant Blue FCF aluminium lake (E133) (400mg and 600mg) and
Carnauba wax.
What Moderiba Tablets look like and contents of the pack
This medicine consists of film-coated tablets. The tablets are unscored blue capsule-shaped film-coated
tablets marked with 3RP logo on one side and with ‘200’, ‘400’, ‘600’ on the other. Pack size of 168 filmcoated tablets (for the 200mg) and 56 film-coated tablets (for the 400mg and 600mg).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Three Rivers Global Pharma Limited
Suite A
6 Honduras Street
London
EC1Y 0TH
United Kingdom
Manufacturer:
Penn Pharmaceutical Services Limited
Tafarnaubach Industrial Estate
Tredegar, Gwent
NP22 3AA
United Kingdom
AbbVie Deutschland GmbH & Co. KG
Knollstrasse
67061 Ludwigshafen
Germany

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria

Moderiba 200mg 400mg 600mg Filmtabletten

Belgium

Moderyba 200mg 400mg 600mg Comprimés Pelliculés

Denmark
Estonia

Moderiba Filmovertrukne Tabletter
Moderiba

Finland

Moderiba 200mg 400mg 600mg kalvopäällysteiset tabletit

France

Moderiba 200mg 400mg 600mg Comprimés Pelliculés

Germany
Greece

Moderiba 200mg 400mg 600mg Filmtabletten
Moderiba επικαλυμμένα με λεπτό υμένιο δισκία

Hungary

Moderiba 200mg 400mg 600mg filmtabletta

Ireland

Moderiba 200mg 400mg 600mg film-coated tablets

Italy
Latvia

Moderiba
Moderiba 200mg 400mg 600mg Apvalkotās Tabletes

Lithuania

Moderiba 200mg 400mg 600mg plėvele dengtos tabletės

Luxembourg

Moderyba Comprimés Pelliculés

Netherlands
Poland

Moderyba 200mg 400mg 600mg Filmomhulde Tabletten
Moderiba 200mg 400mg 600mg tabletki powlekane

Romania

Moderiba 200mg 400mg 600mg comprimate filmate

Slovenia

Ribavirin AbbVie 200mg 400mg 600mg filmsko obložene tablete

Spain

Moderiba 200mg 400mg 600mg comprimidos recubiertos con película

Sweden

Moderiba

This leaflet was last revised in 05/2014.

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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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