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Package Leaflet: Information for the patient

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.

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):

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)

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

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):

Lower respiratory tract infections, urinary tract infection, skin infections Liver tumour

Sarcoidosis (areas of inflamed tissue occurring throughout the body), inflammation of the thyroid.

Diabetes (high blood sugar)

Dehydration

Thoughts of suicide, hallucinations (abnormal perceptions), anger

Peripheral neuropathy (disorder of the nerves affecting the extremities)

Bleeding in the retina (back of the eye)

Hearing loss

High blood pressure

Wheezing

Gastrointestinal bleeding, inflammation of the lips, inflammation of the gums 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):

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):

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 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.

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 GJra

Website: www.medicinesauthoritv.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt

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 Generiques 26 avenue Tony Garnier 69007 Lyon - France

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

Cyprus:

Czech Republic:

Germany:

Estonia:

France:

Lithuania:

Latvia:

Malta:

Portugal:

Romania:

Spain:

The united kingdom:

This leaflet was last revised in 10/2014.