patient information leaflet copegus 400mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Copegus 400 mg film-coated tablets

Ribavirin

Read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Copegus is and what it is used for
2. Before you take Copegus
3. How to take Copegus
4. Possible side effects
5. How to store Copegus
6. Further information

1. WHAT COPEGUS IS AND WHAT IT IS USED FOR

Ribavirin, which is the antiviral active substance of Copegus, inhibits the multiplication of many types of viruses, including the hepatitis C viruses.

Copegus 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, adult patients who have previously been treated for hepatitis C. In patients who are co-infected with HIV and HCV, Copegus is only used in combination with peginterferon alfa-2a.

Copegus 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. BEFORE YOU TAKE COPEGUS

Do not take Copegus

if you are allergic (hypersensitive) to ribavirin or to any of the other ingredients of Copegus.
if you have had a heart attack or have suffered from any other severe heart disease in the previous six months.
if you have a blood disorder such as sickle cell anaemia or thalassaemia.
if you have advanced liver disease (e.g. your skin has become yellow and you have excess fluid in your abdomen).
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 Copegus in combination with peginterferon alfa-2a should not be started. Your doctor will determine if this is the case.
if you are pregnant or breast-feeding (see section “Pregnancy and breast-feeding”).

Please read also the package leaflet for peginterferon alfa-2a or interferon alfa-2a for further information.

Take special care with Copegus

Tell your doctor

if you are a woman of childbearing age (see section “Pregnancy and breast-feeding”).
if you are a man and your female partner is of childbearing age (see section “Pregnancy and breast-feeding”).
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 Copegus.
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. Copegus treatment may need to be decreased or stopped.
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. Copegus 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 Copegus (see section 4).
if you are under the age of 18. The efficacy and safety of Copegus 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.

Before treatment with Copegus, kidney function must be tested in all patients. Your doctor must also test your blood before starting treatment with Copegus. 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 Copegus, every month during treatment and during the 4 months after treatment (see section “Pregnancy and breast-feeding”).

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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 Copegus 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 Copegus 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 Copegus.

Co-administration of Copegus 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.

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.

Taking Copegus with food and drink

Copegus film-coated tablets are normally taken at two times in the day with food (morning and evening) and should be swallowed whole.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Copegus 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. Copegus 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 Copegus, you must have a negative pregnancy test before treatment, each month during therapy and for the 4 months after treatment is stopped. You and your partner must each use an effective contraceptive during the time you are taking the treatment and 4 months after stopping treatment. This can be discussed with your doctor. If your male partner is being treated with Copegus, please see the section “If you are a man”.

If you are a man who is taking Copegus, 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 and your partner must each 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 Copegus

Ask your doctor or pharmacist for advice before taking any medicine.

It is not known whether Copegus is excreted in human milk. Women should not breast-feed while taking Copegus as this may harm the baby. If treatment with Copegus is necessary, breast-feeding should be stopped.

Driving and using machines

Copegus 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 COPEGUS

Always take Copegus as your doctor has told you. You should 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 usual dose is:

800 mg/day: Take 1 Copegus 400 mg tablet in the morning and 1 tablet in the evening
1000 mg/day: Patients are advised to take Copegus 200 mg tablets
1200 mg/day: Patients are advised to take Copegus 200 mg tablets

Swallow the tablets whole and take the tablets with food.

The amount of time you have to continue taking Copegus tablets varies from 24 weeks to 48 weeks depending on the type of virus you are infected with. Please check with your doctor and follow the recommended duration of treatment.

For patients who are co-infected with HIV and HCV the recommended dosage of Copegus is 800 mg/day in combination with 180 micrograms once weekly of peginterferon alfa-2a. This treatment should be continued for 48 weeks.

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 Copegus 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.

Copegus is administered together with peginterferon alfa-2a or interferon alfa-2a.

See also the patient leaflet of peginterferon alfa-2a or interferon alfa-2a for dosing of the concerned product.

If you take more Copegus than you should

Contact your doctor or pharmacist as soon as possible.

If you forget to take Copegus

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 Copegus

Only your doctor can decide how your treatment should be continued. 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Copegus can cause side effects, although not everybody gets them.

Some people get depressed when taking Copegus in combination treatment with an interferon, and in some cases people had suicidal thoughts or aggressive behaviour (sometimes directed against 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 Copegus 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 Copegus and peginterferon alfa-2a or interferon alfa-2a (occurring in more than 10 out of 100 patients) are:

flu-like symptoms such as headache, fever, weakness, fatigue, shaking and chills;
cough; shortness of breath;
dizziness;
pain in joints and muscles;
nausea, and diarrhoea; abdominal pain; loss of appetite; loss of weight;
inability to sleep, irritability, difficulty concentrating; feeling depressed;
loss of hair; injection site irritation and skin reactions (including itching, dermatitis and dry skin).

Common side effects with the combination of Copegus and peginterferon alfa-2a or interferon alfa-2a (occurring in more than 5 out of 100 patients) are mood/emotion changes; poor memory, anxiety, vomiting; dry mouth; indigestion; rash; increased sweating and back pain.

Other less common side effects with the combination of Copegus and peginterferon alfa-2a or interferon alfa-2a (occurring in more than 1 out of 100 patients) are; infections of the nose, sinuses, throat or airway; inflammation of the mouth, lip, tongue, nose or throat; blocked sinuses, fungal infection of the mouth, sore throat, difficulty swallowing, thirst, taste disturbance; runny nose; mouth sores, nosebleeds, gingival bleeding; earache; flatulence or wind, blurred vision; eye inflammation; dry eyes; eye pain; numbness or tingling; tremor; migraine; sleepiness; nightmares; night sweats; nervousness, aggression, decreased sexual desire, impotence, fainting; increased sensitivity; muscle weakness, cramps, musculoskeletal pain; arthritis, anaemia, decreased platelets; thyroid disorders; swollen glands; vertigo; swelling; fast heartbeat, palpitations; chest pain, flushing; shortness of breath on exercise; eczema; psoriasis; increased sensitivity to light and itchy rash.

Uncommon to rare side effects with the combination of Copegus and peginterferon alfa-2a or interferon alfa-2a (occurring in less than 1 out of 100 patients) are pneumonia; external ear infections; inflammation of the lining of the lungs; blood clot on the lungs; extreme allergic reaction including angioedema (swelling in the throat and airway); skin infections; diabetes; coma; problems with the eyes (ulcer, bleeding, swelling); loss of vision; heart problems (as myocardial infarction, rhythm disorders or inflammation of the heart); high blood pressure; TTP (syndrome of blood disorder and also involves kidneys and nervous system) cerebral haemorrhage; gastrointestinal problems (as peptic ulcer and gastrointestinal bleeding), or liver problems (as liver dysfunction or failure, fatty liver, cholangitis), liver tumour; inflammation of the pancreas (upper abdominal pain); muscle inflammation, substance overdose, peripheral neuropathy (disorder of the nerves outside the brain and spinal cord), hallucinations and psychotic disorder (severe problems with personality and some disruption in normal social functioning); and autoimmune phenomena (where the body attacks its own cells) such as idiopathic thrombocytopenic purpura (increased bruising, bleeding, and decreased platelets), thyroiditis (inflammation of the thyroid), systemic lupus erythomatosus (SLE), rheumatoid arthritis and sarcoidosis (area of inflamed tissue occurring throughout the body).

You should see your doctor immediately if you experience symptoms of angioedema, such as

swollen face, tongue or pharynx (throat)
difficulty in swallowing
hives and difficulty breathing

Very rarely, Copegus in combination with peginterferon alfa-2a or interferon alfa-2a may cause aplastic anaemia or pancytopenia (failure of the bone marrow to produce red blood cells, white blood cells and platelets) and erythema multiforme (a rash which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes).

If you are infected with both viruses, HCV and HIV, and are receiving HAART (Highly Active Anti-Retroviral Therapy), the addition of Copegus 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

See also the patient leaflet of peginterferon alfa-2a or interferon alfa-2a for additional information regarding side effects of the concerned product.

5. HOW TO STORE COPEGUS

Keep out of reach and sight of children.

Do not use Copegus after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage condition.

Do not use Copegus if the bottle or packaging is damaged.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Copegus contains

Each film-coated tablet contains 400 mg of ribavirin.
The other ingredients are
- Tablet core; pregelatinised maize starch, sodium starch glycolate (derived from potato starch), microcrystalline cellulose, maize starch, magnesium stearate
- Film coating; hypromellose, talcum , titanium dioxide (E171) yellow iron oxide (E172), red iron oxide (E172), triacetin.

Medicine: copegus 400mg