How does it work?

Copegus tablets contain the active ingredient ribavirin, which is a type of medicine called a nucleoside analogue. Ribavirin is an antiviral medicine that is used in combination with interferon alfa or peginterferon alfa to treat chronic hepatitis C.

Hepatitis C is a virus that infects the liver and leads to liver damage. Once the virus is inside the liver cells it multiplies. Part of this process involves the virus making copies of its genetic material (RNA and DNA).

It is not understood exactly how the combination of ribavirin and interferon alfa works. However, it is known to reduce the amount of hepatitis C virus RNA in the body. This lowers the amount of hepatitis C virus in the body and leads to a reduction in liver damage and an improvement in liver function.

Ribavirin must be used in combination with either peginterferon alfa-2a or interferon alfa-2a to treat chronic hepatitis C. It is ineffective when used on its own.

What is it used for?

• Treatment of chronic hepatitis C, in combination with either interferon alfa-2a (Roferon-A) or peginterferon alfa-2a (Pegasys).

Warning!

• Copegus tablets should be taken twice a day with food. If you forget to take a dose you can take it as soon as you remember. However, more than two doses should not be taken on the same day. The tablets should be swallowed whole and not broken, crushed or chewed.
• Before starting treatment with this medicine you will need to have blood tests to monitor your kidney and liver function, as well as the level of blood cells and haemoglobin in your blood. These tests will need to be repeated after two and four weeks of treatment, and then regularly during treatment.
• Treatment with ribavirin in combination with interferon alfa or peginterferon alfa has been associated with psychiatric side effects, particularly depression, which can occur at any time during treatment and even after treatment has finished. You should discuss this with your doctor before starting treatment. It is important to talk to your doctor immediately if you have any distressing thoughts or feelings, thoughts about suicide or self-harm, mood changes, confusion, aggressive behaviour or any other unusual change in behaviour while having treatment with this medicine. It may be necessary to stop treatment.
• Teeth and gum disorders, which may lead to loss of teeth, have been reported when this medicine is used in combination with interferon alfa or peginterferon alfa. You should have regular dental checks and follow a good dental care routine whilst having treatment with this medicine. Teeth should be brushed thoroughly twice daily. If you experience vomiting as a side effect of this medicine it is important to rinse out the mouth thoroughly afterwards.
• The combination of ribavirin and interferon alfa or peginterfon alfa has rarely been associated with side effects on the eyes. You should have an eye examination before starting treatment. Tell your doctor if you experience any disturbances in your vision during treatment. If you have any existing eye disorders you should have regular eye examinations throughout treatment with this medicine.
• If you experience signs of a severe allergic reaction (such as difficulty in breathing, wheezing, swelling of the face, tongue or throat, or hives) while on this medication, seek medical help immediately.
• This medicine can be harmful to a developing baby. It is very important for women and men taking this medicine, and female partners of men taking this medicine, to use effective methods of contraception to avoid exposing a developing baby to the medicine. Contraception must also be continued after treatment is finished. Please read the pregnancy and breastfeeding section below for more details.
• The safety and efficacy of this medicine have not been established in children less than 18 years of age.

Use with caution in

• Decreased kidney function.
• People with a history of severe psychiatric disorders, eg depression.
• Heart disease.
• History of heart failure, heart attack or irregular heartbeats (arrhythmias).
• People with history of gout.
• People co-infected with HIV and taking antiretroviral medicines, particularly if they also have a low CD4 count.
• People with low levels of haemoglobin in their blood (anaemia).

Not to be used in

• People with severe heart disease, particularly if unstable or uncontrolled in the last six months.
• People who have liver cirrhosis with complications (decompensated cirrhosis), or severely decreased liver function.
• People co-infected with hepatitis C and HIV who have liver cirrhosis and moderate to severely decreased liver function.
• Blood disorders involving problems with haemoglobin, such as thalassaemia, sickle-cell anaemia.
• Pregnancy.
• Breastfeeding.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine may cause serious birth defects and must not be used during pregnancy. For this reason, women will need to have a pregnancy test before treatment with this medicine is started. Women taking this medicine who could get pregnant must use two effective methods of contraception to prevent pregnancy, for example the pill and condoms. You will be given advice on which forms are suitable for you. Contraception should be started before your treatment begins and continued all the time you are taking this medicine. You should continue to use contraception to prevent pregnancy for at least four months after your treatment is finished. You will need to have a pregnancy test every month throughout the treatment and every month for four months after treatment is finished. You should consult your doctor immediately if you think you could be pregnant.
• Men taking this medicine must use condoms to avoid fathering a child, both during treatment and for at least seven months after treatment is finished. Men taking this medicine must also use condoms if their partner is pregnant, because the medicine passes into semen and could be harmful to the developing baby. The manufacturer recommends that female partners of men taking this medicine also use another method of contraception, such as the pill. In addition they should have a pregnancy test every month while their partner is taking this medicine and for seven months after treatment is stopped.
• It is not known if this medicine passes into breast milk. However, because the medicine could be harmful to a nursing infant the manufacturer states that women needing treatment with this medicine should not breastfeed. Breastfeeding should be stopped before treatment with this medicine is started. Seek further medical advice from your doctor.

Label warnings

• This medicine should be taken with or after food.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine when used in combination with either interferon alfa or peginterferon alfa. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

• Decrease in the number of white blood cells, haemoglobin or platelets in the blood.
• Loss of appetite, weight loss.
• Emotional problems or mood changes, for example depression, anxiety, agitation, aggression, suicidal thoughts (see warning above).
• Difficulty sleeping (insomnia).
• Headache.
• Dizziness.
• Concentration difficulties.
• Cough, shortness of breath (dyspnoea).
• Disturbances of the gut such as diarrhoea, nausea, vomiting, indigestion or abdominal pain.
• Dry mouth, mouth ulcers, bleeding gums.
• Skin reactions such as rash, itching, dry skin, hair loss, increased sweating.
• Changes in sensation, eg tingling or numb sensations.
• Pain in the muscles or joints.
• Menstrual disorders such as heavy periods (menorrhagia), painful periods (dysmenorrhoea).
• Decreased sex drive, impotence.
• Underactive or overactive thyroid gland.
• Chest pain, increased heart rate, palpitations.
• Visual disturbances such as blurred vision, eye pain or dryness of the eye.
• Liver disorders.

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Ribavirin may decrease the effect of zidovudine and stavudine, which are used to treat people with HIV infection. If you are prescribed ribavirin while taking these medicines your doctor may need to carry out extra monitoring to check that these HIV medicines are working effectively in the body. If this medicine is used in combination with zidovudine there may also be an increased risk of anaemia.

Ribavirin may increase the blood level of didanosine, a medicine used to treat people with HIV. Didanosine is not recommended for use with this medicine, because the combination may increase the risk of liver problems, pancreatitis, lactic acidosis and peripheral neuropathy.

Other medicines containing the same active ingredient