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|Copegus

Copegus

Copegus is used for:

Treating hepatitis C infection in certain patients when used in combination with interferon. It may also be used for other conditions as determined by your doctor.

Copegus is an antiviral medicine. How Copegus works to treat hepatitis C is not completely understood.

Do NOT use Copegus if:

• you are pregnant
• your female sexual partner is pregnant or could become pregnant within the next 6 months
• you have certain blood disorders (eg, sickle-cell anemia, thalassemia major), a history of serious heart problems, severe kidney problems, or inflammation of your pancreas (acute pancreatitis)
• you are also using interferon and have autoimmune hepatitis (liver problems caused by your own body instead of a virus) or severely decreased liver function
• you are taking didanosine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Copegus :

Some medical conditions may interact with Copegus . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you plan to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a female sexual partner who is of childbearing age
• if you have a history of cancer, heart problems or heart attack, high blood pressure, kidney problems, diabetes, pancreas problems, lung or breathing problems, sarcoidosis, blood problems (eg, anemia), thyroid problems, or HIV infection
• if you have liver problems (other than hepatitis C infection) such as hepatitis B infection, cirrhosis of the liver, or decreased liver function
• if you have a history of anxiety or other mood or mental disorders, thoughts of suicide, or suicidal behavior
• if you have used interferon before to treat hepatitis C and it did not work
• if you have a history of drug or alcohol abuse

Some MEDICINES MAY INTERACT with Copegus . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Didanosine or other nucleoside reverse transcriptase inhibitors (NRTIs) (eg, lamivudine), immunosuppressants (eg, cyclosporine), or other antiretroviral medicines for HIV infection because serious side effects, including risk of infection, nerve problems (peripheral neuropathy), pancreas problems, lactic acidosis, and severe or fatal liver failure, may be increased by Copegus
• Anticoagulants (eg, warfarin) because the effectiveness of Copegus may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Copegus may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Copegus :

Use Copegus as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Copegus comes with an additional patient information sheet called a Medication Guide. Read it carefully and reread it each time you get Copegus refilled.
• Copegus should be taken with food.
• Drinking extra fluids while you are taking Copegus is recommended. Check with your doctor for instructions.
• Take Copegus regularly to receive the most benefit from it. Taking Copegus at the same times each day will help you remember to take it.
• Continue to use Copegus even if you feel well. Do not miss any doses.
• If you miss a dose of Copegus , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Copegus .

Important safety information:

• Copegus may cause dizziness, drowsiness, tiredness, confusion, or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Copegus . Using Copegus alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol, including beer, wine, and liquor, because it could worsen liver disease.
• LAB TESTS, including pregnancy tests; blood counts; hemoglobin levels; and heart, liver, kidney, thyroid, and lung function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• At least 2 reliable forms of effective birth control must be used during treatment with Copegus and for 6 months after treatment with Copegus is stopped.
• Women of childbearing potential who either take Copegus or are sexual partners of men who take Copegus must have a pregnancy test before therapy with Copegus is started, monthly during therapy, and monthly for 6 months after Copegus is stopped.
• Caution is advised when using Copegus in CHILDREN because they may be more sensitive to its effects.
• Use Copegus with caution in the ELDERLY because they may be more sensitive to its effects.
• PREGNANCY and BREAST-FEEDING: Do not use Copegus if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Copegus is excreted in breast milk. Do not breast-feed while taking Copegus .

Possible side effects of Copegus :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; dizziness; dry mouth; dry skin; loss of appetite; mild headache, nausea, or vomiting; mild pain, redness, or swelling at the injection site; tiredness; upset stomach; weakness or fatigue

Severe allergic reactions (rash; hives; difficulty breathing; itching; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; changes in hearing, taste, or vision; chest pain; dark urine; decrease in the amount of urine; fever, chills, or sore throat; hair loss; irregular heartbeat; joint pain; loss of appetite; muscle pain or weakness; numbness or tingling of arms or legs; prolonged nausea and vomiting; rapid breathing; severe headache; severe stomach or back pain; shortness of breath; sinus problems; thoughts of suicide; trouble sleeping; unusual bruising or bleeding; unusual mental or mood changes; unusual or severe tiredness and fatigue; vomit that looks like coffee grounds; weight loss; yellowing of eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Copegus at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Copegus out of the reach of children and away from pets.

General information:

• If you have any questions about Copegus , please talk with your doctor, pharmacist, or other health care provider.
• Copegus is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Copegus . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.