Manufacturer's name : Chugai Pharmaceutical Co., Ltd. |
620004852 |
Revised: 10/2011 |
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Brand name : |
COPEGUS Tablet 200mg |
Active ingredient: |
Ribavirin |
Dosage form: |
pale red tablet (major axis: approx. 12.5mm, minor axis: approx. 6.7mm, thickness: approx. 4.9mm) |
Printings on wrapping: |
コペガス200 |
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Effects of this medicine
Combination use with interferon preparation (peginterferon alfa-2a) enhances this medicine's antiviral action against chronic hepatitis C virus. It is usually used to treat chronic hepatitis C or compensated cirrhosis related to hepatitis C. |
Before using this medicine, tell your doctor/pharmacist
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If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are a patient with heart disease (myocardial infarction, cardiac failure, arrhythmia, etc.), neurosychiatric disease, or diabetes.
If you ever had any of those diseases mentioned above.
If you are a patient with abnormal hemoglobin disease, renal/hepatic disorder, hypertension, myelosuppresion (anemia, leukopenia, thrombocytopenia), glucose intolerance, autoimmune disease or its predisposing condition.
If any of your relatives ever had diabetes.
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If you are pregnant or breastfeeding.
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If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)
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Dosage regimen (proper use of this medicine)
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Your dosage regimen is:(order of your doctor)
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General dosage regimen: For adults, take this medicine according to your weight. If you weigh 60kg and below, take 3 tablets (600mg of the active ingredient) a day [1 tablet (200mg) after breakfast and 2 tablets (400mg) after dinner]. If your weight ranges over 60kg to 80kg, take 4 tablets (800mg) a day [2 tablets (400mg) after breakfast and 2 tablets (400mg) after dinner]. If you weigh over 80kg, take 5 tablets (1000mg) a day [2 tablets (400mg) after breakfast and 3 tablets (600mg) after dinner]. The dosage should be reduced or this medicine should be discontinued according to your symptoms. Strictly follow the instructions of your doctor/pharmacist.
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Missed dose: Skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.
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Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
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Others: Do not stop taking the medicine without the instructions of your doctor.
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Precautions while using this medicine
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Teratogenic action (possibility to cause fetal malformation) has been reported in animal experiments. If you/your partner have/has a possibility of pregnancy, avoid pregnancy while you are taking the medicine and for 6 months after you discontinue it. Also, you/your partner need to have a pregnancy test once a month in order to confirm that you/your partner do/does not become pregnant.
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The medicine may be moved into sperm. If your partner is pregnant or she has a possibility to have gotten pregnant, you need to be informed of it until you fully understand it. Use condom to prevent the medicine from moving into the womb while you are taking it and for 6 months after you discontinue it.
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Avoid breastfeeding.
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The medicine may cause anemia. You need to be informed of anemic symptoms such as dizziness until you fully understand them.
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Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: fever, injection site reaction, lassitude, pruritus, etc.Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.
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palpitation, shortness of breath, headache, ear ringing, dizziness, lassitude, nose bleeding, blue spot, gum bleeding, subcutaneous bleeding, continuous bleeding, bleeding tendency, fever, sore throat[anemia, aplastic anemia, pure red cell aplasia, pancytopenia, agranulocytosis, leukopenia, thrombocytopenia]
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gum/nose bleeding, fever, subcutaneous bleeding, purplish bruise, blue spot, anemia, shortness of breath, breathlessness, yellowness in the skin and/or the white of the eye, yellow urine, decreased consciousness, impaired mind/judgment, numbness, decreased urinary volume, convulsion, swelling[thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS)]
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shortness of breath, breathlessness, fever, cough, phlegm, weight loss, loss of appetite[interstitial pneumonia, pulmonary infiltration, breathing difficulty]
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discouraged feeling, sleeplessness, depressed feeling, indisposition, anxiety, irritation, considering suicide on impulse, suicide attempt[depression, suicidal thought, suicide attempt]
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coming up many ideas, difficulty in falling asleep, talkactiveness, highly strung nerves, intense emotion[manic high]
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feeling irritated, excitement, anxiety[aggressive behavior]
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nausea, vomiting, loss of appetite, yellowness in the skin and/or the white of the eye, dark urine, itch, lassitude[worsening of hepatitis, hepatic function disorder]
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nausea, vomiting, lassitude, loss of appetite, yellowness in the skin and/or the white of the eye, brown urine, dizziness, lightheadedness, dizziness on standing up, easy fatigability, top-heavy feeling, palpitation/shortness of breath when moving, gum bleeding, subcutaneous bleeding, nose bleeding, fever, abdominal pain, mucous/bloody stool, diarrhea, joint pain, rigid hand in the morning, butterfly-shaped red punctum on the face, angialgia, purplish bruise, swelling, bloodshot eyes, seeing flash-like light, scotoma in the visual field, failing vision, ear ringing, difficulty hearing, headache, loss of hair, gray hair, white spots on the skin [autoimmune phenomenon]
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breathlessness, shortness of breath, palpitation, palpitation when moving, pounding heart, fast pulse, easy breathing in upright position, chest pain, anginal pain, chest oppressive/constrictive feeling, strongly pressured feeling in the chest, swollen body, lassitude, cold sweat, dizziness, faint, fever[myocardiosis, cardiac failure, angina, arrhythmia (ventricular tachycardia), myocardial infarction, endocarditis, pericarditis]
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sudden fever with shiver, joint/muscle pain, chills[sepsis]
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nausea, vomiting, paralysis in one side of the body, paralysis/numbness of the limbs, partial paralysis, difficulty speaking, headache, decreased consciousness, impaired mind/judgment, falling asleep in a faint[cerebral hemorrhage, cerebral infarction]
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chest pain, sweat, decreased consciousness, cough, fever, breathlessness[pulmonary embolism]
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decreased/confused/disturbed consciousness, loss of consciousness, impaired mind/judgment, muscle stiffness/tremor, retrograde amnesia, inability to recognize time, place and name, seeing or hearing something that is not really there, bad memory loss, inability to memorize/calculate[consciousness disorder, convulsion, epilepsy seizure, disorientation, coma, delirium, confusion, hallucination, dementia-like symptom]
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excess intake of water, increased urinary volume, lassitude, weight loss, thirst[diabetes]
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swollen thyroid, sleeplessness, weight loss, tendency to sweat, bulging eyes, pounding heart, shaky hands, lassitude, slowness in conversation or in motion, swelling, intolerance to cold[thyroid dysfunction]
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high fever, fever, inflamed eyelid/eye, conjunctival sore, severe stomatitis, lip/intraoral sore, red rash with dropsical swelling in the center, red rash, red spots and breakable blisters (bullas) all over the body, rash and blister, joint pain, pain in the genitalia, lassitude, loss of appetite[mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrosis (TEN), erythema multiforme]
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itch, scab, dry skin[psoriasis]
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decreased consciousness, swollen eyes, easy fatigability, decreased urinary volume, headache, lassitude, breathlessness, swollen body[acute renal failure, nephrotic syndrome]
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bloody stool, black stool, nausea, vomiting, vomiting of blood, abdominal pain, heavy stomach feeling, heartburn, feeling sick at the stomach, back pain, fever, diarrhea[gastrointestinal bleeding (melena, bloody stool, etc.), peptic ulcer, ischemic colitis]
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cold sweat, dizziness, faint consciousness, impaired judgment/mind, pale face, shortness of breath[shock]
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failing vision, scotoma in the visual field[retinopathy]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. |
Storage and other information
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Keep out of the reach of children. Store at room temperature (1-30℃), away from direct sunlight and moisture.
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Discard the remainder. Do not store them. Ask the pharmacist how to discard.
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For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency. |