Drug Information Sheet("Kusuri-no-Shiori")
Internal
Revised: 04/2015
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,
patients should understand their medication and cooperate with the treatment.
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)
Print on wrapping:コペガス 200
Effects of this medicine
This medicine shows antiviral action and enhances the effect against hepatitis C virus in combination with interferon
preparation (peginterferon alfa-2a) and/or other antiviral agents.
It is usually used to treat chronic hepatitis C or compensated cirrhosis related to hepatitis C.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have: heart disease (myocardial infarction, cardiac failure, arrhythmia, etc.), neurosychiatric disease, or
diabetes.
If you ever had any of those diseases mentioned above.
If you have: 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.
・If you are pregnant, possibly pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal
effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
・Your dosing schedule prescribed by your doctor is<<
to be written by a healthcare professional>>
・In general, for adults, take this medicine according to your weight. If you weigh 60kg and below, take 3 tablets (600
mg of the active ingredient) a day [1 tablet (200 mg) after breakfast and 2 tablets (400 mg) after dinner]. If your
weight ranges over 60kg to 80kg, take 4 tablets (800 mg) a day [2 tablets (400 mg) after breakfast and 2 tablets
(400 mg) after dinner]. If you weigh over 80kg, take 5 tablets (1,000 mg) a day [2 tablets (400 mg) after breakfast
and 3 tablets (600 mg) after dinner]. The dosage should be reduced or this medicine should be discontinued
according to your symptoms. Strictly follow the instructions.
・If you miss a dose, skip the missed dose and continue your regular dosing schedule. You should never take two
doses at one time.
・If you accidentally take more than your prescribed dose, consult, with your doctor or pharmacist.
・Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
・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.
・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.
・Avoid breastfeeding.
・The medicine may cause anemia. You need to be informed of anemic symptoms such as dizziness until you fully
understand them.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include fever, injection site reaction, lassitude, pruritus, anemia,
headache and nausea. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated
in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor
immediately.
・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)]
・shortness of breath, breathlessness, fever, cough, phlegm, weight loss, loss of appetite [interstitial pneumonia,
pulmonary infiltration, breathing difficulty]
・discouraged feeling, sleeplessness, depressed feeling, indisposition, anxiety, irritation, considering suicide on
impulse, suicide attempt, coming up many ideas, talkativeness, highly strung nerves, intense emotion, feeling
irritated, excitement [depression, suicidal thought, suicide attempt, manic state, aggressive behavior]
・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]
・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]
・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]
・sudden fever with shiver, joint/muscle pain, chills [sepsis]
・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]
・chest pain, sweat, decreased consciousness, cough, fever, breathlessness [pulmonary embolism]
・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]
・excess intake of water, increased urinary volume, lassitude, weight loss, thirst [diabetes]
・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]
・high fever, fever, inflamed eyelid/eye, conjunctival sore, severe stomatitis, lip/intraoral sore, red spots 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]
・itch, scab, dry skin [psoriasis]
・decreased consciousness, swollen eyes, easy fatigability, decreased urinary volume, headache, lassitude,
breathlessness, swollen body [acute renal failure, nephrotic syndrome]
・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]
・cold sweat, dizziness, faint consciousness, impaired judgment/mind, pale face, shortness of breath [shock]
・failing vision, scotoma in the visual field [retinopathy]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your
doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
・Keep out of the reach of children. Store at room temperature (1 to 30℃), away from direct sunlight and moisture.
・Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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