Download Drug Information Sheet("Kusuri-no-Shiori") Internal Published: 01

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Drug Information Sheet("Kusuri-no-Shiori")
Internal
Published: 01/2016
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:Metolate tablets 2mg
Active ingredient:Methotrexate
Dosage form:pale yellow tablet, major axis: 12.0 mm, minor axis: 5.5 mm
Print on wrapping:(face) Metolate tab. 2mg, メトレート錠 2mg, 抗リウマチ剤(メトトレキ
サート), 2, (back) メトレート錠 2mg, 2
Effects of this medicine
This medicine eases inflammation of rheumatoid arthritis or juvenile idiopathic arthritis by helping abnormal immunity
return to normal. It may take 4 to 8 weeks until the effect of the medicine is obtained.
It is usually used to treat rheumatoid arthritis or juvenile idiopathic arthritis with arthral symptom.
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: marrow depression, chronic liver disease, kidney disorder, pleural effusion, ascites,
tuberculosis/history of tuberculosis, lung disorder/history of lung disorder, infection or chickenpox.
If you drink alcohol on a regular basis.
・If you are pregnant, breastfeeding, or possibly pregnant.
・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>>
・For treatment of rheumatoid arthritis: In general, take 3 tablets (6 mg of the active ingredient) all at once or in 2 or
3 divided doses on a weekly basis. If taking in divided doses, take every 12 hours, from day 1 to day 2 in a 7-day
cycle. If taking all at once or divided in two doses, do not take for the remaining 6 days. If taking divided in three
doses, do not take for the remaining 5 days. This treatment course should be repeated every week. The dosage
should be adjusted according to your age, symptoms, tolerance and response to this medicine. However, the
weekly dosage should not exceed 8 tablets (16 mg). Strictly follow the instructions.
・For treatment of juvenile idiopathic arthritis with arthral symptom: In general, take 4 to 10 mg/m2 (body surface) all
at once or in 2 or 3 divided doses on a weekly basis. If taking in divided doses, take every 12 hours, from day 1 to
day 2 in a 7-day cycle. If taking all at once or divided in two doses, do not take for the remaining 6 days. If taking
divided in three doses, do not take for the remaining 5 days. This treatment course should be repeated every
week. The dosage should be adjusted according to your age, symptoms, tolerance and response to this medicine. 1
tablet contains 2mg of the active ingredient. Strictly follow the instructions.
・If you are an elderly patient, you should especially follow your doctor's instructions.
・Avoid taking this medicine at bedtime, as it can cause esophagus ulcer when the tablet stays in the esophagus.
Swallow it with more water or lukewarm water, without chewing or cracking.
・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 or change the dosage unless your doctor instructs you to do so.
Precautions while taking this medicine
・Intake of alcohol may induce liver disease. Avoid drinking alcohol during the medication course.
・Case of teratogenic potential is reported. Avoid pregnancy or pregnancy of your partner while you take this
medicine.
・Getting a live-virus vaccination may intensify and continue the vaccine-derived infection during this medication
course. If you want to get vaccinated, tell the doctor that you are taking this medicine.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include hives, fever, rash, itch, nausea and photosensitivity. 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.
・chills, dyspnoea, hypotension [shock, anaphylaxis]
・fever, sore throat, flu-like symptoms [marrow depression]
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・fever, cough, dyspnoea [interstitial pneumonitis, pulmonary fibrosis, pleural effusion]
・decreased urine output, swelling, headache [acute renal failure, tubular necrosis, severe nephropathy]
・loss of appetite, malaise, yellowing of the skin or eyes [fulminant hepatitis, hepatic failure]
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 reach of children. Store away from heat and moisture in a shaded place.
・Discard the remainder. Do not store them. Ask your pharmacy or medical institution how to discard.
For healthcare professional use only
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For further information, talk to your doctor or pharmacist.
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