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Drug Information Sheet ("Kusuri-no-Shiori")
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here. Brand name
： BICALUTAMIDE TABLETS 80mg "OHARA"
Active ingredient： Bicalutamide Dosage form： white tablet, diameter: 7.6 mm, thickness: 4.4 mm Printings on wrapping： ビカルタミド 80mg「オーハラ」, ビカルタミド「オ
ーハラ」, 80mg, Bicalutamide 80mg 「OHARA」, 1
Effects of this medicine
This medicine inhibits androgen (male hormone) receptor binding to control activities of male hormones. It consequently suppresses cell growth of prostate tumor. It is usually used in the treatment of prostate cancer.
Before using this medicine, tell your doctor/pharmacist
・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
If you are a patient with hepatic disorder.
・ If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:
・ General dosage regimen: For adults, take 1 tablet (80 mg of the active ingredient) at a time, once
daily. Strictly follow the instructions of your doctor/pharmacist.
・ Missed dose: Take a dose as soon as possible when you remember that you missed a dose. However,
if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.
・ Overdose: If you took too much of the medicine (more than ordered), check with your
・ Others: Do not stop taking the medicine without the instructions of your doctor.
Precautions while using this medicine
Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: breast swelling, breast tenderness, hot flash, erectile dysfunction, etc.
In rare cases, 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.
・ general malaise, loss of appetite, yellowing in the skin or conjunctiva ocular［fulminant hepatitis,
・ throat pain, fever, subcutaneous hemorrhage, submucosal hemorrhage［leukopenia,
・ fever, dry cough, breathing difficulty［interstitial pneumonia］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom. Storage and other information
・ Keep the medicine out of the reach of children. Store it away from direct sunlight, heat and
・ Do not store the remainder and ask your pharmacist how to discard it.
For doctor use only
: Day Month Year
For further information, ask your doctor/pharmacist. Japanese package insert information (for medical
professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.
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