NIPPON KAYAKU
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.
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Brand name :
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NKS-1 combination capsule T25
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Active ingredient:
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Gimeracil
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Oteracil potassium
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Dosage form:
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white/orange capsule (No. 4 capsule), total length 14.5 mm, long diameter 5.2 mm, short diameter 5.0 mm, weight about 214 mg
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Effects of this medicine
This medicine is biotransformed into fluorouracil (anti-cancer drug), enhances antitumor activity by increased concentration and relieves gastrointestinal toxicities (side effects).
It is usually used to treat gastric cancer.
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Before using this medicine, be sure to tell your doctor and pharmacist
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If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have bone marrow suppression (including leukopenia), renal/hepatic disorder, infectious disease, diabetes, gastrointestinal ulcers or hemorrhage.
If you have a current or past history of interstitial pneumonia or heart disease.
If you are using fluoropyrimidine-group drugs. (NKS-1 and fluropyrimidine-group drugs may interact strongly with each other and cause serious side effects.)
If your medicine was switched from fluropyrimidine-group drugs to this medicine (NKS-1). (An appropriate washout period must be provided in consideration of the influence of these prior agents.)
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If you are pregnant, breastfeeding or possibly pregnant.
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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.)
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Dosing schedule (How to take this medicine)
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Your dosing schedule prescribed by your doctor is << to be written by a healthcare professional>>
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In general, for adults, the initial dose is determined based on body surface area as follows: 40 mg of Tegafur for patients with under 1.25 m2 of body surface area; 50 mg of Tegafur for patients with 1.25 to 1.5 m2 of body surface area; 60 mg of Tegafur for patients with over 1.5 m2 of body surface area. The medicine is administered twice daily after breakfast and dinner, for 28 consecutive days, followed by a 14-day rest. This is regarded as one course, which is repeated. The dose can be decreased or increased according to the patient's condition in stages of: 40, 50, 60, or 75 mg. The maximum dose is limited to 75 mg at a time, and the minimum dose is 40 mg at a time. This medicine contains 25 mg of Tegafur in a capsule. Strictly follow the instructions.
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This medicine must NOT be taken with other fluoropyrimidine-group anticancer drugs.
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Record your drug consumption, your physical condition and symptoms, and show your records to your physician or pharmacist on your next visit.
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If you miss a dose, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
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If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
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Do not stop taking this medicine unless your doctor instructs you to do so.
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Precautions while taking this medicine
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During the treatment, laboratory tests (hematological, liver and renal function tests) are performed regularly at least once every 2 weeks to detect asymptomatic side effects as early as possible. Be sure to keep your visiting schedule.
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Possible adverse reactions to this medicine
The most commonly reported adverse reactions include loss of appetite, nausea, vomiting, dullness, stomatitis, pigmentation, rash and lacrimation. 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.
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bleeding tendency, dullness, fever, sore throat [bone marrow depression, haemolytic anaemia]
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yellowness in the skin, dullness, yellowness in the whites of the eyes, loss of appetite [serious liver disorder]
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diarrhea, severe stomachache [serious enteritis]
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breathlessness, fever, dry cough [interstitial pneumonia]
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sore in the mouth, blood in stool, darkened stool, hematemesis, stomachache [serious stomatitis, gastrointestinal ulceration, gastrointestinal hemorrhage, gastrointestinal perforation]
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severe stomatitis, red rash, redness of the eyelid/eye [toxic epidermal necrolysis, oculomucocutaneous syndrome]
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.
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Storage conditions and other information
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Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
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Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
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