くすりのしおり

Internal
Revised: 6/2017

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 :
S-1Meiji Combination Capsules T25
 Active ingredient:
Tegafur
Gimeracil
Oteracil potassium
 Dosage form:
orange/white capsule, full length: 14.5 mm, diameter: 5.2 mm
 Print on wrapping:
エスワンメイジ配合T25, MS059, S-1Meiji Combination T25

Effects of this medicine

This medicine is converted to fluorouracil (anticancer medicine) in the body, enhances antitumor activity by increasing concentration and relieves gastrointestinal toxicities (adverse reactions).
It is usually used to treat gastric cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, inoperable or recurrent breast cancer, pancreatic cancer and biliary cancer.

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 (including leukopenia), renal or liver disorder, infection, diabetes mellitus, current/history of interstitial pneumonia, current/history of cardiac disease, gastrointestinal ulcers or bleeding.
    If you are transferring the medicine from fluoropyrimidine-group anti-cancer medicine to this medicine.
  • 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 twice a day after breakfast and dinner for 28 consecutive days, followed by 14-day rest. This is repeated as one course but it may change according to the condition. Initial standard dose of tegafur is determined based on body surface area (BSA) as follows: 40 mg per dose for patients with a BSA less than 1.25 m2; 50 mg per dose for patients with a BSA 1.25 m2 to less than 1.5 m2; 60 mg per dose for patients with a BSA equal to or greater than 1.5 m2. The dosage may be adjusted to 40 mg, 50 mg, 60 mg or 75 mg for single dose. The maximum single dose should not exceed 75 mg, with the minimum dose of 40 mg. This preparation contains 25 mg of tegafur in a capsule. Strictly follow the instructions.
  • You should never take any fluorinated pyrimidine medicine together with this medicine.
  • Take memos about your medication status, health condition and any symptoms you have noticed, and show those memos to your doctor or pharmacist at visits.
  • If you miss a dose, skip the missed dose and follow 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

  • During the treatment, laboratory tests (hematological, liver and renal function test, etc.) are performed regularly at least once every 2 weeks to detect asymptomatic adverse reactions as early as possible. Be sure to keep your visiting schedule.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include loss of appetite, nausea, vomit, diarrhea, general malaise, 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.
  • prolonged bleeding, general malaise, fever, sore throat [marrow depression]
  • yellowing of the skin, general malaise, yellowing of the white of eyes, loss of appetite [serious liver disorder]
  • diarrhea, severe abdominal pain [serious enterocolitis]
  • breathing difficulty, fever, dry cough  [interstitial pneumonia]
  • bloody stool, black stool, vomiting of blood, abdominal pain [serious stomatitis, gastrointestinal ulcer/bleeding/perforation]
  • severe stomatitis, red rash, hyperemia of the eyelid and eye bloodshot [toxic epidermal necrolysis, muco-cutaneo-ocular 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.

Storage conditions and other information

  • Keep out of reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Seek advice of your pharmacy or medical institution about proper disposal of the unused medicines.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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