くすりのしおり

Internal
Revised: 5/2017

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 :
EES-1 Combination tab. T25
 Active ingredient:
Tegafur
Gimeracil
Oteracil potassium
 Dosage form:
white tablet, diameter: approx. 7.6 mm, thickness: approx. 3.8 mm
 Print on wrapping:
(front) EEエスワン配合錠T25, EEエスワン 25mg, T25
(back) EES-1 combination T25, 月日〜月日, ご自分で服用開始日を記入, EEエスワン, T25

Effects of this medicine

This medicine enhances the antitumor activity in proportion to the increase in the concentration of 5-fluorouracil (5-FU) in the body via the biotransformation of FT to 5-FU. Also, this medicine relieves gastrointestinal toxicities (adverse reactions) through the effects of oteracil pottasium.
It is usually used for treatment of gastric cancer, colorectal cancer, head and neck cancer, non-small cell lung cancer, unresectable or recurrent breast cancer, pancreatic cancer, or biliary tract 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 present a condition indicative of bone marrow suppression (including leukopenia).
    If you have: renal or hepatic dysfunction, an infectious disease or diabetes, a current or past history of interstitial pneumonia, a heart disease or a history of heart disease, gastrointestinal ulcers or hemorrhage.
    If your medicine is changed from other fluoropyrimidine-group anti-cancer drugs 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, the initial dose is determined based on body surface area. This medicine is administered 40 mg of tegafur for patients with under 1.25 m2 of body surface area; 50 mg of tegaful for patients with 1.25 to less than 1.5 m2 of body surface area; 60 mg of tegaful for patients with 1.5 m2 and over of body surface area; twice daily after breakfast and dinner, for 28 consecutive days (4 weeks), followed by a 14-day (2 weeks) rest. This 6-week period is regarded as one course, which is repeated. The dose can be decreased or increased according to the patient's condition. Adjustment of the dose is determined 40, 50, 60, or 75 mg in incremental steps. 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 tablet. Strictly follow the instructions.
  • This medicine must NOT be taken with other fluoropyrimidine-group anti-cancer drugs.
  • Record your medicine consumption, your physical condition and symptoms and show your records to your doctor or pharmacist on your next visit.
  • If you miss a dose, proceed with the prescribed schedule of medication starting from the next dose. 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 tests) are performed regularly at least once every 2 weeks to detect asymptomatic adverse reactions as early as possible. Be sure to consult your doctor.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include loss of appetite, nausea, vomiting, 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.
  • bleeding tendency, tiredness, fever, sore throat [bone marrow suppression, hemolytic anemia]
  • yellowing of the skin, tiredness, yellowing of the whites of the eyes, loss of appetite [severe hepatic dysfunction]
  • diarrhea, severe abdominal pain [severe enteritis]
  • difficult breathing, fever, dry cough [interstitial pneumonia]
  • sore in the mouth, blood in stool, darkened stool, hematemesis, abdominal pain [severe stomatitis, gastrointestinal ulcer / gastrointestinal hemorrhage / gastrointestinal perforation]
  • severe stomatitis, red rash, eyelid or eye redness [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 the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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