Effects of this medicine

Before using this medicine, be sure to tell your doctor and pharmacist

• If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
  If you present a condition indicative of bone marrow suppression (including leukopenia).
  If you have renal or hepatic dysfunction.
  If you have an infectious disease or diabetes.
  If you have a current or past history of interstitial pneumonia.
  If you have a heart disease or a history of heart disease.
  If you have gastrointestinal ulcers or hemorrhage.
• If you are using fluoropyrimidine-group anti-cancer drugs. (TS-1 and these medicines may interact strongly with each other and cause serious side effects.)
• If you use TS-1 after withdrawal of other fluoropyrimidine-group anti-cancer drugs. (An appropriate washout period must be provided in consideration of the influence of these prior agents.)

• If you are 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))

• General dosage regimen: For adults, TS-1 is usually administered twice daily after breakfast and dinner for 28 consecutive days, followed by a 14-day rest, at a dose determined based on body surface area (BSA): BSA less than 1.25 m2, 40 mg; 1.25 m2 or less BSA less than 1.5 m2, 50 mg; BSA or over 1.5 m2, 60 mg of tegafur.This 6-week period is regarded as one course, which is repeated. However, the dose may be decreased or increased according to the patient's condition. The doses are staged thus: 40mg, 50mg, 60mg, and 75mg. The maximum single dose should not exceed 75 mg, with the minimum dose of 40 mg. Each package of TS-1 contains 25mg of tegafur. Strictly follow the instructions of your doctor/pharmacist.
• TS-1 must NOT be taken with other fluoropyrimidine-group anti-cancer drugs.
• Record your drug consumption, your physical condition and symptoms and show your records to your physician or pharmacist on your next visit.

• Proceed with the prescribed schedule of medication starting from the next dose. DO NOT take double doses to make up for the missed dose.

• If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.

• Do not change your dose and schedule of your chemotherapy without the instructions of your doctor.

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 side effects as early as possible. Be sure to consult your doctor.

Possible adverse reactions to this medicine

• bleeding tendency, tiredness, fever, sore throat [bone marrow suppression]
• yellowing of the skin, tiredness, yellowing of the whites of the eyes, anorexia [severe hepatic dysfunction]
• diarrhea, severe abdominal pain [severe enteritis]
• difficult breathing, fever, dry cough [interstitial pneumonia]
• blood in stool, darkened stool, hematemesis, abdominal pain [gastrointestinal ulcer / gastrointestinal hemorrhage / gastrointestinal perforation]
• severe stomatitis, red rash, eyelid or eye redness [muco-cutaneo-ocular syndrome]

Storage conditions and other information

• Keep the medicine out of the reach of babies, infants, and children. Store away from direct sunlight, heat, and humidity.
• Discard the remainder. Do not store them. Check with the pharmacy regarding how to discard.

For healthcare professional use only : Day Month Year