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, 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 1.5 m² of body surface area; 60 mg of Tegaful for patients with over 1.5 m² 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 20 mg of Tegafur in a capsule. 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 a double dose to make up for the missed dose.

• If you took too much of this 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.