Download Drug Information Sheet ("Kusuri-no

Drug Information Sheet ("Kusuri-no-Shiori")
621930101
Newly-created: 09/2009
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： UFT E combination granule T200
［Tegafur -Uracil monotherapy］
Active ingredient： Tegafur, uracil
Dosage form： granules, white to yellowish white
Printings on wrapping：ユーエフティ E 配合顆粒 T200 200mg/1.0g, TC439
Effects of this medicine
Tegafur is converted to 5-fluorouracil (5-FU), which kills cancer cells. Uracil inhibits degradation of the
released 5-FU.The combination of these two drugs enhances the antitumor activity of Tegafur. 5-FU can
reduce tumor size and alleviate symptoms.
This drug is commonly used in the treatment of head and neck cancer, gastric cancer, colorectal cancer,
hepatic cancer, gallbladder cancer, bile-duct cancer, pancreatic cancer, lung cancer, breast cancer, bladder
cancer, prostatic cancer, or uterine cervical cancer.
Before using this medicine, tell your doctor/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 leucopenia).
If you have diarrhea.
If you have an infection.
If you have hepatic dysfunction or a history of hepatic dysfunction.
If you have renal dysfunction.
If you have a heart disease or a history of heart disease.
If you have gastrointestinal ulcers or hemorrhage.
If you have diabetes or varicella.
If you are having radiotherapy.
If you have been previously treated with other chemotherapy medicines.
If you are using TS-1, fluoropyrimidine anticancer drug, currently or within the last 7 days.
・ If you are pregnant or breastfeeding.
・ If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the
risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:(order of your doctor)
・ General dosage regimen (for adults): UFT is administered 1.5-3g (equivalent to 300-600mg of Tegafur)
daily in two to three divided doses. For uterine cervical cancer, UFT is administered 3g (equivalent to
600mg of Tegafur) daily in two to three divided doses. Be sure to follow the dosage instructions.
・ UFT must not be combined with TS-1, fluoropyrimidine anticancer drug. A minimum washout period of 7
days must be provided when UFT is used after withdrawal of TS-1.
・ Missed dose: 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.
・ Overdose: If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
・ Others: Do not stop taking medicine without the instructions of your doctor.
Precautions while using this medicine
・ During the treatment, laboratory tests (hematological, liver and renal function tests) are performed
regularly to detect asymptomatic side effects as early as possible. Be sure to consult your doctor.
Continued on next page.
UFT E combination granule T200［Tegafur -Uracil monotherapy］
Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:
anorexia, nausea, vomiting, diarrhea, pigmentation, etc.
In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If
they occur, stop taking your medicine and check with your doctor immediately.
・ bleeding tendency, tiredness, sore throat, fever［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］
・ unstableness, forgetfulness, trouble speaking［psychoneurologic disorders including
leukoencephalopathy or other symptoms］
・ olfactory disturbance［anosmia］
・ difficult breathing, fever, dry cough［interstitial pneumonia］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Storage 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 doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert
information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices
Agency.
Drug Information Sheet ("Kusuri-no-Shiori")
621930101
Newly-created: 09/2009
Information is based on approvals granted in Japan. In some cases, the approved details may vary in countries
other than Japan.
In deciding to use a medicine, the risk (side effects) of taking the medicine must be weighed against the benefit
(effects) it will do. The patient's cooperation is indispensable here.
Brand name： UFT E combination granule T200
［Folinate plus Tegafur-Uracil combination therapy］
Active ingredient： Tegafur, uracil
Dosage form： granules, white to yellowish white
Printings on wrapping： ユーエフティ E 配合顆粒 T200 200mg/1.0g, TC439
Effects of this medicine
Tegafur is converted to 5-fluorouracil (5-FU), which kills cancer cells. Uracil inhibits degradation of the
released 5-FU.The combination of these two drugs enhances the antitumor activity. 5-FU can reduce tumor
size and alleviate symptoms.
The concomitant use of UFT (Tegafur-Uracil) and Uzel (folinate) boosts the effectiveness of the 5-FU.
This combination therapy is commonly used to treat colorectal cancer.
Before using this medicine, tell your doctor/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 leucopenia).
If you have diarrhea.
If you have an infection.
If you have hepatic dysfunction or a history of hepatic dysfunction.
If you have renal dysfunction.
If you have a heart disease or a history of heart disease.
If you have gastrointestinal ulcers or hemorrhage.
If you have diabetes or varicella.
If you are having radiotherapy.
If you have been previously treated with other chemotherapy medicines.
If you are using TS-1, fluoropyrimidine anticancer drug, currently or within the last 7 days.
・ If you are pregnant or breastfeeding.
・ If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the
risk of drug interactions.)
Dosage regimen (proper use of this medicine)
・ Your dosage regimen is:(order of your doctor)
・ General dosage regimen (for adults): UFT is administered 0.5-1g (equivalent to 100-200mg of Tegafur) 3
times daily (at an interval of approximately 8 hours) together with 1 tablet (equivalent to 25mg of Calcium
Folinate) of 25mg Uzel or 25mg Leucovorin. Administration should be withheld during one hour before or
after meal. Repeat a course of 28 consecutive days (4 weeks) followed by a 7-day (1 week) rest period.
Be sure to follow the dosage instructions.
・ UFT must not be combined with TS-1, fluoropyrimidine anticancer drug. A minimum washout period of 7
days must be provided when UFT is used after withdrawal of TS-1.
・ Missed dose: 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.
・ Overdose: If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.
・ Others: Do not change your dose and schedule of your chemotherapy without the instructions of your
doctor.
Precautions while using this medicine
・ During the treatment, laboratory tests (hematological, liver and renal function tests) are performed
regularly to detect asymptomatic side effects as early as possible. Be sure to consult your doctor.
Continued on next page.
UFT E combination granule T200 (Folinate plus Tegafur-Uracil combination therapy)
Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:
diarrhea, stomatitis, anorexia, nausea, vomiting, tiredness, pigmentation, abdominal pain, etc.
In rare cases, symptoms described below may be the sign of side effects indicated in brackets [ ]. If
they occur, stop taking your medicine and check with your doctor immediately.
・ bleeding tendency, tiredness, sore throat, fever［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］
・ unstableness, forgetfulness, trouble speaking［psychoneurologic disorders including
leukoencephalopathy or other symptoms］
・ olfactory disturbance［anosmia］
・ difficult breathing, fever, dry cough［interstitial pneumonia］
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any
worrisome symptom.
Storage 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 doctor use only: Day
Month
Year
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert
information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices
Agency.