Drug Information Sheet ("Kusuri-no-Shiori") 614210128 Revised: 03/2007 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: FURTULON Capsule 100 Active ingredient: Doxifluridine Dosage form: pale reddish white/white capsule Printings on wrapping: NR421 100mg Effects of this medicine This medicine inhibits DNA synthesis and blocks RNA function in order to suppress malignant tumor growth. It is usually used to treat stomach/colon/rectum/breast/cervical/bladder cancer. Before using this medicine, tell your doctor/pharmacist ・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with myelosuppresion, renal/hepatic disorder, infection, gastric/duodenal ulcer, or chickenpox. If you have/had heart disease. ・ 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: Take 8-12 capsules (800-1200mg of the active ingredient) in 3-4 divided doses a day. It should be adjusted according to your disease, age and symptoms. Strictly follow the instructions of your doctor/pharmacist. ・ Missed dose: Skip the missed dose and continue your regular dosing schedule. 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 this medicine without the instructions of your doctor. Precautions while using this medicine Continued on next page. FURTULON Capsule 100 Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: diarrhea, loss of appetite, rash, eczema, urticaria. 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. ・ thirst, bad diarrhea, decreased urinary volume, urinary retention, greatly increased urinary volume, increased frequency of urination, bloody urine, swollen body/legs/eyes, lassitude, easy fatigability [dehydration, acute renal failure] ・ fever, lassitude, cold-like symptoms such as sore throat, bleeding tendency such as nose bleeding, continuous bleeding, persistent bruise, easy fatigability, anemia [ myelosuppresion, hemolytic anemia] ・ abdominal pain, frequent loose stool, diarrhea[serious enteritis (hemorrhagic/ischemic/necrotizing enteritis, etc.)] ・ easily staggering/tripping over when walking, occasional difficulty remembering something trivial, absent-mindedness, impaired judgment, rigid neck muscle, upward eye movement, arbitrary movement of tongue/jaw, slurred speech, inability to articulate properly, numbness in the limbs loss of coordination, incontinence[serious psychoneurotic disorder (leukoencephalopathy, etc.)] ・ fever, cough, breathing difficulty, shortness of breath[interstitial pneumonia] ・ shortness of breath, breathing difficulty, chest pain, chest pressured feeling[cardiac failure] ・ yellowness in the skin and/or the white of the eye, lassitude, loss of appetite, itch[hepatic disorder, jaundice] ・ bad abdominal pain, back/lower-back pain, fever, nausea, vomiting, loss of appetite [ acute pancreatitis] ・ disturbance of smell sensation[olfactory anesthesia] Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. Storage and other information ・ Keep out of the reach of children. Store at room temperature (1-30℃), away from direct sunlight and moisture. ・ Discard the remainder. Do not store them. Ask the pharmacist how to discard. For doctor use only: Day Month Year For further information, ask your doctor/pharmacist. Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency. Drug Information Sheet ("Kusuri-no-Shiori") 614210129 Revised: 03/2007 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: FURTULON Capsule 200 Active ingredient: Doxifluridine Dosage form: pale reddish white/white capsule Printings on wrapping: NR422 200mg Effects of this medicine This medicine inhibits DNA synthesis and blocks RNA function in order to suppress malignant tumor growth. It is usually used to treat stomach/colon/rectum/breast/cervical/bladder cancer. Before using this medicine, tell your doctor/pharmacist ・ If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with myelosuppresion, renal/hepatic disorder, infection, gastric/duodenal ulcer, or chickenpox. If you have/had heart disease. ・ 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: Take 4-6 capsules (800-1200mg of the active ingredient) in 3-4 divided doses a day. It should be adjusted according to your disease, age and symptoms. Strictly follow the instructions of your doctor/pharmacist. ・ Missed dose: Skip the missed dose and continue your regular dosing schedule. 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 this medicine without the instructions of your doctor. Precautions while using this medicine Continued on next page. FURTULON Capsule 200 Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: diarrhea, loss of appetite, rash, eczema, urticaria. 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. ・ thirst, bad diarrhea, decreased urinary volume, urinary retention, greatly increased urinary volume, increased frequency of urination, bloody urine, swollen body/legs/eyes, lassitude, easy fatigability [dehydration, acute renal failure] ・ fever, lassitude, cold-like symptoms such as sore throat, bleeding tendency such as nose bleeding, continuous bleeding, persistent bruise, easy fatigability, anemia [ myelosuppresion, hemolytic anemia] ・ abdominal pain, frequent loose stool, diarrhea[serious enteritis (hemorrhagic/ischemic/necrotizing enteritis, etc.)] ・ easily staggering/tripping over when walking, occasional difficulty remembering something trivial, absent-mindedness, impaired judgment, rigid neck muscle, upward eye movement, arbitrary movement of tongue/jaw, slurred speech, inability to articulate properly, numbness in the limbs loss of coordination, incontinence[serious psychoneurotic disorder (leukoencephalopathy, etc.)] ・ fever, cough, breathing difficulty, shortness of breath[interstitial pneumonia] ・ shortness of breath, breathing difficulty, chest pain, chest pressured feeling[cardiac failure] ・ yellowness in the skin and/or the white of the eye, lassitude, loss of appetite, itch[hepatic disorder, jaundice] ・ bad abdominal pain, back/lower-back pain, fever, nausea, vomiting, loss of appetite [ acute pancreatitis] ・ disturbance of smell sensation[olfactory anesthesia] Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom. Storage and other information ・ Keep out of the reach of children. Store at room temperature (1-30℃), away from direct sunlight and moisture. ・ Discard the remainder. Do not store them. Ask the pharmacist how to discard. For doctor use only: Day Month Year For further information, ask your doctor/pharmacist. Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.