Drug Information Sheet ("Kusuri-no-Shiori") 613960002 Revised: 08/2007 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: EUGLUCON Tablet 1.25mg Active ingredient: Glibenclamide Dosage form: white tablet (φ: 6.0mm, thickness: 2.1mm) Printings on wrapping: オイグルコン 1.25mg Euglucon 1.25mg Effects of this medicine This medicine works on the pancreas and promotes insulin secretion in order to lower blood glucose (sugar in the blood). It is usually used to treat non-insulin dependent diabetes mellitus. (Only when a patient does not respond sufficiently to just diet and exercise therapy.) 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 ketosis (overbreathing, faint, tremor of the limbs), diabetic coma, insulin-dependent diabetes mellitus, hepatic/renal disorder, infection, serious injury, digestive trouble such as diarrhea and vomiting, or hypophysis/adrenal function disorder. If you are just after/before having surgery. If you are malnourished, starving, or debilitated. If you have irregular eating habit, or you do not eat enough. If you do hard muscular exercise, or drink a lot. ・ 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 1-2 tablet(s) (1.25-2.5mg of the active ingredient) once a day (before or after breakfast), or take 0.5-1 tablet (0.625-1.25mg of the active ingredient) twice a day (before or after meals both in the morning and in the evening). It should be increased according to your symptoms. But daily dosage should not exceed 8 tablets (10mg of the active ingredient). 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. (Taking double dose may cause hypoglycemia to you.) ・ Overdose: If you took too much of this medicine (more than ordered), check with your doctor/pharmacist. Because you may have hypoglycemic symptom. ・ Others: Do not stop taking this medicine without the instructions of your doctor. Precautions while using this medicine ・ This medicine may cause hypoglycemia. Exercise caution to work at heights, or drive a car. ・ Be sure to let your family and friends know that you are taking this medicine, because you may have consciousness disorder as one of hypoglycemic symptoms. ・ When hypoglycemic symptom without consciousness disorder occurs, take sugar. If you take α-glucosidase inhibitor (Acarbose, Voglibose, Miglitol) in combination with this medicine and such symptom occurs, take glucose. If you are feeling faint, contact your doctor. ・ While taking this medicine, you need to undergo tests for glucose in blood and in urine periodically. ・ This medicine may lose effectiveness if you neglect your health or if you have accompanying infection. Make sure to follow the hospital's advice on your daily life. Continued on next page. EUGLUCON Tablet 1.25mg Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: hypoglycemia, platelet depletion, leukopenia, rash, solar sensitivity, pruritus. 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. ・ feeling of weariness, hungry feeling, cold sweat, palpitation, headache, tremor of the limbs, lightheadedness, dizziness[hypoglycemia] ・ fever, sore throat[agranulocytosis] ・ lightheadedness, dizziness on standing up, yellowness in the skin and/or the white of the eye, easy fatigability, brown urine, top-heavy feeling, dizziness, lassitude, palpitation/shortness of breath when moving[hemolytic anemia] ・ yellowness in the skin and/or the white of the eye, yellow/brown urine, vomiting, nausea, loss of appetite, itch, lassitude[hepatitis, hepatic function disorder, jaundice] 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. "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") 613960003 Revised: 08/2007 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: EUGLUCON Tablet 2.5mg Active ingredient: Glibenclamide Dosage form: white tablet (major axis: 8.0mm, minor axis: 4.0mm, thickness: 2.2mm) Printings on wrapping: オイグルコン 2.5mg Euglucon 2.5mg Effects of this medicine This medicine works on the pancreas and promotes insulin secretion in order to lower blood glucose (sugar in the blood). It is usually used to treat non-insulin dependent diabetes mellitus. (Only when a patient does not respond sufficiently to just diet and exercise therapy.) 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 ketosis (overbreathing, faint, tremor of the limbs), diabetic coma, insulin-dependent diabetes mellitus, hepatic/renal disorder, infection, serious injury, digestive trouble such as diarrhea and vomiting, or hypophysis/adrenal function disorder. If you are just after/before having surgery. If you are malnourished, starving, or debilitated. If you have irregular eating habit, or you do not eat enough. If you do hard muscular exercise, or drink a lot. ・ 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 1.25-2.5mg of the active ingredient once a day (before or after breakfast), or take 0.625-1.25mg of the active ingredient twice a day (before or after meals both in the morning and in the evening). It should be increased according to your symptoms. But daily dosage should not exceed 10mg of the active ingredient. 1 tablet contains 2.5mg of the active ingredient. 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. (Taking double dose may cause hypoglycemia to you.) ・ Overdose: If you took too much of this medicine (more than ordered), check with your doctor/pharmacist. Because you may have hypoglycemic symptom. ・ Others: Do not stop taking this medicine without the instructions of your doctor. Precautions while using this medicine ・ This medicine may cause hypoglycemia. Exercise caution to work at heights, or drive a car. ・ Be sure to let your family and friends know that you are taking this medicine, because you may have consciousness disorder as one of hypoglycemic symptoms. ・ When hypoglycemic symptom without consciousness disorder occurs, take sugar. If you take α-glucosidase inhibitor (Acarbose, Voglibose, Miglitol) in combination with this medicine and such symptom occurs, take glucose. If you are feeling faint, contact your doctor. ・ While taking this medicine, you need to undergo tests for glucose in blood and in urine periodically. ・ This medicine may lose effectiveness if you neglect your health or if you have accompanying infection. Make sure to follow the hospital's advice on your daily life. Continued on next page. EUGLUCON Tablet 2.5mg Side effects of this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: hypoglycemia, platelet depletion, leukopenia, rash, solar sensitivity, pruritus. 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. ・ feeling of weariness, hungry feeling, cold sweat, palpitation, headache, tremor of the limbs, lightheadedness, dizziness[hypoglycemia] ・ fever, sore throat[agranulocytosis] ・ lightheadedness, dizziness on standing up, yellowness in the skin and/or the white of the eye, easy fatigability, brown urine, top-heavy feeling, dizziness, lassitude, palpitation/shortness of breath when moving[hemolytic anemia] ・ yellowness in the skin and/or the white of the eye, yellow/brown urine, vomiting, nausea, loss of appetite, itch, lassitude[hepatitis, hepatic function disorder, jaundice] 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. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency.