英文药名：SEIBULE（Miglitol Tablets）
中文药名：米格列醇片
生产厂家：大日本住友制药
适 用 症：糖尿病血糖的改善
包装规格：
セイブル錠 25mg：100錠（PTP10錠×10）、210錠（PTP21錠×10）、500錠（PTP10錠×50）、1050錠（PTP21錠×50）
セイブル錠 50mg：100錠（PTP10錠×10）、210錠（PTP21錠×10）、500錠（PTP10錠×50）、1050錠（PTP21錠×50）
セイブル錠 75mg：100錠（PTP10錠×10）、210錠（PTP21錠×10）、500錠（PTP10錠×50）、1050錠（PTP21錠×50）
Manufacturer's name : SANWA KAGAKU KENKYUSHO CO.,LTD. 620003128
Revised: 12/2008
Brand name : SEIBULE Tablet 25mg 50mg 75mg
Active ingredient: Miglitol
Dosage form: white tablet (major axis: 10.0mm, minor axis: 4.5mm, thickness: 2.9mm)
Printings on wrapping: 糖尿病用薬、Sc396、SEIBULE50、セイブル50mg、食直前に服用
Effects of this medicine
This medicine inhibits enzyme activity digesting carbohydrate to glucose.
Usually used to treat diabetes.
Before using this medicine, tell your doctor/pharmacist
If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
Patient with ketosis, diabetic coma or precoma, infection, pre and post operation, wound, intestinal disease, Roemheld syndroma, or kidney/liver disorder.
If you experienced the abdominal operation.
If you are a patient with intestinal obstruction.
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, take 1 tablet (equals to 50mg of active ingredient) at a time, three times a day. If you do not respond to this medicine sufficiently, a dose may be increased up to 1.5 tablets (75mg of the active ingredient). Strictly follow the instructions of your doctor/pharmacist. Dose BEFORE you start eating.
Missed dose: If you are ordered to take this medicine on regular schedule and you missed a dose, take it as soon as possible during meal. If NOT during meal, 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
Take 10-20g of glucose not sucrose(sugar) when hypoglycemic symptoms occur.
Avoid working at heights or driving a car while taking this medicine because hypoglycemic symptoms can lead to an accident.
Side effects of this medicine
Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: borborygmus, abdomen enlarged, diarrhea, hypoglycemia, loose stool, rash.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.
flopsweat, feeling of hungry, hands/feet tremor[hypoglycemia]
failure of bowel movement, abdominal pain, abdomen enlarged feeling[intestinal obstruction-like symptoms]
generalized fatigability, vomiting, yellowness in skin or in conjunctiva[liver 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 away from direct sunlight, heat and moisture.
Discard the remainder.Do not store them.
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.
部份中文米格列醇处方信息（仅供参考）
【药理毒理】米格列醇属于氧化野尻霉素衍生物，它可延迟摄入的糖份的消化，从而导致餐后血糖浓度只有轻微升高，因此降低血糖。米格列醇可降低2型糖尿病患者的糖基化血红蛋白水平。通过糖基化血红蛋白水平而反映出的系统的非酶蛋白糖基化作用，随时间不同而影响血糖浓度。
【药代动力学】
【适应症】降低餐后血糖峰，显著控制糖化血红蛋白，保护心肌，有效改善Ⅱ型糖尿病的血糖控制，可单独或联合用药。
【用法用量】糖尿病患者使用米格列醇或其他降糖药都无固定的剂量。米格列醇的剂量必须参照其疗效与病人耐受量具体而定，但不可超过最大推荐量（100mg，3次/日）。
初始剂量：推荐的初始剂量为25mg，每日正餐前服用，3次/日。
维持剂量：50mg，3次/日。
最大剂量：100mg，3次/日。
服用磺酰脲药物的患者：磺酰脲可引起低血糖症。米格列醇与磺酰脲联用，若发生低血糖症，应及时调整药物的剂量。
【不良反应】
胃肠道反应：胃肠道症状是米格列醇最常见的不良反应。主要表现为腹痛，泻泄，胃胀气。其中腹痛和腹泄的发生率会随着持续给药而有所减轻。
皮肤反应：使用米格列醇时皮疹发病率为4.3%，通常是暂时性的。
异常实验室指标：使用米格列醇的患者血清铁含量降低，但是大多数病人都是暂时性的且未伴见血色素降低和其它血液学指标的异常。
【禁忌】对本品过敏者禁用
【注意事项】
1.低血糖症：由于米格列醇本身的作用机理使得单独用药时不会引起餐后或快速低血糖症。
2.血糖控制失调：当糖尿病患者伴有发热，外伤，感染或手术时，会产生暂时性的血糖控制失调。此刻必须进行临时胰岛素治疗。
3.肾损害：在肾损害患者中，米格列醇血清浓度随着肾损害程度和肾功能的降低成比例的上升。长期临床实验发现，伴有严重肾功能低下的糖尿病患者（血肌酐>2.0mg/dL）并没有得到控制。因此，对于这些病人不推荐使用米格列醇。
【孕妇及哺乳期妇女用药】只有明确需要时方可在孕妇使用。不推荐给哺乳期妇女。
【儿童用药】本品对儿童的安全性和有效性没有被证实。
【老年患者用药】米格列醇的有效性与安全性在青年人与老年人之间并不显著。
【药物过量】可能不会引起严重的全身系统反应。
【贮藏】遮光，密封保存。