伏格列波糖片剂药品说明书(英文)

Revised: October 2009 (12th version) Standard Commodity Classification No. of Japan

873969

- Improving agent for postprandial hyperglycemia –

BASEN®Tablets 0.2

BASEN®Tablets 0.3

Prescription drug

Caution - Use only pursuant to the prescription of a physician etc.

CONTRAINDICATIONS (BASEN® Tablets are contra-indicated in the following patients.)

(1) Patients with severe ketosis, or in a state of diabetic

coma or pre-coma [Since it becomes essential to quickly rectify hyperglycemia with administration of intrave-

nous fluid or insulin, the use of BASEN® Tablets is not suitable.]

(2) Patients with severe infections, before or after operation,

or with serious trauma [It is desirable to control plasma glucose with the injection of insulin. Therefore, ad-

ministration of this drug is not appropriate.]

(3) Patients with a history of hypersensitivity to any of the

ingredients of this drug

DESCRIPTION

351 352

Upper Lower Side Upper Lower Side

7.1 8.1

2.6

3.1 Inactive ingredients:

Corn Starch, Hydroxypropylcellulose, Magnesium Stearate, Lactose INDICATIONS

○I mprovement of postprandial hyperglycemia in diabetes mel-litus (However, BASEN® Tablets should be used only when sufficient effect has not been obtained in patients already un-dergoing dietary treatment and/or exercise therapy, or when sufficient effect has not been obtained in patients who have been using oral hypoglycemic drugs or insulin preparations, in addition to dietary treatment and/or exercise therapy.)

○P revention of onset of type 2 diabetes mellitus in impaired glucose tolerance (only for BASEN® Tablets 0.2) (However, BASEN® Tablets should be used only when im-paired glucose tolerance has not been improved in patients al-ready undergoing appropriate dietary treatment and/or exercise therapy.)

< Precautions >

Prevention of onset of type 2 diabetes mellitus in impaired glucose tolerance (only for BASEN® Tablets 0.2) Administration of BASEN® Tablets should be limited to those who is judged as impaired glucose tolerance (fasting plasma glucose is <126mg/dL and two-hour plasma glucose levels is 140 to 199mg/dL in 75 grams oral glucose tolerance test) and has not improved by dietary treatment and/or exercise therapy, which are the basics for the prevention of onset of diabetes mellitus, for three to six months and has any of followings; hypertension, dyslipidemia (hypertriglyceridemia, low HDL cholesterolemia etc.), obesity (Body Mass Index: BMI ≥25kg/m2) or a family history of diabetes mellitus in first-degree or second-degree relatives.

DOSAGE AND ADMINISTRATION

○I mprovement of postprandial hyperglycemia in diabetes mellitus

Storage

Store at room temperature.

Expiration date

Do not use after the expiration date in-dicated on the package. (Use as soon as possible after unsealing, even before the expiration date.)

Tablets 0.2 Tablets 0.3 Approval No.(6AM)1120(6AM)1121 Date of listing in the NHI reimbursement price August 1994August 1994 Date of initial marketing in Japan September 1994September 1994 Date of latest reexamination September 2004September 2004 Date of latest approval of indications October 2009 -