Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
gliclazide
Perdaman Pharmaceuticals Pvt. Ltd.
A10BB09
gliclazide
60mg
tablets modified-release
(100/10x10/) in blister
Prescription
Registered
2017-12-12
PERDAMAN PHARMACEUTICALS PVT. LTD. _ _ _ _ _DIAZONE-MR _ _ _ _PAGE 1 OF 7_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PAGE 1 OF 7 _ THE SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT DIAZONE-MR ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each uncoated modified release tablet contains: _ACTIVE INGREDIENTS: _ Gliclazide 60 mg _EXCIPIENTS: _ Lactose, Methacrylic Acid Copolymer, Povidone, Magnesium stearate, Purified Talc, Isopropyl alcohol 3. PHARMACEUTICAL FORM Modified-Release Tablets 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use. For adult use only. The daily dose may vary from 30 to 120 mg taken orally in a single intake at breakfast time. It is recommended that the tablet(s) be swallowed whole. If a dose is forgotten, there must be no increase in the dose taken the next day. As with any hypoglycaemic agent, the dose should be adjusted according to the individual patient's metabolic response (blood glucose, HbAlc) • Initial dose: The recommended starting dose is 30 mg daily. If blood glucose is effectively controlled, this dose may be used for maintenance treatment. If blood glucose is not adequately controlled, the dose may be increased to 60, 90 or 120 mg daily, in successive steps. The interval between each dose increment should be at least 1 month except in patients whose blood glucose has not reduced after two weeks of treatment. In such cases, the dose may be increased at the end of the second week of treatment. The maximum recommended daily dose is 120 mg. • Switching from another oral antidiabetic agent to Gliclazide 60 mg MR Tablets: Gliclazide 60 mg MR Tablets can be used to replace other oral antidiabetic agents. The dosage and the half-life of the previous antidiabetic agent should be taken into account when switching to Gliclazide 60 mg MR Tablets. A transitional period is Прочитать полный документ