Metformin Hydrochloride Sustained Release and Glimepiride Tablets (500mg + 2mg) Technical Specification:
| Product Name: | Metformin Hydrochloride Sustained Release and Glimepiride Tablets |
| Brand Name: | Generic |
| Strength: | 500mg + 2mg, 500mg + 1mg |
| Dosage Form: | Uncoated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 30s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | Anti-diabetic, Hypoglycaemic |
| Indication: | To treat type 2 Diabetes Mellitus |
| Storage: | Store below 25°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Metformin Hydrochloride Sustained Release and Glimepiride Tablets (500mg + 2mg)
Glimepiride 1mg + Metformin Hydrochloride 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Metformin Hydrochloride Sustained Release and Glimepiride Tablets (500mg + 2mg)
Metformin Hydrochloride BP……………….500mg
(As Sustained Release form)
Glimepiride USP………………………………………1mg
Excipients……………………………………….……Q.S.
Colour: Yellow Oxide of iron
THERAPEUTIC INDICATIONS:
This medication is used for the treatment of type 2 diabetes mellitus, when diet, exercise and glimepiride or metformin alone is unable to control your blood sugar levels adequately.
CAUTION & WARNING:
Keep medicine out of reach of children.
To be sold by retail on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
STORAGE: Store below 30°C. Protect from light and moisture.
DOSAGE: As directed by the Physician.