| Product Name: | Metformin Hydrochloride and Glimepiride Sustained-Release Tablets |
| Brand Name: | Glucotaj MET SR |
| Strength: | 500mg/2mg |
| Dosage Form: | Tablets (un-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 15s, 100s, 150s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-diabetic, sulfonylureas |
| Indication: | Glimepiride and metformin are used for the treatment of type 2 diabetes mellitus when diet, exercise, and glimepiride or metformin alone are unable to control your blood sugar levels adequately. |
| Storage: | Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture. |
Metformin Hydrochloride and Glimepiride Sustained Release Tablets 500mg/2mg Technical Specification:
GENERIC NAME OF THE MEDICINAL PRODUCT:
Metformin Hydrochloride and Glimepiride Sustained Release Tablets 500mg/2mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Metformin Hydrochloride IP………….500mg
Glimepiride IP……………………….2mg
(In sustained release form)
Excipients……………………………………q.s.
THERAPEUTIC INDICATIONS:
Glimepiride and metformin are used for the treatment of type 2 diabetes mellitus when diet, exercise, and glimepiride or metformin alone are unable to control your blood sugar levels adequately.
CAUTION & SCHEDULE:
CAUTION: The tablet should not be broken crushed or chewed or swallowed whole.
Read the enclosed leaflet before use.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Keep medicine out of reach of children.
STORAGE & DOSAGE:
Storage: Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture.
Dosage: As directed by the Physician.