Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (1000mg + 3mg) Technical Specification:
| Product Name: | Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP |
| Brand Name: | Generic |
| Strength: | (500mg + 0.5mg), (1000mg + 0.5mg), (500mg + 1mg), (750mg + 1mg), (850mg + 1mg), (1000mg + 1mg), (500mg + 2mg), (750mg + 2mg), (850mg + 2mg), (1000mg + 2mg), (500mg + 3mg), (750mg + 3mg), (850mg + 3mg), (1000mg + 3mg), (500mg + 4mg), (1000mg + 4mg) |
| Dosage Form: | Tablet (Uncoated Bilayer) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 15s, 50s, 100s, 150s, 300s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-diabetic, Hypoglycaemic |
| Indication: | To treat type 2 Diabetes Mellitus |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (500mg + 0.5mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (1000mg + 0.5mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (500mg + 1mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (750mg + 1mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (850mg + 1mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (1000mg + 1mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (500mg + 2mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (750mg + 2mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (850mg + 2mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (1000mg + 2mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (500mg + 3mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (750mg + 3mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (850mg + 3mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (1000mg + 3mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (500mg + 4mg)
Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (1000mg + 4mg)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Metformin Hydrochloride Prolonged-release and Glimepiride Tablets IP (1000mg + 3mg)
Each Uncoated Bilayered Tablet Contains:
Metformin Hydrochloride IP……………….1000mg
(As Prolonged-release form)
Glimepiride IP………………………………………3mg
Excipients……………………………………….……Q.S.
Colour: Ferric Oxide Red USP-NF
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 & SCHEDULE:
CAUTION:
Keep medicine out of reach of children.
Do not Crush or Chew the Tablet. Swallow the whole Tablet with water.
SCHEDULE:
SCHEDULE H PRESCRIPTION DRUG: WARNING: TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A registered medical practitioner ONLY.
SCHEDULE G PRESCRIPTION DRUG: CAUTION: it is dangerous to take this preparation except under medical supervision.
STORAGE & DOSAGE:
STORAGE: Store in cool & dry place at a temperature not exceeding 30°C. Protect from light and moisture.
DOSAGE: As directed by the Physician.