| Product Name: | Glimepiride Tablet USP |
| Brand Name: | Generics |
| Strength: | 1mg, 2mg, 3mg, 4mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via oral Route |
| Packing: | 40s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antidiabetic, Diabetology |
| Indication: | Glimepiride is indicated for the treatment of type 2 diabetes mellitus, when diet, physical exercise and weight reduction alone are not adequate. |
| 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. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Glimepiride Tablet USP 1mg
- Glimepiride Tablet USP 2mg
- Glimepiride Tablet USP 3mg
- Glimepiride Tablet USP 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Glimepiride Tablet USP 1mg
Each uncoated Tablets contains:
Glimepiride tablets USP………….1mg
Excipients…………………….…. q.s.
Colour: Red oxide of iron. - Glimepiride Tablet USP 2mg
Each uncoated Tablets contains:
Glimepiride tablets USP……………….2mg
Excipients………………………………. q.s.
Colour: Yellow oxide of iron. - Glimepiride Tablet USP 3mg
Each uncoated Tablets contains:
Glimepiride tablets USP………………3mg
Excipients……………………………. q.s.
Colour: Lake of Erythrosine. - Glimepiride Tablet USP 4mg
Each uncoated Tablets contains:
Glimepiride tablets USP…………….4mg
Excipients……………………………. q.s.
Colour: Ponceau 4 R
THERAPEUTIC INDICATIONS:
Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
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.
