| Product Name: | Metformin Hydrochloride + Glibenclamide tablets 500mg+2.5mg |
| Brand Name: | Glucotaj-ZET |
| Strength: | 400mg+2.5mg, 500mg+2.5mg, 500mg+5mg |
| Dosage Form: | Tablets (Film coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 30s, 90s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-diabetic, sulfonylureas |
| Indication: | This combination medication is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. |
| Storage: | Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Metformin Hydrochloride + Glibenclamide 400mg+2.5mg
- Metformin Hydrochloride + Glibenclamide 500mg+2.5mg
- Metformin Hydrochloride + Glibenclamide 500mg+5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Metformin Hydrochloride + Glibenclamide 400mg+2.5mg
Each film-coated tablet contains:
Metformin Hydrochloride IP………………….400mg
Glibenclamide IP……………………….2.5mg
Excipients……………………………………………q.s.
Colours: Quinoline Yellow - Metformin Hydrochloride + Glibenclamide 500mg+2.5mg
Each film-coated tablet contains:
Metformin Hydrochloride IP………………….500mg
Glibenclamide IP……………………….2.5mg
Excipients……………………………………………q.s.
Colours: Quinoline Yellow - Metformin Hydrochloride + Glibenclamide 500mg+5mg
Each film-coated tablet contains:
Metformin Hydrochloride IP………………….500mg
Glibenclamide IP……………………….5mg
Excipients……………………………………………q.s.
Colours: Quinoline Yellow
THERAPEUTIC INDICATIONS:
Treatment of type 2 diabetes in adults, as replacement for previous combination therapy with metformin and Glibenclamide in patients whose glycaemia is stable and well-controlled.
CAUTION & SCHEDULE :
CAUTION:
Read enclosed leaflet before use.
Any unused product or waste material should be disposed of in accordance with local requirements.
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 form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.