GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg
C. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/250mg
D. Glibenclamide and Metformin Hydrochloride Tablets 5mg/500mg
E. Glibenclamide and Metformin Hydrochloride Tablets 5mg/850mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each film-coated tablet contains:
Glibenclamide IP……………………….2.5mg
Metformin Hydrochloride IP………………….500mg
Excipients…………………………………………...q.s.
Colours: Iron oxide Red
B. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg
Each film-coated tablet contains:
Glibenclamide IP………………………...2.5m
Metformin Hydrochloride IP…………………...400mg
Excipients……………………………………………q. s
Colours: Iron oxide Yellow
C. Glibenclamide and Metformin Hydrochloride Tablets 2.5.mg/250mg
Each film-coated tablet contains:
Glibenclamide IP………………………...2.5m
Metformin Hydrochloride IP…………………...250mg
Excipients……………………………………………q. s
Colours: Iron oxide Black
D. Glibenclamide and Metformin Hydrochloride Tablets 5mg/500mg
Each film-coated tablet contains:
Glibenclamide IP………………………...5mg
Metformin Hydrochloride IP……………...…...500mg
Excipients …………………………………………... q.s.
Colours: Quinoline Yellow
E. Glibenclamide and Metformin Hydrochloride Tablets 5mg/850mg
Each film-coated tablet contains:
Glibenclamide IP………………………...5mg
Metformin Hydrochloride IP……………...…...850mg
Excipients …………………………………………... q.s.
Colours: Titanium Dioxide
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
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:
Do not freeze.
Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg Technical Specification:
Product Name: | Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg |
Brand Name: | Glucotaj-ZET |
Strength: | 2.5mg/500mg, 2.5mg/400mg, 2.5mg/250mg, 5mg/500mg, 5mg/850mg |
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:
- Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/400mg
Each film-coated tablet contains:
Glibenclamide IP……………………….2.5mg
Metformin Hydrochloride IP………………….400mg
Excipients……………………………………………q.s.
Colours: Iron oxide 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.