GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg
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:

A. Glibenclamide and Metformin Hydrochloride Tablets 2.5mg/500mg
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:

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.

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.