GENERIC NAME OF THE MEDICINAL PRODUCT:

Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/500mg (Glucotaj-ZET)
Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/400mg (Glucotaj-ZET)
Glibenclamide and Metformin Hydrochloride Tablets USP 5mg/500mg (Glucotaj-ZET)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/500mg
Each film-coated tablet contains:
Glibenclamide USP……………………….2.5mg
Metformin Hydrochloride USP………………….500mg
Excipients…………………………………………...q.s.
Colours: Iron oxide Red

b) Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/400mg
Each film-coated tablet contains:
Glibenclamide USP………………………...2.5mg
Metformin Hydrochloride USP…………………...400mg
Excipients……………………………………………q.s.
Colours: Iron oxide Yellow

c) Glibenclamide and Metformin Hydrochloride Tablets USP 5mg/500mg
Each film-coated tablet contains:
Glibenclamide USP………………………...5mg
Metformin Hydrochloride USP……………...…...500mg
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 & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
ANY UNUSED PRODUCT OR WASTE MATERIAL SHOULD BE DISPOSED OF IN ACCORDANCE WITH LOCAL REQUIREMENTS.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at temperatures up to 25°C (77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Glibenclamide and Metformin Hcl Tablets USP 5mg/500mg Technical Specification:

Product Name:
 Glibenclamide + Metformin Hydrochloride Tablets USP
Brand Name: Glucotaj-ZET
Strength: 2.5mg/500mg, 2.5mg/400mg, 5mg/500mg
Dosage Form: Tablets (Film coated)
Route of Administration: Via Oral Route
Packing: 30s, 90s, 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: 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: Store at temperatures up to 25°C (77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/500mg (Glucotaj-ZET)
  • Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/400mg (Glucotaj-ZET)
  • Glibenclamide and Metformin Hydrochloride Tablets USP 5mg/500mg (Glucotaj-ZET)  

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • a) Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/500mg
    Each film-coated tablet contains:
    Glibenclamide USP……………………….2.5mg
    Metformin Hydrochloride USP………………….500mg
    Excipients……………………………………………q.s.
    Colours: Iron oxide Red
  • b) Glibenclamide and Metformin Hydrochloride Tablets USP 2.5mg/400mg
    Each film-coated tablet contains:
    Glibenclamide USP…………………………2.5mg
    Metformin Hydrochloride USP……………………400mg
    Excipients……………………………………………q.s.
    Colours: Iron oxide Yellow
  • c) Glibenclamide and Metformin Hydrochloride Tablets USP 5mg/500mg
    Each film-coated tablet contains:
    Glibenclamide USP…………………………5mg
    Metformin Hydrochloride USP……………………500mg
    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 & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    Any unused product or waste material should be disposed of in accordance with local requirements.
  • Warning:To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Store at temperatures up to 25°C (77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
  • Dosage:As directed by the Physician.
Attach dispensing label as per end county.