GENERIC NAME OF THE MEDICINAL PRODUCT:

Glibenclamide, Pioglitazone + Metformin Hydrochloride ER Tablets 5mg+15mg+500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Glibenclamide, Pioglitazone + Metformin Hydrochloride Extended-Release Tablets 5mg+15mg+500mg
Each bilayer Un-coated tablet contains:
Glibenclamide IP………………………….…….5mg
Pioglitazone Hydrochloride IP
Equivalent to Pioglitazone ……………………15mg
Metformin Hydrochloride IP………………….500mg
(In extended-release form) Excipients…………………………………………...q.s.
Colours: Iron oxide Red

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.
SWELLOW WHOLE DO NOT CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

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, Pioglitazone + Metformin Hydrochloride ER Tablets 5mg+15mg+500mg Technical Specification:

Product Name:       Glibenclamide, Pioglitazone + Metformin Hydrochloride ER Tablets
Brand Name: Generics
Strength: (5mg+15mg+500mg)
Dosage Form: Tablets (Un-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, Diabetology, 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, Pioglitazone + Metformin Hydrochloride ER Tablets 5mg+15mg+500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • a) Glibenclamide, Pioglitazone + Metformin Hydrochloride Extended-Release Tablets 5mg+15mg+500mg
    Each bilayer Un-coated tablet contains:
    Glibenclamide IP………………………….…….5mg
    Pioglitazone Hydrochloride IP
    Equivalent to Pioglitazone ……………………15mg
    Metformin Hydrochloride IP………………….500mg
    (In extended-release form)
    Excipients……………………………………………q.s.
    Colours: Iron oxide Red

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.
    SWELLOW WHOLE DO NOT CRUSH
  • SCHEDULE “H” Prescription Drug –Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

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.