Gliclazide and Metformin SR Tablets 30+500mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Gliclazide and Metformin SR Tablets 30+500mg
 B) Gliclazide and Metformin SR Tablets 60+500mg
C) Gliclazide and Metformin SR Tablets 60+850mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Gliclazide and Metformin SR Tablets 30+500mg
Each uncoated tablet contains:
Gliclazide BP………………………………….30mg
Metformin Hydrochloride USP……….500mg
Excipients……………….q.s.
Colour: Sunset Yellow

 B) Gliclazide and Metformin SR Tablets 60+500mg
Each uncoated tablet contains:
Gliclazide BP………………………………….60mg
Metformin Hydrochloride USP……….500mg
Excipients……………….q.s.
Colour: Titanium Oxide

C) Gliclazide and Metformin SR Tablets 60+800mg
Each uncoated tablet contains:
Gliclazide BP………………………………….60mg
Metformin Hydrochloride USP……….800mg
Excipients……………….q.s.
Colour: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Gliclazide and Metformin SR Tablets is used in the treatment of type 2 diabetes mellitus (DM). It improves blood glucose levels in adults when taken along with proper diet and regular exercise.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at room temperature. Protect from light and moisture.
Dispense in tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.

Gliclazide and Metformin SR Tablets 30+500mg Technical Specification:

Product Name:Gliclazide and Metformin SR Tablets
Brand Name:Generic
Strength: 30+500mg, 60+500mg, 60+850mg
Dosage Form:Tablets (Uncoated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 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:Antidiabetic
Indication: Gliclazide and Metformin SR Tablet is used in the treatment of type 2 diabetes mellitus (DM). It improves blood glucose levels in adults when taken along with proper diet and regular exercise.
Storage:Store at room temperature. Protect from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Gliclazide and Metformin SR Tablets 30+500mg
  • Gliclazide and Metformin SR Tablets 60+500mg
  • Gliclazide and Metformin SR Tablets 60+850mg

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Gliclazide and Metformin SR Tablets 30+500mg
    Each uncoated tablet contains:
    Gliclazide BP………………………………….30mg
    Metformin Hydrochloride USP……….500mg
    Excipients……………….q.s.
    Colour: Sunset Yellow
  • Gliclazide and Metformin SR Tablets 60+500mg
    Each uncoated tablet contains:
    Gliclazide BP………………………………….60mg
    Metformin Hydrochloride USP……….500mg
    Excipients……………….q.s.
    Colour: Titanium Oxide
  • Gliclazide and Metformin SR Tablets 60+800mg
    Each uncoated tablet contains:
    Gliclazide BP………………………………….60mg
    Metformin Hydrochloride USP……….800mg|
    Excipients……………….q.s.
    Colour: Ponceau 4 R

 THERAPEUTIC INDICATIONS:

Gliclazide and Metformin SR Tablet is used in the treatment of type 2 diabetes mellitus (DM). It improves blood glucose levels in adults when taken along with proper diet and regular exercise.

CAUTION & WARNING:

CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at room temperature. Protect from light and moisture.
Dispense in a tight container.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.