Gliclazide Modified Release Tablets BP 60mg Technical Specification:

Product Name:
Gliclazide Modified Release Tablets BP  60mg
Brand Name:Generic
Strength:30mg, 60mg
Dosage Form:Tablets (Uncoated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s
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, hypoglycemic
Indication: Gliclazide is used to treat type 2 diabetes. It’s a medicine known as a sulfonylurea. Sulfonylureas increase the amount of insulin your pancreas makes. This lowers your blood sugar.
Storage:Protect form moisture at a temperature not exceeding 25˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Gliclazide Modified Release Tablets BP 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Gliclazide Modified Release Tablets BP 60mg
    Each modified release tablet contains:
    Gliclazide BP……………………60mg
    Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

Gliclazide is used to treat type 2 diabetes. It’s a medicine known as a sulfonylurea. Sulfonylureas increase the amount of insulin your pancreas makes. This lowers your blood sugar.

CAUTION & WARNING:

CAUTION:  SWALLOW WHOLE DO NOT CHEW OR CRUSH

Read enclosed leaflet before use.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 25˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage:  The recommended dose of gliclazide ranges from 60mg to 320mg daily. Doses of 160mg & above should be taken in two equally divided doses. Gliclazide should be taken with meals if possible. The daily dose should not exceed 320mg.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Gliclazide Modified Release Tablets BP 30mg
B. Gliclazide Modified Release Tablets BP 60mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Gliclazide Modified Release Tablets BP 30mg
Each modified release tablet contains:
Gliclazide BP……………………30mg
Excipients………………………...q.s.

B. Gliclazide Modified Release Tablets BP 60mg
Each modified release tablet contains:
Gliclazide BP……………………60mg
Excipients………………………...q.s.


THERAPEUTIC INDICATIONS:

Gliclazide is used to treat type 2 diabetes. It's a medicine known as a sulfonylurea. Sulfonylureas increase the amount of insulin your pancreas makes. This lowers your blood sugar.

CAUTION & WARNING:

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

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 25˚C.
Do not freeze.
Keep the container tightly closed in order to protect from moisture.
Dosage: The recommended dose of gliclazide ranges from 60mg to 320mg daily.
Doses of 160mg & above should be taken in two equally divided doses.
Gliclazide should be taken with meals if possible.
The daily dose should not exceed 320mg.
Attach dispensing label as per end country.