| Product Name: | Gliclazide Modified Release Tablets BP |
| Brand Name: | Generic |
| Strength: | 30mg, 60mg, 80mg |
| 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 30mg
- Gliclazide Modified Release Tablets BP 60mg
- Gliclazide Modified Release Tablets BP 80mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Gliclazide Modified Release Tablets BP 30mg
Each modified release tablet contains:
Gliclazide BP……………………30mg
Excipients…………………………q.s. - Gliclazide Modified Release Tablets BP 60mg
Each modified release tablet contains:
Gliclazide BP……………………60mg
Excipients…………………………q.s. - Gliclazide Modified Release Tablets BP 80mg
Each modified release tablet contains:
Gliclazide BP……………………80mg
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
Keep medicine out of reach of children.
Read enclosed leaflet before use.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
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.