| Product Name: | Gliclazide + Metformin Hydrochloride tablets |
| Brand Name: | Generic |
| Strength: | (MR 30mg+SR 500mg), (MR 60mg+ER 500mg), (MR 80mg+SR 500mg) |
| Dosage Form: | Tablets (uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s,12s,15s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Anti-diabetic |
| Indication: | Gliclazide+Metformin is a combination of two medicines: Gliclazide and Metformin. This medicine 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: | Preserve in tight container. Keep in a cool & dry place, Protect from Light & Moisture. Keep out of reach and sight of children. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Gliclazide + Metformin Hydrochloride tablets MR 30mg+SR 500mg
B. Gliclazide + Metformin Hydrochloride tablets MR 60mg+ER 500mg
C. Gliclazide + Metformin Hydrochloride tablets MR 80mg+SR 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Gliclazide + Metformin Hydrochloride tablets MR 30mg+SR 500mg
Each un-coated sustained release Tablet contains:
Gliclazide BP………………………………30 mg
Metformin Hydrochloride USP……500 mg
Excipients…………………………qs
B. Gliclazide + Metformin Hydrochloride tablets MR 60mg+ER 500mg
Each un-coated extended-release Tablet contains:
Gliclazide BP………………………………60 mg
Metformin Hydrochloride USP……500 mg
Excipients…………………………qs
C. Gliclazide + Metformin Hydrochloride tablets MR 80mg+SR 500mg
Each un-coated sustained release Tablet contains:
Gliclazide BP………………………………80 mg
Metformin Hydrochloride USP……500 mg
Excipients…………………………qs
THERAPEUTIC INDICATIONS:
Gliclazide+Metformin is a combination of two medicines: Gliclazide and Metformin. This medicine 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: DRUG-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only
SWALLOW WHOLE DO NOT CHEW OR CRUSH
STORAGE & DOSAGE:
Storage: Preserve in tight container.
Keep in a cool & dry place, Protect from Light & Moisture.
Keep out of reach and sight of children.
Dosage: As directed by the Physician.