| Product Name: | Indapamide Tablets USP |
| Brand Name: | Generic |
| Strength: | 1.5mg, 2.5mg |
| Dosage Form: | Tablets (film-coated) |
| 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: | Antihypertensive |
| Indication: | Indapamide is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Indapamide Tablets USP 1.5mg
- Indapamide Tablets USP 2.5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Indapamide Tablets USP Tablets USP 1.5mg
Each film-coated tablet contains:
Indapamide USP ……………1.5mg
Excipients ……………………..q.s
Color: Sunset yellow FCF - Indapamide Tablets USP Tablets USP 2.5mg
Each film-coated tablet contains:
Indapamide USP …………………2.5mg
Excipients …………………………….q.s
Color: Sunset yellow lake
THERAPEUTIC INDICATIONS:
Indapamide is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defined in the USP.
Keep the container tightly closed.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.