| Product Name: | Silodosin tablets |
| Brand Name: | Generic |
| Strength: | 4mg, 8mg |
| Dosage Form: | tablets |
| 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: | Andrology |
| Indication: | Silodosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). |
| Storage: | Store below 30°C. Protect from Light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Silodosin tablets 4mg
- Silodosin tablets 8mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Silodosin tablets 4mg
Each tablets contains:
Silodosin………………….4mg
Excipients…………………q.s.
Approved colours used in capsule shells. - Silodosin tablets 8mg
Each tablets contains:
Silodosin…………………8mg
Excipients…………………q.s.
Approved colours used in capsule shells.
THERAPEUTIC INDICATIONS:
Silodosin is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
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 below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician.