Sildenafil Citrate Tablets Technical Specification:
| Product Name: | Sildenafil Citrate Tablets IP 100mg |
| Brand Name: | Generic |
| Strength: | 50mg,100mg |
| Dosage Form: | Tablets (film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 4s,10s,100s,120s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | For erectile dysfunction |
| Indication: | Sildenafil is used to treat erectile dysfunction (also called sexual impotence). Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors and prevent an enzyme called phosphodiesterase type-5 from working too quickly. |
| Storage: | Store protected from moisture, at temperature not exceeding than 30℃. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Sildenafil Citrate Tablets 50mg
Sildenafil Citrate Tablets 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Sildenafil Citrate IP
Equivalent to Sildenafil………….100mg
Excipients………………………………Q.S.
Colour: Ferric Oxide Red USP-NF, Titanium Dioxide IP, Lake indigo Carmine, Lake of Ponceau 4R USP
THERAPEUTIC INDICATIONS:
Sildenafil is used to treat erectile dysfunction (also called sexual impotence). Sildenafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors and prevent an enzyme called phosphodiesterase type-5 from working too quickly.
CAUTION & SCHEDULE:
Keep out of reach of children.
SCHEDULE H PRESCRIPTION DRUG: WARNING: Not to be sold by retail without Registered Medical Practitioner/ Urology/Psychiatrist/Endocrinologist/Venereologist/ Dermatologist.
STORAGE & DOSAGE:
Storage: Store protected from moisture, at temperature not exceeding than 30℃.
Dosage: As directed by the Physician.