Tadalafil Tablets Technical Specification:
| Product Name: | Tadalafil Tablet USP 5mg |
| Brand Name: | Generic |
| Strength: | 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg |
| Dosage Form: | Tablets (film-coated tablet) |
| Route of Administration: | Via Oral Route |
| Packing: | 4s, 10s, 28s, 30s, 60s, 100s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | For erectile dysfunction |
| Indication: | Tadalafil is used to treat men who have erectile dysfunction (also called sexual impotence). Tadalafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. |
| Storage: | Store at 25℃ (77 °F); excusions permitted to 15° to 30℃ (59° to 86 °F)(See USP Controlled Room Temperature) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Tadalafil Tablet USP 2.5mg
Tadalafil Tablet USP 5mg
Tadalafil Tablet USP 10mg
Tadalafil Tablet USP 20mg
Tadalafil Tablet USP 40mg
Tadalafil Tablet USP 60mg
Tadalafil Tablet USP 80mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Film-coated tablet contains:
Tadalafil USP………….5mg
Excipients………………Q.S.
THERAPEUTIC INDICATIONS:
Tadalafil is used to treat men who have erectile dysfunction (also called sexual impotence). Tadalafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly.
CAUTION :
Keep out of reach of children.
Dispense in tight container.
Entire dose should be taken.
Tablet should not be split.
STORAGE & DOSAGE:
Storage: Store at 25℃ (77 °F); excusions permitted to 15° to 30℃ (59° to 86 °F)(See USP Controlled Room Temperature)
Dosage: As directed by the Physician.