Dapoxetine HCl Tablets 60mg Technical Specification:
| Product Name: | Dapoxetine HCl Tablets 60mg |
| Brand Name: | Generic |
| Strength: | 30mg, 60mg, 90mg |
| Dosage Form: | Film Coated Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 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: | Selective Serotonin Reuptake Inhibitor |
| Indication: | To treat premature ejaculation in adult men. |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Dapoxetine HCl Tablets 30mg
Dapoxetine HCl Tablets 60mg
Dapoxetine HCl Tablets 90mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Dapoxetine HCl Tablets 60mg
Each Film Coated Tablet Contains:
Dapoxetine Hydrochloride
eq. to Dapoxetine……………….60mg
Excipients……………………………. Q.S.
Approved colours used.
THERAPEUTIC INDICATIONS:
It is used to treat premature ejaculation in adult men by increasing the time to ejaculate and improves control over ejaculation. This helps to relieve the anxiety or frustration about fast ejaculation.
CAUTION & WARNING:
Keep medicine out of reach of children.
May be injurious if taken in large dosage for a long time.
Do not exceed the recommended dose (1 Tablet only) without consulting a physician.
STORAGE & DOSAGE:
STORAGE: Keep in a cool and dry place away from light.
DOSAGE: As directed by the Physician.