| Product Name: | Sildenafil + Dapoxetine Effervescent Tablets |
| Brand Name: | Generic |
| Strength: | 100mg+60mg |
| Dosage Form: | Effervescent Tablet |
| Route of Administration: | Via Oral Route |
| Packing: | 5 Tabs., 10Tabs. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Erectile Dysfunction (ED), Phosphodiesterase Inhibitors (PDEI) & Selective Serotonin Reuptake inhibitor |
| Indication: | Sildenafil and Dapoxetine treat male erectile dysfunction and premature ejaculation. |
| Storage: | Store below 25°C. Keep in a cool, dry & dark place. Protect from light. Keep out of reach and sight of children. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Sildenafil + Dapoxetine Effervescent Tablets 100mg+60mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Sildenafil + Dapoxetine Effervescent Tablets 100mg+60mg
Composition:
Each Effervescent Tablet Contains:
Sildenafil Citrate USP
Equivalent to Sildenafil………………….100mg
Dapoxetine HCL
Equivalent to Dapoxetine………………60mg
Excipients………………………………………Q.S
Colour: Sunset yellow FCF
THERAPEUTIC INDICATIONS:
Sildenafil and Dapoxetine treat male erectile dysfunction and premature ejaculation. Sildenafil is a phosphodiesterase type 5 (PDE 5) inhibitor that works by increasing blood flow to the penis during sexual stimulation and enables its erection following sexual stimulation. Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) that increases the level of serotonin in nerves to increase the time taken to ejaculate and improve control over ejaculation.
DIRECTION FOR USE:
Dissolve the tablet in a glass of water. Stir the solution well before drinking.
CAUTION & WARNING:
CAUTION:
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
STORAGE & DOSAGE:
Storage: Store below 25°C.
Keep in a cool, dry & dark place.
Protect from light.
Keep out of reach and sight of children.
Dosage: As directed by the Physician.