Vardenafil Hydrochloride disintegrating Tablets Technical Specification:
| Product Name: | Vardenafil Hydrochloride orally disintegrating tablets |
| Brand Name: | Generic |
| Strength: | 10mg |
| Dosage Form: | Tablet (uncoated tablets) |
| Route of Administration: | Via Oral Route |
| Packing: | 4s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristic) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSC and CTD Dossier |
| Therapeutic use: | For erectile dysfunction & phosphodiesterase 5 (PDE5) inhibitors |
| Indication: | Vardenafil is used to treat men with erectile dysfunction (sexual impotence). It 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);excursion permitted to 15- 30℃ (59-86 °F(See USP Controlled Room Temperature) |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Vardenafil Hydrochloride orally disintegrating 10mg tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Tablet contains:
Each tablet contains 11.85mg of Vardenafil Hydrochloride USP
equivalent to Vardenafil…………………10mg
THERAPEUTIC INDICATIONS:
Vardenafil is used to treat men with erectile dysfunction (sexual impotence). It 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.
Do not take more than one tablet per day.
TO THE PHARMACIST:
Each tablet pack contains information intended for the patient.
Pack is to be dispense to patients without repackaging.
DIRECTION OF USE:
Place the orally disintegrating tablet in the mouth, on the tongue.
The orally disintegrating tablet should be taken without liquid.
STORAGE & DOSAGE:
Storage: Store at 25℃ (77 °F); excursion permitted to 15- 30℃ (59-86 °F(See USP Controlled Room Temperature)
Dosage: Take one tablet as needed.