| Product Name: | Reboxetine Tablets |
| Brand Name: | Generic |
| Strength: | 2mg ,4mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antidepressants, Central nervous system |
| Indication: | Reboxetine is a selective noradrenaline reuptake inhibitor (NaRI), the first drug of new antidepressant class. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Reboxetine Tablets 2mg
- Reboxetine Tablets 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Reboxetine Tablets 2mg
Each uncoated tablet contains:
Reboxetine Methane sulphonate
Equivalent to Reboxetine……….2mg
Excipients………………………………. q.s.
Colors: Lake of indigo carmine - Reboxetine Tablets 4mg
Each uncoated tablet contains:
Reboxetine Methane sulphonate
Equivalent to Reboxetine……….4mg
Excipients………………………………. q.s.
Colors: Lake of indigo carmine
THERAPEUTIC INDICATIONS:
Reboxetine is primarily used to treat depression but has also been found useful in the treatment of narcolepsy and panic disorders. Reboxetine is a selective inhibitor of noradrenaline reuptake. It inhibits noradrenaline reuptake in vitro to a similar extent to the tricyclic antidepressant dimethyl imipramine.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight container.
Protect from light and moisture.
Dosage: As directed by the Physician.