| Product Name: | Amisulpride Tablets BP |
| Brand Name: | Generic |
| Strength: | 50mg, 100mg, 200mg |
| 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: | Antipsychotic |
| Indication: | Amisulpride Tablets are indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, and thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterized by predominant negative symptoms. |
| Storage: | Store at 25°C away from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Amisulpride Tablets BP 50mg
- Amisulpride Tablets BP 100mg
- Amisulpride Tablets BP 200mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Amisulpride Tablets BP 50mg
Each uncoated tablet contains:
Amisulpride BP ……………50mg
Excipients………………q.s.
Colour: Titanium Dioxide - Amisulpride Tablets BP 100mg
Each uncoated tablet contains:
Amisulpride BP ……………100mg
Excipients………………q.s.
Colour: Ferric oxide red - Amisulpride Tablets BP 200mg
Each uncoated tablet contains:
Amisulpride BP ……………200mg
Excipients………………q.s.
Colour: Ponceau 4 R
THERAPEUTIC INDICATIONS:
Amisulpride Tablets are indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.
CAUTION & WARNING:
CAUTION: Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20°C
Dispense in a tight container.
Dosage: As directed by the Physician