| Product Name: | Zotepine Tablets |
| Brand Name: | Generic |
| Strength: | 25mg, 50mg, 100mg |
| Dosage Form: | Tablets (film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 tablets each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antidepressant, Antianxiety, Antipsychotic |
| Indication: | Zotepine is used in the treatment of schizophrenia and mania. Zotepine is an atypical antipsychotic. It works by modulating the action of certain chemical messengers in the brain that affect thoughts. |
| Storage: | Store in a cool & dry place. Protect from direct sunlight, heat and moisture. Keep out of reach of children. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Zotepine 25mg Tablets
B. Zotepine 50mg Tablets
C. Zotepine 100 mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Zotepine 25mg Tablets
Each film-coated tablet contains:
Zotepine IP……………………………25mg
Excipients………………………………………q.s
Colour: Tartrazine
B. Zotepine 50mg Tablets
Each uncoated tablet contains:
Zotepine IP………………………………50mg
Excipients………………………………………q.s
Colour: Quinoline Yellow
C. Zotepine 100mg Tablets
Each uncoated tablet contains:
Zotepine IP………………………………100mg
Excipients………………………………………q.s
Colour: Quinoline Yellow
THERAPEUTIC INDICATIONS:
Zotepine is used in the treatment of schizophrenia and mania. Zotepine is an atypical antipsychotic. It works by modulating the action of certain chemical messengers in the brain that affect thoughts.
CAUTION & SCHEDULE:
CAUTION: Not to be sold by retail without the prescription of a registered medicinal practitioner.
SCHEDULE G PRESCRIPTION DRUG-CAUTION: It is dangerous to take the prescription except under medical supervision.
SCHEDULE H PRESCRIPTION DRUG-CAUTION: To be sold by retail on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
Storage: Store in a cool & dry place. Protect from direct sunlight, heat and moisture.
Keep out of reach of children.
Dosage: As directed by the Physician.