| Product Name: | Pimozide Tablets USP |
| Brand Name: | Generic |
| Strength: | 1mg, 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: | Central Nervous System, Antipsychotic |
| Indication: | Pimozide is used to control motor or verbal tics (an uncontrollable need to repeat certain movements or sounds) caused by Tourette’s disorder (a condition characterized by motor or verbal tics). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Pimozide Tablets USP 1mg
- Pimozide Tablets USP 2mg
- Pimozide Tablets USP 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Pimozide Tablets USP 1mg
Each uncoated tablet contains:
Pimozide USP……………….1mg
Excipients…………………….q.s.
Colour: Panceau 4R - Pimozide Tablets USP 2mg
Each uncoated tablet contains:
Pimozide USP……………….2mg
Excipients…………………….q.s.
Colour: Yellow Oxide of Iron - Pimozide Tablets USP 4mg
Each uncoated tablet contains:
Pimozide USP……………….4mg
Excipients…………………….q.s.
Colour: Red Oxide of Iron
THERAPEUTIC INDICATIONS:
Pimozide works in the central nervous system to help control the vocal outbursts and uncontrolled, repeated movements of the body (tics) that may interfere with the patient’s normal life. It will not completely cure the tics, but will help to reduce their number and severity.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
Keep 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].
Protect from light and moisture.
Dosage: As directed by the Physician