| Product Name: | Paliperidone Extended-Release Tablets |
| Brand Name: | Generic |
| Strength: | 1.5mg, 3mg, 6mg, 9mg, 12mg |
| Dosage Form: | Tablets (Film-coated Extended-Release) |
| 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: | Paliperidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Paliperidone Extended-Release Tablets 1.5mg
- Paliperidone Extended-Release Tablets 3mg
- Paliperidone Extended-Release Tablets 6mg
- Paliperidone Extended-Release Tablets 9mg
- Paliperidone Extended-Release Tablets 12mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Paliperidone Extended-Release Tablets 1.5mg
Each film-coated Extended-Release tablet contains:
Paliperidone USP……………………………………..1.5mg
Excipients…………………………………………………q.s.
Colours: Indigo carmine - Paliperidone Extended-Release Tablets 3mg
Each film-coated Extended-Release tablet contains:
Paliperidone USP……………………………………..3mg
Excipients…………………………………………………q.s.
Colours: Ferric Oxide Red - Paliperidone Extended-Release Tablets 6mg
Each film-coated Extended-Release tablet contains:
Paliperidone USP……………………………………..6mg
Excipients…………………………………………………q.s.
Colours: Ferric Oxide Yellow - Paliperidone Extended-Release Tablets 9mg
Each film-coated Extended-Release tablet contains:
Paliperidone USP……………………………………..9mg
Excipients…………………………………………………q.s.
Colours: Ferric Oxide Black - Paliperidone Extended-Release Tablets 12mg
Each film-coated Extended-Release tablet contains:
Paliperidone USP……………………………………..12mg
Excipients…………………………………………………q.s.
Colours: Ferric Oxide Black
THERAPEUTIC INDICATIONS:
Paliperidone is used to treat the symptoms of psychotic (mental) disorders, including schizophrenia. It may also be used alone or together with other medicines to treat patients with schizoaffective disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.
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 Psychiatrist 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.