GENERIC NAME OF THE MEDICINAL PRODUCT:

Risperidone Tablets USP 0.25mg
Risperidone Tablets USP 0.5mg
Risperidone Tablets USP 1mg
Risperidone Tablets USP 2mg
Risperidone Tablets USP 3mg
Risperidone Tablets USP 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Risperidone Tablets USP 0.25mg
Each film-coated Tablet Contains:
Risperidone…………….0.25mg
Excipients……………………q.s.
Colures: F&D Yellow 5

b) Risperidone Tablets USP 0.5mg
Each film-coated Tablet Contains:
Risperidone…………….0.5mg
Excipients……………………q.s.
Colures: Indigo Carmine

b) Risperidone Tablets USP 1mg
Each film-coated Tablet Contains:
Risperidone…………….1mg
Excipients……………………q.s.
Colures: Brilliant Blue

c) Risperidone Tablets USP 2mg
Each film-coated Tablet Contains:
Risperidone…………….2mg
Excipients……………………q.s.
Colures: Sunset Yellow

d) Risperidone Tablets USP 3mg
Each film-coated Tablet Contains:
Risperidone…………….3mg
Excipients……………………q.s.
Colures: Iron Oxide Yellow

e) Risperidone Tablets USP 4mg
Each film-coated Tablet Contains:
Risperidone………………4mg
Excipients……………………q.s.
Colures: Quinoline Yellow

THERAPEUTIC INDICATIONS:

It is indicated for the treatment of schizophrenia, moderate to severe manic episodes associated with bipolar disorders, and short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
keep medicine out of reach of children.
swallow whole does not chew or crush
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Risperidone Tablets USP Technical Specification:

Product Name:          Risperidone Tablets USP
Brand Name: RESPERITAJ
Strength: 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg
Dosage Form: Tablets (Film- coated)
Route of Administration: Via oral Route
Packing: 30s, 90s, 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, Central Nervous System
Indication: it is indicated for the treatment of schizophrenia, moderate to severe manic episodes associated with bipolar disorders, and short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Risperidone Tablets USP0.25mg
  • Risperidone Tablets USP 0.5mg
  • Risperidone Tablets USP 1mg
  • Risperidone Tablets USP 2mg
  • Risperidone Tablets USP 3mg
  • Risperidone Tablets USP 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Risperidone Tablets USP 0.25mg
Each film-coated Tablet Contains:
Risperidone…………….0.25mg
Excipients……………………q.s.
Colures: F&D Yellow 5

 b) Risperidone Tablets USP 0.5mg
Each film-coated Tablet Contains:
Risperidone…………….0.5mg
Excipients……………………q.s.
Colures: Indigo Carmine

c) Risperidone Tablets USP 1mg
Each film-coated Tablet Contains:
Risperidone…………….1mg
Excipients……………………q.s.
Colures: Brilliant Blue

d) Risperidone Tablets USP 2mg
Each film-coated Tablet Contains:
Risperidone…………….2mg
Excipients……………………q.s.
Colures: Sunset Yellow

d) Risperidone Tablets USP 3mg
Each film-coated Tablet Contains:
Risperidone…………….3mg
Excipients……………………q.s.
Colures: Iron Oxide Yellow

e) Risperidone Tablets USP 4mg
Each film-coated Tablet Contains:
Risperidone………………4mg
Excipients……………………q.s.
Colures: Quinoline Yellow

THERAPEUTIC INDICATIONS:

  • It is indicated for the treatment of schizophrenia, moderate to severe manic episodes associated with bipolar disorders, and short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    keep medicine out of reach of children.
    swallow whole does not chew or crush
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
  • Dosage:  As directed by the Physician.
Attach dispensing label as per end county.