GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Risperidone Tablets USP 0.25mg
B. Risperidone Tablets USP 0.5mg
C. Risperidone Tablets USP 1mg
D. Risperidone Tablets USP 2mg
E. Risperidone Tablets USP 3mg
F. Risperidone Tablets USP 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

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

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

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

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

F. Risperidone Tablets USP 4mg
Each film-coated Tablet Contains:
Risperidone USP………………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: Swallow whole does not chew or crush.
*Not suitable for children under 10 years.
*Treatment of moderate to severe manic episodes associated with bipolar disorders.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
WARNING: If you are using risperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.
Keep medicine out of reach of children.

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.
NOTE: Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults & adolescents aged 13-17 years.
Attach dispensing label as per end country.

Risperidone Tablets USP 4mg Technical Specification:

Product Name:
Risperidone Tablets USP 4mg
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 USP 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Risperidone Tablets USP 4mg
    Each film-coated Tablet Contains:
    Risperidone USP…………….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:  Swallow whole does not chew or crush

*Not suitable for children under 10 years.

*Treatment of moderate to severe manic episodes associated with bipolar disorders.

Read enclosed leaflet before use.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Warning: If you are using risperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

Keep medicine out of reach of children.

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.

NOTE: Risperidone is an atypical antipsychotic agent indicated for:
Treatment of schizophrenia in adults & adolescents aged 13-17 years.

Attach dispensing label as per end country.