GENERIC NAME OF THE MEDICINAL PRODUCT:
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:
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:
CAUTION & WARNING:
Keep medicine out of reach of children.
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.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
If you are using risperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.
STORAGE & DOSAGE:
Keep the container tightly closed in order to protect it 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 3mg Technical Specification:
Product Name: | Risperidone Tablets USP 3mg |
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 from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it from moisture. |
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:
- Risperidone Tablets USP 0.25mg
Each film-coated Tablet Contains
Risperidone…………….0.25mg
Excipients……………………q.s.
Colures: F&D Yellow 5 - Risperidone Tablets USP 0.5mg
Each film-coated Tablet Contains:
Risperidone…………….0.5mg
Excipients……………………q.s.
Colures: Indigo Carmine - Risperidone Tablets USP 1mg
Each film-coated Tablet Contains:
Risperidone…………….1mg
Excipients……………………q.s.
Colures: Brilliant Blue - Risperidone Tablets USP 2mg
Each film-coated Tablet Contains:
Risperidone…………….2mg
Excipients……………………q.s.
Colures: Sunset Yellow - Risperidone Tablets USP 3mg
Each film-coated Tablet Contains:
Risperidone…………….3mg
Excipients……………………q.s.
Colures: Iron Oxide Yellow - 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 the enclosed leaflet before use.
Keep the medicine out of reach of children.
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. <br>
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only. <br>
If you are using risperidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.
STORAGE & DOSAGE:
Storage: Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect it 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.