RISPERIDONE-AS risperidone 0.5mg film-coated tablet blister pack

Active ingredient:

risperidone, Quantity: 0.5 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Risperidone

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; iron oxide red; lactose monohydrate; hypromellose; magnesium stearate; microcrystalline cellulose; maize starch; titanium dioxide; macrogol 400

Administration route:

Oral

Units in package:

30 tablets, 60 tablets, 100 tablets, 15 tablets, 20 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Risperidone-AS is indicated for the treatment of schizophrenia and related psychoses. Risperidone-AS is indicated for the treatment of behavioural disturbances in dementia. Risperidone-AS is indicated for the treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. (See Clinical Trials for maintenance data).

Product summary:

Visual Identification: Red, film-coated, round tablet with "R" engraved on one face and a breakline on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-09-26