RISPERIDONE-AS risperidone 2mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

risperidone, Quantity: 2 mg

Available from:

Medis Pharma Pty Ltd

INN (International Name):

Risperidone

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

60 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: Orange, film-coated, oblong tablet engraved with "R", a breakline and "2" on one side and a plain face 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