RISPERIDONE CH risperidone 2mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Active ingredient:

risperidone, Quantity: 2 mg

Available from:

Amneal Pharma Australia Pty Ltd

INN (International Name):

Risperidone

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Risperidone CH is indicated for the treatment of schizophrenia and related psychoses. Risperidone CH is indicated for the treatment of behavioural disturbances in dementia. Risperidone CH 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: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-09-26