RISPERIDONE RBX risperidone 3mg tablet blister pack

Active ingredient:

risperidone, Quantity: 3 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Risperidone

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; pregelatinised maize starch; sodium lauryl sulfate; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; macrogol 4000; quinoline yellow aluminium lake; macrogol 400

Administration route:

Oral

Units in package:

60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

OZIDAL is indicated for - treatment of schizophrenia and related psychoses; short-term treatment of acute mania associated with bipolar 1 disorder; treatment (up to 12 weeks) of psychotic symptoms or persistent agitations or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type; treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (eg. aggression, impulsivity and self-injurious behaviours) are prominent; treatment of behavioural disorders associated with autism in children and adolescents.

Product summary:

Visual Identification: Yellow coloured, film coated, capsule shaped tablets with a scoreline on both sides and 'RSN' and '3' debossed on either side of the scoreline on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-06-14