Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
risperidone, Quantity: 1 mg
Sun Pharma ANZ Pty Ltd
Risperidone
Tablet
Excipient Ingredients: microcrystalline cellulose; pregelatinised maize starch; colloidal anhydrous silica; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; titanium dioxide; hypromellose; propylene glycol; hyprolose; purified talc
Oral
6 and 60 tablets per pack
(S4) Prescription Only Medicine
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.
Visual Identification: White, film coated, capsule shaped tablets with a scoreline on both sides and 'RSN' and '1' debossed on either side of the scoreline on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2009-04-07
Ozidal CMI V4 October 2019 Page 1 of 15 OZIDAL RISPERIDONE TABLETS CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about OZIDAL (risperidone) tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING OZIDAL, ASK YOUR DOCTOR OR PHARMACIST. YOUR DOCTOR AND PHARMACIST HAVE MORE INFORMATION. KEEP THIS LEAFLET WITH YOUR OZIDAL TABLETS. You may need to read it again. WHAT OZIDAL IS USED FOR OZIDAL is used to treat symptoms of schizophrenia and other types of related psychoses. These are disorders related to thought, feeling and/or action. OZIDAL may be taken for both sudden (acute) and long-lasting (chronic) schizophrenia. OZIDAL is also used for the short-term treatment of acute mania associated with bipolar 1 disorder. This condition is characterised by symptoms such as elevated, expansive or irritable mood, inflated self esteem, decreased need for sleep, pressured speech, racing thoughts, distractability or poor judgement including disruptive or aggressive behaviours. OZIDAL is also used to treat behavioural problems in patients with a decline in mental abilitiy (dementia) caused by Alzheimer’s disease. These problems include: aggression through words or action, morbid suspiciousness, agitation or wandering. OZIDAL can be used to treat conduct and other disruptive behaviours such as aggression, impulsiveness and self-injury in children (over 5 years old), adolescents and adults who are intellectually disabled. OZIDAL can also be used to treat behavioural symptoms of autism in children and adolescents. OZIDAL helps to correct a chemical imbalance in the brain associated with these conditions. OZIDAL has been approved for the uses mentioned above. However, your doctor may prescribe this medicine for an Read the complete document
OZIDAL PI V4 Oct 2019 Page 1 of 45 AUSTRALIAN PRODUCT INFORMATION - OZIDAL (RISPERIDONE) TABLETS 1. NAME OF THE MEDICINE Risperidone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of OZIDAL contains 0.5 mg, 1mg, 2 mg, 3 mg or 4 mg of risperidone. Excipient with known effect: lactose monohydrate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM OZIDAL 0.5 mg tablets - available as brown-coloured, film-coated, oval-shaped tablets with a scoreline on both sides and ‘RSN’ and ‘0.5’ debossed on either side of the scoreline on one side. OZIDAL 1 mg tablets - available as white, film-coated, capsule-shaped tablets with a scoreline on both sides and ‘RSN’ and ‘1’ debossed on either side of the scoreline on one side. OZIDAL 2 mg tablets - available as peach-coloured, film-coated, capsules-shaped tablets with a scoreline on both sides and ‘RSN’ and ‘2’ debossed on either side of the scoreline on one side. OZIDAL 3 mg tablets - available as yellow-coloured, film-coated, capsule-shaped tablets with a scoreline on both sides and ‘RSN’ and ‘3’ debossed on either side of the scroreline on one side. OZIDAL 4 mg tablets - available as green-coloured, film-coated, capsule-shaped tablets with a scoreline on both sides and ‘RSN’ and ‘4’ debossed on either side of the scoreline on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS OZIDAL is indicated for the treatment of schizophrenia and related psychoses. OZIDAL is indicated for the short-term treatment of acute mania associated with bipolar 1 disorder. OZIDAL PI V4 Oct 2019 Page 2 of 45 OZIDAL is also indicated for the 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. OZIDAL is indicated in the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intelle Read the complete document