Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
risperidone, Quantity: 4 mg
Alphapharm Pty Ltd
Risperidone
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; magnesium stearate; lactose monohydrate; sodium lauryl sulfate; pregelatinised maize starch; colloidal anhydrous silica; titanium dioxide; hypromellose; propylene glycol; purified talc; quinoline yellow aluminium lake; indigo carmine aluminium lake
Oral
56, 28, 20, 60, 10, 6
(S4) Prescription Only Medicine
RIXADONE is indicated for,- the treatment of schizophrenia and related psychoses.,- the short term treatment of acute mania associated with bipolar 1 disorder (See DOSAGE AND ADMINISTRATION: Bipolar mania).,- the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type. (See DOSAGE AND ADMINISTRATION: Behavioural Disturbances in Dementia).,- the 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 (e.g. aggression, impulsivity and self-injurious behaviours) are prominent (See CLINICAL TRIALS for maintenance data).,- the treatment of behavioural disorders associated with autism in children and adolescents (See CLINICAL TRIALS).
Visual Identification: Green, round, biconvex, film coated tablet with break line on one side and debossed "4" on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2013-09-03
RIXADONE ® _risperidone_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about RIXADONE. 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 RIXADONE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING RIXADONE, ASK YOUR DOCTOR OR PHARMACIST. Your doctor and pharmacist have more information. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT RIXADONE IS USED FOR RIXADONE belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain types of mental illness. It is used for: • treatment of sudden (acute) and long-term (chronic) schizophrenia and other types of related psychoses. These are disorders related to thought, feeling and/or action, • 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, distractibility or poor judgement including disruptive or aggressive behaviours, • treatment of behavioural problems in patients with a decline in mental ability (dementia) caused by Alzheimer's disease. These problems include: aggression through words or action, morbid suspiciousness, agitation or wandering, • treatment of 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, • treatment of behavioural symptoms of autism in children and adolescent. RIXADONE helps to correct a chemical imbalance in the brain associated with these conditions. RIXADONE cannot be recommended for use in children with schizophrenia under 15 years at the present time as there is little experience with the product in this Leggi il documento completo
AUSTRALIAN PRODUCT INFORMATION RIXADONE ® _Risperidone film coated tablet _ 1 NAME OF THE MEDICINE Risperidone 2 QUALITATIVE AND QUANTITATIVE COMPOSITION RIXADONE contains risperidone as the active ingredient, and is available as 0.5, 1, 2, 3 and 4 mg oral film- coated tablets. Excipients with known effect: Egg products and sugars as lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM RIXADONE 0.5 mg : Red-brown, round, biconvex, film coated tablet with break line on one side and debossed “0.5” on the other side. RIXADONE 1 mg : White, round, biconvex, film coated tablet with break line on one side and debossed “1” on the other side. RIXADONE 2 mg : Orange, round, biconvex, film coated tablet with break line on one side and debossed “2” on the other side. RIXADONE 3 mg : Yellow, round, biconvex, film coated tablet with break line on one side and debossed “3” on the other side. RIXADONE 4 mg : Green, round, biconvex, film coated tablet with break line on one side and debossed “4” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RIXADONE is indicated for • the treatment of schizophrenia and related psychoses. • the short term treatment of acute mania associated with bipolar 1 disorder (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION: Bipolar mania). • the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION: Behavioural Disturbances in Dementia). • the 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 (e.g. aggression, impulsivity and self-injurious behaviours) are prominent (see Section 5.1 PHARMACODYNAMIC PROPERTIES – clinical trials for maintenance data). RIXAD Leggi il documento completo