Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
risperidone, Quantity: 1 mg
Generic Health Pty Ltd
Risperidone
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; pregelatinised maize starch; lactose monohydrate; sodium lauryl sulfate; purified talc; magnesium stearate; titanium dioxide; hypromellose; propylene glycol
Oral
60 tablets
(S4) Prescription Only Medicine
? Risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. ? Risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see Section 4.2 Dose and Method of Administration ? Bipolar mania)). ? Risperidone tablets are also indicated for 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) ? Risperidone tablets are indicated in 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 (eg. aggression, impulsivity and self-injurious behaviours) are prominent. (see Section 5.1 Pharmacodynamic Properties ? Clinical Trials for maintenance data). ? Risperidone tablets are indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see Section 5.1 Pharmacodynamic Properties ? Clinical Trials)
Visual Identification: White, capsule-shaped, biconvex film-coated tablet, debossed '1' on one side and break line on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2008-07-07
CONSUMER MEDICINE INFORMATION RISPERIDONE GENERICHEALTH (RISPERIDONE) FILM-COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Risperidone generichealth. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, 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 RISPERIDONE GENERICHEALTH IS USED FOR Risperidone generichealth 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. Risperidone generichealth helps to correct a chemical imbalance in the brain associated with these conditions. This medicine has been approved for the uses mentioned above. However, your doctor may prescribe it for another use. It is only available with a doctor’s prescription. IF YOU WANT MORE INFORMATION, A Прочетете целия документ
AUSTRALIAN PRODUCT INFORMATION – RISPERIDONE GENERICHEALTH (RISPERIDONE) FILM COATED TABLET 1 NAME OF THE MEDICINE Risperidone. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Risperidone generichealth tablet contains 1 mg, 2 mg, 3 mg or 4 mg of risperidone. List of excipients with known effects: lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Risperidone generichealth 1 mg tablets are white, capsule-shaped, biconvex film-coated tablets, debossed with ‘1’ on one side and scoreline on the other side. Risperidone generichealth 2 mg tablets are orange, capsule-shaped, biconvex film-coated tablets, debossed with ‘2’ on one side and scoreline on the other side. Risperidone generichealth 3 mg tablets are dark yellow, capsule-shaped, biconvex film-coated tablets, debossed with ‘3’ on one side and scoreline on the other side. Risperidone generichealth 4 mg tablets are red brown, capsule-shaped, biconvex film-coated tablets, debossed with ‘4’ on one side and scoreline on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Risperidone tablets are indicated for the treatment of schizophrenia and related psychoses. Risperidone tablets are indicated for the short-term treatment of acute mania associated with bipolar 1 disorder (see SECTION 4.2 DOSE AND METHOD OF ADMINISTRATION – BIPOLAR MANIA). Risperidone tablets are also indicated for 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) Risperidone tablets are indicated in 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 (eg. aggression, impulsivity and self-injurious behaviours) are prominen Прочетете целия документ