Land: Nya Zeeland
Språk: engelska
Källa: Medsafe (Medicines Safety Authority)
Risperidone 0.25mg; ;
Janssen-Cilag (New Zealand) Ltd
Risperidone 0.25 mg
0.25 mg
Film coated tablet
Active: Risperidone 0.25mg Excipient: Colloidal silicon dioxide Hypromellose E-15 Hypromellose E-5 Iron oxide yellow Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Propylene glycol Purified talc Sodium laurilsulfate Titanium dioxide
Blister pack, Al-PVC/LDPE/PVDC, 60 tablets
Prescription
Prescription
Janssen Pharmaceutical Sciences Unlimited Company (JPSUC)
Package - Contents - Shelf Life: Blister pack, Al-PVC/LDPE/PVDC - 60 tablets - 24 months from date of manufacture stored at or below 30°C
1998-08-17
RISPERDAL ® (211014)NZCMI 1 RISPERDAL ® _TABLETS; ORAL SOLUTION _ _Risperidone _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about RISPERDAL. 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 USING RISPERDAL, 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 RISPERDAL IS USED FOR RISPERDAL 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. RISPERDAL 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, ASK YOUR DOCTOR. RISPERDAL is not addictive. Läs hela dokumentet
CCDS200407ver21 Page 1 of 24 RISPERDAL TABS ORAL (211014) ADS RISPERDAL ® RISPERIDONE NEW ZEALAND DATA SHEET 1. PRODUCT NAME RISPERDAL ® 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg film-coated tablets RISPERDAL ® 1 mg/mL oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION RISPERDAL FILM-COATED TABLETS Each film-coated tablet contains 0.5 mg, 1mg, 2 mg, 3 mg or 4 mg of risperidone. _Excipients with known effect: _ Sugars as lactose. Each 0.5 mg, 1mg, 2 mg, 3 mg or 4 mg film-coated tablet contains 91 mg, 131 mg, 130 mg, 195 mg or 260 mg lactose monohydrate, respectively. For the full list of excipients, see SECTION 6.1. RISPERDAL ORAL SOLUTION 1 ml oral solution contains 1 mg of risperidone _Excipients with known effect: _ Benzoates. For the full list of excipients, see SECTION 6.1. 3. PHARMACEUTICAL FORM FILM-COATED TABLETS 0.5 mg: brownish-red, film-coated biconvex, half-scored oblong tablets (marked on the grooved side with “Ris 0.5” and “JANSSEN” on the other side) 1 mg: white, film-coated, half-scored, oblong tablets (marked on the grooved side with "Ris 1") 2 mg: orange, film-coated, half-scored, oblong tablets (marked on the grooved side with "Ris 2") 3 mg: yellow, film-coated, half-scored, oblong tablets (marked on the grooved side with "Ris 3") 4 mg: green, film-coated, half-scored, oblong tablets (marked on the grooved side with "Ris 4") ORAL SOLUTION 1mg/mL: clear colourless solution CCDS200407ver21 Page 2 of 24 RISPERDAL TABS ORAL(211014) ADS 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RISPERDAL is indicated for the treatment of schizophrenia and other psychotic disorders. These include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent. RISPERDAL is also indicated for the treatment and long term control Läs hela dokumentet