国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
RISPERIDONE
Janssen-Cilag Ltd
N05AX08
RISPERIDONE
1 Milligram
Orodispersible Tablet
Product subject to prescription which may not be renewed (A)
Other antipsychotics
Authorised
2004-03-05
PACKAGE LEAFL ET: INFORMATION FOR THE USER 0.5, 1, 2, 3, 4 AND 6 MG FILM-COATED TABLETS QUICKLET 0.5, 1, 2, 3 AND 4 MG ORODISPERSIBLE TABLETS Risperidone READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING THIS MEDICINEBECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side eff ects, talk to your doctor or pharmacist.This includes any possible side eff ects not listed in this leafl et.See section 4. WHAT IS IN THIS LEAFL ET 1 WHAT RISPERDALIS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERDAL 3 HOW TO TAKE RISPERDAL 4 POSSIBLE SIDE EFF ECTS 5 HOW TO STORE RISPERDAL 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT RISPERDAL IS AND WHAT IT IS USED FOR Risperdal belongs to a group of medicines called ‘antipsychotics’. Risperdal is used to treat the following: • Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, or confused • Mania, where you may feel very excited, elated, agitated, enthusiastic or hyperactive. Mania occurs in an illness called “bipolar disorder” • Short-term treatment (up to 6 weeks) of long-term aggression in people with Alzheimer’s dementia, who harm themselves or others. Alternative (non-drug) treatments should have been used previously • Short-term treatment (up to 6 weeks) of long-term aggression in intellectually disabled children (at least 5 years of age) and adolescents with conduct disorder. Risperdal can help alleviate the symptoms of your disease and stop your symptoms from coming back. 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERDAL DO NOT TAKE RISPERDAL • If you are allergic (hypersensitive) to risperidone or any of the other ingredients of this medicine 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT RISPERDAL Quicklet 1 mg orodispersible tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 1 mg of risperidone Excipients with known effect: Each 1 mg orodispersible tablet contains 0.5 mg aspartame (E951) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet 1 mg risperidone as light coral, square, biconvex tablets of 11 mm. Orodispersible tablets are etched on one side with R1. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RISPERDAL is indicated for the treatment of schizophrenia. RISPERDAL is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. RISPERDAL is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. RISPERDAL is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Adults_ RISPERDAL may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg. Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most p 阅读完整的文件