국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Risperidone
Chanelle Medical
N05AX; N05AX08
Risperidone
1 milligram(s)/millilitre
Oral solution
Product subject to prescription which may not be renewed (A)
Other antipsychotics; risperidone
Not marketed
2006-12-15
ID: P 103M IE Version: 10 Effective Date: 03/05/2018 PAGE 1 OF 13 PACKAGE LEAFLET: INFORMATION FOR THE USER RISPATAL 1 MG/ML ORAL SOLUTION Risperidone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have 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 effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Rispatal Oral Solution is and what it is used for. 2. What you need to know before you take Rispatal Oral Solution. 3. How to take Rispatal Oral Solution. 4. Possible side effects. 5. How to store Rispatal Oral Solution. 6. Contents of the pack and other information. Rispatal Oral Solution belongs to a group of medicines called ‘anti-psychotics’. Rispatal Oral Solution 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. Rispatal Oral Solution can help alleviate the symptoms of your disease and stop your symptoms from coming back. DO NOT TAKE RISPATAL ORAL SOLUTION IF: • If you are allergic to risperidone or any of the other ingredients of this medicine (list 전체 문서 읽기
HealthProductsRegulatoryAuthority 19June2019 CRN0094KL Page1of18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Rispatal1mg/mlOralSolution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml ofsolutioncontains:1mgofrisperidone. Excipients:eachmlofsolutioncontains1.5mgbenzoicacid(E210). Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Theoralsolutionisclearandcolourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Risperidoneisindicatedforthetreatmentofschizophrenia. Risperidoneisindicatedforthetreatmentofmoderatetoseveremanicepisodesassociatedwithbipolardisorders. Risperidoneisindicatedfortheshort-termtreatment(upto6weeks)ofpersistentaggressioninpatientswithmoderateto severeAlzheimer’sdementiaunresponsivetonon-pharmacologicalapproachesandwhenthereisariskofharmtoselfor others. Risperidoneisindicatedfortheshort-termsymptomatictreatment(upto6weeks)ofpersistentaggressioninconductdisorder inchildrenfromtheageof5yearsandadolescentswithsubaverageintellectualfunctioningormentalretardationdiagnosed accordingtoDSM-IVcriteria,inwhomtheseverityofaggressiveorotherdisruptivebehavioursrequirepharmacologic treatment.Pharmacologicaltreatmentshouldbeanintegralpartofamorecomprehensivetreatmentprogramme,including psychosocialandeducationalintervention.Itisrecommendedthatrisperidonebeprescribedbyaspecialistinchildneurology andchildandadolescentpsychiatryorphysicianswellfamiliarwiththetreatmentofconductdisorde 전체 문서 읽기