Rispatal 1 mg/ml Oral Solution

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Risperidone

Tillgänglig från:

Chanelle Medical

ATC-kod:

N05AX; N05AX08

INN (International namn):

Risperidone

Dos:

1 milligram(s)/millilitre

Läkemedelsform:

Oral solution

Receptbelagda typ:

Product subject to prescription which may not be renewed (A)

Terapiområde:

Other antipsychotics; risperidone

Bemyndigande status:

Not marketed

Tillstånd datum:

2006-12-15

Bipacksedel

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

Produktens egenskaper

HealthProductsRegulatoryAuthority
19June2019
CRN0094KL
Page1of18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rispatal1mg/mlOralSolution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml ofsolutioncontains:1mgofrisperidone.
Excipients:eachmlofsolutioncontains1.5mgbenzoicacid(E210).
Forthefulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
Theoralsolutionisclearandcolourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Risperidoneisindicatedforthetreatmentofschizophrenia.
Risperidoneisindicatedforthetreatmentofmoderatetoseveremanicepisodesassociatedwithbipolardisorders.
Risperidone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.
Risperidone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disorde