Risperidone 1mg/ml Oral Solution

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Risperidone

Dostupno od:

Chanelle Medical Unlimited Company

ATC koda:

N05AX; N05AX08

INN (International ime):

Risperidone

Doziranje:

1 milligram(s)/millilitre

Farmaceutski oblik:

Oral solution

Tip recepta:

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

Područje terapije:

Other antipsychotics; risperidone

Status autorizacije:

Not marketed

Datum autorizacije:

2006-12-15

Uputa o lijeku

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_Page 1 of 13 _
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDONE 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 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 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 Risperidone Oral Solution is and what it is used for
2.
What you need to know before you take Risperidone Oral Solution
3.
How to take Risperidone Oral Solution
4.
Possible side effects
5.
How to store Risperidone Oral Solution
6.
Contents of the pack and other information
1.
WHAT RISPERIDONE ORAL SOLUTION IS AND WHAT IT IS USED FOR
Risperidone Oral Solution belongs to a group of medicines called
‘anti-psychotics’.
Risperidone 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.
Risperidone Oral Solution can help alleviate the symptoms of your
disease and stop your
symptoms from coming back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDONE ORAL SOLUTION
DO NOT TAKE

Svojstava lijeka

HealthProductsRegulatoryAuthority
12May2022
CRN00CT24
Page1of19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risperidone1mg/mlOralSolution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachmlof solutioncontains 1mgofrisperidone.
Excipientswithknowneffect:
1mloforalsolutioncontains1.5mgofBenzoicacid(E210)
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
behaviors 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 adol