RISPERDAL 1 mg/ml oral solution

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Risperidone

Disponível em:

Janssen-Cilag Ltd

Código ATC:

N05AX08

DCI (Denominação Comum Internacional):

Risperidone

Dosagem:

1 milligram(s)/millilitre

Forma farmacêutica:

Oral solution

Tipo de prescrição:

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

Área terapêutica:

risperidone

Status de autorização:

Marketed

Data de autorização:

1996-12-13

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERDAL 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 Risperdal is and what it is used for
2.
What you need to know before you take Risperdal
3.
How to take Risperdal
4.
Possible side effects
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 to risperidone or any of the other ingredients of
this medicine (listed in section 6).
If you are not sure if the above applies to you, talk to

Características técnicas

Health Products Regulatory Authority
10 October 2018
CRN008P0Z
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
RISPERDAL 1 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml oral solution contains 1 mg of risperidone
Excipients with known effect
1 ml oral solution contains 2 mg benzoic acid (E 210).
For the full list of excipients, see section 6.1.
1 ml oral solution contains 1 mg of risperidone
3 PHARMACEUTICAL FORM
Oral Solution
The solution is clear and colourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RISPERDAL is indicated for thetreatment 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.
Health Products Regulatory Authority
10 October 2018
CRN008P0Z
Page 2 of 28
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Schizophrenia_
_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. Su