Risperidone 1mg/ml Oral Solution

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Risperidone

Disponible depuis:

Pinewood Laboratories Ltd,

Code ATC:

N05AX; N05AX08

DCI (Dénomination commune internationale):

Risperidone

Dosage:

1 milligram(s)/millilitre

forme pharmaceutique:

Oral solution

Domaine thérapeutique:

Other antipsychotics; risperidone

Statut de autorisation:

Not marketed

Date de l'autorisation:

2008-11-28

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE
PATIENT
RISPERIDONE 1MG/ML ORAL
SOLUTION
Risperidone
(sugar free)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, nurse 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, pharmacist or nurse.
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 six 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 six weeks) of long-term aggression in
intellectually disabled children (at least
five 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 ta

Résumé des caractéristiques du produit

Health Products Regulatory Authority
29 January 2021
CRN00C40X
Page 1 of 18
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 1mg of risperidone.
Excipient with known effect:
Sodium methylparaben (E219) 1.8mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
The 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 five 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
Posology
Schizophrenia:
_Adults_
Risperidone Oral Solution 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 patients will ben