Rispone 1 mg/ml oral solution

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Risperidone

Dostupno od:

Rowex Ltd

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:

Marketed

Datum autorizacije:

2006-10-13

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPONE 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
Rispone is and what it is used for
2.
What you need to know before you take Rispone
3.
How to take Rispone
4.
Possible side effects
5.
How to store Rispone
6.
Contents of the pack and other information
1.
WHAT RISPONE IS AND WHAT IT IS USED FOR
Rispone contains the active substance risperidone. It belongs to a
group of medicines called ‘anti-
psychotics’.
Rispone 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.
Rispone can help alleviate the symptoms of your disease and stop your
symptoms from coming back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPONE
DO NOT TAKE RISPONE:
•
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 a

Svojstava lijeka

Health Products Regulatory Authority
02 January 2024
CRN00DWZ4
Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rispone 1 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 1 mg of risperidone.
Each bottle contains 100 ml of oral solution, which equals to 100 mg
of risperidone.
Excipient with known effect:
Each ml of oral solution contains 2.0 mg benzoic acid.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
clear, colourless solution
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 disorder of children and
adolescents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Schizophrenia
_Adults_
Risperidone 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 mainta