Risperidone Oral Solution 1mg/ml

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RISPERIDONE

Available from:

Syri Limited

ATC code:

N05AX08

INN (International Name):

RISPERIDONE

Pharmaceutical form:

ORAL SOLUTION

Composition:

RISPERIDONE 1 mg/ml

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Patient Information leaflet

DCP/DAY 120-145 1.3.1 Package leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDONE 1MG/ML ORAL SOLUTION
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.
The name of your medicine is Risperidone1mg/ml Oral Solution but it
will be referred to as
Risperidone throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
WHAT RISPERIDONE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDONE
3.
HOW TO TAKE RISPERIDONE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE RISPERIDONE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT RISPERIDONE IS AND WHAT IT IS USED FOR
Risperidone belongs to a group of medicines called
‘anti-psychotics’.
Risperidone 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 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
DO NOT TAKE RISP

Summary of Product characteristics

Thame Laboratories
Risperidone 1mg/ml Oral Solution
Page 1 of 25
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Risperidone 1mg/ml Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 1mg risperidone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
A 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
.
Thame Laboratories
Risperidone 1mg/ml Oral Solution
Page 2 of 25
Patients should start with 2 ml/day (2 mg/day) risperidone. The dosage
may be
increased on the second day to 4 ml (4 mg). Subsequently, the dosage
can be
maintained unchanged, or further individualised, if needed. Most
patients will benefit
from