Risperon

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Risperidone 1 mg/mL

Available from:

Viatris Limited

INN (International Name):

Risperidone 1 mg/mL

Dosage:

1 mg/mL

Pharmaceutical form:

Oral solution

Composition:

Active: Risperidone 1 mg/mL Excipient: Benzoic acid Hydrochloric acid Purified water Tartaric acid

Units in package:

Bottle, glass, Type III amber glass bottle with a child resistant PP/LDPE cap, 30 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Jubilant Generics Limited

Therapeutic indications:

Risperidone is indicated for the treatment of schizophrenia and other psychotic disorders. These include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Product summary:

Package - Contents - Shelf Life: Bottle, glass, Type III amber glass bottle with a child resistant PP/LDPE cap - 30 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, Type III amber glass bottle with a child resistant PP/LDPE cap - 60 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, Type III amber glass bottle with a child resistant PP/LDPE cap - 100 mL - 36 months from date of manufacture stored at or below 30°C - Bottle, glass, Type III amber glass bottle with a child resistant PP/LDPE cap - 120 mL - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2007-02-23

Patient Information leaflet

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
RISPERON
®
_RISPERIDONE ORAL SOLUTION 1 MG/ML_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Risperon.
This leaflet answers some common
questions about Risperon.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Risperon
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT RISPERON IS
TAKEN FOR
Risperon Oral Solution contains the
active ingredient Risperidone. It
belongs to a group of medicines
called antipsychotic agents.
It is taken for:
•
treatment of sudden (acute)
and long-term (chronic)
schizophrenia and other
types of related psychoses.
These are illnesses with
disturbances in thinking,
feelings and behaviour.
•
treatment and long term
control of mania in bipolar
disorder. This condition is
characterised by symptoms
such as elevated,
expansive or irritable mood,
inflated self-esteem,
decreased need for sleep,
pressured speech, racing
thoughts, distractibility or
poor judgement including
disruptive or aggressive
behaviours.
•
treatment of behavioural
problems, such as
aggression (through spoken
words or physical actions),
morbid suspiciousness,
agitation or wandering, in
Alzheimer patients with
declining mental ability
(dementia).
•
treatment of conduct and
other disruptive behaviours
such as aggression,
impulsivity and self-injurious
behaviours in children (over
5 years of age),
adolescents and adults who
are intellectually disabled.
•
treatment of autism in
children and adolescents.
Risperon helps to correct a
chemical imbalance in the brain
which is thought to be associated
with these conditions.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your

Summary of Product characteristics

Page 1 of 23
NEW ZEALAND DATA SHEET
RISPERON
®
1. PRODUCT NAME
Risperon, 1 mg/mL, oral solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL of solution contains 1 mg of risperidone.
Excipient with known effect: contains benzoic acid.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Risperon is a clear, colourless solution.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Risperidone is indicated for the treatment of schizophrenia and other
psychotic disorders. These
include first episode psychoses, acute schizophrenic exacerbations,
chronic schizophrenia and other
psychotic conditions, in which positive symptoms (such as
hallucinations, delusions, thought
disturbances,
hostility,
suspiciousness),
and/or
negative
symptoms
(such
as
blunted
effect,
emotional and social withdrawal, poverty of speech) are prominent.
Risperidone is also indicated for the treatment and long term control
of mania in bipolar disorder.
These episodes are characterised by symptoms such as elevated,
expansive or irritable mood,
inflated self-esteem, decreased need for sleep, pressured speech,
racing thoughts, distractibility, or
poor judgement, including disruptive or aggressive behaviours.
Risperidone
also
alleviates
affective
symptoms
(such
as
depression,
guilt-feelings,
anxiety)
associated with schizophrenia. In addition, risperidone also appears
effective in maintaining the
clinical improvement during continuation therapy in patients who have
shown an initial response to
treatment with this agent.
Risperidone is also indicated for the treatment (up to 12 weeks) of
agitation, aggression or psychotic
symptoms in patients with moderate to severe dementia of the Alzheimer
type.
Risperidone is also indicated for the treatment of conduct and other
disruptive behaviour disorders
in children (over 5 years), adolescents and adults with subaverage
intellectual functioning or mental
retardation, or average IQ, in whom destructive behaviours (e.g.
aggression, impulsivity and self-
injurious behaviours) are prom