RIXADONE risperidone 1 mg/mL oral liquid solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risperidone, Quantity: 1 mg/mL

Available from:

Boucher & Muir Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: tartaric acid; benzoic acid; purified water; hydrochloric acid

Administration route:

Oral

Units in package:

30 mL, 100 mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Rixadone is indicated for the treatment of schizophrenia and related psychoses.,Rixadone is indicated for the short-term treatment of acute mania associated with Bipolar 1 Disorder.,Rixadone is indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type.,Rixadone is indicated in the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent.,Rixadone is indicated for the treatment of behavioural disorders associated with autism in children and adolescents.

Product summary:

Visual Identification: Clear, colourless solution.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-12-06

Patient Information leaflet

1
RIXADONE
Consumer Medicine Information
RIXADONE
_RISPERIDONE _
Oral solution 1 mg/mL
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Rixadone.
This leaflet answers some common questions about Rixadone. It does not
contain all the
available information. The most up-to-date Consumer Medicine
Information can be
downloaded from www.ebs.tga.gov.au.
Reading this leaflet 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
Rixadone against the benefits this medicine is expected to 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 want to read it again.
WHAT RIXADONE IS USED FOR
Rixadone contains risperidone. Risperidone belongs to a group of
medicines called
antipsychotic agents which improve the symptoms of certain types of
mental illness. It
works by helping to correct a chemical imbalance in the brain
associated with these
conditions.
Rixadone is used for:

treatment of sudden (acute) and long-term (chronic) schizophrenia and
other types of
related psychoses. These are disorders related to thought, feeling
and/or action.

short term treatment of sudden (acute) mania associated with bipolar 1
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 in patients with a decline in mental
ability (dementia)
caused by Alzheimer's disease. These problems include: aggression
through words or
action, morbid suspiciousness, agitation or wandering.

treatment
of
conduct
and
other
disruptive
behaviours
such
as
aggression,
impulsiveness and self-injury in children (over 5 years), adolescents
and adults who
are intellectually disabled.
2
RIXADONE

treat

Summary of Product characteristics

1
RIXADONE
AUSTRALIAN PRODUCT INFORMATION
RIXADONE
(RISPERIDONE)
ORAL SOLUTION
1
NAME OF THE MEDICINE
Risperidone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rixadone oral solution contains 1 mg risperidone per 1 mL.
Excipients with known effect: benzoic acid.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Rixadone is a clear, colourless oral solution.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rixadone is indicated for the treatment of schizophrenia and related
psychoses.
Rixadone is indicated for the short-term treatment of acute mania
associated with Bipolar 1
Disorder (see Section 4.2 Dose and method of administration: Bipolar
mania)
_. _
Rixadone is indicated for the treatment (up to 12 weeks) of psychotic
symptoms, or persistent
agitation or aggression unresponsive to non-pharmacological approaches
in patients with
moderate to severe dementia of the Alzheimer type (see Section 4.2
Dose and method of
administration: Behavioural disturbances in dementia).
Rixadone is indicated in the treatment of conduct and other disruptive
behaviour disorders
in children (over 5 years), adolescents and adults with sub-average
intellectual functioning
or mental retardation in whom destructive behaviours (e.g. aggression,
impulsivity and self-
2
RIXADONE
injurious behaviours) are prominent (see Section 5.1 Pharmacodynamic
properties: Clinical
trials for maintenance data).
Rixadone is indicated for the treatment of behavioural disorders
associated with autism in
children and adolescents (see Section 5.1 Pharmacodynamic properties:
Clinical trials).
4.2 DOSE AND METHOD OF ADMINISTRATION
_ _
_SCHIZOPHRENIA _
Studies on the efficacy and safety of risperidone have been performed
predominantly in
patients with schizophrenia. The pivotal studies lasted up to 8 weeks,
but more than
600 patients have been treated for at least 12 months.
_ _
_Switching from other antipsychotics: _
When
medically
appropriate,
gradual
discontinuation
of
the
previous
treatment
is
recommended while Rixadon