APO-RISPERIDONE risperidone 4mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risperidone

Available from:

Apotex Pty Ltd

INN (International Name):

Risperidone

Authorization status:

Registered

Patient Information leaflet

APO-RISPERIDONE
TABLETS
_Risperidone_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about risperidone. 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 using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Risperidone. It contains the active
ingredient risperidone.
Risperidone belongs to a group of
medicines called antipsychotic
agents, which improve the symptoms
of certain types of mental illness.
Risperidone is used for:
•
symptoms of schizophrenia and
other types of related psychoses
in adults and adolescents over 15
years of age. These are conditions
related to thoughts, feelings and/
or actions
•
short term treatment of acute
mania associated with Bipolar 1
Disorder – symptoms of this
condition may include elevated,
expansive or irritable mood,
inflated self-esteem, decreased
need for sleep, pressured speech,
racing thoughts, distractibility or
poor judgment including
disruptive or aggressive
behaviours
•
short term treatment of
behavioural problems in patients
with a decline in mental ability
(dementia) – these problems
include aggression through words
or actions, morbid suspiciousness,
agitation or wandering
•
conduct and other disruptive
disorders such as aggression,
impulsiveness and self-injury in
adults, adolescents and children
aged over 5 years old who are
intellectually disabled
•
certain behaviours seen in
children and adolescents with
autism
_HOW IT WORKS_
Risperidone helps to correct a
chemical imbalance in the brain
associated with the above conditions.
Ask your doctor if you have any
questions a

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
APO-RISPERIDONE (RISPERIDONE) TABLETS
1
NAME OF THE MEDICINE
Risperidone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg of risperidone
as the active ingredient.
EXCIPIENT WITH KNOWN EFFECT
Lactose monohydrate.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
0.5 MG TABLETS:
Brick red coloured, round, biconvex, film-coated tablets plain on both
sides. As the 0.5 mg
risperidone tablets do not have a break line, alternative risperidone
products should be used if
a 0.25 mg dose is required. _The 0.5 mg tablets MUST NOT be broken in
half to give a 0.25 mg _
_dose._
1 MG TABLETS:
White to off white, capsule shaped, biconvex film-coated tablets,
plain on both sides.
2 MG TABLETS:
Light orange coloured, capsule shaped, biconvex film-coated tablets
plain on both sides.
3 MG TABLETS:
Light yellow coloured, oval shaped, biconvex film-coated tablets with
a break line on one side
and plain on other side.
4 MG TABLETS:
Green coloured, capsule shaped, biconvex film-coated tablet plain on
both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of schizophrenia and related psychoses.
Short-term treatment of acute mania associated with bipolar 1
disorder.
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).
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 (see section 5.1 - PHARMACODYNAMIC PROPERTIES, CLINICAL
TRIALS FOR MAINTENANCE
DATA).
Treatment of behavioural disorders associated with autism in children
and adolesce