RISPERDAL risperidone 1mg/mL oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risperidone, Quantity: 1 mg/mL

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: purified water; benzoic acid; tartaric acid; sodium hydroxide

Administration route:

Oral

Units in package:

1 x 100mL, 30 mL bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

RISPERDAL is indicated for the treatment of schizophrenia and related psychoses. RISPERDAL is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. RISPERDAL is also indicated for the treatment of behavioural disturbances in dementia. RISPERDAL 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 (see Clinical Trials for maintenance data). RISPERDAL is indicated for the treatment of behavioural disorders associated with autism in children and adolescents (see Clinical Trials).

Product summary:

Visual Identification: Clear colourless solution; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1996-09-13

Patient Information leaflet

RISPERDAL®
1
RISPERDAL
®
_TABLETS; ORAL SOLUTION _
_Risperidone _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
RISPERDAL. It does not contain all
of the available information. It does
not take the place of talking to your
doctor or pharmacist.
IF YOU HAVE ANY CONCERNS ABOUT
USING RISPERDAL, ASK YOUR
DOCTOR OR PHARMACIST.
Your doctor and pharmacist have
more information.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT RISPERDAL IS
USED FOR
RISPERDAL belongs to a group of
medicines called antipsychotic agents
which improve the symptoms of
certain types of mental illness.
It 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 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 old), adolescents and adults
who are intellectually disabled,
•
treatment of behavioural
symptoms of autism in children
and adolescent.
RISPERDAL helps to correct a
chemical imbalance in the brain
associated with these conditions.
This medicine has been approved for
the uses mentioned above. However,
your doctor may prescribe it for
another use. It is only available with
a doctor's prescription.
IF YOU WANT MORE INFORMATION, ASK
YOUR DOCTOR.
RISPERDAL is not addictive.
BEFORE YOU USE

Summary of Product characteristics

CCDS200407ver21
Page 1 of 18
RISPERDAL(210811) API
AUSTRALIAN PRODUCT INFORMATION
RISPERDAL
®
RISPERIDONE
FILM COATED TABLETS
ORAL SOLUTION
1
NAME OF THE MEDICINE
Risperidone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RISPERDAL contains risperidone as the active ingredient, and is
available as 0.5, 1, 2, 3 and
4 mg oral film-coated tablets or as a 1 mg/mL oral solution.
Excipients of known effect:
Tablets: Sugars as lactose
Oral solution: Benzoates.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
RISPERDAL Tablets:
0.5 mg brownish-red, film-coated, biconvex, half-scored oblong
tablets, “Ris 0.5” on the scored
side and “JANSSEN” on the other side.
1 mg white, film-coated, half-scored oblong tablets, "Ris 1" on the
scored side.
2 mg orange, film-coated, half-scored oblong tablets, "Ris 2" on the
scored side.
3 mg yellow, film-coated, half-scored oblong tablets, "Ris 3" on the
scored side.
4 mg green, film-coated, half-scored oblong tablets, "Ris 4" on the
scored side.
RISPERDAL Oral Solution:
1mg/mL clear, colourless oral solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
RISPERDAL is indicated for the treatment of schizophrenia and related
psychoses.
RISPERDAL 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).
Product Information - Australia
CCDS200407ver21 Page 2 of 34
RISPERDAL(210811)API
RISPERDAL 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)
RISPERDAL 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.