RISPERIDONE SANDOZ risperidone 3mg film-coated tablet in blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risperidone, Quantity: 3 mg

Available from:

Sandoz Pty Ltd

INN (International Name):

Risperidone

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: quinoline yellow; lactose monohydrate; magnesium stearate; pregelatinised maize starch; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; macrogol 4000

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of schizophrenia and related psychoses.,Short-term treatment of acute mania associated with bipolar I 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.,Treatment of conduct and other disruptive disorders in children (over 5 years), adolescents and adults with subaverage intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent.,Treatment of behavioural disorders associated with autism in children and adolescents.

Product summary:

Visual Identification: yellow coated, oval, scored tablet, coded "3" on one side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2007-09-06

Patient Information leaflet

RISPERIDONE SANDOZ
®
1
RISPERIDONE SANDOZ
®
_risperidone tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Risperidone Sandoz.
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 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 need to read it again.
WHAT RISPERIDONE
SANDOZ IS USED
FOR
Risperidone Sandoz 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.
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. Symptoms of this
condition include 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 (older than
5 years), adolescents and adults
who are intellectually disabled.
•
Treatment of behavioural
symptoms of autism in children
and adolescents.
This medicine helps to correct a
chemical imbalance in the brain
associated with the conditions
mentioned above.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY RISPERIDONE
SANDOZ WAS

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION
RISPERIDONE SANDOZ (RISPERIDONE) TABLETS
1.
NAME OF THE MEDICINE
Risperidone
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Risperidone Sandoz 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg tablets contain
either 0.5 mg, 1 mg, 2 mg, 3
mg, or 4 mg of risperidone, respectively.
_List of excipients with known effect_
: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Risperidone Sandoz 0.5 mg tablets - Red, oval shaped tablets with a
breaking notch.
Risperidone Sandoz 1 mg tablets - White coated, oval, scored tablets,
coded “1” on one side.
Risperidone Sandoz 2 mg tablets - Apricot coated, oval, scored
tablets, coded “2” on one side.
Risperidone Sandoz 3 mg tablets - Yellow coated, oval, scored tablets,
coded “3” on one side.
Risperidone Sandoz 4 mg tablets - Green coated, oval, scored tablets,
coded “4” on one side.
4.
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Treatment of schizophrenia and related psychoses.
Short-term treatment of acute mania associated with bipolar I
disorder. (See Section 4.2 Dose and
method of administration – Bipolar mania)
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 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 adolescents (see Section
5.1 Pharmacodynamic properties – Clinical trials).
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