RIXADONE risperidone 0.5 mg film coated tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

risperidone, Quantity: 0.5 mg

Dostępny od:

Alphapharm Pty Ltd

INN (International Nazwa):

Risperidone

Forma farmaceutyczna:

Tablet, film coated

Skład:

Excipient Ingredients: sodium lauryl sulfate; lactose monohydrate; pregelatinised maize starch; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; propylene glycol; purified talc; iron oxide red; iron oxide black

Droga podania:

Oral

Sztuk w opakowaniu:

56, 60, 28, 20, 6, 10

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

RIXADONE is indicated for - the treatment of schizophrenia and related psychoses.,- the short term treatment of acute mania associated with bipolar 1 disorder (See DOSAGE AND ADMINISTRATION: Bipolar mania).,-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 DOSAGE AND ADMINISTRATION: Behavioural Disturbances in Dementia).,- 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).,- the treatment of behavioural disorders associated with autism in children and adolescents (See CLINICAL TRIALS).

Podsumowanie produktu:

Visual Identification: Red-brown, round, biconvex, film coated tablet with break line on one side and debossed "0.5" on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Status autoryzacji:

Licence status A

Data autoryzacji:

2013-09-03

Ulotka dla pacjenta

RIXADONE
®
_risperidone_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about
RIXADONE. It does not contain all
of 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 RIXADONE
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING RIXADONE, 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 RIXADONE IS
USED FOR
RIXADONE 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.
RIXADONE helps to correct a
chemical imbalance in the brain
associated with these conditions.
RIXADONE cannot be
recommended for use in children
with schizophrenia under 15 years at
the present time as there is little
experience with the product in this

Charakterystyka produktu

AUSTRALIAN PRODUCT INFORMATION
RIXADONE
®
_Risperidone film coated tablet _
1
NAME OF THE MEDICINE
Risperidone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RIXADONE contains risperidone as the active ingredient, and is
available as 0.5, 1, 2, 3 and 4 mg oral film-
coated tablets.
Excipients with known effect: Egg products and sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
RIXADONE 0.5 mg
:
Red-brown, round, biconvex, film coated tablet with break line on one
side
and debossed “0.5” on the other side.
RIXADONE 1 mg
:
White, round, biconvex, film coated tablet with break line on one side
and
debossed “1” on the other side.
RIXADONE 2 mg
:
Orange, round, biconvex, film coated tablet with break line on one
side and
debossed “2” on the other side.
RIXADONE 3 mg
:
Yellow, round, biconvex, film coated tablet with break line on one
side and
debossed “3” on the other side.
RIXADONE 4 mg
:
Green, round, biconvex, film coated tablet with break line on one side
and
debossed “4” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RIXADONE is indicated for
•
the treatment of schizophrenia and related psychoses.
•
the short term treatment of acute mania associated with bipolar 1
disorder (see Section 4.2 DOSE AND
METHOD OF ADMINISTRATION: Bipolar mania).
•
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).
•
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 Section 5.1
PHARMACODYNAMIC PROPERTIES – clinical trials for maintenance data).
RIXAD