RISPERIBELL risperidone 4mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

risperidone, Quantity: 4 mg

제공처:

Lupin Australia Pty Limited

INN (International Name):

Risperidone

약제 형태:

Tablet, film coated

구성:

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

관리 경로:

Oral

패키지 단위:

60 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Risperidone tablet is indicated for the treatment of schizophrenia and related psychoses. Risperidone tablet is indicated for the short term treatment of acute mania associated with bipolar 1 disorder. Risperidone tablet is indicated for the treatment of behavioural disturbances in dementia. Risperidone tablet is indicated in the 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. Risperidone tablet is indicated for the treatment of behavioural disorders associated with autism in children and adolescents.

제품 요약:

Visual Identification: Red brown, capsule-shaped, biconvex film-coated tablet, debossed '4' on one side and break line on the other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2008-07-07

환자 정보 전단

CONSUMER MEDICINE
INFORMATION
RISPERIBELL TABLETS
RISPERIDONE
(Lupin Australia Pty. Ltd.)
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about Risperibell tablets.
It
does
not
contain
all
the
available
information.
It does not take the place of talking to your
doctor or pharmacist.
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
RISPERIBELL TABLETS ARE USED FOR
Risperibell
tablets
are
used
to
treat
symptoms of schizophrenia and other types
of
related
psychoses.
These
are
disorders
related to thought, feeling and/or action.
Risperibell tablets may be taken for both
sudden
(acute)
and
long-lasting
(chronic)
schizophrenia.
Risperibell tablets are also used for the 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, distractability or poor
judgement including disruptive or aggressive
behaviours.
Risperibell
tablets
are
also
used
to
treat
behavioural problems in patients with a decline
in mental ability (dementia). These problems
include: aggression through words or action,
morbid suspiciousness, agitation or wandering
Risperibell tablets can be used to treat 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.
Risperibell tablets can also be used to treat
behavioural
symptoms
of
autism
in
children
and adolescents
Risperibell tablets helps to correct a chemical
imbalance in the brain associated with these
conditions.
Risperibell tablets have been approved for the
uses mentioned above. However, your doctor
may prescribe this medicine for another use. If
you want more information, ask your doctor.
Risperibell tablets are not addictive.
Page 2 of 10
B

제품 특성 요약

PRODUCT INFORMATION
RISPERIBELL TABLETS
(LUPIN AUSTRALIA PTY. LTD)
NAME OF THE MEDICINE:
Risperidone is chemically identified as 3-[2-[4-(6-fluoro-1,
2-benzisoxazol-3-yl)-1-piperidinyl] ethyl]-6, 7, 8, 9-tetrahydro-2-
methyl-4_H_-pyrido[1, 2-_a_]pyrimidin-4-one.
Empirical formula C
23
H
27
FN
4
O
2
Molecular Weight: 410.49
CAS: 106266-06-2
DESCRIPTION:
Risperidone is a novel antipsychotic belonging to a new class of
antipsychotic agents, the benzisoxazole-derivatives.
Each tablet contains 1 mg, 2 mg, 3 mg or 4mg of risperidone and
following inactive ingredients: lactose, pregelatinised
maize starch, microcrystalline cellulose, magnesium stearate,
colloidal anhydrous silica, sodium lauryl sulphate, purified
talc.
In addition the 1 mg tablet contains hypromellose (E464), titanium
dioxide (E171) and propylene glycol (E1520), the 2 mg
tablet contains hypromellose (E464), titanium dioxide (E171),
propylene glycol (E1520), FD and C yellow # 6/sunset
yellow FCF aluminum lake (E110), the 3 mg tablet contains hypromellose
(E464), iron oxide yellow (E172), titanium
dioxide (E171), and propylene glycol (E1520) and the 4 mg tablet
contains hypromellose (E464), titanium dioxide (E171),
propylene glycol (E1520), iron oxide red (E172).
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1506 Risperibell PI v3 ref: 04/2015
Page 2 of 33
PHARMACOLOGY:
PHARMACODYNAMICS
Risperidone is a selective monoaminergic antagonist with a high
affinity for serotoninergic 5-HT
2
and dopaminergic D
2
receptors. Risperidone binds also to alpha
1
-adrenergic receptors, and with lower affinity, to H
1
-histaminergic and alpha
2
-
adrenergic receptors. Risperidone has no affinity for cholinergic
receptors. The antipsychotic activity of risperidone is
considered to be attributed to both. risperidone and its active
metabolite 9-hydroxy risperidone.
Central dopamine D
2
receptor antagonism is considered to be the mechanism of action by
which conventional
neuroleptics improve the positive symptoms of schizophrenia, but also
induce extrapyramidal symptoms and release of
prolactin.
Although risperidone