RISPERNIA risperidone 6mg tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risperidone, Quantity: 6 mg

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Risperidone

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; colloidal anhydrous silica; lactose monohydrate; quinoline yellow; maize starch; hypromellose; magnesium stearate; titanium dioxide; macrogol 400

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Risperidone is indicated for the treatment of schizophrenia and related psychoses. Risperidone is indicated for the treatment of behavioural disturbances in dementia. Risperidone is indicated for 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.

Product summary:

Visual Identification: Yellow, film-coated, oblong tablet engraved with "R", a breakline and "6" on one side and a plain face on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-06-26

Patient Information leaflet

RISPERNIA™
CONSUMER MEDICINE INFORMATION
Risperidone 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg & 6 mg film-coated tablets
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions about RISPERNIA. 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 RISPERNIA, 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 RISPERNIA IS USED FOR
RISPERNIA is used to treat symptoms of schizophrenia and other types
of related psychoses.
These are disorders related to thought, feeling and/or action.
RISPERNIA may be taken for both
sudden (acute) and long-lasting (chronic) schizophrenia.
RISPERNIA is also used to treat behavioural problems in patients with
a decline in mental ability
(dementia). These problems include:

Aggression through words or action;

Severe suspiciousness;

Agitation; or

Wandering.
RISPERNIA can be used to treat conduct and other disruptive behaviors
such as aggression,
impulsiveness and self-injury in children (over 5 years old),
adolescents and adults who are
intellectually disabled.
RISPERNIA helps to correct a chemical imbalance in the brain
associated with these conditions.
RISPERNIA has 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.
RISPERNIA is not addictive.
BEFORE YOU USE RISPERNIA
_ _
_WHEN YOU MUST NOT USE IT_
DO NOT USE RISPERNIA:

If you know you are allergic to any of its ingredients (signs of
allergy include skin rash, itching,
shortness of breath, and/or swollen face - see the last section of
this leaflet for a list of
ingredients).

If the packaging is torn or shows signs of being tampered with.

If the tablets do not look right.

To treat any other complaints unless your doctor says it is safe to do
so.
_BEFORE YOU START TO USE IT _
RISPERNIA sh

Summary of Product characteristics

Page 1 of 15
PRODUCTION INFORMATION
RISPERNIA
FILM-COATED TABLETS
NAME OF THE MEDICINE
Active ingredient: risperidone
Chemical structure
CAS - 106266-06-2
C
23
H
27
FN
4
O
2
MW 410.49
DESCRIPTION
Risperidone
is
a
novel
antipsychotic
belonging
to
a
new
class
of
antipsychotic
agents,
the
benzisoxazole-derivatives. 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-4H-pyrido[1,2-a]pyrimidin-4-one. It
is a white
or almost white powder, practically insoluble in water, freely soluble
in methylene chloride, sparingly
soluble in alcohol. It dissolves in dilute acid solutions.
The other ingredients in the tablet cores are: lactose,
microcrystalline cellulose, maize starch, colloidal
anhydrous silica and magnesium stearate. Ingredients in the tablet
coating are listed according to different
strengths in the table below:
Coating ingredients for different strengths of risperidone
STRENGTH
INGREDIENTS
0.5 mg
hypromellose, titanium dioxide, macrogol 400 and iron oxide red.
1 mg
hypromellose, titanium dioxide and macrogol 400.
2 mg
hypromellose, titanium dioxide, macrogol 400, iron oxide red and
quinoline yellow.
3 mg
hypromellose, titanium dioxide, macrogol 400 and quinoline yellow.
4 mg
hypromellose, titanium dioxide, macrogol 400, indigo carmine and
quinoline yellow.
6 mg
hypromellose, titanium dioxide, macrogol 400, quinoline yellow.
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
Page 2 of 15
cholinergic receptors.
The antipsychotic activity of risperidone is considered to be
attributable 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
neu