OZIDAL

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Risperidone

Tilgængelig fra:

Ranbaxy Australia Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

 
Ozidal 
CMI 
V3 
Mar 
2011 

Page 1 of 10 

OZIDAL

RISPERIDONE TABLETS 
CONSUMER MEDICINE INFORMATION 
WHAT IS IN THIS LEAFLET 
This leaflet answers some of the common questions about OZIDAL 
(risperidone) tablets.  
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 this medicine against the benefits it is expected
to have 
for you. 
IF YOU HAVE ANY CONCERNS ABOUT USING OZIDAL, ASK YOUR DOCTOR OR 
PHARMACIST. YOUR DOCTOR AND PHARMACIST HAVE MORE INFORMATION.  
KEEP THIS LEAFLET WITH YOUR OZIDAL TABLETS. 
You may need to read it 
again.  
WHAT OZIDAL IS USED FOR 
OZIDAL
 is used to treat symptoms of schizophrenia and other types of 
related psychoses. These are disorders related to thought,
feeling 
and/or action.  
OZIDAL
 may be taken for both sudden (acute) and long-lasting (chronic) 
schizophrenia.  
OZIDAL
 is 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.  
OZIDAL 
is also used to treat behavioural problems in patients with a 
decline in mental abilitiy (dementia).  These problems include: 
aggression through words or action, morbid suspiciousness,
agitation or 
wandering. 
OZIDAL
 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. 
OZIDAL
 can also be used to treat behavioural symptoms of a

Produktets egenskaber

 
OZIDAL PI V3 Mar 2011 

Page 1 of 29 

OZIDAL 
 RISPERIDONE TABLETS 

NAME OF THE MEDICINE 

Risperidone  

Structural formula: 

Molecular formula: C
23
H
27
FN
4
O
2

Chemical name: 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. 

Molecular weight: 410.49. 

CAS Number:_ _106266-06-2. 

DESCRIPTION 
Each tablet of OZIDAL contains 0.5 mg, 1mg, 2 mg, 3 mg or
4 mg of risperidone, a novel 
antipsychotic belonging to a new class of antipsychotic agents,
the benzisoxazole-derivatives. 
OZIDAL contains the following inactive ingredients
lactose monohydrate, pregelatinised starch, 
microcrystalline cellulose, sodium lauryl sulphate,
colloidal anhydrous silica and magnesium 
stearate. In addition the 0.5 mg tablet contains Opadry II 31G 56729, brown, 1 mg tablet contains 
Opadry 20H 58983 white, the 2 mg tablet contains Opadry II 31G
53291 orange; the 3 mg tablet 
contains Opadry II 31G 52408 yellow and the 4 mg tablet contains
 Opadry II 31G 51195  green.  
PHARMACOLOGY 

PHARMACODYNAMIC PROPERTIES 
Risperidone is a selective monoaminergic antagonist with a
high affinity for serotoninergic 5-HT
2

and dopaminergic D
2
 receptors. Risperidone binds also to α
1
-adrenergic receptors, and with lower 
affinity, to H
1
-histaminergic and α
2
-adrenergic receptors. Risperidone has no affinity for
cholinergic 
receptors.  

OZIDAL PI V3 Mar 2011 

Page 2 of 29 

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 antagonises dopamine D
2
 receptors and causes release of p