OZIDAL risperidone 4mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risperidone

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Risperidone

Authorization status:

Registered

Patient Information leaflet

Ozidal CMI V4 October 2019
Page 1 of 15
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) caused by Alzheimer’s disease.
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 autism in
children and adolescents.
OZIDAL helps to correct a chemical imbalance in the brain associated
with these conditions.
OZIDAL has been approved for the uses mentioned above. However, your
doctor may prescribe this medicine for an

Summary of Product characteristics

OZIDAL PI V4 Oct 2019
Page 1 of 45
AUSTRALIAN PRODUCT INFORMATION - OZIDAL (RISPERIDONE) TABLETS
1. NAME OF THE MEDICINE
Risperidone
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of OZIDAL contains 0.5 mg, 1mg, 2 mg, 3 mg or 4 mg of
risperidone.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
OZIDAL 0.5 mg tablets - available as brown-coloured, film-coated,
oval-shaped tablets with a
scoreline on both sides and ‘RSN’ and ‘0.5’ debossed on either
side of the scoreline on one side.
OZIDAL 1 mg tablets - available as white, film-coated, capsule-shaped
tablets with a scoreline on
both sides and ‘RSN’ and ‘1’ debossed on either side of the
scoreline on one side.
OZIDAL 2 mg tablets - available as peach-coloured, film-coated,
capsules-shaped tablets with a
scoreline on both sides and ‘RSN’ and ‘2’ debossed on either
side of the scoreline on one side.
OZIDAL 3 mg tablets - available as yellow-coloured, film-coated,
capsule-shaped tablets with a
scoreline on both sides and ‘RSN’ and ‘3’ debossed on either
side of the scroreline on one side.
OZIDAL 4 mg tablets - available as green-coloured, film-coated,
capsule-shaped tablets with a
scoreline on both sides and ‘RSN’ and ‘4’ debossed on either
side of the scoreline on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
OZIDAL is indicated for the treatment of schizophrenia and related
psychoses.
OZIDAL is indicated for the short-term treatment of acute mania
associated with bipolar 1 disorder.
OZIDAL PI V4 Oct 2019
Page 2 of 45
OZIDAL is also indicated for the treatment (up to 12 weeks) of
psychotic symptoms, or persistent
agitations
or
aggression
unresponsive
to
non-pharmacological
approaches,
in
patients
with
moderate to severe dementia of the Alzheimer type.
OZIDAL is indicated in the treatment of conduct and other disruptive
behaviour disorders in children
(over 5 years), adolescents and adults with sub-average intelle