OZIDAL risperidone 2mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

risperidone, Quantity: 2 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Risperidone

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: sodium lauryl sulfate; lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; sunset yellow FCF aluminium lake; purified talc; macrogol 4000; macrogol 400

Administration route:

Oral

Units in package:

60 tablets per pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

OZIDAL is indicated for - treatment of schizophrenia and related psychoses; short-term treatment of acute mania associated with bipolar 1 disorder; 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; 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 (eg. aggression, impulsivity and self-injurious behaviours) are prominent; treatment of behavioural disorders associated with autism in children and adolescents.

Product summary:

Visual Identification: Peach coloured, film coated, capsulel shaped tablets with a scoreline on both sides and 'RSN' and '2' debossed on either side of the scoreline on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-04-07

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