Apo-Risperidone

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Risperidone 0.5mg;  

Available from:

Apotex NZ Ltd

INN (International Name):

Risperidone 0.5 mg

Dosage:

0.5 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Risperidone 0.5mg   Excipient: Hyprolose Hypromellose Iron oxide red Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Microcrystalline cellulose Titanium dioxide

Units in package:

Blister pack, aluminium/aluminium, 20 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Apotex Pharmachem India Pvt. Ltd.

Therapeutic indications:

APO-RISPERIDONE is indicated for the treatment of schizophrenia and other psychotic disorders. These include first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted effect, emotional and social withdrawal, poverty of speech) are prominent.

Product summary:

Package - Contents - Shelf Life: Blister pack, aluminium/aluminium - 20 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Blister pack, aluminium/aluminium - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE with polypropylene cap - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

2006-08-18

Summary of Product characteristics

NEW ZEALAND DATA SHEET
APO-RISPERIDONE
Risperidone 0.5mg, 1mg, 2mg, 3mg, 4mg tablets and
Risperidone 1mg/ml Oral solution
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1
PRESENTATION
APO-RISPERIDONE is available as oral, film-coated tablets of the
following strengths:
0.5 mg APO-RISPERIDONE: Brownish-red, capsule shaped, film coated
tablets engraved “APO”
on one side, “RI” score “.5” on the other side.
1 mg APO-RISPERIDONE: White, capsule shaped, film coated tablets
engraved “APO” on one
side, “RI” score “1” on the other side.
2 mg APO-RISPERIDONE: Light orange, capsule shaped, film coated
tablets engraved “APO” on
one side, “RI” score “2” on the other side.
3 mg APO-RISPERIDONE: Beige, capsule shaped, film coated tablets
engraved “APO” on one
side, “RI” score “3” on the other side.
4 mg APO-RISPERIDONE: Light green, capsule shaped, film coated tablets
engraved “APO” on
one side, “RI” score “4” on the other side.
APO-RISPERIDONE is also available as a 1 mg/ml oral solution.
INDICATIONS
APO-RISPERIDONE
is
indicated
for
the
treatment
of
schizophrenia
and
other
psychotic
disorders. These include first episode psychoses, acute schizophrenic
exacerbations, chronic
schizophrenia
and
other
psychotic
conditions,
in
which
positive
symptoms
(such
as
hallucinations,
delusions,
thought
disturbances,
hostility,
suspiciousness),
and/or
negative
symptoms (such as blunted effect, emotional and social withdrawal,
poverty of speech) are
prominent.
APO-RISPERIDONE is also indicated for the treatment and long term
control of mania in bipolar
disorder. These episodes are 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
behaviors.
APO-RISPERIDONE also alleviates affective symptoms (such as
depression, guilt-feelings,
anxiety) associated with schizophrenia. In