RISPATAL 4 Milligram Film Coated Tablet
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
06-06-2024
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Virkt innihaldsefni:
RISPERIDONE
Fáanlegur frá:
WPR Healthcare Limited
ATC númer:
N05AX08
INN (Alþjóðlegt nafn):
RISPERIDONE
Skammtar:
4 Milligram
Lyfjaform:
Film Coated Tablet
Gerð lyfseðils:
Product subject to prescription which may not be renewed (A)
Lækningarsvæði:
Other antipsychotics
Leyfisstaða:
Authorised
Leyfisdagur:
2011-08-05
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rispatal 4 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 4mg risperidone.
Also contains lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
_Product imported from the UK:_
Green, round scored biconvex film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RISPERIDONE is indicated for the treatment of schizophrenia.
RISPERIDONE is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.
RISPERIDONE is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with
moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches and when there is a risk of
harm to self or others.
RISPERIDONE is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in
conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental
retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours
require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive
treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be
prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the
treatment of conduct disorder of children and adolescents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Schizophrenia
_Adults_
RISPERIDONE may be given once daily or twice daily.
Patients should start with 2 mg/day risperidone. The dosage may be increased on the secon
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