RISPATAL 3 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-05-2024
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Active ingredient:
RISPERIDONE
Available from:
WPR Healthcare Limited
ATC code:
N05AX08
INN (International Name):
RISPERIDONE
Dosage:
3 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Other antipsychotics
Authorization status:
Authorised
Authorization date:
2011-08-05
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rispatal 3 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 3mg risperidone.
Also contains lactose monohydrate and sunset yellow FCF aluminium lake (E110)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablets
_Product imported from the UK:_
Yellow, round, film-coated tabets.
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 m
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