RISPERDAL 2 Milligram Film Coated Tablet

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

RISPERIDONE

Boleh didapati daripada:

B & S Healthcare

Kod ATC:

N05AX08

INN (Nama Antarabangsa):

RISPERIDONE

Dos:

2 Milligram

Borang farmaseutikal:

Film Coated Tablet

Jenis preskripsi:

Product subject to prescription which may not be renewed (A)

Kawasan terapeutik:

Other antipsychotics

Status kebenaran:

Authorised

Tarikh kebenaran:

2009-11-20

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risperdal 2mg Film-Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg risperidone.
Excipients: Also contains lactose and orange yellow S (E110).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product sourced from Italy:_
Pale orange, oblong, film-coated tablets marked Ris/2 on one side and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
RISPERDAL is indicated for the treatment of schizophrenia.
RISPERDAL is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.
RISPERDAL 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.
RISPERDAL 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_
RISPERDAL may be given once daily or twice daily.
Patients should start with 2 m