Risperidone tablets coated

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

risperidone

MAH:

Arpimed LLC

ATC_code:

N05AX08

INN:

risperidone

dosage:

2mg

pharmaceutical_form:

tablets coated

units_in_package:

(30/3x10/) blisters

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2017-07-31

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
RISPERIDONE
2 MG COATED TABLETS
1.1 NAME OF THE MEDICAL PRODUCT - RISPERIDONE
1.2 INTERNATIONAL NON-PROPERTY NAME - RISPERIDONE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 2 mg of risperidone
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablets.
Oval biconvex, coated one-sided scored light green tablets; odorless.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Risperidone is indicated for the treatment of schizophrenia.
Risperodone 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
Posology
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 second day
to 4 mg. Subsequently, the dosage can be maintained unchanged, or
further individualised, if
needed. Most patients will benefit from daily doses between 4 and 6
mg. In some patients, a
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