Risperidone-Remedica 2mg tablets film-coated

Land: Armenien

Sprog: engelsk

Kilde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiv bestanddel:

risperidone

Tilgængelig fra:

REMEDICA LTD

ATC-kode:

N05AX08 վերարտադրված դեղի առաջին դեղաձև, դեղաչափ

INN (International Name):

risperidone

Dosering:

2mg (60/6x10/) in blister

Lægemiddelform:

tablets film-coated

Enheder i pakken:

2mg (60/6x10/) in blister

Recept type:

Prescription

Autorisation status:

Registered

Autorisation dato:

2020-03-20

Indlægsseddel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDONE-REMEDICA 2 MG FILM-COATED TABLETS
risperidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Risperidone-Remedica is and what it is used for
2.
What you need to know before you take Risperidone-Remedica
3.
How to take Risperidone-Remedica
4.
Possible side effects
5.
How to store Risperidone-Remedica
6.
Contents of the pack and other information
1.
WHAT RISPERIDONE-REMEDICA IS AND WHAT IT IS USED FOR
Risperidone-Remedica belongs to a group of medicines called
‘anti-psychotics’.
Risperidone-Remedica is used to treat the following:
•
schizophrenia, where you may see, hear or feel things that are not
there, believe things that are
not true or feel unusually suspicious, or confused.
•
mania, where you may feel very excited, elated, agitated, enthusiastic
or hyperactive. Mania
occurs in an illness called ‘bipolar disorder’.
•
short-term treatment (up to 6 weeks) of long-term aggression in people
with Alzheimer’s
dementia, who harm themselves or others. Alternative (non – drug)
treatments should have been
used previously.
•
short-term treatment (up to 6 weeks) of long-term, aggression in
intellectually disabled children
(at least 5 years of age) and adolescents with conduct disorder.
Risperidone-Remedica can help alleviate the symptoms of your disease
and stop your symptoms
from coming back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDONE-REMEDICA
DO NOT TAKE RI

Produktets egenskaber

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Risperidone-Remedica 2 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2 mg risperidone.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
Light peach, round, film-coated tablets, scored and embossed with
Remedica’s logo on the same
side.
The tablet can be divided into equal doses using a pill cutter.
4. CLINICAL PARTICULARS
_ _
4.1. THERAPEUTIC INDICATIONS
Risperidone-Remedica is indicated for the treatment of schizophrenia.
Risperidone-Remedica
is
indicated
for
the
treatment
of
moderate
to
severe
manic
episodes
associated with bipolar disorders.
Risperidone-Remedica 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-Remedica 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
sub average 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
_ _
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_Adults _
_ _
Risperidone-Remedica may be given once daily or twice daily.
Patients should start with a 2 mg/day risperidone. T