Risperidone-Remedica 1mg 1mg tablets film-coated

Country: Armenja

Lingwa: Ingliż

Sors: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredjent attiv:

risperidone

Disponibbli minn:

Remedica Ltd

Kodiċi ATC:

N05AX08

INN (Isem Internazzjonali):

risperidone

Dożaġġ:

1mg

Għamla farmaċewtika:

tablets film-coated

Unitajiet fil-pakkett:

(60/6x10/) blisters

Tip ta 'preskrizzjoni:

Prescription

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2015-05-29

Fuljett ta 'informazzjoni

P18-0689RPILECY2
000058
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDONE-REMEDICA, 1 MG, FILM-COATED TABLETS
RISPERIDONE-REMEDICA, 2 MG, FILM-COATED TABLETS
RISPERIDONE-REMEDICA, 3 MG, FILM-COATED TABLETS
RISPERIDONE-REMEDICA, 4 MG, FILM-COATED TABLETS
RISPERIDONE-REMEDICA, 6 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-Re

Karatteristiċi tal-prodott

SmPC
RISPERIDONE - REMEDICA TABLETS
Remedica
Risperidone
Cyprus
RISPERIDONE - REMEDICA TABS-M1.3-V4-00
Section 1.3 p 1
SUMMARY OF PRODUCT CHARACTERISTICS
_1. NAME OF THE MEDICINAL PRODUCT _
Risperidone – Remedica, 6 mg, Film-Coated Tablets
Risperidone – Remedica, 4 mg, Film-Coated Tablets
Risperidone – Remedica, 3 mg, Film-Coated Tablets
Risperidone – Remedica, 2 mg, Film-Coated Tablets
Risperidone – Remedica, 1 mg, Film-Coated Tablets
_2. QUALITATIVE AND QUANTITATIVE COMPOSITION _
Each Risperidone – Remedica 6 mg film-coated tablet contains
Risperidone EP 6 mg.
Each Risperidone – Remedica 4 mg film-coated tablet contains
Risperidone EP 4 mg.
Each Risperidone – Remedica 3 mg film-coated tablet contains
Risperidone EP 3 mg.
Each Risperidone – Remedica 2 mg film-coated tablet contains
Risperidone EP 2 mg.
Each Risperidone – Remedica 1 mg film-coated tablet contains
Risperidone EP 1 mg.
For the full list of excipients, see section 6.1.
_3. PHARMACEUTICAL FORM _
Tablets for oral use.
_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
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