Risperidone-Remedica 2mg tablets film-coated

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

risperidone

متاح من:

REMEDICA LTD

ATC رمز:

N05AX08 վերարտադրված դեղի առաջին դեղաձև, դեղաչափ

INN (الاسم الدولي):

risperidone

جرعة:

2mg (60/6x10/) in blister

الشكل الصيدلاني:

tablets film-coated

الوحدات في الحزمة:

2mg (60/6x10/) in blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2020-03-20

نشرة المعلومات

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDONE-REMEDICA 2MG FILM-COATED TABLETS
RISPERIDONE-REMEDICA 4MG 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 BE

خصائص المنتج

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Risperidone-Remedica 2mg film-coated tablets
Risperidone-Remedica 4mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Risperidone-Remedica 2mg film-coated tablets: Each film-coated tablet
contains 2 mg
risperidone.
Risperidone-Remedica 4mg film-coated tablets: Each film-coated tablet
contains 4 mg
risperidone.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
Risperidone-Remedica 2mg 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.
Risperidone-Remedica 4mg film-coated tablets:
Green, round, film-coated tablets, scored on one side.
The tablet can be divided into equal doses.
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.
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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 presc