Risperidone Mylan 2mg orodispersible Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RISPERIDONE

Available from:

Mylan S.A.S. 117 Allee des Parcs, 69800 Saint Priest, France

ATC code:

N05AX08

INN (International Name):

RISPERIDONE

Pharmaceutical form:

ORODISPERSIBLE TABLET

Composition:

RISPERIDONE 2 milligram(s)

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2012-07-13

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDONE MYLAN 0.5 MG ORODISPERSIBLE TABLETS
RISPERIDONE MYLAN 1 MG ORODISPERSIBLE TABLETS
RISPERIDONE MYLAN 2 MG ORODISPERSIBLE TABLETS
RISPERIDONE MYLAN 3MG ORODISPERSIBLE TABLETS
RISPERIDONE MYLAN 4 MG ORODISPERSIBLE 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 or pharmacist.


This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.


If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:
1.
What Risperidone Mylan is and what it is used for
2.
What you need to know before you take Risperidone Mylan
3.
How to take Risperidone Mylan
4.
Possible side effects
5.
How to store Risperidone Mylan
6.
Contents of the pack and other information.
1.
WHAT RISPERIDONE MYLAN IS AND WHAT IT IS USED FOR
This medicine belongs to a group of medicines called
‘anti-psychotics’.
Risperidone Mylan 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 Mylan can hel

Summary of Product characteristics

1/9
PUBLIC ASSESSMENT REPORT
SCIENTIFIC DISCUSSION
RISPERIDONE MYLAN 0.5MG, 1MG, 2MG, 3MG, 4MG ORODISPERSIBLE TABLETS
RISPERIDONE
MT/H/0145/001-005/DC
THIS MODULE REFLECTS THE SCIENTIFIC DISCUSSION FOR THE APPROVAL OF
RISPERIDONE MYLAN
0.5MG, 1MG, 2MG, 3MG AND 4MG ORODISPERSIBLE TABLETS. THE PROCEDURE WAS
FINALISED ON
22/05/2012 ON DAY 210. FOR INFORMATION ON CHANGES AFTER THIS DATE
PLEASE REFER TO THE
MODULE ‘UPDATE’.
2/9
I.
INTRODUCTION
_ _
Based on the review of the quality, safety and efficacy data, the
Member States have granted a
marketing
authorisation
for
Risperidone
Mylan
0.5mg,
1mg,
2mg,
3mg
and
4mg
Orodispersible tablets, from Mylan
_._
The product is indicated in:
-
Treatment of schizophrenia.
-
Treatment of moderate to severe manic episodes associated with bipolar
disorders.
-
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 themself or others.
-
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.
A comprehensive description of the indications and posology is given
in the SmPC.
_ _
_ _
This decentralised procedure concerns a generic application claiming
essential similarity with
the reference product
RISPERDAL 1 mg, 2 mg, 3 mg & 4 mg film-coated tablets
by Janssen-Cilag
Ltd, registered since 1992 in UK.
_ _
The marketing authorisation has been granted pursuant to Article 10 of
Directive 2001/83/EC.
_ _
_ _
II.
QUALITY ASPECTS
_II.1_
_ _
_INTRODUCTION _
Pharmaceutical form: Orodispersible tablet
_ _
_ _
Formulation
Active Ingredient: Risperidone
Excipients
Polacrilex resin
Crospovidone
Silica, colloidal anhydrous
Cellulose, microcrystalline (E460)
Guar gu