Risperidon Mylan 4 mg Munsönderfallande tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

risperidon

Tillgänglig från:

Mylan S.A.S.

ATC-kod:

N05AX08

INN (International namn):

risperidone

Dos:

4 mg

Läkemedelsform:

Munsönderfallande tablett

Sammansättning:

mannitol Hjälpämne; aspartam Hjälpämne; risperidon 4 mg Aktiv substans

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Risperidon

Produktsammanfattning:

Förpacknings: Blister, 10 tabletter; Blister, 14 tabletter; Blister, 20 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 84 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 180 tabletter; Blister, 200 tabletter

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2010-06-11

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISPERIDON MYLAN 3 MG ORODISPERSIBLE TABLETS
RISPERIDON 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 Risperidon Mylan
is and what it is used for
2.
What you need to know before you take Risperidon Mylan
3.
How to take Risperidon Mylan
4.
Possible side effects
5.
How to store Risperidon Mylan
6.
Contents of the pack and other information
1.
WHAT RISPERIDON MYLAN IS AND WHAT IT IS USED FOR
Risperidon Mylan belongs to a group of medicines called
‘anti-psychotics’.
Risperidon 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDON MYLAN
DO NOT TAKE RISPERIDON MYLAN

if you are allergic to risperidone or any of the other ingredients of
this medicine (listed in
section 6 ).
WARNINGS AND PRECAUTIONS
Talk to you

Produktens egenskaper

Produktinformationen för Risperidon Mylan 3, 4 mg munsönderfallande
tablett, MTnr 42086,
42087, gäller vid det tillfälle då läkemedlet godkändes.
Informationen kommer inte att
uppdateras eftersom läkemedlet inte marknadsförs i Sverige. Av samma
anledning finns inte
någon svensk produktinformation.
Den engelska produktinformationen kommer dock att uppdateras för de
produkter där Sverige
är referensland.
Om läkemedelsnamnet i följande produktinformation inte stämmer med
namnet på
dokumentet, beror det på att läkemedlet i Sverige är godkänt under
ett annat namn.
1.
NAME OF THE MEDICINAL PRODUCT
Risperidon Mylan 3 mg orodispersible tablets
Risperidon Mylan 4 mg orodispersible tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible tablet contains 3 mg risperidone.
Each orodispersible tablet contains 4 mg risperidone.
Excipients:
Each orodispersible tablet contains 2.40 mg aspartame and 0.021 mg
sorbitol.
Each orodispersible tablet contains 3.20 mg aspartame and 0.028 mg
sorbitol.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible tablet.
Round, slightly convex, pink marbled orodispersible tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Risperidon Mylan is indicated for the treatment of schizophrenia.
Risperidon Mylan is indicated for the treatment of moderate to severe
manic episodes associated with
bipolar disorders.
Risperidon Mylan 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.
Risperidon Mylan 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
pharmaco