Risperidon disper STADA 2 mg, orodispergeerbare tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

RISPERIDON 2 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

N05AX08

INN (Algemene Internationale Benaming):

RISPERIDON 2 mg/stuk

farmaceutische vorm:

Orodispergeerbare tablet

Samenstelling:

ASPARTAAM (E 951) ; BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER ; CALCIUMSILICAAT (E 552) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COMPOSITION UNKNOWN (RI) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; IJZEROXIDE ROOD (E 172) ; KRUISMUNTSMAAKSTOF ; MAGNESIUMSTEARAAT (E 470b) ; MANNITOL (D-) (E 421) ; PEPPERMINT FLAVOR, NATURAL & ARTIFICIAL ; POVIDON (E 1201),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Risperidone

Product samenvatting:

Hulpstoffen: ASPARTAAM (E 951); BASISCH GEBUTYLEERD METHACRYLAAT COPOLYMEER; CALCIUMSILICAAT (E 552); CELLULOSE, MICROKRISTALLIJN (E 460); COMPOSITION UNKNOWN (RI); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); IJZEROXIDE ROOD (E 172); KRUISMUNTSMAAKSTOF; MAGNESIUMSTEARAAT (E 470b); MANNITOL (D-) (E 421); PEPPERMINT FLAVOR, NATURAL & ARTIFICIAL; POVIDON (E 1201);

Autorisatie datum:

2006-11-03

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
RISPERIDON DISPER STADA 0.5, 1 AND 2 MG ORODISPERGEERBARE TABLETTEN
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 DISPER STADA is and what it is used for
2. What you need to know before you take RISPERIDON DISPER STADA
3. How to take RISPERIDON DISPER STADA
4. Possible side effects
5. How to store RISPERIDON DISPER STADA
6. Contents of the pack and other information
1. WHAT RISPERIDON DISPER STADA IS AND WHAT IT IS USED FOR
RISPERIDON DISPER STADA belongs to a group of medicines called
‘anti-psychotics’.
RISPERIDON DISPER STADA 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.
RISPERIDON DISPER STADA can help alleviate the symptoms of your
disease and stop your
symptoms from coming back.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISPERIDON DISPER STADA
DO NOT TAKE RISPERIDON DISPER STADA
•
If you ar

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Risperidon disper STADA 0.5 mg orodispergeerbare tabletten
Risperidon disper STADA 1 mg orodispergeerbare
Risperidon disper STADA 2 mg orodispergeerbare tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One orodispersible tablet contains 0.5 mg, 1 mg or 2 mg risperidone
Excipient with known effect
Each 0.5 mg orodispersible tablet contains 0.40 mg aspartame.
Each 1 mg orodispersible tablet contains 0.80 mg aspartame.
Each 2 mg orodispersible tablet contains 1.60 mg aspartame.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Orodispersible tablet
0.5 mg orodispersible tablets: round, slightly biconvex tablets, pink
marbled.
1 mg orodispersible tablets: round, slightly biconvex tablets, pink
marbled.
2 mg orodispersible tablets: round, slightly biconvex tablets, pink
marbled.
The tablet must not be divided.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
is indicated for the treatment of schizophrenia.
is indicated for the treatment of moderate to severe
manic episodes
associated with bipolar disorders.
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.
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 adolescen