Flustad 20 mg, dispergeerbare tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

FLUOXETINEHYDROCHLORIDE SAMENSTELLING overeenkomend met ; ; FLUOXETINE

Beschikbaar vanaf:

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

ATC-code:

N06AB03

INN (Algemene Internationale Benaming):

FLUOXETINEHYDROCHLORIDE COMPOSITION corresponding to ; ; FLUOXETINE

farmaceutische vorm:

Dispergeerbare tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Fluoxetine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551);

Autorisatie datum:

2002-06-18

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUSTAD 20 MG, DISPERGEERBARE TABLETTEN
Fluoxetine
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 Fluoxetine STADA is and what it is used for
2. What you need to know before you take Fluoxetine STADA
3. How to take Fluoxetine STADA
4. Possible side effects
5. How to store Fluoxetine STADA
6. Contents of the pack and other information
1. WHAT FLUOXETINE STADA IS AND WHAT IT IS USED FOR
Fluoxetine STADA belongs to a group of anti-depressant medicines
called selective serotonin
reuptake inhibitors (SSRIs).
FLUOXETINE STADA IS USED:
IN ADULTS TO TREAT

Depressive illness (major depressive episodes)

Obsessive-compulsive
disorder
(repetitive,
obsessive
thoughts
with
uncontrollable
behaviour) (OCD)

Bulimia nervosa (an eating disorder). Fluoxetine STADA is used as an
additional treatment
besides psychotherapy for the reduction of binge-eating and purging
activity.
IN CHILDREN AND ADOLESCENTS AGED 8 YEARS AND ABOVE TO TREAT

Moderate
to
severe
major
depressive
episode,
if
depression
is
unresponsive
to
psychological therapy (after 4 to 6 sessions). The doctor will offer
antidepressant medication
to a child or young person with moderate to severe depression only in
combination with a
concurrent psychological therapy.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUOXETINE STADA
DO NOT TAKE FLUOXETINE STADA
You MUST NOT take Fluoxetine STADA:

if you are allergic to fluoxetine or any of the other ingredients of
this medicine (listed in
section 6, “

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Flustad 20 mg, dispergeerbare tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains 22.40 mg of fluoxetine hydrochloride
equivalent to 20 mg
fluoxetine.
Excipients with known effect
Each tablet contains 146.60 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Dispersible tablet
White round tablet with breaking notches on both sides
The tablet can be divided into equal doses
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Adults
Major depressive episodes.
Obsessive-compulsive disorder.
Bulimia nervosa: Fluoxetin STADA 20 mg is indicated as a complement of
psychotherapy for
the reduction of binge-eating and purging activity.
Children and adolescents aged 8 years and above
Moderate to severe major depressive episode, if depression is
unresponsive to psychological
therapy after 4–6 sessions. Antidepressant medication should be
offered to a child or young
person
with
moderate
to
severe
depression
only
in
combination
with
a
concurrent
psychological therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
MAJOR DEPRESSIVE EPISODES
_Adults and older people _
A dose of 20 mg/day is recommended.
Dosage should be reviewed and adjusted if necessary within 3 to 4
weeks of initiation of
therapy and thereafter as judged clinically appropriate. Although
there may be an increased
potential for undesirable effects at higher doses, in some patients,
with insufficient response
to 20 mg, the dose may be increased gradually up to a maximum of 60 mg
(see section 5.1).
Dosage adjustments should be made carefully on an individual patient
basis, to maintain the
patients at the lowest effective dose.
2
Patients with depression should be treated for a sufficient period of
at least 6 months to ensure
that they are free from symptoms.
OBSESSIVE-COMPULSIVE DISORDER
_Adults and older people _
The recommended dose is 20 mg daily.
Although there may be an increased potential for undesirable