Fluoxetine 20mg capsules

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Fluoxetine hydrochloride

Disponível em:

Relonchem Ltd

Código ATC:

N06AB03

DCI (Denominação Comum Internacional):

Fluoxetine hydrochloride

Dosagem:

20mg

Forma farmacêutica:

Oral capsule

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 04030300; GTIN: 5055144200644

Folheto informativo - Bula

FLUOXETINE 20 MG CAPSULES
Fluoxetine Hydrochloride
PACKAGE LEAFLET: INFORMATION FOR THE USER
Medicines like Fluoxetine Capsules (so called
SSRIs/SNRIs) may cause symptoms of sexual
dysfunction (see section 4). In some cases,
these symptoms have continued after stopping
treatment.
THOUGHTS OF SUICIDE AND WORSENING OF YOUR
DEPRESSION OR ANXIETY DISORDER
If you are depressed and/or have anxiety
disorders you can sometimes have thoughts of
harming or killing yourself. These may be
increased when first starting anti-depressants,
since these medicines all take time to work,
usually about two weeks but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about
killing or harming yourself.
• If you are a young adult. Information from
clinical trials has shown an increased risk of
suicidal behaviour in adults aged less than
25 years with psychiatric conditions who
were treated with an anti-depressant.
If you have thoughts of harming or killing
yourself at any time, CONTACT YOUR DOCTOR OR
GO TO A HOSPITAL STRAIGHT AWAY.
YOU MAY FIND IT HELPFUL TO TELL A RELATIVE OR
CLOSE FRIEND that you are depressed or have an
anxiety disorder and ask them to read this
leaflet. You might ask them to tell you if they
think your depression or anxiety is getting
worse or if they are worried about changes in
your behaviour.
Use in children and adolescents aged 8 to 18 years:
Patients under 18 have an increased risk of
side-effects such as suicide attempt, suicidal
thoughts and hostility (predominantly aggression,
oppositional behaviour and anger) when they take
this class of medicines. Fluoxetine Capsules should
only be used in children and adolescents aged 8 to
18 years for the treatment of moderate to severe
major depressive episodes (in combination with
psychological therapy) and it should not be used
to treat other conditions. Additionally, only limited
information concerning the long-term safety of
Fluoxetine Capsules on growth, puberty, mental,
emotional and behavioural development in th

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 20mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Fluoxetine 20 mg as Fluoxetine Hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule.
Size 3. Capsule cap is light green opaque. Capsule body is standard
yellow
opaque. Markings are "F20".
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS:
_Depression: _Fluoxetine is indicated for the treatment of the
symptoms of
Major depressive episodes, with or without associated anxiety
symptoms,
especially where sedation is not required.
_Obsessive-compulsive disorder. _
_Bulimia nervosa: _Fluoxetine is indicated 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
Fluoxetine capsules are meant for oral administration in adults only.
The
capsules should be swallowed whole with a glass of water.
_ _
_Adults _
_ _
_Major depressive disorders/episodes _
_Adults and the elderly_: 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 20mg, the dose may be increased
gradually up to
a maximum of 60mg (see section 5.1). Dosage adjustments should be made
carefully on an individual patient basis, to maintain the patients at
the lowest
effective dose. Patients with depression should be treated for a
sufficient
period of at least 6 months to ensure that they are free from
symptoms.
_ _