Fluoxetine 20mg capsules

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Fluoxetine hydrochloride

Disponible desde:

Flamingo Pharma (UK) Ltd

Código ATC:

N06AB03

Designación común internacional (DCI):

Fluoxetine hydrochloride

Dosis:

20mg

formulario farmacéutico:

Oral capsule

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 04030300; GTIN: 5060464500978

Información para el usuario

370 mm
310 mm
FLUOXETINE 20MG CAPSULES
Leaflet Size : L-370 x W-310 mm
MPLLFLU0020CPCOMFPLXXX032V08
(POM)
XXXX
PHARMA
CODE
FONTS : Arial
FONTS SIZE :
Generic Name font size : 11 pt.
Composition fonts size : 8 pt.
Printing Zone
Fold as per booklet
PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUOXETINE 20MG CAPSULES
Fluoxetine hydrochloride
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 Capsule is and what it is used for
2.
What you need to know before you take Fluoxetine Capsule
3.
How to take Fluoxetine Capsule
4.
Possible side effects
5.
How to store Fluoxetine Capsule
6. Contents of the pack and other information
1. WHAT FLUOXETINE CAPSULE IS AND WHAT IT IS USED FOR
The name of this medicine is Fluoxetine 20mg Capsule (referred to as
Fluoxetine throughout this leaflet). Fluoxetine 20mg Capsule
contains the active substance fluoxetine which is one of a group of
medicines called selective serotonin re-uptake inhibitor (SSRI)
antidepressants.
This medicine is used to treat the following conditions:
_Adults:_
• Major depressive episodes
• Obsessive-compulsive disorder
• Bulimia nervosa: Fluoxetine is used alongside psychotherapy for
the reduction of binge-eating and purging.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUOXETINE CAPSULE
DO NOT TAKE FLUOXETINE IF YOU ARE:
- allergic to fluoxetine or any of the other ingredients of this
medicine (listed in section 6).
IF YOU DEVELOP A RASH OR OTHER ALLERGIC REACTION (LIKE ITCHING,
SWOLLEN LIPS OR FACE OR SHORTNESS OF BREATH

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 20 mg Capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One hard capsule contains 22.36mg of fluoxetine hydrochloride
equivalent to
20mg fluoxetine base.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Fluoxetine capsules are blue and white, and marked ‘R9’
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults:
-
Major depressive episodes.
-
Obsessive-compulsive disorder
-
Bulimia nervosa; Fluoxetine 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
Adults
_Major depressive episodes:_
Adults and the elderly: The recommended dose is 20mg daily. 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.
_Obsessive-compulsive disorder:_
Adults and the elderly: The recommended dose is 20mg daily. Although
there
may
be an increased potential for undesirable effects at higher doses, in
some
patients,
if after two weeks there is insufficient response to 20mg, the dose
may
be increased
gradually up to a