Fluoxetine 20mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Fluoxetine hydrochloride

Tilgjengelig fra:

Milpharm Ltd

ATC-kode:

N06AB03

INN (International Name):

Fluoxetine hydrochloride

Dosering :

20mg

Legemiddelform:

Oral capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04030300; GTIN: 5060035110858

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUOXETINE 20MG CAPSULES
(fluoxetine)
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT FLUOXETINE CAPSULES
FLUOXETINE CAPSULES TREATS DEPRESSION AND ANXIETY DISORDERS. Like all
medicines it
can have unwanted effects. It is therefore important that you and your
doctor weigh up the
benefits of treatment against the possible unwanted effects, before
starting treatment.
FLUOXETINE CAPSULE IS NOT FOR USE IN CHILDREN AND ADOLESCENTS UNDER
18. See section 2,
Children and adolescents aged 8 to 18 years.
FLUOXETINE CAPSULES WON’T WORK STRAIGHT AWAY. Some people taking
antidepressants feel
worse before feeling better. Your doctor should ask to see you again a
couple of weeks after
you first start treatment. Tell your doctor if you haven’t started
feeling better. See section 3,
How to take Fluoxetine capsules.
SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING
THEMSELVES.
If you start to feel worse, or think of harming or killing yourself,
SEE YOUR DOCTOR OR GO TO A
HOSPITAL STRAIGHT AWAY. See section 2.
DON’T STOP TAKING FLUOXETINE CAPSULES WITHOUT TALKING TO YOUR
DOCTOR. If you stop taking
Fluoxetine capsules suddenly or miss a dose, you may get withdrawal
effects. See section 3
for further information.
IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL,
TELL YOUR DOCTOR. Increasing
the dose of Fluoxetine capsules may make these feelings worse. See
section 4, Possible
side-effects.
TAKING SOME OTHER MEDICINES WITH FLUOXETINE CAPSULES CAN CAUSE
PROBLEMS. You may
need to talk to your doctor. See section 2, Taking other medicines.
IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT, talk to your doctor.
See section 2,
_Pregnancy, breast-feeding and fertility_.
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 onl

Preparatomtale

1.
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 20 mg Capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluoxetine hydrochloride equivalent to 20mg
fluoxetine.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, Hard.
Green/Off-white hard gelatin self locked capsules of size ‘2’
imprinted with
‘FLX’ and 'MIL' on cap / body in black edible ink containing white
powder.
4.1
THERAPEUTIC INDICATIONS
Adults:
Major depressive disorders/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 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.
_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