Fluoxetine 20mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluoxetine hydrochloride

Available from:

DE Pharmaceuticals

ATC code:

N06AB03

INN (International Name):

Fluoxetine hydrochloride

Dosage:

20mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300

Patient Information leaflet

296x210 Leaflet Reel Fed Bi Fold Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Fluoxetine, 20mg, Capsules,
30s - UK
296x210 (Reel Fed)
50982559
Leaflet for Blisters
2892
RH
13-11-19
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FLUOXETINE 20MG 30 CAPSULES PIL - UK
Black
Profile
BBBA6939
S.Anson
14.11.19
296 x 210
7pt
Accord Barnstaple
n/a
n/a
1
Version 3
05.11.2019
page 4
page 1
50982559 BBBA6939
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FLUOXETINE 20MG CAPSULES
(fluoxetine hydrochloride)
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EIGHT IMPORTANT THINGS YOU NEED TO KNOW
ABOUT FLUOXETINE CAPSULES
•
FLUOXETINE CAPSULES TREAT 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 CAPSULES ARE NOT FOR USE IN
CHILDREN AND ADOLESCENTS UNDER 18. See
section 2, _Use in 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 20 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg Fluoxetine as the hydrochloride
Excipient(s) with known effect
Each capsule contains 146.6 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule (green)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS:
•
Major depressive episodes.
•
Obsessive-compulsive disorder.
•
Bulimia nervosa: Fluoxetine 20 mg capsules 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:
20
mg/day
to
60
mg/day.
A
dose
of
20
mg/day
is
recommended
as
the
initial
dose.
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.
In agreement with the consensus statement of the WHO, antidepressant
medication
should be continued for at least 6 months to ensure that they are free
from symptoms.
_Obsessive-compulsive disorder _
Adults
and
the
elderly:
20
mg/day
to
60
mg/day.
A
dose
of
20
mg/day
is
recommended as the initial dose. Although there may be an increased
potential for
side-effects at h