Fluoxetine 20mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluoxetine hydrochloride

Available from:

Genus Pharmaceuticals Ltd

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 20mg Hard Capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20mg fluoxetine as the hydrochloride.
For the full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Hard Capsules.
Hard shell gelatine, size 3 capsules, opaque light green coloured cap
and body,
filled with a homogenous white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Depression:
Fluoxetine is indicated for the treatment of the symptoms of
depressive illness, with
or without associated anxiety symptoms, especially where sedation is
not required.
Bulimia nervosa:
Fluoxetine is indicated for the reduction of binge eating and purging
activity.
Obsessive-compulsive disorder.
Pre-menstrual dysphoric disorder (PMDD):
Fluoxetine is indicated for the treatment of pre-menstrual dysphoric
disorder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
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 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.
Patients with depression should be treated for a sufficient period of
at least 6
months to ensure that they are free from symptoms.
BULIMIA NERVOSA ADULTS AND THE ELDERLY: A dose of 60 mg/day is recommended. Long-term
efficacy (more than 3 months) has not been demonstrated in bulimia
nervosa.
OBSESSIVE-COMPULSIVE DISORDER
ADULTS AND THE ELDERLY: 20mg/day to 60mg/day. A dose of 20mg/day is
recommended as the initial dose. Although there may be an increased
potential
for side-effects at higher doses, in some patients, a dose