Fluoxetine 20mg capsules

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Fluoxetine hydrochloride

Mevcut itibaren:

Wockhardt UK Ltd

ATC kodu:

N06AB03

INN (International Adı):

Fluoxetine hydrochloride

Doz:

20mg

Farmasötik formu:

Oral capsule

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 04030300; GTIN: 5012727903309

Bilgilendirme broşürü

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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DATE SENT:
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SUPPLIER:
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GTIN 13:
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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

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 20 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 22.36 mg fluoxetine hydrochloride equivalent to
20 mg
fluoxetine.
Excipient with known effect: 58 mg of lactose monohydrate per capsule.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules hard.
Olive/green capsules marked FLE 20
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
_Major depressive episodes _
Adults and older people: The recommended dose is 20 mg 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.
_ _
_Obsessive-compulsive disorder _
_ _
Adults and older people: The recommended dose is 20 mg 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