Fluoxetine 60mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Fluoxetine hydrochloride

Available from:

Teva UK Ltd

ATC code:

N06AB03

INN (International Name):

Fluoxetine hydrochloride

Dosage:

60mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030300; GTIN: 5017007027454

Patient Information leaflet

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v1/May 2015
1/2
1
Myriad Pro
9 pt
9 pt
170 x 580 mm
Fluoxetine Hydrochloride 60 mg 30
Leaflet
913312
713975
913312
04569/0477
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LT1329AH
20
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284357
3
UK
1
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Black
06 Jul 2016
10:54
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLUOXETINE 60 MG
CAPSULES, HARD
(fluoxetine)
EIGHT IMPORTANT THINGS YOU NEED TO KNOW
ABOUT FLUOXETINE.
Please read all of this leaflet. It includes a lot
of additional important information about
this medicine.
• FLUOXETINE 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. See section 4
‘Possible side effects’, inside this leaflet.
• FLUOXETINE IS NOT FOR USE IN CHILDREN UNDER
8 YEARS.
• FLUOXETINE 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 have
started feeling better. See section 3, ‘How to
take Fluoxetine’.
• 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 ‘What you need to
know before you take Fluoxetine’.
• DON’T STOP TAKING FLUOXETINE WITHOUT TALKING
TO YOUR DOCTOR. If you stop taking Fluoxetine
suddenly or miss a dose, you may get
withdrawal effects. See section 3, ‘If you stop
taking Fluoxetine’.
• IF YOU FEEL RESTLESS AND FEEL LIKE

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 60mg Hard Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 60 mg of fluoxetine (as hydrochloride)
Excipients with known effects:
Each capsule also contains the colouring agents, Tartrazine (E102)
[0.37 mg] and
Sunset Yellow FCF (E110) [0.0009 mg].
For a full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Capsule, Hard
Hard gelatin capsules with yellow cap and white body imprinted with
‘FLX’ on cap
and ‘60’ on body with black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Major depression
Obsessive-compulsive disorder
Bulimia nervosa: fluoxetine is indicated as a complement to
psychotherapy for
reduction of binge eating and purging activity.
_Children_ _and adolescents aged 8 years and above (moderate to severe
major _
_depressive episode):_ Fluoxetine 60mg capsules are not licensed and
are not
appropriate for use in children or adolescents. Other suitable
formulations (20mg
capsules, liquid formulation) are available for this patient
population.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Major depressive_ _episodes_
Adults and the elderly: 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 the elderly: The recommended dose is 20 mg daily Although
there
may be an increased potential for undesirable effects at higher doses,
in some
patient