Fluoxetine 20 mg capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUOXETINE

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

N06AB03

INN (International Name):

FLUOXETINE 20 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

FLUOXETINE 20 mg

Prescription type:

POM

Therapeutic area:

PSYCHOANALEPTICS

Authorization status:

Authorised

Authorization date:

2014-07-24

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FLUOXETINE AUROBINDO 20 MG CAPSULES, HARD
FLUOXETINE AUROBINDO 60 MG CAPSULES, HARD
fluoxetine hydrochloride
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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Fluoxetine Aurobindo is and what is used for
2.
What you need to know before you take Fluoxetine Aurobindo
3.
How to take Fluoxetine Aurobindo
4.
Possible side effects
5.
How to store Fluoxetine Aurobindo
6.
Contents of the pack and other information
1.
WHAT FLUOXETINE AUROBINDO IS AND WHAT IS USED FOR
Fluoxetine Aurobindo contains fluoxetine which is one of a group of
medicines called selective serotonin
re-uptake inhibitors (SSRI) antidepressants.
This medicine is used to treat the following conditions:
_ _
_Adults: _
•
Major depressive episodes
•
Obsessive-compulsive disorder
•
Bulimia nervosa: Fluoxetine Aurobindo is used alongside psychotherapy
for the reduction of binge-
eating and purging.
_ _
_Children and adolescents aged 8 years and above: _
Moderate to severe major depressive disorder, if the depression does
not respond to psychological therapy
after 4-6 sessions. Fluoxetine Aurobindo should be offered to a child
or young person with moderate to
severe major depressive disorder only in combination with
psychological therapy.
HOW FLUOXETINE AUROBINDO WORKS
Everyone has a substance called serotonin in their brain. People who
are depressed or have obsessive-
compulsive disorder or bulimia nervosa have lower levels of serotonin
than others. It is not fully
understood how Fl

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Fluoxetine 20 mg capsules, hard
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 22.357 mg fluoxetine hydrochloride
equivalent to 20 mg of Fluoxetine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Opaque green cap/yellow body, size “4” hard gelatin capsule filled
with white to off-white powder and
imprinted with ‘J’ on opaque green cap and ‘96’ on yellow body
with black ink.
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
_Adults _
_ _
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.
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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(OCD)
_Adults and the elderly:_
The recommended dose is 20mg daily. Although there may be an i