Prozac 20mg hard capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FLUOXETINE

Available from:

Eli Lilly Nederland B.V Papendorpseweg 83, 3528 BJ, Utrecht, NL-3991, Netherlands

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:

Withdrawn

Authorization date:

2007-01-29

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROZAC 20 MG HARD CAPSULES
_fluoxetine _
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 Prozac hard capsules are and what they are used for
2.
What you need to know before you take Prozac hard capsules
3.
How to take Prozac hard capsules
4.
Possible side effects
5.
How to store Prozac hard capsules
6.
Content of the pack and other information
1.
WHAT PROZAC HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
Prozac 20 mg hard capsules contain the active substance 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: Prozac 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. Prozac should be offered to
a child or young person
with moderate to severe major depressive disorder
ONLY
in combination with psychological
therapy.
How Prozac 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 Prozac and other SSRIs work but they may help by
increasing the level of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Prozac 20 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg of fluoxetine (as fluoxetine
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules.
The capsules are green and yellow, printed ‘Lilly 3105’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS:
Major depressive episodes.
Obsessive-compulsive disorder.
Bulimia nervosa: Prozac 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 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 patients,
if after two weeks there is
insufficient response to 20 mg, the dose may be increased gradually up
to a maximum of 60 mg.
If