GEROZAC

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUOXETINE HYDROCHLORIDE

Available from:

Generics (UK) Limited

ATC code:

N06AB03

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Dosage:

20 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

fluoxetine

Authorization status:

Marketed

Authorization date:

1999-02-19

Patient Information leaflet

1. What Gerozac is and what it is used for
2. What you need to know before you take
Gerozac
3. How to take Gerozac
4. Possible side effects
5. How to store Gerozac
6. Contents of the pack and other information.
Gerozac
20
mg
Capsules, Hard
What is in this leaflet
1. What Gerozac is and what it is
used for
The name of your medicine is Gerozac
20 mg Capsules, hard. It contains the active
substance fluoxetine.
Gerozac belongs to a group of medicines called
selective serotonin reuptake inhibitor (SSRI)
antidepressants.
Gerozac can be given to treat the following
conditions:
Adults:
• Major depressive episodes
• The symptoms of a condition called
obsessive-compulsive disorder (OCD)
• The eating disorder bulimia nervosa. This
medicine 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.
Gerozac should be offered to a child or
young person with moderate to severe major
depressive disorder only in combination with
psychological therapy.
2. What you need to know before
you take Gerozac
Do not take Gerozac:
• if you are allergic to fluoxetine or any of the
other ingredients of this medicine (listed in
section 6). If you develop a rash or other
allergic reactions (like itching, swollen lips
or face or shortness of breath), stop taking
the capsules straight away and contact
your doctor immediately.
• if you are taking the medicine metoprolol,
used to treat heart failure
• if you are taking medicines known specifically
as irreversible, non-selective monoamine
oxidase inhibitors (MAOIs) since serious or
even fatal reactions can occur. An example of
such a medicine is ipronazid, which is used
to treat depression.
Treatment with fluoxetine should only be
started two weeks after discontinuation of an
irreversible MAOI (for instance tranylcypromine).
Do not take any MAOIs for at least 5 weeks
after stopping fluoxetine

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gerozac 20 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20 mg fluoxetine as fluoxetine hydrochloride.
Excipient with known effect
Each capsule contains 139.64 mg lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
A hard gelatin capsule with a light green opaque body and a purple
opaque cap; printed “FL20” on the body and “
” on
the cap in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults:_
Major depressive episodes.
Obsessive-compulsive disorder.
Bulimia nervosa: Gerozac 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 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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A