Gerozac 20 mg Capsules, Hard

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

FLUOXETINE HYDROCHLORIDE

Disponível em:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Código ATC:

N06AB; N06AB03

DCI (Denominação Comum Internacional):

FLUOXETINE HYDROCHLORIDE

Dosagem:

20 milligram(s)

Forma farmacêutica:

Capsule, hard

Tipo de prescrição:

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

Área terapêutica:

Selective serotonin reuptake inhibitors; fluoxetine

Status de autorização:

Not marketed

Data de autorização:

1999-02-19

Folheto informativo - Bula

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GEROZAC 20 MG CAPSULES, HARD
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 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 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.
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

Características técnicas

Health Products Regulatory Authority
16 July 2021
CRN009X9Z
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gerozac 20 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20mg fluoxetine as fluoxetine hydrochloride.
Excipient with known effect
Each capsule contains 139.64mg 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 “α” 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 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 20mg, the dose may be increased
gradually up to a maximum of 60mg (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 20mg daily. Although
there may b