Gerozac 60 mg Capsules, Hard

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

FLUOXETINE HYDROCHLORIDE

Disponible depuis:

McDermott Laboratories Ltd., T/A Gerard Laboratories

Code ATC:

N06AB; N06AB03

DCI (Dénomination commune internationale):

FLUOXETINE HYDROCHLORIDE

Dosage:

60 milligram(s)

forme pharmaceutique:

Capsule, hard

Type d'ordonnance:

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

Domaine thérapeutique:

Selective serotonin reuptake inhibitors; fluoxetine

Statut de autorisation:

Not marketed

Date de l'autorisation:

2006-03-03

Notice patient

PAGE 1 OF 10
PACKAGE LEAFLET
PAGE 2 OF 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GEROZAC 60 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 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 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
Gerozac is one of a type of antidepressants known as Selective
Serotonin Reuptake Inhibitors (SSRIs).
Gerozac is used to treat:
_Adults: _

The symptoms of depression and feelings of anxiety

The symptoms of a condition called obsessive-compulsive disorder (OCD)

The eating disorder bulimia nervosa
_Children and adolescents aged 8 years and above _
(Under specialist supervision only):

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 any medicines known specifically

Résumé des caractéristiques du produit

Health Products Regulatory Authority
26 February 2021
CRN00C408
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gerozac 60 mg Capsules, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluoxetine hydrochloride equivalent to 60 mg of
fluoxetine.
Excipient with known effect
Each capsule contains 256.92 mg lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Capsule size 1 with a light yellow opaque body and cap, printed
“FL60” on the body and “G” on the cap in black ink.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Gerozac 60 mg capsules are indicated for:
_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