Prozac 20 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUOXETINE HYDROCHLORIDE

Available from:

Eli Lilly Nederland B.V.

ATC code:

N06AB; N06AB03

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Dosage:

20 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

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

Therapeutic area:

Selective serotonin reuptake inhibitors; fluoxetine

Authorization status:

Not marketed

Authorization date:

1989-02-09

Patient Information leaflet

TEXTE
TEXTE
1
3
VERSO
RECTO
Recto
DÉFILEMENT
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
b

Summary of Product characteristics

Health Products Regulatory Authority
10 November 2019
CRN008JVQ
Page 1 of 15
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, t