PROZAC 20 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUOXETINE HYDROCHLORIDE

Available from:

B & S Healthcare

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:

Selective serotonin reuptake inhibitors

Authorization status:

Authorised

Authorization date:

2007-01-12

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
PROZAC
®
 20MG HARD CAPSULES 

fluoxetine (as hydrochloride)    

The name of your product is Prozac 20mg hard
capsules, but it will be referred to as Prozac 
throughout this leaflet.  

EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT PROZAC 

PROZAC TREATS DEPRESSION AND ANXIETY DISORDERS. 
Like all medicines it can have unwanted effects. It is therefore
important that you and your 
doctor weigh up the benefits of treatment against the
possible unwanted effects, before 
starting treatment. 

PROZAC IS NOT FOR USE IN CHILDREN AND ADOLESCENTS UNDER 18. See
section 2, _Use in _
_children and adolescents aged 8 to 18 years. _

PROZAC WON’T WORK STRAIGHT AWAY. Some people taking
antidepressants feel worse before 
feeling better. Your doctor should ask to see you again a couple of
weeks after you first start 
treatment. Tell your doctor if you haven’t started feeling better.
See section 3, _How to take _
_Prozac hard capsules. _

SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK
OF HARMING OR KILLING THEMSELVES. If 
you start to feel worse, or think of harming or killing
yourself, SEE YOUR DOCTOR OR GO TO A 
HOSPITAL STRAIGHT AWAY. See section 2. 

DON’T STOP TAKING PROZAC WITHOUT TALKING TO YOUR DOCTOR. If
you stop taking Prozac 
suddenly or miss a dose, you may get withdrawal effects. See
section 3 for further 
information. 

IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND
STILL, TELL YOUR DOCTOR. Increasing 
the dose of Prozac may make these feelings worse. See section
4, _Possible side-effects. _

TAKING SOME OTHER MEDICINES WITH PROZAC CAN CAUSE PROBLEMS. You
may need to talk to 
your doctor. See section 2, _Taking other medicines. _

IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT, talk to your
doctor. See section 2, 
_Pregnancy and breast-feeding._ 

READ ALL OF T

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prozac 20mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains fluoxetine hydrochloride equivalent to 20 mg of fluoxetine.
This product contains soya lecithin as one of the components of the capsule shell printing ink.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsules
_Product imported from the UK:_
The capsules are yellow and green, marked with ‘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 AGES 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 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 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