Prozac 20 mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUOXETINE HYDROCHLORIDE

Available from:

PCO Manufacturing Ltd.

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:

Authorised

Authorization date:

1996-10-10

Patient Information leaflet

_ _
_ _
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 ARE PROZAC HARD CAPSULES 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 by increasing the
level of se

Summary of Product characteristics

Health Products Regulatory Authority
23 October 2019
CRN00951G
Page 1 of 3
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 fluozetine
hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard Capsules
_Product imported from France, Italy, Spain & the Czech Republic.:_
Hard capsules with pale yellow body and green cap, printed with
‘Lilly 3105’ on each part.
_Product imported from the UK:_
Hard capsules with pale yellow body and green cap, printed
‘Prozac’ on the body and ‘20 mg’ on the cap.
4 CLINICAL PARTICULARS
As per PA2276/004/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2276/004/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Excipients in the product imported from the Netherlands, France,
Belgium and Italy:
Maize starch
Dimeticone
Yellow iron oxide (E 172)
Titanium dioxide (E 171)
Gelatin
Patent blue V (E 131)
Excipients in the product imported from the Czech Republic:
Maize Starch
Dimeticone
Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin
Patent blue V (E131)
Black edible printing ink
Excipients in the product imported from Spain:
Maize Starch
Dimeticone
Gelatin
Patent blue V (E131)
Yellow iron oxide (E172)
Health Products Regulatory Authority
23 October 2019
CRN00951G
Page 2 of 3
Titanium dioxide (E171)
Black edible ink including black iron oxide (E 172) and
2-ethoxyethanol
Excipients in the product imported from the UK:
Maize starch flowable
Dimeticone
Gelatin
Patent blue V (E131)
Yellow iron oxide (E172)
Titanium dioxide (E171)
Black edible printing ink, which contains shellac, black iron oxide
(E172), propylene glycol and may contain ammonium
hydroxide and potassium hydroxide.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product is the date shown on the
container and outer package of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STOR