Prozac 20 mg hard capsules

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Fluoxetine

Pieejams no:

Imbat Limited

ATĶ kods:

N06AB; N06AB03

SNN (starptautisko nepatentēto nosaukumu):

Fluoxetine

Deva:

20 milligram(s)

Zāļu forma:

Capsule, hard

Receptes veids:

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

Ārstniecības joma:

Selective serotonin reuptake inhibitors; fluoxetine

Autorizācija statuss:

Authorised

Autorizācija datums:

2014-05-23

Lietošanas instrukcija

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROZAC
® 20MG HARD CAPSULES
(fluoxetine)
Your medicine is available using the name Prozac 20mg Hard
Capsules but will be referred to as Prozac throughout this
leaflet.
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 are and what they are used for
2.
What you need to know before you take Prozac
3.
How to take Prozac
4.
Possible side effects
5.
How to store Prozac
6.
Content of the pack and other information
1.
WHAT PROZAC ARE AND WHAT THEY ARE USED
FOR
Prozac contains 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 wor

Produkta apraksts

Health Products Regulatory Authority
08 October 2019
CRN0093RG
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prozac 20 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 20mg of fluoxetine (as fluoxetine
hydrochloride).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
_Product imported from the UK_
The capsules are green and yellow, printed 'Lilly 3105'.
4 CLINICAL PARTICULARS
As per PA2276/004/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2276/004/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Maize Starch flowable
Dimeticone
_Capsule components:_
Patent blue V (E131)
Yellow iron oxide (E172)
Titanium dioxide (E171)
Gelatin
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 of this product is the date shown on the
blister strips and outer carton of the product as marked in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30
o
C.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC/aluminium blister packs of 30 hard capsules, presented in an outer
cardboard carton.
Health Products Regulatory Authority
08 October 2019
CRN0093RG
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/221/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 23rd May 2014
10 DATE OF REVISION OF THE TEXT
October 2019