Prozit 20mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUOXETINE HYDROCHLORIDE

Available from:

Unichem Laboratories 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:

Marketed

Authorization date:

2001-05-04

Patient Information leaflet

PA 1063/012/01 1 November 2018
PACKAGE LEAFLET: INFORMATION FOR THE USER PROZIT 20MG HARD CAPSULES
Fluoxetine (as hydrochloride)
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.

If you are a carer or are helping someone else to take their capsules,
please read this leaflet before
you give the first dose.
WHAT IS IN THIS LEAFLET
1. What Prozit Hard Capsules are and what they are used for
2. What you need to know before you take Prozit Hard Capsules
3. How to take Prozit Hard Capsules
4. Possible side effects
5. How to store Prozit Hard Capsules
6. Contents of the pack and other information
1.
What PROZIT HARD CAPSULES ARE AND WHAT THEY ARE USED FOR
Prozit Hard Capsules contain fluoxetine which is one of a group of
medicines called selective serotonin
reuptake inhibitor (SSRI) antidepressants.
Prozit Hard Capsules are used in the treatment of:
Adults:

Severe depression

Anxiety disorders with compulsive thoughts or actions, which means
that you may have
uncontrollable thoughts or carry out repetitive actions. This
condition is known as obsessive
compulsive disorder.

Binge-eating (bulimia nervosa), alongside psychotherapy, in order to
avoid binge-eating and
vomiting
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. Fluoxetine 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 NEE

Summary of Product characteristics

Health Products Regulatory Authority
07 January 2019
CRN008RR2
Page 1 of 22
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Prozit 20mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 22.36 mg fluoxetine hydrochloride equivalent to
20 mg
fluoxetine.
Excipient with known effect: 58 mg of lactose monohydrate per capsule.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules hard.
Olive/green capsules marked FLE 20.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS:
_Major depressive episodes. _
_Obsessive-compulsive disorder. _
_Bulimia nervosa_: Fluoxetine 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 older people: 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
Health Products Regulatory Authority
07 January 2019
CRN008RR2
Page 2 of 22
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 older people: The recommended dose is 20 mg daily. Although
there may
be