Prozac Capsule 20mg

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Fluoxetine Hydrochloride.

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

Fluoxetine Hydrochloride.

Units in package:

28 Capsule Capsules

Manufactured by:

PATHEON FRANCE S.A.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PROZAC
® CAPSULE
Fluoxetine (20mg)
________________________________________________________________________________________________________________________
__________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET?
1.
What Prozac is used for
2.
How Prozac works
3.
Before you use Prozac
4.
How to use Prozac
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Prozac
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial Number
WHAT PROZAC IS USED FOR
_Depression:_
Prozac is indicated for the
treatment
of
the
symptoms
of
depressive
illness,
with
or
without
associated anxiety symptoms.
_Obsessive-compulsive disorder_
,
_ _
which
is
anxiety
disorder
characterised
by
recurrent,
unwanted
thoughts
(obsessions)
and/or
repetitive
behaviours (compulsion).
_ _
_Pre-mestrual _
_Dysphoroc _
_Disorder _
_(PMDD)_
,
a
severe
form
of
premenstrual syndrome that affects a
woman’s
daily
activities
and
relationship
with
others
before
menstruation.
HOW PROZAC WORKS
Prozac 20 mg hard capsules contains
the active substance fluoxetine, which
is one of a group of medicines called
selective serotonin re-uptake inhibitors
(SSRI) antidepressants. It is not fully
understood
how
Prozac
and
other
SSRIs work, but they may help by
increasing the level of serotonin in the
brain which are involved in controlling
mood.
BEFORE YOU USE PROZAC
-
_When you must not use it_
DO NOT TAKE PROZAC IF YOU ARE:
•
allergic to fluoxetine or any of the
other
ingredients
of
this
medicine
(see
PRODUCT DESCRIPTION
).
•
taking
other
medicines
known
as
monoamine
oxidase
inhibitors
(MAOIs),
since
serious
or
fatal
reaction
(e.g.
serotonin
syndrome,
see
SIDE EFFECT
) can occur. Examples
of MAOIs include medicines used to
treat:
-
depression
(such
as
nialamide,
iproniazide and moclobemide),
-
infections (such as
linezolid)
-
a
blood
disorder
called
methaemoglobinaemia
(high
levels
of alt

Summary of Product characteristics

Prozac_PI_EUSPC 22 Dec 2020 and AUS PMDD 17 May 2016_23 Feb 2021
PROZAC
®
1.
NAME OF THE MEDICINAL PRODUCT
PROZAC
®
20mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITIO
N
Each capsule contains 20mg 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
_ _
_Depression: _
Prozac is indicated for the treatment of the symptoms of depressive
illness, with
or without associated anxiety symptoms.
_ _
_Obsessive-compulsive disorder _
_ _
_Pre-menstrual Dysphoric Disorder (PMDD):_
Prozac is indicated for the treatment of pre-
menstrual dysphoric disorder.
_Diagnosis of PMDD:_
The essential diagnostic features of PMDD are clear and established
cyclicity (occurring during the last week of the luteal phase in most
menstrual cycles) of
symptoms such as depressed mood, anxiety, affective liability,
accompany by impairment in
social and/or occupational function and physical symptoms (such as
breast tenderness or
swelling, headaches, joint or muscle pain, a sensation of bloating,
weight gain) – all of which
must be severe. This syndrome should be distinguished from the
commoner “pre-menstrual
tension (distinguished from PMDD by milder symptoms and less impact on
normal
activities)” and from any co-existing psychiatric disorder.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration to adults only.
_ _
_Depression, with or without associated anxiety symptoms _
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
car