Magrilan 20mg Capsules

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

Fluoxetine HCl (eq. to Fluoxetine 20mg)

Dostupné z:

KOMEDIC SDN BHD

INN (Medzinárodný Name):

Fluoxetine HCl (eq. to Fluoxetine 20mg)

Počet v balení:

100Capsule Capsules; 12Capsule Capsules; 30Capsule Capsules; 10Capsule Capsules; 20Capsule Capsules

Výrobca:

MEDOCHEMIE LTD

Príbalový leták

_Consumer Medication Information Leaflet (RiMUP) _
MAGRILAN CAPSULE
Fluoxetine (20mg)
1
WHAT IS IN THIS LEAFLET
1.
What MAGRILAN is used for
2.
How MAGRILAN works
3.
Before you use MAGRILAN
4.
How to use MAGRILAN
5.
While you are using it
6.
Side effects
7.
Storage and disposal of MAGRILAN
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MAGRILAN IS USED FOR
This medicine is used to treat the
following conditions:
_Adults: _
•
Major depressive episodes
•
Obsessive-compulsive
disorder
(persistent, obsessive thoughts that
make
you
carry
out
repetitive
behaviour)
•
Premenstrual
dysphoric
disorder
(PMDD)
(a
severe
form
of
premenstrual syndrome that affect
the
woman's
daily
activities
and
relationship
with
others
before
menstruation)
HOW MAGRILAN WORKS
MAGRILAN
contains
the
active
ingredient
fluoxetine
hydrochloride.
MAGRILAN
belongs
to
a
group
of
medicines called selective serotonin re-
uptake inhibitor (SSRI) antidepressants.
When
serotonin
is
released
from
the
nerve cells in the brain, it acts to lighten
mood.
SSRIs
work
by
preventing
serotonin
from being reabsorbed back
into the nerve cells in the brain. This
helps prolong the mood lifting effect of
any
released
serotonin,
thus
relieving
depression.
BEFORE YOU USE MAGRILAN
-
_When you must not use it _
Do not take MAGRILAN:
•
If you are hypersensitive (allergic)
to fluoxetine or any of the other
ingredients
of
MAGRILAN
(see
section
PRODUCT
DESCRIPTION
).
If
you develop a rash or other allergic
reactions (like itching, swollen lips
or face or shortness of breath), stop
taking
the
capsules
straight
away
and
contact
your
doctor
immediately.
•
If you are taking other medicines
used to treat depression, known as
non-selective monoamine oxidase
inhibitors
(MAOIs)
or
reversible
monoamine oxidase inhibitors type
A,
since
serious
or
even
fatal
reactions (serotonin syndrome;
see
section
SIDE
EFFECTS
)
can
occur.
Examples
of
MAOIs
include
nialamide,
iproniazide,
selegiline,
moclobemide,
phenelzine,
tranylcypromine, is

Súhrn charakteristických

\fluox\spc6
MAGRILAN 20MG CAPSULES
(Fluoxetine Hydrochloride)
PHARMACEUTICAL FORM
Yellow/violet cap/body hard gelatin capsule of size ‘4’ containing
white free flowing powder
Each “MAGRILAN” 20mg capsule, contains Fluoxetine Hydrochloride
equivalent to 20mg of Fluoxetine base
For excipients see section Pharmaceutical Particulars
Capsules for oral administration
THERAPEUTIC INDICATIONS
Depression: MAGRILAN 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): MAGRILAN 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 lability,
accompanied 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.
DOSAGE AND METHOD OF ADMINISTRATION
For oral administration to adults only
Depression, with or without associated anxiety symptoms – adults and
the elderly: A dose of 20mg/day is recommended.
Obsessive-compulsive disorder – adults and the elderly: 20mg/day to
60mg/day. A dose of 20mg/day is recommended as
the initial dose. Although there may be an increased potential for
side-effects at higher doses, a dose increase may be
considered after several weeks if there is no response.
Pre-menstrual Dysphoric Disorder (PMDD): A dose of 20mg per day is
recommended. Initial treatment should be limited to
6 months, after which patients should be reassessed regarding the
benefit of c