Proezine Tablet 25mg Film Coated

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PROMETHAZINE HYDROCHLORIDE

Boleh didapati daripada:

Duopharma Marketing Sdn. Bhd.

INN (Nama Antarabangsa):

PROMETHAZINE HYDROCHLORIDE

Unit dalam pakej:

1000 mcg/mL; 100Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PROEZINE FILM COATED TABLET
Promethazine hydrochloride (25mg)
WHAT IS IN THE LEAFLET
1.
What Proezine Tablet is
used for
2.
How Proezine Tablet works
3.
Before you use Proezine
Tablet
4.
How to use Proezine Tablet
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Proezine Tablet
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PROEZINE TABLET IS USED
FOR
Proezine
Tablet
may
be
provided to you for use in the
following situations:
•
To treat allergic conditions of
the upper respiratory tract and
skin
such
as
to
relief
symptoms
of
perennial
(throughout
the
year)
and
seasonal
rhinitis
(inflammation of the mucous
membrane inside the nose),
hives.
•
To treat or stop you feeling
sick
or
vomiting
such
as
travel
sickness
or
vomiting
due
to
medicine
or
after
operation.
•
To help you feel more relaxed
before and after surgery and
during labour.
•
For short term use:
-
To
treat
adults
with
difficulty sleeping
-
As
a
sedative
(calm
or
inducing sleep) for children
HOW PROEZINE TABLET WORKS
This
medicine
contains
the
active ingredient Promethazine
which is an antihistamine.
Histamine
is
a
chemical
released into the body during an
allergic reaction. It works by
blocking
the
effects
of
histamine,
calming
down
the
body's
allergic
reaction
and
starting
to
relieve
the
symptoms.
It also works directly on the
brain
to
help
you
feel
more
relaxed.
BEFORE
YOU
USE
PROEZINE
TABLET
-
_When you must not use it _
_ _
Do not take this medicine if:
•
You are hypersensitive to, or
have had an allergic reaction
to promethazine or any of the
ingredients listed at the end of
this leaflet.
•
you have glaucoma
(increased eye pressure)
•
you
have
central
nervous
system
depression
such
as
decreased
breathing
rate,
heart rate
•
You use in premature infants
or neonates
•
You
are
taking
a
class
of
medicine
known
as
_'monoamine _
_oxidase _
inhibitors'
(MAOIs)
(often
taken for depression), or you
have taken such a medici

Ciri produk

A 6.5mm, round convex core tablet, film coated blue, one side marked
‘UP’ and
scored, the other side plain.
Each tablet contains Promethazine HCI 25mg
As symptomatic treatment for allergic conditions of the upper
respiratory tract
and skin including allergic rhinitis, urticaria and anaphylactic
reactions to drugs
and foreign proteins.
As an adjunct in preoperative sedation in surgery and obstetrics.
As an antiemetic.
For short term use:
Sedation and treatment of insomnia in adults.
As a paediatric sedative.
Promethazine is a phenothiazine-derivative antihistamine which acts by
blocking
the action of histamine through competitive, reversible inhibition of
H
1
receptor
sites on tissues; it does not inactivate histamine or prevent its
synthesis or release.
It thereby prevents, but does not reverse responses mediated by
histamine alone.
Histamine H
1
receptors are responsible for vasodilation, increased capillary
permeability, flare and itch reactions in the skin, and to some extent
for
contraction of smooth muscle in the bronchial and gastrointestinal
tract. Thus,
blockage of H
1
receptors may inhibit these reactions. In addition, its anticholin-
ergic effects which mediates via muscarinic receptors provide a drying
effect on
the nasal and oral mucosa. The mechanism by which promethazine exerts
its
antiemetic, anti-motion sickness, and anti-vertigo effects is not
precisely known
but may be relatcd to its centrally anticholinergic actions, It
diminishes vestibular
stimulation and depresses labyrinthine function. Activity on the
medullary
chemoreceptive trigger zone may also be involved in the antiemetic
effect.
Promethazine crosses the blood-brain-barrier and produces sedation due
to the
inhibition of histamine N- methyl transferase and blockage of central
histaminer-
gic receptors. Antagonism of other central nervous system receptor
sites, such as
those for serotonin, acetylcholine, and alpha-adrenergic stimulation,
may also be
involved. Promethazine are thought to cause indirect reduction of
stimuli to the
brai