Cetizal 5 mg Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVOCETIRIZINE DIHYDROCHLORIDE

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

LEVOCETIRIZINE DIHYDROCHLORIDE

Unit dalam pakej:

10x10 Tablets

Dikeluarkan oleh:

Unison Laboratories Co. Ltd.

Risalah maklumat

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CETIZAL 5MG TABLET
Levocetirizine dihydrochloride (5 mg) 1
WHAT IS IN THIS LEAFLET
1.
What Cetizal is used for
2.
How Cetizal works
3.
Before you use Cetizal
4.
How to use Cetizal
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of Cetizal
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CETIZAL IS USED FOR
Cetizal is used to treat the symptoms
of:
•
Allergic rhinitis (inflammation of
the mucous membrane inside the
nose) including persistent allergic
rhinitis
•
Chronic
idiopathic
urticaria
(a
raised,
itchy
rash
of
unknown
cause)
HOW CETIZAL WORKS
Cetizal contains the active ingredient
levocetirizine
dihydrochloride.
Cetizal is an antiallergic medication.
It works by blocking a certain natural
substance (histamine) that your body
makes during an allergic reaction.
BEFORE YOU USE CETIZAL
_- When you must not use it _
Do not take Cetizal:
•
if you are allergic (hypersensitive)
to
the
active
substance,
levocetirizine
dihydrochloride,
cetirizine, hydroxyzine or to an
antihistamine, or any of the other
ingredients of Cetizal
•
if
you
have
a
severe
kidney
impairment
with
creatinine
clearance below 10 ml/min.
The use of Cetizal is not recommended
for infants and children under 6 years.
_Pregnancy and breastfeeding _
Ask your doctor or pharmacist for advice
before taking any medicine. Tell your
doctor if you are pregnant, trying to get
pregnant or breastfeeding. Levocetirizine
is excreted in human milk. Talk to your
doctor or pharmacist before taking this
medicine if you are breastfeeding.
_- Before you start to use it _
Tell your doctor if you have any of
the following conditions:
•
If you have difficulties emptying
your bladder due to factors such
as spinal cord lesion or prostatic
hyperplasia (enlargement of the
prostate gland).
•
If you have been told by your
doctor
that
you
have
an
intolerance to some sugars. This
tablet contains lactose.
•
If you have e

Ciri produk

-1-
-2-
-3-
ANTIHISTAMINE FOR SYSTEMIC USE
19 cm.
26 cm.
CETIZAL 5 _Insert_ICMY 0081 By...DA 12/05/2023
Product
CETIZAL 5
ICMY 0081
Code No.
Dimension
W 26 x L 19 cm.
Packaging Type
Thickness
60 g (0.08 mm.)
Designed by:
(PDM, ASPD, PDC-M, PDC-A, PDO-M, PDO-A)
Checked by:
(PDM/ASPD)
Approved by:
PLC:
(Date)
LRA:
(Date)
Approved by:
(MD
(Only Pattern and Colors)
)
IRA:
(Date)
QCC-PM:
(Date)
CUSTOMER/SALES DEPT.:
(Date)
Wood Free Paper (กระดาษปอนด‹)
Each film coated tablet contains:
LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG
PRODUCT DESCRIPTION:
White, oblong, biconvex, film coated tablet with engraved LC on one
side and 5 on the left of the
scored side
MECHANISM OF ACTION:
Pharmacotherapeutic group: Antihistamine for systemic use, piperazine
derivative
_PHARMACOLOGY_
Levocetirizine, the (R) enantiomer of Cetirizine, is a potent and
selective antagonist of peripheral
H
1
-receptors. Levocetirizine has high affinity for human H
1
-receptors. Levocetirizine dissociates from
H
1
-receptors with a half-life of 115 ± 38 min. After single
administration, Levocetirizine shows a
receptor occupancy of 90% at 4 hours and 57% at 24 hours.
_PHARMACOKINETICS_
The pharmacokinetics of Levocetirizine are linear with dose- and
time-independent with low inter-subject
variability. The pharmacokinetic profile is the same when given as the
single enantiomer or when given
as Cetirizine. No chiral inversion occurs during the process of
absorption and elimination.
Absorption
Levocetirizine is rapidly and extensively absorbed following oral
administration. In adults, peak plasma
concentrations are achieved 0.9 hour after dosing. The extent of
absorption is dose-independent and
is not altered by food, but the peak concentration is reduced and
delayed.
Distribution
No tissue distribution data are available in humans, neither
concerning the passage of Levocetirizine
through the blood-brain-barrier.
Levocetirizine is 90% bound to plasma proteins. The distribution of
Levocetirizine is restrictive, as
the volume of distribution i