Aerius Tablet 5mg

Country: Malaysia

Language: English

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

Active ingredient:

DESLORATADINE

Available from:

ORGANON MALAYSIA SDN. BHD.

INN (International Name):

DESLORATADINE

Units in package:

500Tablet Tablets; 100Tablet Tablets; 10Tablet Tablets

Manufactured by:

Organon Heist bv

Patient Information leaflet

_Consumer Medication Information Leaflet _
_(RiMUP) _
AERIUS
® TABLET 5MG
Desloratadine 5 mg
1
Copyright 2023 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What
_AERIUS TABLET _
is
used for
2.
How
_AERIUS TABLET_
_ _
works
3.
Before you use
_AERIUS _
_TABLET_
_ _
4.
How to use
_AERIUS _
_TABLET_
_ _
5.
While you are using
_AERIUS _
_TABLET_
_ _
6.
Side effects
7.
Storage and Disposal of
_AERIUS TABLET_
_ _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT
_AERIUS TABLET _
IS
USED FOR
_AERIUS TABLET _
relieves
symptoms associated with
allergic rhinitis (inflammation of
the nasal passages caused by an
allergy, for example, hay fever
or allergy to dust mites). These
symptoms include sneezing,
runny or itchy nose, itchy palate,
and itchy, red or watery eyes.
_AERIUS TABLET _
is also used to
relieve the symptoms associated
with urticaria (a skin condition
caused by an allergy). These
symptoms include itching and
hives.
Relief of these symptoms lasts a
full day and helps you to resume
your normal daily activities and
sleep.
HOW
_AERIUS TABLET _
WORKS
_AERIUS TABLET _
is an
antiallergy medicine that does
not make you drowsy. It helps
control your allergic reaction
and its symptoms.
BEFORE YOU USE
_AERIUS _
_TABLET_
_ _
_ _
-
_When you must not use it _
•
Do not use
_AERIUS _
if you
are allergic (hypersensitive)
to desloratadine, to any of
the other ingredients of
_AERIUS TABLET _
or to
loratadine.
-
_Before you start to use it _
Talk to your doctor or
pharmacist before taking
_AERIUS TABLET _
if you have
medical or familial history of
seizures.
_ _
Efficacy and safety of
_AERIUS _
_TABLET _
in children under 12
years of age have not been
established.
PREGNANCY AND BREAST-FEEDING
•
Ask your doctor or
pharmacist for advice
before taking any medicine
during pregnancy and
breast-feeding.
•
If you are pregnant or
nursing a baby, taking
_AERIUS TABLET _
is not
recommended.
IMPORTANT INFORMATION ABOUT
SOME OF THE INGREDIENTS OF
_AERIUS TABLET_

Summary of Product characteristics

Copyright 2023 Organon group of companies. All rights reserved.
LPC-OG4117-MTL-112017a
AERIUS
®
TABLETS
Brand of desloratadine
DESCRIPTION: Each AERIUS Tablet contains 5.0 mg of desloratadine.
AERIUS Tablet is a
light blue round tablet, embossed with elongated letters 'S' and 'P'
on one side and plain on
the other.
Inactive Ingredients: dibasic calcium phosphate dihydrate,
microcrystalline cellulose, corn
starch, talc, Dye Opadry II Blue, Dye Opadry Clear, carnauba wax,
white wax and purified
water.
ACTIONS: Desloratadine is a non-sedating long-acting histamine
antagonist with potent,
selective
peripheral
H
1
-receptor
antagonist
activity.
Desloratadine
has
demonstrated
antiallergic, antihistaminic,
and anti-inflammatory activity.
PRECLINICAL TOXICOLOGY: Desloratadine is the primary active metabolite
of loratadine.
Preclinical studies conducted with desloratadine and loratadine
demonstrated that there are
no qualitative or quantitative differences in the toxicity profile of
desloratadine and loratadine
at comparable levels of exposure to desloratadine.
Preclinical
data
with
desloratadine
reveal
no
special
hazard
for
humans
based
on
conventional studies of safety pharmacology, repeated dose toxicity,
genotoxicity, and
toxicity to reproduction. The lack of carcinogenic potential was
demonstrated in studies
conducted with loratadine.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES: After oral administration, desloratadine
selectively blocks
peripheral histamine H
1
-receptors because the drug is effectively excluded from entry to the
central nervous system (CNS).
In addition to antihistaminic activity, desloratadine has demonstrated
antiallergic and anti-
inflammatory activity from numerous
_in vitro _
(mainly conducted on cells of human origin) and
_in vivo _
studies. These studies have shown that desloratadine inhibits the
broad cascade of
events that initiate and propagate allergic inflammation, including,
Copyright 2023 Organon group of companies. All rights reserved.
• the release of proinflammatory cytokin