AERIUS Syrup 0.5 mg ml

Country: Malaysia

Language: English

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

Active ingredient:

DESLORATADINE (SCH 34117)

Available from:

ORGANON MALAYSIA SDN. BHD.

INN (International Name):

DESLORATADINE (SCH 34117)

Units in package:

50ml mL; 60ml mL; 100ml mL; 120ml mL

Manufactured by:

Organon Heist bv

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP) _
AERIUS
® SYRUP
Desloratadine 0.5 mg/ml
1
Copyright 2023 Organon group of companies. All rights reserved.
WHAT IS IN THIS LEAFLET
1.
What
_AERIUS SYRUP _
is used
for
2.
How
_AERIUS SYRUP _
works
3.
Before you take
_AERIUS _
_SYRUP _
4.
How to take
_AERIUS SYRUP _
5.
While you are taking
_AERIUS _
_SYRUP _
6.
Side effects
7.
Storage and Disposal of
_AERIUS SYRUP _
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT _AERIUS SYRUP _IS USED
FOR
_AERIUS SYRUP _
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 SYRUP _
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 SYRUP _WORKS
_AERIUS SYRUP _
is an anti-
allergy medicine that does not
make you drowsy. It helps
control your allergic reaction and
its symptoms.
BEFORE YOU TAKE _AERIUS _
_SYRUP _
_ _
_-_
_ _
_When you must not take it _
DO NOT TAKE _AERIUS SYRUP _
•
if you are allergic
(hypersensitive) to
desloratadine, loratadine, or
to any of the other
ingredients of
_AERIUS _
_SYRUP_
.
_AERIUS SYRUP _
is indicated for
children 1 through 11 years of
age, adolescents (12 years of age
and older), and adults, including
the elderly.
_-_
_ _
_Before you start to take it _
Talk to your doctor or pharmacist
before taking
_AERIUS SYRUP _
if
you have medical or familial
history of seizure
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 SYRUP _
is
not recommended.
IMPORTANT INFORMATION ABOUT
SOME OF THE INGREDIENTS OF
_AE

Summary of Product characteristics

Copyright 2023 Organon group of companies. All rights reserved.
LPC-OG4117-MTL-112017a
AERIUS
® SYRUP
Brand of desloratadine
DESCRIPTION: Each 1 ml of AERIUS Syrup contains 0.5 mg of
desloratadine. AERIUS Syrup is a
clear, orange solution.
Inactive Ingredients: propylene glycol, sorbitol liquid, citric acid
anhydrous, sodium citrate dihydrate,
sodium benzoate, disodium edetate, sucrose, natural and artificial
flavor, FD&C Yellow Dye No. 6 and
purified water. Preservative: sodium benzoate 1.00 mg/ml.
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,
•
the release of proinflammatory cytokines including IL-4, IL-6, IL-8,
IL-13,
Copyright 2023 Organon gr