AERIUS TABLET 5 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

DESLORATADINE

Available from:

ORGANON SINGAPORE PTE. LTD.

ATC code:

R06AX27

Dosage:

5 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

DESLORATADINE 5 mg

Administration route:

ORAL

Prescription type:

Pharmacy Only

Manufactured by:

Organon Heist bv

Authorization status:

ACTIVE

Authorization date:

2001-12-26

Patient Information leaflet

AERIUS® Tablets
Brand of desloratadine
Read this leaflet carefully before you start taking this medicine
because it contains important information for
you.
This medicine is available without a prescription. However, you will
still need to take Aerius Tablets carefully to
get the best results from it.
-
Keep this leaflet. You may need to read it again.
-
This medicine is available without a prescription. Do not pass it on
to others. It may harm them, even if
their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor or pharmacist.
In this leaflet:
1. What Aerius is and what it is used for
2. Before you take Aerius
3. How to take Aerius
4. Possible side effects
5. How to store Aerius
6. Further information
1. WHAT AERIUS IS AND WHAT IT IS USED FOR
Aerius is an antiallergy medicine that does not make you drowsy. It
helps control your allergic reaction and its
symptoms.
Aerius 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, stuffy or
itchy nose, itchy palate, itchy, red or watery eyes and coughing.
Aerius 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.
2. BEFORE YOU TAKE AERIUS
Do not take Aerius
-
if you are allergic (hypersensitive) to desloratadine, to any of the
other ingredients of Aerius or to loratadine.
Aerius is indicated for adults and adolescents (12 years of age and
older).
Taking other medicines
There are no known interactions of Aerius
with other medicines.
Taking Aerius with food and drink
Aerius may be taken with or without a meal.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine
during pregnancy a

Summary of Product characteristics

S-CCDS-MK4117-MTL-112017
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, film coat
[containing lactose monohydrate, hypromellose, titanium dioxide,
macrogol 400, indigotin (E132)], clear
coat (containing hypromellose, macrogol 400), carnauba wax, and white
wax.
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.
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,

the
release
of
important
proinflammatory
chemokines
such
as
RANTES
(Regulated
upon
Activation, Normal T-cell Expressed and Secreted),

superoxide anion production by activated polymorphonuclear
neutrophils,

eosinophil adhesion and chemotaxis,

the expression of the adhesion molecules such as P-selectin,

IgE-dependent release of histamine, prostaglandin (PGD2), and
leukotriene (LTC4),

the acute allergic bronchoconstrictor response and allergic cough in
animal models.
PRECLINICAL TOXICOLOGY: Desloratadine is the primary active metabolite
of loratadine. Non-clinical
studies
conducted
with
desloratadine
and
loratadine
demonstrated
comparable
qualitative
and
quantitative
toxicity
profile
of
desloratadine
and
loratadine
at
comparable
levels
of
exposure
to
desloratadine.
Carcinogenesis, Mutagenesis, Im