Aerius D-12 Modified Release Tablet

Country: Malaysia

Language: English

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

Active ingredient:

PSEUDOEPHEDRINE SULPHATE; DESLORATADINE (SCH 34117)

Available from:

ORGANON MALAYSIA SDN. BHD.

INN (International Name):

PSEUDOEPHEDRINE SULPHATE; DESLORATADINE (SCH 34117)

Units in package:

02 mcg/mL; 4 mcg/mL; 10Tablet Tablets

Manufactured by:

PATHEON INC

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
AERIUS
®
D-12 MODIFIED RELEASE TABLET
Desloratadine/Pseudoephedrine sulphate (2.5 mg/120 mg)
[Organon] Proprietary
WHAT IS IN THIS LEAFLET
1.
What AERIUS D-12 is used for
2.
How AERIUS D-12 works
3.
Before you take AERIUS D-12
4.
How to take AERIUS D-12
5.
While you are taking AERIUS D-
12
6.
Side effects
7.
Storage and Disposal of AERIUS
D-12
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT AERIUS D-12 IS USED FOR
AERIUS D-12 tablets
RELIEVE
SYMPTOMS
associated with seasonal
allergic rhinitis (
HAY FEVER
), such as,
sneezing, runny or itchy nose, and
eyes,
WHEN ACCOMPANIED BY NASAL
CONGESTION
.
HOW AERIUS D-12 WORKS
AERIUS D-12 tablets contain a
combination of two active
ingredients, desloratadine which is an
antihistamine and pseudoephedrine
sulphate which is a decongestant.
Antihistamines help to reduce
allergic symptoms by blocking the
effects of a substance called
histamine, which is produced by the
body. Decongestants help to clear
nasal congestion.
BEFORE YOU TAKE AERIUS D-12
_When you must not take it _
Do not take AERIUS D-12 if you:
•
are allergic (hypersensitive) to
desloratadine, loratadine,
pseudoephedrine sulphate or to
any of the other ingredients of
AERIUS D-12
•
have severe high blood pressure,
heart or blood vessel disease or a
history of stroke
•
have glaucoma (build-up of
pressure within the eye),
difficulty in urinating, urinary
tract blockage, or an overactive
thyroid
•
are taking monoamine oxidase
(MAO) inhibitor (a class of
antidepressant agents) therapy or
have stopped taking these types
of medicines within the
last 14 days.
_Before you start to take it _
Certain conditions may make you
unusually sensitive to the
decongestant pseudoephedrine
sulphate contained in this medicine.
Before taking AERIUS D-12, tell
your doctor or pharmacist if you:
•
are 60 years of age or older.
Older adults may be more
sensitive to the effects of this
medicine
•
have diabetes
•
have high blood pre

Summary of Product characteristics

Not Applicable