EZEDE-D ORAL SOLUTION

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Pseudoephedrine Sulfate; LORATADINE

Boleh didapati daripada:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

Pseudoephedrine Sulfate; LORATADINE

Unit dalam pakej:

60 ml; 90 ml; 120 ml

Dikeluarkan oleh:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
EZEDE`-D
ORAL SOLUTION
Loratadine (5mg per 5ml) / Pseudoephedrine Sulfate (60mg per 5ml)
WHAT IS IN THIS LEAFLET
1.
What ezede`-D is used for
2.
How ezede`-D works
3.
Before you use ezede`-D
4.
How to use ezede`-D
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of ezede`-D
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT EZEDE`-D IS USED FOR
ezede`-D is indicated
for the relief of
symptoms
associated
with
allergic
rhinitis and the common cold including
nasal
congestion,
sneezing,
rhinorrhea,
pruritus and lacrimation.
ezede`-D is recommended when both the
antihistaminic
properties
of
loratadine
and
the
decongestant
effect
of
pseudoephedrine sulfate are desired.
HOW EZEDE`-D WORKS
ezede`-D
contains
active
substance
loratadine
which
helps
to
reduce
your
allergy symptoms by stopping the effects
of a substance called ‘histamine’, which
is produced in the body when you are
allergic to something.
ezede`-D also contains pseusoephedrine
sulfate,
which
works
to
restrict
blood
vessels, reduces swelling and production
of mucous and so relieves congestion.
BEFORE YOU USE EZEDE`-D
_- When you must not to use it _
Do not use ezede`-D if:

You
are
known
hypersensitivity
to
any ingredients in this medicine.

You
are
taking
MAO
inhibitor
or
within fourteen days of discontinuing
such treatment.

You
are
having
narrow
angle
glaucoma
(high
pressure
in
the
eyeball),
severe
hypertension
(high
blood
pressure),
urinary
retention
(difficulty
passing
urine),
severe
coronary artery disease (heart disease)
and
hyperthyroidism
(overactive
thyroid).
_ _
_Pregnancy and lactation _

Do
not
take
ezede`-D
if
you
are
pregnant,
trying
to
get
pregnant
or
think you may be pregnant.

Do not take ezede`-D if you are breast-
feeding. Ask your doctor or pharmacist
for advice before taking any medicine.
_ _
_ _
_ _
_ _
_- Before you start to use it _
Tell your doctor or pharmacist if:

You
are
pregnant
or
plan
to
get

Ciri produk

EZEDE`-D
ORAL SOLUTION
COMPOSITION
Each 5ml contains Loratadine 5mg and Pseudoephedrine Sulfate 60mg.
Sodium Benzoate 0.1% w/v as preservative.
PHARMACODYNAMICS
Loratadine is a long-acting, non-sedating H
1
-antagonist antihistamine with no significant
antimuscarinic activity.
Pseudoephedrine is a direct and indirect acting sympathomimetic. It is
a stereoisomer of
ephedrine and has a similar action, but has been stated to have less
pressor activity and
fewer CNS effects.
PHARMACOKINETICS
Loratadine is rapidly absorbed from the gastrointestinal tract after
oral doses, peak plasma
concentrations being attained in about 1 hour. Bioavailability is
increased and time to peak
plasma concentrations is delayed when taken with food.
Loratadine undergoes
extensive metabolism. The major metabolite, desloratadine has
potent antihistaminic activity. Reported mean elimination half-lives
for loratadine
and desloratadine are 8.4 and 28 hours respectively.
Loratadine is about 98% bound to plasma proteins and desloratadine is
less extensively
bound. Most of the dose is excreted equally in the urine and faeces,
mainly in the form of
metabolites.
Pseudoephedrine is readily absorbed from the gastrointestinal tract.
It is excreted largely
unchanged in the urine with small amounts of its hepatic metabolite.
It has a half-life of
about 5 to 8 hours; elimination is enhanced and half-life accordingly
shorter in acid urine.
INDICATIONS
ezede`-D is indicated for the relief of symptoms associated with
allergic rhinitis and the
common cold including nasal congestion, sneezing, rhinorrhea, pruritus
and lacrimation.
ezede`-D is recommended when both the antihistaminic properties of
loratadine and the
decongestant effect of pseudoephedrine sulfate are desired.
DOSAGE AND ADMINISTRATION
For oral use only. Can be taken with or without food.
Adults
5ml (1 teaspoon) twice daily.
Children 6 -12 years old

Body weight > 30kg : 5ml (1 teaspoon) twice daily.

Body weight ≤ 30kg : 2.5ml (
½
teaspoon) twice daily.
CONTRAINDICATIONS
Known
hypersen