SEDILIX-DM LINCTUS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Boleh didapati daripada:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Unit dalam pakej:

120ml mL; 90ml mL

Dikeluarkan oleh:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
SEDILIX-DM LINCTUS
Pseudoephedrine Hydrochloride/ Dextromethorphan
Hydrobromide/Promethazine Hydrochloride (30mg/15mg/3.125mg per 5ml)
1
WHAT IS IN THIS LEAFLET:
1.
What Sedilix-DM Linctus is used for
2.
How Sedilix-DM Linctus works
3.
Before you use Sedilix-DM Linctus
4.
How to use Sedilix-DM Linctus
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Sedilix-DM
Linctus
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of revision
_ _
WHAT SEDILIX-DM LINCTUS IS USED FOR
Sedilix-DM Linctus is used:

for the relief of dry irritating coughs such
as those associated with common cold or
upper respiratory tract infections.

to relieve nose congestion, sneezing and
rhinorrhea (runny nose) associated with
allergy and common cold.
HOW SEDILIX-DM LINCTUS WORKS
Dextromethorphan
Hydrobromide
is
a
cough
suppressant.
Pseudoephedrine
Hydrochloride
is
a
decongestant
which
works by reducing swelling of the blood
vessels in the air passages, thereby making
it
easier
to
breathe.
Promethazine
Hydrochloride
is
an
antihistamine
and
works
by
blocking
a
certain
natural
substance
(histamine)
that
your
body
makes
during
an
allergic
reaction.
BEFORE YOU USE SEDILIX-DM LINCTUS
-
_When you must not use it _
Do not use Sedilix-DM Linctus if you

are allergic to any ingredients in this
medicine.

This
product
contains
promethazine
hydrochloride. It should not be used in
pediatric patients less than 2 years of
age because of the potential for fatal
respiratory depression. To be used with
cautions,
and
as
advised
by
the
physician/pharmacist for children age 2
to 6 years.
_BEFORE YOU START TO USE IT _
Tell your doctor or pharmacist before using
Sedilix-DM Linctus if you:

are pregnant or plan to get pregnant.

are breast-feeding or plan to start breast-
feeding.

have persistent cough due to smoking,
lung disease or asthma.

are coughing with excessive secretions.

have
liver,
lungs,
heart
or
metabolic
problems,
e.g.
asthm

Ciri produk

Important information. Please read carefully
SEDILIX®-DM
LINCTUS
FOR THE RELIEF OF RESISTANT,
DRY AND UNPRODUCTIVE COUGH
COMPOSITION
Each 5ml linctus contains:
Dextromethorphan Hydrobromide ………... 15mg
Pseudoephedrine Hydrochloride ............... 30mg
Promethazine Hydrochloride………………..3.125mg
Parabens 0.125% w/v as preservative
PHARMACODYNAMICS
Dextromethorphan is a non-narcotic cough suppressant which acts
centrally
to raise the threshold for coughing. Its effectiveness in suppressing
cough has
been found to be about equal to codeine. Pseudoephedrine hydrochloride
is
used as a nasal and bronchial decongestant. It is said to have less
pressor
activity
and
CNS
effects
than
ephedrine
of
which
it
is
a
stereoisomer.
Promethazine hydrochloride is a H1 -receptor blocking agent. In
therapeutic
dosages, promethazine produces no significant effects on the
cardiovascular
system.
PHARMACOKINETICS
Dextromethorphan is rapidly absorbed from the gastrointestinal tract.
It is
metabolised
in
the
liver
and
excreted
in
the
urine
as
unchanged
dextromethorphan and demethylated metabolites including dextrorphan,
which has some cough suppressant activity.
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. Small amounts are
distributed into
breast milk.
Promethazine is well absorbed after oral or intramuscular doses. Peak
plasma
concentrations have been seen 2 to 3 hours after a dose by these
routes,
although there is low systemic bioavailability after oral doses, due
to high first-
pass metabolism in the liver. Promethazine crosses the blood-brain
barrier
and the placenta, and is distributed into breast milk. Values ranging
from 76
to
93%
have
been
reported
for
plasma-protein
binding.
Promethazine
undergoes extensive metabolism, predominantly to promethazine
sulfoxide,
and also to _N_-desmethylp