COLDNIL Dry Cough & Congestion Relief Syrup

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

MAH:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN:

DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

units_in_package:

60 ml; 90 ml; 100 ml

manufactured_by:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

PIL

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
COLDNIL DRY COUGH & CONGESTION RELIEF SYRUP
Pseudoephedrine Hydrochloride/ Dextromethorphan Hydrobromide
(30mg/10mg per 5ml)
1
WHAT IS IN THIS LEAFLET
1.
What COLDNIL
Dry Cough &
Congestion Relief is used for
2.
How COLDNIL Dry Cough &
Congestion Relief works
3.
Before you use COLDNIL Dry
Cough & Congestion Relief
4.
How to use COLDNIL Dry Cough
& Congestion Relief
5.
While you are using COLDNIL Dry
Cough & Congestion Relief
6.
Side effects
7.
Storage and disposal
8.
Product description
9.
Manufactured by and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT
COLDNIL
DRY
COUGH
&
CONGESTION RELIEF IS USED FOR
It is used for the relief of cough and nasal
congestion
associated
with
common
cold, allergy and and other respiratory
infections.
HOW
COLDNIL
DRY
COUGH
&
CONGESTION RELIEF WORKS
Dextromethorphan
Hydrobromide
is
a
cough suppressant which acts centrally
to raise the threshold for coughing.
Pseudoephedrine Hydrochloride is used
to relieve nose congestion by narrowing
of the blood vessel in the nasal passages.
BEFORE YOU USE COLDNIL DRY COUGH
& CONGESTION RELIEF
_-When you must not use it _
Tell your doctor before using COLDNIL
Dry Cough & Congestion Relief if you
have
hypersensitivity
to
pseudoephedrine, dextromethorphan or
to any of the excipients.
_-Pregnancy and breastfeeding _
Tell your doctor or pharmacist if you are
pregnant, planning to get pregnant or are
breastfeeding. Use of pseudoephedrine
during pregnancy is not recommended.
Pseudoephedrine has been detected in
human
milk
and
thus
use
of
pseudoephedrine
should
be
avoided
during breast feeding. It is not known
whether
dextromethorphan
or
its
metabolites are excreted in breast milk
and therefore use of this product during
lactation should be avoided.
_-Before you start to use it_
Use with caution if you:

have severe heart disease

have high blood pressure

are
taking
medicines
for
antidepressant,
e.g.
MAOIs
(monoamine
oxidase
inhibitors)
or
within 2
weeks from stoppi

SPC

Font: 6
COLDNIL DRY COUGH & CONGESTION RELIEF SYRUP
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Each 5ml contains:
Pseudoephedrine HCl ……………………..30mg
Dextromethorphan HBr ……..…………….10mg
Preservatives:
Sodium Benzoate ………………………….0.1% w/v
Potassium Sorbate …………………………0.1% w/v
PRODUCT DESCRIPTION
Reddish pink colour syrup with cherry flavour and raspberry flavour.
PHARMACODYNAMICS
Pseudoephedrine is a sympathomimetic agent with direct and indirect
effects on adrenergic receptors. It has alpha and beta-adrenergic
activity and some stimulant effect on the central
nervous system. The sympathomimetic effect of pseudoephedrine produces
vasoconstriction which in turn relieves nasal congestion.
Dextromethorphan is a cough suppressant.
_ _
PHARMACOKINETICS
Pseudoephedrine is readily and completely absorbed from the
gastrointestinal tract and is largely excreted in the urine unchanged.
It has an elimination half-life of 5 to 8 hours but its
urinary elimination and hence half-life is pH dependent.
Pseudoephedrine is rapidly distributed throughout the body, its volume
of distribution being 2 to 3 L/kg bodyweight.
Dextromethorphan is well absorbed from the gastrointestinal tract,
metabolized in the liver and excreted as both unchanged drug and
demethylated metabolites.
Dextromethorphan undergoes rapid and extensive first-pass metabolism
in the liver after oral administration. Genetically controlled
O-demethylation (CYD2D6) is the main determinant
of dextromethorphan pharmacokinetics in human volunteers.
It appears that there are distinct phenotypes for this oxidation
process resulting in highly variable pharmacokinetics between
subjects. Unmetabolised dextromethorphan, together with the
three demethylated morphinan metabolites dextrorphan (also known as
3-hydroxy-N-methylmorphinan), 3-hydroxymorphinan and
3-methoxymorphinan have been identified as conjugated
products in the urine.
Dextrorphan, which also has antitussive action, is the main
metabolite. In some indiv