PROMEDYL PLUS LINCTUS

Country: Malaysia

Language: English

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

Active ingredient:

CHLORPHENIRAMINE MALEATE; PHOLCODINE

Available from:

Duopharma Marketing Sdn. Bhd.

INN (International Name):

CHLORPHENIRAMINE MALEATE; PHOLCODINE

Units in package:

90 ml

Manufactured by:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP)_
_ _
1
PROMEDYL PLUS LINCTUS
Pholcodine / Chlorpheniramine Maleate (10mg/4mg per 5ml)
WHAT IS IN THIS LEAFLET
1.
What Promedyl Plus Linctus is used
for
2.
How Promedyl Plus Linctus works
3.
Before you use Promedyl Plus
Linctus
4.
How to use Promedyl Plus Linctus
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Promedyl
Plus Linctus
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT PROMEDYL PLUS LINCTUS IS USED
FOR
Promedyl Plus Linctus is used for the
relief of dry and irritating cough.
HOW PROMEDYL PLUS LINCTUS WORKS
Pholcodine works on the cough centre in
the brain to control and stop coughing. It
has
no
analgesic
(to
relieve
pain)
properties
and
in
general
has
little
sedative activity.
Chlorpheniramine
maleate
is
an
antihistamine which works by blocking a
certain natural substance (histamine) that
your
body
makes
during
an
allergic
reaction. It also helps to dry up the nasal
mucosa.
BEFORE YOU USE PROMEDYL PLUS LINCTUS
-
_When you must not use it_
_ _
_ _
Do not take Promedyl Plus Linctus if
you:
•
are
allergic
to
any
medicine
containing
pholcodine
or
chlorpheniramine maleate.
•
have liver disease.
•
have
a
very
serious
breathing
problem (respiratory failure).
•
are taking or have taken monoamine
oxidase inhibitors
_Use in children_
_ _
When Promedyl Plus Linctus is used for
treatment of cough and cold, it is not to
be used in children less than 2 years of
age. It is needed to be used with caution
and doctor’s or pharmacist’s advice in
children 2 to 6 years of age.
_Pregnancy and breastfeeding_
_ _
Tell your doctor or pharmacist if you are
pregnant or plan to become pregnant or
are breastfeeding.
Small amounts of chlorpheniramine are
distributed into the breast milk. Use is
not recommended in nursing mothers due
to risk of adverse effects such as unusual
excitement or irritability in infants.
Do not take this medicine after the expiry
date
printed
on
the
pack
or
if
the
packaging
is
to

Summary of Product characteristics

Glue
Pg 3
Pg 4
Pg 5
Pg 1
Pg 2
Glue
Glue
Spine
Pg 10
FOR HOLOGRAM :
22MM(W) X12MM(H)
Name/Nama :
Date/Tarikh :
ml
ml
Take
Minum
Times Daily
Before/After Food
Kali Sehari
Sebelum/Selepas Makan
DOSAGE AND ADMINISTRATION
Children 2 to 12 years: 2.5ml three times daily.
Adults & Children above 12 years: 5ml three times daily.
KEEP CONTAINER TIGHTLY CLOSED.
STORE IN A DRY PLACE BELOW 30°C. PROTECT FROM LIGHT.
KEEP OUT OF REACH OF CHILDREN.
JAUHI DARIPADA KANAK-KANAK.
CONTROLLED MEDICINE
FOR INKJET PRINTING:
LOT
MFG
EXP
25MM(W) X 15MM(H)
SHAKE BEFORE USE. GONCANG SEBELUM
DIGUNAKAN
PRODUCT REGISTRATION HOLDER:
DUOPHARMA MARKETING SDN. BHD.
Lot No. 2, 4, 6, 8 & 10, Jalan P/7, Section 13,
Bangi Industrial Estate, 43650 Bandar Baru
Bangi, Selangor, Malaysia.
MANUFACTURER:
DUOPHARMA MANUFACTURING (BANGI)
SDN. BHD.
Lot No. 2 & 4, Jalan P/7, Section 13, Bangi
Industrial Estate, 43650 Bandar Baru Bangi,
Selangor, Malaysia.
150000xxxx xx
Revision Date: Feb 2021
_Chlorpheniramine maleate:_
Chlorpheniramine maleate is absorbed
relatively slowly from the gastro-intesti-
nal tract, peak plasma concentrations
occurring
about
2.5-6
hours
after
administration by mouth. Bioavailability
is low, values of 25% to 50% have been
reported. Chlorpheniramine undergoes
considerable
first-pass
metabolism.
About 70% of Chlorpheniramine in the
circulation is bound to plasma proteins.
The half-life values range from 2-43
hours.
Chlorpheniramine
is
widely
distributed
and
extensively
metabolized. A duration of action of 4-6
hours has been reported.
INDICATIONS
For the relief of dry and irritating cough.
PHARMACODYNAMICS
_Pholcodine: _
Pholcodine is a centrally acting cough
suppressant. It has a central action on
the cough center in the medulla. It has
no analgesic properties and in general
has little sedative activity.
_Chlorpheniramine maleate:_
Chlorpheniramine
maleate
is
an
alkylamine-derivative
antihistamine
which acts by competing with histamine
for H1-receptor sites on effector cells. It
thereby prevents, but does not reverse,
responses
mediate