Dextrophan Syrup 15mg5ml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DEXTROMETHORPHAN HYDROBROMIDE

Boleh didapati daripada:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Nama Antarabangsa):

DEXTROMETHORPHAN HYDROBROMIDE

Unit dalam pakej:

90 ml

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
DEXTROPHAN SYRUP 15MG/5ML
Dextromethorphan hydrobromide (15mg / 5ml)
WHAT IS IN THE LEAFLET
1.
What
DEXTROPHAN
is
used for
2.
How
DEXTROPHAN
works
3.
Before
you
use
DEXTROPHAN
4.
How
to
use
DEXTROPHAN
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
DEXTROPHAN
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT
DEXTROPHAN
IS
USED FOR
This
medicine
is
used
to
relieve dry cough due to minor
throat irritation occurring with
cold or inhaled irritants.
HOW DEXTROPHAN WORKS
Dextromethorphan is a cough
suppressant.
It
acts
on
the
cough
centre
in
the
brain,
hence reducing cough.
BEFORE
YOU
USE
DEXTROPHAN
-
_When you must not take it_
Do not take this
medicine
if
you
have
allergy
to
Dextromethorphan
or
any
of
the other ingredients listed at
the end of this leaflet
Do not give the
medicine to
children
below
2
years
old.
Consult
your
doctor
or
pharmacist’s
advice
for
children from 2 to 6 years old.
-
_Before you start to use it_
Inform you doctor if:
•
You
have
productive
cough (with phlegm).
•
You have any history of
asthma
or
respiratory
disease.
•
You have any liver disease.
•
You
are
pregnant
or
planning
to
become
pregnant
-
_Taking other medicines_
Alert your doctor or pharmacist
if
you
are
taking
or
have
recently
taken
any
other
medicines, including those you
bought without a prescription
Some
medicines
and
DEXTROPHAN may interfere
with each other, including but
not limited to:
•
_Monoamine _
_oxidase_
inhibitor
-
furazolidone
and procarbazine (To treat
depression)
•
Central
nervous
system
depressant
-
alcohol,
medicines
that
cause
sleepiness
HOW TO USE DEXTROPHAN
-
_How much to use_
Follow all instructions exactly
as given to you by your doctor
or
pharmacist.
The
following
information
only
serves
as
guidance, hence the dose and
frequency
for
you
may
be
different
The
recommended
dose
of
DEXTROPHAN is:
_Adults _
_and _
_children _
_over _
_12 _
_years: _
5ml
every
4
hours
or
10ml
every
6
-

Ciri produk

Glue
Glue
Spine
Glue
Glue
IMMEDIATE LABEL
PANTONE 2035 C
Syrup 15mg/5ml
Dextrophan Syrup 15mg/5ml
FOR INKJET PRINTING:
LOT
MFG
EXP
25MM(W) X 15MM(H)
150000xxxx xx
Revision Date: Nov 2020
PRODUCT REGISTRATION HOLDER:
DUOPHARMA MANUFACTURING
(BANGI) 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.
FOR HOLOGRAM :
22MM(W) X12MM(H)
Pg 1
Pg 2
Pg 3
Pg 4
Pg 5
Pg 6
Pg 7
Pg 8
IMMEDIATE LABEL
ADULT: 5ML EVERY 4 HOURS OR 10 ML EVERY 6-8 HOURS.
(MAX.40ML/DAY)
CHILDREN: 6-12 YEARS: 2.5ML EVERY 4 HOURS OR 5ML EVERY
6-8 HOURS. (MAX. 20ML/DAY)
CHILDREN: 2-6 YEARS: 1-2ML EVERY 4 HOURS OR 2.5ML EVERY
6-8 HOURS. (MAX. 10ML/DAY)
Syrup 15mg/5ml
Pg 1
Pg 2
Pg 3
Pg 4
DESCRIPTION
A
brown,
cherry
flavoured
syrup
contains
Dextromethorphan HBr 15 mg every 5 ml.
_Preservative :_
Methylparaben 0.21% w/v & Propylparaben
0.031% w/v.
This product contains 0.2125% v/v ethanol
INDICATION
Dextromethorphan
is
indicated
for
the
symptomatic relief of nonproductive cough due
to minor throat and bronchial irritation occuring
with colds or inhaled irritants.
DOSAGE
Adults : 5 ml every 4 hours or 10ml
every
6-8 hours. (max. 40ml/day)
_CHILDREN 6 TO 12 YEARS :_ 2.5 ml every
4 hours or 5ml every 6-8 hours (max.
20ml/day)
_CHILDREN 2 TO 6 YEARS:_ 1 - 2 ml every
4 hours or 2.5ml every 6-8 hours (max.
10ml/day).
_CHILDREN UNDER 2 YEARS:_ Use is not
recommended.
ROUTE OF ADMINISTRATION: ORAL
OVERDOSAGE
Dextromethorphan may produce central
excitement
and
mental
confusion.
Toxic psychosis such as hyperactivity,
visual
and
auditory
hallucinations
and
respiratory
depression
have
been reported to occur with very high
doses.
Dextromethorphan
abuse
and
dependence may occur rarely especially
following prolonged use of high dose.
Induce emesis if patient is alert prior to
6 hours following ingestion. Precautions
against
aspiration
m