DURO-TUSS Regular Cough Liquid 1mg/mL

Land: Malaysia

Sprog: engelsk

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

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Indlægsseddel Indlægsseddel (PIL)
14-10-2020
Produktets egenskaber Produktets egenskaber (SPC)
21-08-2020

Aktiv bestanddel:

PHOLCODINE

Tilgængelig fra:

iNova Pharmaceuticals (Singapore) Pte Ltd (incorporated In Singapore) Malaysia Branch

INN (International Name):

PHOLCODINE

Enheder i pakken:

90 ml

Fremstillet af:

ENSIGN LABS PTY LTD

Indlægsseddel

                                1
_Consumer Medication Information Leaflet (RiMUP) _
DURO-TUSS REGULAR COUGH LIQUID
1MG/ML
Pholcodine 1mg/mL
WHAT IS IN THIS LEAFLET
1.
What DURO-TUSS Regular
Cough Liquid 1mg/mL is used for
2.
How DURO-TUSS Regular
Cough Liquid 1mg/mL works
3.
Before you use DURO-TUSS
Regular Cough Liquid 1mg/mL
4.
How to use DURO-TUSS Regular
Cough Liquid 1mg/mL
5.
While you are using it
6.
Side effects
7.
Storage and disposal of DURO-
TUSS Regular Cough Liquid
1mg/mL
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DURO-TUSS REGULAR COUGH
LIQUID 1MG/ML IS USED FOR
DURO-TUSS Regular Cough Liquid
1mg/mL is used to relieve dry cough.
HOW DURO-TUSS REGULAR COUGH
LIQUID 1MG/ML WORKS
Pholcodine, which works on the cough
center in the brain to control and help
stop coughing.
BEFORE YOU USE DURO-TUSS
REGULAR COUGH LIQUID 1MG/ML
_-When you must not use it _
Do not use this medicine if you have
an allergy to:
•
any medicine containing
Pholcodine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
_ _
•
wheezing or difficulty breathing
_ _
•
swelling of the face, lips, tongue or
other parts of the body
_ _
•
rash, itching or hives on the skin.
Do not take this medicine if you have
•
Severe asthma, bronchitis or other
serious respiratory conditions.
Do not take this medicine after the
expiry date printed on the pack or if the
packaging is torn or shows signs of
tampering.
If you are not sure whether the patient
should start using this medicine, talk to
your pharmacist or doctor.
_-Before you start to use it _
Tell your pharmacist if you have
allergies to any other medicines, foods,
preservatives or dyes.
Tell your doctor or pharmacist if the
patient has or has had any of the
following medical conditions:
•
Asthma or other breathing
problems
Tell your doctor or pharmacist if you
are breast-feeding.
It is not known if Pholcodine passes
into the breast milk. Your pharmacist
or doctor will dis
                                
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Produktets egenskaber

                                Black
ARTWORK
COLOUR
100%
JOB NO. :
JB-02146
UIC
:
A2920
SKU
:
100511
A2920_DURO-TUSS DRY REGULAR SOLN 90ML
COMPONENT : LEAFLET
COUNTRY : MY
DIELINE REF: PP-1026
EMO: ENSIGN
PRINTER: Xxxxxx Xxxxxxxxxxxx
PLEASE NOTE
V5
G247 FILE NAME:
89023_A2920_DURO-TUSS DRY REGULAR
SOLN 90ML_MY_LT_V5
09.10.19 - V0 - Artwork build - Sunny
24.10.19 - V1 - Amends - Chanon
20.11.19 - V2 - Amends - Soravit
12.06.20 - V3 - Amends - Nueng
18.08.20 - V4 - Amends - Chanon
19.08.20 - V5 - Amends - Chanon
Guide
THIS HI RES PDF IS NOT TO BE USED AS FINAL ARTWORK
SUPPLIER INFORMATION MAY BE PRESENT ON THE
PACKAGING
EMO/PRINTING VENDOR:
PLEASE SHARE THE ARTWORK PDF TO PRINTER FOR
CHECKS ON:
• COLOURS - NO. OF COLOURS, SEQUENCE, CMYK/PMS
• TEXT - LINE THICKNESS, FONT SIZE
• DIELINE - SIZE, EYEMARK, PRINT DIRECTION
• CODING - SIZE, LOCATION, VFA, FORMAT BKG COLOUR
ANY ADDITONAL INFORMATION AND TECHNICAL CHECK
REQUIRED BY EMO ON THE ARTWORK BEFORE
APPROVING.
DURO-TUSS
®
Regular Cough Liquid
1mg/mL
PRODUCT DESCRIPTION
A colourless, slightly viscous solution with fruity odour.
COMPOSITION
Each 5mL contains
Pholcodine 5mg
Sodium Benzoate 10mg as preservative.
PHARMACODYNAMICS
Pholcodine is an opioid chemically related to morphine. Pholcodine is
a cough
suppressant and has a mild sedative effect which relieves local
irritation of the
respiratory tract over 8 to 10 hours. Pholcodine acts primarily on the
CNS causing
depression of the cough reflex which is due partly to the direct
effect on the cough
centre in the medulla. Pholcodine has little or no analgesic action.
Unlike morphine,
codeine and dihydrocodeine, therapeutic doses of pholcodine do not
cause depression of
respiration, CNS excitation, constipation or other side effects
associated with narcotics.
Pholcodine has a selective effect on the cough centre without
affecting the respiratory
centre. Pholcodine is not euphorigenic, therefore psychological
dependence is unlikely to
be a problem. There is no evidence of physical dependence after
prolonged
administration of pholcodine, so it
                                
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