Difflam mouth gel

Country: Malaysia

Language: English

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

Active ingredient:

BENZYDAMINE HYDROCHLORIDE; CETYLPYRIDINIUM CHLORIDE

Available from:

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

INN (International Name):

BENZYDAMINE HYDROCHLORIDE; CETYLPYRIDINIUM CHLORIDE

Units in package:

10gm mcg/mL

Manufactured by:

ENSIGN LABS PTY LTD

Patient Information leaflet

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DIFFLAM MOUTH GEL
Benzydamine hydrochloride / Cetylpyridinium chloride (1%w/w / 0.1%w/w)
WHAT IS IN THIS LEAFLET
1.
What Difflam Mouth Gel is used
for
2.
How Difflam Mouth Gel works
3.
Before you use Difflam Mouth
Gel
4.
How to use Difflam Mouth Gel
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Difflam
Mouth Gel
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DIFFLAM MOUTH GEL IS USED FOR
Difflam Mouth Gel is used to relieve
inflammation and pain in the mouth,
denture ulcers and sore gums.
Cetylpyridinium chloride has antiseptic
activities.
HOW DIFFLAM MOUTH GEL WORKS
Difflam Mouth Gel works by reducing
the pain, redness and swelling.
BEFORE YOU USE DIFFLAM MOUTH GEL
_-When you must not use it _
Do not use this medicine if you have
an allergy to:

any medicine containing
Benzydamine hydrochloride or
Cetylpyridinium chloride

any of the ingredients listed at the
end of this leaflet.
Do not use this medicine if you are
pregnant or plan to become pregnant. It
may affect your developing baby if you
use it during pregnancy. Your
pharmacist or doctor will discuss the
benefits and possible risks of taking the
medicine during pregnancy.
Do not use 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 you 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 pharmacist if you have or
have had any of the following medical
conditions:

impaired kidney or liver function
It is not known if Benzydamine
hydrochloride or Cetylpyridinium
chloride passes into the breast milk.
Your pharmacist or doctor will discuss
the potential benefits and risks of using
the medicine if you are breastfeeding.
If you have not told your pharmacist or
doctor about any of the above,

Summary of Product characteristics

PRODUCT
BRAND: Difflam
PRODUCT VARIANT:
PACK SIZE: 10g
COUNTRY: SG, MY
DATE: 02/03/2018
COMPONENT: Leaflet
DIMENSIONS: 152mm w x 220mm h
FILENAME: 81923_LT0045_DL_Mouth-
Gel_10g_Leaflet_SG_MY_V0.ai
DIELINE REF: XXX
BLACK
PRINTER: XXX
ARTWORK SOFTWARE: Illustrator CC 2017
BARCODE %:
SIGNED:
ARTWORKER:
DATE: 00/00/2018
EMO: Ensign
SKU NO: 100037
PRINTER DETAILS
FONTS USED:
BODY COPY SIZE: 6.5pts
MIN. FONT SIZE: 1.268mm
FONTS
CODES
APPROVALS
UIC: LT0045
02/03/18 : New Artwork Build - Elaine
AMENDS
ARTWORKER INFO
COLOURS
VERSION: 0
JOB NO: 81923
PLEASE NOTE: THIS IS A LOW RESOLUTION PDF & IS NOT TO BE USED FOR
PRINTING
Helvetica Regular
Helvetica Bold
Helvetica Neue 77 Bold Condensed
Helvetica Neue 57 Condensed
Bauhaus Heavy
Mouth Gel
PRODUCT INFORMATION
PHARMACODYNAMICS
The mechanism of anti-inflammatory action is not related
to stimulation of the pituitary-adrenal axis. Like other
non-steroidal
anti-inflammatory
agents,
benzydamine
inhibits the biosynthesis of prostaglandins under certain
conditions but its properties in this respect have not
been fully elucidated. The stabilising effect on cellular
membranes may also be involved in the mechanism
of action.
PHARMACOKINETICS
_ABSORPTION_
Benzydamine
is
well
absorbed
following
oral
administration.
Following
topical
administration
of
benzydamine
hydrochloride,
benzydamine
is
well
absorbed into the inflamed oral mucosa where it exerts
anti-inflammatory and local anaesthetic action. Plasma
benzydamine levels following use of benzydamine orally
are low and paralled the amount actually ingested.
_EXCRETION_
Benzydamine and its metabolites are excreted largely in
the urine. Metabolism is largely by oxidative pathways
although dealkylation can also be shown. Benzydamine
has been detected in blood and urine following use of
oral solutions of benzydamine. Most of the absorbed
dose was eliminated in the first 24 hours. Repeated
administration for 7 days did not result in accumulation of
benzydamine in plasma.
INDICATIONS
Temporarily relieves painful inflamed conditions of the