Difflam Anti-inflammatory Anti-Bacterial Lozenges (Raspberry)

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:

16units Units

Manufactured by:

UNIQUE PHARMACEUTICAL LABORATORIES

Patient Information leaflet

1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DIFFLAM ANTI-INFLAMMATORY ANTI-
BACTERIAL LOZENGES (RASPBERRY)
Benzydamine hydrochloride / Cetylpyridinium chloride (3mg/1.33mg)
WHAT IS IN THIS LEAFLET
1.
What Difflam Anti-Inflammatory
Anti-Bacterial Lozenges
(Raspberry) is used for
2.
How Difflam Anti-Inflammatory
Anti-Bacterial Lozenges
(Raspberry) works
3.
Before you use Difflam Anti-
Inflammatory Anti-Bacterial
Lozenges (Raspberry)
4.
How to use Difflam Anti-
Inflammatory Anti-Bacterial
Lozenges (Raspberry)
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Difflam
Anti-Inflammatory Anti-Bacterial
Lozenges (Raspberry)
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
WHAT DIFFLAM ANTI-INFLAMMATORY
ANTI-BACTERIAL LOZENGES (RASPBERRY)
IS USED FOR
Benzydamine hydrochloride in Difflam
Anti-Inflammatory Anti-Bacterial
Lozenges (Raspberry) is used to relieve
inflammation and pain in the throat.
Cetylpyridinium chloride has antiseptic
activities and is used in the treatment
of infections of the mouth and throat.
HOW DIFFLAM ANTI-INFLAMMATORY
ANTI-BACTERIAL LOZENGES (RASPBERRY)
WORKS
Difflam Anti-Inflammatory Anti-
Bacterial Lozenges (Raspberry) works
by reducing the pain, redness and
swelling of painful mouth and throat
conditions.
BEFORE YOU USE DIFFLAM ANTI-
INFLAMMATORY ANTI-BACTERIAL
LOZENGES (RASPBERRY)
_-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.
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 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 ta

Summary of Product characteristics

Black
ARTWORK
COLOUR
100%
JOB NO. : JB-02178
UIC
: A3157
SKU
: 100458
A3157_DIFFLAM RASP S/FREE LOZ 16
COMPONENT : LEAFLET
COUNTRY : MY
DIELINE REF: PP-1070
EMO: UNIQUE
PRINTER: Xxxxxx Xxxxxxxxxxxx
PLEASE NOTE
V3
G247 FILE NAME: 89297_A3157
_DIFFLAM RASP S/FREE LOZ
16_MY_LT_V3
18.12.19 - V0 - Artwork build - Chanon
23.12.19 - V1 - Amend - Pornpawee
02.03.20 - V2 - Amend - Pornpawee
29.04.20 - V3 - Amend - Pornpawee
Guide
RE-TYPESET ARTWORK. DUE TO THE NATURE OF THE FILES RECEIVED, THIS
ARTWORK HAS BEEN RE-TYPESET.
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.
PRODUCT DESCRIPTION
Round, red-pink colour, flat beveled shape, firm, smooth surface,
approximately 19mm diameter with Raspberry flavour.
COMPOSITION
Each lozenge contains
Benzydamine Hydrochloride 3.00mg
Cetylpyridinium Chloride 1.33mg
PHARMACOLOGY
Benzydamine is anti-inflammatory analgesic agent structurally
unrelated to the steroid group. Benzydamine differs
chemically from other non-steroidal anti-inflammatory agents in that
it is a base rather than acid.
Animal model show that when administered systemically, benzydamine is
effective against pain and oedema due to
inflammatory conditions. It also inhibits granuloma formation. At
concentration used for topical treatment,
benzydamine possesses local anaesthetic action. Benzydamine does not
cause erosion of the gastric mucosa when
given orally to rats at doses of up to 100mg/kg
The analgesic activity of benzydamine was more pronounced in models
involving an experimental inflammatory rather
than in non-inflammatory pain. In common with the aspirin like drugs,
benzydamine possesses an antipyretic activity