SOBENZ LOZENGE (MELON)

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
01-06-2023
Ciri produk Ciri produk (SPC)
14-05-2019

Bahan aktif:

BENZYDAMINE HYDROCHLORIDE; CETYLPYRIDINIUM CHLORIDE

Boleh didapati daripada:

Duopharma Marketing Sdn. Bhd.

INN (Nama Antarabangsa):

BENZYDAMINE HYDROCHLORIDE; CETYLPYRIDINIUM CHLORIDE

Unit dalam pakej:

16tablet Tablets; 80tablet Tablets

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

                                SOBENZ LOZENGE
®
Benzydamine hydrochloride, Cetylpyridinium chloride (3mg/1.33mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Sobenz Lozenge is used for
2.
How Sobenz Lozenge works
3.
Before you use Sobenz Lozenge
4.
How to use Sobenz Lozenge
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Sobenz
Lozenge
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SOBENZ LOZENGE IS USED FOR
Benzydamine
hydrochloride
in
Sobenz
Lozenges is used to relieve inflammation
and pain in the throat.
Cetylpyridium
chloride
has
antiseptic
activities and is used in the treatment of
infections of the mouth and throat.
Ask
your
doctor
if
you
have
any
questions
about
why
Sobenz
Lozenge
has been prescribed for you. Your doctor
may
have
prescribed
it
for
another
purpose.
HOW SOBENZ LOZENGE WORKS
Sobenz Lozenges contains the principle
active
ingredient,
Benzydamine
hydrochloride for fast effective action.
Sobenz Lozenges directly target the site
of inflammation to reduce swelling and
pain.
It
gently
numbs
the
throat
in
a
matter of seconds.
BEFORE YOU USE SOBENZ LOZENGE
-
_When you must not use it_
Do not take Sobenz Lozenge if you have
ever had an allergic reaction to:
•
Any
medicine
containing
Benzydamine
hydrochloride
or
Cetylpyridinium chloride
•
Any of the ingredients listed at the end
of this leaflet.
Symptoms of an allergic reaction may
include:
•
Shortness of breath
•
Wheezing or difficulty in breathing
•
Swelling of the face, lips, tongue or
any other parts of the body
•
Rash, itching or hives on the skin
Do not take Sobenz Lozenge 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.
Talk to your doctor or pharmacist if you
are not sure
whether
you should start
taking this medicine.
_Pregnancy and lactation _
Do not take Sobenz Lozenge if you are
pregnant, or plan
                                
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Ciri produk

                                SOBENZ LOZENGE
ANTI-INFLAMMATORY LOZENGES
(with antibacterial)
COMPOSITION
Actives: Benzydamine hydrochloride 3 mg, and
Cetylpyridinium chloride 1.33 mg.
DESCRIPTION
Orange Flavour: A 16mm, round, flat, orange
coloured tablet and beveled edge.
Melon Flavour: A 16mm, round, flat, green coloured
tablet and bevelled edge.
This product containing ASPARTAME 7.8mg
(Artificial sweetening substance) . UNSUITABLE
FOR PHENYLKETONURICS.
PHARMACODYNAMICS
BENZYDAMINE HYDROCHLORIDE
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 prosta-
glandins under certain conditions, but its properties
in this respect have not been fully elucidated.
The stabilizing effect on cellular membranes may
also be involved in the mechanism of action.
CETYLPYRIDINIUM CHLORIDE
Cetylpyridinium Chloride is a quarternary pyridinium
antiseptic with actions and uses similar to those of
other cationic surfactants. It is used chiefly as
lozenges or solutions for the treatment of minor
infections of the mouth and throat. It is a broad
spectrum antimicrobial agent with a long history of
use to promote gingival health.
PHARMACOKINETICS
BENZYDAMINE HYDROCHLORIDE
_Absorption_ - Benzydamine is well absorbed
following oral administration. Benzydamine is well
absorbed into the inflamed oral mucosa where it
exerts anti-inflammatory and local anaesthetic
actions. Plasma benzydamine levels following use
of benzydamine orally are low and parallel the
amount actually ingested.
_Excretion_ - Benzydamine and its metabolites are
excreted largely in the urine. Metabolism is largely
by oxidative pathways, although dealkylation can be
shown. 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.
CETYLPYRIDINIUM CHLORIDE
Cetylpyridinium chloride is a quaternary pyridinium
antiseptic with actions and uses similar to those of
other cat
                                
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