B GARGLE SOLUTION 0.15% WV

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

BENZYDAMINE HYDROCHLORIDE

MAH:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN:

BENZYDAMINE HYDROCHLORIDE

units_in_package:

100ml mL

manufactured_by:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

PIL

_Consumer Medication Information Leaflet (RiMUP) _
1
B GARGLE SOLUTION 0.15%W/V
Benzydamine hydrochloride 0.15%w/v
WHAT IS IN THIS LEAFLET:

What
B
GARGLE
Solution
0.15%w/v is used for

How B GARGLE Solution 0.15%w/v
works

Before
you
take
B
GARGLE
Solution 0.15%w/v

How to take B GARGLE Solution
0.15%w/v

While
you
are
using
B
GARGLE
Solution 0.15%w/v

Side Effects

Storage and Disposal of B GARGLE
Solution 0.15%w/v

Product description

Manufacturer
and
Product
Registration Holder

Date of Revision
WHAT B GARGLE SOLUTION 0.15%W/V
IS USED FOR
B GARGLE is indicated for the relief of
painful
conditions
of
the
oral
cavity
including: tonsillitis, sore throat, radiation
mucositis,
aphthous
ulcers,
post
orosurgical and periodontal procedures.
HOW B GARGLE SOLUTION 0.15%W/V
WORKS?
B
GARGLE
belongs
to
a
group
of
medicines
called
non-steroidal
anti-
inflammatory drugs or NSAIDS. It works
by
stopping
pain
and
swelling
(inflammation).
BEFORE YOU TAKE B GARGLE SOLUTION
0.15%W/V
_When you must not take it _
Do not use B GARGLE if:

you are allergic to benzydamine
hydrochloride

you are allergic to any of the other
ingredients of B GARGLE.
If you are not sure whether you should
use
B
GARGLE,
talk
to
your
doctor,
dentist or pharmacist
_Before you start to take it _
You must tell your doctor if :

you have allergies to any medicine
which you have taken previously to
treat your current condition.

you
suffer
from
phenylketonuria
(because
B
GARGLE
contains
aspartame).

you are pregnant, trying to become
pregnant or breast-feeding. There is
no
evidence
on
safety
of
benzydamine
hydrochloride
in
pregnant
patients.
Risk
to
benefit
ratio should be established if to be
used in these patients.
_Taking other medicines _
Tell your doctor, dentist or pharmacist if
you are taking any other medicines, even
medicines
obtained
without
a
prescription.
HOW
TO
TAKE
B
GARGLE
SOLUTION
0.15%W/V
_How much to use _
Adults:
15mL
(approximately
one
tablespoon)
gargled
or
rinsed
in
the
mouth for at least 30 se

SPC

7190-00
B GARGLE SOLUTION 0.15%W/V
Anti-inflammatory, analgesic solution for use as gargle / rinse /
mouthwash.
PHARMACOLOGY:
Benzydamine is an anti-inflammatory analgesic agent. Chemically it is
a base whereas other non steroidal
anti-inflammatory agents are acids.
Systemic administration in animal model showed that benzydamine is
effective against pain and oedema
due to inflammatory conditions. It inhibits granuloma formation.
When administrated orally to rats at doses up to 100mg/kg, benzydamine
does not cause erosion of the
gastric mucosa and it gives local anaesthetic action when used at
concentration for topical treatment.
Benzydamine has more analgesic activity in inflammatory condition
rather than in non inflammatory pain.
Benzydamine posseses an anti-pyretic effect in common with the aspirin
like drugs.
The mechanism of action for anti-inflammatory property is by
inhibiting the biosynthesis of prostaglandins
and may also by stabilising the cellular membranes, but not related to
stimulation of the pituitary –adrenal
axis.
PHARMACOKINETICS:
ABSORBTION
Oral doses of benzydamine are well absorbed and peak plasma drug
concentration is attained fairly rapidly
and then declined with a half life of about 13 hours. Upon topical
administration benzydamine is well
absorbed into the inflammed oral mucosa and produces anti-inflammatory
and local anaesthetic action.
Plasma drug concentration are low and parallel the amount actually
ingested.
EXCRETION
Benzydamine and its metabolites are excreted largely in urine.
Benzydamine is metabolised by oxidation,
conjugation and dealkylation.
Benzydamine was detected in blood and urine after gargling and mostly
eliminated in the first 24 hours.
Benzydamine accumulation in plasma was not seen upon repeated
adminstration for 7 days
.
COMPOSITION:
Benzydamine Hydrochloride 0.15%w/v.
INDICATIONS:
It is indicated for the relief of painful conditions of the oral
cavity including: tonsillitis, sore throat,
radiation mucositis, aphthous ulcers, post orosurgical and periodontal
proced