Easiflam Mouthwash 0.15 % wv

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BENZYDAMINE HYDROCHLORIDE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

BENZYDAMINE HYDROCHLORIDE

Unit dalam pakej:

100 ml

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
EASIFLAM MOUTHWASH
Benzydamine Hydrochloride (0.15% w/v)
WHAT IS IN THIS LEAFLET
1.
What Easiflam Mouthwash is used
for
When used
as a rinse for oral lesions,
the
dose
is
15ml
(approximately
1
tablespoon) which should be held in the
mouth and swirled around for at least 30
2.
How Easiflam Mouthwash works
3.
Before
you
use
Easiflam
Mouthwash
4.
How to use Easiflam Mouthwash
5.
While you are using Easiflam
Mouthwash
6.
Side effects
7.
Storage and Disposal of Easiflam
Mouthwash
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT EASIFLAM MOUTHWASH IS
USED
FOR
•
For the temporary relief of painful
conditions
of
the
oral
cavity
including:
tonsillitis,
sore
throat,
radiation
mucositis,
aphthous
ulcers,
post-orosurgical
and
periodontal procedures.
HOW EASIFLAM MOUTHWASH WORKS
Easiflam
Mouthwash
contains
Benzydamine Hydrochloride, one of a
group of medicines called non-steroidal
anti-inflammatory
drugs
(NSAIDs).
Benzydamine Hydrochloride has anti-
inflammatory and analgesic effect to
stop pain and inflammation. It does this
by stabilizing the cellular membrane
and
stopping
the
formation
of
prostaglandin.
Prostaglandin
forms
where there is injury or infection, which
causes the pain, redness, swelling and
feeling of heat at the area of injury.
BEFORE YOU USE EASIFLAM MOUTHWASH
_-_
_ _
_When you must not use it _
_ _
Do not take this mouthwash if:
•
you
are
allergic
to
Benzydamine
Hydrochloride
or
any
of
the
ingredients listed at the end of this
leaflet.
If you are not sure whether you should
start taking this medicine, talk to your
doctor, dentist or pharmacist.
Be careful not to splash the mouthwash
in your eyes. If you get it in your eyes
accidentally,
wash
them
immediately
with cold water.
_-_
_ _
_Before you start to use it _
_ _
Tell your doctor, dentist or pharmacist
if:
•
you
are
pregnant,
think
you
are
pregnant
or
plan
to
become
pregnant
•
you
are
breastfeeding
or
plan
to
breastfeed
_-_
_ _
_Taking other medici

Ciri produk

EASIFLAM MOUTHWASH 0.15 % W/V
VIEASxx-01 (MY)
026
DESCRIPTION
Clear green solution with an odour of peppermint.
COMPOSITION
Each 15 ml dose contains:
Benzydamine Hydrochloride 22.5mg
ACTIONS AND PHARMACOLOGY
The indazole analogue benzydamine has physicochemical
properties and pharmacological activities which differ from
those of the aspirin-like NSAIDs. Unlike aspirin-like NSAIDs
which are acids or metabolised to acids, benzydamine is a
weak base. In further contrast, benzydamine is a weak
inhibitor of the prostaglandin synthesis. Only at concentration
of
1mM
and
above
benzydamine
effectively
inhibits
cyclooxygenase
and
lipooxygenase
enzyme
activity.
It
mostly exerts its effects through inhibition of the synthesis of
proinflammatory
cytokines
including
tumour
necrosis
factor-alpha
(TNF-α)
and
Interleukin-1β
(IL-1β)
without
significantly affecting other pro-inflammatory (IL-6 and 8) or
anti-inflammatory cytokines (IL-10, IL-1 receptor antagonist).
Further mechanisms of action are hypothesised including the
inhibition of the oxidative burst of neutrophils as well as
membrane stabilisation as demonstrated by the inhibition of
granule release from neutrophils and the stabilization of
lysosomes. The local anaesthetic activity of the compound
has been related to an interaction with cationic channels.
PHARMACOKINETICS
Oral doses of benzydamine are well absorbed and plasma
drug concentrations reach a peak fairly rapidly and then
decline with a half-life of about 13 hours. Less than 20% of
the drug is bound to plasma proteins.
Although local drug concentrations are relatively large, the
systemic
absorption
of
mouthwash-gargle
doses
of
benzydamine is relatively low compared to oral doses. This
low absorption should greatly diminish the potential for any
systemic
drug
side-effects
when
benzydamine
is
administered by this route. Benzydamine is metabolized
primarily by oxidation, conjugation and dealkylation.
INDICATION
For the temporary relief of painful conditions of the oral
cavity including: tonsillitis, sore throat, r