Zipelor Forte Benzydamine 0.3% wv oromucosal spray

Country: Malaysia

Language: English

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

Active ingredient:

BENZYDAMINE HYDROCHLORIDE

Available from:

UNIMED SDN BHD

INN (International Name):

BENZYDAMINE HYDROCHLORIDE

Units in package:

15 ml; 15 ml

Manufactured by:

JOINT STOCK COMPANY FARMAK

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ZIPELOR FORTE BENZYDAMINE 0.3%W/V OROMUCOSAL
SPRAY
Benzydamine 0.3%w/v oromucosal spray
WHAT IS IN THIS LEAFLET
1.
What Zipelor Forte
Benzydamine 0.3%w/v
oromucosal spray is used
for
2.
How Zipelor Forte
Benzydamine 0.3%w/v
oromucosal spray works
3.
Before you use Zipelor Forte
Benzydamine 0.3%w/v
oromucosal spray
4.
How to use Zipelor Forte
Benzydamine 0.3%w/v
oromucosal spray
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Zipelor
Forte
Benzydamine
0.3%w/v
oromucosal spray
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT
ZIPELOR
FORTE
BENZYDAMINE
0.3%W/V
OROMUCOSAL SPRAY IS USED FOR
Benzydamine hydrochloride in Zipelor
Forte
Benzydamine
0.3%w/v
oromucosal spray is used to temporary
relief of painful conditions of the mouth
and throat including sore throat, ulcers,
after dental surgery or procedures.
HOW
ZIPELOR
FORTE
BENZYDAMINE
0.3%W/V
OROMUCOSAL SPRAY WORKS
Zipelor
Forte
Benzydamine
0.3%w/v
oromucosal spray works by reducing
the pain, redness and swelling of painful
mouth and throat conditions.
BEFORE YOU USE ZIPELOR FORTE
BENZYDAMINE 0.3%W/V
OROMUCOSAL SPRAY
_-When you must not use it _
_ _
Do not use this medicine if you have
an allergy to:
•
any medicine containing
Benzydamine hydrochloride
•
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.
If any of the above happen, tell your
doctor immediately or go to Accident
and
Emergency
at
your
nearest
hospital.
Pregnancy and breastfeeding
If you are pregnant, trying to become
pregnant
or
breastfeeding,
ask
your
pharmacist or doctor for advice before
using
Zipelor
Forte
Benzydamine
0.3%w/v oromucosal spray.
Do not use this medicine after the expiry
date
printed
on
the
pack
or
if
the
packaging is torn or shows sign

Summary of Product characteristics

PATIENT INFORMATION LEAFLET
ZIPELOR FORTE, oromucosal spray
BRAND OR PRODUCT NAME
Zipelor Forte, 0.3 % w/v Oromucosal Spray
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each ml of Zipelor forte contains:
Benzydamine Hydrochloride 3 mg/ml
EXCIPIENTS
Ethanol 96 % - 80 mg/ml
Glycerol
Methyl parahydroxybenzoate (as antimicrobial preservative) - 1.0
mg/ml.
Saccharin sodium
Macrogolglycerol hydroxystearate
Mint (flavour)
Purified water
PRODUCT DESCRIPTION
Clear, colourless liquid with a characteristic mint odour. 1 released
spray contains 0.51 mg of benzydamine hydrochloride. 15 ml packed in
amber
glass bottle equipped with a plastic metered-dose pump-dispenser for
oral use with a protective cap.
PHARMACODYNAMICS
The mechanism of anti-inflammatory action of benzydamine 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.
Benzydamine is an 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 an
acid.
PHARMACOKINETICS
Benzydamine is well absorbed following oral administration. Following
topical administration, benzydamine is well absorbed into the inflamed
local
mucosa where it exerts anti-inflammatory and local anaesthetic
actions. Plasma benzydamine levels following use are low and
proportionate to the
amount actually ingested.
Benzydamine and its metabolites are excreted largely in the urine.
Metabolism is largely excreted by oxidative pathways, although
dealkylation can
be shown.
Benzydamine has been detected in blood and urine following gargling of
solution form. Most of the absorbed dose is eliminated in the first 24
hours.
Repeated administration for 7 days does not result in accumu