MediThroat Spray 3.0 mgml

Country: Malaysia

Language: English

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

Active ingredient:

BENZYDAMINE HYDROCHLORIDE

Available from:

World Medicare Supplies Sdn Bhd

INN (International Name):

BENZYDAMINE HYDROCHLORIDE

Units in package:

34 ml

Manufactured by:

Yuan Chou Chemical & Pharmaceutical Co., Ltd.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
MEDITHROAT SPRAY 3.0MG/ML
Benzydamine HCl 0.3% w/v
___________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What MediThroat is used
for
2.
How MediThroat works
3.
Before
you
use
MediThroat
4.
How to use MediThroat
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
MediThroat
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT MEDITHROAT IS USED FOR
MediThroat
Spray
3.0
mg/ml
works
by
relieving
pain
and
swelling
(inflammation).
It
is
used
to
treat
many
painful
conditions of the mouth or throat
including:
-
Mouth ulcers
-
Sore throat
-
Sore tongue or gums
Discomfort
associated
with
dentures or dental work.
HOW MEDITHROAT_ _WORKS
Benzydamine
hydrochloride,
which
belongs
to
a
group
of
medicines
called
non-steroidal
anti-inflammatory
drugs
or
NSAIDS
works
by
relieving
pain
and
swelling
(inflammation).
BEFORE YOU USE MEDITHROAT
-
_When you must not use it_
Do not use if:
-You
are
allergic
to
benzydamine hydrochloride
-You are allergic to any of the
other ingredients
-If you are
pregnant, trying to
get
pregnant
or
think
you
may be pregnant.
-If you are breast-
feeding.
Ask
your
doctor
or
pharmacist
for advice before
taking any medicine.
-
_Before you start to use it: _
Talk
to
your
doctor
or
pharmacist:
-
If you have a history of
asthma.
-
If
you
are
allergic
to
acetylsalicylic
acid
or
other
non
steroidal
anti
inflammatory
(NSAID)
drug.
-
_Taking other medicines_
Tell your doctor or pharmacist if
you
are
taking,
have
recently
taken or might take any other
medicines.
HOW TO USE MEDITHROAT
-
_How much to use_
Adults
and
children
over
12
years:
2-4
sprays
(1-2
mg)
directly onto the sore/inflamed
area and swallow gently. Repeat
every
1½
to
3
hours
as
necessary.
Children (6-12 years): 2 sprays
(1
mg)
directly
onto
sore/inflamed area and swallow
gently. Repeat every 1½ to 3
hours as necessary.
Children under 6 years: Not
recommended.
-
_How long to use it _

Summary of Product characteristics

YUAN CHOU CHEMICAL & PHARMACEUTICAL CO., LTD
NO. 272 , NANGANG 3RD RD., NANTOU CITY , NANTOU COUNTY 54067, TAIWAN
R.O.C
PACKAGE INSERT
1. Name of the medicinal product
MediThroat Spray 3.0 mg/ml
2. Qualitative and quantitative composition
The active substance is Benzydamine HCl 0.3% w/v
3. Pharmaceutical form
Throat Spray that is a clear, colourless solution and smells of
strawberry.
4. Clinical particulars
4.1 Therapeutic indications
Temporary relief of painful conditions of the mouth and throat
including tonsillitis, sore
throat, radiation mucositis, aphthous ulcers, pharyngitis, swelling,
redness, inflammatory
conditions, post orosurgical and periodontal procedures.
4.2 Posology and method of administration
Route of administration: Oromucosal.
Adults and children over 12 years: 2-4 sprays (1-2 mg) directly onto
the sore/inflamed
area and swallow gently. Repeat every 1½ to 3 hours as necessary.
Children (6-12 years): 2 sprays (1 mg) directly onto sore/inflamed
area and swallow
gently. Repeat every 1½ to 3 hours as necessary.
Children under 6 years: Not recommended.
Uninterrupted
treatment
should
not
exceed
seven
days,
unless
under
medical
supervision.
Instruction for Use:
(1)
Hold the bottle in an upright position.
(2)
Prime the spray the first time using it (max. 5 sprays). Point the
spray-tube away from
the face. Press down firmly until a fine spray appears from the end of
the spray-tube.
(3)
Aim the spray-tube at the affected area and press down. One press
releases one
actuation.
(4)
After finishing the desired number of puffs, wipe the end of the
spray-tube with a clean
tissue.
This will prevent the spray-tube from getting blocked.
(5)
Do not squeeze anything into the spray-tube if it becomes blocked.
YUAN CHOU CHEMICAL & PHARMACEUTICAL CO., LTD
NO. 272 , NANGANG 3RD RD., NANTOU CITY , NANTOU COUNTY 54067, TAIWAN
R.O.C
4.3 Contraindications
Patients with known hypersensitivity to benzydamine or to the other
components
listed in section 6.
4.4 Special warnings and precautions for use
If a sore throat is ei