COOLORA (BENZYDAMINE MOUTHWASH BP 0.15% WV)

Country: Malasja

Lingwa: Ingliż

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

Ingredjent attiv:

BENZYDAMINE HYDROCHLORIDE

Disponibbli minn:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Isem Internazzjonali):

BENZYDAMINE HYDROCHLORIDE

Unitajiet fil-pakkett:

100ml x 10 BOTTLE

Manifatturat minn:

ICPA Health Products Limited,

Fuljett ta 'informazzjoni

COOLORA
_Consumer Medication Information Leaflet (RiMUP)_
(Benzydamine Mouthwash BP 0.15%w/v)
1
WHAT IS IN THIS LEAFLET
1.
What COOLORA is used for
2.
How COOLORA works
3.
Before you use COOLORA
4.
How to use COOLORA
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
COOLORA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT IS COOLORA USED FOR
Benzydamine
hydrochloride
in
COOLORA
is
used
to
relieve
inflammation and pain in the throat.
HOW COOLORA WORKS
COOLORA works by reducing the
pain, redness and swelling of painful
mouth and throat conditions.
BEFORE YOU USE COOLORA
_-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.
Pregnancy and breastfeeding
If you are pregnant, trying to become
pregnant or breastfeeding, ask your
pharmacist or doctor for advice before
using COOLORA.
Do not use this medicine after the
expiry date printed on the pack or if
the packaging is torn or shows signs
of tampering.
If you are not sure whether you should
start using this medicine, talk to your
pharmacist or doctor.
_-Before you start to use it _
Tell
your
pharmacist
if
you
have
allergies
to
any
other
medicines,
foods, preservatives or dyes.
Tell your doctor or pharmacist if you
have any of the following medical
conditions:
•
Liver problems
•
Kidney problems
If you have not told your pharmacist
or doctor about any of the above, tell
him/her
before
you
start
using
COOLORA.
_-Taking other medicines _
Tell your pharmacist or doctor if you
are
taking
any
other
medicines,
including any that you get without a
prescription or that are herbal from
your pharmacy, supermarket or health
food shop.

Karatteristiċi tal-prodott

For the use of a Registered Medical Practitioner or Hospital or a
Laboratory.
COOLORA
(BENZYDAMINE MOUTHWASH BP 0.15% W/V)
ACTIVE INGREDIENT:
Benzydamine Hydrochloride BP
(Each mL contains 1.5 mg of Benzydamine hydrochloride)
Sodium Benzoate BP 0.20%w/v as preservative
EXCIPIENT:
Glycerin BP, Propylene Glycol BP, PEG Hydrogenated Castor Oil (Acrysol
K 140), Menthol BP, Flavor
Booster, Flavor Dill Relish, Sodium Saccharin BP, Brilliant Blue
FCF
Color,
Tartrazine
Yellow
Color,
Purified
Water BP.
DOSAGE FORM:
Liquid for use as mouthwash/ gargle.
PRODUCT DESCRIPTION:
A Light green coloured clear liquid with characteristic taste and
fennel odour.
PHARMACODYNAMICS:
Pharmacotherapeutic group: Other agents for local oral treatment
Benzydamine exerts an anti-inflammatory and analgesic action by
stabilizing the cellular membrane and inhibiting
prostaglandin synthesis.
Mechanism of action:
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 metabolized 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 pro-inflammatory cytokines including tumor
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
hypothesized including the inhibition of the oxidative burst of
neutrophils as well as membrane stabilization 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.
Pharmacodynamic effects:
Benzydamine specific