FLUTIMATE NS 50 (Fluticasone Nasal Spray BP 50mcg)

País: Malàisia

Idioma: anglès

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

ingredients actius:

FLUTICASONE PROPIONATE

Disponible des:

MEDISPEC (M) SDN.BHD

Designació comuna internacional (DCI):

FLUTICASONE PROPIONATE

Unidades en paquete:

1units Units

Fabricat per:

Jewim Pharmaceutical (Shandong) Co., Ltd

Informació per a l'usuari

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FLUTIMATE NS 50 (FLUTICASONE NASAL SPRAY BP
50MCG)
Fluticasone propionate 0.05% w/w (Fluticasone propionate BP 50 mcg per
actuation)
1
WHAT IS IN THIS LEAFLET
1. What FLUTIMATE NS is used for
2. How FLUTIMATE NS works
3. Before you use FLUTIMATE NS
4. How to use FLUTIMATE NS
5. While you are using it
6. Side effects
7. Storage and Disposal of
FLUTIMATE NS
8. Product description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
WHAT FLUTIMATE NS IS USED FOR
FLUTIMATE NS contains a medicine
called
Fluticasone
propionate.
This
belongs to a group of medicines called
steroids (also called ‘cortico-steroids’)
•
Steroids
work
by
reducing
inflammation.
• They reduce swelling and irritation
in your nose.
•
This
helps
to
relieve
itching,
sneezing and your blocked or runny
nose.
FLUTIMATE NS is used to prevent
and treat:
• Inflammation in the lining of your
nose (rhinitis) due to seasonal allergies,
such as Hayfever.
• Inflammation in the lining of your
nose
(rhinitis)
due
to
year
round
(perennial) allergies, such as animal
allergies.
HOW FLUTIMATE NS WORKS
Fluticasone propionate is a synthetic,
trifluorinated
corticosteroid,
it
has
local
anti-inflammatory
and
anti-allergic activity.
BEFORE YOU USE FLUTIMATE NS
-_When you must not use it_
•
DO NOT USE FLUTIMATE NS IF
YOU
HAVE
EVER
HAD
AN
ALLERGIC
REACTION TO FLUTICASONE PROPIONATE OR
ANY OF THE INGREDIENTS.
Read the side effects section to find
out
the
symptoms
of
an
allergic
reaction to FLUTIMATE NS.
• DO NOT USE FLUTIMATE NS IF
YOU ARE PREGNANT, TRYING TO BECOME
PREGNANT
OR
BREASTFEEDING,
UNLESS
YOUR DOCTOR OR PHARMACIST SAYS YOU
SHOULD.
• DO NOT USE FLUTIMATE NS AFTER
THE EXPIRY DATE (EXP) PRINTED ON
THE PACK.
• IF YOU USE THE PRODUCT AFTER THE
EXPIRY DATE HAS PASSED, IT MAY NOT
WORK AS WELL.
• DO NOT USE FLUTIMATE NS IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
If you're not sure whether you should
be
using
FLUTIMATE
NS,
talk
to
your doctor o

Fitxa tècnica

FLUTIMATE NS 50 (FLUTICASONE NASAL SPRAY BP 50MCG)
PRODUCT NAME
GENERIC NAME:
Fluticasone Nasal Spray BP 50mcg
TRADE NAME:
FLUTIMATE NS 50 (Fluticasone Nasal Spray BP 50mcg)
NAME AND STRENGTH OF ACTIVE INGREDIENT (S)
Name: Fluticasone Propionate
Strength:
Fluticasone
propionate
0.05%
w/w
(Fluticasone
propionate
BP
50
mcg
per
actuation)
DOSAGE FORM
Aqueous suspension for intranasal inhalation via metered-dose valve
system
PRODUCT DESCRIPTION
FLUTIMATE NS 50 (Fluticasone Nasal Spray BP 50mcg) is a white aqueous
suspension with
aromatic smell of microfine fluticasone propionate (0.05% w/w) for
topical administration to
the nasal mucosa by means of a metered-dose valve system. Each spray
delivered by the nasal
adaptor contains fluticasone propionate 50mcg.
FLUTIMATE NS 50 (Fluticasone Nasal Spray BP 50mcg) is supplied in a
brown glass bottle
fitted with a metered-dose valve system, nasal adaptor and a dust
cover.
PHARMACODYNAMICS
Fluticasone
propionate
is
a
synthetic,
trifluorinated
corticosteroid,
it
has
local
anti-inflammatory and anti-allergic activity.
PHARMACOKINETICS
Absorption: Direct absorption in the nose is negligible due to the low
aqueous solubility with
the majority of the dose being eventually swallowed. When administered
ora
lly, the systemic
exposure is <1% due to poor absorption and presystemic metabolism. The
total systemic
absorption arising from both nasal and oral absorption of the
swallowed dose is therefore
negligible.
Distribution: Fluticasone propionate has a large volume of
distribution at steady state. Plasma
protein-binding is moderately high.
Metabolism: Fluticasone propionate is cleared rapidly from the syste
mic circulation,
principally by hepatic metabolism to an inactive carboxylic acid
metabolite, by the
cytochrome P-450 enzyme CYP3A4. Swallowed fluticasone propionate is
also subject to
extensive first-pass metabolism. Care should be taken when
co-administering potent CYP3A4
inhibitors eg, ketoconazole and ritonavir, as there is potential for
increased systemic exposure
to fluticason