Flomist Aqueous Nasal Spray 50 mcg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Fluticasone Propionate BP

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

Fluticasone Propionate BP

Unit dalam pakej:

100 Units

Dikeluarkan oleh:

Cipla Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FLOMIST AQUEOUS NASAL SPRAY ® _ _
Fluticasone propionate (50 mcg per spray)
____________________________________________________________________________________ 1
WHAT IS IN THIS LEAFLET
1
What FLOMIST is used for
2
How FLOMIST works
3
Before you use FLOMIST
4
How to use FLOMIST
5
While you are using it
6
Side effects
7
Storage and Disposal of FLOMIST
8
Product Description
9
Manufacturer and Product
Registration Holder
10
Date of Revision
WHAT FLOMIST IS USED FOR
Flomist is used to prevent and treat
inflammation in the lining of your nose
(rhinitis) due to:
•
Seasonal
allergies,
such
as
hay
fever
•
year
round
(perennial)
allergies,
such as animal allergies.
HOW FLOMIST WORKS
Flomist
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.
BEFORE YOU USE FLOMIST
_- When you must not use it _
Do not use Flomist if:
You
are
allergic
to
fluticasone
propionate
or
any
of
the
other
ingredients of this medicine
_ _
-_ Before you start to use it _
Talk
to
your
doctor
or
pharmacist
before using Flomist:
•
If you have ever had an operation
on your nose.
•
If you have an infection in your
nose _- Taking other medicines _
Tell your doctor if you are taking, have
recently taken or might take any other
medicines,
including
medicines
obtained without a prescription. This
includes herbal medicines.
Check with your doctor or pharmacist
before using your medicine if:
•
you have had steroids for a long
time, either as an injection or by
your mouth
•
you are taking some medicines for
HIV
such
as
cobicistat
or
ritonavir.
TAKING FLOMIST WITH FOOD AND DRINK
•
You
can
use
Flomist
with
or
without food.
HOW TO USE FLOMIST
_Instructions for use _
Parts of Flomist
Before using
1.
Shake
the
bottle
gently,
then
remove the dus

Ciri produk

For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
FLOMIST
(Fluticasone Propionate Aqueous Nasal Spray 50 mcg)
EACH SPRAY DELIVERS:
Fluticasone Propionate BP ................... 50mcg
COMPOSITION
Fluticasone propionate BP ……….... 0.05% w/w
Benzalkonium chloride NF ……..….. 0.02% w/w
(As preservative)
Phenyl ethyl alcohol USP ……..…… 0.25% w/w
(As preservative)
DESCRIPTION
A white uniform, homogenous, redispersible suspension filled in White
Opaque HDPE vial with
crimped nasal spray assembly.
PHARMACOLOGY
PHARMACODYNAMICS
Fluticasone propionate is a synthetic, trifluorinated corticosteroid
with anti-inflammatory activity. In vitro dose
response studies on a cloned human glucocorticoid receptor system
involving binding and gene expression
afforded 50% responses at 1.25 and 0.17 nM concentrations,
respectively. Fluticasone propionate was
3-fold to 5-fold more potent than dexamethasone in these assays. Data
from the McKenzie vasoconstrictor
assay in man also support its potent glucocorticoid activity.
In preclinical studies, fluticasone propionate revealed
progesterone-like activity similar to the natural
hormone. However, the clinical significance of these findings in
relation to the low plasma levels (see
Pharmacokinetics) is not known.
The precise mechanism through which fluticasone propionate affects
allergic rhinitis symptoms is not known.
Corticosteroids have been shown to have a wide range of effects on
multiple cell types (e.g., mast cells,
eosinophils, neutrophils, macrophages, and lymphocytes) and mediators
(e.g., histamine, eicosanoids,
leukotrienes, and cytokines) involved in inflammation. In 7 trials in
adults, Flomist has decreased nasal
mucosal eosinophils in 66% (35% for placebo) of patients and basophils
in 39% (28% for placebo) of
patients. The direct relationship of these findings to long-term
symptom relief is not known.
Flomist, like other corticosteroids, is an agent that does not have an
immediate effect on allergic symptoms.
A decrease in nasa