AVAMYS NASAL SPRAY

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FLUTICASONE FUROATE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

FLUTICASONE FUROATE

Unit dalam pakej:

60 ACTUATIONS; 120 ACTUATIONS

Dikeluarkan oleh:

GLAXO WELLCOME S.A.

Risalah maklumat

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
AVAMYS
_ _
Fluticasone furoate (27.5 micrograms)
1
WHAT IS IN THIS LEAFLET
1.
What AVAMYS is used for
2.
How AVAMYS works
3.
Before you use AVAMYS
4.
How to use AVAMYS
5.
While you are using it
6.
Side effects
7.
Storage and disposal of AVAMYS
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT AVAMYS IS USED FOR
AVAMYS nasal spray is used to treat
allergic symptoms which include:
•
Stuffy, runny or itchy nose
•
Sneezing
•
Water, itchy or red eyes
Symptoms can be seasonal. These are
caused by allergies to pollen from grass or
trees (hayfever). They can also occur
throughout the year and can be caused by
animal allergies, house-dust mites or
moulds.
HOW AVAMYS WORKS
AVAMYS belongs to a group of
medicines called glucocorticoids.
AVAMYS decreases inflammation in the
nose and irritation of the eyes caused by
allergies (rhinitis).
_ _
BEFORE YOU USE AVAMYS
_When you must not use it _
_ _
If you are allergic (
_hypersensitive_
) to
fluticasone furoate or any other
ingredients of AVAMYS.
_Before you start to use it _
_ _
Before you use AVAMYS your doctor
needs to know:
•
If you have liver disease, your doctor
may lower your dose of AVAMYS
Check with your doctor if you think this
may apply to you.
If you are pregnant, or think you could be,
or if you are planning to become pregnant,
don’t take AVAMYS without checking
with your doctor. Your doctor will weigh
up the benefit to you against the risk to
your baby of taking AVAMYS while
you’re pregnant.
It is not known whether the ingredients of
AVAMYS can pass into breast milk. If
you are breast-feeding, you must check
with your doctor before you take
AVAMYS.
_Taking other medicines _
_ _
Tell your doctor or pharmacist if you are
taking any other medicines, if you’ve
taken any recently, or if you start taking
new ones. This includes medicine bought
without a prescription.
Some medicines may affect how
AVAMYS works, or make it more likely
that you’ll have side

Ciri produk

[GSK logo]
AVAMYS
FLUTICASONE FUROATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_AVAMYS _
Nasal Spray is a white, uniform suspension contained in an amber glass
bottle,
fitted with a metering (50 microlitres) atomising spray pump. This
inner pack is
incorporated within a predominantly off-white plastic device with a
blue side-actuated
lever and a lid which contains a stopper. Each spray of the suspension
delivers
approximately 27.5 micrograms of micronised fluticasone furoate as an
ex-device dose.
PHARMACEUTICAL FORM
Nasal spray, suspension.
CLINICAL PARTICULARS
INDICATIONS
ADULTS AND ADOLESCENTS (12 YEARS AND OLDER)
Treatment of the nasal symptoms (rhinorrhea, nasal congestion, nasal
itching and
sneezing) and ocular symptoms (itching/burning, tearing/watering, and
redness of the
eye) of seasonal allergic rhinitis.
Treatment of the nasal symptoms (rhinorrhea, nasal congestion, nasal
itching and
sneezing) of perennial allergic rhinitis.
CHILDREN (2 TO 11 YEARS)
Treatment of the nasal symptoms (rhinorrhea, nasal congestion, nasal
itching and
sneezing) of seasonal and perennial allergic rhinitis.
DOSAGE AND ADMINISTRATION
_AVAMYS _
Nasal Spray is for administration by the intranasal route only. For
full
therapeutic benefit, regular scheduled usage is recommended. Onset of
action has been
observed as early as 8 hours after initial administration. It may take
several days of
treatment to achieve maximum benefit. An absence of an immediate
effect should be
explained to the patient (
_see Clinical Studies_
).
POPULATIONS
For the treatment of seasonal allergic rhinitis and perennial allergic
rhinitis:
ADULTS AND ADOLESCENTS (12 YEARS AND OLDER)
The recommended starting dosage is 2 sprays (27.5 micrograms per
spray) in each nostril
once daily (total daily dose, 110 micrograms).
Once adequate control of symptoms is achieved, dose reduction to 1
spray in each nostril
once daily (total daily dose, 55 micrograms) may be effective for
maintenance.
CHILDREN (2 TO 11 YEARS)
The recommended starting dosage is 1 spray (27.5 microgr