AVAMYS fluticasone furoate nasal spray bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluticasone furoate, Quantity: 27.5 microgram

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Fluticasone furoate

Pharmaceutical form:

Spray, suspension

Composition:

Excipient Ingredients: purified water; disodium edetate; polysorbate 80; dispersible cellulose; glucose; benzalkonium chloride

Administration route:

Nasal

Units in package:

60 x 27.5 microgram spray, 120 x 27.5 microgram spray, 30 x 27.5 microgram spray

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of seasonal allergic rhinitis and perennial allergic rhinitis in adults and children of ages 2 years and older.

Product summary:

Visual Identification: Avamys is a white suspension in a glass bottle with a metering spray pump in an off-white plastic device with a blue side-actuated lever with a lid.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2008-02-14

Patient Information leaflet

AVAMYS
_NASAL SPRAY_
_Fluticasone furoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you use AVAMYS.
This leaflet answers some common
questions about AVAMYS. It does
not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the expected benefits of you taking
AVAMYS against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS AVAMYS USED
FOR?
AVAMYS is used to treat symptoms
of allergic rhinitis including stuffy,
runny or itchy nose, sneezing, and
watery, itchy or red eyes. The effects
are usually felt within the first day,
although some people will not feel
the effects until several days after
first taking it.
AVAMYS contains the medicine
fluticasone furoate. This medicine
belongs to a group of medicines
known as corticosteroids, frequently
called 'steroids'. They are not
'anabolic steroids' which are the
steroids sometimes misused by
athletes.
AVAMYS works to decrease
inflammation caused by allergy
(rhinitis).
Your doctor may have prescribed
AVAMYS for another reason.
AVAMYS is not addictive.
BEFORE YOU USE
AVAMYS
_DO NOT USE IF:_
You must not use AVAMYS if:
•
you have ever had an allergic
reaction to fluticasone furoate or
any of the ingredients listed
toward the end of this leaflet.
(See "Ingredients")
•
THE EXPIRY DATE (EXP) PRINTED
ON THE PACK HAS PASSED.
•
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
_TELL YOUR DOCTOR IF:_
You must tell your doctor if:
•
YOU ARE ALLERGIC TO FOODS, DYES,
PRESERVATIVES OR ANY OTHER
MEDICINES.
•
YOU ARE TAKING AN ANTIVIRAL
MEDICINE CALLED A PROTEASE
INHIBITOR (E.G. RITONAVIR) OR A
TYPE OF MEDICINE USED TO TREAT
FUNGAL INFECTIONS (E.G.
KETOCONAZOLE).
•
YOU ARE TAKING ANY OTHER
MEDICINES, INCLUDING MEDICINES
YOU BUY WITHOUT A PRESCRIPTION.
T

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
AVAMYS (FLUTICASONE FUROATE) NASAL SPRAY
1
NAME OF THE MEDICINE
Fluticasone furoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AVAMYS Nasal Spray is a white suspension of micronised fluticasone
furoate for topical
administration to the nasal mucosa by means of a metering atomising
spray pump. Each
spray of the suspension delivers approximately 27.5 micrograms of
micronised fluticasone
furoate as an ex-device dose. _ _
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Suspension spray
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of seasonal allergic rhinitis and perennial allergic
rhinitis in adults and
children of ages 2 years and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
Fluticasone furoate Nasal Spray is for administration by the
intranasal route only.
For full therapeutic benefit regular usage is recommended. Onset of
action has been
observed as early as 8 hours after administration. It may take several
days of treatment to
achieve maximum benefit. An absence of an immediate effect should be
explained to the
patient.
Patients should be instructed that the device must be primed:
•
before first use, and
•
if the cap is left off
•
if the device does not seem to be working
•
if the nasal spray has not been used for 30 days or more.
In order to prime the device, the nasal spray needs to be shaken
vigorously for about 10
seconds with the cap on. This is important as fluticasone furoate is a
thick suspension that
becomes liquid when vigorously shaken. It will only spray when it
becomes liquid.
The patient must then press the button firmly all the way in,
approximately 6 times until a fine
mist is seen, (to ensure a full dose is delivered).
Once primed, the patient must shake the nasal spray vigorously each
time before use.
2
The cap must be replaced after use to keep the nozzle clean and to
prevent the need for re-
priming.
Patients must follow the step-by-step instructions in the instruction
leaflet for use a