FLIXONASE NASULE DROPS fluticasone propionate 400mcg unit dose ampoule strip pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluticasone propionate, Quantity: 400 microgram

Available from:

GlaxoSmithKline Australia Pty Ltd

Pharmaceutical form:

Nasal Drops

Composition:

Excipient Ingredients: polysorbate 20; sorbitan monolaurate; monobasic sodium phosphate; dibasic sodium phosphate; sodium chloride; water for injections

Administration route:

Nasal

Units in package:

28 (4 x 7) ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS: For the treatment of mild to moderate nasal polyps and associated symptoms of nasal obstruction in adults and adolescents over 16 years of age.

Product summary:

Visual Identification: White opaque, freely dispersed suspension free from any visible foreigh matter.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-11-16

Patient Information leaflet

FLIXONASE NASULE
DROPS
_Fluticasone propionate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before taking Flixonase Nasule
Drops.
This leaflet answers some common
questions about Flixonase Nasule
Drops. 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 risks of you taking Flixonase
Nasule Drops against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT FLIXONASE
NASULE DROPS ARE
USED FOR
Flixonase Nasule Drops contain a
steroid called fluticasone propionate,
which treats inflamed tissue.
Flixonase Nasule Drops work by
shrinking swelling inside your nose.
This makes breathing easier. You
may not feel the maximum benefit
for a few weeks.
Inflamed tissue inside the nose can
form grape-like swellings called
'polyps'. They cause nasal blockage
and discomfort. Flixonase Nasule
Drops are used to relieve the
symptoms caused by nasal polyps by
shrinking them. Flixonase Nasule
Drops have not been studied in
patients under 16 years of age.
Your doctor may have prescribed
Flixonase Nasule Drops for another
reason.
Ask your doctor if you have any
questions or if you aren't sure why
Flixonase Nasule Drops has been
prescribed for you.
Flixonase Nasule Drops are not
addictive.
BEFORE YOU USE
FLIXONASE NASULE
DROPS
_WHEN YOU MUST NOT USE_
_FLIXONASE NASULE DROPS_
•
DO NOT USE FLIXONASE NASULE
DROPS IF YOU HAVE EVER HAD AN
ALLERGIC REACTION TO FLUTICASONE
PROPIONATE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET. READ THE SIDE EFFECTS SECTION TO
FIND OUT THE SYMPTOMS OF AN
ALLERGIC REACTION.
•
DO NOT USE FLIXONASE NASULE
DROPS IF YOU ARE PREGNANT,
TRYING TO BECOME PREGNANT OR
BREASTFEEDING, UNLESS YOUR
DOCTOR SAYS YOU SHOULD.
Your doctor will discuss the risks
and benefits o

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
FLIXONASE NASULE DROPS (FLUTICASONE PROPIONATE) NASAL DROPS
1
NAME OF THE MEDICINE
Fluticasone propionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of FLIXONASE NASULE DROPS contains 400

g of fluticasone propionate
in 400

L.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Nasal drops.
White opaque, freely dispersed suspension free from any visible
foreign matter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
FLIXONASE NASULE DROPS are indicated for the treatment of mild to
moderate nasal
polyps and associated symptoms of nasal obstruction in adults and
adolescents over 16
years of age.
4.2
DOSE AND METHOD OF ADMINISTRATION
For full therapeutic benefit regular usage is essential. Nasal polyps
require regular medical
assessment to monitor severity of the condition. The drops should be
administered in a
‘head down’ position (see Section 4.2 DOSE AND METHOD OF
ADMINISTRATION,
Instructions for use).
ADULTS AND ADOLESCENTS OVER 16 YEARS OLD:
The contents of one container (400

g in 400

L) to be instilled once or twice daily.
The dose should be divided evenly between both affected nostrils.
Unilateral polyposis rarely occurs, and could be indicative of other
conditions. Diagnosis
should be confirmed by a specialist, and management individualised by
them.
ELDERLY:
The normal adult dosage is applicable.
CHILDREN:
There are insufficient data at present to recommend the use of
fluticasone propionate for the
treatment of nasal polyps in children.
2
INSTRUCTIONS FOR USE:
Gently blow each nostril, in turn, to clear. Open the foil pack by
tearing off one side. Detach
one NASULE and return the remaining containers, in the foil pack, to
the carton. It is
important to ensure that the contents of the container are well mixed
before use. While
holding the container horizontally by the larger tab, 'flick' the
other end a few times and
shake. Repeat this process several times until the entire contents of
the container are