AXOTIDE CFC-Free fluticasone propionate 125 microgram/dose inhalation metered dose aerosol can

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluticasone propionate, Quantity: 125 microgram/actuation

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

fluticasone propionate

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: norflurane

Administration route:

Inhalation

Units in package:

120 metered doses

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For use in the prophylactic management of asthma in adults and children over 4 years of age.

Product summary:

Visual Identification: metal can with concave base fitted with a metering valve, containing a white to off-white suspension, fitted to an actuator. The internal surfaces of the can & valve are free from obvious defects.; Container Type: Aerosol Can - Metered Dose; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2016-03-11

Patient Information leaflet

AXOTIDE CFC-FREE
INHALER AND JUNIOR
CFC-FREE INHALER
['PUFFER']
_Fluticasone propionate_
CONSUMER MEDICINE INFORMATION
_PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING AXOTIDE
(CFC-FREE) INHALER._
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Axotide Junior
(CFC-Free) Inhaler and Axotide
(CFC-Free) Inhaler. 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 using Axotide Junior
(CFC-Free) Inhaler or Axotide (CFC-
Free) Inhaler against the benefits this
medicine is expected to 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 AXOTIDE INHALERS
('PUFFERS') ARE USED FOR
You may know your Inhaler better as
a 'puffer'. Axotide puffers contain a
medicine called fluticasone
propionate. 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.
Your Axotide puffer provides a
measured amount of steroid for you
to breathe into your lungs. By using
your Axotide puffer regularly every
day, the medicine reduces the
swelling and irritation in the walls of
the small air passages in your lungs.
Your Axotide puffer contains the
type of asthma medicine known as a
'preventer'. It does not give
immediate relief from an asthma
attack and may take up to a week to
start to work. If your shortness of
breath or wheeze does not get better
after 7 days, tell your doctor. When
used every day, your Axotide puffer
helps to ease breathing problems and
prevent asthma attacks.
This medicine is only one part of a
general plan to help you manage your
asthma. You should discuss this plan
with your doctor. You may also be
using a 'reliever puffer'. Keep using it
according to your doctor's advice.
Ask your doctor to chec

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
AXOTIDE (FLUTICASONE PROPIONATE) (CFC-FREE) INHALER, JUNIOR
(CFC-FREE) INHALER, ACCUHALER AND JUNIOR ACCUHALER
1
NAME OF THE MEDICINE
Fluticasone propionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
AXOTIDE ACCUHALER is a moulded plastic device containing a foil strip
with regularly
placed blisters each containing a mixture of microfine fluticasone
propionate (100
micrograms, 250 micrograms or 500 micrograms) and larger particle size
lactose
monohydrate
AXOTIDE INHALEr contains a pressurised inhalation suspension,
delivering either 50, 125 or
250 micrograms of fluticasone propionate per inhalation.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
AXOTIDE ACCUHALER also contains the excipient lactose monohydrate
(which contains
milk protein).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
AXOTIDE ACCUHALER: Powder for inhalation_ _
AXOTIDE INHALEr: Pressurised inhalation
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use in the prophylactic management of asthma in adults and
children of ages 1 year and
older.
4.2
DOSE AND METHOD OF ADMINISTRATION
Fluticasone propionate has a marked anti-inflammatory effect in the
lungs. It reduces
symptoms and exacerbations of asthma in patients receiving either no
prophylactic
treatment or other available anti-asthma therapy.
AXOTIDE ACCUHALER IS ADMINISTERED VIA THE INHALED ROUTE ONLY.
AXOTIDE INHALER is administered via the inhaled route only. It is
intended that each
prescribed dose is given by a minimum of 2 inhalations.
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult, a spacer
may be used with AXOTIDE Inhaler.
2
Patients should be made aware of the prophylactic nature of therapy
with inhaled fluticasone
propionate and that it should be taken regularly even when they are
asymptomatic. The
onset of therapeutic effect is within 4 to 7 days.
If patients find that relief with short-acting bronchodilator
treatment becomes less effective or
they need more inhalations than us