ARNUITY ELLIPTA fluticasone furoate 100 microgram powder for inhalation dry powder inhaler

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluticasone furoate, Quantity: 100 microgram

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Fluticasone furoate

Pharmaceutical form:

Inhalation, powder for

Composition:

Excipient Ingredients: lactose monohydrate

Administration route:

Oral

Units in package:

14 blisters (sample pack), 30 blisters

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma in patients aged 5 years and over.

Product summary:

Visual Identification: A plastic inhaler with a light grey body, an orange mouthpiece cover and a dose counter, packed in a foil tray containing a desiccant sachet. The tray is sealed with a peelable foil lid.; Container Type: Inhaler - dry powder; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2015-09-11

Patient Information leaflet

ARNUITY ELLIPTA
_Fluticasone furoate 50, 100 or 200 micrograms per inhalation_
AUSTRALIAN CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using ARNUITY
ELLIPTA.
This leaflet answers some common
questions about ARNUITY
ELLIPTA.
It does not contain all 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 ARNUITY
ELLIPTA against the benefits they
expect it will 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 ARNUITY
ELLIPTA IS USED FOR
ARNUITY ELLIPTA is used to treat
asthma in patients 5 years and over.
To use ARNUITY ELLIPTA, you
breathe it into your lungs through
your mouth using the ELLIPTA
inhaler.
Asthma is when the muscles
surrounding the smaller airways
become tight (bronchoconstriction),
swollen and irritated (inflammation).
Symptoms come and go and include
shortness of breath, wheezing, chest
tightness and cough.
ARNUITY ELLIPTA contains the
active ingredient fluticasone furoate.
Fluticasone furoate belongs to a
group of medicines called
corticosteroids, often simply called
steroids. Corticosteroids are used to
reduce inflammation. They reduce
the swelling and irritation in the
small air passages in the lungs and so
ease breathing problems.
Corticosteroids also help to prevent
attacks of asthma.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
ARNUITY ELLIPTA should not be
used in children under the age of 5
years.
BEFORE YOU USE
ARNUITY ELLIPTA
Your doctor has weighed any risks of
you using ARNUITY ELLIPTA
against the benefits they expect it
will have for you. You can talk to

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
ARNUITY ELLIPTA
1.
NAME OF THE MEDICINE
Fluticasone furoate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each foil strip contains regularly distributed blisters containing 50,
100 or 200 micrograms
of fluticasone furoate.
EXCIPIENTS WITH KNOWN EFFECT:
Lactose monohydrate (which contains milk protein). There are 12.5
milligrams of lactose
monohydrate per dose.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Powder for inhalation
White powder in a light grey inhaler (Ellipta) with a pale orange
mouthpiece cover and a
dose counter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARNUITY ELLIPTA is indicated for the maintenance treatment of asthma
in patients aged
≥5 years.
4.2
DOSE AND METHOD OF ADMINISTRATION
ARNUITY ELLIPTA is for oral inhalation only.
ARNUITY ELLIPTA should be administered once daily either morning or
evening but at
the same time every day.
Do not use ARNUITY ELLIPTA more than once every 24 hours. If symptoms
arise
between doses, an inhaled short-acting beta
2
-agonist should be used for immediate relief.
The starting dosage for ARNUITY ELLIPTA is based upon patients’
asthma severity and
age. After inhalation, the patient should rinse their mouth with water
without swallowing.
Patients should be made aware that fluticasone furoate must be used
regularly, even
when asymptomatic.
2
Patients should be regularly reassessed by a healthcare professional
so that the dose of
fluticasone furoate they are receiving remains optimal and is only
changed on medical
advice.
To minimise adverse reactions, inhaled corticosteroids should be used
at the lowest dose
that maintains symptom control.
Prescribers should be aware that fluticasone furoate is a novel
inhaled corticosteroid with
different dosing requirements to older inhaled corticosteroids
including fluticasone
propionate.
DOSE
Adults and adolescents aged 12 years and over
100 or 200 micrograms of ARNUITY ELLIPTA once daily.
The usual recommended starting dose for patients n