BREO ELLIPTA fluticasone furoate 200 microgram / vilanterol (as trifenatate) 25 microgram powder for inhalation

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluticasone furoate, Quantity: 200 microgram; vilanterol trifenatate, Quantity: 40 microgram (Equivalent: vilanterol, Qty 25 microgram)

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Fluticasone furoate,Vilanterol trifenatate

Pharmaceutical form:

Inhalation, powder for

Composition:

Excipient Ingredients: magnesium stearate; lactose monohydrate

Administration route:

Inhalation

Units in package:

30, 14

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Asthma,Breo Ellipta is indicated in the regular treatment of moderate to severe asthma in patients who require a medium to high dose inhaled corticosteroid combined with a long-acting beta-2-agonist.,Vilanterol, an active ingredient in Breo Ellipta, is a long-acting beta-2-agonist (LABA). A class effect of all LABAs can be an increased risk of asthma death (see Precautions).

Product summary:

Visual Identification: A plastic inhaler with light grey body, pale blue mouthpiece cover and a dose counter, containing two strips of blisters each containing a white powder; 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:

2014-04-17

Patient Information leaflet

BREO ELLIPTA
_Fluticasone furoate 100 or 200 micrograms and vilanterol (as
trifenatate) 25 micrograms per inhalation_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using BREO
ELLIPTA.
This leaflet answers some common
questions about BREO 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 BREO
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 BREO ELLIPTA
IS USED FOR
BREO ELLIPTA is used to treat
asthma and chronic obstructive
pulmonary disease (COPD). To use
BREO 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.
COPD is a long-term condition that
slowly gets worse. Symptoms
include shortness of breath, cough,
chest discomfort and coughing up
mucus. BREO ELLIPTA has been
shown to reduce flare-ups of COPD
symptoms.
BREO ELLIPTA contains two active
ingredients: fluticasone furoate and
vilanterol trifenatate.
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.
Vilanterol trifenatate belongs to a
group of medicines called
bronchodilators. It relaxes the
muscles of the small air passages in
the lungs. This helps to open the
airways and makes it easier for air to
get in and out of the lungs. When it is
taken regul

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
BREO ELLIPTA (FLUTICASONE FUROATE/VILANTEROL TRIFENATATE) POWDER
FOR INHALATION
1
NAME OF THE MEDICINE
Fluticasone furoate/vilanterol trifenatate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BREO ELLIPTA 100/25: Each foil strip contains regularly distributed
blisters with one strip
containing a powder formulation of 100 micrograms of fluticasone
furoate and the other strip
containing 25 micrograms of vilanterol (as trifenatate). Each
delivered dose (the dose
leaving the mouthpiece) contains of 92 micrograms of fluticasone
furoate and 22 micrograms
of vilanterol (as trifenatate).
BREO ELLIPTA 200/25: Each foil strip contains regularly distributed
blisters with one strip
containing a powder formulation of 200 micrograms of fluticasone
furoate and the other strip
containing 25 micrograms of vilanterol (as trifenatate). Each
delivered dose (the dose
leaving the mouthpiece) contains of 184 micrograms of fluticasone
furoate and
22 micrograms of vilanterol (as trifenatate)._ _
Excipients with known effect
BREO ELLIPTA 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
Powder for inhalation.
White powder in a light grey inhaler (Ellipta) with a pale blue
mouthpiece cover and a dose
counter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
COPD
BREO ELLIPTA is indicated for symptomatic treatment of patients with
COPD with a FEV
1
<70% predicted normal (post-bronchodilator) in patients with an
exacerbation history despite
regular bronchodilator therapy.
BREO ELLIPTA is not indicated for the initiation of bronchodilator
therapy in COPD.
2
ASTHMA
BREO ELLIPTA is indicated in the regular treatment of moderate to
severe asthma in
patients who require a medium to high dose inhaled corticosteroid
combined with a long-
acting beta
2
-agonist.
Vilanterol, an active ingredient in BREO ELLIPTA, is a long-acting
beta
2
-agonist (LABA). A
class effect of all LABAs can be an increased risk o