FLUTIFORM

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluticasone propionate, Quantity: 40 mg; formoterol fumarate dihydrate, Quantity: 1.6 mg

Available from:

Mundipharma Pty Ltd

INN (International Name):

fluticasone propionate,formoterol (eformoterol) fumarate dihydrate

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: ethanol absolute; sodium cromoglycate; apaflurane

Administration route:

Inhalation

Units in package:

120 actuations per inhaler

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

FLUTIFORM inhaler is indicated for the regular maintenance treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting beta2-agonist) is appropriate. This includes patients not adequately controlled with inhaled corticosteroids and inhaled short-acting beta2-agonist on an ?as required? basis.

Product summary:

Visual Identification: white slurry residue after propellant evaporation, free of agglomerates; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-06-14

Patient Information leaflet

FLUTIFORM
® INHALER
_Fluticasone propionate/formoterol (eformoterol) fumarate dihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about FLUTIFORM
pressurised inhalation ("inhaler").
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 using FLUTIFORM
inhaler against the benefits they
expect it will 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 FLUTIFORM
INHALER IS USED FOR
FLUTIFORM inhaler is used to help
with asthma in people who need
regular treatment.
Asthma is a disease where the lining
of the lungs become inflamed (red
and swollen), making it difficult to
breathe. This may be due to an
allergy to house dust mites, smoke,
air-borne pollution or other irritants.
Symptoms of asthma include
shortness of breath, wheezing, chest
tightness and cough.
FLUTIFORM inhaler contains two
different medicines called fluticasone
propionate and formoterol
(eformoterol) fumarate dihydrate.
Fluticasone propionate belongs to a
group of medicines known as
corticosteroids, frequently called
'steroids'. They are not 'anabolic
steroids' which are sometimes
misused by athletes. Corticosteroids
help to reduce swelling and
inflammation in the lungs.
Formoterol (Eformoterol) fumarate
dihydrate belongs to a group of
medicines known as long-acting
beta-2-agonists. Beta-2-agonists help
the airways in your lungs to stay
open, making it easier for you to
breathe.
When used together regularly,
fluticasone propionate and
formoterol (eformoterol) fumarate
dihydrate help to control your asthma
symptoms and prevent asthma
attacks. FLUTIFORM inhaler is
known as a 'preventer'. It does not
work if you are already having an
asthma attack, i.e. you are already
wheezing and breathless. You will
need to use a fast acting 'reliever'

Summary of Product characteristics

FLUTIFORM
®
PRESSURISED METERED DOSE INHALER
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION – FLUTIFORM
® [FLUTICASONE
PROPIONATE/FORMOTEROL (EFORMOTEROL) FUMARATE
DIHYDRATE] PRESSURISED METERED DOSE INHALER
1
NAME OF THE MEDICINE
Fluticasone propionate and eformoterol fumarate dihydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Fluticasone propionate_: It is a white to almost white powder,
practically insoluble in water, slightly
soluble in alcohol and sparingly soluble in dichloromethane.
_Eformoterol fumarate dihydrate_: It is a white to almost white or
yellowish powder. It is slightly
soluble in water, sparingly soluble in isopropyl alcohol, soluble in
methanol and practically
insoluble in acetonitrile.
_FLUTIFORM_ _inhaler_: FLUTIFORM
pressurised inhalation (‘inhaler’) is a white to off-white liquid
suspension inside a pressurised metal canister. The inactive
ingredients are sodium cromoglycate,
absolute ethanol and apaflurane (HFA 227). The active ingredients
delivered by each metered dose
from the canister valve are given in the table below:
STRENGTHS (MICROGRAMS)
ACTIVE INGREDIENTS DELIVERED PER ACTUATION
FLUTIFORM 50/5
50 micrograms of fluticasone propionate and 5 micrograms of
eformoterol fumarate dihydrate (equivalent to an ex-actuator
delivered dose of approximately 46 micrograms of fluticasone
propionate and 4.5 micrograms of eformoterol fumarate
dihydrate).
FLUTIFORM 125/5
125 micrograms of fluticasone propionate and 5 micrograms of
eformoterol fumarate dihydrate (equivalent to an ex-actuator
delivered dose of approximately 115 micrograms of fluticasone
propionate and 4.5 micrograms of eformoterol fumarate
dihydrate).
FLUTIFORM 250/10
250 micrograms of fluticasone propionate and 10 micrograms of
eformoterol fumarate dihydrate (equivalent to an ex-actuator
delivered dose of approximately 230 micrograms of fluticasone
propionate and 9 micrograms of eformoterol fumarate
dihydrate).
3
PHARMACEUTICAL FORM
FLUTIFORM pressurised inhalation is contained in an aluminium
pressurised canister crimped
wi