FLUTIFORM Pressurised inhalation, suspension Ref.[28075] Active ingredients: Eformoterol Fluticasone

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, United Kingdom, CB4 0GW

Product name and form

Flutiform 50 microgram/5 microgram, 125 microgram/5 microgram and 250 microgram/10 microgram per actuation pressurised inhalation, suspension.

Pharmaceutical Form
Pressurised inhalation, suspension. The canister contains white to off white liquid suspension. The canister is in a white actuator with a grey integrated dose indicator and a light grey mouthpiece cover.

Qualitative and quantitative composition

Each metered dose (ex-valve) contains:

50 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 46 micrograms of fluticasone propionate and 4.5 micrograms of formoterol fumarate dihydrate.
125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 115 micrograms of fluticasone propionate and 4.5 micrograms of formoterol fumarate dihydrate.
250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 230 micrograms of fluticasone propionate and 9.0 micrograms of formoterol fumarate dihydrate.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Eformoterol	Formoterol is a predominantly selective β₂-stimulator. Formoterol has bronchodilator activity in patients with reversible obstructive airway diseases. In humans formoterol is effective in the prophylaxis of bronchospasm induced by methacholine challenge.
Fluticasone	Fluticasone has anti-inflammatory and vasoconstrictive features. Fluticasone given by inhalation at recommended doses has a potent glucocorticoid anti-inflammatory action within the lungs, resulting in a reduction of both symptoms and exacerbations of asthma, with a lower incidence and severity of adverse effects than those observed when corticosteroids are administered systemically.

List of Excipients
Sodium cromoglicate Ethanol anhydrous Apaflurane HFA 227

Pack sizes and marketing

120 actuations per inhaler.

The actuator is white with a grey integrated dose indicator and a light grey mouthpiece cover. The suspension is contained in an aluminium pressurised canister crimped with a standard metering valve. This canister is inserted into a press-and-breathe actuator fitted with a mouthpiece cover (both made of polypropylene) and an integrated dose indicator which indicates the number of actuations (puffs) remaining. Each container delivers 120 actuations. The assembled MDI inhaler is pouched in an aluminium foil laminate and is packed in a cardboard carton.

Pack sizes:

1 inhaler (120 actuations)

multipack of 3 × 1 inhaler (120 actuations)

Not all pack sizes may be marketed.

Marketing authorization holder

Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, United Kingdom, CB4 0GW

Marketing authorization dates and numbers

PL 16950/0167-0169

22/08/12

Drugs

Drug	Countries
FLUTIFORM	Austria, Australia, Cyprus, Germany, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Nigeria, Netherlands, Poland, Romania, Singapore, United Kingdom

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