FLIXONASE Nasal spray Ref.[27690] Active ingredients: Fluticasone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Glaxo Wellcome UK Limited trading as: GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Product name and form

Flixonase Aqueous Nasal Spray.

Pharmaceutical Form

Aqueous suspension for intranasal inhalation via metered dose atomising pump.

Qualitative and quantitative composition

Aqueous suspension of 0.05% w/w micronised fluticasone propionate. Each metered dose contains 50 micrograms of fluticasone propionate.

Excipient with known effect:

Benzalkonium Chloride

For the full list of excipients, see section 6.1.

Active Ingredient Description
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

Glucose (anhydrous)
Cellulose microcrystalline
Carmellose sodium
Phenylethyl alcohol
Benzalkonium chloride
Polysorbate 80
Water purified

Pack sizes and marketing

Flixonase Aqueous Nasal Spray is supplied in an amber glass bottle fitted with a metering, atomising pump. Pack size of 120 and 150 metered sprays.

Not all pack sizes may be marketed.

Marketing authorization holder

Glaxo Wellcome UK Limited trading as: GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS

Marketing authorization dates and numbers

PL 10949/0036

Date of first authorisation: 08th March 1990
Date of latest renewal: 13th September 2005

Drugs

Drug Countries
FLIXONASE Austria, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, South Africa
 
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