Fluticasone Propionate Aerosol

1. NAME OF THE MEDICINAL PRODUCTFluticasone 50 micrograms Fluticasone 125 micrograms Fluticasone 250 micrograms

2. QUALITATIVE AND QUANTITATIVE COMPOSITIONFluticasone 50 micrograms , Fluticasone 125 micrograms and Fluticasone 250 micrograms are pressurised inhalation, delivering either 50, 125 or 250 micrograms of fluticasone propionate per actuation, respectively.

3. PHARMACEUTICAL FORMPressurised inhalation

4.3 ContraindicationsHypersensitivity to any ingredient of the preparation.

4.7 OverdoseAcute : Inhalation of the drug in doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not necessitate emergency action being taken. In these patients treatment with fluticasone propionate by inhalation should be continued at a dose sufficient to control asthma adrenal function recovers in a few days and can be verified by measuring plasma cortisol.

Chronic : refer to section 4.4: risk of adrenal suppression. Monitoring of adrenal reserve may be indicated. Treatment with inhaled fluticasone propionate should be continued at a dose sufficient to control asthma.