Salflumix Easyhaler Dosage/Direction for Use

Posology: Patients should be made aware that Salflumix Easyhaler must be used daily for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the strength of Salflumix Easyhaler they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. For dosages which cannot be achieved with Salflumix Easyhaler (i.e. 50 micrograms salmeterol and 100 micrograms fluticasone propionate) other fixed-dose combination products containing these two active ingredients are available.
Where the control of symptoms is maintained with the lowest strength of the combination given twice daily then the next step could include a test of inhaled corticosteroid alone. As an alternative, patients requiring a long-acting β₂ agonist could be titrated to Salflumix Easyhaler given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control. In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly daytime symptoms the dose should be given in the morning.
Patients should be given the strength of Salflumix Easyhaler containing the appropriate fluticasone propionate dosage for the severity of their disease. If an individual patient should require dosages outside the recommended regimen, appropriate doses of β₂ agonist and/or corticosteroid should be prescribed.
Recommended Doses: Asthma: Adults and adolescents 12 years and older: One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily or one inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
A short-term trial of salmeterol/fluticasone propionate may be considered as initial maintenance therapy in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential. In these cases, the recommended initial dose is one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily, a strength which is available for other similar fixed-dose combination products containing these two active ingredients. Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone. Regular review of patients as treatment is stepped down is important.
A clear benefit has not been shown as compared to inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing. In general inhaled corticosteroids remain the first line treatment for most patients. Salflumix Easyhaler is not intended for the initial management of mild asthma. Salmeterol/fluticasone propionate 50 microgram/100 micrograms strength is not appropriate in adults and children with severe asthma; it is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-combination can be used in patients with severe asthma.
Paediatric population: Salflumix Easyhaler should not be used in children younger than 12 years.
COPD: Adults: One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
Special patient groups: There is no need to adjust the dose in elderly patients or in those with renal impairment. There are no data available for use of Salflumix Easyhaler in patients with hepatic impairment.
Method of administration: Inhalation use.
Instructions for correct use of Salflumix Easyhaler: The inhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note: It is important to instruct the patient: To carefully read the instructions for use in the patient information leaflet which is packed together with each Salflumix Easyhaler.
To hold the inhaler upright, gripping it between finger and thumb.
To vigorously shake the inhaler up and down 3 to 5 times before actuation.
To actuate (click) the inhaler before inhalation.
To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
To hold breath after inhaling for at least 5 seconds.
Never to breathe out through the mouthpiece as this will result in a reduction in the delivered dose. Should this happen the patient is instructed to tap the mouthpiece onto a table top or the palm of a hand to empty the powder, and then to repeat the dosing procedure.
Never to actuate the device more than once without inhalation of the powder. Should this happen the patient is instructed to tap the mouthpiece onto a table top or the palm of a hand to empty the powder, and then to repeat the dosing procedure.
To always replace the dust cap (and, if in use, close the protective cover) after use to prevent accidental actuation of the device (which could result in either overdosing or under dosing the patient when subsequently used).
To rinse the mouth out with water and/or brush teeth after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
Water should never be used for cleaning the inhaler because the powder is sensitive to moisture.
To replace Salflumix Easyhaler when the counter reaches zero even though powder could still be observed within the inhaler.