SALFLUMIX EASYHALER INHALATION POWDER 50µG/500µG/DOSE

4.1 Therapeutic indications

Asthma

Salflumix Easyhaler is indicated in the regular treatment of asthma in adults and adolescents 12 years and over where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate.

Chronic Obstructive Pulmonary Disease (COPD)

Salflumix Easyhaler is indicated for the symptomatic treatment of patients with COPD, and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

4.3 Contraindications

Hypersensitivity to the active substances or to the excipient listed in section 6.1 (lactose, which contains small amounts of milk protein) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.2 Posology and method of administration

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.

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.

If a patient is inadequately controlled on inhaled corticosteroid therapy alone, substitution with Salflumix Easyhaler at a therapeutically equivalent corticosteroid dose may result in an improvement in asthma control.

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.

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 or 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.