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Salfluae Forspiro

Document: Salfluae Forspiro Inhalation powder, pre-dispensed, ENG SmPC change

Summary of Product Characteristics


1. NAME OF THE MEDICINAL PRODUCT


Salfluae Forspiro, 50 microgram/500 microgram/dose, inhalation powder, pre-dispensed


2. QUALITATIVE AND QUANTITATIVE COMPOSITION


Each metered dose of Salfluae Forspiro provides:
For 50 microgram/500 microgram/dose, inhalation powder, pre-dispensed:

50 micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms of fluticasone propionate.

Corresponding with a delivered dose of:

45 micrograms of salmeterol (as salmeterol xinafoate) and 465 micrograms of fluticasone propionate


Excipient with known effect: lactose monohydrate: 11.95 mg per metered dose.

For the full list of excipients, see section 6.1.


3. PHARMACEUTICAL FORM


Inhalation powder, pre-dispensed.


White, homogenous powder.


The pre-dispensed powder, contained in blister, is delivered by a purple plastic dry-powder inhalation device.


4. CLINICAL PARTICULARS


4.1 Therapeutic indications


Salfluae Forspiro is indicated for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD), with a FEV1<60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations and who have significant symptoms despite regular bronchodilator therapy.


Salfluae Forspiro is intended for use by adults 18 years of age and older only.


4.2 Posology and method of administration


Method of administration:Inhalation use


Patients should be made aware that Salfluae Forspiro must be used regularly, every day for optimum benefit, even when asymptomatic.


Salfluae Forspiro is available in the strength of 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate per metered dose only.


Posology

Recommended doses:


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 Salfluae Forspiro in patients with hepatic impairment.


Paediatric population:

Salfluae Forspirois not for use in children and adolescents less than 18 years of age.


Instructions for use:

Patients should be demonstrated how to use the Forspiroinhaler and correct use should be checked regularly.

The inhaler contains 60 doses of powder medication in a coiled strip of foil. It has a dose counter which indicates how many doses are left counting down from 60 to 0. When the last 10 doses have been reached the numbers will be on a red background.

The inhaler is not refillable – it should be disposed of when it is empty and be replaced with a new one.



Before using the inhaler