Setirenol

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Document: Setirenol inhalation powder, pre-dispensed ENG SmPC change

Summary of Product Characteristics

1. NAME OF THE MEDICINAL PRODUCT

Setirenol, 50 microgram/250 microgram/dose, inhalation powder, predispensed

Setirenol, 50 microgram/500 microgram/dose, inhalation powder, predispensed

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each metered dose of Setirenolprovides:
For 50 microgram/250 microgram/dose, inhalation powder, predispensed:

50 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate

Corresponding with a delivered dose of:

45 micrograms of Salmeterol (as salmeterol xinafoate) and 233 micrograms of fluticasone propionate

Excipient with known effect: lactose monohydrate: 12.20 mg per metered dose

Each metered dose of Setirenol provides:
For 50 microgram/500 microgram/dose, inhalation powder, predispensed:

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

Asthma

Setirenol is indicated in the regular treatment of asthma where use of a combination product (long-acting β₂agonist and inhaled corticosteroid) is appropriate:

patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short acting β₂ agonist

patients already adequately controlled on both inhaled corticosteroid and long-acting β₂ agonist.

Chronic Obstructive Pulmonary Disease (COPD)

Setirenol is indicated for the symptomatic treatment of patients with COPD, with a FEV₁<60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

4.2 Posology and method of administration

Method of administration:
Setirenol is for inhalation use only.

Patients should be made aware that Setirenol must be used daily for optimum benefit, even when asymptomatic.

Patients should be regularly reassessed by a doctor, so that the strength of Setirenol 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. 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 β₂agonist could be titrated to Setirenol 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 Setirenol 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 β₂agonist and/or corticosteroid should be prescribed.

Posology:

Recommended Doses:

Asthma

Adults and adolescents 12 years and older:

One inhalation of 250 micrograms fluticasone propionate and 50 micrograms salmeterol twice daily.

One inhalation of 500 micrograms fluticasone propionate and 50 micrograms salmeterol twice daily.

A short term trial of Setirenol 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 100 micrograms fluticasone propionate and 50 micrograms salmeterol (given singly or as fixed combination) twice daily.

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. Setirenol 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.

For dosages, which cannot be achieved with Setirenol other strengths of salmeterol/fluticasone medicinal products are available.

COPD

Adults:

One inhalation of 500 micrograms fluticasone propionate and 50 micrograms salmeterol 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 Setirenol in patients with hepatic impairment.

Paediatric population:

Asthma:

Setirenol should not be used in children.

COPD:

Setirenolshould not be used in children and adolescents.

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

The transparent side chamber door should be opened.
The foil strip should be removed from the side chamber by carefully tearing away the full length of strip against the ‘teeth’ of the side chamber as shown below. The strip should not be pulled or tugged.