Flaxxone Forspiro
Summary of Product Characteristics
1. NAME OF THE MEDICINAL PRODUCT
Flaxxone Forspiro, 50 microgram/250 microgram/dose, inhalation powder, predispensed
Flaxxone Forspiro, 50 microgram/500 microgram/dose, inhalation powder, predispensed
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose of Flaxxone Forspiroprovides:
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 Flaxxone Forspiro
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
Flaxxone Forspiro 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
or
patients already adequately controlled on both inhaled corticosteroid and long-acting β2 agonist.
Chronic Obstructive Pulmonary Disease (COPD)
Flaxxone Forspiro 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:
Flaxxone Forspiro is for inhalation use only.
Patients should be made aware that Flaxxone Forspiro must be used daily for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the strength of Flaxxone Forspiro 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 Flaxxone Forspiro 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 Flaxxone Forspirocontaining the appropriate fluticasone propionate dosage for the severity of their disease. Prescribers should be aware that, in patients with asthma, fluticasone propionate is as effective as other inhaled steroids at approximately half the microgram daily dose. For example, 100 micrograms of fluticasone propionate is approximately equivalent to 200 micrograms of beclomethasone dipropionate (CFC containing) or budesonide. 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.
or
One inhalation of 500 micrograms fluticasone propionate and 50 micrograms salmeterol twice daily.
A short term trial of Flaxxone Forspiro 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. Flaxxone Forspiro 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 Flaxxone Forspiro 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 Flaxxone Forspiroin patients with hepatic impairment.
Paediatric population:
Asthma:
Flaxxone Forspiroshould not be used in children.
COPD:
Flaxxone Forspiroshould 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.
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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.