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...OF AN ESTABLISHED COMBINATION


An intuitive, award-winning inhaler with clear feedback for patients3-5


20% savings vs Seretide® Accuhaler®6 1,2


FOR THE TREATMENT OF COPD†


†AirFluSal Forspiro is indicated for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD), with a FEV1 <60% predicted normal (prebronchodilator) and a history of repeated exacerbations and who have significant symptoms despite regular bronchodilator therapy. AirFluSal Forspiro is intended for use by adults 18 years of age and older only.


Device not actual size Prescribing Information: AirFluSal®


(Please refer to the full Summary of Product Characteristics before prescribing)


AirFluSal® Forspiro® (salmeterol xinafoate and fluticasone propionate) Indications: AirFluSal Forspiro is indicated in 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. For use by adult patients aged 18 years and older only. Dosage and administration: Inhalation only. One inhalation b.d. of AirFluSal Forspiro 50/500 (salmeterol 50 mcg/fluticasone propionate 500 mcg) Contraindications: Hypersensitivity to the active ingredients or to any of the excipients. Precautions: Pulmonary tuberculosis, fungal, viral or other infections of the airway, severe cardiovascular disorders, heart rhythm abnormalities, diabetes mellitus, hypokalaemia and thyrotoxicosis. Increased reporting of pneumonia and bronchitis in patients with COPD receiving AirFluSal compared with placebo. If a patient with severe COPD has experienced pneumonia, treatment with AirFluSal should be re-evaluated. Paradoxical bronchospasm post-dose. Acute symptoms: Not for acute symptoms. Use short-acting inhaled bronchodilator. Systemic effects: Systemic effects of inhaled corticosteroids may occur, particularly at high doses for prolonged periods, but much less likely than with oral corticosteroids. May include Cushing’s syndrome, cushingoid features, adrenal suppression, adrenal crisis, growth retardation in children


1. AirFluSal® Forspiro® SmPC. 2. Seretide® Forspiro®


and adolescents, decrease in bone mineral density, cataract, glaucoma and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression. Tremor, palpitations and headache, have been reported with β2 agonist treatment. Treatment should not be abruptly stopped due to risk of exacerbation. Patients should not be initiated on AirFluSal during an exacerbation. Data from a large clinical trial suggested patients of black African or Afro-Caribbean ancestry were at increased risk of serious respiratory-related events or deaths when using salmeterol. All patients should continue treatment but seek medical advice if symptoms remain uncontrolled or worsen when initiated on AirFluSal or using AirFluSal. Cessation of therapy may also be associated with decompensation and should be supervised by a physician. Transfer from oral steroids: Special care needed. Consider appropriate steroid therapy in stressful situations. Drug interactions: Avoid beta-blockers. Avoid concomitant administration of ketoconazole or other potent (e.g. itraconazole, telithromycin, ritonavir) and moderate (erythromycin) CYP3A4 inhibitors unless benefits outweigh potential risk. β2 adrenergic blockers may weaken or antagonise the effect of salmeterol. Potentially serious hypokalaemia may result from β2 agonist therapy. This effect may be potentiated by concomitant treatment with xanthine derivatives, steroids and diuretics. Pregnancy and lactation: Experience limited. Balance risks against benefits. Side effects: Very Common: headache, nasopharyngitis. Common: candidiasis of the mouth


Accuhaler® SmPC. 3. Virchow JC et al. Identifying the features of an easy-


to-use and intuitive dry powder inhaler for asthma and chronic obstructive pulmonary disease therapy: results from a 28-day device handling study, and an airflow resistance study. Expert Opin Drug Deliv 2014;11(12):1849–57. 4. Red Dot Design Award. http://red-dot.de/pd/online-exhibition/work/?lang= en&code=2011-14-3170&y=2011&c=167&a=0. Last accessed September 2015. 5. Alufoil Trophy 2015: The winners. http://www.alufoil.org/alufoil-trophy-2015.html Last accessed September 2015. 6. MIMS UK September 2015.


Date of preparation: November 2015 Seretide®


and Accuhaler® are registered trademarks of the GlaxoSmithKline Group of Companies. UK/MKT/AFS/15-0066


and throat, hoarseness/dysphonia, throat irritation, pneumonia, bronchitis, hypokalaemia, sinusitis, contusions, traumatic fractures, arthralgia, myalgia, muscle cramps. Uncommon: respiratory symptoms (dyspnoea), anxiety, tremor, palpitations, tachycardia, angina pectoris, atrial fibrillation, cutaneous hypersensitivity reactions, hyperglycaemia, sleep disorders, cataract. Rare: angioedema, respiratory symptoms (bronchospasm), anaphylactic reactions including anaphylactic


shock,


Cushings syndrome, cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, oesophageal candidiasis, behavioural changes including psychomotor hyperactivity and irritability, glaucoma, cardiac arrhythmias and paradoxical bronchospasm. Not known: depression or aggression. Paradoxical bronchospasm: substitute alternative therapy. Legal category: POM. Presentation and Basic NHS cost: AirFluSal Forspiro 50/500 60 inhalations. £32.74. Product Licence (PL) no: PL 04416/1431 PL holder: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey. GU16 7SR. Last date of revision: October 2015.


Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also be reported to Sandoz Ltd, 01276 698020 or uk.drugsafety@sandoz.com


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