Available in 50 / 500 mcg strength only . Indicated in COPD where FEV 1 < 60 % predicted normal ( pre-bronchodilator ) and a history of repeated exacerbations , who have significant symptoms despite regular bronchodilator therapy . 1 Indicated in patients with severe asthma 12 years of age and older only . 1
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Prescribing information for Stalpex ( salmeterol xinafoate / fluticasone propionate ) 50 microgram / 500 microgram / dose inhalation powder , pre-dispensed . Please refer to the Summary of Product Characteristics ( SmPC ) before prescribing . Indications : Asthma : Stalpex is indicated for use in patients with severe asthma 12 years of age and older only . Indicated in the regular treatment of patients with severe asthma where use of a combination product ( long-acting ß2 agonist and inhaled corticosteroid ) is appropriate : patients not adequately controlled on a lower strength corticosteroid combination product , or patients already adequately controlled on an inhaled corticosteroid in a high strength and a long-acting ß2 agonist . Chronic Obstructive Pulmonary Disease ( COPD ): Stalpex 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 . Dosage and administration : Use daily for optimum benefit , even when asymptomatic . Titrate to the lowest dose at which effective control of symptoms is maintained . Stalpex is only available in one strength therefore when titrating down , change to an alternative lower fixed-dose combination of salmeterol and fluticasone propionate . Asthma : Adults and adolescents 12 years and older : One 50 micrograms salmeterol and 500 micrograms fluticasone propionate inhalation twice daily . Once asthma is controlled , consider stepping down to a lower dose inhaled corticosteroid / LABA combination or ICS alone . In general , inhaled corticosteroids remain the first line treatment . Stalpex is not intended for the initial management of mild or moderate asthma . Children : Limited data are available . COPD : Adults : One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily . Elderly : no dose adjustment required . Renal impairment : no dose adjustment required . Hepatic impairment : no data are available for use of Stalpex in patients with hepatic impairment . Contraindications : Hypersensitivity to the active substances or to any of the excipients . Precautions : For severe asthma only ; not for acute treatment , during an exacerbation or worsening asthma . Increased use of , or decreased response to , reliever medication indicates deterioration warranting physician review . Sudden and progressive deterioration is potentially life-threatening and the patient should undergo urgent medical assessment ; consider increasing corticosteroid therapy . Once asthma symptoms are controlled , consideration may be given to gradually reducing the dose of the inhaled corticosteroid and therefore a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose . The lowest dose of inhaled corticosteroid should be used . Treatment with Stalpex should not be stopped abruptly in patients with asthma due to risk of exacerbation . Therapy should be down-titrated under physician supervision . For patients with COPD , cessation of therapy may also be associated with symptomatic decompensation and should be supervised by a physician . Caution in patients with active or quiescent pulmonary tuberculosis and fungal , viral or other infections of the airway . Stalpex should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with diabetes mellitus , thyrotoxicosis , uncorrected hypokalaemia or patients predisposed to low levels of serum potassium . Caution in diabetes mellitus ( some reports of hyperglycaemia ). If paradoxical bronchospasm develops , Stalpex should be discontinued immediately , the patient assessed and alternative therapy instituted if necessary . Ensure regular review of patients on long term or high dose treatment to obtain lowest effective dose . Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis . Triggers of acute adrenal crisis include trauma , surgery , infection or any rapid reduction in dosage . Additional systemic corticosteroid cover should
be considered during periods of stress or elective surgery . Caution in patients transferring from oral steroids as they may remain at risk of impaired adrenal reserve for a considerable time . An increase in the incidence of pneumonia has been observed in patients with COPD receiving inhaled corticosteroids . If a patient presents with symptoms such as blurred vision or other visual disturbances , the patient should be considered for referral to an ophthalmologist for evaluation . Adolescents < 16 years taking high doses of fluticasone propionate ( typically ≥ 1000 micrograms / day ) may be at particular risk . Systemic effects such as Cushing ’ s syndrome , Cushingoid features , adrenal suppression , acute adrenal crisis and growth retardation in adolescents and more rarely , a range of psychological or behavioural effects including psychomotor hyperactivity , sleep disorders , anxiety , depression or aggression may occur , particularly at high doses prescribed for long periods . Consider referring adolescents to a paediatric respiratory specialist . Regularly monitor the height of adolescents receiving prolonged treatment . Interaction with fluticasone : ß adrenergic blockers . Avoid non-selective and selective ß blockers . Potentially serious hypokalaemia may result from ß2 agonist therapy . Particular caution is advised in acute severe asthma as this effect may be potentiated by concomitant treatment with xanthine derivatives , steroids and diuretics . Avoid ritonavir ( can greatly increase plasma concentration of fluticasone propionate ). Combinations with CYP3A inhibitors should be avoided unless the benefit outweighs the potential increased risk of systemic corticosteroid side-effects , in which case patients should be monitored for systemic corticosteroid side-effects . Interaction with salmeterol : Avoid potent CYP3A4 inhibitors . Adverse reactions : Common and very common : Candidiasis of the mouth and throat , pneumonia ( in COPD patients ), bronchitis , hypokalaemia , headache , nasopharyngitis , throat irritation , hoarseness / dysphonia , sinusitis , Contusions , muscle cramps , traumatic fractures , arthralgia , myalgia . Uncommon , rare and unknown frequency serious reactions : Oesophageal candidiasis , hypersensitivity reactions with the following manifestations ; cutaneous hypersensitivity reactions , angioedema ( mainly facial and oropharyngeal oedema ), respiratory symptoms ( dyspnoea ), respiratory symptoms ( bronchospasm ), anaphylactic reactions including anaphylactic shock , Cushing ’ s syndrome , Cushingoid features , adrenal suppression , growth retardation in adolescents , decreased bone mineral density , hyperglycaemia , anxiety , sleep disorders , behavioural changes , including psychomotor hyperactivity and irritability ( predominantly in adolescents ), depression , aggression ( predominantly in adolescents ), tremor , cataract , glaucoma , blurred vision , Palpitations , tachycardia , cardiac arrhythmias ( including supraventricular tachycardia and extrasystoles ), atrial fibrillation , angina pectoris , Paradoxical bronchospasm . Please consult the summary of product characteristics for a full list of adverse reactions . Marketing authorization number : PL : 25258 / 0296 . Marketing Authorization Holder : Glenmark Pharmaceuticals Europe Limited , Laxmi House , 2B Draycott Avenue , Kenton , Middlesex , HA3 0BU , United Kingdom Distributor : As above . Legal classification : POM . Price : £ 16.37 . Job code : PP-UK-STAL-0047 Date of preparation : April 2021
Adverse events should be reported . Reporting forms and information can be found at https :// yellowcard . mhra . gov . uk . Adverse events should also be reported to Glenmark Pharmaceuticals Europe Ltd medical _ information @ glenmarkpharma . com
PIP code : Stalpex 50 / 500 mcg - 4098661
References : 1 . Stalpex Summary of Product Characteristics . 2 . BNF . July 2021 . ( See NHS indicative price ). Available at : https :// bnf . nice . org . uk / medicinalforms / fluticasone-with-salmeterol . html . Accessed July 2021 . 3 . MHRA April 2019 Public Assessment Report : Stalpex 50 / 500 Mcg UK / H / 6498 / 003 / DC . Available at : https :// mhraproducts4853 . blob . core . windows . net / docs / 77c1424dd55258e03d0555b648ea3eecbb92fc03 . Accessed July 2021 . 4 . Seretide ® Accuhaler ® Summary of Product Characteristics .
Seretide ® and Accuhaler ® are registered trademarks of the GlaxoSmithKline group of companies . Stalpex ® is a registered trademark of Glenmark Pharmaceuticals Europe Limited .
© 2021 Glenmark Pharmaceuticals Europe Ltd . All rights reserved . Date of preparation : July 2021 PP-UK-STAL-0069