Fixkoh Airmaster® Prescribing Information
Please refer to the appropriate Summary of Product Characteristics (SmPC) before prescribing.
Fixkoh Airmaster 50 microgram/100 microgram/ dose inhalation powder, pre-dispensed. Single inhalation provides a delivered dose of 47 micrograms of salmeterol (as salmeterol xinafoate) and 92 micrograms of fluticasone propionate. Corresponds to a pre-metered dose of 50 micrograms of salmeterol and 100 micrograms fluticasone propionate. Fixkoh Airmaster 50 microgram/250 microgram/ dose inhalation powder, pre-dispensed. Single inhalation provides a delivered dose of 45 micrograms of salmeterol (as salmeterol xinafoate) and 229 micrograms of fluticasone propionate. Corresponds to a pre-metered dose of 50 micrograms of salmeterol and 250 micrograms fluticasone propionate. Fixkoh Airmaster 50 microgram/500 microgram/ dose inhalation powder, pre-dispensed. Single inhalation provides a delivered dose of 43 micrograms of salmeterol (as salmeterol xinafoate) and 432 micrograms of fluticasone propionate. Corresponds to a pre-metered dose of 50 micrograms of salmeterol and 500 micrograms fluticasone propionate.
Presentation: Inhalation powder, pre-dispensed.
Indication: Fixkoh Airmaster is indicated in adults and adolescents 12 years of age and older. Asthma: For the regular treatment of asthma where use of a combination product (long- acting β2 agonist and inhaled corticosteroid) is appropriate. In 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. Fixkoh Airmaster 50 microgram/100 micrograms is not appropriate in adults and children with severe asthma. Chronic Obstructive Pulmonary Disease (COPD): 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: Fixkoh Airmaster must be used daily for optimal benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so the strength 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, steps could include a test of inhaled corticosteroid alone. Recommended Doses: Asthma: Adults and adolescents 12 years and older: One inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily or one inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily or one inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily.
A short-term trial of Fixkoh Airmaster may be considered as initial maintenance therapy with moderate persistent asthma for whom rapid control of asthma is essential. The recommended initial dose is one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. Once control of asthma is attained treatment should be reviewed and consideration given to use of an inhaled corticosteroid alone. Regular review of patients as treatment is stepped down is important. Fixkoh Airmaster is not intended for the initial management of mild asthma. COPD: Adults: One inhalation of 50 micrograms salmeterol and 500 micrograms fluticasone propionate twice daily. Method of administration: Inhalation use. Patients must also be advised to rinse their mouth afterwards with water and spit it out and/or brush their teeth after inhaling.
Contraindications: Hypersensitivity to the active substances or to any of the excipients.
Warnings and Precautions: Deterioration of disease: Fixkoh Airmaster should not be used to treat acute asthma symptoms for which a fast- and short- acting bronchodilator is required. Patients should be advised to have their inhaler available at all times for relief in an acute asthma attack.
Patients should not be initiated on Fixkoh Airmaster during an exacerbation, or if they have significantly worsened or acutely deteriorating asthma.
Serious asthma-related adverse events and exacerbations may occur during treatment. Patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen. Increased requirements for use of reliever medication or decreased response to reliever medication indicate deterioration of control and patients should be reviewed by a physician. Sudden and progressive deterioration in control of asthma is potentially life-threatening and the patient should undergo urgent medical assessment. Once asthma symptoms are controlled, consider gradually reducing the dose. Regular review of patients as treatment is stepped down is important. For patients with COPD experiencing exacerbations, treatment with systemic corticosteroids is indicated, therefore patients should be instructed to seek medical attention if symptoms deteriorate. Cessation of therapy: Treatment should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down titrated under supervision. For patients with COPD cessation of therapy may be associated with symptomatic decompensation and should be supervised by a physician. Caution with special diseases: Administer with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral, or other infections of the airway. Cardiovascular effects: May cause cardiac arrhythmias e.g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. Use 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 serum potassium levels. Hyperglycaemia: Use with caution in patients with a history of diabetes mellitus. Paradoxical bronchospasm: may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway. Fixkoh Airmaster should be discontinued immediately. Beta 2 adrenoreceptor agonists: Side effects of β2 agonist treatment, such as tremor, palpitations, and headache, have been reported, but tend to be transient and reduce with regular therapy. Systemic corticosteroid effects: Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, cataract, and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression, or aggression (particularly in children). The patient should be reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained. Adrenal function: Prolonged treatment with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Patients transferring from oral steroids may be at risk of impaired adrenal reserve for a considerable time and should be treated with special care with adrenocortical function regularly monitored. Patients who have required high dose emergency corticosteroid therapy may also be at risk. The possibility of residual impairment should be borne in mind in emergency and elective situations likely to produce stress. Visual disturbance: If a patient presents with symptoms such as blurred vision or other visual disturbances, refer to an ophthalmologist for evaluation. Consideration should be given to referring the adolescent to a paediatric respiratory specialist. It is recommended that the height of adolescents receiving prolonged treatment with inhaled corticosteroid is regularly monitored. The dose of inhaled corticosteroid should be reduced to the lowest dose at which effective control of asthma is maintained. Contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pregnancy and breastfeeding: Administration of Fixkoh Airmaster to pregnant women should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus. The lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women. Breastfeeding: A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue Fixkoh Airmaster therapy considering the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Undesirable effects: Serious common side effects: Pneumonia (in COPD patients), hypokalaemia. Other serious side effects: Oesophageal candidiasis, anaphylactic reactions including anaphylactic shock, Cushing’s syndrome, adrenal suppression, cataract, glaucoma, cardiac arrhythmias, atrial fibrillation, angina pectoris. Other very common side effects: Headache, nasopharyngitis. Other common side effects: Candidiasis of the mouth and throat, bronchitis, throat irritation, hoarseness/dysphonia, sinusitis, contusions, muscle cramps, traumatic fractures, arthralgia, myalgia. For full list of side effects, consult SmPC.
Legal Category: POM
Pack size: 1× 60 dose Fixkoh Airmaster, 2 x 60 dose Fixkoh Airmaster, 3 x 60 dose Fixkoh Airmaster, 10 x 60 dose Fixkoh Airmaster
Price: 50/100mcg £14.47; Fixkoh Airmaster 50/250mcg £19.29; Fixkoh Airmaster 50/500mcg £16.12
MA Numbers: PL 06831/0434, PL 06831/0435, PL 06831/0436
MA Holder: Genus Pharmaceuticals Ltd. (trading as ‘STADA’), Linthwaite, Huddersfield, HD7 5QH, UK
Date of preparation: September 2025
Unique ID no. UK-FIXK-133(3)