Presentation and Composition: Each delivered dose contains 45 mcg salmeterol and 229 mcg fluticasone propionate (corresponds to pre-metered dose of 50 mcg salmeterol and 250 mcg fluticasone propionate). An inhalation powder, pre- dispensed, white to off white inhalation powder. Indication: For adults and adolescents ≥12 years of age, in the regular treatment of asthma where use of a combination product (long- acting β2 agonist and inhaled corticosteroid) is appropriate, for 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 (note: Campona Airmaster 50 mcg/100 mcg strength is not appropriate in adults and children with severe asthma). Dosage: Asthma in adults and adolescents ≥12 years: one inhalation of 50 mcg salmeterol and 100 mcg fluticasone propionate twice daily or one inhalation of 50 mcg salmeterol and 250 mcg fluticasone propionate twice daily. Please consult Summary of Product Characteristics for dosing of patients 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. Paediatric population: Not recommended for use in children aged under 12 years of age. Safety and efficacy in children <12 years of age has not been established. Special patient groups: No need to adjust the dose in elderly patients or in those with renal impairment. No data available for use in patients with hepatic impairment. Administration: Used daily for optimal benefit, even when asymptomatic. Titrate to lowest dose at which effective control of symptoms is maintained. When achieved as twice daily dosing, next step includes a test of inhaled corticosteroid alone. Alternatively, patients requiring long acting β2 agonist could be titrated to Campona Airmaster 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. Contraindications: Hypersensitivity to the active substances or to any of the excipients (lactose monohydrate). Warnings and Precautions: Deterioration of disease: Should not be used to treat acute asthma symptoms for which a fast- and short- acting bronchodilator is required. Patients should not be initiated during an exacerbation, or if they have significantly worsened or acutely deteriorating asthma. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation. Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of control and patients should be reviewed by a physician. Cessation of therapy: Treatment should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down titrated under physician supervision. Caution with special diseases: Should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral, or other infections of the airway. Appropriate treatment should be promptly instituted, if indicated. Cardiovascular effects: Rarely, may cause cardiac arrhythmias. Campona Airmaster 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. Hyperglycaemia: Very rare reports of increases in blood glucose levels. This should be considered when prescribing to patients with a history of diabetes mellitus. Paradoxical bronchospasm: 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. Campona Airmaster should be discontinued immediately, patient assessed, and alternative therapy instituted if necessary. Beta 2 adrenoreceptor agonists: Pharmacological 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. Excipients: Campona Airmaster contains approximately 13 mg/dose of lactose monohydrate which may cause allergic reactions. Systemic corticosteroid effects: Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. 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. Important the patient is reviewed regularly, and the dose of inhaled corticosteroid is reduced to 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. Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures. Interactions with other medicinal products: Ritonavir can increase the concentration of fluticasone propionate in plasma. Therefore, concomitant use should be avoided, unless potential benefit to the patient outweighs the risk of systemic corticosteroid side effects. There is also an increased risk of systemic side effects when combining fluticasone propionate with other potent CYP3A inhibitors. Concomitant use of systemic ketoconazole significantly increases systemic exposure to salmeterol. This may increase the incidence of systemic effects. Concomitant treatment with ketoconazole or other potent CYP3A4 inhibitors should, therefore, be avoided unless benefits outweigh the potentially increased risk of systemic undesirable effects of salmeterol treatment. Visual disturbance: Visual disturbance may be reported with systemic and topical corticosteroid use. If Campona Airmaster® 50 microgram/100 microgram/dose inhalation powder, pre-dispensed. Campona Airmaster® 50 microgram/250 microgram/dose inhalation powder, pre-dispensed. Campona Airmaster® 50 microgram/500 microgram/dose inhalation powder, pre-dispensed. Please consult Summary of Product Characteristics (SmPC) before prescribing. 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 of possible causes which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Paediatric population: Adolescents <16 years taking high doses of fluticasone propionate (typically ≥1,000 micrograms/day) may be at particular risk. Possible systemic effects include 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. Recommended that the height of adolescent receiving prolonged treatment with inhaled corticosteroid is regularly monitored. Interactions: β adrenergic blockers may weaken or antagonise the effect of salmeterol. Both non- selective and selective β blockers should be avoided unless there are compelling reasons for their use. Potentially serious hypokalaemia may result from β2 agonist therapy. Fluticasone Propionate: Low plasma concentrations of fluticasone propionate are achieved after inhaled dosing, due to extensive first pass metabolism and high systemic clearance mediated by cytochrome CYP3A4 in the gut and liver. Hence, clinically significant interactions with other active substances mediated by fluticasone propionate are unlikely. Salmeterol: Potent CYP3A4 inhibitors: Concomitant administration of ketoconazole should be avoided unless benefits outweigh the potentially increased risk of systemic side effects of salmeterol treatment. There is likely to be a similar risk of interaction with other potent CYP3A4 inhibitors (e.g. itraconazole, telithromycin, ritonavir). Moderate CYP 3A4 inhibitors: Co- administration with erythromycin was not associated with any serious adverse effects. Fertility, Pregnancy and Lactation: Fertility: No data in humans. Animal studies showed no effects of salmeterol or fluticasone propionate on fertility. Pregnancy: Data on pregnant women indicates no malformative or feto/neonatal toxicity related to salmeterol and fluticasone propionate. Administration to pregnant women only considered if expected benefit to the mother is greater than any possible risk to the foetus. Lowest effective dose of fluticasone propionate needed to maintain adequate asthma control should be used in the treatment of pregnant women. Breastfeeding: Unknown whether salmeterol and fluticasone propionate/metabolites are excreted in human milk. Risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue therapy, considering the benefit of breastfeeding for the child and the benefit of therapy for the woman. Undesirable effects: Very Common & Common: Infections and infestations (candidiasis of the mouth and throat), Nervous system disorders (headache), Respiratory, thoracic, and mediastinal disorders (throat irritation, hoarseness/dysphonia), Musculoskeletal and connective tissue disorders (muscle cramps, arthralgia, myalgia). Serious: Anaphylactic reactions (anaphylactic shock), cardiac arrhythmias, paradoxical bronchospasm. Prescribers should consult the summary of product characteristics in relation to other adverse reactions. Legal Classification: POM. NHS Price: Campona Airmaster 50 microgram/100 microgram/dose, inhalation powder, pre- dispensed; £7.95, Campona Airmaster 50 microgram/250 microgram/dose; £8.95, Campona Airmaster 50 microgram/500 microgram/dose, inhalation powder, pre- dispensed, £9.95. UK (Great Britain) Marketing Authorisation number: PL 28444/0242. Marketing Authorisation Holder: Activase Pharmaceuticals Limited, 11 Boumpoulinas, Nicosia, 1060, Cyprus. Job code: GPLNA23- 01. Date of Preparation: August 2023.