(Please refer to the full SmPC before prescribing)
Indications: Regular treatment of asthma where use of a combination product (long-acting β2 agonist 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. Available strengths: 25µg/50µg; 25µg/125µg & 25µg/250µg salmeterol/fluticasone per metered dose pressurised inhalation, suspension. Dosage and method of use: Inhalation use. Adults and adolescents 12 years and older: two inhalations twice daily. Children 4 years and older: two inhalations 25 µg/50 µg twice daily. Titrate to lowest dose at which effective control of symptoms is maintained and if long-term control maintained at lowest dose, consider testing inhaled corticosteroid alone or combination once daily. Combisal 25 µg /50 µg not appropriate for adults and children with severe asthma. Maximum licensed dose of fluticasone propionate in children is 100 µg twice daily. No data in children under 4 years. AeroChamber Plus® spacer device can be used. This may increase drug delivery to lungs with increase in risk of systemic adverse effects. Advise patients to rinse mouth out with water and spit out, and/or brush teeth after each dose of medicine to minimize risk of oropharyngeal candidiasis and hoarseness. Patients should be made aware that Combisal must be used daily for optimum benefit, even when asymptomatic. Contraindications: Hypersensitivity to active substance or excipients. Special warnings and precautions for use: Do not use to treat acute asthma for which fast- and short-acting bronchodilator required or initiate Combisal during an exacerbation, or if asthma is significantly worsening or acutely deteriorating. Serious asthma related adverse events and exacerbations may occur during treatment, ask patient to continue treatment but to seek medical advice if symptoms remain uncontrolled or worsen. Increased use of reliever medication, or decreased response to reliever medication, indicate deterioration of asthma control and 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 gradual dose reduction with regular review of the patient. The lowest effective dose of combisal should be used. Treatment should not be stopped abruptly. Use with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway; severe cardiovascular disorders or heart rhythm abnormalities, diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or predisposed to low levels of serum potassium. Discontinue if paradoxical bronchospasm occurs. Systemic effects may occur with ICS, including 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. It is important the patient is reviewed regularly, and the dose of ICS is reduced to the lowest dose at which effective asthma control is maintained. Prolonged use of high doses of ICS may result in adrenal suppression and acute adrenal crisis. Consider additional systemic corticosteroid cover during periods of stress or elective surgery. Monitor patients transferring from oral steroids for impaired adrenal reserve. Avoid concomitant use with Ritonavir unless potential benefit outweighs the risk. Combisal is not indicated for use in the treatment of patients with COPD. Visual disturbance reported with steroid use – if blurred vision or other visual disturbances, consider referral to ophthalmologist for evaluation of possible causes e.g. cataract, glaucoma, central serous chorioretinopathy. If prolonged treatment in children, monitor height and ensure dose of inhaled steroid is lowest at which effective asthma control is maintained. Interactions: The following combinations should be avoided: Ritonavir, ketoconazole, itraconazole, cobicistat containing products or other potent CYP3A4 inhibitors, moderate CYP3A inhibitors e.g. erythromycin (if benefit outweighs risk, monitor for systemic steroid side effects); non- selective and selective β blockers; xanthine derivatives, steroids and diuretics in acute severe asthma. Other β adrenergic containing drugs can have an additive effect. Pregnancy & Lactation: Administer only if expected benefit to mother is greater than any possible risk to fetus. Discontinue breastfeeding or discontinue combisal therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman. Effects on ability to drive and use machines: No or negligible influence. Side effects: For full list of side effects consult SmPC. ‘Very Common’ and ‘Common’ side effects included in prescribing information. Very common (≥1/10) side effects: headache, nasopharyngitis. Common (≥1/100 to <1/10) side effects: candidiasis of mouth and throat, pneumonia, bronchitis, hypokalaemia, throat irritation, hoarseness/dysphonia, sinusitis, contusions, muscle cramps, traumatic fractures, arthralgia, myalgia. MA number: PL 36532/0001-0003. Cost: £13.50 for 25/50µg, £10.48 for 25/125µg, £13.99 for 25/250µg. MAH: Genetic S.p.A., Via G. Della Monica 26, 84083 Castel San Giorgio (SA), Italy. Distributed in the UK by: Aspire Pharma Ltd, Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG. Legal category: POM. Date reviewed: February 2025 Version number: 1010422348 v 8.0
XLW1010311M2_MAR2025
