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Combisal (Salmeterol/ Fluticasone) Prescribing Information
(please refer to the full SmPC before prescribing)
Indications: Regular treatment of asthma where use of 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 25μg/250 μg 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. 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. 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. 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. Safety and efficacy in COPD not established. Patients of black African or Afro-Caribbean ancestry should seek medical advice if asthma uncontrolled or worsens on Combisal. If prolonged treatment in children, monitor height. ?Interactions: The following combinations should be avoided: Ritonavir or other potent CYP3A inhibitors; ketoconazole or other potent CYP3A4 inhibitors; 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. Not to be used during breastfeeding. Side effects: For full list of side effects consult SmPC. ‘Very Common’ ‘Common’ and ‘Serious’ 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. Uncommon Serious (≥1/1000 to <1/100) side effects: cutaneous hypersensitivity reactions, dyspnoea, hyperglycaemia, anxiety, sleep disorders, tremor, cataract, palpitations, tachycardia, atrial fibrillation, angina pectoris. Rare serious (≥1/10,000 to <1/1000) side effects: oesophageal candidiasis, facial and oropharyngeal angioedema, bronchospasm, anaphylactic reactions including anaphylactic shock, Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, behavioural changes (psychomotor hyperactivity and irritability predominantly in children), glaucoma, cardiac arrhythmias, paradoxical bronchospasm. Serious side effects (unknown frequency): depression, aggression (predominantly in children). MA number: PL 36532/0001-0003. Cost: ￡13.50 for 25/50μg, ￡17.59 for 25/125μg, ￡27.99 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: December 2018. Version number: 1010422348 v 4.0