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(FEV1 < 50% predicted)

Fostair 100/6 and 200/6 Prescribing Information Please refer to the full Summary of Product Characteristics before prescribing. Presentation: Each Fostair pressurised metered dose inhaler (pMDI) 100/6 dose contains 100 micrograms (mcg) of beclometasone dipropionate (BDP) and 6mcg of formoterol fumarate dihydrate (formoterol). Each Fostair pMDI 200/6 dose contains 200mcg of BDP and 6mcg of formoterol. Each Fostair NEXThaler 100/6 dry powder inhaler (DPI) dose contains 100mcg of BDP anhydrous and 6mcg of formoterol. Each Fostair NEXThaler 200/6 DPI dose contains 200mcg of BDP anhydrous and 6mcg of formoterol. Indications: Asthma: Regular treatment of asthma where use of an inhaled corticosteroid/

long-acting beta2-agonist (ICS/LABA) combination is appropriate: patients not adequately controlled on ICS and ‘as needed’ (prn) short-acting beta2- agonist, or patients already adequately controlled on both ICS and LABA.

COPD (Fostair 100/6 only): Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have signifi cant symptoms despite regular therapy with long-acting bronchodilators. Dosage and administration: For inhalation in adult patients (≥18 years). Asthma: Maintenance And Reliever Therapy (Fostair pMDI 100/6 only) taken as a regular maintenance treatment and prn in response to asthma symptoms: 1 inhalation twice daily (bd) plus 1 additional inhalation prn in response to symptoms. If symptoms persist after a few minutes, an additional inhalation is recommended. The maximum daily dose is 8 inhalations. Fostair pMDI 100/6 may also be used as maintenance therapy (with a separate short-acting bronchodilator prn). Fostair pMDI 200/6 and NEXThaler (100/6 and 200/6) should be used as maintenance therapy only. Maintenance therapy: Fostair pMDI and NEXThaler 100/6: 1–2 inhalations bd. Fostair pMDI and NEXThaler 200/6: 2 inhalations bd. The maximum daily dose is 4 inhalations. Patients should receive the lowest dose that effectively controls their symptoms. COPD (Fostair 100/6 only): 2 inhalations bd. Fostair pMDI can be used with the AeroChamber Plus® spacer device. BDP in Fostair is characterised by an extrafi ne particle size distribution which results in a more potent effect than formulations of BDP with a non-extrafi ne particle size distribution (100mcg of BDP extrafi ne in Fostair are equivalent to 250mcg of BDP in a non-extrafi ne formulation). When switching patients from previous treatments, it should be considered that the recommended total daily dose of BDP for Fostair is lower than that for non-extrafi ne BDP containing products and should be adjusted to the needs of the individual patient. However, patients who are transferred between Fostair NEXThaler and Fostair pMDI do

not need dose adjustment. Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and precautions: Use with caution in patients with cardiac arrhythmias, aortic stenosis, hypertrophic obstructive cardiomyopathy, ischemic heart disease, severe heart failure, congestive heart failure, occlusive vascular diseases, arterial hypertension, severe arterial hypertension, aneurysm, thyrotoxicosis, diabetes mellitus, phaeochromocytoma and untreated hypokalaemia. Caution should also be used when treating patients with known or suspected prolongation of the QTc interval (QTc > 0.44 seconds). Formoterol itself may induce QTc prolongation.

Potentially serious hypokalaemia may result from beta2-agonist therapy and may also be potentiated by concomitant treatments (e.g. xanthine derivatives, steroids and diuretics) and increase the risk of arrhythmias. Formoterol may cause a rise in blood glucose levels. Fostair should not be administered for at least 12 hours before the start of anaesthesia, if halogenated anaesthetics are planned. Use with caution in patients with pulmonary tuberculosis or fungal/ viral airway infections. Fostair treatment should not be stopped abruptly. Treatment should not be initiated during exacerbations or acutely deteriorating asthma. Fostair treatment should be discontinued immediately if the patient experiences a paradoxical bronchospasm. Systemic effects: Systemic effects of ICS may occur, particularly at high doses for long periods, but are less likely than with oral steroids. These 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 and aggression. Prolonged treatment with high doses of ICS may result in adrenal suppression and acute adrenal crisis. Lactose contains small amounts of milk proteins, which may cause allergic reactions. Interactions: Beta-blockers should be avoided in asthmatic patients.


administration of other beta-adrenergic drugs may have potentially additive effects. Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines, monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants can prolong the QTc interval and increase the risk of ventricular arrhythmias. L-dopa, L-thyroxine, oxytocin and alcohol can

impair cardiac tolerance towards beta2-sympathomimetics. Hypertensive reactions may occur following co-administration with MAOIs including agents with similar properties (e.g. furazolidone, procarbazine). Concomitant treatment with xanthine derivatives, steroids or diuretics may potentiate a possible hypokalaemic effect of beta2-agonists. Hypokalaemia may increase

the likelihood of arrhythmias in patients receiving digitalis glycosides. Fertility, pregnancy and lactation: Fostair should only be used during pregnancy or lactation if the expected benefi ts outweigh the potential risks. Effects on driving and operating machinery: Fostair is unlikely to have any effect on the ability to drive and use machines. Side effects: Common: pharyngitis,

oral candidiasis, headache, dysphonia, pneumonia, granulocytopenia, tremor. Uncommon:

infl uenza, oral fungal infection, oropharyngeal candidiasis, nasopharyngitis, oesophageal candidiasis, vulvovaginal candidiasis, gastroenteritis, sinusitis, rhinitis,

allergic dermatitis, tachyarrhythmia, sinus bradycardia, hypokalaemia,

hyperglycaemia, hypertriglyceridaemia, restlessness, dizziness, otosalpingitis, palpitations,

angina pectoris,

prolongation of QTc interval, ECG change, tachycardia, atrial fi brillation,

myocardial ischaemia, blood pressure increased, hyperaemia, fl ushing, cough, productive cough, throat irritation, asthmatic crisis, exacerbation of asthma, dyspnoea, pharyngeal erythema, diarrhoea, dry mouth, dyspepsia, dysphagia, burning sensation of the lips, nausea, dysgeusia, pruritus, rash, hyperhidrosis, urticaria, muscle spasms, myalgia, C-reactive protein increased, platelet count increased, free fatty acids increased, blood insulin increased, blood ketone body increased, blood cortisol decrease, oropharyngeal pain, fatigue, irritability, cortisol free urine decreased, blood potassium increased, blood glucose increased, ECG poor r-wave progression. Rare: ventricular extrasystoles,

pressure decreased. Very rare: thrombocytopenia, hypersensitivity reactions, including erythema,

paradoxical bronchospasm, lips,

face, eyes and pharyngeal oedema, adrenal

suppression, glaucoma, cataract, peripheral oedema, bone density decreased. Unknown frequency: psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes (Refer to SPC for full list of side effects). Legal category: POM Packs and price: £29.32 1x120 actuations Marketing authorisation (MA) Nos: PL 08829/0156, PL 08829/0175, PL 08829/0173, PL 08829/0174 MA holder: Chiesi Ltd, 333 Styal Road, Manchester, M22 5LG. Date of preparation: Oct 2015. Aerochamber Plus® is a registered trademark of Trudell Medical International.

Adverse events should be reported. Reporting forms and information can be found at Adverse events should also be reported to Chiesi Ltd on 0161 488 5555.

CHFTB20150968a. Jan 16. angioedema, nephritis, blood

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