Immediately discontinue treatment in case of signs suggesting allergic reactions, in particular, angioedema (including breathing/swallowing difficulties, swelling of tongue/lips/face), urticaria or skin rash. Not indicated for treatment of acute episodes of bronchospasm, or acute disease exacerbation (ie, as rescue therapy). Risk of paradoxical bronchospasm. Do not abruptly stop treatment. Reassess therapy if disease deteriorates. Higher risk of adverse reactions (eg, local fungal infections or dysphonia) in asthmatic patients w/ CV co-morbidities or risk factors. Do not administer Trimbow for at least 12 hr before start of halogenated anaesth. Increased incidence of pneumonia, including pneumonia requiring hospitalisation, in patients w/ COPD receiving inhaled corticosteroids. Systemic effects may occur w/ any inhaled corticosteroid, particularly at high doses prescribed for long periods. Possible systemic corticosteroid effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation, decrease in bone mineral density &, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in childn). Potentially serious hypokalaemia may result from β
2-agonist therapy. Caution if co-administered w/ other medicinal products which can induce hypokalaemia. Inhalation of formoterol may cause a rise in blood glucose levels. Long-term co-administration w/ other anticholinergic-containing medicinal products is not recommended. Rinse mouth or gargle w/ water w/o swallowing or brush teeth after inhaling the prescribed dose to reduce the risk of oropharyngeal candida infection. Visual disturbance may be reported w/ systemic & topical corticosteroid use. Regularly reassess doses of beclometasone/formoterol/glycopyrronium & titrate to the lowest doses at which effective control of asthma symptoms is maintained. Contains 8.856 mg of ethanol per actuation. Theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole. Caution in patients w/ cardiac arrhythmias, especially 3rd degree AV block & tachyarrhythmias (accelerated &/or irregular heartbeat, including atrial fibrillation), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute MI, ischaemic heart disease, CHF), occlusive vascular diseases (particularly arteriosclerosis), arterial HTN & aneurysm; known or suspected QTc interval prolongation, either congenital or induced by medicinal products; thyrotoxicosis, DM, pheochromocytoma & untreated hypokalaemia; active or quiescent pulmonary TB; fungal & viral airway infections; narrow-angle glaucoma, prostatic hyperplasia or urinary retention; severe renal impairment (GFR <30 mL/min/1.73 m
2) or ESRD requiring dialysis (GFR <15 mL/min/1.73 m
2), especially if associated w/ significant body wt reduction; severe hepatic impairment (Child-Pugh C). Avoid use during pregnancy & labour. Infants & neonates born to mothers receiving substantial doses should be observed for adrenal suppression. Discontinue breast-feeding or discontinue/abstain from therapy. No relevant use in paed population <18 yr for COPD. Safety & efficacy in paed population <18 yr have not yet been established for asthma.
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