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Device choice can help meet your COPD patients’ needs1,2

Trimbow is the only extrafine formulation ICS/LABA/LAMA combination available in both a pMDI and NEXThaler (DPI) for the maintenance treatment of adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS/LABA or LABA/LAMA3,4

Think triple (ICS/LABA/LAMA), think Trimbow

To find out more visit ChiesiAir.co.uk

Prescribing Information can be found below. UK-TRI-2100399 January 2022

8/5/9 are d NEXThaler 88

Trimbow pMDI 87/5/9 and NEXThaler 88/5/9 are indicated for maintenance treatment in adult Trimbow pMDI 87/5/9 and NEXThaler 88 patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1 of the SPC).3,4

COPD: chronic obstructive pulmonary disease; DPI: dry powder inhaler; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; pMDI: pressurised metered dose inhaler; SPC: Summary of Product Characteristics. References: 1. Usmani OS. Ther Clin Risk Manag. 2019; 15: 461–472. 2. Navaie M, et al. Medicine (Baltimore). 2020; 99: e20718. 3. Trimbow pMDI 87/5/9 Summary of Product Characteristics. Chiesi Limited. 4. Trimbow NEXThaler 88/5/9 Summary of Product Characteristics. Chiesi Limited.

Trimbow 87/5/9 Pressurised Metered Dose Inhaler (pMDI) & Trimbow 88/5/9 NEXThaler Prescribing Information Please refer to the Summary of Product Characteristics (SPC) before prescribing. Presentation: Each Trimbow 87/5/9 pMDI delivered dose contains 87micrograms (mcg) of beclometasone dipropionate (BDP), 5mcg of formoterol fumarate dihydrate (formoterol) and 9mcg of glycopyrronium. Each Trimbow 88/5/9 NEXThaler delivered dose contains 88 micrograms of BDP, 5 micrograms of formoterol and 9 micrograms of glycopyrronium These are both the equivalent to a metered dose of 100mcg BDP, 6mcg formoterol and 10mcg glycopyrronium. Indication: COPD: Maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (for effects on symptoms control and prevention of exacerbations see section 5.1 of the SPC). Asthma (Trimbow 87/5/9 pMDI only): Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year. Dosage and administration: For inhalation in adult patients (≥18 years). COPD & Asthma: 2 inhalations twice daily. Maximum dose 2 inhalations twice daily. Trimbow pMDI can be used with the AeroChamber Plus® spacer device. Patients should be advised to take Trimbow every day even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief. When choosing the starting dose strength of Trimbow in asthma patients, the patients’ disease severity, their previous asthma therapy including the inhaled corticosteroid (ICS) dose as well as the patients’ current control of asthma symptoms and risk of future exacerbation should be considered. The aerosol particles of Trimbow are characterised by an extrafine particle size distribution. For BDP this results in a more potent effect than formulations of BDP with a non-extrafine particle size distribution (100mcg of BDP extrafine in Trimbow are equivalent to 250mcg of BDP in a non-extrafine formulation). Contraindications: Hypersensitivity to the active substances or to any of the excipients. Warnings and precautions: Not for acute use in treatment of acute episodes of bronchospasm or to treat an acute disease exacerbation. Discontinue immediately if hypersensitivity or paradoxical bronchospasm occur. Deterioration of disease: Trimbow should not be stopped abruptly. Cardiovascular effects: Due to the presence of a long-acting beta2-agonist and a long-acting muscarinic antagonist, use with caution in patients with cardiac arrhythmias, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, occlusive vascular diseases, arterial hypertension and aneurysm. Caution should also be used when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females) either congenital or induced by medicinal products. Limited data in asthmatic patients with cardiovascular co-morbidities or risk-factors suggest that these patients are also at higher risk of adverse reactions like local fungal infections or dysphonia. Trimbow should not be administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias. Caution in patients with thyrotoxicosis, diabetes mellitus,

pheochromocytoma and untreated hypokalaemia. Increase in pneumonia and pneumonia hospitalisation in COPD patients receiving ICS observed. Clinical features of pneumonia may overlap with symptoms of COPD exacerbations. Systemic effects of ICS may occur, particularly at high doses for long periods, but are less likely than with oral steroids. The daily dose of both Trimbow 87/5/9 & 88/5/9 correspond to a medium dose of ICS. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation, decrease in bone mineral density and, more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression and aggression. Patients on Trimbow should be reviewed regularly and the dose of ICS is reduced to the lowest dose at which effective control of asthma is maintained. Use with caution in patients with pulmonary tuberculosis or fungal/viral airway infections. Potentially serious hypokalaemia may result from beta2-agonist therapy (particular caution with severe disease). Formoterol may cause a rise in blood glucose levels. Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or urinary retention. Use in patients with severe hepatic impairment (classified as having Child-Pugh class C) or severe renal impairment (glomerular filtration rate [GFR] < 30mL/min/1.73m2), should only be considered if benefit outweighs the risk. Consider referral of patients reporting blurred vision or visual disturbances to an ophthalmologist as causes may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy. To reduce risk of oropharyngeal candida infection, patients should be advised to rinse mouth or gargle with water without swallowing or brush teeth after inhaling prescribed dose. Trimbow 88/5/9 NEXThaler contains lactose. Lactose includes small amounts of milk proteins, which may cause allergic reactions. Interactions: Since glycopyrronium is eliminated via renal route, interactions could occur with medicinal products affecting renal excretion mechanisms e.g. with cimetidine (an inhibitor of OCT2 and MATE1 transporters in the kidney) co-administration, glycopyrronium showed a slight decrease in renal clearance (20%) and a limited increase in total systemic exposure (16%). Possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded and therefore caution and appropriate monitoring is advised. Related to formoterol: Non-cardioselective beta-blockers (including eye drops) should be avoided as reduces effect of formoterol. Concomitant administration of other beta-adrenergic drugs may have potentially additive effects. Concomitant treatment with quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants and phenothiazines 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 drugs with similar properties (e.g. furazolidone, procarbazine). Risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons. 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. Related to glycopyrronium: Co-administration with other anticholinergiccontaining medicinal products is not recommended. Excipients: Presence of ethanol in Trimbow 87/5/9 pMDI may cause theoretical potential interaction in sensitive patients taking metronidazole or disulfiram. Fertility, pregnancy and lactation: No studies have been performed in regards to safety in human fertility, but animal studies show impaired fertility. Should only be used during pregnancy if the expected benefits outweigh the potential risks. Children born to mothers receiving substantial doses should be observed for adrenal suppression. Glucocorticoids and metabolites are excreted in human milk. It is unknown whether formoterol or glycopyrronium (including their metabolites) pass into human breast-milk but they have been detected in the milk of lactating animals. Anticholinergics like glycopyrronium could suppress lactation. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy. Effects on driving and operating machinery: None or negligible. Side effects: Common: pneumonia (in COPD patients), pharyngitis, oral candidiasis, urinary tract infection, nasopharyngitis, headache, dysphonia. Uncommon: influenza, oral fungal infection, oropharyngeal candidiasis, oesophageal candidiasis, fungal oropharyngitis, sinusitis, rhinitis, gastroenteritis, vulvovaginal candidiasis, granulocytopenia, dermatitis allergic, hypokalaemia, hyperglycaemia, restlessness, tremor, dizziness, dysgeusia, hypoaesthesia, otosalpingitis, atrial fibrillation, electrocardiogram QT prolonged, tachycardia, tachyarrhythmia, palpitations, hyperaemia, flushing, hypertension, asthmatic crisis, cough, productive cough, throat irritation, epistaxis, pharyngeal erythema, diarrhoea, dry mouth, dysphagia, nausea, dyspepsia, burning sensation of the lips, dental caries, aphthous stomatitis, rash, urticaria, pruritus, hyperhidrosis, muscle spasms, myalgia, pain in extremity, musculoskeletal chest pain, fatigue, C-reactive protein increased, platelet count increased, free fatty acids increased, blood insulin increased, blood ketone body increased, cortisol decreased. Rare: Lower respiratory tract infection (fungal), hypersensitivity reactions, including erythema, lips, face, eye and pharyngeal oedema, decreased appetite, insomnia, hypersomnia, angina pectoris (stable and unstable), extrasystoles (ventricular and supraventricular), nodal rhythm, sinus bradycardia, blood extravasation, paradoxical bronchospasm, exacerbation of asthma, oropharyngeal pain, pharyngeal inflammation, dry throat, angioedema, dysuria, urinary retention, nephritis, asthenia, blood pressure increased, blood pressure decreased. Very rare: thrombocytopenia, adrenal suppression, glaucoma, cataract, dyspnoea, growth retardation, peripheral oedema, bone density decreased. Frequency not known: psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural changes, blurred vision. (Refer to SPC for full list of side effects). Legal category: POM. Price and Pack: £44.50 1x120 actuations. Marketing authorisation (MA) No(s): PLGB 08829/0193 (GB), EU/1/17/1208/002 (UKNI), PLGB 08829/0200 (GB), EU/1/17/1208/010 (UKNI). GB MA holder/UKNI Distributor: Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, United Kingdom. Date of Preparation: Dec 2021.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcardwww.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.comPV.UK@Chiesi.com.

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