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ON TOP OF THE WORLD CHAPTER ONE


Chris could feel the cool air entering his lungs and it felt good! He was so pleased he'd reached the top and now he could relax and enjoy his favourite view. What more would today bring...?


ULTIBRO® BREEZHALER® offers benefits beyond current


standard COPD maintenance therapies:1-4* VS. salmeterol/fluticasone ULTIBRO®


BREEZHALER®


can significantly improve your patients' breathlessness.4 VS. open-label tiotropium ULTIBRO®


BREEZHALER®


can increase the number of days your patients are able to perform everyday activities.1


VS. open-label tiotropium4 ULTIBRO®


BREEZHALER® well tolerated.1-4


A STORY WORTH SHARING ULTIBRO


® and vs. salmeterol/fluticasone is generally


BREEZHALER


® INDACATEROL MALEATE/GLYCOPYRRONIUM BROMIDE INHALATION POWDER *Open-label tiotropium 18µg and salmeterol/fluticasone 50/500µg.


85 micrograms/43 micrograms inhalation powder, hard capsules (indacaterol/glycopyrronium) Refer to Ultibro®


ULTIBRO® BREEZHALER® ▼ PRESCRIBING INFORMATION Breezhaler®


Summary of Product Characteristics (SmPC) before prescribing.


Indications: Ultibro Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Presentation: Hard capsules for inhalation containing 110 micrograms indacaterol and 50 micrograms glycopyrronium, with the delivered dose equivalent to 85 micrograms of indacaterol and 43 micrograms of glycopyrronium. Dose and administration: The recommended dose is the inhalation of the content of one capsule once a day using the Ultibro Breezhaler inhaler. Ultibro Breezhaler should be administered at the same time of day each day. No dose adjustment is required for elderly patients or patients with mild to moderate renal impairment or patients with mild to moderate hepatic impairment. There is no relevant use of Ultibro Breezhaler in patients under 18 years. Ultibro Breezhaler capsules are for inhalation use only and must not be swallowed. Contraindications: Hypersensitivity to the active substance, lactose monohydrate or magnesium stearate. Precautions: Ultibro Breezhaler should not be used for the treatment of asthma. Ultibro Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as a rescue therapy. In clinical studies with Ultibro Breezhaler, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with other inhalation therapy and can be life-threatening. If this occurs, Ultibro Breezhaler should be discontinued immediately. Immediate hypersensitivity


after administration of Ultibro Breezhaler components. If signs suggesting allergic reactions occur, in particular, angioedema, urticaria or skin rash, Ultibro Breezhaler should be discontinued immediately and alternative therapy instituted. Ultibro Breezhaler should be used with caution in patients with narrow-angle glaucoma or urinary retention. Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be informed to stop using Ultibro Breezhaler and contact their doctor immediately should this event occur. In patients with severe renal impairment, including those with end-stage renal disease requiring dialysis, Ultibro Breezhaler should be used only if the expected benefit outweighs the potential risk and these patients should be


reactions have been reported


monitored closely for potential adverse reactions. Ultibro Breezhaler should be used with caution in patients with a history of cardiovascular disorders such as coronary artery disease,


and hypertension. Beta2-adrenergic agonists may produce a clinically significant cardiovascular effect in some patients; if such effects occur, treatment may need to be discontinued. Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc was prolonged were excluded from the clinical trials, and as there is no experience in these patient groups, Ultibro Breezhaler should be used with caution. Upon initiation of treatment plasma glucose should be monitored more closely in diabetic patients. Use with caution in patients with convulsive disorders or thyrotoxicosis. Patients with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine. Drug interactions: Concomitant administration of orally inhaled indacaterol and glycopyrronium, under steady-state conditions of both components, did not affect the pharmacokinetics of either component. No specific interaction studies were conducted for Ultibro Breezhaler. Information on the potential for interactions is based on the potential for each individual component. The concomitant use of Ultibro Breezhaler with beta-adrenergic blockers,


or sympathomimetic agents is not recommended. Caution is required with the concomitant use of hypokalaemic treatment. Pregnancy and lactation: There are no data from the use of Ultibro Breezhaler in pregnant women. Indacaterol may inhibit labour due to a relaxant effect on uterine smooth muscle and therefore Ultibro Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. The use of Ultibro Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant. Effects on ability to drive and use machines: This medicinal product has no or negligible influence on the ability to drive and use machines. However, the occurrence of


References: 1. Bateman ED, et al. Eur Respir J. 2013;42:1484–94. 2. Wedzicha JA, et al. Lancet Respir Med. 2013;1:199–209. 3. Mahler D, et al. Eur Respir J. 2014;43:1599–609. 4. Vogelmeier CF, et al. Lancet Respir Med. 2013;1:51–60. ©2013 Novartis Pharma AG.


Date of preparation: November 2015 UK/ULT/15-0434 anticholinergics acute myocardial infarction, cardiac arrhythmias


dizziness may influence the ability to drive and use machines. Undesirable effects: Very common (≥1/10): upper respiratory tract infection. Common (≥1/100 to <1/10): nasopharyngitis, urinary tract infection, sinusitis, rhinitis, dizziness, headache, cough (usually of mild intensity), oropharyngeal pain (including throat irritation), dyspepsia, dental caries, gastroenteritis, musculoskeletal pain, pyrexia and chest pain. Uncommon (≥1/1000 to <1/100: Hypersensitivity, angioedema, diabetes mellitus and hyperglycaemia, insomnia, paraesthesia, glaucoma, tachycardia,


ischaemic


epistaxis, dry mouth, pruritus/rash, muscle spasm, myalgia, pain in extremity, bladder obstruction and urinary retention, peripheral oedema, fatigue. Ultibro Breezhaler showed similar adverse reactions to the individual components; indacaterol and glycopyrronium, and as such, the type and severity of adverse reactions associated with each of these components may be expected in the combination. Quantities and basic NHS price (excl. VAT): Ultibro Breezhaler with 30 day supply of 85 micrograms/43 micrograms capsules: £32.50. Ultibro Breezhaler with 12 day supply of 85 micrograms/43 micrograms capsules: £13.00. Marketing authorisation number: EU/1/13/862/002, 003 Legal category: POM. Date of last revision of prescribing information: September 2015. UB05


Full prescribing information is available from Novartis Pharmaceuticals UK Ltd, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR. Telephone: 01276 698370. E-mail: medinfo.uk@novartis.com


Adverse events should be reported.


Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis 01276 698370.


palpitations, heart paradoxical disease, atrial bronchospasm, fibrillation,


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