Australian Doctor Australian Doctor 15th September 2017

An easy to inhale Soft Mist ™ designed to †1–6 go deep into the lungs A slow-moving aerosol cloud with approx. 66% fine-particle fraction (<5.8 μm) 4–7 † 8,9 Visit LungLearning.com.au for more information SPIRIVA Respimat PBS Information: Restricted benefit. Bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease. SPIOLTO Respimat PBS Information: Authority required (STREAMLINED). Code 5763. Chronic obstructive pulmonary disease (COPD). Refer to PBS schedule for full authority information. Please review Product Information before prescribing. Full Product Information is available at www.boehringer-ingelheim.com.au/PI. Further information is available from Boehringer Ingelheim Pty Ltd. MINIMUM PRODUCT INFORMATION (COMBINED – COPD). SPIRIVA ® RESPIMAT ® (tiotropium bromide) solution for inhalation 2.5 microgram/actuation and SPIOLTO ® RESPIMAT ® [tiotropium (as bromide monohydrate)/olodaterol (as hydrochloride)] solution for inhalation 2.5 micrograms/2.5 micrograms. INDICATIONS: SPIRIVA RESPIMAT: Long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD). Prevention of COPD exacerbations. SPIOLTO RESPIMAT: Once-daily maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. CONTRAINDICATIONS: SPIRIVA RESPIMAT and SPIOLTO RESPIMAT: Hypersensitivity to tiotropium bromide, olodaterol (SPIOLTO only), atropine or its derivatives, or to any of the excipients. PRECAUTIONS: SPIRIVA RESPIMAT and SPIOLTO RESPIMAT: Should not be used: more frequently than once daily; for relief of acute symptoms, treatment of acute episodes of bronchospasm, immediate hypersensitivity reactions, paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, urinary retention, micturition difficulties, recent myocardial infarction (<6 months for SPIRIVA, <12 months for SPIOLTO), unstable or life-threatening cardiac arrhythmia within past year, hospitalisation for heart failure within past year, moderate to severe renal impairment (CrCL ≤ 50 mL/min), pregnancy, lactation and children. Avoid solution or mist entering eyes. SPIRIVA RESPIMAT: Should not be used for: first-line treatment for asthma, dry mouth. SPIOLTO RESPIMAT: Should not be used: in treatment of asthma (LABAs may increase the risk of asthma-related hospitalisations and death); initiated in acutely deteriorating COPD, severe hepatic impairment, convulsive disorders, thyrotoxicosis, QT interval prolongation, unusual responsiveness to sympathomimetic amines; increases in pulse rate, blood pressure and/or symptoms of clinically significant cardiovascular effect, paroxysmal tachycardia (>100 beats per minute), hypokalaemia, hyperglycaemia. INTERACTIONS: SPIRIVA RESPIMAT and SPIOLTO RESPIMAT: Co-administration with anticholinergic drugs. SPIOLTO RESPIMAT: Co-administration with adrenergic agents, xanthine derivatives, steroids, non- potassium sparing diuretics, beta-blockers, MAO inhibitors, tricyclic antidepressants, QTc interval prolonging drugs, LAMAs, LABAs. ADVERSE EFFECTS: SPIRIVA RESPIMAT: Common: Dry mouth, usually mild. SPIOLTO RESPIMAT: Very common: nasopharyngitis. Common: pneumonia, bronchitis, influenza, urinary tract infection, sinusitis, cough, dyspnoea, back pain, dry mouth. Others, see full PI. DOSAGE: SPIRIVA RESPIMAT: For oral inhalation. 5 μg tiotropium given as two puffs once daily, at the same time each day. SPIOLTO RESPIMAT: For oral inhalation. 5 μg tiotropium and 5 μg olodaterol given as two puffs once daily, at the same time each day. Do not exceed recommended dose. Cartridges to be used only with RESPIMAT inhaler. January 2017. References: 1. Hodder R and Price D. Int J Chron Obstruct Pulmon Dis 2009; 4: 381–390. 2. Schürmann W et al. Treat Respir Med 2005; 4: 53–61. 3. Kardos P et al. Eur Respir J 2005; 26 (Suppl 49): 338s (abstract 2213). 4. Dalby R et al. Int J Pharm 2004; 283: 1–9. 5. Zierenberg B. J Aerosol Med 1999; 12 Suppl 1: S19–S24. 6. Pitcairn G et al. J Aerosol Med 2005; 18: 264–272. 7. Hochrainer D et al. J Aerosol Med 2005; 18: 273–282. 8. SPIRIVA Respimat approved Product Information (13 September 2016). 9. SPIOLTO Respimat approved Product Information (10 June 2015). TM Trademark. ® Registered trademark. Boehringer Ingelheim Pty Ltd. ABN 52 000 452 308. 78 Waterloo Road, North Ryde, NSW 2113. AUS/SPRES-171036. McCann Health 10745256. SEPTEMBER 2017.

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