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Tiotropium Clear capsule Cost savings† †Zonda device is supplied with every bottle of Braltus® capsules, not sold separately.2 COPD=chronic obstructive pulmonary disease. LAMA=long-acting muscarinic antagonist. Long,flat mouthpiece* *Description based on device appearance, not on specific clinical or observational data. Ergonomic and compact* *Description based on device appearance, not on specific clinical or observational data. + capsule bottle ++ + PBS Information: Restricted benefit. Chronic obstructive pulmonary disease (COPD) Please review Product Information (PI) before prescribing. Full PI is available from https://medicines.org.au/files/tbpbralt.pdf or from Medical Information on 1800 AU TEVA (1800 28 8382). Braltus® (tiotropium) 13 mcg powder for inhalation, hard capsule with ZONDA® device. Indication: long term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease (COPD), prevention of COPD exacerbations. Dosage and administration: The patient should be trained in the use of the inhaler by the prescribing physician or other suitable healthcare professional. The delivered dose is 10 mcg of tiotropium per capsule. Instructions for use: Do not swallow capsules. Must be used only with the supplied ZONDA® device. Inhale the contents of one capsule, once daily with the ZONDA® device, at the same time each day. Do not place the capsule directly into the mouthpiece. Discard the ZONDA® device after 30 doses. Contraindications: Hypersensitivity to tiotropium bromide, atropine or its derivatives, or to any other components of the product. Precautions: Patients must be instructed in the correct administration of tiotropium. Avoid contact with eyes; specialist advice should be sought immediately should any symptoms of narrow-angle glaucoma develop. BRALTUS® capsules are only to be used with the supplied ZONDA® device. Should not be taken more than once daily. Should not be used for treatment of acute bronchospasm (i.e. rescue therapy). May cause hypersensitivity reactions and inhalation-induced bronchospasm. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, bladder-neck obstruction, recent myocardial infarction <6 months, cardiac arrhythmia, hospitalisation of heart failure within the past year – see full PI. Dry mouth may in the long term be associated with dental caries. Elderly: No special dosing considerations. An increase in anticholinergic effects may occur with increasing age. Paediatric: No data is available in infants, children or adolescents. Do not use in this age group. Renal Impairment: Use in patients with moderate to severe renal impairment (CrCL ≤50 mL/min) only if expected benefits outweigh potential risks; these patients should be monitored closely. Hepatic Impairment: No special dosing considerations. Contains lactose. Use in pregnancy: Category B1; limited data is available in pregnant women. It is preferable to avoid the use of tiotropium during pregnancy. Lactation: it is unknown whether tiotropium is excreted in human milk. Should not be used in lactating women unless the expected benefit to the mother outweighs any potential risk to the infant. The occurrence of dizziness or blurred vision may influence the ability to drive and use machinery. Interactions: No formal clinical drug interaction studies have been performed. Tiotropium has been used concomitantly with other drugs commonly used in treating COPD; LABA, ICS and their combinations used by COPD patients were not found to alter exposure to tiotropium. Limited information about coadministration with other anticholinergic medicines is available from clinical trial. See Full PI. Adverse effects: Many undesirable effects are due to the anticholinergic properties of tiotropium. Common – dry mouth; uncommon – dizziness, vision blurred, atrial fibrillation, cough, constipation. See full PI. Presentation: Available in cartons containing a HDPE bottle of 30 BRALTUS® (tiotropium) capsules and a ZONDA® device. TIO-2020-0004 Feb 2020. Based on PI approved 31 Oct 2018. References: 1. Karner C et al. Cochrane Database Syst Rev 2014;21(7):CD009285. doi: 10.1002/14651858.CD009285.pub3. 2. Braltus Product Information, 31 October 2018. Sponsored in Australia by TEVA Pharma Australia Pty Ltd, ABN 41 169 715 664, Level 1, 37 Epping Road, Macquarie Park, Sydney, NSW 2113. Copyright © 2020 Mylan N.V. All rights reserved. Alphapharm Pty Ltd (trading as Mylan Australia) ABN 93 002 359 739. Level 1, 30–34 Hickson Road, Millers Point NSW 2000. Tel: 1800 274 276. www.mylan.com.au. DH MYL-001230-00. TIO-2020-0009. Date of preparation: April 2020.