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Please review Product Information (PI) before prescribing. Full PI is available from
https://medicines.org.au/fi les/tbpbralt.pdf or from Medical Information on 1800 AU TEVA (1800 28 8382).
References: 1.
Karner C
et al. Cochrane Database Syst Rev
2014;21(7):CD009285. doi: 10.1002/14651858.CD009285.pub3. Braltus Product Information, 31 October 2018. Sponsored in Australia by TEVA Pharma Australia Pty Ltd,
2.
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.
Braltus (tiotropium) 13 mcg powder for inhalation, hard capsule with ZONDA device. Indication:
®
®
long with dental caries.
term maintenance treatment of bronchospasm and dyspnoea associated with chronic obstructive pulmonary increasing age.
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 benefi ts outweigh potential risks; these patients should be monitored closely.
is 10 mcg of tiotropium per capsule.
Instructions for use:
Do not swallow capsules. Must be used only with the considerations.
supplied ZONDA® device. Inhale the contents of one capsule, once daily with the ZONDA device, at the same preferable to avoid the use of tiotropium during pregnancy.
®
time each day. Do not place the capsule directly into the mouthpiece. Discard the ZONDA device after 30 doses. in human milk. Should not be used in lactating women unless the expected benefi t to the mother outweighs any
®
Contraindications:
Hypersensitivity to tiotropium bromide, atropine or its derivatives, or to any other components potential risk to the infant. The occurrence of dizziness or blurred vision may infl uence the ability to drive and use
of the product.
Precautions:
Patients must be instructed in the correct administration of tiotropium. Avoid contact machinery.
with eyes; specialist advice should be sought immediately should any symptoms of narrow-angle glaucoma develop. used concomitantly with other drugs commonly used in treating COPD; LABA, ICS and their combinations used by
BRALTUS capsules are
®
only
to be used with the supplied ZONDA device. Should not be taken more than once COPD patients were not found to alter exposure to tiotropium. Limited information about coadministration with other
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daily. Should not be used for treatment of acute bronchospasm (i.e. rescue therapy). May cause hypersensitivity anticholinergic medicines is available from clinical trial. See Full PI.
reactions and inhalation-induced bronchospasm. Use with caution in patients with narrow-angle glaucoma, due to the anticholinergic properties of tiotropium. Common – dry mouth; uncommon – dizziness, vision blurred,
prostatic hyperplasia, bladder-neck obstruction, recent myocardial infarction <6 months, cardiac arrhythmia, atrial fi brillation, cough, constipation. See full PI.
hospitalisation of heart failure within the past year – see full PI. Dry mouth may in the long term be associated
Elderly:
No special dosing considerations. An increase in anticholinergic effects may occur with
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
≤
Hepatic Impairment:
No special dosing
Contains lactose.
Use in pregnancy:
Category B1; limited data is available in pregnant women. It is
Lactation:
it is unknown whether tiotropium is excreted
Interactions:
No formal clinical drug interaction studies have been performed. Tiotropium has been
Adverse effects:
Many undesirable effects are
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.
®
®
COPD=chronic obstructive pulmonary disease. LAMA=long-acting muscarinic antagonist.
PBS Information:
Restricted benefi t. Chronic obstructive pulmonary disease (COPD)
capsule bottle
+ +
+ +
Tiotropium
Long, flat mouthpiece
*
* *
Description based on device escription based on device
appearance, not on specifi c
clinical or observational data.
Cost savings
†
†
Zonda device is supplied with every bottle
of Braltus capsules, not sold separately.
®
2
D
appearance, not on specifi c
clinical or observational data.
Cost savings
†
Clear
capsule
Ergonomic
and compact
*
*
Description based on device appearance,
not on specifi c clinical or observational data.