Nursing in Practice May/June 2020 (issue 114) | Page 17

formation from Boehringer Ingelheim
y LAMA licensed in patients aged
and above with severe asthma¹
at ® reusable inhaler:
e with
1
5th
6th
generates a unique mist of
slow-moving, long-lasting fine
droplets, designed to deliver
medication deep into your
patients’ lungs 2
es, the overall product carbon footprint
sing the inhaler with one cartridge 3
r treatment in patients aged 6 years and older with severe asthma who
a exacerbations in the preceding year. 1
drug interaction studies have been performed,
tiotropium bromide has been used concomitantly
with other drugs commonly used in the treatment
of COPD and asthma, including sympathomimetic
bronchodilators, methylxanthines, oral and inhaled
steroids, antihistamines, mucolytics, leukotriene
modifiers, cromones, anti-IgE treatment without
clinical evidence of drug interactions. Use of LABA or
ICS was not found to alter the exposure to tiotropium.
The co-administration of tiotropium bromide with
other anticholinergic-containing drugs has not
been studied and is therefore not recommended.
Fertility, Pregnancy and Lactation: Very limited
amount of data in pregnant women. Avoid the use
of Spiriva Respimat during pregnancy. It is unknown
whether tiotropium bromide is excreted in human
breast milk. Use of Spiriva Respimat during breast
feeding is not recommended. A decision on whether
to continue/discontinue breast feeding or therapy
with Spiriva Respimat should be made taking into
account the benefit of breast feeding to the child
and the benefit of Spiriva Respimat therapy to the
woman. Clinical data on fertility are not available
for tiotropium. Effects on ability to drive and
use machines: No studies have been performed.
The occurrence of dizziness or blurred vision may
influence the ability to drive and use machinery.
Undesirable effects: COPD: Common (≥1/100 to
<1/10) Dry mouth. Uncommon (≥1/1,000 to
<1/100) Dizziness, headache, cough, pharyngitis,
dysphonia, constipation, oropharyngeal candidiasis,
rash, pruritus, urinary retention, dysuria. Rare
(≥1/10,000 to <1/1,000): Insomnia, glaucoma,
intraocular pressure increased, vision blurred, atrial
fibrillation, palpitations, supraventricular tachycardia,
tachycardia, epistaxis, bronchospasm, laryngitis,
dysphagia, gastrooesophageal reflux disease,
dental caries, gingivitis, glossitis, angioneurotic
oedema, urticaria, skin infection/skin ulcer, dry
skin, urinary tract infection. Not known (cannot be
estimated from the available data): Dehydration,
sinusitis, stomatitis, intestinal obstruction including
ileus paralytic, nausea, hypersensitivity (including
immediate reactions), anaphylactic reaction, joint
swelling. Asthma: Uncommon (≥ 1/1,000 to < 1/100)
Dizziness, headache, insomnia, palpitations, cough,
pharyngitis, dysphonia, bronchospasm, dry mouth,
oropharyngeal candidiasis, rash. Rare (≥1/10,000
to <1/1,000): Epistaxis, constipation, gingivitis,
stomatitis, pruritus, angioneurotic oedema, urticaria,
hypersensitivity (including immediate reactions),
urinary tract infection. Not known (cannot be
estimated from the available data): Dehydration,
glaucoma, intraocular pressure increased,
vision blurred, atrial fibrillation, supraventricular
tachycardia, tachycardia, laryngitis, sinusitis,
dysphagia, gastrooesophageal reflux disease,
dental caries, glossitis, intestinal obstruction
including ileus paralytic, nausea, skin infection/skin
ulcer, dry skin, anaphylactic reaction, joint swelling,
urinary retention, dysuria. Serious undesirable
effects consistent with anticholinergic effects:
glaucoma, constipation, intestinal obstruction
including ileus paralytic and urinary retention. An
increase in anticholinergic effects may occur with
increasing age. Prescribers should consult the
Summary of Product Characteristics for further
information on undesirable effects. Pack sizes
and NHS price: Single pack: 1 Respimat reusable
inhaler and 1 cartridge providing 60 puffs
(30 medicinal doses) £23.00; Single refill pack: 1
cartridge providing 60 puffs (30 medicinal doses)
£23.00. Legal category: POM. MA number: PL
14598/0084. Marketing Authorisation Holder:
Boehringer Ingelheim International GmbH, D-55216
Ingelheim am Rhein, Germany. Prescribers should
consult the Summary of Product Characteristics for
full prescribing information. Prepared in September
2019
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 Boehringer Ingelheim Drug Safety on
0800 328 1627 (freephone).