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©2015 GSK group of companies. All Rights Reserved.
ANORO ELLIPTA was developed in collaboration with
UK/UCV/0011/14v February 2015
Anoro
®
Ellipta
®
(umeclidinium bromide/vilanterol [as trifenatate]) Prescribing information
(Please consult the full Summary of Product Characteristics (SmPC) before prescribing)
Anoro
®
Ellipta
®
55/22mcg (umeclidinium bromide/vilanterol [as trifenatate])
inhalation powder.
Each single inhalation of umeclidinium bromide (UMEC) 62.5
micrograms (mcg) and vilanterol (VI) 25mcg provides a delivered dose of UMEC 55mcg
and VI 22mcg.
Indications:
COPD:
Maintenance bronchodilator treatment to relieve
symptoms in adult patients with COPD.
Dosage and administration:
Inhalation only.
COPD:
One inhalation once daily of Anoro Ellipta.
Contraindications:
Hypersensitivity
to the active substances or to any of the excipients (lactose monohydrate and
magnesium stearate).
Precautions:
Anoro Ellipta should not be used in patients
with asthma. Treatment with Anoro Ellipta should be discontinued in the event of
paradoxical bronchospasm and alternative therapy initiated if necessary. Cardiovascular
effects may be seen after the administration of muscarinic receptor antagonists and
sympathomimetics therefore Anoro Ellipta should be used with caution in patients with
severe cardiovascular disease. Anoro Ellipta should be used with caution in patients
with urinary retention, narrow angle glaucoma, convulsive disorders, thyrotoxicosis,
hypokalaemia, hyperglycaemia and severe hepatic impairment. No dosage adjustment
is required in renal or mild to moderate hepatic impairment.
Acute symptoms:
Anoro
Ellipta is not indicated for acute episodes of bronchospasm. Warn patients to seek
medical advice if short-acting inhaled bronchodilator use increases, a re-evaluation of
the patient and of the COPD treatment regimen should be undertaken.
Interactions
with other medicinal products:
Interaction studies have only been performed in
adults. Avoid
E
-blockers. Caution is advised when co-administering with strong CYP3A4
inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin).
Anoro Ellipta should not be used in conjunction with other long-acting
E
2
-adrenergic
agonists or medicinal products containing long-acting muscarinic antagonists.
Caution is advised with concomitant use with methylxanthine derivatives, steroids or
non-potassium-sparing diuretics as it may potentiate possible hypokalaemic effect
of
E
2
-adrenergic agonists.
Fertility, pregnancy, and breast-feeding:
No available
data. Balance risks against benefits.
Side effects:
Common: Urinary tract infection,
sinusitis, nasopharyngitis, pharyngitis, upper respiratory tract infection, headache,
cough, oropharyngeal pain, constipation and dry mouth. Uncommon: Atrial fibrillation,
supraventricular tachycardia, rhythm idioventricular, tachycardia, supraventricular
extrasystoles and rash.
Legal category:
POM.
Presentation and Basic NHS cost:
Anoro
®
Ellipta
®
. 1 inhaler x 30 doses. Anoro Ellipta 55/22mcg - £32.50.
Marketing
authorisation (MA) nos. 55/22mcg 1x30 doses [EU/1/14/898/002]; MA holder:
Glaxo Group Ltd, 980 Great West Road, Brentford, Middlesex TW8 9GS, UK.
Last date
of revision:
October 2014. UK/RESP/0077/14c. Anoro
®
and Ellipta
®
are registered
trademarks of the GlaxoSmithKline group of companies. All rights reserved. Anoro
®
Ellipta
®
was developed in collaboration with Theravance,Inc.
References
1. Decramer
et al
. Lancet Resp Med 2014 ; Vol 2 No. 6 pp 472-4486.
2. Maleki-Yazdi
et al
. Respir Med. 2014;108(12):1752-1760.
A maintenance bronchodilator treatment to
relieve symptoms in patients with COPD
Anoro® Ellipta® improves lung function
(trough FEV
1
) compared with tiotropium
and has a similar adverse event profile
in clinical trials
1-2
Give your patients the benefits
of dual bronchodilation.
Visit
Anoro.co.uk
to find out more.
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 GlaxoSmithKline on 0800 221 441.