Anoro Ellipta

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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This medicinal product is subject to additional monitoring. This will allow quick identification of new 
safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 
4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 65 micrograms 
umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as 
trifenatate). This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent 
to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate). 
 
Excipient with known effect 
Each delivered dose contains approximately 25 mg of lactose (as monohydrate). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Inhalation powder, pre-dispensed (inhalation powder). 
 
White powder in a light grey inhaler (ELLIPTA) with a red mouthpiece cover and a dose counter. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
ANORO ELLIPTA is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult 
patients with chronic obstructive pulmonary disease (COPD). 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults  

The recommended dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily.   
 
ANORO ELLIPTA should be administered at the same time of the day each day to maintain bronchodilation. 
The maximum dose is one inhalation of ANORO ELLIPTA 55/22 micrograms once daily. 
 
Special populations  

Elderly patients 
No dose adjustment is required in patients over 65 years. 
 
Renal impairment 
No dose adjustment is required in patients with renal impairment. 
 
Hepatic impairment 
No dose adjustment is required in patients with mild or moderate hepatic impairment. The use of ANORO 



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ELLIPTA has not been studied in patients with severe hepatic impairment and should be used with caution. 
 
Paediatric population 

There is no relevant use of ANORO ELLIPTA in the paediatric population (under 18 years of age) for the 
indication of COPD. 

Method of administration  
 
ANORO ELLIPTA is for inhalation use only. 
 
The following instructions for the 30 dose inhaler (30 day supply) also apply to the 7 dose inhaler (7 day 
supply). 
 
The ELLIPTA inhaler contains pre-dispensed doses and is ready to use. 
 
The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture. The desiccant sachet 
should be thrown away and it should not be opened, eaten or inhaled. The patient should be advised to not 
open the tray until they are ready to inhale a dose. 
 
The inhaler will be in the ‘closed’ position when it is first taken out of its sealed tray. The “Discard by” date 
should be written on the inhaler label in the space provided. The “Discard by” date is 6 weeks from the date 
of opening the tray. After this date the inhaler should no longer be used. The tray can be discarded after first 
opening. 
 
If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost. The 
lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled. 
 
It is not possible to accidentally take extra medicinal product or a double dose in one inhalation. 
 
Instructions for use: 
 
a) Prepare a dose 
 
Open the cover when ready to inhale a dose. The inhaler should not be shaken. 
 
Slide the cover down until a “click” is heard. The medicinal product is now ready to be inhaled. 
 
The dose counter counts down by 1 to confirm. If the dose counter does not count down as the “click” is 
heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice. 
 
b) How to inhale the medicinal product 
 
The inhaler should be held away from the mouth breathing out as far as is comfortable. But not breathing out 
into the inhaler. 
 
The mouthpiece should be placed between the lips and the lips should then be closed firmly around it. The air 
vents should not be blocked with fingers during use. 
 

• Inhale with one long, steady, deep breath in. This breath should be held in for as long as possible (at 
least 3-4 seconds). 

• Remove the inhaler from the mouth. 
• Breathe out slowly and gently. 

 
The medicinal product may not be tasted or felt, even when using the inhaler correctly. 



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The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover. 
 
c) Close the inhaler 
 
Slide the cover upwards as far as it will go, to cover the mouthpiece. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 
 
4.4 Special warnings and precautions for use 
 
Asthma 
Umeclidinium/vilanterol should not be used in patients with asthma since it has not been studied in this 
patient population. 
 
Paradoxical bronchospasm 
Administration of umeclidinium/vilanterol may produce paradoxical bronchospasm that may be life-
threatening. Treatment with umeclidinium/vilanterol should be discontinued immediately if paradoxical 
bronchospasm occurs and alternative therapy instituted if necessary. 
 
Not for acute use  
Umeclidinium/vilanterol is not indicated for the treatment of acute episodes of bronchospasm.  
 
Deterioration of disease 
Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control. In the 
event of deterioration of COPD during treatment with umeclidinium/vilanterol, a re-evaluation of the patient 
and of the COPD treatment regimen should be undertaken.  
 
Cardiovascular effects 
Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after 
the administration of muscarinic receptor antagonists and sympathomimetics, including 
umeclidinium/vilanterol. Patients with clinically significant uncontrolled cardiovascular disease were 
excluded from clinical studies. Therefore, umeclidinium/vilanterol should be used with caution in patients 
with severe cardiovascular disease. 
 
Antimuscarinic activity  
Consistent with its antimuscarinic activity, umeclidinium/vilanterol should be used with caution in patients 
with urinary retention or with narrow-angle glaucoma. 
 
Hypokalaemia  
Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to 
produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring 
supplementation.  
 
No clinically relevant effects of hypokalaemia were observed in clinical studies with umeclidinium/vilanterol 
at the recommended therapeutic dose. Caution should be exercised when umeclidinium/vilanterol is used 
with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5). 
 
Hyperglycaemia 
Beta2-adrenergic agonists may produce transient hyperglycemia in some patients.  
 
No clinically relevant effects on plasma glucose were observed in clinical studies with 
umeclidinium/vilanterol at the recommended therapeutic dose. Upon initiation of treatment with 
umeclidinium/vilanterol plasma glucose should be monitored more closely in diabetic patients. 
 



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Coexisting conditions  
Umeclidinium/vilanterol should be used with caution in patients with convulsive disorders or thyrotoxicosis, 
and in patients who are unusually responsive to beta2-adrenergic agonists. 
 
Excipients 
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total 
lactase deficiency or glucose-galactose malabsorption should not use this medicinal product. 
  
4.5 Interaction with other medicinal products and other forms of interaction 
 
Beta-adrenergic blockers 
Medicinal products containing beta-adrenergic blockers may weaken or antagonise the effect of 
beta2-adrenergic agonists, such as vilanterol. Concurrent use of either non-selective or selective 
beta-adrenergic blockers should be avoided unless there are compelling reasons for their use. 
 
Metabolic and transporter based interactions  
Vilanterol is a substrate of cytochrome P450 3A4 (CYP3A4). Concomitant administration of strong CYP3A4 
inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin) may inhibit the 
metabolism of, and increase the systemic exposure to, vilanterol. Co-administration with ketoconazole 
(400 mg) in healthy volunteers increased mean vilanterol AUC(0-t) and Cmax, 65% and 22% respectively. The 
increase in vilanterol exposure was not associated with an increase in beta-adrenergic agonist related 
systemic effects on heart rate, blood potassium or QT interval (corrected using the Fridericia method). Care 
is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong 
CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol, which could lead to 
an increase in the potential for adverse reactions. Verapamil, a moderate CYP3A4 inhibitor, did not 
significantly affect the pharmacokinetics of vilanterol. 
 
Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6). The steady-state pharmacokinetics of 
umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers). No effect on 
umeclidinium AUC or Cmax was observed at a 8-fold higher dose. An approximately 1.3-fold increase in 
umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax. Based on the 
magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol 
is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in 
CYP2D6 activity (poor metabolisers). 
 
Both umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp). The effect of the 
moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of 
umeclidinium and vilanterol was assessed in healthy volunteers. No effect of verapamil was observed on 
umeclidinium or vilanterol Cmax. An approximately 1.4-fold increase in umeclidinium AUC was observed 
with no effect on vilanterol AUC. Based on the magnitude of these changes, no clinically relevant drug 
interaction is expected when umeclidinium/vilanterol is co-administered with P-gp inhibitors. 
 
Other antimuscarinics and sympathomimetics 
Co-administration of umeclidinium/vilanterol with other long-acting muscarinic antagonists, long-acting 
beta2-adrenergic agonists or medicinal products containing either of these agents has not been studied and is 
not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist 
adverse reactions (see sections 4.4 and 4.9). 
 
Hypokalaemia 
Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing 
diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with 
caution (see section 4.4). 
 



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Other medicinal products for COPD 
Although no formal in vivo drug interaction studies have been performed, inhaled umeclidinium/vilanterol 
has been used concomitantly with other COPD medicinal products including short acting sympathomimetic 
bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
There are no data from the use of umeclidinium/vilanterol in pregnant women. Studies in animals have 
shown reproductive toxicity at exposures which are not clinically relevant after administration of vilanterol 
(see section 5.3). 
 
Umeclidinium/vilanterol should be used during pregnancy only if the expected benefit to the mother justifies 
the potential risk to the foetus. 
 
Breast-feeding 
It is unknown whether umeclidinium or vilanterol are excreted in human milk. However, other 
beta2-adrenergic agonists are detected in human milk. A risk to the newborns/infants cannot be excluded. A 
decision must be made whether to discontinue breast-feeding or to discontinue umeclidinium/vilanterol 
therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the 
woman. 
 
Fertility 
There are no data on the effects of umeclidinium/vilanterol on human fertility. Animal studies indicate no 
effects of umeclidinium or vilanterol on fertility.  
 
4.7 Effects on ability to drive and use machines 
 
Umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.  
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most frequently reported adverse reaction with umeclidinium/vilanterol was nasopharyngitis (9%). 
 
Tabulated summary of adverse reactions 
The safety profile of ANORO ELLIPTA is based on safety experience with umeclidinium/vilanterol and the 
individual components from the clinical development program comprising of 6,855 patients with COPD and 
from spontaneous reporting. The clinical development programme included 2,354 patients who received 
umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 1,296 
patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients received a 
higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 micrograms in a 
12-month study. 
 
The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates 
observed in the integration of five 24-week studies and in the 12-month safety study.  
 
The frequency of adverse reactions is defined using the following convention: very common (≥1/10); 
common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 
(<1/10,000) and not known (cannot be estimated from available data). 
  



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System Organ Class Adverse reactions 
 

Frequency 

Infections and infestations Urinary tract infection  
Sinusitis 
Nasopharyngitis 
Pharyngitis 
Upper respiratory tract infection 

Common 
Common 
Common 
Common 
Common 

Immune system disorders Hypersensitivity reactions including: 
 
Rash  
 
Anaphylaxis, angioedema, and urticaria 

 
 
Uncommon 
 
Rare 

Nervous system disorders Headache 
Tremor 
Dysgeusia 
Dizziness 

Common 
Uncommon 
Uncommon 
Not known 

Eye disorders Vision blurred 
Glaucoma 
Intraocular pressure increased 

Rare 
Rare 
Rare 

Cardiac disorders Atrial fibrillation 
Supraventricular tachycardia 
Rhythm idioventricular  
Tachycardia 
Supraventricular extrasystoles 
Palpitations 

Uncommon 
Uncommon 
Uncommon 
Uncommon 
Uncommon 
Uncommon 

Respiratory, thoracic and 
mediastinal disorders  

Cough 
Oropharyngeal pain 
Dysphonia 
Paradoxical bronchospasm 

Common 
Common 
Uncommon 
Rare 

Gastrointestinal disorders  Constipation 
Dry mouth 

Common 
Common 

Skin and subcutaneous tissue 
disorders 

Rash Uncommon 

Renal and urinary disorders Urinary retention 
Dysuria 
Bladder outlet obstruction 

Rare 
Rare 
Rare 

 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 
to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
 
4.9 Overdose 
 
An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual 
components’ actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry 
mouth, visual accommodation disturbances and tachycardia) or those with overdose of other beta2-adrenergic 
agonists (e.g. arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia). 
 
If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. 
 
 



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5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with 
anticholinergics incl. triple combinations with corticosteroids, ATC code: R03AL03 
 
Mechanism of action 
Umeclidinium/vilanterol is a combination inhaled long-acting muscarinic receptor antagonist/long-acting 
beta2-adrenergic agonist (LAMA/LABA). Following oral inhalation both compounds act locally on airways 
to produce bronchodilation by separate mechanisms. 
 
Umeclidinium 
Umeclidinium is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic). It is a 
quinuclidine derivative with activity across multiple muscarinic receptor subtypes. Umeclidinium exerts its 
bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors 
on airway smooth muscle. It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in 
vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models. 
 
Vilanterol 
Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (beta2-adrenergic agonist).  
The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to 
stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine 
triphosphate (ATP) to cyclic-3’,5’-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels 
cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate 
hypersensitivity from cells, especially from mast cells. 
 
Pharmacodynamic effects 
In Phase III, 6-month studies umeclidinium/vilanterol provided clinically meaningful improvements over 
placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours 
following once daily administration, which were evident at 15 minutes following administration of the first 
dose (improvement over placebo by 112 ml (p <0.001*). Mean peak improvements in FEV1 within the first 6 
hours following dosing relative to placebo was 224 ml (p<0.001∗) at Week 24. There was no evidence for 
tachyphylaxis in the effect of ANORO ELLIPTA over time. 
 
Cardiac electrophysiology  
The effect of umeclidinium/vilanterol on the QT interval was evaluated in a placebo and active 
(moxifloxacin) controlled QT study involving once daily administration of umeclidinium/vilanterol 
113/22 micrograms or 500/100 micrograms (pre-dispensed dose with umeclidinium at eight times the 
recommended dose and vilanterol at four times the recommended dose) for 10 days in 103 healthy 
volunteers. The maximum mean difference in prolongations of QT interval (corrected using the Fridericia 
method, QTcF) from placebo after baseline-correction was 4.3 (90% CI=2.2 to 6.4) milliseconds seen 10 
minutes after administration with umeclidinium/vilanterol 113/22 micrograms and 8.2 (90% CI=6.2 to 10.2) 
milliseconds seen 30 minutes after administration with umeclidinium/vilanterol 500/100 micrograms. 
Therefore, no clinically relevant pro-arrhythmic potential related to QT-interval prolongations was observed 
with umeclidinium/vilanterol 113/22 micrograms. 
 
A dose-dependent increase in heart rate was also observed. The maximum mean difference in heart rate from 
placebo after baseline-correction was 8.4 (90% CI=7.0 to 9.8) beats/minute and 20.3 (90% CI=18.9 to 21.7) 
beats/minute seen 10 minutes after administration of umeclidinium/vilanterol 113/22 micrograms and 
500/100 micrograms respectively.  
 
In addition, no clinically significant effects on cardiac rhythm were observed on 24-hour Holter monitoring 
in 53 patients with COPD who were treated with umeclidinium/vilanterol 55/22 micrograms once daily in 

 
∗ A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did 
not achieve statistical significance. Therefore, statistical significance on this comparison cannot be inferred. 



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one 6-month study, or in a further 55 patients who received umeclidinium/vilanterol 113/22 micrograms once 
daily in another 6-month study and 226 patients who received 113/22 micrograms once daily in the 12-month 
study. 
 
Clinical efficacy and safety 
The clinical efficacy of umeclidinium/vilanterol administered once daily was evaluated in eight Phase III 
clinical studies in 6,835 adult patients with a clinical diagnosis of COPD; 5,618 patients from five 6-month 
studies (two placebo-controlled and three active [tiotropium]-comparator controlled), 655 patients from two 
3-month exercise endurance/lung function studies and 562 patients from a 12-month supportive study.  
 
Effects on lung function 
ANORO ELLIPTA demonstrated improvements in lung function (as defined by change from baseline in 
trough FEV1) in several studies. In one 6-month Phase III study, ANORO ELLIPTA demonstrated 
statistically significant improvements in trough FEV1 (primary endpoint) at Week 24 compared with placebo 
and each monotherapy component treatment arm.  In addition, ANORO ELLIPTA demonstrated clinically 
meaningful and statistically significant improvements in trough FEV1 compared with tiotropium in two of the 
three 6-month active-comparator studies and numerically greater improvements from tiotropium in the third 
active-comparator study (see Table 1). There was no attenuation of the bronchodilator effect over time. 
 
Symptomatic outcomes 
Breathlessness: 
ANORO ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in 
breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) 
compared with placebo (see Table 1). Improvements in TDI focal score compared with each monotherapy 
component and tiotropium were not statistically significant (see Table 1). 
 
The proportion of patients who responded with at least the minimum clinically important difference (MCID) 
of 1 unit TDI focal score at Week 24 was greater for ANORO ELLIPTA (58%) compared with placebo 
(41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).  
 
Health-related quality of life: 
ANORO ELLIPTA has also shown an improvement in health-related quality of life measured using the 
St. George’s Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 24 
compared with placebo and each monotherapy component (see Table 1). ANORO ELLIPTA showed a 
statistically significant reduction in SGRQ total score compared with tiotropium in one of the three active-
comparator studies (see Table 1). 
 
The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 
4 units from baseline) at Week 24 was greater for ANORO ELLIPTA (49%) compared with placebo (34%) 
and each monotherapy component (44% for umeclidinium and 48% for vilanterol). In one active-comparator 
study, a higher percentage of patients receiving ANORO ELLIPTA responded with a clinically meaningful 
improvement in SGRQ score at Week 24 (53%) compared to tiotropium (46%). In the other two 
active-comparator studies, a similar proportion of patients achieved at least the MCID with ANORO 
ELLIPTA and tiotropium; 49% and 54% for ANORO ELLIPTA 55/22 micrograms and 52% and 55% for 
tiotropium. 
  
Use of rescue medication 
ANORO ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared with 
placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion of 
days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline on 
placebo (on average 0.9%).  
 
In the three 6-month active-comparator-controlled studies, ANORO ELLIPTA reduced the use of rescue 
medication with salbutamol compared with tiotropium, with statistically significant reductions observed in 
two of the studies (see Table 1). ANORO ELLIPTA also demonstrated a greater increase from baseline in the 
proportion of days when no rescue medication was needed in all three studies (average within the range 
17.6% to 21.5%) compared with tiotropium (average within the range 11.7% to 13.4%). 



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Table 1. Lung function, symptomatic and health related quality of life outcomes at Week 24 
 

Treatment comparisons 
with ANORO 
ELLIPTA 55/22 mcg 

Treatment difference1 (95% confidence intervals, p-value) 

Trough FEV1 
(ml) 

TDI 
Focal Score 

SGRQ 
Total Score 

Use of rescue 
medication3 

ANORO ELLIPTA (N = 
413)  
versus 
Placebo (N = 280) 

167 
(128, 207) 

<0.001 

1.2  
(0.7,1.7) 
<0.001 

-5.51 
(-7.88, -3.13) 

<0.001∗ 

-0.8 
(-1.3,-0.3) 

0.001* 

ANORO ELLIPTA (N = 
413)  
versus 
Umeclidinium 55 mcg 
(N = 418) 

52 
(17, 87) 
0.004 

0.3 
(-0.2, 0.7) 

0.244 

-0.82 
(-2.90, 1.27) 

0.441 

-0.6 
(-1.0, -0.1) 

0.014* 

ANORO ELLIPTA (N = 
413)  
versus 
Vilanterol 22 mcg 
(N = 421) 

95 
(60, 130) 
<0.001 

0.4 
(-0.1, 0.8) 

0.117 

-0.32 
(-2.41, 1.78) 

0.767 

0.1 
(-0.3, 0.5) 

0.675 

ANORO ELLIPTA 
(N = 454)  
versus 
tiotropium 18 mcg 
(N = 451) 
(Study ZEP117115) 

112 
(81, 144) 
<0.001 

n/e 
-2.10 

(-3.61, -0.59) 
0.006 

-0.5 
(-0.7, -0.2) 

<0.001 

ANORO ELLIPTA 
(N = 207)  
versus 
tiotropium 18 mcg 
(N = 203) 
(Study DB2113360) 

90 
(39, 141) 
<0.001 

0.12 

(-0.4, 0.5) 
0.817 

0.75 
(-2.12, 3.63) 

0.607 

-0.7 
(-1.2, -0.1) 

0.022 

ANORO ELLIPTA 
(N = 217)  
versus 
tiotropium 18 mcg 
(N =  215) 
(Study DB2113374) 

60 
(10, 109) 

0.018* 

-0.17 
(-2.85, 2.52) 

0.904 

-0.6 
(-1.2, 0.0) 

0.069 

N=number in Intent-to-treat population  
mcg = micrograms 
n/e = not evaluated 
1. Least squares mean 
2. Pooled data from Study DB2113360 and Study DB2113374 
3. Difference in the mean number of puffs per day over Weeks 1-24 
 

 
∗ A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did 
not achieve statistical significance. Therefore, statistical significance on this comparison cannot be inferred. 



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A higher dose of umeclidinium/vilanterol (113/22 micrograms) was also studied in a 24-week placebo 
controlled clinical study and in two of the three 24-week active-controlled studies. The results were similar to 
those for the ANORO ELLIPTA dose and provided additional supportive evidence for the efficacy of 
ANORO ELLIPTA.  
 
COPD exacerbations 
In a 24-week placebo-controlled study in patients with symptomatic COPD, ANORO ELLIPTA reduced the 
risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis of time to 
first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with umeclidinium 
(HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 0.4, 1.1; 
p=0.121). From the three active-comparator studies in patients with symptomatic COPD, the risk of a 
moderate/severe COPD exacerbation compared with tiotropium was reduced by 50% in one study (HR 0.5; 
95% CI: 0.3, 1.0; p=0.044). In the other two studies, the risk of a moderate/severe COPD exacerbation was 
increased by 20% and 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 and HR 1.9; 95% CI: 1.0, 3.6; p=0.062 
respectively). These studies were not specifically designed to evaluate the effect of treatments on COPD 
exacerbations and patients were withdrawn from the study if an exacerbation occurred. 
 
Supporting efficacy studies   
In a randomised, double-blind, 52-week study (CTT116855, IMPACT), 10,355 adult patients with 
symptomatic COPD and a history of 1 or more moderate/severe exacerbations in the prior 12 months were 
randomised (1:2:2) to receive umeclidinium/vilanterol (UMEC/VI 55/22 micrograms), fluticasone 
furoate/umeclidinium/vilanterol (FF/UMEC/VI 92/55/22 micrograms), or fluticasone furoate/vilanterol 
(FF/VI 92/22 micrograms) administered once daily as a single inhaler. The primary endpoint was annual rate 
of on-treatment moderate and severe exacerbations in subjects treated with FF/UMEC/VI compared with 
FF/VI and UMEC/VI. The mean annual rate of exacerbations was 0.91, 1.07 and 1.21 for FF/UMEC/VI, 
FF/VI, and UMEC/VI respectively. 
 
The comparison of FF/UMEC/VI to FF/VI and UMEC/VI resulted in a statistically significant 14.8% 
reduction in risk of a moderate/severe exacerbation (based on analysis of time to first exacerbation) (Hazard 
Ratio 0.85; 95% CI: 0.80, 0.91; p<0.001) and 16.0% reduction in risk of a moderate/severe exacerbation 
respectively (based on analysis of time to first exacerbation) (Hazard Ratio 0.84; 95% CI: 0.78, 0.91; 
p<0.001). 
 
Exercise endurance and lung volumes 
ANORO ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as 
evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung 
volume measures compared with placebo in both studies in adult COPD patients with hyperinflation 
(functional residual capacity [FRC] >120%). In the first study, ANORO ELLIPTA 55/22 micrograms 
demonstrated a statistically significant and clinically relevant improvement (based on a minimal clinically 
important difference (MCID) between 45 to 85 seconds) over placebo in exercise endurance time (EET) 
obtained 3 hours after dosing at Week 12 (69.4 seconds [p=0.003]). Improvement in EET compared with 
placebo was seen at Day 2 and was sustained at Week 6 and Week 12. In the second study, the treatment 
difference in EET between ANORO ELLIPTA 55/22 micrograms and placebo was 21.9 seconds (p=0.234) at 
Week 12. 
 
ANORO ELLIPTA 55/22 micrograms also showed statistically significant improvements compared with 
placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 in 
the first study (inspiratory capacity: 237 ml and 316 ml respectively, residual volume: -466 ml and -643 ml 
respectively and functional residual capacity: -351 ml and -522 ml respectively; all p<0.001). In the second 
study, ANORO ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from 
baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml 
and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual 
capacity: -238 ml and -302 ml respectively); all p<0.001∗). 
 

 
∗ A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did 
not achieve statistical significance. Therefore, statistical significance on this comparison cannot be inferred. 



12 

Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with ANORO 
ELLIPTA in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric 
use). 
 
5.2 Pharmacokinetic properties 
 
When umeclidinium and vilanterol were administered in combination by the inhaled route, the 
pharmacokinetics of each component was similar to those observed when each active substance was 
administered separately. For pharmacokinetic purposes each component can therefore be considered 
separately. 
 
Absorption 
 
Umeclidinium 
Following inhaled administration of umeclidinium in healthy volunteers, Cmax occurred at 5 to 15 minutes. 
The absolute bioavailability of inhaled umeclidinium was on average 13% of the dose, with negligible 
contribution from oral absorption. Following repeat dosing of inhaled umeclidinium, steady state was 
achieved within 7 to 10 days with 1.5 to 1.8-fold accumulation.  
 
Vilanterol 
Following inhaled administration of vilanterol in healthy volunteers, Cmax occurred at 5 to 15 minutes. The 
absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption. 
Following repeat dosing of inhaled vilanterol, steady state was achieved within 6 days with up to 2.4-fold 
accumulation.  
 
Distribution 
 
Umeclidinium  
Following intravenous administration to healthy volunteers, the mean volume of distribution was 86 litres. 
In vitro plasma protein binding in human plasma was on average 89%.   
 
Vilanterol 
Following intravenous administration to healthy volunteers, the mean volume of distribution at steady state 
was 165 litres. In vitro plasma protein binding in human plasma was on average 94%. 
 
Biotransformation 
 
Umeclidinium 
In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and 
is a substrate for the P-glycoprotein (P-gp) transporter. The primary metabolic routes for umeclidinium are 
oxidative (hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range 
of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not 
been established. Systemic exposure to the metabolites is low. 
 
Vilanterol 
In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a 
substrate for the P-gp transporter. The primary metabolic routes for vilanterol are O-dealkylation to a range 
of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity. Plasma metabolic 
profiles following oral administration of vilanterol in a human radiolabel study were consistent with high 
first-pass metabolism. Systemic exposure to the metabolites is low. 
 
Elimination 
 
Umeclidinium  
Plasma clearance following intravenous administration was 151 litres/hour. Following intravenous 
administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered 



13 

radioactivity) was excreted in faeces by 192 hours post-dose. Urinary elimination accounted for 22% of the 
administered radiolabelled dose by 168 hours (27% of recovered radioactivity). The excretion of the 
drug-related material in the faeces following intravenous dosing indicated secretion into the bile. Following 
oral administration to healthy male volunteers, total radioactivity was excreted primarily in faeces (92% of 
the administered radiolabelled dose or 99% of the recovered radioactivity) by 168 hours post-dose. Less than 
1% of the orally administered dose (1% of recovered radioactivity) was excreted in urine, suggesting 
negligible absorption following oral administration. Umeclidinium plasma elimination half-life following 
inhaled dosing for 10 days averaged 19 hours in healthy volunteers, with 3% to 4% excreted unchanged in 
urine at steady-state. 
  
Vilanterol 
Plasma clearance of vilanterol following intravenous administration was 108 litres/hour. Following oral 
administration of radiolabelled vilanterol, mass balance showed 70% of the radiolabel in urine and 30% in 
faeces. Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine 
and faeces. Vilanterol plasma elimination half-life following inhaled dosing for 10 days averaged 11 hours. 
 
Characteristics in specific groups of healthy volunteers or patients 
 
Elderly 
A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium and vilanterol were 
similar between COPD patients 65 years and older and those younger than 65 years of age. 
 
Renal impairment 
Patients with severe renal impairment showed no evidence of an increase in systemic exposure to either 
umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with 
umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of 
altered protein binding between patients with severe renal impairment and healthy volunteers. 
 
Hepatic impairment 
Patients with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in 
systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of 
umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the 
recommended dose and no evidence of altered protein binding between patients with moderate hepatic 
impairment and healthy volunteers. Umeclidinium/vilanterol has not been evaluated in patients with severe 
hepatic impairment. 
 
Other special populations 
A population pharmacokinetic analysis showed that no dose adjustment is required for umeclidinium or 
vilanterol based on the effect of age, race, gender, inhaled corticosteroid use, or weight. A study in CYP2D6 
poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on 
systemic exposure to umeclidinium.  
 
5.3 Preclinical safety data  
 
In nonclinical studies with umeclidinium and vilanterol, alone and in combination, findings were those 
typically associated with the primary pharmacology of either muscarinic receptor antagonists or 
beta2-adrenergic agonists respectively and/or local irritancy. The following statements reflect studies 
conducted on the individual components. 
 
Genotoxicity and carcinogenicity 
Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime 
inhalation studies in mice or rats at exposures ≥ 26 or ≥ 22-fold, times the human clinical exposure of 
umeclidinium 55 micrograms, based on AUC, respectively. 
 
In genetic toxicity studies, vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic 
indicating that vilanterol (as trifenatate) does not represent a genotoxic hazard to humans. Consistent with 
findings for other beta2-adrenergic agonists, in lifetime inhalation studies, vilanterol trifenatate caused 



14 

proliferative effects in the female rat and mouse reproductive tract and in the rat pituitary gland. There was 
no increase in tumour incidence in rats or mice at exposures 0.5- or 13-fold, times the human clinical 
exposure of vilanterol 22 micrograms based on AUC, respectively. 
 
Toxicity to reproduction 
Umeclidinium was not teratogenic in rats or rabbits. In a pre- and post-natal study, subcutaneous 
administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption 
and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose 
(approximately 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC). 
 
Vilanterol was not teratogenic in rats. In inhalation studies in rabbits, vilanterol caused effects similar to 
those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb 
flexure/malrotation) at 6-times the human clinical exposure based on AUC. When given subcutaneously 
there were no effects at 36-times the human clinical exposure of vilanterol 22 micrograms, based on AUC. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Lactose monohydrate 
Magnesium stearate 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
2 years 
 
In-use shelf-life after opening the tray: 6 weeks 
 
6.4 Special precautions for storage 
 
Do not store above 30°C. If stored in a refrigerator allow the inhaler to return to room temperature for at least 
an hour before use. 
  
Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before 
first use. 
 
Write the date the inhaler should be discarded on the label in the space provided. The date should be added as 
soon as the inhaler has been removed from the tray. 
 
6.5 Nature and contents of container  
 
The ELLIPTA inhaler consists of a light grey body, red mouthpiece cover and a dose counter, packed into a 
foil laminate tray containing a silica gel desiccant sachet. The tray is sealed with a peelable foil lid.   
 
The inhaler is a multi-component device composed of polypropylene, high density polyethylene, 
polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless 
steel. 
 
The inhaler contains two aluminium foil laminate blisters of 7 or 30 doses.  
 
Pack sizes of 7 or 30 dose inhalers. Multipack of 3 x 30 dose inhalers. 
 



15 

Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline (Ireland) Limited  
12 Riverwalk  
Citywest Business Campus 
Dublin 24 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/898/001 
EU/1/14/898/002 
EU/1/14/898/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 08 May 2014 
Date of latest renewal: 15 January 2019 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu. 



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 
USE 

 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 
 



17 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
 
 
Name and address of the manufacturers responsible for batch release 
 
Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations)  
Priory Street 
Ware, Hertfordshire SG12 0DJ 
United Kingdom 
 
Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations)  
Harmire Road  
Barnard Castle, County Durham DL12 8DT 
United Kingdom 
 
Glaxo Wellcome Production 
Zone Industrielle No.2, 
23 Rue Lavoisier,  
27000 Evreux,  
France 
 
The printed package leaflet of the medicinal product must state the name and address of the manufacturer 
responsible for the release of the concerned batch. 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription. 
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE 

OF THE MEDICINAL PRODUCT   
 
• Risk Management Plan (RMP) 

 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 
 
An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information being 

received that may lead to a significant change to the benefit/risk profile or as the result of an important 
(pharmacovigilance or risk minimisation) milestone being reached. 

 
 
• Obligation to conduct post-authorisation measures  
 



18 

The MAH shall complete, within the stated timeframe, the below measure: 
 
Description Due date 
Submission of the final clinical study report on a Post-Authorisation Safety (PAS) 
Observational Cohort Study to Quantify the Incidence and Comparative Safety of 
Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Anoro 
Ellipta compared with tiotropium (study 201038), according to a protocol agreed by the 
PRAC. 

By Q3 2024 
 

 



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (SINGLE PACKS) 
 
55 micrograms/22 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed 
umeclidinium/vilanterol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium 
bromide) and 22 micrograms vilanterol (as trifenatate). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: lactose and magnesium stearate. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Inhalation powder, pre-dispensed.  
1 inhaler of 7 doses  
1 inhaler of 30 doses 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Once daily 
Read the package leaflet before use. 
Inhalation use. 
 

 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
  
 
8. EXPIRY DATE 
 
EXP 
In use shelf-life: 6 weeks. 
 



22 

 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C.  
Store in the original package in order to protect from moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland 
GlaxoSmithKline (Ireland) Limited logo  
  
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/898/001 1 inhaler of 7 doses 
EU/1/14/898/002 1 inhaler of 30 doses  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
anoro ellipta 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 
 
55 micrograms/22 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed 
umeclidinium/vilanterol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium 
bromide) and 22 micrograms vilanterol (as trifenatate). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: lactose and magnesium stearate. 
See package leaflet for further information. 
  
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Inhalation powder, pre-dispensed. 
Multipack: 90 (3 packs of 30) doses 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Once daily 
Read the package leaflet before use. 
Inhalation use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
In use shelf-life: 6 weeks. 
 
 



24 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C.  
Store in the original package in order to protect from moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland 
GlaxoSmithKline (Ireland) Limited logo  
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/898/003  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
anoro ellipta 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



25 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 
 
55 micrograms/22 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed 
umeclidinium/vilanterol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium 
bromide) and 22 micrograms vilanterol (as trifenatate). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: lactose and magnesium stearate 
See package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Inhalation powder, pre-dispensed 
1 inhaler of 30 doses  
Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Once daily 
Read the package leaflet before use. 
Inhalation use. 

 
 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 
THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
  
 
8. EXPIRY DATE 
 
EXP 
In use shelf-life: 6 weeks. 
 
 



26 

9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C.  
Store in the original package in order to protect from moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland 
GlaxoSmithKline (Ireland) Limited logo 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/14/898/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
anoro ellipta 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 



27 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
FOIL LAMINATE TRAY LID  
 
55 micrograms/22 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
ANORO ELLIPTA 55/22 mcg inhalation powder 
umeclidinium/vilanterol 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline (Ireland) Limited logo   
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Do not open until ready to inhale. 
In use shelf-life: 6 weeks. 
7 doses 
30 doses 
 



28 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
INHALER LABEL 
 
55 micrograms/22 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
ANORO ELLIPTA 55/22 mcg inhalation powder 
umeclidinium/vilanterol 
Inhalation use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
In use shelf-life: 6 weeks. 
Discard by: 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
7 doses  
30 doses  
 
 
6. OTHER 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 



29 

 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



30 

Package leaflet: Information for the user 
 

ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed 
 

umeclidinium/vilanterol 
 

This medicine is subject to additional monitoring. This will allow quick identification of new safety 
information. You can help by reporting any side effects you may get. See the end of section 4 for how to 
report side effects. 
 
Read all of this leaflet carefully before you start using this medicine because it contains important 
information for you. 
 
- Keep this leaflet. You may need to read it again.  
- If you have any further questions, ask your doctor, pharmacist or nurse. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 

their signs of illness are the same as yours.  
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What ANORO ELLIPTA is and what it is used for  
2. What you need to know before you use ANORO ELLIPTA 
3. How to use ANORO ELLIPTA 
4. Possible side effects  
5. How to store ANORO ELLIPTA 
6. Contents of the pack and other information 
 Step-by-step instructions  
 
 
1. What ANORO ELLIPTA is and what it is used for 
 
What ANORO ELLIPTA is  
 
ANORO ELLIPTA contains two active substances umeclidinium bromide and vilanterol. These belong to a 
group of medicines called bronchodilators. 
 
What ANORO ELLIPTA is used for  
 
ANORO ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a 
long-term condition characterised by breathing difficulties that slowly get worse.  
 
In COPD the muscles around the airways tighten. This medicine blocks the tightening of these muscles in the 
lungs, making it easier for air to get in and out of the lungs. When used regularly, it can help to control your 
breathing difficulties and reduce the effects of COPD on your everyday life.  
 

ANORO ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing.  
If you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol). If you 
do not have a quick-acting inhaler contact your doctor. 

 
 
2. What you need to know before you use ANORO ELLIPTA 
 
Do not use ANORO ELLIPTA: 



31 

- if you are allergic to umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in 
section 6). 

If you think this applies to you, don’t use this medicine until you have checked with your doctor.  
 
Warnings and precautions   
Talk to your doctor before using this medicine: 
- if you have asthma (Don’t use ANORO ELLIPTA to treat asthma) 
- if you have heart problems or high blood pressure 
- if you have an eye problem called narrow-angle glaucoma 
- if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder 
- if you suffer from epilepsy 
- if you have thyroid gland problems 
- if you have diabetes 
- if you have severe liver problems 
 
 Check with your doctor if you think any of these may apply to you. 
 
Immediate breathing difficulties 
If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your ANORO 
ELLIPTA inhaler: 

Stop using this medicine and seek medical help immediately, as you may have a serious condition 
called paradoxical bronchospasm. 

 
Eye problems during treatment with ANORO ELLIPTA 
If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association 
with red eyes during treatment with ANORO ELLIPTA: 
  

Stop using this medicine and seek medical help immediately, these may be signs of an acute attack 
of narrow-angle glaucoma. 

 
Children and adolescents 
Do not give this medicine to children or adolescents below the age of 18 years. 
 
Other medicines and ANORO ELLIPTA 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If 
you are not sure what your medicine contains talk to your doctor or pharmacist. 
 
Some medicines may affect how this medicine works, or make it more likely that you’ll have side effects. 
These include: 
- medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart 

problems 
- ketoconazole or itraconazole, to treat fungal infections 
- clarithromycin or telithromycin, to treat bacterial infections  
- ritonavir, to treat HIV infection 
- medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) or 

some medicines used to treat asthma (such as methylxanthine or steroids)   
- other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. 

tiotropium, indacaterol. Don’t use ANORO ELLIPTA if you already use these medicines. 
 
Tell your doctor or pharmacist if you are taking any of these. 
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 
doctor for advice before using this medicine. Don’t use this medicine if you are pregnant unless your doctor 
tells you that you can. 
 



32 

It is not known whether the ingredients of ANORO ELLIPTA can pass into breast milk. If you are breast-
feeding, you must check with your doctor before you use ANORO ELLIPTA. Don’t use this medicine if 
you are breast-feeding unless your doctor tells you that you can. 
 
Driving and using machines 
It is unlikely that ANORO ELLIPTA will affect your ability to drive or use machines. 
 
ANORO ELLIPTA contains lactose 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before 
using this medicine. 
 
 
3. How to use ANORO ELLIPTA 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure.  
 
The recommended dose is one inhalation every day at the same time of day. You only need to inhale once a 
day because the effect of this medicine lasts for 24 hours. 
Don’t use more than your doctor tells you to use.  
 
Use ANORO ELLIPTA regularly 
It is very important that you use ANORO ELLIPTA every day, as instructed by your doctor.  This will help 
to keep you free of symptoms throughout the day and night. 
 
ANORO ELLIPTA should not be used to relieve a sudden attack of breathlessness or wheezing. If you get 
this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol). 
 
How to use the inhaler 
See ‘Step-by-step instructions’ in this leaflet for full information. 
 
ANORO ELLIPTA is for inhalation use. To use ANORO ELLIPTA, you breathe it into your lungs through 
your mouth using the ELLIPTA inhaler. 
 
If your symptoms do not improve 
If your COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse, or if you are using 
your quick-acting inhaler more often: 

 contact your doctor as soon as possible. 
 
If you use more ANORO ELLIPTA than you should 
If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice 
immediately as you may need medical attention. If possible, show them the inhaler, the package or this 
leaflet. You may notice that your heart is beating faster than usual, you feel shaky, you have visual 
disturbances, have a dry mouth, or have a headache. 
 
If you forget to use ANORO ELLIPTA 
Don’t inhale an extra dose to make up for a forgotten dose. Just inhale your next dose at the usual time.  
If you become wheezy or breathless, use your quick-acting reliever inhaler (such as salbutamol), then seek 
medical advice. 
 
If you stop using ANORO ELLIPTA 
Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. 
Don’t stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse. 
 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 
 



33 

 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Allergic reactions 
If you have any of the following symptoms after taking ANORO ELLIPTA stop using this medicine and 
tell your doctor immediately. 
 
Uncommon side effects (may affect up to 1 in 100 people): 

•  skin rash (hives) or redness 
 
Rare side effects (may affect up to 1 in 1,000 people):  

•  swelling, sometimes of the face or mouth (angioedema) 
•  becoming very wheezy, coughing or having difficulty in breathing 
•  suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness) 

 
Immediate breathing difficulties 
Immediate breathing difficulties after using ANORO ELLIPTA are rare.  If you get tightness of the chest, 
coughing, wheezing or breathlessness immediately after using this medicine: 

 Stop using this medicine and seek medical help immediately, as you may have a serious 
condition called paradoxical bronchospasm. 
 
Common side effects 
These may affect up to 1 in 10 people:  

• painful and frequent urination (may be signs of a urinary tract infection)  
• combination of sore throat and runny nose 
• sore throat 
• feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses 

called sinusitis) 
• headache 
• cough 
• pain and irritation in the back of the mouth and throat 
• constipation 
• dry mouth 
• infection of the upper airways. 

 
Uncommon side effects 
These may affect up to 1 in 100 people:  

• irregular heart beat  
• faster heart beat 
• awareness of heart beat (palpitations) 
• rash 
• tremor 
• taste disturbance  
• hoarseness. 

 



34 

Rare side effects 
These may affect up to 1 in 1,000 people:  

• blurred vision 
• increase of the measured eye pressure 
• decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma). 
• difficulty and pain when passing urine – these may be signs of a bladder obstruction or urinary 

retention. 
 
Frequency not known 
Frequency cannot be estimated from the available data: 

• dizziness. 
 

Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store ANORO ELLIPTA 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP’. The 
expiry date refers to the last day of that month.  
 
Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before 
first use.  Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening 
the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should 
be added as soon as the inhaler has been removed from the tray. 
 
Do not store above 30°C. 
 
If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose 
of medicines no longer required.  This will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What ANORO ELLIPTA contains  
The active substances are umeclidinium bromide and vilanterol. 
 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms 
umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as 
trifenatate) 

 
The other ingredients are lactose monohydrate (see section 2 under ‘ANORO ELLIPTA contains lactose’) 
and magnesium stearate. 
 
What ANORO ELLIPTA looks like and contents of the pack 
ANORO ELLIPTA is an inhalation powder, pre-dispensed. 
The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter. It is 
packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant packet, to reduce 
moisture in the packaging.  
 



35 

The active substances are present as a white powder in separate blisters inside the inhaler. Each inhaler 
contains either 7 or 30 doses. Multipacks containing 90 (3 inhalers of 30) doses are also available. Not all 
pack sizes may be marketed.  
 
Marketing Authorisation Holder: 
 
GlaxoSmithKline (Ireland) Limited  
12 Riverwalk  
Citywest Business Campus 
Dublin 24 
Ireland 
 
Manufacturer: 
 
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)  
Priory Street 
Ware 
Hertfordshire  
SG12 0DJ  
United Kingdom 
 
Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) 
Harmire Road 
Barnard Castle 
County Durham 
DL12 8DT 
United Kingdom 
 
Glaxo Wellcome Production 
Zone Industrielle No.2, 
23 Rue Lavoisier,  
27000 Evreux,  
France 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien  
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 (0) 10 85 52 00 
 
 

Lietuva  
GlaxoSmithKline Lietuva UAB 
Tel: + 370 5 264 90 00 
info.lt@gsk.com 

България  
ГлаксоСмитКлайн ЕООД  
Teл.: + 359 2 953 10 34 
 

Luxembourg/Luxemburg  
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Belgique/Belgien 
Tél/Tel: + 32 (0) 10 85 52 00 
 

Česká republika  
GlaxoSmithKline, s.r.o. 
Tel: + 420 222 001 111 
cz.info@gsk.com 

Magyarország  
GlaxoSmithKline Kft. 
Tel.: + 36 1 225 5300 
 
 

Danmark  
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 

Malta  
GlaxoSmithKline (Malta) Limited 
Tel: + 356 21 238131 



36 

dk-info@gsk.com  
 

Deutschland  
GlaxoSmithKline GmbH & Co. KG 
Tel.: + 49 (0)89 36044 8701 
produkt.info@gsk.com 

Nederland  
GlaxoSmithKline BV 
Tel: + 31 (0)33 2081100 
 

 
Eesti  
GlaxoSmithKline Eesti OÜ 
Tel: + 372 6676 900 
estonia@gsk.com  

Norge  
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
 

 
Ελλάδα  
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. 
Τηλ: + 30 210 68 82 100 
 
 

Österreich  
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com 

España  
GlaxoSmithKline, S.A. 
Tel: + 34 900 202 700 
es-ci@gsk.com 

Polska  
GSK Services Sp. z o.o. 
Tel.: + 48 (0)22 576 9000 
 
 

France  
Laboratoire GlaxoSmithKline 
Tél: + 33 (0)1 39 17 84 44 
diam@gsk.com 

Portugal  
GlaxoSmithKline – Produtos Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com 
 

Hrvatska 
GlaxoSmithKline d.o.o. 
Tel: + 385 1  6051 999 
 

România  
GlaxoSmithKline (GSK) S.R.L.  
Tel: + 4021 3028 208 

Ireland  
GlaxoSmithKline (Ireland) Limited 
Tel: + 353 (0)1 4955000 
 
 

Slovenija  
GlaxoSmithKline d.o.o. 
Tel: + 386 (0)1 280 25 00 
medical.x.si@gsk.com 

Ísland  
Vistor hf. 
Sími: + 354 535 7000 
 
 

Slovenská republika  
GlaxoSmithKline Slovakia s. r. o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 

Italia  
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 7741111 
 
 

Suomi/Finland  
GlaxoSmithKline Oy 
Puh/Tel: + 358 (0)10 30 30 30 
Finland.tuoteinfo@gsk.com 

Κύπρος  
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 397000 
gskcyprus@gsk.com 
 

Sverige  
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 

Latvija  
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com 

United Kingdom   
GlaxoSmithKline UK Ltd 
Tel: + 44 (0)800 221441 
customercontactuk@gsk.com 

 
This leaflet was last revised in  



37 

 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 



38 

Step-by-step instructions 
 
What is the inhaler? 
The first time you use ANORO ELLIPTA you do not need to check that the inhaler is working properly; it 
contains previously measured doses and is ready to use straight away. 
 
Your ANORO ELLIPTA inhaler carton contains 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The inhaler is packaged in a tray.  Don’t open the tray until you are ready to start using your new 
inhaler.  When you are ready to use your inhaler, peel back the lid to open the tray.  The tray contains a 
desiccant sachet, to reduce moisture. Throw this desiccant sachet away – don’t open, eat or inhale it. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
When you take the inhaler out of its tray, it will be in the ‘closed’ position. Don’t open the inhaler until you 
are ready to inhale a dose of medicine. When the tray is opened, write the “Discard by” date on the inhaler 
label in the space provided. The “Discard by” date is 6 weeks from the date you open the tray.  After this date 
the inhaler should no longer be used.  The tray can be discarded after first opening. 
 
The instructions for use of the inhaler provided below can be used for either the 30-dose inhaler (30 day 
supply) or the 7-dose inhaler (7 day supply). 
 

Desiccant 

This leaflet 

Carton 

Tray lid 

Inhaler 

Desiccant 

Tray 



39 

1) Read this before you start 

If you open and close the cover without inhaling the medicine, you will lose the dose.  
The lost dose will be securely held inside the inhaler, but it will no longer be available. 
It is not possible to accidentally take extra medicine or a double dose in one inhalation. 
 

 

2) Prepare a dose 

Wait to open the cover until you are ready to inhale your dose.  
Do not shake the inhaler. 

• Slide the cover down until you hear a “click”. 

 
Your medicine is now ready to be inhaled. 

The dose counter counts down by 1 to confirm. 

• If the dose counter does not count down as you hear the “click”, the inhaler will not deliver 
medicine.  
Take it back to your pharmacist for advice. 

3) Inhale your medicine 

• While holding the inhaler away from your mouth, breathe out as far as is comfortable.  
Don’t breathe out into the inhaler. 

• Put the mouthpiece between your lips, and close your lips firmly around it. 
Don’t block the air vent with your fingers. 



40 

 
• Take one long, steady, deep breath in. Hold this breath in for as long as possible (at least 3-4 

seconds). 

• Remove the inhaler from your mouth. 

• Breathe out slowly and gently. 

You may not be able to taste or feel the medicine, even when you are using the inhaler correctly. 
 
If you want to clean the mouthpiece, use a dry tissue, before you close the cover. 
 
4) Close the inhaler 

 

 
Slide the cover upwards as far as it will go, to cover the mouthpiece.  
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET