Incruse 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 
 
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece of the inhaler) of 
55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) This 
corresponds to a pre-dispensed dose of 62.5 micrograms umeclidinium equivalent to 74.2 micrograms 
umeclidinium bromide. 
 
Excipient with known effect: 
Each delivered dose contains approximately 12.5 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 grey inhaler (Ellipta) with a light green mouthpiece cover and a dose counter. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Incruse 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 umeclidinium bromide once daily.  
 
Incruse Ellipta should be administered at the same time of the day each day to maintain 
bronchodilation. The maximum dose is one inhalation of umeclidinium bromide once daily. 
 
Special populations  

Elderly patients 
No dose adjustment is required in patients over 65 years (see section 5.2). 
 
Renal impairment 
No dose adjustment is required in patients with renal impairment (see section 5.2). 
 
Hepatic impairment 
No dose adjustment is required in patients with mild or moderate hepatic impairment. Incruse Ellipta 
has not been studied in patients with severe hepatic impairment and should be used with caution (see 



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section 5.2). 
 

Paediatric population 

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

Method of administration  
 
Incruse 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 take 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. 
 
The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover. 



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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 substance or to any of the excipients listed in section 6.1 
 
4.4 Special warnings and precautions for use 
 
Asthma 
Umeclidinium bromide should not be used in patients with asthma since it has not been studied in this 
patient population. 
 
Paradoxical bronchospasm 
Administration of umeclidinium bromide may produce paradoxical bronchospasm that may be life-
threatening. Treatment should be discontinued immediately if paradoxical bronchospasm occurs and 
alternative therapy instituted if necessary. 
 
Deterioration of disease 
Umeclidinium bromide is intended for the maintenance treatment of COPD. It should not be used for 
the relief of acute symptoms, i.e. as rescue therapy for the treatment of acute episodes of 
bronchospasm. Acute symptoms should be treated with an inhaled short-acting bronchodilator. 
Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control. 
In the event of deterioration of COPD during treatment with umeclidinium bromide, 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 including umeclidinium bromide. In 
addition, patients with clinically significant uncontrolled cardiovascular disease were excluded from 
clinical studies. Therefore, umeclidinium bromide should be used with caution in patients with severe 
cardiovascular disorders, particularly cardiac arrhythmias. 
 
Antimuscarinic activity  
Consistent with its antimuscarinic activity, umeclidinium bromide should be used with caution in 
patients with urinary retention or with narrow-angle glaucoma. 
 
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 
 
Clinically significant interactions mediated by umeclidinium bromide at clinical doses are considered 
unlikely due to the low plasma concentrations achieved after inhaled dosing. 
 
Other antimuscarinics  
Co-administration of umeclidinium bromide with other long-acting muscarinic antagonists or 
medicinal products containing this active substance has not been studied and is not recommended as it 
may potentiate known inhaled muscarinic antagonist adverse reactions. 
Metabolic and transporter based interactions  
Umeclidinium bromide is a substrate of cytochrome P450 2D6 (CYP2D6). The steady-state 
pharmacokinetics of umeclidinium bromide were assessed in healthy volunteers lacking CYP2D6 
(poor metabolisers). No effect on umeclidinium AUC or Cmax was observed at a dose 4-fold higher 



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than the therapeutic dose. An approximately 1.3-fold increase in umeclidinium bromide AUC was 
observed at an 8-fold higher dose with no effect on umeclidinium bromide Cmax. Based on the 
magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium is 
co-administered with CYP2D6 inhibitors or when administered to subjects genetically deficient in 
CYP2D6 activity (poor metabolisers). 
 
Umeclidinium bromide is a substrate of P-glycoprotein (P-gp) transporter. The effect of the moderate 
P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium 
bromide was assessed in healthy volunteers. No effect of verapamil was observed on umeclidinium 
bromide Cmax. An approximately 1.4-fold increase in umeclidinium bromide AUC was observed. 
Based on the magnitude of these changes, no clinically relevant interaction is expected when 
umeclidinium bromide is co-administered with P-gp inhibitors. 
 
Other medicinal products for COPD 
Although no formal in vivo interaction studies have been performed, inhaled umeclidinium bromide 
has been used concomitantly with other COPD medicinal products including short and long acting 
sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of 
interactions. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are no data from the use of umeclidinium bromide in pregnant women. Animal studies do not 
indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). 
 
Umeclidinium bromide 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 bromide is excreted in human milk. A risk to breastfed 
newborns/infants cannot be excluded.  
 
A decision must be made whether to discontinue breast-feeding or to discontinue Incruse Ellipta 
therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the 
woman. 
 
Fertility 
 
There are no data on the effects of umeclidinium bromide on human fertility. Animal studies indicate 
no effects of umeclidinium bromide on fertility. 
 
4.7 Effects on ability to drive and use machines 
 
Umeclidinium bromide 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 reactions with Incruse Ellipta were nasopharyngitis and upper 
respiratory tract infection. 
 
Tabulated summary of adverse reactions 
The safety profile of umeclidinium bromide was evaluated from 1663 patients with COPD who 
received doses of 55 micrograms or greater for up to one year. This includes 576 patients who 
received the recommended dose of 55 micrograms once daily. 



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The frequencies assigned to the adverse reactions identified in the table below include crude incidence 
rates observed from four efficacy studies and the long-term safety study (which involved 1,412 
patients who received umeclidinium bromide). 
 
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). 
 
System Organ Class 
 

Adverse reactions Frequency 

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

Common 
Common 
Common 
Common 
Uncommon 

Immune system disorders Hypersensitivity reactions including: 
Rash, urticaria and pruritus 

 
Uncommon 

Nervous system disorders Headache 
Dysgeusia  
Dizziness 

Common 
Uncommon 
Not Known 

Eye disorders Glaucoma 
Vision blurred 
Eye pain 
Intraocular pressure increased 

Not known 
Not known 
Rare 
Not known 

Cardiac disorders Atrial fibrillation 
Rhythm idioventricular 
Supraventricular tachycardia 
Supraventricular extrasystoles 
Tachycardia 

Uncommon 
Uncommon 
Uncommon 
Uncommon 
Common 

Respiratory, thoracic and 
mediastinal disorders  

Cough Common 

Gastrointestinal disorders Constipation 
Dry mouth 

common 
Uncommon 

Skin and subcutaneous tissue 
disorders 

Rash Uncommon 

Renal and urinary disorders Urinary retention 
Dysuria 

Not known 
Not known 

 
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 bromide will likely produce signs and symptoms consistent with the 
known inhaled muscarinic antagonist adverse effects (e.g. dry mouth, visual accommodation 
disturbances and tachycardia). 
 
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, anticholinergics, ATC code: 
R03BB07 
 
Mechanism of action 
 
Umeclidinium bromide is a long acting muscarinic receptor antagonist (also referred to as an 
anticholinergic). It is a quinuclidine derivative that is a muscarinic receptor antagonist with activity 
across multiple muscarinic cholinergic receptor subtypes. Umeclidinium bromide exerts its 
bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic 
cholinergic 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. 
 
Pharmacodynamic effects 
 
In a Phase III, 6-month study (DB2113373) Incruse Ellipta provided a clinically meaningful 
improvement over placebo in lung function (as measured by forced expiratory volume in 1 second 
[FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following 
administration of the first dose (improvement over placebo by 102 mL, p<0.001*). The mean peak 
improvements in FEV1 within the first 6 hours following dosing relative to placebo were 130 ml 
(p<0.001*) at Week 24. There was no evidence for tachyphylaxis in the effect of Incruse Ellipta over 
time. 
 
Cardiac electrophysiology  
 
The effect of umeclidinium 500 micrograms (pre-dispensed) on the QT interval was evaluated in a 
placebo- and moxifloxacin-controlled QT trial of 103 healthy volunteers. Following repeat doses of 
umeclidinium 500 micrograms once daily for 10 days, no clinically relevant effect on prolongation of 
QT interval (corrected using the Fridericia method) or effects on heart rate were observed. 
 
Clinical efficacy and safety 
 
The clinical efficacy of Incruse Ellipta administered once daily was evaluated in 904 adult patients 
who received umeclidinium bromide or placebo from two pivotal Phase III clinical studies with a 
clinical diagnosis of COPD; a 12-week study (AC4115408) and a 24-week study (DB2113373). 
 
Pivotal Efficacy Studies: 
Effects on lung function 
In both of the pivotal 12-week and 24-week studies, Incruse Ellipta demonstrated statistically 
significant and clinically meaningful improvements in lung function (as defined by change from 
baseline trough FEV1 at Week 12 and Week 24 respectively, which was the primary efficacy endpoint 
in each study) compared with placebo (see Table 1). The bronchodilatory effects with Incruse Ellipta 
compared with placebo were evident after the first day of treatment in both studies and were 
maintained over the 12-week and 24-week treatment periods. 
 
There was no attenuation of the bronchodilator effect over time. 
 

                                                      
*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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Table 1:  Trough FEV1 (ml) at Week 12 and Week 24 (primary endpoint)  
 
Treatment with Incruse 

Ellipta 55 mcg 
 

12-Week Study 
Treatment difference1 

95% Confidence interval 
p-value 

24-Week Study 
Treatment difference1 

95% Confidence interval 
p-value 

Versus  
Placebo 

127  
(52, 202) 
<0.001 

115  
(76, 155) 
<0.001 

mcg = micrograms 
1.least squares mean (95% confidence interval)  
 
Incruse Ellipta demonstrated a statistically significant greater improvement from baseline in weighted 
mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p<0.001) in the 12-
week pivotal study.  Incruse Ellipta demonstrated a greater improvement from baseline in weighted 
mean FEV1 over 0-6 hours post-dose at Week 24 compared with placebo (150 ml, p<0.001*) in the 24-
week pivotal study. 
 
Symptomatic outcomes 
Breathlessness: 
In the 12-week study, a statistically significant improvement compared with placebo in the TDI focal 
score at Week 12 was not demonstrated for Incruse Ellipta (1.0 units, p=0.05). A statistically 
significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated 
for Incruse Ellipta (1.0 units, p<0.001) in the 24-week study. 
 
The proportion of patients who responded with at least the minimum clinically important difference 
(MCID) of 1 unit TDI focal score at Week 12 was greater for Incruse Ellipta (38%) compared with 
placebo (15%) in the 12-week study. Similarly, a greater proportion of patients achieved 1 unit TDI 
focal score for Incruse Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study. 
 
Health-related quality of life: 
Incruse Ellipta also demonstrated a statistically significant 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 12 compared with placebo (-7.90 units, p<0.001) in the 12-week study.  A 
greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 
24 was demonstrated for Incruse Ellipta (-4.69 units, p<0.001) in the 24-week study. 
 
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 12 was greater for Incruse Ellipta 55 micrograms (44%) 
compared with placebo (26%) in the 12-week study. Similarly, a greater proportion of patients 
achieved at least the MCID for Incruse Ellipta at Week 24 (44%) compared with placebo (34%) in the 
24-week study.  
 
COPD exacerbations 
In the 24-week placebo-controlled study in patients with symptomatic COPD, Incruse Ellipta reduced 
the risk of a moderate/severe COPD exacerbation by 40% compared with placebo (analysis of time to 
first exacerbation; Hazard Ratio 0.6; 95% CI: 0.4, 1.0,  p=0.035*). The probability of having an 
exacerbation in patients receiving Incruse Ellipta at week 24 was 8.9% compared with 13.7% for 
placebo. 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. 

                                                      
*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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Use of rescue medicinal product 
In the 12-week study, Incruse Ellipta statistically significantly reduced the use of rescue medication 
with salbutamol compared with placebo (on average a reduction of 0.7 puffs per day over Weeks 1-12, 
p=0.025) and demonstrated a higher percentage of days when no rescue medication was needed (on 
average 46.3%) compared with placebo (on average 35.2%; no formal statistical analysis was 
performed on this endpoint). In the 24-week study treatment with Incruse Ellipta, the mean (SD) 
change from baseline in the number of puffs of rescue salbutamol over the 24-week treatment period 
was -1.4 (0.20) for placebo and -1.7 (0.16) for Incruse Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, 
p=0.276). Patients receiving Incruse Ellipta had a higher percentage of days when no rescue 
medication was needed (on average 31.1%) compared with placebo (on average 21.7%). No formal 
statistical testing was performed on this endpoint. 
 
Supporting efficacy studies 
In a randomised, double-blind, 52-week study (CTT116855, IMPACT) of 10,355 adult patients with 
symptomatic COPD and a history of 1 or more moderate or severe exacerbations within the prior 12 
months, treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 
99/55/22 micrograms) once daily as a single inhaler was compared with fluticasone furoate/vilanterol 
(FF/VI 99/22 micrograms) once daily as a single inhaler. The primary endpoint was annual rate of on-
treatment moderate and severe exacerbations in subjects treated with FF/UMC/VI compared with 
FF/VI. The mean annual rate of exacerbations was 0.91 and 1.07 for FF/UMEC/VI and FF/VI 
respectively (Rate Ratio: 0.85; 95% CI: 0.80, 0.90; p<0.001). 
 
At Week 52, a statistically significant improvement in the least-squares (LS) mean change from 
baseline in trough FEV1 was observed for FF/UMEC/VI compared with FF/VI (mean change: +94 mL 
vs. -3 mL; treatment difference: 97 mL; 95% CI: 85, 109; p<0.001). 
 
In two 12-week, placebo controlled studies (200109 and 200110), the addition of Incruse Ellipta to 
fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical 
diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the 
primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 
154; p<0.001and 122 mL 95% CI: 91, 152; p<0.001). 
 
Improvements in lung function were supported with reductions in use of salbutamol over Weeks 1-12 
(-0.4 puffs per day (95% CI: -0.7, -0.2; p<0.001) and -0.3 puffs per day (95% CI: -0.5, -0.1; p=0.003)) 
compared to placebo plus FF/VI but improvements in SGRQ at week 12 were not statistically 
significant (200109) or clinically relevant (200109 and 200110). The short duration of these two 
studies and limited number of exacerbation events, preclude any conclusion regarding additional effect 
of Incruse Ellipta on COPD exacerbation rate. 
 
No new adverse drug reactions were identified with the addition of Incruse Ellipta to FF/VI in these 
studies. 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with 
Incruse Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on 
paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Following inhaled administration of umeclidinium bromide in healthy volunteers, Cmax occurred at 5 to 
15 minutes. The absolute bioavailability of inhaled umeclidinium bromide was on average 13% of the 
dose, with negligible contribution from oral absorption. Following repeat dosing of inhaled 
umeclidinium bromide, steady state was achieved within 7 to 10 days with 1.5 to 1.8-fold 
accumulation. 



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Distribution 
Following intravenous administration to healthy subjects, the mean volume of distribution was 86 
litres. In vitro plasma protein binding in human plasma was on average 89%. 
 
Biotransformation 
In vitro studies showed that umeclidinium bromide is principally metabolised by cytochrome P450 
2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter. The primary metabolic 
routes for umeclidinium bromide 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. 
 
Elimination 
Plasma clearance following intravenous administration was 151 litres/hour. Following intravenous 
administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered 
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 subjects, 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 
bromide plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours, with 3% 
to 4% active substance excreted unchanged in urine at steady-state. 
 
Characteristics in specific groups of subjects or patients 
 
Elderly 
A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium bromide are 
similar between COPD patients 65 years and older and those younger than 65 years of age. 
 
Renal impairment 
Subjects with severe renal impairment (creatinine clearance <30mL/min) showed no evidence of an 
increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered 
protein binding between subjects with severe renal impairment and healthy volunteers. 
 
Hepatic impairment 
Subjects with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase 
in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein 
binding between subjects with moderate hepatic impairment and healthy volunteers. Umeclidinium 
bromide has not been evaluated in subjects with severe hepatic impairment. 
 
Other special populations 
A population pharmacokinetic analysis showed that no dose adjustment is required for umeclidinium 
bromide 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 bromide. 
 
5.3 Preclinical safety data  
 
Non clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In nonclinical studies 
with umeclidinium bromide, findings were those typically associated with the primary pharmacology 
of muscarinic receptor antagonists and/or local irritancy.  
 



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Toxicity to reproduction 
 
Umeclidinium bromide was not teratogenic in rats or rabbits. In a pre- and post-natal study, 
subcutaneous administration of umeclidinium bromide 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). 
 
 
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 the 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 grey body, light green 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 one aluminium foil laminate blister of 7 or 30 doses. 
 
Pack sizes of 7 and 30 dose inhaler. 
Multipack of 3 x 30 dose inhalers. 
 
Not all pack sizes may be marketed. 
 



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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/1/14/922/001 
EU/1/14/922/002 
EU/1/14/922/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 28 April 2014 
Date of latest renewal: 11 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. 



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ANNEX II 
 

A. MANUFACTURER 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 

 
 



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A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations)  
Priory Street 
Ware, Hertfordshire SG12 0DJ 
United Kingdom 
 
or 
 
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  
 
The MAH shall complete, within the stated timeframe, the below measure: 
 



15 

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 
Incruse Ellipta compared with tiotropium (study 201038), according to a protocol 
agreed by the PRAC. 

By Q3 2024 
 

 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 



16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



17 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (SINGLE PACKS) 
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed 
umeclidinium (umeclidinium bromide) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of 
umeclidinium bromide). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: lactose and magnesium stearate. 
See package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Inhalation powder, pre-dispensed.  
7 doses 
30 doses 
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 



18 

In use shelf-life: 6 weeks. 
 
 
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/1/14/922/001 
EU/1/14/922/002  
 
13. BATCH NUMBER 
 
Lot 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
incruse ellipta 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



19 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BUNDLE LABEL (WITH BLUE BOX - MULTIPACK) 
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed 
umeclidinium (umeclidinium bromide) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of 
umeclidinium bromide). 
 
 
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. 
 
 



20 

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/1/14/922/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
incruse ellipta 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed 
umeclidinium (umeclidinium bromide) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of 
umeclidinium bromide). 
 
 
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. 
 
 



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/1/14/922/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
incruse ellipta 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 

 

 



23 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
FOIL LAMINATE TRAY LID  
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Incruse Ellipta 55 mcg inhalation powder 
umeclidinium (umeclidinium bromide) 
 
 
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  
 
 
 
 
 
 
 
 
 
 



24 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
INHALER LABEL 
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Incruse Ellipta 55 mcg inhalation powder 
umeclidinium (umeclidinium bromide) 
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 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



26 

Package leaflet: Information for the user 
 

Incruse Ellipta 55 micrograms inhalation powder, pre-dispensed 
umeclidinium (umeclidinium bromide)  

 

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 Incruse Ellipta is and what it is used for  
2. What you need to know before you use Incruse Ellipta  
3. How to use Incruse Ellipta 
4. Possible side effects  
5. How to store Incruse Ellipta 
6. Contents of the pack and other information 
Step-by-step instructions for use 
 
 
1. What Incruse Ellipta is and what it is used for 
 
What Incruse Ellipta is 
 
Incruse Ellipta contains the active substance umeclidinium bromide, which belongs to a group of 
medicines called bronchodilators. 
 
What Incruse Ellipta is used for 
 
This medicine is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a 
long-term condition in which the airways and air-sacs in the lungs gradually become blocked or 
damaged, leading to breathing difficulties that slowly get worse. Difficulties in breathing is added to 
by tightening of the muscles around the airways, which narrows the airways and so restricts the flow 
of air. 
 
This medicine blocks the tightening of these muscles, making it easier for air to get in and out of the 
lungs. When used regularly, it can help control your breathing difficulties and reduce the effects of 
COPD on your everyday life. 
 
Incruse 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 Incruse Ellipta 
 
Do not use Incruse Ellipta: 



27 

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

If you think the above 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 Incruse Ellipta to treat asthma) 
- if you have heart problems 
- 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 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 
Incruse 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 Incruse 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 Incruse 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 Incruse 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. 
 
In particular, tell your doctor or pharmacist if you are taking other long-acting medicines similar to 
this medicine for breathing problems, e.g. tiotropium. Don’t use Incruse Ellipta as well as these other 
medicines. If you are not sure what your medicine contains talk to your doctor or pharmacist. 
 
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 so.  
 
It is not known whether the ingredients of Incruse Ellipta can pass into breast milk. If you are 
breast-feeding, you must check with your doctor before you use Incruse Ellipta. 
 
Driving and using machines 
It is unlikely that this medicine will affect your ability to drive or use machines. 
 
Incruse 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. 
 
 



28 

3. How to use Incruse 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 Incruse Ellipta regularly 
It is very important that you use Incruse Ellipta every day, as instructed by your doctor. This will help 
to keep you free of symptoms throughout the day and night. 
 
Do not use this medicine 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 for use’ in this leaflet for full information. 
 
Incruse Ellipta is for inhalation use. To use Incruse 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 Incruse 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 have visual disturbances or 
have a dry mouth. 
 
If you forget to use Incruse 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 inhaler (such as salbutamol), then seek 
medical advice. 
 
If you stop using Incruse 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. 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Allergic reactions  
Allergic reactions are uncommon (may affect up to 1 in 100 people).  
If you have any of the following symptoms after taking Incruse Ellipta, stop using this medicine and 
tell your doctor immediately: 

 itching 
 skin rash (hives) or redness  

 



29 

 
Common side effects 
These may affect up to 1 in 10 people:  

 faster heart beat 
 painful and frequent urination (may be signs of a urinary tract infection) 
 common cold 
 infection of nose and throat 
 cough 
 feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the 

sinuses called sinusitis) 
 headache  
 constipation. 

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

 irregular heart beat 
 sore throat 
 dry mouth 
 rash 
 taste disturbance. 

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

 eye pain 
 
Other side effects 
Other side effects have occurred in a very small number of people but their exact frequency is 
unknown (cannot be estimated from the available data): 
 

 Decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma). 
 Blurred vision  
 Increase of the measured eye pressure 
 Difficulty and pain when passing urine – these may be signs of a bladder obstruction or 

urinary retention 
 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 Incruse 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. 



30 

 
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 Incruse Ellipta contains  
The active substance is umeclidinium bromide. 
 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms 
umeclidinium (equivalent to 65 micrograms of umeclidinium bromide). 
  
The other ingredients are lactose monohydrate (see section 2 under ‘Incruse Ellipta contains lactose’) 
and magnesium stearate. 
 
What Incruse Ellipta looks like and contents of the pack 
Incruse Ellipta is an inhalation powder, pre-dispensed.  
The Ellipta inhaler consists of a grey plastic body, a light green 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. 
 
The active substance is present as a white powder in a blister 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 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 

Lietuva 
GlaxoSmithKline Lietuva UAB 



 

31 

s.a./n.v. 
Tél/Tel: + 32 (0) 10 85 52 00 
 

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 
dk-info@gsk.com 
 

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

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

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 6938100 
nlinfo@gsk.com  

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

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no  
 

Ελλάδα 
GlaxoSmithKline 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: + 34 902 202 700 
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 6051999 
 

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 



 

32 

 
Italia 
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 

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

Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
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  
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
 



 

33 

This leaflet 

Carton 

Tray lid 

Inhaler 

Desiccant 

Tray 

Step-by-step instructions for use 
 
What is the inhaler? 
The first time you use Incruse 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 Incruse Ellipta inhaler carton contains 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The inhaler is packaged in a tray. Do not 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 opened the tray. 
After this date the inhaler should no longer be used.  The tray can be discarded after first opening. 
 
 
 
 

Desiccant 



 

34 

The instructions for use of the Ellipta inhaler provided below can be used for either the 30-dose inhaler (30 
day supply) or the 7-dose inhaler (7 day supply). 
 
 
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.  



 

35 

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. 

 

 
 

 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. MANUFACTURER 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 ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET