Rolufta 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 
 
Rolufta 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 
 
Rolufta 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.  
 
Rolufta Ellipta should be administered once daily 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. Rolufta Ellipta has not 
been studied in patients with severe hepatic impairment and should be used with caution (see section 5.2). 

 



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Paediatric population 

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

Method of administration  
 
Rolufta 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 medicine 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. 
 
The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover. 
 
c) Close the inhaler 



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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 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, the 
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 than the 
therapeutic dose. An approximately 1.3-fold increase in umeclidinium bromide AUC was observed at an 8-



5 

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 fetus. 
 
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 Rolufta 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 Rolufta 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 
Intraocular pressure increased 
Eye pain 

Not known 
Not known 
Not known 
Rare 

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. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
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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) Rolufta 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 Rolufta 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 Rolufta 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, Rolufta 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 Rolufta 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. 
 

                                                      
 



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

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)  
 
Rolufta 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.  Rolufta 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 Rolufta 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 Rolufta 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 Rolufta Ellipta (38%) compared with placebo (15%) in 
the 12-week study. Similarly, a greater proportion of patients achieved ≥1 unit TDI focal score for Rolufta 
Ellipta (53%) compared with placebo (41%) at Week 24 in the 24-week study. 
 
Health-related quality of life: 
Rolufta 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 Rolufta 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 Rolufta 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 Rolufta 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, Rolufta 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 Rolufta 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, Rolufta 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 Rolufta 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 
Rolufta Ellipta (Difference = -0.3; 95% CI: -0.8, 0.2, p=0.276). Patients receiving Rolufta 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 92/55/22 micrograms) once daily 
as a single inhaler was compared with fluticasone furoate/vilanterol (FF/VI 92/22 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 Rolufta 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<0.001 and 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 Rolufta Ellipta on COPD 
exacerbation rate. 
 
No new adverse drug reactions were identified with the addition of Rolufta Ellipta to FF/VI in these studies. 
 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with Rolufta 
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. 
 
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%. 
 



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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.  
 
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). 
 



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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. 
 
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 Trading Services Limited 
12 Riverwalk  
Citywest Business Campus 



12 

Dublin 24 
Ireland 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1174/001 
EU/1/17/1174/002 
EU/1/17/1174/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20th March 2017 
 
 
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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13 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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 
 

 



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A. MANUFACTURERS 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 (PSURs) 
 
The requirements for submission of PSURs 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 marketing authorisation holder (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 Rolufta 
Ellipta compared with tiotropium (study 201038), according to a protocol agreed by 
the PRAC. 

By Q3 2024 
 

 
  



16 

 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 

 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



18 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (SINGLE PACKS) 
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rolufta 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 



19 

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 Trading Services Limited 
12 Riverwalk 
Citywest Business Campus 
Dublin 24 
Ireland 
GlaxoSmithKline Trading Service Limited logo 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1174/001 
EU/1/17/1174/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
rolufta ellipta 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 



20 

SN: 
NN: 



21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BUNDLE LABEL (WITH BLUE BOX - MULTIPACK) 
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rolufta 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 inhalers 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 Trading Services Limited 
12 Riverwalk 
Citywest Business Campus 
Dublin 24 
Ireland 
GlaxoSmithKline Trading Service Limited logo 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1174/003  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
rolufta 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 
 
INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rolufta 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. 
 
 



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 Trading Services Limited 
12 Riverwalk 
Citywest Business Campus 
Dublin 24 
Ireland 
GlaxoSmithKline Trading Services Limited logo 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1174/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
rolufta ellipta 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
 

 



25 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
FOIL LAMINATE TRAY LID  
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rolufta Ellipta 55 mcg inhalation powder 
umeclidinium (umeclidinium bromide) 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services 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  
 
 
 
 
 
 
 
 
 
 



26 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
INHALER LABEL 
 
55 micrograms 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Rolufta 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 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



27 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 



28 

Package leaflet: Information for the user 
 

Rolufta 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 Rolufta Ellipta is and what it is used for  
2. What you need to know before you use Rolufta Ellipta  
3. How to use Rolufta Ellipta 
4. Possible side effects  
5. How to store Rolufta Ellipta 
6. Contents of the pack and other information 
Step-by-step instructions for use 
 
 
1. What Rolufta Ellipta is and what it is used for 
 
What Rolufta Ellipta is 
 
Rolufta Ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines 
called bronchodilators. 
 
What Rolufta 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. 
 
Rolufta 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 Rolufta Ellipta 
 
Do not use Rolufta Ellipta: 
- if you are allergic to umeclidinium or any of the other ingredients of this medicine (listed in section 

6). 



29 

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 Rolufta 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 Rolufta 
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 Rolufta 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 Rolufta 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 Rolufta 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 Rolufta 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 Rolufta Ellipta can pass into breast milk. If you are 
breast-feeding, you must check with your doctor before you use Rolufta Ellipta. 
 
Driving and using machines 
It is unlikely that this medicine will affect your ability to drive or use machines. 
 
Rolufta 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 Rolufta Ellipta 
 
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you 
are not sure.  
 



30 

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 Rolufta Ellipta regularly 
It is very important that you use Rolufta 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. 
 
Rolufta Ellipta is for inhalation use. To use Rolufta 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 Rolufta 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 Rolufta 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 Rolufta 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 Rolufta Ellipta, stop using this medicine and tell 
your doctor immediately: 

• itching 
• skin rash (hives) or redness  

 
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 



31 

• 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 Rolufta 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 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


32 

 
What Rolufta 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 ‘Rolufta Ellipta contains lactose’) and 
magnesium stearate. 
 
What Rolufta Ellipta looks like and contents of the pack 
Rolufta 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 Trading Services 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 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 
 



 

33 

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 
BERLIN-CHEMIE AG 
Tel: +49 (0) 30 67070 
 

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 
FAES FARMA, S.A. 
Tel.: +34 900 460 153 
aweber@faes.es 
 

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 
 

Italia 
A. Menarini Industrie Farmaceutiche Riunite 
s.r.l.  
Tel: +39-055 56801 
 

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

Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 

Sverige 
GlaxoSmithKline AB 

mailto:cz.info@gsk.com
mailto:cz.info@gsk.com


 

34 

Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com  

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. 
 

http://www.ema.europa.eu/
http://www.ema.europa.eu/


 

35 

This leaflet 

Carton 

Tray lid 

Inhaler 

Desiccant 

Tray 

Step-by-step instructions for use 
 
What is the inhaler? 
The first time you use Rolufta 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 Rolufta 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 



 

36 

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.  



 

37 

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. 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
{'Title': '1. what rolufta ellipta is and what it is used for', 'Section_Content': 'what rolufta ellipta is rolufta ellipta contains the active substance umeclidinium bromide, which belongs to a group of medicines called bronchodilators. what rolufta 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. rolufta 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.', 'Entity_Recognition': [{'Text': 'rolufta ellipta', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 4, 'BeginOffset': 5, 'EndOffset': 20, 'Score': 0.8913421630859375, 'Text': 'rolufta ellipta', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 24, 'EndOffset': 39, 'Score': 0.9292789101600647, 'Text': 'rolufta ellipta', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'the active substance umeclidinium bromide', 'Type': 'TREATMENT', 'BeginOffset': 49, 'EndOffset': 90}, {'Id': 7, 'BeginOffset': 137, 'EndOffset': 152, 'Score': 0.4226704239845276, 'Text': 'bronchodilators', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 159, 'EndOffset': 174, 'Score': 0.8435312509536743, 'Text': 'rolufta ellipta', 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{'Title': '2. what you need to know before you use rolufta ellipta', 'Section_Content': "do not use rolufta ellipta: - 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 rolufta 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 rolufta 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 rolufta 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 rolufta 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 rolufta 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 rolufta 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 rolufta ellipta can pass into breast milk. if you are breast-feeding, you must check with your doctor before you use rolufta ellipta. driving and using machines it is unlikely that this medicine will affect your ability to drive or use machines. rolufta 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.", 'Entity_Recognition': [{'Text': 'rolufta ellipta', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 9, 'BeginOffset': 11, 'EndOffset': 26, 'Score': 0.8847007751464844, 'Text': 'rolufta ellipta', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': 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{'Title': '3. how to use rolufta ellipta', 'Section_Content': "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 rolufta ellipta regularly it is very important that you use rolufta 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. rolufta ellipta is for inhalation use. to use rolufta 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 rolufta 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 rolufta 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 rolufta 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.", 'Entity_Recognition': [{'Text': 'rolufta ellipta', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 11, 'EndOffset': 24}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 251, 'EndOffset': 264}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 275, 'EndOffset': 277}, {'Id': 6, 'BeginOffset': 339, 'EndOffset': 354, 'Score': 0.9333821535110474, 'Text': 'rolufta ellipta', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 7, 'BeginOffset': 399, 'EndOffset': 414, 'Score': 0.8917340040206909, 'Text': 'rolufta ellipta', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'FREQUENCY', 'Score': 0.947849690914154, 'RelationshipScore': 1.0, 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{'Title': '4. possible side effects', 'Section_Content': '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 rolufta ellipta, stop using this medicine and tell your doctor immediately: itching skin rash (hives) or redness 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 31 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.', 'Entity_Recognition': [{'Text': 'rolufta ellipta', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 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{'Title': '5. how to store rolufta ellipta', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information step-by-step instructions for use', 'Section_Content': "what rolufta 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 'rolufta ellipta contains lactose') and magnesium stearate. what rolufta ellipta looks like and contents of the pack rolufta 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 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