Elebrato 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 
 
Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms 
fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 
22 micrograms vilanterol (as trifenatate). This corresponds to a pre-dispensed dose of 100 micrograms 
fluticasone furoate, 74.2 micrograms umeclidinium bromide equivalent to 62.5 micrograms umeclidinium 
and 25 micrograms vilanterol (as trifenatate). 
 
Excipient with known effect 
Each delivered dose contains approximately 25 mg of lactose (as monohydrate). 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Inhalation powder, pre-dispensed (inhalation powder). 
 
White powder in a light grey inhaler (Ellipta) with a beige mouthpiece cover and a dose counter. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Elebrato Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic 
obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled 
corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting 
muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1). 
 
4.2 Posology and method of administration 
 
Posology 
 
Adults  
 
The recommended and maximum dose is one inhalation of Elebrato Ellipta 92/55/22 micrograms once daily, 
at the same time each day. 
 
If a dose is missed the next dose should be inhaled at the usual time the next day. 
 
Special populations  
 
Elderly patients 
 
No dose adjustment is required in patients over 65 years (see section 5.2). 



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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, moderate or severe hepatic impairment. Elebrato 
Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 
and 5.2).  
 
Paediatric population 
 
There is no relevant use of Elebrato Ellipta in the paediatric population (under 18 years of age) for the 
indication of COPD. 
 
Method of administration 
 
Elebrato Ellipta is for inhalation use only. 
 
Instructions for use: 
 
The following instructions for the 30 dose (30 day supply) Ellipta inhaler also apply to the 14 dose (14 day 
supply) Ellipta inhaler. 
 
 
a) Prepare a dose 
 
Open the cover when ready to inhale a dose. The inhaler should not be shaken. 
 
Slide the cover down fully 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 and rinse your mouth 



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Slide the cover upwards as far as it will go, to cover the mouthpiece. 
 
Rinse your mouth with water after you have used the inhaler, do not swallow.  
 
This will make it less likely to develop a sore mouth or throat as side effects. 
 
For further instructions on handling the device, see section 6.6. 
 
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  
 
Elebrato Ellipta should not be used in patients with asthma since it has not been studied in this patient 
population. 
 
Not for acute use 
 
There are no clinical data to support the use of Elebrato Ellipta for the treatment of acute episodes of 
bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy). 
 
Deterioration of disease 
 
Increasing use of short-acting bronchodilators to relieve symptoms may indicate deterioration of disease 
control. In the event of deterioration of COPD during treatment with Elebrato Ellipta, a re-evaluation of the 
patient and of the COPD treatment regimen should be undertaken. 
 
Patients should not stop therapy with Elebrato Ellipta without physician supervision since symptoms may 
recur after discontinuation. 
 
Paradoxical bronchospasm 
 
Administration of fluticasone furoate/umeclidinium/vilanterol may produce paradoxical bronchospasm with 
an immediate wheezing and shortness of breath after dosing and may be life-threatening. Treatment with 
Elebrato Ellipta should be discontinued immediately if paradoxical bronchospasm occurs. The patient should 
be assessed and alternative therapy instituted if necessary. 
 
Cardiovascular effects  
 
Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after 
the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and 
vilanterol, respectively. Therefore, Elebrato Ellipta should be used with caution in patients with unstable or 
life-threatening cardiovascular disease. 
 
Patients with hepatic impairment 
 
Patients with moderate to severe hepatic impairment receiving Elebrato Ellipta should be monitored for 
systemic corticosteroid-related adverse reactions (see section 5.2). 
 
Systemic corticosteroid effects 
 
Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long 
periods. These effects are much less likely to occur than with oral corticosteroids.  



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Visual disturbance  
 
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with 
symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to 
an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases 
such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical 
corticosteroids. 
 
Coexisting conditions  
 
Elebrato Ellipta should be used with caution in patients with convulsive disorders or thyrotoxicosis, and in 
patients who are unusually responsive to beta2-adrenergic agonists. 
 
Elebrato Ellipta should be administered with caution in patients with pulmonary tuberculosis or in patients 
with chronic or untreated infections. 
 
Anticholinergic activity 
 
Elebrato Ellipta should be used with caution in patients with narrow-angle glaucoma or urinary retention. 
Patients should be informed about the signs and symptoms of acute narrow-angle glaucoma and should be 
informed to stop using Elebrato Ellipta and to contact their doctor immediately should any of these signs or 
symptoms develop. 
 
Pneumonia in patients with COPD 
 
An increase in the incidence of pneumonia, including pneumonia requiring hospitalisation, has been 
observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased 
risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all 
studies. 
 
There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk 
among inhaled corticosteroid products. 
 
Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the 
clinical features of such infections overlap with the symptoms of COPD exacerbations. 
 
Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index 
(BMI) and severe COPD. 
 
Hypokalaemia 
 
Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to 
produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring 
supplementation.  
 
No clinically relevant effects of hypokalaemia were observed in clinical studies with Elebrato Ellipta at the 
recommended therapeutic dose. Caution should be exercised when Elebrato Ellipta is used with other 
medicinal products that also have the potential to cause hypokalaemia (see section 4.5). 
 
Hyperglycaemia 
 
Beta2-adrenergic agonists may produce transient hyperglycaemia in some patients. No clinically relevant 
effects on plasma glucose were observed in clinical studies with fluticasone furoate/umeclidinium/vilanterol 
at the recommended therapeutic dose. There have been reports of increases in blood glucose levels in 
diabetic patients treated with fluticasone furoate/umeclidinium/vilanterol and this should be considered when 



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prescribing to patients with a history of diabetes mellitus. Upon initiation of treatment with Elebrato Ellipta, 
plasma glucose should be monitored more closely in diabetic patients. 
 
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 drug interactions mediated by fluticasone furoate/umeclidinium/vilanterol at clinical 
doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing. 
 
Interaction with beta-blockers 
 
Beta2-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as 
vilanterol. If beta-blockers are required, cardioselective beta-blockers should be considered, however, 
caution should be exercised during concurrent use of both non-selective and selective beta-blockers. 
 
Interaction with CYP3A4 inhibitor 
 
Fluticasone furoate and vilanterol are rapidly cleared by extensive first pass metabolism mediated by enzyme 
CYP3A4. 
 
Caution is advised when co-administering with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, 
cobicistat-containing products) as there is potential for increased systemic exposure to both fluticasone 
furoate and vilanterol, which could lead to an increased potential for adverse reactions. Co-administration 
should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse 
reactions, in which case patients should be monitored for systemic corticosteroid adverse reactions. A repeat 
dose study was performed in healthy subjects with the fluticasone furoate/vilanterol combination 
(184/22 micrograms) and ketoconazole (400 milligrams, a strong CYP3A4 inhibitor). Co-administration 
increased mean fluticasone furoate AUC(0-24) and Cmax by 36% and 33%, respectively. The increase in 
fluticasone furoate exposure was associated with a 27% reduction in 0-24 hours weighted mean serum 
cortisol. Co-administration increased mean vilanterol AUC(0-t) and Cmax by 65% and 22%, respectively. The 
increase in vilanterol exposure was not associated with an increase in beta2-agonist related systemic effects 
on heart rate or blood potassium. 
 
Interaction with CYP2D6 inhibitors/CYP2D6 polymorphism 
 
Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6). The steady-state pharmacokinetics of 
umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers). No effect on 
umeclidinium AUC or Cmax was observed at a dose 8-fold higher than the therapeutic dose. An 
approximately 1.3-fold increase in umeclidinium AUC was observed at 16-fold higher dose with no effect on 
umeclidinium Cmax. Based on the magnitude of these changes, no clinically relevant drug interaction is 
expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or 
when administered to patients who are genetically deficient in CYP2D6 activity (poor metabolisers). 
 
Interaction with P-glycoprotein inhibitors 
 
Fluticasone furoate, umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp). The 
effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of 
umeclidinium and vilanterol was assessed in healthy volunteers. No effect of verapamil was observed on 
umeclidinium or vilanterol Cmax. An approximately 1.4-fold increase in umeclidinium AUC was observed 
with no effect on vilanterol AUC. Based on the magnitude of these changes, no clinically relevant drug 
interaction is expected when fluticasone furoate/umeclidinium/vilanterol is co-administered with P-gp 
inhibitors. Clinical pharmacology studies with a specific P-gp inhibitor and fluticasone furoate have not been 
conducted. 



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Other long acting antimuscarinics and long acting beta2- adrenergic agonists 
 
Co-administration of Elebrato Ellipta with other long-acting muscarinic antagonists or long-acting beta2- 
adrenergic agonists has not been studied and is not recommended as it may potentiate the adverse reactions 
(see sections 4.8 and 4.9). 
 
Hypokalaemia 
 
Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing 
diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution 
should be exercised (see section 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
There are limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women. 
Studies in animals have shown reproductive toxicity at exposures which are not clinically relevant (see 
section 5.3). 
 
Administration of Elebrato Ellipta to pregnant women should only be considered if the expected benefit to 
the mother justifies the potential risk to the foetus. 
 
Breast-feeding 
 
It is unknown whether fluticasone furoate, umeclidinium, vilanterol or their metabolites are excreted in 
human milk.  However, other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are 
detected in human milk.  A risk to newborns/infants cannot be excluded.  A decision must be made whether 
to discontinue breast-feeding or to discontinue Elebrato Ellipta therapy taking into account the benefit of 
breast-feeding for the child and the benefit of therapy for the woman. 
 
Fertility 
 
There are no data on the effects of fluticasone furoate/umeclidinium/vilanterol on human fertility.  Animal 
studies indicate no effects of fluticasone furoate, umeclidinium or vilanterol on male or female fertility (see 
section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
Fluticasone furoate/umeclidinium/vilanterol has no or negligible influence on the ability to drive and use 
machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most frequently reported adverse reactions with Elebrato Ellipta were nasopharyngitis (7%), headache 
(5%) and upper respiratory tract infection (2%). 
 
Tabulated summary of adverse reactions 
The safety profile of Elebrato Ellipta is based on three phase III clinical studies. 
 
The first study included safety data from 911 patients with COPD who received fluticasone 
furoate/umeclidinium/vilanterol 92/55/22 micrograms, once daily, for up to 24 weeks, of whom 210 patients 
received fluticasone furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, 
with an active comparator (study CTT116853, FULFIL). 



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The second study included safety data from 527 patients with COPD who received fluticasone 
furoate/umeclidinium/vilanterol (92/55/22 micrograms) and 528 patients with COPD who received 
fluticasone furoate/vilanterol (92/22 micrograms) + umeclidinium (55 micrograms) once daily for up to 
24 weeks (study 200812). 
 
The third study included safety data from 4,151 patients with COPD who received fluticasone 
furoate/umeclidinium/vilanterol 92/55/22 micrograms once daily for up to 52 weeks, with two active 
comparators (study CTT116855, IMPACT). 
 
Where adverse reaction frequencies differed between studies, the higher frequency is reported below. 
 
Adverse reactions detected during these clinical trials are listed by MedDRA system organ class. 
 
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 Pneumonia 
Upper respiratory tract infection 
Bronchitis 
Pharyngitis 
Rhinitis 
Sinusitis  
Influenza  
Nasopharyngitis 
Candidiasis of mouth and throat 
Urinary tract infection 

Common 

Viral respiratory tract infection Uncommon 
Nervous system disorders Headache Common 
Eye disorders Vision blurred (see section 4.4) Not known 
Cardiac disorders Supraventricular tachyarrhythmia 

Tachycardia 
Atrial fibrillation 

Uncommon 

Respiratory, thoracic & 
mediastinal disorders 

Cough 
Oropharyngeal pain 

Common 

Dysphonia Uncommon 
Gastrointestinal disorders 
 

Constipation Common 
Dry mouth Uncommon 

Musculoskeletal and 
connective tissue disorders 

Arthralgia 
Back pain 

Common 

Fractures Uncommon 
 
Description of selected adverse reactions 
 
Pneumonia  
In a total of 1810 patients with advanced COPD (mean post bronchodilatory screening FEV1 45% of 
predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD 
exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia 
events reported up to 24 weeks in patients receiving Elebrato Ellipta (20 patients, 2%) than in patients 
receiving budesonide/formoterol (7 patients, <1%).  Pneumonia which required hospitalisation occurred in 
1% of patients receiving Elebrato Ellipta and <1% of patients receiving budesonide/formoterol up to 24 
weeks. One fatal case of pneumonia was reported in a patient who received Elebrato Ellipta. In the subset of 
430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Elebrato Ellipta 



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and budesonide/formoterol arms was equal at 2%. The incidence of pneumonia with Elebrato Ellipta is 
comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical 
studies in COPD. 
 
In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe 
exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 
15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Elebrato Ellipta 
(n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for 
umeclidinium/vilanterol (n = 2,070). Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patient-
years) receiving Elebrato Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone 
furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol. 
 
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 will likely produce signs, symptoms or adverse effects associated with the individual 
components’ pharmacological actions (e.g. Cushing’s syndrome, Cushingoid features, adrenal suppression, 
decrease in bone mineral density, dry mouth, visual accommodation disturbances, tachycardia, arrhythmias, 
tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia). 
 
There is no specific treatment for an overdose with Elebrato Ellipta. If overdose occurs, the patient should be 
treated supportively with appropriate monitoring as necessary. 
 
Cardioselective beta-blockade should only be considered for profound vilanterol overdose effects that are 
clinically concerning and unresponsive to supportive measures. Cardioselective beta-blocking medicinal 
products should be used with caution in patients with a history of bronchospasm. 
 
Further management should be clinically indicated or as recommended by the national poisons centre, where 
available.  
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with 
anticholinergics including triple combinations with corticosteroids, ATC code: R03AL08. 
 
Mechanism of action 
 
Fluticasone furoate/umeclidinium/vilanterol is a combination of inhaled synthetic corticosteroid, long-acting 
muscarinic receptor antagonist and long-acting beta2-adrenergic agonist (ICS/LAMA/LABA). Following oral 
inhalation, umeclidinium and vilanterol act locally on airways to produce bronchodilation by separate 
mechanisms and fluticasone furoate reduces inflammation. 
 
Fluticasone furoate 
Fluticasone furoate is a corticosteroid with potent anti-inflammatory activity. The precise mechanism 
through which fluticasone furoate affects COPD symptoms is not known. Corticosteroids have been shown 
to have a wide range of actions on multiple cell types (e.g. eosinophils, macrophages, lymphocytes) and 
mediators (e.g. cytokines and chemokines) involved in inflammation.  
 

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


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Umeclidinium 
Umeclidinium is a long-acting muscarinic receptor antagonist (also referred to as an anticholinergic). 
Umeclidinium exerts its bronchodilatory activity by competitively inhibiting the binding of acetylcholine 
with muscarinic receptors on airway smooth muscle. It demonstrates slow reversibility at the human M3 
muscarinic receptor subtype in vitro and a long duration of action in vivo when administered directly to the 
lungs in pre-clinical models. 
 
Vilanterol 
Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (LABA). The pharmacologic effects of 
beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular 
adenylate cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3’,5’-
adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth 
muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast 
cells. 
 
Pharmacodynamic effects 

Cardiac electrophysiology 
The effect of fluticasone furoate/umeclidinium/vilanterol on the QT interval has not been evaluated in a 
thorough QT (TQT) study. TQT studies for FF/VI and umeclidinium/vilanterol (UMEC/VI) did not show 
clinically relevant effects on QT interval at clinical doses of FF, UMEC and VI. 
 
No clinically relevant effects on the QTc interval were observed on review of centrally read ECGs from 911 
subjects with COPD exposed to fluticasone furoate/umeclidinium/vilanterol for up to 24 weeks, or in the 
subset of 210 subjects exposed for up to 52 weeks. 
 
Clinical efficacy and safety 
 
The efficacy of Elebrato Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been 
evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, non-
inferiority study. All three studies were multicentre, randomised, double-blind studies that required patients 
to be symptomatic with a COPD Assessment Test (CAT) score ≥10 and on daily maintenance treatment for 
their COPD for at least three months prior to study entry. 
 
FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of 
subjects (n=430), that compared Elebrato Ellipta (92/55/22 micrograms) with budesonide/formoterol 
400/12 micrograms (BUD/FOR) administered twice-daily. At screening, the mean post-bronchodilator 
percent predicted FEV1 was 45% and 65% of patients reported a history of one or more moderate/severe 
exacerbation in the past year. 
 
IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Elebrato Ellipta 
(92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and 
umeclidinium/vilanterol 55/22 micrograms (UMEC/VI). At screening, the mean post-bronchodilator percent 
predicted FEV1 was 46% and over 99% of patients reported a history of one or more moderate/severe 
exacerbation in the past year. 
 
At study entry, the most common COPD medications reported in the FULFIL and IMPACT studies were 
ICS +LABA+LAMA (28%, 34% respectively), ICS+LABA (29%, 26% respectively), LAMA+LABA (10%, 
8% respectively) and LAMA (9%, 7% respectively). These patients may have also been taking other COPD 
medications (e.g. mucolytics or leukotriene receptor antagonists). 
  
Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Elebrato Ellipta 
(92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once 
daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 
12 months. 
 



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Lung Function 
In FULFIL, bronchodilatory effects with Elebrato Ellipta were evident on the first day of treatment and were 
maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on 
day 1 and 160-339 mL at week 24). Elebrato Ellipta significantly improved (p<0.001) lung function (as 
defined by mean change from baseline in trough FEV1 at week 24) (see Table 1) and the improvement was 
maintained in the subset of patients who continued treatment to week 52. 
 
Table 1. Lung function endpoint in FULFIL 

 
Elebrato 
Ellipta 

 
(N= 911) 

BUD/FOR 
 

(N=899) 

Treatment difference 
(95% CI) 

Comparison with 
BUD/FOR 

Trough FEV1 (L) at Week 24, LS mean change 
from baseline (SE)a 

0.142  
(0.0083) 

-0.029 
(0.0085) 

0.171 
0.148, 0.194 

FEV1=forced expiratory volume in 1 second; L=litres; LS=least squares; SE= standard error, N=number in the intent-to-
treat population; CI= confidence interval, a Statistically significant treatment difference for FF/UMEC/VI vs. BUD/FOR 
also observed at the other assessment timepoints (weeks 2, 4 and 12). 
 
In IMPACT, Elebrato Ellipta significantly improved (p<0.001) lung function when compared with FF/VI 
and UMEC/VI over a 52-week period (See Table 2). 
 
Table 2 – Lung function endpoint in IMPACT   

 
 

Elebrato 
Ellipta 

(N = 4,151) 
FF/VI 

(N = 4,134) 
UMEC/VI 
(N = 2,070) 

Treatment difference 95% 
CI 
Comparison 
Elebrato vs. 

FF/VI 

Comparison 
Elebrato vs. 
UMEC/VI 

Trough FEV1 (L) at Week 52, 
LS mean change from baseline 
(SE) a 

0.094 
(0.004) 

-0.003 
(0.004) 

0.040 
(0.006) 

0.097 
0.085, 0.109 

 
0.054 

0.039, 0.069 
FEV1= forced expiratory volume in 1 second; L= litres; LS=least squares; SE= standard error; N= number in the intent-
to-treat population; CI= confidence interval; a Statistically significant treatment differences for FF/UMEC/VI vs. FF/VI 
and FF/UMEC/VI vs. UMEC/VI were also observed at the other assessment timepoints (Weeks 4, 16, 28, and 40).  
 
In Study 200812, Elebrato Ellipta was non-inferior compared with FF/VI+UMEC, co-administered in two 
inhalers, in the improvement from baseline in trough FEV1 at week 24. The pre-specified non-inferiority 
margin was 50 mL. 
 
Exacerbations 
In IMPACT, over 52 weeks, Elebrato Ellipta significantly reduced (p<0.001) the annual rate of 
moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per 
patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient 
year). In FULFIL, based upon data up to 24 weeks, Elebrato Ellipta significantly reduced (p=0.002) the 
annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR. 

In IMPACT, Elebrato Ellipta prolonged the time to first moderate/severe exacerbation and significantly 
decreased (p<0.001) the risk of a moderate/severe exacerbation, as measured by time to first exacerbation, 
compared with both FF/VI (14.8%; 95% CI: 9.3, 19.9) and UMEC/VI (16.0%; 95% CI: 9.4, 22.1). In 
FULFIL, Elebrato Ellipta significantly decreased the risk of a moderate/severe exacerbation compared with 
BUD/FOR over 24 weeks (33%; 95% CI: 12, 48; p=0.004). 

In IMPACT, treatment with Elebrato Ellipta reduced the annual rate of severe exacerbations (i.e., requiring 
hospitalisation or resulting in death) by 13% compared with FF/VI (95% CI: -1, 24; p=0.064). Treatment 
with Elebrato Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with 
UMEC/VI (95% CI: 22, 44; p<0.001). 
 



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Health-Related Quality of Life 
Elebrato Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St 
George’s Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with 
BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 
95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0). 
 
A higher percentage of patients receiving Elebrato Ellipta responded with a clinically meaningful 
improvement in SGRQ total score in FULFIL at week 24 compared with BUD/FOR (50% and 41% 
respectively), odds ratios of response vs. non-response (OR) (1.41; 95% CI: 1.16, 1.70) and in IMPACT at 
week 52 compared with FF/VI and UMEC/VI (42%, 34% and 34% respectively), OR vs. FF/VI (1.41; 95% 
CI:1.29, 1.55) and OR vs. UMEC/VI (1.41; 95% CI: 1.26, 1.57); all treatment comparisons were statistically 
significant (p<0.001). 

In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or 
lower) at week 24, was significantly higher (p<0.001) for patients treated with Elebrato Ellipta compared 
with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75). In IMPACT, the proportion of patients 
who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with 
Elebrato Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; 
OR 1.28; 95% CI: 1.15, 1.43). 
 
Symptom Relief 
Breathlessness was measured using the Transition Dyspnoea Index (TDI) focal score at week 24 in FULFIL 
and week 52 in IMPACT (a subset of patients, n=5,058). In FULFIL the proportion of responders according 
to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Elebrato Ellipta compared with 
BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95). In IMPACT, the proportion of responders was also 
significantly higher (p<0.001) for Elebrato Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 
1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57). 

In FULFIL, Elebrato Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, 
compared with BUD/FOR (≥2 unit decrease from baseline). The proportion of responders during weeks 
21-24 was significantly higher (p<0.001) for patients treated with Elebrato Ellipta compared with BUD/FOR 
(47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94). 
 
Use of Rescue Medication 
In FULFIL, Elebrato Ellipta significantly reduced (p<0.001) the use of rescue medication between weeks 
1-24 compared with BUD/FOR (treatment difference: -0.2 occasions per day; 95% CI: -0.3, -0.1). 
 
In IMPACT, Elebrato Ellipta significantly reduced (p<0.001) the use of rescue medication (occasions per 
day) at each 4-week time period compared with FF/VI and UMEC/VI. At weeks 49-52, the treatment 
difference was -0.28 (95% CI: -0.37, -0.19) when compared with FF/VI and -0.30 (95% CI: -0.41, -0.19) 
with UMEC/VI. 
 
Nighttime awakenings 
In IMPACT, Elebrato Ellipta statistically significantly reduced the mean number of nighttime awakenings 
due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% 
CI: -0.14, -0.05; p<0.001) at weeks 49 to 52. Significant reductions were observed over all other timepoints 
for UMEC/VI (p<0.001) and for the all but two of the of timepoints for FF/VI (p≤0.021). 
 
Paediatric population 
The European Medicines Agency has waived the obligation to submit the results of studies with Elebrato 
Ellipta in all subsets of the paediatric population in COPD (see section 4.2 for information on paediatric use).  
 
5.2 Pharmacokinetic properties 
 
When fluticasone furoate, umeclidinium and vilanterol were administered in combination by the inhaled 
route from a single inhaler in healthy subjects, the pharmacokinetics of each component were similar to those 



13 

observed when each active substance was administered either as fluticasone furoate/vilanterol combination 
or as an umeclidinium/vilanterol combination or umeclidinium monotherapy. 
 
Population PK analyses for FF/UMEC/VI were conducted using a combined PK dataset from three phase III 
studies in 821 COPD subjects. Systemic drug levels (steady state Cmax and AUC) of FF, UMEC and VI 
following FF/UMEC/VI in one inhaler (triple combination) were within the range of those observed 
following FF/VI + UMEC as two inhalers, dual combinations (FF/VI and UMEC/VI), as well as individual 
single inhalers (FF, UMEC and VI). Covariate analysis showed higher FF apparent clearance (42%) when 
comparing FF/VI to FF/UMEC/VI; however, this is not considered clinically relevant. 
 
Absorption 
 
Fluticasone furoate 
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, 
fluticasone furoate Cmax occurred at 15 minutes. The absolute bioavailability of fluticasone furoate when 
administrated as fluticasone furoate/vilanterol by inhalation was 15.2%, primarily due to absorption of the 
inhaled portion of the dose delivered to the lung, with negligible contribution from oral absorption. 
Following repeat dosing of inhaled fluticasone furoate /vilanterol, steady state was achieved within 6 days 
with up to 1.6-fold accumulation. 
 
Umeclidinium 
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, 
umeclidinium Cmax occurred at 5 minutes. The absolute bioavailability of inhaled umeclidinium was on 
average 13%, with negligible contribution from oral absorption. Following repeat dosing of inhaled 
umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 2-fold accumulation. 
 
Vilanterol 
Following inhaled administration of fluticasone furoate/umeclidinium/vilanterol in healthy subjects, 
vilanterol Cmax occurred at 7 minutes. The absolute bioavailability of inhaled vilanterol was 27%, with 
negligible contribution from oral absorption. Following repeat dosing of inhaled umeclidinium/vilanterol, 
steady state was achieved within 6 days with up to 1.5-fold accumulation. 
 
Distribution 
 
Fluticasone furoate 
Following intravenous dosing of fluticasone furoate to healthy volunteers, the mean volume of distribution at 
steady state of 661 litres. Fluticasone furoate has a low association with red blood cells. In vitro plasma 
protein binding in human plasma of fluticasone furoate was high, on average >99.6%. 
 
Umeclidinium  
Following intravenous administration of umeclidinium to healthy volunteers, the mean volume of 
distribution was 86 litres. In vitro plasma protein binding in human plasma was on average 89%. 
 
Vilanterol 
Following intravenous administration of vilanterol to healthy volunteers, the mean volume of distribution at 
steady state was 165 litres. Vilanterol has a low association with red blood cells. In vitro plasma protein 
binding in human plasma was on average 94%. 
 
Biotransformation 
 
Fluticasone furoate 
In vitro studies showed that fluticasone furoate is primarily metabolised by cytochrome P450 3A4 
(CYP3A4) and is a substrate for the P-gp transporter. The primary metabolic route for fluticasone furoate is 
hydrolysis of the S-fluoromethyl carbothioate group to metabolites with significantly reduced corticosteroid 
activity. Systemic exposure to the metabolites is low. 



14 

 
Umeclidinium 
In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and 
is a substrate for the P-gp transporter. The primary metabolic routes for umeclidinium are oxidative 
(hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range of 
metabolites with either reduced pharmacological activity or for which the pharmacological activity has not 
been established. Systemic exposure to the metabolites is low. 
 
Vilanterol 
In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a 
substrate for the P-gp transporter. The primary metabolic routes for vilanterol are O-dealkylation to a range 
of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity. Plasma metabolic 
profiles following oral administration of vilanterol in a human radiolabel study were consistent with high 
first-pass metabolism. Systemic exposure to the metabolites is low. 
 
Elimination 
 
Fluticasone furoate 
The apparent plasma elimination half-life of fluticasone furoate following inhaled administration of 
fluticasone furoate/vilanterol was, on average, 24 hours. Following intravenous administration, the 
elimination phase half-life averaged 15.1 hours. Plasma clearance following intravenous administration was 
65.4 litres/hour. Urinary excretion accounted for approximately 2 % of the intravenously administered dose. 
Following oral administration, fluticasone furoate was eliminated in humans mainly by metabolism with 
metabolites being excreted almost exclusively in faeces, with <1% of the recovered radioactive dose 
eliminated in the urine. 
 
Umeclidinium  
Umeclidinium 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. Plasma clearance following intravenous 
administration was 151 litres/hour. Following intravenous administration, approximately 58% of the 
administered radiolabelled dose was excreted in faeces and approximately 22% of the administered 
radiolabelled dose was excreted in urine. The excretion of the drug-related material in the faeces following 
intravenous dosing indicated secretion into the bile. Following oral administration, 92% of the administered 
radiolabelled dose was excreted primarily in faeces. Less than 1% of the orally administered dose (1% of 
recovered radioactivity) was excreted in urine, suggesting negligible absorption following oral 
administration. 
 
Vilanterol 
Vilanterol plasma elimination half-life following inhaled dosing for 10 days averaged 11 hours. Plasma 
clearance of vilanterol following intravenous administration was 108 litres/hour. Following oral 
administration of radiolabelled vilanterol, 70% of the radiolabel was excreted in urine and 30% in faeces. 
Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine and 
faeces. 
 
Special populations  
 
Elderly 
The effects of age on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were 
evaluated in the population pharmacokinetic analysis. No clinically relevant effects requiring dose 
adjustment were observed. 
 
Renal impairment 
The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with renal 
impairment. However, studies have been conducted with fluticasone furoate/vilanterol and 
umeclidinium/vilanterol that showed no evidence of an increase in systemic exposure to fluticasone furoate, 
umeclidinium or vilanterol. In vitro protein binding studies between subjects with severe renal impairment 



15 

and healthy volunteers were conducted, and no clinically significant evidence of altered protein binding was 
seen.  
 
The effects of haemodialysis have not been studied.  
 
Hepatic impairment 
The effect of fluticasone furoate/umeclidinium/vilanterol has not been evaluated in subjects with hepatic 
impairment. However, studies have been conducted with fluticasone furoate/vilanterol and 
umeclidinium/vilanterol. 
 
The fluticasone furoate/vilanterol component of Elebrato Ellipta was assessed in patients with all severities 
of hepatic impairment (Child-Pugh A, B or C). For fluticasone furoate, patients with moderate hepatic 
impairment showed up to three times higher systemic exposure (FF 184 micrograms); therefore, patients 
with severe hepatic impairment received half the dose (FF 92 micrograms). At this dose, no effects on 
systemic exposure were observed. Therefore, caution is advised in moderate to severe hepatic impairment, 
but no specific dose adjustment based on hepatic function is recommended. There was no significant 
increase in systemic exposure to vilanterol. 
 
Patients with moderate hepatic impairment showed no evidence of an increase in systemic exposure to either 
umeclidinium or vilanterol (Cmax and AUC). Umeclidinium has not been evaluated in patients with severe 
hepatic impairment. 
 
Other special populations 
The effects of race, gender and weight on the pharmacokinetics of fluticasone furoate, umeclidinium and 
vilanterol were also evaluated in the population pharmacokinetic analysis.  
 
In 113 East Asian subjects with COPD (Japanese and East Asian Heritage), who received FF/UMEC/VI 
from a single inhaler (27% subjects), fluticasone furoate AUC(ss) estimates were on average 30% higher 
compared with Caucasian subjects. However, these higher systemic exposures remain below the threshold 
for FF-induced reduction of serum and urine cortisol and are not considered clinically relevant. 
There was no effect of race on pharmacokinetic parameters of umeclidinium or vilanterol in subjects with 
COPD. 
 
No clinically relevant differences requiring dose adjustment based on race, gender or weight were observed 
in fluticasone furoate, umeclidinium or vilanterol systemic exposure. 
 
In terms of other patient characteristics, a study in CYP2D6 poor metabolisers showed no evidence of a 
clinically significant effect of CYP2D6 genetic polymorphism on systemic exposure to umeclidinium.  
 
5.3 Preclinical safety data  
 
Pharmacological and toxicological effects seen with fluticasone furoate, umeclidinium or vilanterol in 
nonclinical studies were those typically associated with glucocorticoids, muscarinic receptor antagonists, or 
beta2-adrenergic receptor agonists. Administration of combined fluticasone furoate, umeclidinium and 
vilanterol to dogs did not result in any significant new toxicity or any major exacerbation of expected 
findings associated with fluticasone furoate, umeclidinium or vilanterol alone.  
 
Genotoxicity and carcinogenicity 
 
Fluticasone furoate 
Fluticasone furoate was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime 
inhalation studies in rats or mice at exposures of 1.4- or 2.9-fold, respectively, those seen in humans at a 
daily dose of 92 micrograms fluticasone furoate, based on AUC.  



16 

 
Umeclidinium 
Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime 
inhalation studies in mice or rats at exposures ≥ 20- or ≥ 17- fold the human clinical exposure at a daily dose 
of 55 micrograms umeclidinium, based on AUC respectively. 
 
Vilanterol 
Vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic indicating that vilanterol 
(as trifenatate) does not represent a genotoxic hazard to humans. Consistent with findings for other beta2 
agonists, in lifetime inhalation studies vilanterol trifenatate caused proliferative effects in the female rat and 
mouse reproductive tract and rat pituitary gland. There was no increase in tumour incidence in rats or mice at 
exposures 0.9- or 22-fold, respectively, the human clinical exposure of vilanterol at a daily dose of 
22 micrograms based on AUC. 
 
Toxicity to reproduction 
 
Fluticasone furoate, umeclidinium and vilanterol did not have any adverse effects on male or female fertility 
in rats.  
 
Fluticasone furoate 
Fluticasone furoate was not teratogenic in rats or rabbits, but delayed development in rats and caused 
abortion in rabbits at maternally toxic doses. There were no effects on development in rats at exposures 6.6-
fold the human clinical exposure at a daily dose of 92 micrograms, based on AUC. Fluticasone furoate had 
no adverse effect on pre- or post-natal development in rats.  
 
Umeclidinium 
Umeclidinium was not teratogenic in rats or rabbits. In a pre- and post-natal study, subcutaneous 
administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption 
and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose 
(approximately 61-fold the human clinical exposure of umeclidinium at a daily dose of 55 micrograms, 
based on AUC). 
 
Vilanterol 
Vilanterol was not teratogenic in rats. In inhalation studies in rabbits, vilanterol caused effects similar to 
those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb 
flexure/malrotation). When given subcutaneously there were no effects at exposures 62-fold the human 
clinical exposure at a daily dose of 22 micrograms, based on AUC. Vilanterol had no adverse effect on pre- 
or post-natal development in rats.  
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Lactose monohydrate 



17 

Magnesium stearate 
 
6.2 Incompatibilities 
 
Not applicable.  
 
6.3 Shelf life 
 
2 years 
Shelf-life after opening the tray: 6 weeks 
 
6.4 Special precautions for storage 
 
Do not store above 30°C.  
If stored in a refrigerator allow the inhaler to return to room temperature for at least an hour before use. 
  
Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before 
first use. 
 
Write the date that the inhaler should be discarded on the label and carton in the space provided. The date 
should be added as soon as the inhaler has been removed from the tray. 
 
6.5 Nature and contents of container  
 
The Ellipta inhaler consists of a light grey body, beige mouthpiece cover and a dose counter, packed into a 
foil laminate tray containing a silica gel desiccant sachet. The tray is sealed with a peelable foil lid. 
 
The inhaler is a multi-component device composed of polypropylene, high density polyethylene, 
polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless 
steel. 
 
The inhaler contains two aluminium foil laminate blister strips that deliver a total of 14 or 30 doses (14 or 30 
day supply). Each blister in one strip contains fluticasone furoate, each blister in the other strip contains 
umeclidinium (as bromide) and vilanterol (as trifenatate). 
 
Pack sizes of 14 or 30 dose inhalers.  
Multipack of 90 (3 packs of 30) dose inhalers. 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal 
 
After inhalation, patients should rinse their mouth with water without swallowing. 
 
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 and carton in the space provided. The date should be added as soon as 
the inhaler has been removed from the tray. 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. 
 



18 

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. 
 
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 
Dublin 24 
Ireland 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1237/001 
EU/1/17/1237/002 
EU/1/17/1237/003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 15 November 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. 
 
 
  

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


19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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 
 



20 

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 
UK 
 
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. 

 
  



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
  



22 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
  



23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON (SINGLE PACKS) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed  
fluticasone furoate/umeclidinium/vilanterol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium 
(equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: lactose and magnesium stearate. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Inhalation powder, pre-dispensed. 
1 inhaler of 14 doses 
1 inhaler of 30 doses 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
ONCE DAILY 
 
Read the package leaflet before use. 
Inhalation use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

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



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 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1237/001 
EU/1/17/1237/002 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
elebrato ellipta  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included.  
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



25 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed  
fluticasone furoate/umeclidinium/vilanterol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium 
(equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate). 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: lactose and magnesium stearate. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Inhalation powder, pre-dispensed. 
Multipack: 90 (3 packs of 30) doses 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
ONCE DAILY 
 
Read the package leaflet before use. 
Inhalation use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

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



26 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Do not store above 30°C. 
Store in the original package in order to protect from moisture. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services Limited 
12 Riverwalk 
Citywest Business Campus 
Dublin 24 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1237/003 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
elebrato ellipta  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included.  
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



27 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed 
fluticasone furoate/umeclidinium/vilanterol 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each delivered dose contains 92 micrograms of fluticasone furoate, 55 micrograms of umeclidinium 
(equivalent to 65 micrograms umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate).  
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: lactose and magnesium stearate. 
See package leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Inhalation powder, pre-dispensed 
1 inhaler of 30 doses. 
Component of a multipack, can’t be sold separately.  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
ONCE DAILY 
 
Read the package leaflet before use. 
Inhalation use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

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



28 

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 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
elebrato ellipta  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 
 
  



29 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
TRAY LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Elebrato Ellipta 92/55/22 mcg inhalation powder 
fluticasone furoate/umeclidinium/vilanterol 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Trading Services Limited 
GSK Logo 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 
Do not open until ready to inhale. 
In use shelf-life: 6 weeks. 
 
14 doses 
30 doses 



30 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
INHALER LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Elebrato Ellipta 92 /55 /22 mcg inhalation powder 
fluticasone furoate/umeclidinium/vilanterol 
Inhalation use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
In use shelf-life: 6 weeks. 
Discard by: 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
14 doses 
30 doses 
 
 
6. OTHER 
 
 
 
  



31 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



32 

Package leaflet: Information for the patient 
 

Elebrato Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed 
fluticasone furoate/umeclidinium/vilanterol 

 
 

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

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

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What Elebrato Ellipta is and what it is used for  
2. What you need to know before you use Elebrato Ellipta  
3. How to use Elebrato Ellipta  
4. Possible side effects  
5. How to store Elebrato Ellipta  
6. Contents of the pack and other information 
Step-by-step instructions 
 
 
1. What Elebrato Ellipta is and what it is used for 
 
What Elebrato Ellipta is 
 
Elebrato Ellipta contains three active substances called fluticasone furoate, umeclidinium bromide and 
vilanterol. Fluticasone furoate belongs to a group of medicines called corticosteroids, often simply called 
steroids. Umeclidinium bromide and vilanterol belong to a group of medicines called bronchodilators. 
 
What Elebrato Ellipta is used for 
 
Elebrato Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a long-
term condition characterised by breathing difficulties that slowly get worse.  
 
In COPD the muscles around the airways tighten, making breathing difficult. This medicine widens these 
muscles in the lungs, reducing the swelling and irritation in the small air passages and making it easier for air 
to get in and out of the lungs. When used regularly, it can help to control your breathing difficulties and 
reduce the effects of COPD on your everyday life.  
 

Elebrato Ellipta should be used every day and not only when you have breathing problems or 
other symptoms of COPD. It 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 inhaler (such as salbutamol). 

 
2. What you need to know before you use Elebrato Ellipta  
 
Don’t use Elebrato Ellipta: 
- if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of 

this medicine (listed in section 6). 



33 

 
 
Warnings and precautions  
Talk to your doctor before using Elebrato Ellipta 
- if you have asthma (Don’t use Elebrato Ellipta to treat asthma) 
- if you have heart problems or high blood pressure 
- if you have liver problems 
- if you have tuberculosis (TB) of the lung, or any long standing or untreated infections 
- if you have an eye problem called narrow-angle glaucoma 
- if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder 
- if you suffer from epilepsy 
- if you have thyroid gland problems 
- if you have low potassium in your blood 
- if you have a history of diabetes 
- if you experience blurred vision or other visual disturbances 

 
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 Elebrato 
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 Elebrato Ellipta 
If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as 
red eyes during treatment with Elebrato Ellipta: 
  

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

 
Infection of the lung 
Because you are using this medicine for COPD you may be at an increased risk of developing an infection of 
the lungs known as pneumonia. See section 4 ‘Possible side effects’ for information on symptoms to look out 
for while you are using this medicine.  
 

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

problems 

- ketoconazole or itraconazole, to treat fungal infections 

- clarithromycin or telithromycin, to treat bacterial infections  

- ritonavir or cobicistat, to treat HIV infection 

- medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets)   



34 

- other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. 
tiotropium, indacaterol. Don’t use Elebrato Ellipta if you already use these medicines. 

Tell your doctor or pharmacist if you are taking any of these. Your doctor may wish to monitor you 
carefully if you are taking any of these medicines as they may increase the side effects of Elebrato Ellipta. 
 
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 taking this medicine. Don’t use this medicine if you are pregnant unless your doctor 
tells you that you can.  
 
It is not known whether the ingredients of this medicine can pass into breast milk. If you are breast-feeding, 
you must check with your doctor before you use Elebrato Ellipta. Don’t use this medicine if you are breast-
feeding unless your doctor tells you that you can.  
 
Driving and using machines 
 
It is unlikely that this medicine will affect your ability to drive or use machines.  
 
Elebrato 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 Elebrato 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 Elebrato Ellipta regularly 
It is very important that you use Elebrato Ellipta every day, as instructed by your doctor. This will help to 
keep you free of symptoms throughout the day and night.  
 
Elebrato Ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. If you get 
this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol). 
 
How to use the inhaler 
See ‘Step-by-step instructions’ in this leaflet for full information.  
 
Once the tray is opened Elebrato Ellipta is ready to use.  
 
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 Elebrato Ellipta than you should 
If you use too much of this medicine, contact your doctor or pharmacist for advice immediately as you 
may need medical attention. If possible, show them the inhaler, the package or this leaflet. You may notice 
that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, 
or have a headache. 
 
If you forget to use Elebrato Ellipta 



35 

Don’t inhale a double 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 Elebrato Ellipta 
Use this medicine for as long as your doctor recommends. 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. 
 
Immediate breathing difficulties 
If your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical 
help immediately. 
 
Pneumonia (infection of the lung) in COPD patients (common side effect) 
Tell your doctor if you have any of the following while using Elebrato Ellipta – these could be symptoms of 
a lung infection:  

• fever or chills 
• increased mucus production, change in mucus colour 
• increased cough or increased breathing difficulties 

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

• sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). Rinsing your 
mouth out with water immediately after using Elebrato Ellipta may help prevent this side effect. 

• infection of the nose, sinuses or throat 
• infection of the upper airways 
• itchy, runny or blocked nose 
• pain in the back of the mouth and throat 
• inflammation of the sinuses 
• inflammation of the lungs (bronchitis) 
• flu (influenza) 
• common cold 
• headache  
• cough 
• painful and frequent urination (may be signs of a urinary tract infection) 
• joint pain  
• back pain 
• constipation. 

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

• irregular heart beat 
• faster heart beat 
• hoarseness 
• weakening of the bones, leading to fractures. 

 
Other side effects 
Other side effects have occurred but their exact frequency is not known (frequency cannot be estimated from 
the available data): 

• blurred vision 



36 

 
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 Elebrato Ellipta 
 
Keep this medicine out of the sight and reach of children. 
 
Don’t 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. 
 
Do not store above 30°C. 
 
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. 
 
If stored in a refrigerator, allow the inhaler to return to room temperature for at least one hour before use. 
 
Do not throw away any medicines via 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 Elebrato Ellipta contains 
The active substances are fluticasone furoate, umeclidinium bromide and vilanterol. 
 
Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of 
fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 
22 micrograms of vilanterol (as trifenatate). 
 
The other ingredients are lactose monohydrate (see section 2 under ‘Elebrato Ellipta contains lactose’) and 
magnesium stearate. 
 
What Elebrato Ellipta looks like and contents of the pack 
The Ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose 
counter. It is packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant sachet, to 
reduce moisture in the packaging. 
 
The active substances are present as a white powder in separate blister strips inside the inhaler. Each inhaler 
contains either 14 or 30 doses (14 or 30 day supply). Multipacks containing 90 (3 inhalers of 30) doses 
(90 day supply) are also available. Not all pack sizes may be marketed in your country. 
 
Marketing Authorisation Holder  
 
GlaxoSmithKline Trading Services Limited 
12 Riverwalk 
Citywest Business Campus 
Dublin 24 
Ireland 
 
Manufacturer  
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) 

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


37 

Priory Street 
Ware 
Hertfordshire SG12 0DJ 
UK 
 
Glaxo Wellcome Production 
Zone Industrielle No.2, 
23 Rue Lavoisier,  
27000 Evreux,  
France 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 (0) 10 85 52 00 
 

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

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

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

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

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

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

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 
Menarini France 

 
Portugal 
BIAL, Portela & Ca. SA. 

mailto:aweber@faes.es
mailto:aweber@faes.es


38 

Tél: + 33 (0)1 45 60 77 20 
 

Tel: + 351 22 986 61 00 
info@bial.com 
 

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

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

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

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

Ísland 
Vistor hf. 
Sími:  +354 535 7000 
 

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

Italia 
A. Menarini Industrie Farmaceutiche Riunite s.r.l. 
Tel: +39 (0)55 56801 

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

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

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

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

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

  
This leaflet was last revised in {month YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.  
 
  



39 

Step-by-step instructions 
 
What is the inhaler? 
The first time you use Elebrato 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 Elebrato Ellipta inhaler carton contains 
 

 
 
The inhaler is packaged in a tray. Do not open the tray until you are ready to inhale a dose of your 
medicine. 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 the sealed tray, it will be in the ‘closed’ position. Don’t open the inhaler 
until you are ready to inhale a dose of medicine. Write the “Discard by” date on the inhaler label and the 
carton in the space provided. The “Discard by” date is 6 weeks from the date you open the tray. After this 
date the inhaler should no longer be used. The tray can be discarded after first opening. 
 
The step-by-step instructions for use of the inhaler provided below can be used for either the 30-dose (30 day 
supply) or the 14-dose (14 day supply) Ellipta inhaler. 
 

This leaflet 

Carton 

Tray lid 

Inhaler 

Desiccant 

Tray 

Desiccant 



40 

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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 

For the 14-dose inhaler, the dose counter will also show half red when there are fewer than 10 doses left, 
and then will show half red with the number 0 after the last dose is used. The dose counter will appear 
completely red if the cover is opened again. 

2) Prepare a dose 
Wait to open the cover until you are ready to take your dose.  
Do not shake the inhaler. 

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

Dose counter 
 
This shows how many doses of medicine are 
left in the inhaler.  
Before the inhaler has been used, it shows 
exactly 30 doses.  
It counts down by 1 each time you open the 
cover. 
When fewer than 10 doses are left, half of 
the dose counter shows red. 
After you have used the last dose, half of the 
dose counter shows red and the number 0 
is displayed. Your inhaler is now empty. 
If you open the cover after this, the dose 
counter will change from half red to 
completely red. 

Cover 
Each time you open 
this, you prepare one 
dose of medicine. 

Mouthpiece 

Air vent 

“Click” 



41 

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. 

• Don’t shake the inhaler at any time. 

3) Inhale your medicine 
• While holding the inhaler away from your mouth, breathe out as far as is comfortable.  

Don’t breathe out into the inhaler. 

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

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

• 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 and rinse your mouth 

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

Your lips fit over the 
contoured shape of the 
mouthpiece for inhaling. 
Don’t block the air vent with 
your fingers. 



42 

 
• Rinse your mouth with water after you have used the inhaler, do not swallow.  

This will make it less likely that you will develop a sore mouth or throat as side effects.  
 
 
 


	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
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{'Title': '2. what you need to know before you use elebrato ellipta', 'Section_Content': "don't use elebrato ellipta: - if you are allergic to fluticasone furoate, umeclidinium, vilanterol or any of the other ingredients of this medicine (listed in section 6). warnings and precautions talk to your doctor before using elebrato ellipta - if you have asthma (don't use elebrato ellipta to treat asthma) - if you have heart problems or high blood pressure - if you have liver problems - if you have tuberculosis (tb) of the lung, or any long standing or untreated infections - if you have an eye problem called narrow-angle glaucoma - if you have an enlarged prostate, difficulty passing urine or a blocking in your bladder - if you suffer from epilepsy - if you have thyroid gland problems - if you have low potassium in your blood - if you have a history of diabetes - if you experience blurred vision or other visual disturbances 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 elebrato 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 elebrato ellipta if you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images as well as red eyes during treatment with elebrato ellipta: stop using this medicine and seek medical help immediately, these may be signs of an acute attack of narrow-angle glaucoma. infection of the lung because you are using this medicine for copd you may be at an increased risk of developing an infection of the lungs known as pneumonia. see section 4 'possible side effects' for information on symptoms to look out for while you are using this medicine. tell your doctor as soon as possible if you develop any of these symptoms. children and adolescents do not give this medicine to children or adolescents below the age of 18 years. other medicines and elebrato ellipta tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. some medicines may affect how this medicine works, or make it more likely that you'll have side effects. these include: - medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart problems - ketoconazole or itraconazole, to treat fungal infections - clarithromycin or telithromycin, to treat bacterial infections - ritonavir or cobicistat, to treat hiv infection - medicines that lower the amount of potassium in your blood, such as some diuretics (water tablets) 34 - other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. tiotropium, indacaterol. don't use elebrato ellipta if you already use these medicines. tell your doctor or pharmacist if you are taking any of these. your doctor may wish to monitor you carefully if you are taking any of these medicines as they may increase the side effects of elebrato ellipta. 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 taking this medicine. don't use this medicine if you are pregnant unless your doctor tells you that you can. it is not known whether the ingredients of this medicine can pass into breast milk. if you are breast-feeding, you must check with your doctor before you use elebrato ellipta. don't use this medicine if you are breast- feeding unless your doctor tells you that you can. driving and using machines it is unlikely that this medicine will affect your ability to drive or use machines. elebrato 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': 'elebrato ellipta', 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{'Title': '3. how to use elebrato 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 elebrato ellipta regularly it is very important that you use elebrato ellipta every day, as instructed by your doctor. this will help to keep you free of symptoms throughout the day and night. elebrato ellipta should not be used to relieve a sudden attack of breathlessness or wheezing. if you get this sort of attack you must use a quick-acting reliever inhaler (such as salbutamol). how to use the inhaler see 'step-by-step instructions' in this leaflet for full information. once the tray is opened elebrato ellipta is ready to use. 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 elebrato ellipta than you should if you use too much of this medicine, contact your doctor or pharmacist for advice immediately as you may need medical attention. if possible, show them the inhaler, the package or this leaflet. you may notice that your heart is beating faster than usual, you feel shaky, you have visual disturbances, have a dry mouth, or have a headache. if you forget to use elebrato ellipta 35 don't inhale a double 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 elebrato ellipta use this medicine for as long as your doctor recommends. don't stop unless your doctor advises you to, even if you feel better, as your symptoms may get 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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. immediate breathing difficulties if your breathing or wheezing gets worse straight after using this medicine, stop using it and get medical help immediately. pneumonia (infection of the lung) in copd patients (common side effect) tell your doctor if you have any of the following while using elebrato ellipta these could be symptoms of a lung infection: fever or chills increased mucus production, change in mucus colour increased cough or increased breathing difficulties common side effects these may affect up to 1 in 10 people: sore, raised patches in the mouth or throat caused by a fungal infection (candidiasis). rinsing your mouth out with water immediately after using elebrato ellipta may help prevent this side effect. infection of the nose, sinuses or throat infection of the upper airways itchy, runny or blocked nose pain in the back of the mouth and throat inflammation of the sinuses inflammation of the lungs (bronchitis) flu (influenza) common cold headache cough painful and frequent urination (may be signs of a urinary tract infection) joint pain back pain constipation. uncommon side effects these may affect up to 1 in 100 people: irregular heart beat faster heart beat hoarseness weakening of the bones, leading to fractures. other side effects other side effects have occurred but their exact frequency is not known (frequency cannot be estimated from the available data): blurred vision 36 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': 'elebrato ellipta', 'Type': 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{'Title': '5. how to store elebrato ellipta', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information step-by-step instructions', 'Section_Content': "what elebrato ellipta contains the active substances are fluticasone furoate, umeclidinium bromide and vilanterol. each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 92 micrograms of fluticasone furoate, 65 micrograms umeclidinium bromide equivalent to 55 micrograms umeclidinium and 22 micrograms of vilanterol (as trifenatate). the other ingredients are lactose monohydrate (see section 2 under 'elebrato ellipta contains lactose') and magnesium stearate. what elebrato ellipta looks like and contents of the pack the ellipta inhaler consists of a light grey plastic body, a beige coloured mouthpiece cover and a dose counter. it is packaged in a foil laminate tray with a peelable foil lid. the tray contains a desiccant sachet, to reduce moisture in the packaging. the active substances are present as a white powder in separate blister strips inside the inhaler. each inhaler contains either 14 or 30 doses (14 or 30 day supply). multipacks containing 90 (3 inhalers of 30) doses (90 day supply) are also available. not all pack sizes may be marketed in your country.", 'Entity_Recognition': [{'Text': 'elebrato ellipta', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 57, 'EndOffset': 76, 'Score': 0.9551453590393066, 'Text': 'fluticasone furoate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'ROUTE_OR_MODE', 'Score': 0.27208220958709717, 'RelationshipScore': 0.9471306204795837, 'RelationshipType': 'ROUTE_OR_MODE', 'Id': 3, 'BeginOffset': 127, 'EndOffset': 137, 'Text': 'inhalation', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 1, 'BeginOffset': 78, 'EndOffset': 98, 'Score': 0.9651221036911011, 'Text': 'umeclidinium bromide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'ROUTE_OR_MODE', 'Score': 0.27208220958709717, 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