Laventair Ellipta

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 

 

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

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 65 micrograms 

umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as 

trifenatate). This corresponds to a pre-dispensed dose of 74.2 micrograms umeclidinium bromide equivalent 

to 62.5 micrograms umeclidinium and 25 micrograms vilanterol (as trifenatate). 

 

Excipient with known effect 

Each delivered dose contains approximately 25 mg of lactose (as monohydrate). 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

Inhalation powder, pre-dispensed (inhalation powder). 

 

White powder in a light grey inhaler (ELLIPTA) with a red mouthpiece cover and a dose counter. 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

LAVENTAIR 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 LAVENTAIR ELLIPTA 55/22 micrograms once daily.   

 

LAVENTAIR ELLIPTA should be administered at the same time of the day each day to maintain 

bronchodilation. The maximum dose is one inhalation of LAVENTAIR ELLIPTA 55/22 micrograms once 

daily. 

 

Special populations   

Elderly patients 

No dose adjustment is required in patients over 65 years. 

 

Renal impairment 

No dose adjustment is required in patients with renal impairment. 

 



 

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Hepatic impairment 

No dose adjustment is required in patients with mild or moderate hepatic impairment. The use of 

LAVENTAIR ELLIPTA has not been studied in patients with severe hepatic impairment and should be used 

with caution. 

 

Paediatric population 

There is no relevant use of LAVENTAIR ELLIPTA in the paediatric population (under 18 years of age) for 

the indication of COPD. 

Method of administration  

 

LAVENTAIR ELLIPTA is for inhalation use only. 

 

The following instructions for the 30 dose inhaler (30 day supply) also apply to the 7 dose inhaler (7 day 

supply). 

 

The ELLIPTA inhaler contains pre-dispensed doses and is ready to use. 

 

The inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture. The desiccant sachet 

should be thrown away and it should not be opened, eaten or inhaled. The patient should be advised to not 

open the tray until they are ready to inhale a dose. 

 

The inhaler will be in the ‘closed’ position when it is first taken out of its sealed tray. The “Discard by” date 

should be written on the inhaler label in the space provided. The “Discard by” date is 6 weeks from the date 

of opening the tray. After this date the inhaler should no longer be used. The tray can be discarded after first 

opening. 

 

If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost. The 

lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled. 

 

It is not possible to accidentally take extra medicinal product or a double dose in one inhalation. 

 

Instructions for use: 

 

a) Prepare a dose 

 

Open the cover when ready to inhale a dose. The inhaler should not be shaken. 

 

Slide the cover down until a “click” is heard. The medicinal product is now ready to be inhaled. 

 

The dose counter counts down by 1 to confirm. If the dose counter does not count down as the “click” is 

heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice. 

 

b) How to inhale the medicinal product 

 

The inhaler should be held away from the mouth breathing out as far as is comfortable. But not breathing out 

into the inhaler. 

 

The mouthpiece should be placed between the lips and the lips should then be closed firmly around it. The air 

vents should not be blocked with fingers during use. 

 

• Inhale with one long, steady, deep breath in. This breath should be held in for as long as possible (at 

least 3-4 seconds). 

• Remove the inhaler from the mouth. 

• Breathe out slowly and gently. 

 



 

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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 

 

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

 

4.3 Contraindications 

 

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. 

 

4.4 Special warnings and precautions for use 

 

Asthma 

Umeclidinium/vilanterol should not be used in patients with asthma since it has not been studied in this 

patient population. 

 

Paradoxical bronchospasm 

Administration of umeclidinium/vilanterol may produce paradoxical bronchospasm that may be life-

threatening. Treatment with umeclidinium/vilanterol should be discontinued immediately if paradoxical 

bronchospasm occurs and alternative therapy instituted if necessary. 

 

Not for acute use  

Umeclidinium/vilanterol is not indicated for the treatment of acute episodes of bronchospasm.  

 

Deterioration of disease 

Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control. In the 

event of deterioration of COPD during treatment with umeclidinium/vilanterol, a re-evaluation of the patient 

and of the COPD treatment regimen should be undertaken.  

 

Cardiovascular effects 

Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after 

the administration of muscarinic receptor antagonists and sympathomimetics, including 

umeclidinium/vilanterol. Patients with clinically significant uncontrolled cardiovascular disease were 

excluded from clinical studies. Therefore, umeclidinium/vilanterol should be used with caution in patients 

with severe cardiovascular disease. 

 

Antimuscarinic activity  

Consistent with its antimuscarinic activity, umeclidinium/vilanterol should be used with caution in patients 

with urinary retention or with narrow-angle glaucoma. 

 

Hypokalaemia  

Beta2-adrenergic agonists may produce significant hypokalaemia in some patients, which has the potential to 

produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring 

supplementation.  

 

No clinically relevant effects of hypokalaemia were observed in clinical studies with umeclidinium/vilanterol 

at the recommended therapeutic dose. Caution should be exercised when umeclidinium/vilanterol is used 

with other medicinal products that also have the potential to cause hypokalaemia (see section 4.5). 

 

Hyperglycaemia 

Beta2-adrenergic agonists may produce transient hyperglycemia in some patients.  

 

No clinically relevant effects on plasma glucose were observed in clinical studies with 

umeclidinium/vilanterol at the recommended therapeutic dose. Upon initiation of treatment with 

umeclidinium/vilanterol plasma glucose should be monitored more closely in diabetic patients. 



 

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Coexisting conditions  

Umeclidinium/vilanterol should be used with caution in patients with convulsive disorders or thyrotoxicosis, 

and in patients who are unusually responsive to beta2-adrenergic agonists. 

 

Excipients 

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total 

lactase deficiency or glucose-galactose malabsorption should not use this medicinal product. 

  

4.5 Interaction with other medicinal products and other forms of interaction 

 

Beta-adrenergic blockers 

Medicinal products containing beta-adrenergic blockers may weaken or antagonise the effect of 

beta2-adrenergic agonists, such as vilanterol. Concurrent use of either non-selective or selective 

beta-adrenergic blockers should be avoided unless there are compelling reasons for their use. 

 

Metabolic and transporter based interactions  

Vilanterol is a substrate of cytochrome P450 3A4 (CYP3A4). Concomitant administration of strong CYP3A4 

inhibitors (e.g. ketoconazole, clarithromycin, itraconazole, ritonavir, telithromycin) may inhibit the 

metabolism of, and increase the systemic exposure to, vilanterol. Co-administration with ketoconazole 

(400 mg) in healthy volunteers increased mean vilanterol AUC(0-t) and Cmax, 65% and 22% respectively. The 

increase in vilanterol exposure was not associated with an increase in beta-adrenergic agonist related 

systemic effects on heart rate, blood potassium or QT interval (corrected using the Fridericia method). Care 

is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong 

CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol, which could lead to 

an increase in the potential for adverse reactions. Verapamil, a moderate CYP3A4 inhibitor, did not 

significantly affect the pharmacokinetics of vilanterol. 

 

Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6). The steady-state pharmacokinetics of 

umeclidinium was assessed in healthy volunteers lacking CYP2D6 (poor metabolisers). No effect on 

umeclidinium AUC or Cmax was observed at a 8-fold higher dose. An approximately 1.3-fold increase in 

umeclidinium AUC was observed at 16-fold higher dose with no effect on umeclidinium Cmax. Based on the 

magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol 

is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in 

CYP2D6 activity (poor metabolisers). 

 

Both umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp). The effect of the 

moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of 

umeclidinium and vilanterol was assessed in healthy volunteers. No effect of verapamil was observed on 

umeclidinium or vilanterol Cmax. An approximately 1.4-fold increase in umeclidinium AUC was observed 

with no effect on vilanterol AUC. Based on the magnitude of these changes, no clinically relevant drug 

interaction is expected when umeclidinium/vilanterol is co-administered with P-gp inhibitors. 

 

Other antimuscarinics and sympathomimetics 

Co-administration of umeclidinium/vilanterol with other long-acting muscarinic antagonists, long-acting 

beta2-adrenergic agonists or medicinal products containing either of these agents has not been studied and is 

not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist 

adverse reactions (see sections 4.4 and 4.9). 

 

Hypokalaemia 

Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing 

diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with 

caution (see section 4.4). 

 



 

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Other medicinal products for COPD 

Although no formal in vivo drug interaction studies have been performed, inhaled umeclidinium/vilanterol 

has been used concomitantly with other COPD medicinal products including short acting sympathomimetic 

bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

There are no data from the use of umeclidinium/vilanterol in pregnant women. Studies in animals have 

shown reproductive toxicity at exposures which are not clinically relevant after administration of vilanterol 

(see section 5.3). 

 

Umeclidinium/vilanterol should be used during pregnancy only if the expected benefit to the mother justifies 

the potential risk to the foetus. 

 

Breast-feeding 

It is unknown whether umeclidinium or vilanterol are excreted in human milk. However, other 

beta2-adrenergic agonists are detected in human milk. A risk to the newborns/infants cannot be excluded. A 

decision must be made whether to discontinue breast-feeding or to discontinue umeclidinium/vilanterol 

therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the 

woman. 

 

Fertility 

There are no data on the effects of umeclidinium/vilanterol on human fertility. Animal studies indicate no 

effects of umeclidinium or vilanterol on fertility.  

 

4.7 Effects on ability to drive and use machines 

 

Umeclidinium/vilanterol has no or negligible influence on the ability to drive and use machines.  

 

4.8 Undesirable effects 

 

Summary of the safety profile 

The most frequently reported adverse reaction with umeclidinium/vilanterol was nasopharyngitis (9%). 

 

Tabulated summary of adverse reactions 

The safety profile of LAVENTAIR ELLIPTA is based on safety experience with umeclidinium/vilanterol 

and the individual components from the clinical development program comprising of 6,855 patients with 

COPD and from spontaneous reporting. The clinical development programme included 2,354 patients who 

received umeclidinium/vilanterol once daily in the Phase III clinical studies of 24 weeks or more, of whom 

1,296 patients received the recommended dose of 55/22 micrograms in 24-week studies, 832 patients 

received a higher dose of 113/22 micrograms in 24-week studies and 226 patients received 113/22 

micrograms in a 12-month study. 

 

The frequencies assigned to the adverse reactions identified in the table below include crude incidence rates 

observed in the integration of five 24-week studies and in the 12-month safety study.  

 

The frequency of adverse reactions is defined using the following convention: very common (≥1/10); 

common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare 

(<1/10,000) and not known (cannot be estimated from available data). 

  



 

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System Organ Class Adverse reactions 

 

Frequency 

Infections and infestations Urinary tract infection  

Sinusitis 

Nasopharyngitis 

Pharyngitis 

Upper respiratory tract infection 

Common 

Common 

Common 

Common 

Common 

Immune system disorders Hypersensitivity reactions including: 

 

Rash  

 

Anaphylaxis, angioedema, and urticaria 

 

 

Uncommon 

 

Rare 

Nervous system disorders Headache 

Tremor 

Dysgeusia 

Dizziness 

Common 

Uncommon 

Uncommon 

Not known 

Eye disorders Vision blurred  

Glaucoma 

Intraocular pressure increased 

Rare 

Rare 

Rare 

Cardiac disorders Atrial fibrillation 

Supraventricular tachycardia 

Rhythm idioventricular  

Tachycardia 

Supraventricular extrasystoles 

Palpitations 

Uncommon 

Uncommon 

Uncommon 

Uncommon 

Uncommon 

Uncommon 

Respiratory, thoracic and 

mediastinal disorders  

Cough 

Oropharyngeal pain 

Dysphonia 

Paradoxical bronchospasm 

Common 

Common 

Uncommon 

Rare 

Gastrointestinal disorders  Constipation 

Dry mouth 

Common 

Common 

Skin and subcutaneous tissue 

disorders 

Rash Uncommon 

Renal and urinary disorders Urinary retention 

Dysuria 

Bladder outlet obstruction 

Rare 

Rare 

Rare 

 

Reporting of suspected adverse reactions 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 

continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked 

to report any suspected adverse reactions via the national reporting system listed in Appendix V. 

 

4.9 Overdose 

 

An overdose of umeclidinium/vilanterol will likely produce signs and symptoms due to the individual 

components’ actions, consistent with the known inhaled muscarinic antagonist adverse reactions (e.g. dry 

mouth, visual accommodation disturbances and tachycardia) or those with overdose of other beta2-adrenergic 

agonists (e.g. arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia). 

 

If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. 

 

 



 

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5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with 

anticholinergics incl. triple combinations with corticosteroids, ATC code: R03AL03 

 

Mechanism of action 

Umeclidinium/vilanterol is a combination inhaled long-acting muscarinic receptor antagonist/long-acting 

beta2-adrenergic agonist (LAMA/LABA). Following oral inhalation both compounds act locally on airways 

to produce bronchodilation by separate mechanisms. 

 

Umeclidinium 

Umeclidinium is a long acting muscarinic receptor antagonist (also referred to as an anticholinergic). It is a 

quinuclidine derivative with activity across multiple muscarinic receptor subtypes. Umeclidinium exerts its 

bronchodilatory activity by competitively inhibiting the binding of acetylcholine with muscarinic receptors 

on airway smooth muscle. It demonstrates slow reversibility at the human M3 muscarinic receptor subtype in 

vitro and a long duration of action in vivo when administered directly to the lungs in pre-clinical models. 

 

Vilanterol 

Vilanterol is a selective long-acting, beta2-adrenergic receptor agonist (beta2-adrenergic agonist).  

The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to 

stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine 

triphosphate (ATP) to cyclic-3’,5’-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels 

cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate 

hypersensitivity from cells, especially from mast cells. 

 

Pharmacodynamic effects 

In Phase III, 6-month studies umeclidinium/vilanterol provided clinically meaningful improvements over 

placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours 

following once daily administration, which were evident at 15 minutes following administration of the first 

dose (improvement over placebo by 112 ml (p <0.001*). Mean peak improvements in FEV1 within the first 6 

hours following dosing relative to placebo was 224 ml (p<0.001) at Week 24. There was no evidence for 

tachyphylaxis in the effect of LAVENTAIR ELLIPTA over time. 

 

Cardiac electrophysiology  

The effect of umeclidinium/vilanterol on the QT interval was evaluated in a placebo and active 

(moxifloxacin) controlled QT study involving once daily administration of umeclidinium/vilanterol 

113/22 micrograms or 500/100 micrograms (pre-dispensed dose with umeclidinium at eight times the 

recommended dose and vilanterol at four times the recommended dose) for 10 days in 103 healthy 

volunteers. The maximum mean difference in prolongations of QT interval (corrected using the Fridericia 

method, QTcF) from placebo after baseline-correction was 4.3 (90% CI=2.2 to 6.4) milliseconds seen 10 

minutes after administration with umeclidinium/vilanterol 113/22 micrograms and 8.2 (90% CI=6.2 to 10.2) 

milliseconds seen 30 minutes after administration with umeclidinium/vilanterol 500/100 micrograms. 

Therefore, no clinically relevant pro-arrhythmic potential related to QT-interval prolongations was observed 

with umeclidinium/vilanterol 113/22 micrograms. 

 

A dose-dependent increase in heart rate was also observed. The maximum mean difference in heart rate from 

placebo after baseline-correction was 8.4 (90% CI=7.0 to 9.8) beats/minute and 20.3 (90% CI=18.9 to 21.7) 

beats/minute seen 10 minutes after administration of umeclidinium/vilanterol 113/22 micrograms and 

500/100 micrograms respectively.  

 

In addition, no clinically significant effects on cardiac rhythm were observed on 24-hour Holter monitoring 

in 53 patients with COPD who were treated with umeclidinium/vilanterol 55/22 micrograms once daily in 

 
 A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did 

not achieve statistical significance. Therefore, statistical significance on this comparison cannot be inferred. 



 

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one 6-month study, or in a further 55 patients who received umeclidinium/vilanterol 113/22 micrograms once 

daily in another 6-month study and 226 patients who received 113/22 micrograms once daily in the 12-month 

study. 

 

Clinical efficacy and safety 

The clinical efficacy of umeclidinium/vilanterol administered once daily was evaluated in eight Phase III 

clinical studies in 6,835 adult patients with a clinical diagnosis of COPD; 5,618 patients from five 6-month 

studies (two placebo-controlled and three active [tiotropium]-comparator controlled), 655 patients from two 

3-month exercise endurance/lung function studies and 562 patients from a 12-month supportive study.  

 

Effects on lung function 

LAVENTAIR ELLIPTA demonstrated improvements in lung function (as defined by change from baseline 

in trough FEV1) in several studies. In one 6-month Phase III study, LAVENTAIR ELLIPTA demonstrated 

statistically significant improvements in trough FEV1 (primary endpoint) at Week 24 compared with placebo 

and each monotherapy component treatment arm.  In addition, LAVENTAIR ELLIPTA demonstrated 

clinically meaningful and statistically significant improvements in trough FEV1 compared with tiotropium in 

two of the three 6-month active-comparator studies and numerically greater improvements from tiotropium in 

the third active-comparator study (see Table 1). There was no attenuation of the bronchodilator effect over 

time. 

 

Symptomatic outcomes 

Breathlessness: 

LAVENTAIR ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in 

breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) 

compared with placebo (see Table 1). Improvements in TDI focal score compared with each monotherapy 

component and tiotropium were not statistically significant (see Table 1). 

 

The proportion of patients who responded with at least the minimum clinically important difference (MCID) 

of 1 unit TDI focal score at Week 24 was greater for LAVENTAIR ELLIPTA (58%) compared with placebo 

(41%) and each monotherapy component (53% for umeclidinium and 51% for vilanterol).  

 

Health-related quality of life: 

LAVENTAIR ELLIPTA has also shown an improvement in health-related quality of life measured using the 

St. George’s Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 24 

compared with placebo and each monotherapy component (see Table 1). LAVENTAIR ELLIPTA showed a 

statistically significant reduction in SGRQ total score compared with tiotropium in one of the three active-

comparator studies (see Table 1). 

 

The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 

4 units from baseline) at Week 24 was greater for LAVENTAIR ELLIPTA (49%) compared with placebo 

(34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol). In one 

active-comparator study, a higher percentage of patients receiving LAVENTAIR ELLIPTA responded with a 

clinically meaningful improvement in SGRQ score at Week 24 (53%) compared to tiotropium (46%). In the 

other two active-comparator studies, a similar proportion of patients achieved at least the MCID with 

LAVENTAIR ELLIPTA and tiotropium; 49% and 54% for LAVENTAIR ELLIPTA 55/22 micrograms and 

52% and 55% for tiotropium. 

  

Use of rescue medication 

LAVENTAIR ELLIPTA reduced the use of rescue medication with salbutamol over Weeks 1-24 compared 

with placebo and umeclidinium (see Table 1) and demonstrated an increase from baseline in the proportion 

of days when no rescue medication was needed (on average 11.1%) compared with a decrease from baseline 

on placebo (on average 0.9%).  

 

In the three 6-month active-comparator-controlled studies, LAVENTAIR ELLIPTA reduced the use of 

rescue medication with salbutamol compared with tiotropium, with statistically significant reductions 

observed in two of the studies (see Table 1). LAVENTAIR ELLIPTA also demonstrated a greater increase 



 

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from baseline in the proportion of days when no rescue medication was needed in all three studies (average 

within the range 17.6% to 21.5%) compared with tiotropium (average within the range 11.7% to 13.4%). 

 

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

 

Treatment comparisons 

with LAVENTAIR 

ELLIPTA 55/22 mcg 

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

Trough FEV1 

(ml) 
TDI 

Focal Score 

SGRQ 

Total Score 

Use of rescue 

medication3 

LAVENTAIR ELLIPTA 

(N = 413)  

versus 

Placebo (N = 280) 

167 

(128, 207) 

<0.001 

1.2  

(0.7,1.7) 

<0.001 

-5.51 

(-7.88, -3.13) 

<0.001 

-0.8 

(-1.3,-0.3) 

0.001* 

LAVENTAIR ELLIPTA 

(N = 413)  

versus 

Umeclidinium 55 mcg 

(N = 418) 

52 

(17, 87) 

0.004 

0.3 

(-0.2, 0.7) 

0.244 

-0.82 

(-2.90, 1.27) 

0.441 

-0.6 

(-1.0, -0.1) 

0.014* 

LAVENTAIR ELLIPTA 

(N = 413)  

versus 

Vilanterol 22 mcg 

(N = 421) 

95 

(60, 130) 

<0.001 

0.4 

(-0.1, 0.8) 

0.117 

-0.32 

(-2.41, 1.78) 

0.767 

0.1 

(-0.3, 0.5) 

0.675 

LAVENTAIR ELLIPTA 

(N = 454)  

versus 

tiotropium 18 mcg 

(N = 451) 

(Study ZEP117115) 

112 

(81, 144) 

<0.001 

n/e 

-2.10 

(-3.61, -0.59) 

0.006 

-0.5 

(-0.7, -0.2) 

<0.001 

LAVENTAIR ELLIPTA 

(N = 207)  

versus 

tiotropium 18 mcg 

(N = 203) 

(Study DB2113360) 

90 

(39, 141) 

<0.001 

0.12 

(-0.4, 0.5) 

0.817 

0.75 

(-2.12, 3.63) 

0.607 

-0.7 

(-1.2, -0.1) 

0.022 

LAVENTAIR ELLIPTA 

(N = 217)  

versus 

tiotropium 18 mcg 

(N =  215) 

(Study DB2113374) 

60 

(10, 109) 

0.018* 

-0.17 

(-2.85, 2.52) 

0.904 

-0.6 

(-1.2, 0.0) 

0.069 

N=number in Intent-to-treat population  

mcg = micrograms 

n/e = not evaluated 

1. Least squares mean 

2. Pooled data from Study DB2113360 and Study DB2113374 

3. Difference in the mean number of puffs per day over Weeks 1-24 

 

A higher dose of umeclidinium/vilanterol (113/22 micrograms) was also studied in a 24-week placebo 

controlled clinical study and in two of the three 24-week active-controlled studies. The results were similar to 

 
 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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those for the LAVENTAIR ELLIPTA dose and provided additional supportive evidence for the efficacy of 

LAVENTAIR ELLIPTA.  

 

COPD exacerbations 

In a 24-week placebo-controlled study in patients with symptomatic COPD, LAVENTAIR ELLIPTA 

reduced the risk of a moderate/severe COPD exacerbation by 50% compared with placebo (based on analysis 

of time to first exacerbation: Hazard Ratio (HR) 0.5; 95% CI: 0.3, 0.8; p=0.004*); by 20% compared with 

umeclidinium (HR 0.8; 95% CI: 0.5, 1.3; p=0.391); and by 30% compared with vilanterol (HR 0.7; 95% CI: 

0.4, 1.1; p=0.121). From the three active-comparator studies in patients with symptomatic COPD, the risk of 

a moderate/severe COPD exacerbation compared with tiotropium was reduced by 50% in one study (HR 0.5; 

95% CI: 0.3, 1.0; p=0.044). In the other two studies, the risk of a moderate/severe COPD exacerbation was 

increased by 20% and 90% (HR 1.2; 95% CI: 0.5, 2.6; p=0.709 and HR 1.9; 95% CI: 1.0, 3.6; p=0.062 

respectively). These studies were not specifically designed to evaluate the effect of treatments on COPD 

exacerbations and patients were withdrawn from the study if an exacerbation occurred. 

 

Supporting efficacy studies   

In a randomised, double-blind, 52-week study (CTT116855, IMPACT), 10,355 adult patients with 

symptomatic COPD and a history of 1 or more moderate/severe exacerbations in the prior 12 months were 

randomised (1:2:2) to receive umeclidinium/vilanterol (UMEC/VI 55/22 micrograms), fluticasone 

furoate/umeclidinium/vilanterol (FF/UMEC/VI 92/55/22 micrograms), or fluticasone furoate/vilanterol 

(FF/VI 92/22 micrograms) administered once daily as a single inhaler. The primary endpoint was annual rate 

of on-treatment moderate and severe exacerbations in subjects treated with FF/UMEC/VI compared with 

FF/VI and UMEC/VI. The mean annual rate of exacerbations was 0.91, 1.07 and 1.21 for FF/UMEC/VI, 

FF/VI, and UMEC/VI respectively. 

 

The comparison of FF/UMEC/VI to FF/VI and UMEC/VI resulted in a statistically significant 14.8% 

reduction in risk of a moderate/severe exacerbation (based on analysis of time to first exacerbation) (Hazard 

Ratio 0.85; 95% CI: 0.80, 0.91; p<0.001) and 16.0% reduction in risk of a moderate/severe exacerbation 

respectively (based on analysis of time to first exacerbation) (Hazard Ratio 0.84; 95% CI: 0.78, 0.91; 

p<0.001). 

 

Exercise endurance and lung volumes 

LAVENTAIR ELLIPTA 55/22 micrograms improved exercise endurance time compared with placebo, as 

evaluated with the endurance shuttle walk test (ESWT), in one study but not the second and improved lung 

volume measures compared with placebo in both studies in adult COPD patients with hyperinflation 

(functional residual capacity [FRC] >120%). In the first study, LAVENTAIR ELLIPTA 55/22 micrograms 

demonstrated a statistically significant and clinically relevant improvement (based on a minimal clinically 

important difference (MCID) between 45 to 85 seconds) over placebo in exercise endurance time (EET) 

obtained 3 hours after dosing at Week 12 (69.4 seconds [p=0.003]). Improvement in EET compared with 

placebo was seen at Day 2 and was sustained at Week 6 and Week 12. In the second study, the treatment 

difference in EET between LAVENTAIR ELLIPTA 55/22 micrograms and placebo was 21.9 seconds 

(p=0.234) at Week 12. 

 

LAVENTAIR ELLIPTA 55/22 micrograms also showed statistically significant improvements compared 

with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 

in the first study (inspiratory capacity: 237 ml and 316 ml respectively, residual volume: -466 ml and -643 ml 

respectively and functional residual capacity: -351 ml and -522 ml respectively; all p<0.001). In the second 

study, LAVENTAIR ELLIPTA 55/22 micrograms showed improvements compared with placebo in change 

from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 

198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual 

capacity: -238 ml and -302 ml respectively); all p<0.001). 

 

Paediatric population 

 
 A step-down statistical testing procedure was used in this study and this comparison was below a comparison that did 

not achieve statistical significance. Therefore, statistical significance on this comparison cannot be inferred. 



 

12 

The European Medicines Agency has waived the obligation to submit the results of studies with 

LAVENTAIR ELLIPTA in all subsets of the paediatric population in COPD (see section 4.2 for information 

on paediatric use). 

 

5.2 Pharmacokinetic properties 

 

When umeclidinium and vilanterol were administered in combination by the inhaled route, the 

pharmacokinetics of each component was similar to those observed when each active substance was 

administered separately. For pharmacokinetic purposes each component can therefore be considered 

separately. 

 

Absorption 

 

Umeclidinium 

Following inhaled administration of umeclidinium in healthy volunteers, Cmax occurred at 5 to 15 minutes. 

The absolute bioavailability of inhaled umeclidinium was on average 13% of the dose, with negligible 

contribution from oral absorption. Following repeat dosing of inhaled umeclidinium, steady state was 

achieved within 7 to 10 days with 1.5 to 1.8-fold accumulation.  

 

Vilanterol 

Following inhaled administration of vilanterol in healthy volunteers, Cmax occurred at 5 to 15 minutes. The 

absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption. 

Following repeat dosing of inhaled vilanterol, steady state was achieved within 6 days with up to 2.4-fold 

accumulation.  

 

Distribution 

 

Umeclidinium  

Following intravenous administration to healthy volunteers, the mean volume of distribution was 86 litres. 

In vitro plasma protein binding in human plasma was on average 89%.   

 

Vilanterol 

Following intravenous administration to healthy volunteers, the mean volume of distribution at steady state 

was 165 litres. In vitro plasma protein binding in human plasma was on average 94%. 

 

Biotransformation 

 

Umeclidinium 

In vitro studies showed that umeclidinium is primarily metabolised by cytochrome P450 2D6 (CYP2D6) and 

is a substrate for the P-glycoprotein (P-gp) transporter. The primary metabolic routes for umeclidinium are 

oxidative (hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range 

of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not 

been established. Systemic exposure to the metabolites is low. 

 

Vilanterol 

In vitro studies showed that vilanterol is primarily metabolised by cytochrome P450 3A4 (CYP3A4) and is a 

substrate for the P-gp transporter. The primary metabolic routes for vilanterol are O-dealkylation to a range 

of metabolites with significantly reduced beta1- and beta2-adrenergic agonist activity. Plasma metabolic 

profiles following oral administration of vilanterol in a human radiolabel study were consistent with high 

first-pass metabolism. Systemic exposure to the metabolites is low. 

 

Elimination 

 

Umeclidinium  

Plasma clearance following intravenous administration was 151 litres/hour. Following intravenous 

administration, approximately 58% of the administered radiolabelled dose (or 73% of the recovered 

radioactivity) was excreted in faeces by 192 hours post-dose. Urinary elimination accounted for 22% of the 



 

13 

administered radiolabelled dose by 168 hours (27% of recovered radioactivity). The excretion of the 

drug-related material in the faeces following intravenous dosing indicated secretion into the bile. Following 

oral administration to healthy male volunteers, total radioactivity was excreted primarily in faeces (92% of 

the administered radiolabelled dose or 99% of the recovered radioactivity) by 168 hours post-dose. Less than 

1% of the orally administered dose (1% of recovered radioactivity) was excreted in urine, suggesting 

negligible absorption following oral administration. Umeclidinium plasma elimination half-life following 

inhaled dosing for 10 days averaged 19 hours in healthy volunteers, with 3% to 4% excreted unchanged in 

urine at steady-state. 

  

Vilanterol 

Plasma clearance of vilanterol following intravenous administration was 108 litres/hour. Following oral 

administration of radiolabelled vilanterol, mass balance showed 70% of the radiolabel in urine and 30% in 

faeces. Primary elimination of vilanterol was by metabolism followed by excretion of metabolites in urine 

and faeces. Vilanterol plasma elimination half-life following inhaled dosing for 10 days averaged 11 hours. 

 

Characteristics in specific groups of healthy volunteers or patients 

 

Elderly 

A population pharmacokinetic analysis showed that pharmacokinetics of umeclidinium and vilanterol were 

similar between COPD patients 65 years and older and those younger than 65 years of age. 

 

Renal impairment 

Patients with severe renal impairment showed no evidence of an increase in systemic exposure to either 

umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with 

umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of 

altered protein binding between patients with severe renal impairment and healthy volunteers. 

 

Hepatic impairment 

Patients with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in 

systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of 

umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the 

recommended dose and no evidence of altered protein binding between patients with moderate hepatic 

impairment and healthy volunteers. Umeclidinium/vilanterol has not been evaluated in patients with severe 

hepatic impairment. 

 

Other special populations 

A population pharmacokinetic analysis showed that no dose adjustment is required for umeclidinium or 

vilanterol based on the effect of age, race, gender, inhaled corticosteroid use, or weight. A study in CYP2D6 

poor metabolisers showed no evidence of a clinically significant effect of CYP2D6 genetic polymorphism on 

systemic exposure to umeclidinium.  

 

5.3 Preclinical safety data  

 

In nonclinical studies with umeclidinium and vilanterol, alone and in combination, findings were those 

typically associated with the primary pharmacology of either muscarinic receptor antagonists or 

beta2-adrenergic agonists respectively and/or local irritancy. The following statements reflect studies 

conducted on the individual components. 

 

Genotoxicity and carcinogenicity 

Umeclidinium was not genotoxic in a standard battery of studies and was not carcinogenic in lifetime 

inhalation studies in mice or rats at exposures  26 or  22-fold, times the human clinical exposure of 

umeclidinium 55 micrograms, based on AUC, respectively. 

 

In genetic toxicity studies, vilanterol (as alpha-phenylcinnamate) and triphenylacetic acid were not genotoxic 

indicating that vilanterol (as trifenatate) does not represent a genotoxic hazard to humans. Consistent with 

findings for other beta2-adrenergic agonists, in lifetime inhalation studies, vilanterol trifenatate caused 

proliferative effects in the female rat and mouse reproductive tract and in the rat pituitary gland. There was 



 

14 

no increase in tumour incidence in rats or mice at exposures 0.5- or 13-fold, times the human clinical 

exposure of vilanterol 22 micrograms based on AUC, respectively. 

 

Toxicity to reproduction 

Umeclidinium was not teratogenic in rats or rabbits. In a pre- and post-natal study, subcutaneous 

administration of umeclidinium to rats resulted in lower maternal body weight gain and food consumption 

and slightly decreased pre-weaning pup body weights in dams given 180 micrograms/kg/day dose 

(approximately 80-times the human clinical exposure of umeclidinium 55 micrograms, based on AUC). 

 

Vilanterol was not teratogenic in rats. In inhalation studies in rabbits, vilanterol caused effects similar to 

those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb 

flexure/malrotation) at 6-times the human clinical exposure based on AUC. When given subcutaneously 

there were no effects at 36-times the human clinical exposure of vilanterol 22 micrograms, based on AUC. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

Lactose monohydrate 

Magnesium stearate 

 

6.2 Incompatibilities 

 

Not applicable.  

 

6.3 Shelf life 

 

2 years 

 

In-use shelf-life after opening the tray: 6 weeks 

 

6.4 Special precautions for storage 

 

Do not store above 30°C. If stored in a refrigerator allow the inhaler to return to room temperature for at least 

an hour before use. 

  

Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before 

first use. 

 

Write the date the inhaler should be discarded on the label in the space provided. The date should be added as 

soon as the inhaler has been removed from the tray. 

 

6.5 Nature and contents of container  

 

The ELLIPTA inhaler consists of a light grey body, red mouthpiece cover and a dose counter, packed into a 

foil laminate tray containing a silica gel desiccant sachet. The tray is sealed with a peelable foil lid.   

 

The inhaler is a multi-component device composed of polypropylene, high density polyethylene, 

polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless 

steel. 

 

The inhaler contains two aluminium foil laminate blisters of 7 or 30 doses.  

 

Pack sizes of 7 or 30 dose inhalers. Multipack of 3 x 30 dose inhalers. 

 

Not all pack sizes may be marketed. 



 

15 

 

6.6 Special precautions for disposal 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements.  

 

 

7. MARKETING AUTHORISATION HOLDER 

 

GlaxoSmithKline (Ireland) Limited  

12 Riverwalk  

Citywest Business Campus 

Dublin 24 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/14/899/001 

EU/1/14/899/002 

EU/1/14/899/003 

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation: 08 May 2014 

Date of latest renewal: 11 January 2019 

 

 

10. DATE OF REVISION OF THE TEXT 

 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

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



 

16 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND 

USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 

 



 

17 

A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 

 

Name and address of the manufacturers responsible for batch release 

 

Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations)  

Priory Street 

Ware, Hertfordshire SG12 0DJ 

United Kingdom 

 

Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) 

Harmire Road 

Barnard Castle, County Durham DL12 8DT 

United Kingdom 

 

Glaxo Wellcome Production 

Zone Industrielle No.2, 

23 Rue Lavoisier,  

27000 Evreux,  

France 

 

The printed package leaflet of the medicinal product must state the name and address of the manufacturer 

responsible for the release of the concerned batch. 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  

 

Medicinal product subject to medical prescription. 

 

 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 

 

• Periodic Safety Update Reports 

 

The requirements for submission of periodic safety update reports for this medicinal product are set 

out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 

2001/83/EC and any subsequent updates published on the European medicines web-portal. 

 

 

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

OF THE MEDICINAL PRODUCT   

 

• Risk Management Plan (RMP) 

 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 

agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 

updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information being 

received that may lead to a significant change to the benefit/risk profile or as the result of an important 

(pharmacovigilance or risk minimisation) milestone being reached. 

 

 

• Obligation to conduct post-authorisation measures  

 



 

18 

The MAH shall complete, within the stated timeframe, the below measure: 

 

Description Due date 

Submission of the final clinical study report on a Post-Authorisation Safety (PAS) 

Observational Cohort Study to Quantify the Incidence and Comparative Safety of 

Selected Cardiovascular and Cerebrovascular Events in COPD Patients with Laventair 

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

PRAC. 

By Q3 2024 

 

 

 



 

19 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

 

 



 

21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON (SINGLE PACKS) 

 

55 micrograms/22 micrograms 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

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

umeclidinium/vilanterol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium 

bromide) and 22 micrograms vilanterol (as trifenatate). 

 

 

3. LIST OF EXCIPIENTS 

 

Excipients: lactose and magnesium stearate. 

See package leaflet for further information. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Inhalation powder, pre-dispensed.  

1 inhaler of 7 doses  

1 inhaler of 30 doses   

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Once daily  

Read the package leaflet before use. 

Inhalation use.  

 

 

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

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

  

 

8. EXPIRY DATE 

 

EXP 

In use shelf-life: 6 weeks. 

 



 

22 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C.  

Store in the original package in order to protect from moisture. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland 

GlaxoSmithKline (Ireland) Limited logo  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/14/899/001 1 inhaler of 7 doses 

EU/1/14/899/002 1 inhaler of 30 doses  

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

laventair ellipta 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 



 

23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

BUNDLE LABEL (WITH BLUE BOX- MULTIPACK) 

 

55 micrograms/22 micrograms 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

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

umeclidinium/vilanterol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium 

bromide) and 22 micrograms vilanterol (as trifenatate). 

 

 

3. LIST OF EXCIPIENTS 

 

Excipients: lactose and magnesium stearate. 

See package leaflet for further information. 

  

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Inhalation powder, pre-dispensed. 

Multipack: 90 (3 packs of 30) doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Once daily 

Read the package leaflet before use. 

Inhalation use. 

 

 

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

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP 

In use shelf-life: 6 weeks. 

 

 



 

24 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C.  

Store in the original package in order to protect from moisture. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland 

GlaxoSmithKline (Ireland) Limited logo  

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/14/899/003  

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

laventair ellipta 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

 



 

25 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 

 

55 micrograms/22 micrograms 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

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

umeclidinium/vilanterol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium 

bromide) and 22 micrograms vilanterol (as trifenatate). 

 

 

3. LIST OF EXCIPIENTS 

 

Excipients: lactose and magnesium stearate 

See package leaflet for further information 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Inhalation powder, pre-dispensed 

1 inhaler of 30 doses  

Component of a multipack, can’t be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Once daily 

Read the package leaflet before use. 

Inhalation use.  

 

 

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

THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

  

 

8. EXPIRY DATE 

 

EXP 

In use shelf-life: 6 weeks. 

 

 



 

26 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C.  

Store in the original package in order to protect from moisture. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland 

GlaxoSmithKline (Ireland) Limited logo 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/14/899/003  

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

laventair ellipta 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

 

 



 

27 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

FOIL LAMINATE TRAY LID  

 

55 micrograms/22 micrograms 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

LAVENTAIR ELLIPTA 55/22 mcg inhalation powder 

umeclidinium/vilanterol 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

GlaxoSmithKline (Ireland) Limited logo   

GlaxoSmithKline (Ireland) Limited 

  

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

Do not open until ready to inhale. 

In use shelf-life: 6 weeks. 

7 doses 

30 doses 



 

28 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

 

INHALER LABEL 

 

55 micrograms/22 micrograms 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

LAVENTAIR ELLIPTA 55/22 mcg inhalation powder 

umeclidinium/vilanterol 

Inhalation use 

 

 

2. METHOD OF ADMINISTRATION 

 

 

 

3. EXPIRY DATE 

 

EXP 

In use shelf-life: 6 weeks. 

Discard by: 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

7 doses  

30 doses  

 

 

6. OTHER 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

29 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

30 

Package leaflet: Information for the user 

 

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

 

umeclidinium/vilanterol 

 

This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how to 

report side effects. 

 

Read all of this leaflet carefully before you start using this medicine because it contains important 

information for you. 

 

- Keep this leaflet. You may need to read it again.  

- If you have any further questions, ask your doctor, pharmacist or nurse. 

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if 

their signs of illness are the same as yours.  

- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What LAVENTAIR ELLIPTA is and what it is used for  

2. What you need to know before you use LAVENTAIR ELLIPTA 

3. How to use LAVENTAIR ELLIPTA 

4. Possible side effects  

5. How to store LAVENTAIR ELLIPTA 

6. Contents of the pack and other information 

 Step-by-step instructions  

 

 

1. What LAVENTAIR ELLIPTA is and what it is used for 

 

What LAVENTAIR ELLIPTA is  

 

LAVENTAIR ELLIPTA contains two active substances umeclidinium bromide and vilanterol. These belong 

to a group of medicines called bronchodilators. 

 

What LAVENTAIR ELLIPTA is used for  

 

LAVENTAIR ELLIPTA is used to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is 

a long-term condition characterised by breathing difficulties that slowly get worse.  

 

In COPD the muscles around the airways tighten. This medicine blocks the tightening of these muscles in the 

lungs, making it easier for air to get in and out of the lungs. When used regularly, it can help to control your 

breathing difficulties and reduce the effects of COPD on your everyday life.  

 

LAVENTAIR 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 LAVENTAIR ELLIPTA 

 

Do not use LAVENTAIR ELLIPTA: 



 

31 

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

section 6). 

If you think this applies to you, don’t use this medicine until you have checked with your doctor.  

 

Warnings and precautions   

Talk to your doctor before using this medicine: 

- if you have asthma (Don’t use LAVENTAIR ELLIPTA to treat asthma) 

- if you have heart problems or high blood pressure 

- if you have an eye problem called narrow-angle glaucoma 

- if you have an enlarged prostate, difficulty passing urine or a blockage in your bladder 

- if you suffer from epilepsy 

- if you have thyroid gland problems 

- if you have diabetes 

- if you have severe liver problems 

 

 Check with your doctor if you think any of these may apply to you. 

 

Immediate breathing difficulties 

If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your 

LAVENTAIR 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 LAVENTAIR 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 LAVENTAIR 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 LAVENTAIR ELLIPTA 

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If 

you are not sure what your medicine contains talk to your doctor or pharmacist. 

 

Some medicines may affect how this medicine works, or make it more likely that you’ll have side effects. 

These include: 

 

- medicines called beta blockers (such as propranolol), to treat high blood pressure or other heart 

problems 

- ketoconazole or itraconazole, to treat fungal infections 

- clarithromycin or telithromycin, to treat bacterial infections  

- ritonavir, to treat HIV infection 

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

some medicines used to treat asthma (such as methylxanthine or steroids)  

- other long-acting medicines similar to this medicine that are used to treat breathing problems, e.g. 

tiotropium, indacaterol. Don’t use LAVENTAIR ELLIPTA if you already use these medicines. 

 Tell your doctor or pharmacist if you are taking any of these. 

 

Pregnancy and breast-feeding 

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 

doctor for advice before using this medicine. Don’t use this medicine if you are pregnant unless your doctor 

tells you that you can. 

 



 

32 

It is not known whether the ingredients of LAVENTAIR ELLIPTA can pass into breast milk. If you are 

breast-feeding, you must check with your doctor before you use LAVENTAIR 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 LAVENTAIR ELLIPTA will affect your ability to drive or use machines. 

 

LAVENTAIR 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 LAVENTAIR 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 LAVENTAIR ELLIPTA regularly 

It is very important that you use LAVENTAIR ELLIPTA every day, as instructed by your doctor.  This will 

help to keep you free of symptoms throughout the day and night. 

 

LAVENTAIR 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. 

 

LAVENTAIR ELLIPTA is for inhalation use. To use LAVENTAIR 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 LAVENTAIR ELLIPTA than you should 

If you accidentally use too much of this medicine, contact your doctor or pharmacist for advice 

immediately as you may need medical attention. If possible, show them the inhaler, the package or this 

leaflet. You may notice that your heart is beating faster than usual, you feel shaky, you have visual 

disturbances, have a dry mouth, or have a headache. 

 

If you forget to use LAVENTAIR ELLIPTA  

Don’t inhale an extra dose to make up for a forgotten dose. Just inhale your next dose at the usual time.  

If you become wheezy or breathless, use your quick-acting reliever inhaler (such as salbutamol), then seek 

medical advice. 

 

If you stop using LAVENTAIR ELLIPTA  

Use this medicine for as long as your doctor recommends. It will only be effective as long as you are using it. 

Don’t stop unless your doctor advises you to, even if you feel better, as your symptoms may get worse. 

 

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 

 

 



 

33 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 

Allergic reactions 

If you have any of the following symptoms after taking LAVENTAIR ELLIPTA stop using this medicine 

and tell your doctor immediately. 

 

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

•  skin rash (hives) or redness 

 

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

•  swelling, sometimes of the face or mouth (angioedema) 

•  becoming very wheezy, coughing or having difficulty in breathing 

•  suddenly feeling weak or light headed (which may lead to collapse or loss of consciousness) 

 

Immediate breathing difficulties 

Immediate breathing difficulties after using LAVENTAIR ELLIPTA are rare.  If you get tightness of the 

chest, coughing, wheezing or breathlessness immediately after using this medicine: 

 Stop using this medicine and seek medical help immediately, as you may have a serious 

condition called paradoxical bronchospasm. 

 

Common side effects 

These may affect up to 1 in 10 people:  

• painful and frequent urination (may be signs of a urinary tract infection)  

• combination of sore throat and runny nose 

• sore throat 

• feeling of pressure or pain in the cheeks and forehead (may be signs of inflammation of the sinuses 

called sinusitis) 

• headache 

• cough 

• pain and irritation in the back of the mouth and throat 

• constipation 

• dry mouth 

• infection of the upper airways. 

 

Uncommon side effects 

These may affect up to 1 in 100 people:  

• irregular heart beat  

• faster heart beat 

• awareness of heart beat (palpitations) 

• rash  

• tremor 

• taste disturbance 

• hoarseness.  

 

Rare side effects 

These may affect up to 1 in 1,000 people:  

• blurred vision 

• increase of the measured eye pressure 

• decrease in vision or pain in your eyes due to high pressure (possible signs of glaucoma). 

• difficulty and pain when passing urine – these may be signs of a bladder obstruction or urinary 

retention. 

 



 

34 

Frequency not known 

Frequency cannot be estimated from the available data: 

• dizziness. 

 

Reporting of side effects 

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects 

not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 

Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. 

 

 

5. How to store LAVENTAIR ELLIPTA  

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton, tray and inhaler after ‘EXP’. The 

expiry date refers to the last day of that month.  

 

Keep the inhaler inside the sealed tray in order to protect from moisture and only remove immediately before 

first use.  Once the tray is opened, the inhaler can be used for up to 6 weeks, starting from the date of opening 

the tray. Write the date the inhaler should be thrown away on the label in the space provided. The date should 

be added as soon as the inhaler has been removed from the tray. 

 

Do not store above 30°C. 

 

If stored in a refrigerator, allow the inhaler to return to room temperature for at least an hour before use. 

 

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose 

of medicines no longer required.  This will help to protect the environment. 

 

 

6. Contents of the pack and other information 

 

What LAVENTAIR ELLIPTA contains  

The active substances are umeclidinium bromide and vilanterol. 

 

Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms 

umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as 

trifenatate). 

 

The other ingredients are lactose monohydrate (see section 2 under ‘LAVENTAIR ELLIPTA contains 

lactose’) and magnesium stearate. 

 

What LAVENTAIR ELLIPTA looks like and contents of the pack 

LAVENTAIR ELLIPTA is an inhalation powder, pre-dispensed. 

The Ellipta inhaler consists of a light grey plastic body, a red mouthpiece cover and a dose counter. It is 

packaged in a foil laminate tray with a peelable foil lid. The tray contains a desiccant packet, to reduce 

moisture in the packaging.  

 

The active substances are present as a white powder in separate blisters inside the inhaler. Each inhaler 

contains either 7 or 30 doses. Multipacks containing 90 (3 inhalers of 30) doses are also available. Not all 

pack sizes may be marketed.  



 

35 

Marketing Authorisation Holder: 

 

GlaxoSmithKline (Ireland) Limited  

12 Riverwalk  

Citywest Business Campus 

Dublin 24 

Ireland 

 

Manufacturer: 

 

Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)  

Priory Street 

Ware 

Hertfordshire  

SG12 0DJ  

United Kingdom 

 

Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) 

Harmire Road 

Barnard Castle 

County Durham  

DL12 8DT 

United Kingdom 

 

Glaxo Wellcome Production 

Zone Industrielle No.2, 

23 Rue Lavoisier,  

27000 Evreux,  

France 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien  

GlaxoSmithKline Pharmaceuticals s.a./n.v. 

Tél/Tel: + 32 (0) 10 85 52 00 

 

 

Lietuva  

GlaxoSmithKline Lietuva UAB 

Tel: + 370 5 264 90 00 

info.lt@gsk.com 

България  

ГлаксоСмитКлайн ЕООД  

Teл.: + 359 2 953 10 34 

 

Luxembourg/Luxemburg  

GlaxoSmithKline Pharmaceuticals s.a./n.v. 

Belgique/Belgien 

Tél/Tel: + 32 (0) 10 85 52 00 

 

Česká republika  

GlaxoSmithKline, s.r.o. 

Tel: + 420 222 001 111 

cz.info@gsk.com 

Magyarország  

GlaxoSmithKline Kft. 

Tel.: + 36 1 225 5300 

 

 

Danmark  

GlaxoSmithKline Pharma A/S 

Tlf: + 45 36 35 91 00 

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)33 2081100 

 



 

36 

Eesti  

GlaxoSmithKline Eesti OÜ 

Tel: + 372 6676 900 

estonia@gsk.com  

Norge  

GlaxoSmithKline AS 

Tlf: + 47 22 70 20 00 

 

 

Ελλάδα  

Menarini Hellas A.E. 

Τηλ: + 30 210 8316111-13 

 

 

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 

Tél: + 33 (0)1 45 60 77 20 

 

Portugal  

BIAL, Portela & Ca. SA. 

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  

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

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



 

37 

Step-by-step instructions 

 

What is the inhaler? 

The first time you use LAVENTAIR 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 LAVENTAIR ELLIPTA inhaler carton contains 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The inhaler is packaged in a tray.  Don’t open the tray until you are ready to start using your new 

inhaler.  When you are ready to use your inhaler, peel back the lid to open the tray.  The tray contains a 

desiccant sachet, to reduce moisture. Throw this desiccant sachet away – don’t open, eat or inhale it. 

  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

When you take the inhaler out of its tray, it will be in the ‘closed’ position. Don’t open the inhaler until you 

are ready to inhale a dose of medicine. When the tray is opened, write the “Discard by” date on the inhaler 

label in the space provided. The “Discard by” date is 6 weeks from the date you open the tray.  After this date 

the inhaler should no longer be used.  The tray can be discarded after first opening. 

 

The instructions for use of the inhaler provided below can be used for either the 30-dose inhaler (30 day 

supply) or the 7-dose inhaler (7 day supply). 

 

This leaflet 

Carton 

Tray lid 

Inhaler 

Desiccant 

Tray 

Desiccant 



 

38 

1) Read this before you start 

If you open and close the cover without inhaling the medicine, you will lose the dose.  

The lost dose will be securely held inside the inhaler, but it will no longer be available. 

It is not possible to accidentally take extra medicine or a double dose in one inhalation. 

 

 

2) Prepare a dose 

Wait to open the cover until you are ready to inhale your dose.  

Do not shake the inhaler. 

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

 
Your medicine is now ready to be inhaled. 

The dose counter counts down by 1 to confirm. 

• If the dose counter does not count down as you hear the “click”, the inhaler will not deliver 

medicine.  

Take it back to your pharmacist for advice. 

3) Inhale your medicine 

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

Don’t breathe out into the inhaler. 

• Put the mouthpiece between your lips, and close your lips firmly around it. 

Don’t block the air vent with your fingers. 



 

39 

 

• 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.  

 


	ANNEX I 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