Bretaris Genuair

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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

Bretaris Genuair 322 micrograms inhalation powder

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each delivered dose (the dose leaving the mouthpiece) contains 375 µg aclidinium bromide equivalent 
to 322 µg of aclidinium. This corresponds to a metered dose of 400 µg aclidinium bromide equivalent 
to 343 µg aclidinium.

Excipients with known effect
Each delivered dose contains approximately 12 mg lactose (as monohydrate).

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Inhalation powder.

White or almost white powder in a white inhaler with an integral dose indicator and a green dosage 
button.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

Bretaris Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult 
patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).

4.2 Posology and method of administration

Posology
The recommended dose is one inhalation of 322 micrograms aclidinium twice daily.

If a dose is missed the next dose should be taken as soon as possible. However, if it is nearly time for 
the next dose, the missed dose should be skipped.

Elderly
No dose adjustments are required for elderly patients (see section 5.2).

Renal impairment
No dose adjustments are required for patients with renal impairment (see section 5.2).

Hepatic impairment
No dose adjustments are required for patients with hepatic impairment (see section 5.2).

Paediatric population
There is no relevant use of Bretaris Genuair in children and adolescents (under 18 years of age) for the 
indication of COPD.



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Method of administration
For inhalation use.

Patients should be instructed on how to administer the product correctly as the Genuair inhaler may 
work differently from inhalers the patients may have used previously. It is important to instruct the 
patients to carefully read the Instructions for Use in the Package Leaflet, which is packed together 
with each inhaler.
For Instructions for Use, see section 6.6.

4.3 Contraindications

Hypersensitivity to aclidinium bromide or to the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Paradoxical bronchospasm:
Administration of Bretaris Genuair may cause paradoxical bronchospasm. If this occurs, treatment 
with Bretaris Genuair should be stopped and other treatments considered.

Deterioration of disease:
Aclidinium bromide is a maintenance bronchodilator and should not be used for the relief of acute 
episodes of bronchospasm, i.e. as a rescue therapy. In the event of a change in COPD intensity while 
the patient is being treated with aclidinium bromide so that the patient considers additional rescue 
medication is required, a re-evaluation of the patient and the patients’ treatment regimen should be 
conducted.

Cardiovascular effects:
Bretaris Genuair should be used with caution in patients who had a myocardial infarction during the 
previous 6 months, unstable angina, newly diagnosed arrhythmia within the previous 3 months, or 
hospitalisation within the previous 12 months for heart failure functional classes III and IV as per the 
“New York Heart Association”. Experience in patients with cardiovascular comorbidities in clinical 
trials is limited (see section 5.1). These conditions may be affected by the anticholinergic mechanism 
of action.

Anticholinergic activity:
Dry mouth, which has been observed with anticholinergic treatment, may in the long term be 
associated with dental caries.

Consistent with its anticholinergic activity, aclidinium bromide should be used with caution in patients 
with symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma 
(even though direct contact of the product with the eyes is very unlikely).

Excipients:
This medicinal product contains lactose. Patients with rare hereditary problems of galactose 
intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal 
product.

4.5 Interaction with other medicinal products and other forms of interaction

Co-administration of aclidinium bromide with other anticholinergic-containing medicinal products has 
not been studied and is not recommended.

Although no formal in vivo drug interaction studies have been performed, inhaled aclidinium bromide 
has been used concomitantly with other COPD medicinal products including sympathomimetic 
bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug 
interactions.



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In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide at the 
therapeutic dose are not expected to cause interactions with active substances that are substrates of P-
glycoprotein (P-gp) or active substances metabolised by cytochrome P450 (CYP450) enzymes and 
esterases (see section 5.2).

4.6 Fertility, pregnancy and lactation

Pregnancy
There are no data available on the use of aclidinium bromide in pregnant women.

Studies in animals have shown foetotoxicity only at dose levels much higher than the maximum 
human exposure to aclidinium bromide (see section 5.3). Aclidinium bromide should only be used 
during pregnancy if the expected benefits outweigh the potential risks.

Breast-feeding
It is unknown whether aclidinium bromide / metabolites are excreted in human milk. Animal studies 
have shown excretion of small amounts of aclidinium bromide and/or metabolites into milk. A risk to 
newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding 
or to discontinue/abstain from Bretaris Genuair therapy taking into account the benefit of breast-
feeding for the child and the benefit of therapy for the woman.

Fertility
Studies in rats have shown slight reductions in fertility only at dose levels much higher than the 
maximum human exposure to aclidinium bromide (see section 5.3). It is considered unlikely that 
aclidinium bromide administered at the recommended dose will affect fertility in humans.

4.7 Effects on ability to drive and use machines

Aclidinium bromide may have minor influence on the ability to drive and use machines. The 
occurrence of headache, dizziness or blurred vision following administration of aclidinium bromide 
(see section 4.8) may influence the ability to drive or to use machinery.

4.8 Undesirable effects

Summary of the safety profile
The most frequently reported adverse reactions with Bretaris Genuair were headache (6.6%) and 
nasopharyngitis (5.5%).

Tabulated summary of adverse reactions
The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of 
adverse reactions (i.e. events attributed to Bretaris Genuair) observed with Bretaris Genuair 322 µg 
(636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled 
clinical trials.

A placebo-controlled trial in 1791 patients with moderate to very severe COPD treated with Bretaris 
Genuair up to 36 months did not identify other adverse reactions. 

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 the available data).

System organ class Preferred term Frequency
Infections and infestations Sinusitis Common

Nasopharyngitis Common
Immune system disorders Hypersensitivity Rare

Angioedema Not known



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Anaphylactic reaction Not known
Nervous system disorders Headache Common

Dizziness Uncommon
Eye disorders Blurred vision Uncommon
Cardiac disorders Tachycardia Uncommon

Palpitations Uncommon
Respiratory, thoracic and 
mediastinal disorders

Cough Common
Dysphonia Uncommon

Gastrointestinal disorders Diarrhoea Common
Nausea Common

Dry mouth Uncommon
Stomatitis Uncommon

Skin and subcutaneous tissue 
disorders

Rash Uncommon
Pruritus Uncommon

Renal and urinary disorders Urinary retention Uncommon

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

High doses of aclidinium bromide may lead to anticholinergic signs and symptoms.
However, single inhaled doses up to 6,000 µg aclidinium bromide have been administered to healthy 
subjects without systemic anticholinergic adverse reactions. Additionally, no clinically relevant 
adverse reactions were observed following 7-day twice daily dosing of up to 800 µg aclidinium 
bromide in healthy subjects.

Acute intoxication by inadvertent medicinal product ingestion of aclidinium bromide is unlikely due to 
its low oral bioavailability and the breath-actuated dosing mechanism of the Genuair inhaler.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics; ATC Code: 
R03BB05.

Mechanism of action
Aclidinium bromide is a competitive, selective muscarinic receptor antagonist (also known as an 
anticholinergic), with a longer residence time at the M3 receptors than the M2 receptors. M3 receptors 
mediate contraction of airway smooth muscle. Inhaled aclidinium bromide acts locally in the lungs to 
antagonise M3 receptors of airway smooth muscle and induce bronchodilation. Nonclinical in vitro and 
in vivo studies showed rapid, dose-dependent and long-lasting inhibition by aclidinium of 
acetylcholine-induced bronchoconstriction. Aclidinium bromide is quickly broken down in plasma, the 
level of systemic anticholinergic side effects is therefore low.

Pharmacodynamic effects
Clinical efficacy studies showed that Bretaris Genuair  provided clinically meaningful improvements 
in lung function (as measured by the forced expiratory volume in 1 second [FEV1]) over 12 hours
following morning and evening administration, which were evident within 30 minutes of the first dose 
(increases from baseline of 124-133 mL). Maximal bronchodilation was achieved within 1-3 hours 
after dosing with mean peak improvements in FEV1 relative to baseline of 227-268 mL at steady-state.

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc?_sm_au_=iWHNfPk6pL272dJN


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Cardiac electrophysiology
No effects on QT interval (corrected using either the Fridericia or Bazett method or individually-
corrected) were observed when aclidinium bromide (200 µg or 800 µg) was administered once daily 
for 3 days to healthy subjects in a thorough QT study.

In addition, no clinically significant effects of Bretaris Genuair on cardiac rhythm were observed on 
24-hour Holter monitoring after 3 months treatment of 336 patients (of whom 164 received Bretaris
Genuair 322 µg twice daily).

Clinical efficacy and safety
The Bretaris Genuair Phase III clinical development programme included 269 patients treated with 
Bretaris Genuair 322 µg twice daily in one 6-month randomised, placebo-controlled study and 
190 patients treated with Bretaris Genuair 322 µg twice daily in one 3-month randomised, placebo-
controlled study. Efficacy was assessed by measures of lung function and symptomatic outcomes such 
as breathlessness, disease-specific health status, use of rescue medication and occurrence of 
exacerbations. In the long-term safety studies, Bretaris Genuair was associated with bronchodilatory 
efficacy when administered over a 1-year treatment period.

Bronchodilation
In the 6-month study, patients receiving Bretaris Genuair 322 µg twice daily experienced a clinically 
meaningful improvement in their lung function (as measured by FEV1). Maximal bronchodilatory
effects were evident from day one and were maintained over the 6-month treatment period. After 
6 months treatment, the mean improvement in morning pre-dose (trough) FEV1 compared to placebo 
was 128 mL (95% CI=85-170; p<0.0001).
Similar observations were made with Bretaris Genuair in the 3 month study.

Disease-Specific Health Status and Symptomatic Benefits
Bretaris Genuair provided clinically meaningful improvements in breathlessness (assessed using the 
Transition Dyspnoea Index [TDI]) and disease-specific health status (assessed using the St. George’s 
Respiratory Questionnaire [SGRQ]). The Table below shows symptom relief obtained after 6 months 
treatment with Bretaris Genuair.

Variable
Treatment Improvement over 

placebo
p-value

Bretaris Genuair Placebo

TDI
Percentage of Patients who 
achieved MCIDa

56.9 45.5
1.68-foldc increase 

in likelihood
0.004

Mean Change from baseline 1.9 0.9 1.0 unit <0.001

SGRQ

Percentage of Patients who 
achieved MCIDb

57.3 41.0
1.87-foldc increase 

in likelihood
<0.001

Mean Change from baseline -7.4 -2.8 - 4.6 units <0.0001

a Minimum clinically important difference (MCID) of at least 1 unit change in TDI.
b MCID of at least - 4 units change in SGRQ.
c Odds ratio, increase in the likelihood of achieving the MCID compared to placebo.

Patients treated with Bretaris Genuair required less rescue medication than patients treated with 
placebo (a reduction of 0.95 puffs per day at 6 months [p=0.005]). Bretaris Genuair also improved 
daily symptoms of COPD (dyspnoea, cough and sputum production) and night-time and early morning 
symptoms.

Pooled efficacy analysis of the 6-month and 3-month placebo controlled studies demonstrated a 
statistically significant reduction in the rate of moderate to severe exacerbations (requiring treatment 
with antibiotics or corticosteroids or resulting in hospitalisations) with aclidinium 322 µg twice daily 
compared to placebo (rate per patient per year: 0.31 vs 0.44 respectively; p=0.0149).



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Long Term Safety and Efficacy Trial up to 3 years
The effect of aclidinium bromide on the occurrence of major adverse cardiovascular events (MACE) 
was assessed in a randomised, double-blind, placebo-controlled, parallel-group study in 3630 adult 
patients between 40 and 91 years of age with moderate to very severe COPD, treated for up to 
36 months. 58.7% were male and 90.7% were Caucasian, with a mean postbronchodilator FEV1 of 
47.9% of predicted value and a mean CAT (COPD Assessment Test) of 20.7. All patients had a 
history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors. 
59.8% of patients had at least one COPD exacerbation within the past 12 months from the screening 
visit. Approximately 48% of enrolled patients had a prior history of at least 1 documented previous 
cardiovascular event; cerebrovascular disease (13.1%), coronary artery disease (35.4%), peripheral 
vascular disease or history of claudication (13.6%). 

The study had an event-driven design and was terminated once sufficient MACE events for the 
primary safety analysis were observed. Patients discontinued treatment if they experienced a MACE 
event and entered into the post-treatment follow-up period during the study. 70.7% of patients 
completed the study per investigator assessment. The median time on-treatment in the Bretaris 
Genuair and placebo groups was 1.1 and 1 year, respectively. The median time on-study in the 
Bretaris Genuair and placebo groups was approximately 1.4 and 1.3 years, respectively.

The primary safety endpoint was the time to first occurrence of MACE, defined as any of the 
following adjudicated events: cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal 
ischemic stroke. The frequency of patients with at least one MACE was 3.85% vs. 4.23% patients in 
the aclidinium and placebo groups, respectively. Bretaris Genuair did not increase the MACE risk in 
patients with COPD compared to placebo when added to current background therapy (hazard ratio 
(HR) 0.89; 95% CI: 0.64, 1.23). The upper bound of the confidence interval excluded a pre-defined 
risk margin of 1.8.

The rate of moderate or severe COPD exacerbations per patient per year during the first year of 
treatment was evaluated as the primary efficacy endpoint in the study. Patients treated with Bretaris
Genuair showed a statistically significant reduction of 22% compared to placebo (rate ratio [RR] 0.78; 
95% CI 0.68 to 0.89; p<0.001). In addition, Bretaris Genuair showed a statistically significant 
reduction of 35% in the rate of hospitalisations due to COPD exacerbations while on-treatment during 
the first year compared with placebo (RR 0.65; 95% CI 0.48 to 0.89; p=0.006).

The Bretaris Genuair group showed a statistically significant delay in the time to first moderate or 
severe exacerbation while on-treatment compared to the placebo group. Patients in the aclidinium 
bromide group had a 18% relative reduction of the risk of an exacerbation (HR 0.82; 95% CI [0.73, 
0.92], p<0.001).

Exercise tolerance
In a 3-week crossover, randomised, placebo-controlled clinical study Bretaris Genuair was associated 
with a statistically significant improvement in exercise endurance time in comparison to placebo of 58 
seconds (95% CI=9-108; p=0.021; pre-treatment value: 486 seconds). Bretaris Genuair statistically 
significantly reduced lung hyperinflation at rest (functional residual capacity [FRC]=0.197 L [95% 
CI=0.321, 0.072; p=0.002]; residual volume [RV]=0.238 L [95% CI=0.396, 0.079; p=0.004]) and also 
improved trough inspiratory capacity (by 0.078 L; 95% CI=0.01, 0.145; p=0.025) and reduced 
dyspnoea during exercise (Borg scale) (by 0.63 Borg units; 95% CI=1.11, 0.14; p=0.012).

Paediatric population
The European Medicines Agency has waived the obligation to submit the results of studies with 
Bretaris Genuair in all subsets of the paediatric population in COPD (see section 4.2 for information 
on paediatric use).



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5.2 Pharmacokinetic properties

Absorption
Aclidinium bromide is rapidly absorbed from the lung, achieving maximum plasma concentrations 
within 5 minutes of inhalation in healthy subjects, and normally within the first 15 minutes in COPD 
patients. The fraction of the inhaled dose that reaches the systemic circulation as unchanged 
aclidinium is very low at less than 5%.

Steady state peak plasma concentrations achieved after dry powder inhalation by COPD patients of 
400 µg aclidinium bromide were approximately 224 pg/mL. Steady-state plasma levels were attained 
within seven days of twice daily dosing.

Distribution
Whole lung deposition of inhaled aclidinium bromide via the Genuair inhaler averaged approximately 
30% of the metered dose.

The plasma protein binding of aclidinium bromide determined in vitro most likely corresponded to the 
protein binding of the metabolites due to the rapid hydrolysis of aclidinium bromide in plasma; plasma 
protein binding was 87% for the carboxylic acid metabolite and 15% for the alcohol metabolite. The 
main plasma protein that binds aclidinium bromide is albumin.

Biotransformation
Aclidinium bromide is rapidly and extensively hydrolysed to its pharmacologically inactive alcohol-
and carboxylic acid-derivatives. The hydrolysis occurs both chemically (non-enzymatically) and 
enzymatically by esterases, butyrylcholinesterase being the main human esterase involved in the 
hydrolysis. Plasma levels of the acid metabolite are approximately 100-fold greater than those of the 
alcohol metabolite and the unchanged active substance following inhalation.

The low absolute bioavailability of inhaled aclidinium bromide (<5%) is because aclidinium bromide 
undergoes extensive systemic and pre-systemic hydrolysis whether deposited in the lung or 
swallowed.

Biotransformation via CYP450 enzymes plays a minor role in the total metabolic clearance of 
aclidinium bromide.

In vitro studies have shown that aclidinium bromide at the therapeutic dose or its metabolites do not 
inhibit or induce any of the cytochrome P450 (CYP450) enzymes and do not inhibit esterases 
(carboxylesterase, acetylcholinesterase and butyrylcholinesterase). In vitro studies have shown that 
aclidinium bromide or the metabolites of aclidinium bromide are not substrates or inhibitors of 
P-glycoprotein.

Elimination
The terminal elimination half-life and effective half-life of aclidinium bromide are approximately 14 
hours and 10 hours, respectively, following inhalation of twice daily 400 µg doses in COPD patients.

Following intravenous administration of 400 µg radiolabelled aclidinium bromide to healthy subjects, 
approximately 1% of the dose was excreted as unchanged aclidinium bromide in the urine. Up to 65% 
of the dose was eliminated as metabolites in the urine and up to 33% as metabolites in the faeces.

Following inhalation of 200 µg and 400 µg of aclidinium bromide by healthy subjects or COPD 
patients, the urinary excretion of unchanged aclidinium was very low at about 0.1% of the 
administered dose, indicating that renal clearance plays a minor role in the total aclidinium clearance 
from plasma.

Linearity/non-linearity



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Aclidinium bromide demonstrated kinetic linearity and a time-independent pharmacokinetic behaviour 
in the therapeutic range.

Special populations
Elderly patients
The pharmacokinetic properties of aclidinium bromide in patients with moderate to severe COPD 
appear to be similar in patients aged 40–59 years and in patients aged ≥70 years. Therefore, no dose 
adjustment is required for elderly COPD patients.

Hepatically-impaired patients
No studies have been performed on hepatically-impaired patients. As aclidinium bromide is 
metabolised mainly by chemical and enzymatic cleavage in the plasma, hepatic dysfunction is very 
unlikely to alter its systemic exposure. No dose adjustment is required for hepatically-impaired COPD 
patients.

Renally-impaired patients
No significant pharmacokinetic differences were observed between subjects with normal renal 
function and subjects with renal impairment. Therefore, no dose adjustment and no additional 
monitoring are required for renally-impaired COPD patients.

Race
Following repeated inhalations, the systemic exposure of aclidinium bromide has been observed to be 
similar in Japanese and Caucasian patients.

Pharmacokinetic/pharmacodynamic relationship
Because aclidinium bromide acts locally in the lungs and is quickly broken down in plasma there is no 
direct relationship between pharmacokinetics and pharmacodynamics.

5.3 Preclinical safety data

Nonclinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to 
reproduction and development.

Effects in nonclinical studies with respect to cardiovascular parameters (increased heart rates in dogs), 
reproductive toxicity (foetotoxic effects), and fertility (slight decreases in conception rate, number of 
corpora lutea, and pre- and post-implantation losses) were observed only at exposures considered 
sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

The low toxicity observed in nonclinical toxicity studies is in part due to rapid metabolism of 
aclidinium bromide in plasma and the lack of significant pharmacological activity of the major 
metabolites. The safety margins for human systemic exposure with 400 µg twice daily over the no 
observed adverse effect levels in these studies ranged from 7- to 73-fold.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life



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3 years.

To be used within 90 days of opening the pouch.

6.4 Special precautions for storage

Keep the inhaler inside the pouch until the administration period starts.

6.5 Nature and contents of container

The inhaler device is a multicomponent device made of polycarbonate, acrylonitrile-butadiene-styrene, 
polyoxymethylene, polyester-butylene-terephthalate, polypropylene, polystyrene and stainless steel. It 
is white-coloured with an integral dose indicator and a green dosage button. The mouthpiece is 
covered with a removable green protective cap. The inhaler is supplied in a plastic laminate pouch, 
placed in a cardboard carton.

Carton containing 1 inhaler with 30 doses.
Carton containing 1 inhaler with 60 doses.
Carton containing 3 inhalers each with 60 doses.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

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

Instructions for Use

Getting Started

Read these Instructions for Use before you start using the medicine.

Become familiar with the parts of your Genuair inhaler.

Figure A

Before use:

a) Before first use, tear open the sealed bag and remove the inhaler. Throw away the bag.
b) Do not press the green button until you are ready to take a dose.
c) Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).

Control window
Red = confirms correct inhalation

Green button
Dose
indicator

Mouthpiece

Protective
Cap

Control window
Green = inhaler ready to use



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Figure B

STEP 1: Prepare your dose

1.1 Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).

1.2 Look at the control window (should be red, Figure C).

       Figure C

1.3 Hold the inhaler horizontally with the mouthpiece facing you and the green button on top 

(Figure D).

   Figure D

1.4 Press the green button all the way down to load your dose (Figure E).

When you press the button all the way down, the control window changes from red to green.

Make sure the green button is on top. Do not tilt.

1.5 Release the green button (Figure F).

Make sure you release the button so the inhaler can work correctly.

Squeeze here 
and pull

RED

Check mouthpiece
opening



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Figure E          Figure F

Stop and Check:

1.6 Make sure the control window is now green (Figure G).

Your medicine is ready to be inhaled.

Go to ‘STEP 2: Inhale your medicine’.

Figure G

What to do if the control window is still red after pressing the button (Figure H).

Figure H

The dose is not prepared. Go back to ‘STEP 1 Prepare your dose’ and repeat steps 1.1 to 1.6.

STEP 2: Inhale your medicine

Read steps 2.1 to 2.7 fully before use. Do not tilt.

2.1 Hold the inhaler away from your mouth, and breathe out completely. Never breathe out into

the inhaler (Figure I).

GREEN



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  Figure I

2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips

tightly around it (Figure J).

Do not hold the green button down while inhaling.

2.3 Take a strong, deep breath through your mouth. Keep breathing in for as long as possible.

A ‘click’ will let you know that you are inhaling correctly. Keep breathing in as long as possible 
after you hear the ‘click’. Some patients may not hear the ‘click’. Use the control window to ensure 
you have inhaled correctly.

2.4 Take the inhaler out of your mouth.

2.5 Hold your breath for as long as possible.

2.6 Slowly breathe out away from the inhaler.

Some patients may experience a grainy sensation in their mouth, or a slightly sweet or bitter taste. Do 

not take an extra dose even if you do not taste or feel anything after inhaling.

Stop and Check:

2.7 Make sure the control window is now red (Figure K). This means you have inhaled your 

medicine correctly.

Figure J



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Figure K

What to do if the control window is still green after inhalation (Figure L).

Figure L

This means you have not inhaled your medicine correctly. Go back to ‘STEP 2 Inhale your medicine’

and repeat steps 2.1 to 2.7.

If the control window still does not change to red, you may have forgotten to release the green button
before inhaling, or you may not have inhaled strongly enough. If this happens, try again. Make sure you
have released the green button, and you have breathed out completely. Then take a strong, deep breath
through the mouthpiece.

Please contact your doctor if the control window is still green after repeated attempts.

Push the protective cap back onto the mouthpiece after each use (Figure M), to prevent contamination 
of the inhaler with dust or other materials. You should discard your inhaler if you lose the cap.

Additional information

What should you do if you accidently prepare a dose?

    Figure M

RED



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Store your inhaler with the protective cap in place until it is time to inhale your medicine, then remove 
the cap and start at Step 1.6.

How does the dose indicator work?

 The dose indicator shows the total number of doses left in the inhaler (Figure N).
 On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the 

pack size.
 Each time you load a dose by pressing the green button, the dose indicator moves by a small 

amount towards the next number (50, 40, 30, 20, 10, or 0).

When should you get a new inhaler?

You should get a new inhaler:

 If your inhaler appears to be damaged or if you lose the cap, or
 When a red band appears in the dose indicator, this means you are nearing your last dose 

(Figure N), or
 If your inhaler is empty (Figure O).

Figure N

How do you know that your inhaler is empty?

When the green button will not return to its full upper position and is locked in a middle position, you 
have reached the last dose (Figure O). Even though the green button is locked, your last dose may still 
be inhaled. After that, the inhaler cannot be used again and you should start using a new inhaler.

How should you clean the inhaler?

Figure O

Locked

Dose indicator moves slowly from 
60 to 0: 60, 50, 40, 30, 20, 10, 0.

Dose
indicator

Red band



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NEVER use water to clean the inhaler, as this may damage your medicine.

If you wish to clean your inhaler, just wipe the outside of the mouthpiece with a dry tissue or paper 
towel.

7. MARKETING AUTHORISATION HOLDER

AstraZeneca AB
SE-151 85 Södertälje
Sweden

8. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/781/001
EU/1/12/781/002
EU/1/12/781/003

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 20 July 2012
Date of last renewal: 20 April 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/


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ANNEX II

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

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



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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Industrias Farmacéuticas Almirall, S.A.
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca
Barcelona
Spain

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 
AUTHORISATION

Pharmacovigilance system
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the 
Marketing Authorisation is in place and functioning before and whilst the medicinal product is on the 
market.

Risk Management Plan (RMP)
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as 
agreed in the Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and 
any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use 
(CHMP).

As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the 
updated RMP should be submitted at the same time as the next Periodic Safety Update Report 
(PSUR).

In addition, an updated RMP should be submitted
 When new information is received that may impact on the current Safety Specification, 

Pharmacovigilance Plan or risk minimisation activities
 Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being 

reached 
 At the request of the European Medicines Agency.

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

 Obligation to conduct post-authorisation measures

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

Description Due date
Submission of the results of the agreed post-authorisation safety study 
(PASS) for aclidinium bromide to evaluate the overall mortality and the 
proposed cardiovascular safety endpoints (with an additional endpoint of 
cardiac arrhythmia) among patients with COPD using aclidinium, according 
to a protocol agreed by the PRAC.

2023



19

ANNEX III

LABELLING AND PACKAGE LEAFLET



20

A. LABELLING



21

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON

1. NAME OF THE MEDICINAL PRODUCT

Bretaris Genuair 322 micrograms inhalation powder
aclidinium (aclidinium bromide)

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each delivered dose contains 375 micrograms aclidinium bromide equivalent to 322 micrograms of 
aclidinium.

3. LIST OF EXCIPIENTS

Also contains: Lactose

4. PHARMACEUTICAL FORM AND CONTENTS

1 inhaler containing 30 doses
1 inhaler containing 60 doses
3 inhalers each containing 60 doses

5. METHOD AND ROUTE(S) OF ADMINISTRATION

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
To be used within 90 days of opening the pouch

9. SPECIAL STORAGE CONDITIONS

Keep the Genuair inhaler inside the pouch until the administration period starts.



22

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

AstraZeneca AB
SE-151 85 Södertälje
Sweden

AstraZeneca (AstraZeneca logo)

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/12/781/001 30 doses
EU/1/12/781/002 60 doses
EU/1/12/781/003 3 inhalers each containing 60 doses

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

bretaris genuair

17. UNIQUE IDENTIFIER – 2D BARCODE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA

PC
SN
NN



23

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

Inhaler label

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

Bretaris Genuair 322 mcg inhalation powder
aclidinium (aclidinium bromide)
Inhalation use

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

EXP
To be used within 90 days of opening the pouch.

4. BATCH NUMBER

Lot

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

30 doses
60 doses

6. OTHER

AstraZeneca (AstraZeneca logo)



24

B. PACKAGE LEAFLET



25

Package leaflet: Information for the patient

Bretaris Genuair 322 micrograms inhalation powder
Aclidinium (aclidinium bromide)

This medicine is subject to additional monitoring. This will allow quick identification of new 
safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

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

side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What Bretaris Genuair is and what it is used for
2. What you need to know before you use Bretaris Genuair
3. How to use Bretaris Genuair
4. Possible side effects
5. How to store Bretaris Genuair
6. Contents of the pack and other information

Instructions for Use

1. What Bretaris Genuair is and what it is used for

What Bretaris Genuair is
The active ingredient of Bretaris Genuair is aclidinium bromide, which belongs to a group of 
medicines called bronchodilators. Bronchodilators relax airways and help keep bronchioles open. 
Bretaris Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into 
your lungs. This makes it easier for chronic obstructive pulmonary disease (COPD) patients to breathe.

What Bretaris Genuair is used for
Bretaris Genuair is indicated to help open the airways and relieve symptoms of COPD, a serious, long-
term lung disease characterised by breathing difficulties. Regular use of Bretaris Genuair can help you 
when you have ongoing shortness of breath related to your disease to help you minimise the effects of 
the disease on your everyday life and reduce the number of flare-ups (the worsening of your COPD 
symptoms for several days).

2. What you need to know before you use Bretaris Genuair

Do not use Bretaris Genuair
- if you are allergic to aclidinium bromide or any of the other ingredients of this medicine (listed in 

section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Bretaris Genuair:
- if you have had heart problems recently.
- if you see halos around lights or coloured images (glaucoma).
- if you have an enlarged prostate, problems passing urine, or a blockage in your bladder.



26

Bretaris Genuair is indicated for maintenance treatment and should not be used to treat a sudden attack 
of breathlessness or wheezing. If your COPD symptoms (breathlessness, wheezing, cough) do not 
improve or get worse you should contact your doctor for advice as soon as possible.

Dry mouth, which has been observed with medicines like Bretaris Genuair, may after using your 
medicine for a long time, be associated with tooth decay. Therefore, please remember to pay attention 
to oral hygiene.

Stop taking Bretaris Genuair and seek medical help immediately:
- if you get tightness of the chest, coughing, wheezing or breathlessness immediately after using 

the medicine. These may be signs of a condition called bronchospasm.

Children and adolescents
Bretaris Genuair is not for use in children or adolescents below 18 years of age.

Other medicines and Bretaris Genuair
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines.

Inform your doctor if you have been or are using similar medicines for breathing problems, such as
medicines containing tiotropium, ipratropium. Ask your doctor or pharmacist if you are not sure. The 
use of Bretaris Genuair with these medicines is not recommended.

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 or pharmacist for advice before taking this medicine. You should not use Bretaris Genuair
if you are pregnant or are breast-feeding unless your doctor tells you so.

Driving and using machines
Bretaris Genuair may have minor influence on the ability to drive and use machines. This medicine 
may cause headache, dizziness or blurred vision. If you are affected by any of these side effects do not 
drive or use machinery until the headache has cleared, the feeling of dizziness has passed and your 
vision has returned to normal.

Bretaris Genuair contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product.

3. How to use Bretaris Genuair

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure.

The recommended dose is one inhalation twice a day in the morning and evening.
The effects of Bretaris Genuair last for 12 hours; therefore, you should try to use your Bretaris Genuair 
inhaler at the same time every morning and evening. This ensures that there is always enough 
medicine in your body to help you breathe more easily throughout the day and night. It will also help 
you to remember to use it.

The recommended dose can be used for elderly patients and for patients with kidney or liver problems. 
No dose adjustments are necessary.

COPD is a long-term disease; therefore, it is recommended that Bretaris Genuair is used every day, 
twice a day and not only when breathing problems or other symptoms of COPD are experienced.

Route of administration



27

The medicine is for inhalation use.

Refer to the Instructions for Use for instructions on how to use the Genuair inhaler. If you are not sure 
of how to use Bretaris Genuair, contact your doctor or pharmacist.

You can use Bretaris Genuair any time before or after food or drink.

If you use more Bretaris Genuair than you should
If you think you may have used more Bretaris Genuair than you should, contact your doctor or 
pharmacist.

If you forget to use Bretaris Genuair
If you forget a dose of Bretaris Genuair, inhale the dose as soon as you remember. However, if it is 
nearly time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.

If you stop using Bretaris Genuair
This medicine is for long-term use. If you want to stop treatment, first talk to your doctor, as your 
symptoms may worsen.

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

4. Possible side effects

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

Allergic reactions may rarely occur (may affect up to 1 in 1,000 people). Stop using the medicine and 
contact your doctor immediately if you develop swelling of your face, throat, lips or tongue (with or 
without difficulty breathing or swallowing), dizziness or fainting, faster heart rate or if you get raised
severely itchy bumps on your skin (hives) as these may be symptoms of an allergic reaction.

The following side effects may occur whilst using Bretaris Genuair:
Common: may affect up to 1 in 10 people
- Headache
- Inflammation of the sinuses (sinusitis)
- Common cold (nasopharyngitis)
- Cough
- Diarrhoea
- Nausea

Uncommon: may affect up to 1 in 100 people
- Dizziness
- Dry mouth
- Inflammation of the mouth (stomatitis)
- Hoarseness (dysphonia)
- Faster heart beat (tachycardia)
- Sensation of heart beating (palpitations)
- Difficulty passing urine (urinary retention)
- Blurred vision
- Rash
- Itching of the skin

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 



28

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 Bretaris Genuair

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 inhaler label and carton after 
“EXP”. The expiry date refers to the last day of that month.

Keep the inhaler inside the pouch until the administration period starts.

To be used within 90 days of opening the pouch.

Do not use the Bretaris Genuair if you notice that the pack is damaged or shows signs of tampering.

After you have taken the last dose, the inhaler has to be disposed of. Do not throw away any medicines 
via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer 
use. These measures will help protect the environment.

6. Contents of the pack and other information

What Bretaris Genuair contains
- The active substance is aclidinium bromide. Each delivered dose contains 375 micrograms

aclidinium bromide equivalent to 322 micrograms of aclidinium.
- The other ingredient is lactose monohydrate (refer to Section 2 “Bretaris Genuair contains 

lactose”).

What Bretaris Genuair looks like and contents of the pack
Bretaris Genuair is a white or almost white powder.
The Genuair inhaler device is white coloured with an integral dose indicator and a green dosage 
button. The mouthpiece is covered with a removable green protective cap. It is supplied in a plastic
pouch.

Pack sizes supplied:
Carton containing 1 inhaler with 30 doses.
Carton containing 1 inhaler with 60 doses.
Carton containing 3 inhalers each with 60 doses.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
AstraZeneca AB
SE-151 85 Södertälje
Sweden

Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca, Barcelona
Spain

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

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc?_sm_au_=iWHNfPk6pL272dJN


29

België/Belgique/Belgien
AstraZeneca S.A./N.V.
Tel: +32 2 370 48 11

Lietuva
UAB “BERLIN-CHEMIE MENARINI BALTIC”
Tel: +370 52 691 947

България
“Берлин-Хеми/А. Менарини България” 
EООД
тел.: +359 2 454 0950

Luxembourg/Luxemburg
AstraZeneca S.A./N.V.
Tel: +32 2 370 48 11

Česká republika
Berlin-Chemie/A.Menarini Ceska republika s.r.o.
Tel: +420 267 199 333

Magyarország
Berlin-Chemie/A. Menarini Kft.
Tel.: +36 23501301

Danmark
AstraZeneca A/S
Tlf: +45 43 66 64 62

Malta
Associated Drug Co. Ltd
Tel: +356 2277 8000

Deutschland
Berlin-Chemie AG
Tel: +49 (0) 30 67070

Nederland
AstraZeneca BV
Tel: +31 79 363 2222

AstraZeneca GmbH 
Tel: +49 41 03 7080

Eesti
OÜ Berlin-Chemie Menarini Eesti
Tel: +372 667 5001

Norge
AstraZeneca AS
Tlf: +47 21 00 64 00

Ελλάδα
MENARINI HELLAS AE
Τηλ: +30 210 8316111-13

Österreich
A. Menarini Pharma GmbH.
Tel: +43 1 879 95 85-0

España
Laboratorios Menarini S.A.
Tel: +34-93 462 88 00

Polska
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: +48 22 566 21 00

France
MENARINI France
Tél: +33 (0)1 45 60 77 20

Portugal
A. Menarini Portugal – Farmacêutica, S.A.
Tel: +351 210 935 500

Hrvatska
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: + 385 1 4821 361

România
Berlin-Chemie A.Menarini S.R.L.
Tel: +40 21 232 34 32

Ireland
AstraZeneca Pharmaceuticals (Ireland) DAC
Tel: +353 1609 7100

Slovenija
Berlin-Chemie / A. Menarini Distribution 
Ljubljana d.o.o.
Tel: +386 01 300 2160

Ísland
Vistor hf.
Sími: +354 535 70 00

Slovenská republika
Berlin-Chemie / A. Menarini Distribution 
Slovakia s.r.o.

Tel: +421 2 544 30 730



30

Italia
Laboratori Guidotti S.p.A.
Tel: +39- 050 971011

Suomi/Finland
AstraZeneca Oy
Puh/Tel: +358 10 23 010

Κύπρος
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305

Sverige
AstraZeneca AB
Tel: +46 8 553 26 000

Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103210

United Kingdom
AstraZeneca UK Ltd
Tel: +44 1582 836 836

This leaflet was last revised in <{month YYYY}>.

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

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


31

Instructions for Use

This section contains information on how to use your Genuair inhaler. It is important that you read this 
information as the Genuair may work differently from inhalers you have used previously. If you have 
any questions about how to use your inhaler, please ask your doctor, pharmacist or nurse for 
assistance.

The Instructions for Use is divided into the following sections:

- Getting started
- Step 1: Prepare your dose
- Step 2: Inhale your medicine
- Additional information

Getting Started

Read these Instructions for Use before you start using the medicine.

Become familiar with the parts of your Genuair inhaler.

Figure A

Before use:

a) Before first use, tear open the sealed bag and remove the inhaler. Throw away the bag.
b) Do not press the green button until you are ready to take a dose.
c) Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).

        Figure B

Squeeze here 
and pull

Control window
Red = confirms correct inhalation

Green button

Dose
indicator

Mouthpiece

Protective 
Cap

Control window
Green = inhaler ready to use



32

STEP 1: Prepare your dose

1.1 Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).

1.2 Look at the control window (should be red, Figure C).

Figure C

1.3 Hold the inhaler horizontally with the mouthpiece facing you and the green button on top 

(Figure D).

Figure D

1.4 Press the green button all the way down to load your dose (Figure E).

When you press the button all the way down, the control window changes from red to green.

Make sure the green button is on top. Do not tilt.

1.5 Release the green button (Figure F).

Make sure you release the button so the inhaler can work correctly.

Figure E          Figure F

RED

Check mouthpiece 
opening



33

Stop and Check:

1.6 Make sure the control window is now green (Figure G).

Your medicine is ready to be inhaled.

Go to ‘STEP 2: Inhale your medicine’.

Figure G

What to do if the control window is still red after pressing the button (Figure H).

Figure H

The dose is not prepared. Go back to ‘STEP 1 Prepare your dose’ and repeat steps 1.1 to 1.6.

STEP 2: Inhale your medicine

Read steps 2.1 to 2.7 fully before use. Do not tilt.

2.1 Hold the inhaler away from your mouth, and breathe out completely. Never breathe out into

the inhaler (Figure I).

GREEN



34

    Figure I

2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips

tightly around it (Figure J).

Do not hold the green button down while inhaling.

2.3 Take a strong, deep breath through your mouth. Keep breathing in for as long as possible.

A ‘click’ will let you know that you are inhaling correctly. Keep breathing in as long as possible 
after you hear the ‘click’. Some patients may not hear the ‘click’. Use the control window to ensure 
you have inhaled correctly.

2.4 Take the inhaler out of your mouth.

2.5 Hold your breath for as long as possible.

2.6 Slowly breathe out away from the inhaler.

Some patients may experience a grainy sensation in their mouth, or a slightly sweet or bitter taste. Do 
not take an extra dose even if you do not taste or feel anything after inhaling.

Stop and Check:

2.7 Make sure the control window is now red (Figure K). This means you have inhaled your 

medicine correctly.

Figure J



35

Figure K

What to do if the control window is still green after inhalation (Figure L).

Figure L

This means you have not inhaled your medicine correctly. Go back to ‘STEP 2 Inhale your medicine’

and repeat steps 2.1 to 2.7.

If the control window still does not change to red, you may have forgotten to release the green button
before inhaling, or you may not have inhaled strongly enough. If this happens, try again. Make sure you
have released the green button, and you have breathed out completely. Then take a strong, deep breath
through the mouthpiece.

Please contact your doctor if the control window is still green after repeated attempts.

Push the protective cap back onto the mouthpiece after each use (Figure M), to prevent contamination 
of the inhaler with dust or other materials. You should discard your inhaler if you lose the cap.

Additional information

What should you do if you accidently prepare a dose?
Store your inhaler with the protective cap in place until it is time to inhale your medicine, then remove 
the cap and start at Step 1.6.

Figure M

RED



36

How does the dose indicator work?

 The dose indicator shows the total number of doses left in the inhaler (Figure N).
 On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack 

size.
 Each time you load a dose by pressing the green button, the dose indicator moves by a small 

amount towards the next number (50, 40, 30, 20, 10, or 0).

When should you get a new inhaler?

You should get a new inhaler:

 If your inhaler appears to be damaged or if you lose the cap, or
 When a red band appears in the dose indicator, this means you are nearing your last dose 

(Figure N), or
 If your inhaler is empty (Figure O).

Figure N

How do you know that your inhaler is empty?

When the green button will not return to its full upper position and is locked in a middle position, you 
have reached the last dose (Figure O). Even though the green button is locked, your last dose may still 
be inhaled. After that, the inhaler cannot be used again and you should start using a new inhaler.

Figure O

Locked

Dose
indicator

     Red band

Dose indicator moves slowly from 60 
to 0: 60, 50, 40, 30, 20, 10, 0.



37

How should you clean the inhaler?

NEVER use water to clean the inhaler, as this may damage your medicine.

If you wish to clean your inhaler, just wipe the outside of the mouthpiece with a dry tissue or paper 
towel.


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) 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