Hirobriz Breezhaler
1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



2 

1. NAME OF THE MEDICINAL PRODUCT 
 

Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol. 

 

The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 

120 microgram indacaterol. 

 

Excipient with known effect 

 

Each capsule contains 24.8 mg lactose. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Inhalation powder, hard capsule 

 

Transparent (uncoloured) capsules containing a white powder, with “IDL 150” printed in black above 

a black bar and company logo ( ) printed in black below the black bar. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in 

adult patients with chronic obstructive pulmonary disease (COPD). 

 

4.2 Posology and method of administration 

 

Posology 

 

The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, 

using the Hirobriz Breezhaler inhaler. The dose should only be increased on medical advice. 

 

The inhalation of the content of one 300 microgram capsule once a day, using the Hirobriz Breezhaler 

inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly 

for patients with severe COPD. The maximum dose is 300 microgram once daily. 

 

Hirobriz Breezhaler should be administered at the same time of the day each day. 

 

If a dose is missed the next dose should be taken at the usual time the next day. 

 

Special populations 

Elderly population 

Maximum plasma concentration and overall systemic exposure increase with age but no dose 

adjustment is required in elderly patients. 

 

Hepatic impairment 

No dose adjustment is required for patients with mild and moderate hepatic impairment. There are no 

data available for use of Hirobriz Breezhaler in patients with severe hepatic impairment. 



3 

 

Renal impairment 

No dose adjustment is required for patients with renal impairment. 

 

Paediatric population 

There is no relevant use of Hirobriz Breezhaler in the paediatric population (under 18 years). 

 

Method of administration 

 

For inhalation use only. Hirobriz Breezhaler capsules must not be swallowed. 

 

The capsules must only be removed from the blister immediately before use. 

 

The capsules must be administered only using the Hirobriz Breezhaler inhaler (see section 6.6). The 

Hirobriz Breezhaler inhaler provided with each new prescription should be used. 

 

Patients should be instructed on how to administer the product correctly. Patients who do not 

experience improvement in breathing should be asked if they are swallowing the medicine rather than 

inhaling it. 

 

For instructions on use of the medicinal product before administration, see section 6.6. 

 

4.3 Contraindications 
 

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

 

4.4 Special warnings and precautions for use 
 

Asthma 

 

Hirobriz Breezhaler is a long-acting beta2-adrenergic agonist, which is only indicated for COPD and 

should not be used in asthma due to the absence of long-term outcome data in asthma. 

 

Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, 

including asthma-related deaths, when used for the treatment of asthma. 

 

Hypersensitivity 

 

Immediate hypersensitivity reactions have been reported after administration of Hirobriz Breezhaler. If 

signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of 

tongue, lips and face, urticaria, skin rash) occur, Hirobriz Breezhaler should be discontinued 

immediately and alternative therapy instituted. 

 

Paradoxical bronchospasm 

 

As with other inhalation therapy, administration of Hirobriz Breezhaler may result in paradoxical 

bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs Hirobriz Breezhaler 

should be discontinued immediately and alternative therapy substituted. 

 

Deterioration of disease 

 

Hirobriz Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue 

therapy. In the event of deterioration of COPD during treatment with Hirobriz Breezhaler, a re-

evaluation of the patient and of the COPD treatment regimen should be undertaken. An increase in the 

daily dose of Hirobriz Breezhaler beyond the maximum dose of 300 microgram is not appropriate. 

 



4 

Systemic effects 

 

Although no clinically relevant effect on the cardiovascular system is usually seen after the 

administration of Hirobriz Breezhaler at the recommended doses, as with other beta2-adrenergic 

agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary 

artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with 

convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-

adrenergic agonists. 

 

Cardiovascular effects 

 

Like other beta2-adrenergic agonists, indacaterol may produce a clinically significant cardiovascular 

effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In 

case such effects occur, treatment may need to be discontinued. In addition, beta-adrenergic agonists 

have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, 

prolongation of QT interval and ST segment depression, although the clinical significance of these 

observations is unknown. Therefore, long-acting beta2-adrenergic agonists such as Hirobriz Breezhaler 

should be used with caution in patients with known or suspected prolongation of the QT interval or 

treated with medicinal products affecting the QT interval. 

 

Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical 

studies of Hirobriz Breezhaler at recommended therapeutic doses (see section 5.1). 

 

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. In patients with severe COPD, hypokalaemia may be 

potentiated by hypoxia and concomitant treatment (see section 4.5), which may increase the 

susceptibility to cardiac arrhythmias. 

 

Hyperglycaemia 

 

Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose. Upon 

initiation of treatment with Hirobriz Breezhaler plasma glucose should be monitored more closely in 

diabetic patients. 

 

During clinical studies, clinically notable changes in blood glucose were generally more frequent by 

1-2% on Hirobriz Breezhaler at the recommended doses than on placebo. Hirobriz Breezhaler has not 

been investigated in patients with not well controlled diabetes mellitus. 

 

Excipients 

 

The capsules contain 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 
 

Sympathomimetic medicinal products 

 

Concomitant administration of other sympathomimetic medicinal products (alone or as part of 

combination therapy) may potentiate adverse reactions to Hirobriz Breezhaler. 

 

Hirobriz Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists 

or medicinal products containing long-acting beta2-adrenergic agonists. 

 



5 

Hypokalaemic treatment 

 

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

sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, 

therefore caution is required (see section 4.4). 

 

Beta-adrenergic blockers 

 

Beta-adrenergic blockers and beta2-adrenergic agonists may weaken or antagonise the effect of each 

other when administered concurrently. Therefore indacaterol should not be given together with beta-

adrenergic blockers (including eye drops) unless there are compelling reasons for their use. Where 

required, cardioselective beta-adrenergic blockers should be preferred, although they should be 

administered with caution. 

 

Metabolic and transporter based interactions 

 

Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-glycoprotein (P-gp) raises 

the systemic exposure of indacaterol by up to two-fold. The magnitude of exposure increases due to 

interactions does not raise any safety concerns given the safety experience of treatment with Hirobriz 

Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended 

therapeutic dose. 

 

Indacaterol has not been shown to cause interactions with medicinal products administered 

concomitantly. In vitro investigations have indicated that indacaterol has negligible potential to cause 

metabolic interactions with medicinal products at the systemic exposure levels achieved in clinical 

practice. 

 

4.6 Fertility, pregnancy and lactation 
 

Pregnancy 

 

There are no data from the use of indacaterol in pregnant women available. Animal studies do not 

indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant 

exposures (see section 5.3). Like other beta2-adrenergic agonists, indacaterol may inhibit labour due to 

a relaxant effect on uterine smooth muscle. Hirobriz Breezhaler should only be used during pregnancy 

if the expected benefits outweigh the potential risks. 

 

Breast-feeding 

 

It is not known whether indacaterol/metabolites are excreted in human milk. Available 

pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk 

(see section 5.3). A risk to the breast-fed child cannot be excluded. A decision must be made whether 

to discontinue breast-feeding or to discontinue/abstain from Hirobriz Breezhaler therapy, taking into 

account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 

 

Fertility 

 

A decreased pregnancy rate has been observed in rats. Nevertheless, it is considered unlikely that 

indacaterol will affect reproductive or fertility performance in humans following inhalation of the 

maximum recommended dose (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 
 

Hirobriz Breezhaler has no or negligible influence on the ability to drive and use machines. 

 



6 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most common adverse reactions at the recommended doses were nasopharyngitis (14.3%), upper 

respiratory tract infection (14.2%), cough (8.2%), headache (3.7%) and muscle spasms (3.5%). These 

were in the vast majority mild or moderate and became less frequent if treatment was continued. 

 

At the recommended doses, the adverse reaction profile of Hirobriz Breezhaler in patients with COPD 

shows clinically insignificant systemic effects of beta2-adrenergic stimulation. Mean heart rate 

changes were less than one beat per minute, and tachycardia was infrequent and reported at a similar 

rate as under placebo treatment. Relevant prolongations of QTcF were not detectable in comparison to 

placebo. The frequency of notable QTcF intervals [i.e. >450 ms (males) and >470 ms (females)] and 

reports of hypokalaemia were similar to placebo. The mean of the maximum changes in blood glucose 

were similar between Hirobriz Breezhaler and placebo. 

 

Tabulated summary of adverse reactions 

 

The Hirobriz Breezhaler Phase III clinical development programme involved patients with a clinical 

diagnosis of moderate to severe COPD. 4,764 patients were exposed to indacaterol up to one year at 

doses up to twice the maximum recommended dose. Of these patients, 2,611 were on treatment with 

150 microgram once daily and 1,157 on treatment with 300 microgram once daily. Approximately 

41% of patients had severe COPD. The mean age of patients was 64 years, with 48% of patients aged 

65 years or older, and the majority (80%) was Caucasian. 

 

Adverse reactions in Table 1 are listed according to MedDRA system organ class in the COPD safety 

database. Within each system organ class, adverse reactions are ranked by frequency in descending 

order according to 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), not known 

(cannot be estimated from the available data). 

 

Table 1 Adverse reactions 

 

Adverse reactions Frequency category 

Infections and infestations 

Upper respiratory tract infection Common 

Nasopharyngitis Common 

Sinusitis Common 

Immune system disorders 

Hypersensitivity1 Uncommon 

Metabolism and nutrition disorders 

Diabetes mellitus and hyperglycaemia Uncommon 

Nervous system disorders 

Headache Common 

Dizziness Common 

Paraesthesia Uncommon 

Cardiac disorders 

Ischaemic heart disease Uncommon 

Atrial fibrillation Uncommon 

Palpitations Uncommon 

Tachycardia Uncommon 

  



7 

Respiratory, thoracic and mediastinal disorders 

Cough Common 

Oropharyngeal pain including throat irritation Common 

Rhinorrhoea Common 

Paradoxical bronchospasm Uncommon 

Skin and subcutaneous tissue disorders 

Pruritus/rash Uncommon 

Musculoskeletal and connective tissue disorders 

Muscle spasm Common 

Myalgia Uncommon 

Musculoskeletal pain Uncommon 

General disorders and administration site conditions 

Chest pain Common 

Peripheral oedema Common 
1 Reports of hypersensitivity have been received from post-approval marketing experience in 

association with the use of Hirobriz Breezhaler. These were reported voluntarily from a population of 

uncertain size, and it is therefore not always possible to reliably estimate the frequency or establish a 

causal relationship to exposure to the medicinal product. Therefore the frequency was calculated from 

clinical trial experience. 

 

At 600 microgram once-daily, the safety profile of Hirobriz Breezhaler was overall similar to that of 

recommended doses. An additional adverse reaction was tremor (common). 

 

Description of selected adverse reactions 

 

In Phase III clinical studies, healthcare providers observed during clinic visits that on average 17-20% 

of patients experienced a sporadic cough that occurred usually within 15 seconds following inhalation 

and typically lasted for 5 seconds (about 10 seconds in current smokers). It was observed with a higher 

frequency in female than in male patients and in current smokers than in ex-smokers. This cough 

experienced post inhalation did not lead to any patient discontinuing from the studies at the 

recommended doses (cough is a symptom in COPD and only 8.2% of patients reported cough as an 

adverse event). There is no evidence that cough experienced post inhalation is associated with 

bronchospasm, exacerbations, deteriorations of disease or loss of efficacy. 

 

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 
 

In COPD patients, single doses of 10 times the maximum recommended therapeutic dose were 

associated with a moderate increase in pulse rate, systolic blood pressure and QTc interval. 

 

An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic 

stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular 

arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia. 

 

Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalised. 

Use of cardioselective beta blockers may be considered, but only under the supervision of a physician 

and with extreme caution since the use of beta-adrenergic blockers may provoke bronchospasm. 

 

 

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


8 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 
 

Pharmacotherapeutic group: Drugs for obstructive airways diseases, selective beta-2-adrenoreceptor 

agonists, ATC code: R03AC18 

 

Mechanism of action 

 

The pharmacological effects of beta2-adrenoceptor agonists are at least in part attributable to 

stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine 

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

cyclic AMP levels cause relaxation of bronchial smooth muscle. In vitro studies have shown that 

indacaterol, a long-acting beta2-adrenergic agonist, has more than 24-fold greater agonist activity at 

beta2-receptors compared to beta1-receptors and 20-fold greater agonist activity compared to beta3-

receptors. 

 

When inhaled, indacaterol acts locally in the lung as a bronchodilator. Indacaterol is a partial agonist 

at the human beta2-adrenergic receptor with nanomolar potency. In isolated human bronchus, 

indacaterol has a rapid onset of action and a long duration of action. 

 

Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and 

beta1-receptors are the predominant receptors in the human heart, there are also beta2-adrenergic 

receptors in the human heart comprising 10-50% of the total adrenergic receptors. The precise 

function of beta2-adrenergic receptors in the heart is not known, but their presence raises the 

possibility that even highly selective beta2-adrenergic agonists may have cardiac effects. 

 

Pharmacodynamic effects 

 

Hirobriz Breezhaler, administered once a day at doses of 150 and 300 microgram consistently 

provided clinically significant improvements in lung function (as measured by the forced expiratory 

volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and 

efficacy studies. There was a rapid onset of action within 5 minutes after inhalation, with an increase 

in FEV1 relative to baseline of 110-160 ml, comparable to the effect of the fast-acting beta2-agonist 

salbutamol 200 microgram and statistically significantly faster compared to salmeterol/fluticasone 

50/500 microgram. Mean peak improvements in FEV1 relative to baseline were 250-330 ml at steady 

state. 

 

The bronchodilator effect did not depend on the time of dosing, morning or evening. 

 

Hirobriz Breezhaler was shown to reduce lung hyperinflation, resulting in increased inspiratory 

capacity during exercise and at rest, compared to placebo. 

 

Effects on cardiac electrophysiology 

A double-blind, placebo- and active (moxifloxacin)-controlled study for 2 weeks in 404 healthy 

volunteers demonstrated maximum mean (90% confidence intervals) prolongations of the QTcF 

interval (in milliseconds) of 2.66 (0.55, 4.77) 2.98 (1.02, 4.93) and 3.34 (0.86, 5.82) following 

multiple doses of 150 microgram, 300 microgram and 600 microgram, respectively. Therefore, this 

shows no concern for a pro-arrhythmic potential related to QT-interval prolongations at recommended 

therapeutic doses or at twice the maximum recommended dose. There was no evidence of a 

concentration-delta QTc relationship in the range of doses evaluated. 

 

As demonstrated in 605 patients with COPD in a 26-week, double-blind, placebo-controlled Phase III 

study, there was no clinically relevant difference in the development of arrhythmic events monitored 

over 24 hours, at baseline and up to 3 times during the 26-week treatment period, between patients 

receiving recommended doses of Hirobriz Breezhaler treatment and those patients who received 

placebo or treatment with tiotropium. 



9 

 

Clinical efficacy and safety 

 

The clinical development programme included one 12-week, two six-month (one of which was 

extended to one year to evaluate safety and tolerability) and one one-year randomised controlled 

studies in patients with a clinical diagnosis of COPD. These studies included measures of lung 

function and of health outcomes such as dyspnoea, exacerbations and health-related quality of life. 

 

Lung function 

Hirobriz Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed 

clinically meaningful improvements in lung function. At the 12-week primary endpoint (24-hour 

trough FEV1), the 150 microgram dose resulted in a 130-180 ml increase compared to placebo 

(p<0.001) and a 60 ml increase compared to salmeterol 50 microgram twice a day (p<0.001). The 

300 microgram dose resulted in a 170-180 ml increase compared to placebo (p<0.001) and a 100 ml 

increase compared to formoterol 12 microgram twice a day (p<0.001). Both doses resulted in an 

increase of 40-50 ml over open-label tiotropium 18 microgram once a day (150 microgram, p=0.004; 

300 microgram, p=0.01). The 24-hour bronchodilator effect of Hirobriz Breezhaler was maintained 

from the first dose throughout a one-year treatment period with no evidence of loss in efficacy 

(tachyphylaxis). 

 

Symptomatic benefits 

Both doses demonstrated statistically significant improvements in symptom relief over placebo for 

dyspnoea and health status (as evaluated by Transitional Dyspnoea Index [TDI] and St. George’s 

Respiratory Questionnaire [SGRQ], respectively). The magnitude of response was generally greater 

than seen with active comparators (Table 2). In addition, patients treated with Hirobriz Breezhaler 

required significantly less rescue medication, had more days when no rescue medication was needed 

compared to placebo and had a significantly improved percentage of days with no daytime symptoms. 

 

Pooled efficacy analysis over 6 months’ treatment demonstrated that the rate of COPD exacerbations 

was statistically significantly lower than the placebo rate. Treatment comparison compared to placebo 

showed a ratio of rates of 0.68 (95% CI [ 0.47, 0.98]; p-value 0.036) and 0.74 (95% CI [0.56, 0.96]; p-

value 0.026) for 150 microgram and 300 microgram, respectively. 

 

Limited treatment experience is available in individuals of African descent. 

 

  



10 

Table 2 Symptom relief at 6 months treatment duration 

 
Treatment 

Dose (microgram) 

Indacaterol 

150 

once a day 

Indacaterol 

300 

once a day 

Tiotropium 

18 

once a day 

Salmeterol 

50 

twice a day 

Formoterol 

12 

twice a day 

Placebo 

Percentage of 

patients who 

achieved MCID 

TDI† 

57 a 

62 b 

 

 

71 b 

59 c 

 

57 b 

 

54 a 

 

 

 

 

54 c 

45 a 

47 b 

41 c 

Percentage of 

patients who 

achieved MCID 

SGRQ† 

53 a 

58 b 

 

 

53 b 

55 c 

 

47 b 

 

49 a 

 

 

 

 

51 c 

38 a 

46 b 

40 c 

Reduction in 

puffs/day of 

rescue medication 

use vs. baseline 

1.3 a 

1.5 b 

 

 

1.6 b 

 

 

1.0 b 

 

1.2 a 

 

 

n/e 

0.3 a 

0.4 b 

 

Percentage of  

days with no 

rescue medication 

use 

60 a 

57 b 

 

 

58 b 

 

 

46 b 

 

55 a 

 

 

n/e 

42 a 

42 b 

 

Study design with a: indacaterol 150 microgram, salmeterol and placebo; b: indacaterol 150 and 

300 microgram, tiotropium and placebo; c: indacaterol 300 microgram, formoterol and placebo 
† MCID = minimal clinically important difference (≥1 point change in TDI, ≥4 point change in SGRQ) 

n/e= not evaluated at six months 

 

Paediatric population 

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

Hirobriz Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary 

disease (COPD) (see section 4.2 for information on paediatric use). 

 

5.2 Pharmacokinetic properties 
 

Indacaterol is a chiral molecule with R-configuration. 

 

Pharmacokinetic data were obtained from a number of clinical studies, from healthy volunteers and 

COPD patients. 

 

Absorption 

 

The median time to reach peak serum concentrations of indacaterol was approximately 15 min after 

single or repeated inhaled doses. Systemic exposure to indacaterol increased with increasing dose 

(150 microgram to 600 microgram) in a dose proportional manner. Absolute bioavailability of 

indacaterol after an inhaled dose was on average 43% to 45%. Systemic exposure results from a 

composite of pulmonary and gastrointestinal absorption; about 75% of systemic exposure was from 

pulmonary absorption and about 25% from gastrointestinal absorption. 

 

Indacaterol serum concentrations increased with repeated once-daily administration. Steady state was 

achieved within 12 to 14 days. The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h 

dosing interval on Day 14 compared to Day 1, was in the range of 2.9 to 3.5 for once-daily inhaled 

doses between 150 microgram and 600 microgram. 

 

Distribution 

 

After intravenous infusion the volume of distribution of indacaterol during the terminal elimination 

phase was 2557 litres indicating an extensive distribution. The in vitro human serum and plasma 

protein binding was 94.1-95.3% and 95.1-96.2%, respectively. 

 



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Biotransformation 

 

After oral administration of radiolabelled indacaterol in a human ADME (absorption, distribution, 

metabolism, excretion) study, unchanged indacaterol was the main component in serum, accounting 

for about one third of total drug-related AUC over 24 hours. A hydroxylated derivative was the most 

prominent metabolite in serum. Phenolic O-glucuronides of indacaterol and hydroxylated indacaterol 

were further prominent metabolites. A diastereomer of the hydroxylated derivative, a N-glucuronide of 

indacaterol, and C- and N-dealkylated products were further metabolites identified. 

 

In vitro investigations indicated that UGT1A1 is the only UGT isoform that metabolised indacaterol to 

the phenolic O-glucuronide. The oxidative metabolites were found in incubations with recombinant 

CYP1A1, CYP2D6, and CYP3A4. CYP3A4 is concluded to be the predominant isoenzyme 

responsible for hydroxylation of indacaterol. In vitro investigations further indicated that indacaterol is 

a low affinity substrate for the efflux pump P-gp. 

 

Elimination 

 

In clinical studies which included urine collection, the amount of indacaterol excreted unchanged via 

urine was generally lower than 2% of the dose. Renal clearance of indacaterol was, on average, 

between 0.46 and 1.20 litres/hour. When compared with the serum clearance of indacaterol of 

23.3 litres/hour, it is evident that renal clearance plays a minor role (about 2 to 5% of systemic 

clearance) in the elimination of systemically available indacaterol. 

 

In a human ADME study where indacaterol was given orally, the faecal route of excretion was 

dominant over the urinary route. Indacaterol was excreted into human faeces primarily as unchanged 

parent substance (54% of the dose) and, to a lesser extent, hydroxylated indacaterol metabolites (23% 

of the dose). Mass balance was complete with ≥90% of the dose recovered in the excreta. 

 

Indacaterol serum concentrations declined in a multi-phasic manner with an average terminal half-life 

ranging from 45.5 to 126 hours. The effective half-life, calculated from the accumulation of 

indacaterol after repeated dosing ranged from 40 to 52 hours which is consistent with the observed 

time-to-steady state of approximately 12-14 days. 

 

Special populations 

 

A population pharmacokinetic analysis showed that there is no clinically relevant effect of age (adults 

up to 88 years), sex, weight (32-168 kg) or race on the pharmacokinetics of indacaterol. It did not 

suggest any difference between ethnic subgroups in this population. 

 

Patients with mild and moderate hepatic impairment showed no relevant changes in Cmax or AUC of 

indacaterol, nor did protein binding differ between mild and moderate hepatic impaired subjects and 

their healthy controls. Studies in subjects with severe hepatic impairment were not performed. 

 

Due to the very low contribution of the urinary pathway to total body elimination, a study in renally 

impaired subjects was not performed. 

 

5.3 Preclinical safety data 
 

Effects on the cardiovascular system attributable to the beta2-agonistic properties of indacaterol 

included tachycardia, arrhythmias and myocardial lesions in dogs. Mild irritancy of the nasal cavity 

and larynx were seen in rodents. All these findings occurred at exposures sufficiently in excess of 

those anticipated in humans. 

 

Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease 

in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at 

an exposure 14-fold higher than in humans treated with Hirobriz Breezhaler. Indacaterol was not 

embryotoxic or teratogenic in rats or rabbits. 



12 

 

Genotoxicity studies did not reveal any mutagenic or clastogenic potential. Carcinogenicity was 

assessed in a two-year rat study and a six-month transgenic mouse study. Increased incidences of 

benign ovarian leiomyoma and focal hyperplasia of ovarian smooth muscle in rats were consistent 

with similar findings reported for other beta2-adrenergic agonists. No evidence of carcinogenicity was 

seen in mice. Systemic exposures (AUC) in rats and mice at the no-observed adverse effect levels in 

these studies were at least 7- and 49-fold higher, respectively, than in humans treated with Hirobriz 

Breezhaler once a day at a dose of 300 microgram. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Capsule content 

 

Lactose monohydrate 

 

Capsule shell 

 

Gelatin 

 

6.2 Incompatibilities 
 

Not applicable. 

 

6.3 Shelf life 
 

30 months. 

 

6.4 Special precautions for storage 
 

Do not store above 30°C. 

 

Store in the blister in order to protect from moisture and only remove immediately before use. 

 

6.5 Nature and contents of container 

 

Hirobriz Breezhaler is a single-dose inhalation device. Inhaler body and cap are made from 

acrylonitrile butadiene styrene, push buttons are made from methyl methacrylate acrylonitrile 

butadiene styrene. Needles and springs are made from stainless steel. 

 

PA/Alu/PVC - Alu blister containing 10 hard capsules. 

 

Carton containing 10 capsules and one Hirobriz Breezhaler inhaler. 

Carton containing 30 capsules and one Hirobriz Breezhaler inhaler. 

 

Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler). 

Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler). 

Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler). 

 

Not all pack sizes may be marketed. 

 

  



13 

6.6 Special precautions for disposal and other handling 
 

Each inhaler should be disposed of after all capsules have been used. 

 

Instructions for handling and use 

 

Please read the full Instructions for Use before using the Hirobriz Breezhaler. 

 

 

 
 

 

 

Insert Pierce and release Inhale deeply Check capsule is empty 

 
  

 

 
   

 
   

 

 

 

 

 

 

 

 

 

 

 
Step 1a: 

Pull off cap 

Step 2a: 

Pierce capsule once 

Hold the inhaler upright. 

Pierce capsule by firmly 

pressing both side 

buttons at the same time. 

Step 3a: 

Breathe out fully 

Do not blow into the 

inhaler. 

Check capsule is empty 

Open the inhaler to see if 

any powder is left in the 

capsule. 

 

You should hear a noise 

as the capsule is pierced. 

Only pierce the capsule 

once. 

 

If there is powder left in 

the capsule: 

Close the inhaler. 

Repeat steps 3a to 3c. 

Step 1b: 

Open inhaler 

 
Step 2b: 

Release side buttons 

Step 3b: 

Inhale medicine deeply 

Hold the inhaler as 

shown in the picture. 

Place the mouthpiece in 

your mouth and close 

your lips firmly around 

it. 

Do not press the side 

buttons. 

 
Powder Empty 

remaining 

1 2 3 
Chec

k 



14 

 

 
 

 Breathe in quickly and as 

deeply as you can. 

During inhalation you 

will hear a whirring 

noise. 

You may taste the 

medicine as you inhale. 

 

Step 1c: 

Remove capsule 

Remove one capsule from 

the blister. 

Do not swallow the 

capsule. 

 

 
Step 3c: 

Hold breath 

Hold your breath for up 

to 5 seconds. 

Remove empty capsule 

Put the empty capsule in 

your household waste. 

 

Close the inhaler and 

replace the cap. 

 
Step 1d: 

Insert capsule 

Never place a capsule 

directly into the 

mouthpiece. 

 

  Important Information 

 Hirobriz Breezhaler 
capsules must always be 

stored in the blister card 

and only removed 

immediately before use. 

 Do not swallow the 
capsule. 

 Do not use the Hirobriz 
Breezhaler capsules 

with any other inhaler. 

 Do not use the Hirobriz 
Breezhaler inhaler to 

take any other capsule 

medicine. 

 Never place the capsule 
into your mouth or the 

mouthpiece of the 

inhaler. 

 Do not press the side 
buttons more than once. 

 Do not blow into the 
mouthpiece. 

 Do not press the side 
buttons while inhaling 

through the mouthpiece. 

 Do not handle capsules 
with wet hands. 

 Never wash your inhaler 
with water. 

 
Step 1e: 

Close inhaler 

 



15 

Your Hirobriz Breezhaler Inhaler pack contains: 

 One Hirobriz Breezhaler inhaler 

 One or more blister cards, each containing either 
6 or 10 Hirobriz Breezhaler capsules to be used 

in the inhaler 

 

 
 

 

 

Frequently Asked 

Questions 

 

Why didn’t the inhaler 

make a noise when I 

inhaled? 

The capsule may be stuck 

in the capsule chamber. If 

this happens, carefully 

loosen the capsule by 

tapping the base of the 

inhaler. Inhale the 

medicine again by 

repeating steps 3a to 3c. 

 

What should I do if there 

is powder left inside the 

capsule? 

You have not received 

enough of your medicine. 

Close the inhaler and 

repeat steps 3a to 3c. 

 

I coughed after inhaling 

– does this matter? 

This may happen. As long 

as the capsule is empty 

you have received enough 

of your medicine. 

 

I felt small pieces of the 

capsule on my tongue – 

does this matter? 

This can happen. It is not 

harmful. The chances of 

the capsule breaking into 

small pieces will be 

increased if the capsule is 

pierced more than once. 

Cleaning the inhaler 

Wipe the mouthpiece 

inside and outside with a 

clean, dry, lint-free cloth to 

remove any powder 

residue. Keep the inhaler 

dry. Never wash your 

inhaler with water. 

Disposing of the inhaler 

after use 

Each inhaler should be 

disposed of after all 

capsules have been used. 
Ask your pharmacist how 

to dispose of medicines 

and inhalers that are no 

longer required. 

 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/09/594/001-005 

 

 

  

Cap 

Capsule 

chamber 

Base 

Mouthpiece 

Screen 

Blister 

Side 

buttons 

Inhaler Inhaler base Blister Card 



16 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 30 November 2009 

Date of latest renewal: 18 September 2014 

 

 

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/


17 

1. NAME OF THE MEDICINAL PRODUCT 
 

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 

Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol. 

 

The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 

240 microgram indacaterol. 

 

Excipient with known effect 

 

Each capsule contains 24.6 mg lactose. 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 
 

Inhalation powder, hard capsule 

 

Transparent (uncoloured) capsules containing a white powder, with “IDL 300” printed in blue above a 

blue bar and company logo ( ) printed in blue below the blue bar. 

 

 

4. CLINICAL PARTICULARS 
 

4.1 Therapeutic indications 
 

Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in 

adult patients with chronic obstructive pulmonary disease (COPD). 

 

4.2 Posology and method of administration 

 

Posology 

 

The recommended dose is the inhalation of the content of one 150 microgram capsule once a day, 

using the Hirobriz Breezhaler inhaler. The dose should only be increased on medical advice. 

 

The inhalation of the content of one 300 microgram capsule once a day, using the Hirobriz Breezhaler 

inhaler has been shown to provide additional clinical benefit with regard to breathlessness, particularly 

for patients with severe COPD. The maximum dose is 300 microgram once daily. 

 

Hirobriz Breezhaler should be administered at the same time of the day each day. 

 

If a dose is missed the next dose should be taken at the usual time the next day. 

 

Special populations 

Elderly population 

Maximum plasma concentration and overall systemic exposure increase with age but no dose 

adjustment is required in elderly patients. 

 

Hepatic impairment 

No dose adjustment is required for patients with mild and moderate hepatic impairment. There are no 

data available for use of Hirobriz Breezhaler in patients with severe hepatic impairment. 



18 

 

Renal impairment 

No dose adjustment is required for patients with renal impairment. 

 

Paediatric population 

There is no relevant use of Hirobriz Breezhaler in the paediatric population (under 18 years). 

 

Method of administration 

 

For inhalation use only. Hirobriz Breezhaler capsules must not be swallowed. 

 

The capsules must only be removed from the blister immediately before use. 

 

The capsules must be administered only using the Hirobriz Breezhaler inhaler (see section 6.6). The 

Hirobriz Breezhaler inhaler provided with each new prescription should be used. 

 

Patients should be instructed on how to administer the product correctly. Patients who do not 

experience improvement in breathing should be asked if they are swallowing the medicine rather than 

inhaling it. 

 

For instructions on use of the medicinal product before administration, see section 6.6. 

 

4.3 Contraindications 
 

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

 

4.4 Special warnings and precautions for use 
 

Asthma 

 

Hirobriz Breezhaler is a long-acting beta2-adrenergic agonist, which is only indicated for COPD and 

should not be used in asthma due to the absence of long-term outcome data in asthma. 

 

Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, 

including asthma-related deaths, when used for the treatment of asthma. 

 

Hypersensitivity 

 

Immediate hypersensitivity reactions have been reported after administration of Hirobriz Breezhaler. If 

signs suggesting allergic reactions (in particular, difficulties in breathing or swallowing, swelling of 

tongue, lips and face, urticaria, skin rash) occur, Hirobriz Breezhaler should be discontinued 

immediately and alternative therapy instituted. 

 

Paradoxical bronchospasm 

 

As with other inhalation therapy, administration of Hirobriz Breezhaler may result in paradoxical 

bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs Hirobriz Breezhaler 

should be discontinued immediately and alternative therapy substituted. 

 

Deterioration of disease 

 

Hirobriz Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue 

therapy. In the event of deterioration of COPD during treatment with Hirobriz Breezhaler, a re-

evaluation of the patient and of the COPD treatment regimen should be undertaken. An increase in the 

daily dose of Hirobriz Breezhaler beyond the maximum dose of 300 microgram is not appropriate. 

 



19 

Systemic effects 

 

Although no clinically relevant effect on the cardiovascular system is usually seen after the 

administration of Hirobriz Breezhaler at the recommended doses, as with other beta2-adrenergic 

agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary 

artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with 

convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-

adrenergic agonists. 

 

Cardiovascular effects 

 

Like other beta2-adrenergic agonists, indacaterol may produce a clinically significant cardiovascular 

effect in some patients as measured by increases in pulse rate, blood pressure, and/or symptoms. In 

case such effects occur, treatment may need to be discontinued. In addition, beta-adrenergic agonists 

have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, 

prolongation of QT interval and ST segment depression, although the clinical significance of these 

observations is unknown. Therefore, long-acting beta2-adrenergic agonists such as Hirobriz Breezhaler 

should be used with caution in patients with known or suspected prolongation of the QT interval or 

treated with medicinal products affecting the QT interval. 

 

Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical 

studies of Hirobriz Breezhaler at recommended therapeutic doses (see section 5.1). 

 

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. In patients with severe COPD, hypokalaemia may be 

potentiated by hypoxia and concomitant treatment (see section 4.5), which may increase the 

susceptibility to cardiac arrhythmias. 

 

Hyperglycaemia 

 

Inhalation of high doses of beta2-adrenergic agonists may produce increases in plasma glucose. Upon 

initiation of treatment with Hirobriz Breezhaler plasma glucose should be monitored more closely in 

diabetic patients. 

 

During clinical studies, clinically notable changes in blood glucose were generally more frequent by 

1-2% on Hirobriz Breezhaler at the recommended doses than on placebo. Hirobriz Breezhaler has not 

been investigated in patients with not well controlled diabetes mellitus. 

 

Excipients 

 

The capsules contain 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 
 

Sympathomimetic medicinal products 

 

Concomitant administration of other sympathomimetic medicinal products (alone or as part of 

combination therapy) may potentiate adverse reactions to Hirobriz Breezhaler. 

 

Hirobriz Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists 

or medicinal products containing long-acting beta2-adrenergic agonists. 

 



20 

Hypokalaemic treatment 

 

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

sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, 

therefore caution is required (see section 4.4). 

 

Beta-adrenergic blockers 

 

Beta-adrenergic blockers and beta2-adrenergic agonists may weaken or antagonise the effect of each 

other when administered concurrently. Therefore indacaterol should not be given together with beta-

adrenergic blockers (including eye drops) unless there are compelling reasons for their use. Where 

required, cardioselective beta-adrenergic blockers should be preferred, although they should be 

administered with caution. 

 

Metabolic and transporter based interactions 

 

Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-glycoprotein (P-gp) raises 

the systemic exposure of indacaterol by up to two-fold. The magnitude of exposure increases due to 

interactions does not raise any safety concerns given the safety experience of treatment with Hirobriz 

Breezhaler in clinical studies of up to one year at doses up to twice the maximum recommended 

therapeutic dose. 

 

Indacaterol has not been shown to cause interactions with medicinal products administered 

concomitantly. In vitro investigations have indicated that indacaterol has negligible potential to cause 

metabolic interactions with medicinal products at the systemic exposure levels achieved in clinical 

practice. 

 

4.6 Fertility, pregnancy and lactation 
 

Pregnancy 

 

There are no data from the use of indacaterol in pregnant women available. Animal studies do not 

indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant 

exposures (see section 5.3). Like other beta2-adrenergic agonists, indacaterol may inhibit labour due to 

a relaxant effect on uterine smooth muscle. Hirobriz Breezhaler should only be used during pregnancy 

if the expected benefits outweigh the potential risks. 

 

Breast-feeding 

 

It is not known whether indacaterol/metabolites are excreted in human milk. Available 

pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk 

(see section 5.3). A risk to the breast-fed child cannot be excluded. A decision must be made whether 

to discontinue breast-feeding or to discontinue/abstain from Hirobriz Breezhaler therapy, taking into 

account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 

 

Fertility 

 

A decreased pregnancy rate has been observed in rats. Nevertheless, it is considered unlikely that 

indacaterol will affect reproductive or fertility performance in humans following inhalation of the 

maximum recommended dose (see section 5.3). 

 

4.7 Effects on ability to drive and use machines 
 

Hirobriz Breezhaler has no or negligible influence on the ability to drive and use machines. 

 



21 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most common adverse reactions at the recommended doses were nasopharyngitis (14.3%), upper 

respiratory tract infection (14.2%), cough (8.2%), headache (3.7%) and muscle spasms (3.5%). These 

were in the vast majority mild or moderate and became less frequent if treatment was continued. 

 

At the recommended doses, the adverse reaction profile of Hirobriz Breezhaler in patients with COPD 

shows clinically insignificant systemic effects of beta2-adrenergic stimulation. Mean heart rate 

changes were less than one beat per minute, and tachycardia was infrequent and reported at a similar 

rate as under placebo treatment. Relevant prolongations of QTcF were not detectable in comparison to 

placebo. The frequency of notable QTcF intervals [i.e. >450 ms (males) and >470 ms (females)] and 

reports of hypokalaemia were similar to placebo. The mean of the maximum changes in blood glucose 

were similar between Hirobriz Breezhaler and placebo. 

 

Tabulated summary of adverse reactions 

 

The Hirobriz Breezhaler Phase III clinical development programme involved patients with a clinical 

diagnosis of moderate to severe COPD. 4,764 patients were exposed to indacaterol up to one year at 

doses up to twice the maximum recommended dose. Of these patients, 2,611 were on treatment with 

150 microgram once daily and 1,157 on treatment with 300 microgram once daily. Approximately 

41% of patients had severe COPD. The mean age of patients was 64 years, with 48% of patients aged 

65 years or older, and the majority (80%) was Caucasian. 

 

Adverse reactions in Table 1 are listed according to MedDRA system organ class in the COPD safety 

database. Within each system organ class, adverse reactions are ranked by frequency in descending 

order according to 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), not known 

(cannot be estimated from the available data). 

 

Table 1 Adverse reactions 

 

Adverse reactions Frequency category 

Infections and infestations 

Nasopharyngitis Very common 

Upper respiratory tract infection Very common 

Sinusitis Common 

Immune system disorders  

Hypersensitivity1 Uncommon 

Metabolism and nutrition disorders 

Diabetes mellitus and hyperglycaemia Common 

Nervous system disorders 

Headache Common 

Dizziness Common 

Paraesthesia Uncommon 

Cardiac disorders 

Ischaemic heart disease Common 

Palpitations Common 

Atrial fibrillation Uncommon 

Tachycardia Uncommon 

  



22 

Respiratory, thoracic and mediastinal disorders 

Cough Common 

Oropharyngeal pain including throat irritation Common 

Rhinorrhoea Common 

Paradoxical bronchospasm Uncommon 

Skin and subcutaneous tissue disorders 

Pruritus/rash Common 

Musculoskeletal and connective tissue disorders 

Muscle spasm Common 

Musculoskeletal pain Common 

Myalgia Uncommon 

General disorders and administration site conditions 

Chest pain Common 

Peripheral oedema Common 
1 Reports of hypersensitivity have been received from post-approval marketing experience in 

association with the use of Hirobriz Breezhaler. These were reported voluntarily from a population of 

uncertain size, and it is therefore not always possible to reliably estimate the frequency or establish a 

causal relationship to exposure to the medicinal product. Therefore the frequency was calculated from 

clinical trial experience. 

 

At 600 microgram once-daily, the safety profile of Hirobriz Breezhaler was overall similar to that of 

recommended doses. An additional adverse reaction was tremor (common). 

 

Description of selected adverse reactions 

 

In Phase III clinical studies, healthcare providers observed during clinic visits that on average 17-20% 

of patients experienced a sporadic cough that occurred usually within 15 seconds following inhalation 

and typically lasted for 5 seconds (about 10 seconds in current smokers). It was observed with a higher 

frequency in female than in male patients and in current smokers than in ex-smokers. This cough 

experienced post inhalation did not lead to any patient discontinuing from the studies at the 

recommended doses (cough is a symptom in COPD and only 8.2% of patients reported cough as an 

adverse event). There is no evidence that cough experienced post inhalation is associated with 

bronchospasm, exacerbations, deteriorations of disease or loss of efficacy. 

 

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 
 

In COPD patients, single doses of 10 times the maximum recommended therapeutic dose were 

associated with a moderate increase in pulse rate, systolic blood pressure and QTc interval. 

 

An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic 

stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular 

arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia. 

 

Supportive and symptomatic treatment is indicated. In serious cases, patients should be hospitalised. 

Use of cardioselective beta blockers may be considered, but only under the supervision of a physician 

and with extreme caution since the use of beta-adrenergic blockers may provoke bronchospasm. 

 

 

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


23 

5. PHARMACOLOGICAL PROPERTIES 
 

5.1 Pharmacodynamic properties 
 

Pharmacotherapeutic group: Drugs for obstructive airways diseases, selective beta-2-adrenoreceptor 

agonists, ATC code: R03AC18 

 

Mechanism of action 

 

The pharmacological effects of beta2-adrenoceptor agonists are at least in part attributable to 

stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine 

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

cyclic AMP levels cause relaxation of bronchial smooth muscle. In vitro studies have shown that 

indacaterol, a long-acting beta2-adrenergic agonist, has more than 24-fold greater agonist activity at 

beta2-receptors compared to beta1-receptors and 20-fold greater agonist activity compared to beta3-

receptors. 

 

When inhaled, indacaterol acts locally in the lung as a bronchodilator. Indacaterol is a partial agonist 

at the human beta2-adrenergic receptor with nanomolar potency. In isolated human bronchus, 

indacaterol has a rapid onset of action and a long duration of action. 

 

Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and 

beta1-receptors are the predominant receptors in the human heart, there are also beta2-adrenergic 

receptors in the human heart comprising 10-50% of the total adrenergic receptors. The precise 

function of beta2-adrenergic receptors in the heart is not known, but their presence raises the 

possibility that even highly selective beta2-adrenergic agonists may have cardiac effects. 

 

Pharmacodynamic effects 

 

Hirobriz Breezhaler, administered once a day at doses of 150 and 300 microgram consistently 

provided clinically significant improvements in lung function (as measured by the forced expiratory 

volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and 

efficacy studies. There was a rapid onset of action within 5 minutes after inhalation, with an increase 

in FEV1 relative to baseline of 110-160 ml, comparable to the effect of the fast-acting beta2-agonist 

salbutamol 200 microgram and statistically significantly faster compared to salmeterol/fluticasone 

50/500 microgram. Mean peak improvements in FEV1 relative to baseline were 250-330 ml at steady 

state. 

 

The bronchodilator effect did not depend on the time of dosing, morning or evening. 

 

Hirobriz Breezhaler was shown to reduce lung hyperinflation, resulting in increased inspiratory 

capacity during exercise and at rest, compared to placebo. 

 

Effects on cardiac electrophysiology 

A double-blind, placebo- and active (moxifloxacin)-controlled study for 2 weeks in 404 healthy 

volunteers demonstrated maximum mean (90% confidence intervals) prolongations of the QTcF 

interval (in milliseconds) of 2.66 (0.55, 4.77) 2.98 (1.02, 4.93) and 3.34 (0.86, 5.82) following 

multiple doses of 150 microgram, 300 microgram and 600 microgram, respectively. Therefore, this 

shows no concern for a pro-arrhythmic potential related to QT-interval prolongations at recommended 

therapeutic doses or at twice the maximum recommended dose. There was no evidence of a 

concentration-delta QTc relationship in the range of doses evaluated. 

 

As demonstrated in 605 patients with COPD in a 26-week, double-blind, placebo-controlled Phase III 

study, there was no clinically relevant difference in the development of arrhythmic events monitored 

over 24 hours, at baseline and up to 3 times during the 26-week treatment period, between patients 

receiving recommended doses of Hirobriz Breezhaler treatment and those patients who received 

placebo or treatment with tiotropium. 



24 

 

Clinical efficacy and safety 

 

The clinical development programme included one 12-week, two six-month (one of which was 

extended to one year to evaluate safety and tolerability) and one one-year randomised controlled 

studies in patients with a clinical diagnosis of COPD. These studies included measures of lung 

function and of health outcomes such as dyspnoea, exacerbations and health-related quality of life. 

 

Lung function 

Hirobriz Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed 

clinically meaningful improvements in lung function. At the 12-week primary endpoint (24-hour 

trough FEV1), the 150 microgram dose resulted in a 130-180 ml increase compared to placebo 

(p<0.001) and a 60 ml increase compared to salmeterol 50 microgram twice a day (p<0.001). The 

300 microgram dose resulted in a 170-180 ml increase compared to placebo (p<0.001) and a 100 ml 

increase compared to formoterol 12 microgram twice a day (p<0.001). Both doses resulted in an 

increase of 40-50 ml over open-label tiotropium 18 microgram once a day (150 microgram, p=0.004; 

300 microgram, p=0.01). The 24-hour bronchodilator effect of Hirobriz Breezhaler was maintained 

from the first dose throughout a one-year treatment period with no evidence of loss in efficacy 

(tachyphylaxis). 

 

Symptomatic benefits 

Both doses demonstrated statistically significant improvements in symptom relief over placebo for 

dyspnoea and health status (as evaluated by Transitional Dyspnoea Index [TDI] and St. George’s 

Respiratory Questionnaire [SGRQ], respectively). The magnitude of response was generally greater 

than seen with active comparators (Table 2). In addition, patients treated with Hirobriz Breezhaler 

required significantly less rescue medication, had more days when no rescue medication was needed 

compared to placebo and had a significantly improved percentage of days with no daytime symptoms. 

 

Pooled efficacy analysis over 6 months’ treatment demonstrated that the rate of COPD exacerbations 

was statistically significantly lower than the placebo rate. Treatment comparison compared to placebo 

showed a ratio of rates of 0.68 (95% CI [ 0.47, 0.98]; p-value 0.036) and 0.74 (95% CI [0.56, 0.96]; p-

value 0.026) for 150 microgram and 300 microgram, respectively. 

 

Limited treatment experience is available in individuals of African descent. 

  



25 

 

Table 2 Symptom relief at 6 months treatment duration 

 

Treatment 

Dose (microgram) 

Indacaterol 

150 

once a day 

Indacaterol 

300 

once a day 

Tiotropium 

18 

once a day 

Salmeterol 

50 

twice a day 

Formoterol 

12 

twice a day 

Placebo 

Percentage of 

patients who 

achieved MCID 

TDI† 

57 a 

62 b 

 

 

71 b 

59 c 

 

57 b 

 

54 a 

 

 

 

 

54 c 

45 a 

47 b 

41 c 

Percentage of 

patients who 

achieved MCID 

SGRQ† 

53 a 

58 b 

 

 

53 b 

55 c 

 

47 b 

 

49 a 

 

 

 

 

51 c 

38 a 

46 b 

40 c 

Reduction in 

puffs/day of 

rescue medication 

use vs. baseline 

1.3 a 

1.5 b 

 

 

1.6 b 

 

 

1.0 b 

 

1.2 a 

 

 

n/e 

0.3 a 

0.4 b 

 

Percentage of  

days with no 

rescue medication 

use 

60 a 

57 b 

 

 

58 b 

 

 

46 b 

 

55 a 

 

 

n/e 

42 a 

42 b 

 

Study design with a: indacaterol 150 microgram, salmeterol and placebo; b: indacaterol 150 and 

300 microgram, tiotropium and placebo; c: indacaterol 300 microgram, formoterol and placebo 
† MCID = minimal clinically important difference (≥1 point change in TDI, ≥4 point change in SGRQ) 

n/e= not evaluated at six months 

 

Paediatric population 

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

Hirobriz Breezhaler in all subsets of the paediatric population in chronic obstructive pulmonary 

disease (COPD) (see section 4.2 for information on paediatric use). 

 

5.2 Pharmacokinetic properties 
 

Indacaterol is a chiral molecule with R-configuration. 

 

Pharmacokinetic data were obtained from a number of clinical studies, from healthy volunteers and 

COPD patients. 

 

Absorption 

 

The median time to reach peak serum concentrations of indacaterol was approximately 15 min after 

single or repeated inhaled doses. Systemic exposure to indacaterol increased with increasing dose 

(150 microgram to 600 microgram) in a dose proportional manner. Absolute bioavailability of 

indacaterol after an inhaled dose was on average 43% to 45%. Systemic exposure results from a 

composite of pulmonary and gastrointestinal absorption; about 75% of systemic exposure was from 

pulmonary absorption and about 25% from gastrointestinal absorption. 

 

Indacaterol serum concentrations increased with repeated once-daily administration. Steady state was 

achieved within 12 to 14 days. The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h 

dosing interval on Day 14 compared to Day 1, was in the range of 2.9 to 3.5 for once-daily inhaled 

doses between 150 microgram and 600 microgram. 

 

Distribution 

 

After intravenous infusion the volume of distribution of indacaterol during the terminal elimination 

phase was 2557 litres indicating an extensive distribution. The in vitro human serum and plasma 

protein binding was 94.1-95.3% and 95.1-96.2%, respectively. 

 



26 

Biotransformation 

 

After oral administration of radiolabelled indacaterol in a human ADME (absorption, distribution, 

metabolism, excretion) study, unchanged indacaterol was the main component in serum, accounting 

for about one third of total drug-related AUC over 24 hours. A hydroxylated derivative was the most 

prominent metabolite in serum. Phenolic O-glucuronides of indacaterol and hydroxylated indacaterol 

were further prominent metabolites. A diastereomer of the hydroxylated derivative, a N-glucuronide of 

indacaterol, and C- and N-dealkylated products were further metabolites identified. 

 

In vitro investigations indicated that UGT1A1 is the only UGT isoform that metabolised indacaterol to 

the phenolic O-glucuronide. The oxidative metabolites were found in incubations with recombinant 

CYP1A1, CYP2D6, and CYP3A4. CYP3A4 is concluded to be the predominant isoenzyme 

responsible for hydroxylation of indacaterol. In vitro investigations further indicated that indacaterol is 

a low affinity substrate for the efflux pump P-gp. 

 

Elimination 

 

In clinical studies which included urine collection, the amount of indacaterol excreted unchanged via 

urine was generally lower than 2% of the dose. Renal clearance of indacaterol was, on average, 

between 0.46 and 1.20 litres/hour. When compared with the serum clearance of indacaterol of 

23.3 litres/hour, it is evident that renal clearance plays a minor role (about 2 to 5% of systemic 

clearance) in the elimination of systemically available indacaterol. 

 

In a human ADME study where indacaterol was given orally, the faecal route of excretion was 

dominant over the urinary route. Indacaterol was excreted into human faeces primarily as unchanged 

parent substance (54% of the dose) and, to a lesser extent, hydroxylated indacaterol metabolites (23% 

of the dose). Mass balance was complete with ≥90% of the dose recovered in the excreta. 

 

Indacaterol serum concentrations declined in a multi-phasic manner with an average terminal half-life 

ranging from 45.5 to 126 hours. The effective half-life, calculated from the accumulation of 

indacaterol after repeated dosing ranged from 40 to 52 hours which is consistent with the observed 

time-to-steady state of approximately 12-14 days. 

 

Special populations 

 

A population pharmacokinetic analysis showed that there is no clinically relevant effect of age (adults 

up to 88 years), sex, weight (32-168 kg) or race on the pharmacokinetics of indacaterol. It did not 

suggest any difference between ethnic subgroups in this population. 

 

Patients with mild and moderate hepatic impairment showed no relevant changes in Cmax or AUC of 

indacaterol, nor did protein binding differ between mild and moderate hepatic impaired subjects and 

their healthy controls. Studies in subjects with severe hepatic impairment were not performed. 

 

Due to the very low contribution of the urinary pathway to total body elimination, a study in renally 

impaired subjects was not performed. 

 

5.3 Preclinical safety data 
 

Effects on the cardiovascular system attributable to the beta2-agonistic properties of indacaterol 

included tachycardia, arrhythmias and myocardial lesions in dogs. Mild irritancy of the nasal cavity 

and larynx were seen in rodents. All these findings occurred at exposures sufficiently in excess of 

those anticipated in humans. 

 

Although indacaterol did not affect general reproductive performance in a rat fertility study, a decrease 

in the number of pregnant F1 offspring was observed in the peri- and post-developmental rat study at 

an exposure 14-fold higher than in humans treated with Hirobriz Breezhaler. Indacaterol was not 

embryotoxic or teratogenic in rats or rabbits. 



27 

 

Genotoxicity studies did not reveal any mutagenic or clastogenic potential. Carcinogenicity was 

assessed in a two-year rat study and a six-month transgenic mouse study. Increased incidences of 

benign ovarian leiomyoma and focal hyperplasia of ovarian smooth muscle in rats were consistent 

with similar findings reported for other beta2-adrenergic agonists. No evidence of carcinogenicity was 

seen in mice. Systemic exposures (AUC) in rats and mice at the no-observed adverse effect levels in 

these studies were at least 7- and 49-fold higher, respectively, than in humans treated with Hirobriz 

Breezhaler once a day at a dose of 300 microgram. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 
 

Capsule content 

 

Lactose monohydrate 

 

Capsule shell 

 

Gelatin 

 

6.2 Incompatibilities 
 

Not applicable. 

 

6.3 Shelf life 
 

30 months. 

 

6.4 Special precautions for storage 
 

Do not store above 30°C. 

 

Store in the blister in order to protect from moisture and only remove immediately before use. 

 

6.5 Nature and contents of container 

 

Hirobriz Breezhaler is a single-dose inhalation device. Inhaler body and cap are made from 

acrylonitrile butadiene styrene, push buttons are made from methyl methacrylate acrylonitrile 

butadiene styrene. Needles and springs are made from stainless steel. 

 

PA/Alu/PVC - Alu blister containing 10 hard capsules. 

 

Carton containing 10 capsules and one Hirobriz Breezhaler inhaler. 

Carton containing 30 capsules and one Hirobriz Breezhaler inhaler. 

 

Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler). 

Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler). 

Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler). 

 

Not all pack sizes may be marketed. 

 

  



28 

6.6 Special precautions for disposal and other handling 
 

Each inhaler should be disposed of after all capsules have been used. 

 

Instructions for handling and use 

 

Please read the full Instructions for Use before using the Hirobriz Breezhaler. 

 

 

 
 

 

 

Insert Pierce and release Inhale deeply Check capsule is empty 

 
  

 

 
   

 
   

 

 

 

 

 

 

 

 

 

 

 
Step 1a: 

Pull off cap 

Step 2a: 

Pierce capsule once 

Hold the inhaler upright. 

Pierce capsule by firmly 

pressing both side 

buttons at the same time. 

Step 3a: 

Breathe out fully 

Do not blow into the 

inhaler. 

Check capsule is empty 

Open the inhaler to see if 

any powder is left in the 

capsule. 

 

You should hear a noise 

as the capsule is pierced. 

Only pierce the capsule 

once. 

 

If there is powder left in 

the capsule: 

Close the inhaler. 

Repeat steps 3a to 3c. 

Step 1b: 

Open inhaler 

 
Step 2b: 

Release side buttons 

Step 3b: 

Inhale medicine deeply 

Hold the inhaler as 

shown in the picture. 

Place the mouthpiece in 

your mouth and close 

your lips firmly around 

it. 

Do not press the side 

buttons. 

 
Powder Empty 

remaining 

1 2 3 
Chec

k 



29 

 

 
 

 Breathe in quickly and as 

deeply as you can. 

During inhalation you 

will hear a whirring 

noise. 

You may taste the 

medicine as you inhale. 

 

Step 1c: 

Remove capsule 

Remove one capsule from 

the blister. 

Do not swallow the 

capsule. 

 

 
Step 3c: 

Hold breath 

Hold your breath for up 

to 5 seconds. 

Remove empty capsule 

Put the empty capsule in 

your household waste. 

 

Close the inhaler and 

replace the cap. 

 
Step 1d: 

Insert capsule 

Never place a capsule 

directly into the 

mouthpiece. 

 

  Important Information 

 Hirobriz Breezhaler 
capsules must always be 

stored in the blister card 

and only removed 

immediately before use. 

 Do not swallow the 
capsule. 

 Do not use the Hirobriz 
Breezhaler capsules 

with any other inhaler. 

 Do not use the Hirobriz 
Breezhaler inhaler to 

take any other capsule 

medicine. 

 Never place the capsule 
into your mouth or the 

mouthpiece of the 

inhaler. 

 Do not press the side 
buttons more than once. 

 Do not blow into the 
mouthpiece. 

 Do not press the side 
buttons while inhaling 

through the mouthpiece. 

 Do not handle capsules 
with wet hands. 

 Never wash your inhaler 
with water. 

 
Step 1e: 

Close inhaler 

 



30 

Your Hirobriz Breezhaler Inhaler pack contains: 

 One Hirobriz Breezhaler inhaler 

 One or more blister cards, each containing either 
6 or 10 Hirobriz Breezhaler capsules to be used 

in the inhaler 

 

 
 

 

 

Frequently Asked 

Questions 

 

Why didn’t the inhaler 

make a noise when I 

inhaled? 

The capsule may be stuck 

in the capsule chamber. If 

this happens, carefully 

loosen the capsule by 

tapping the base of the 

inhaler. Inhale the 

medicine again by 

repeating steps 3a to 3c. 

 

What should I do if there 

is powder left inside the 

capsule? 

You have not received 

enough of your medicine. 

Close the inhaler and 

repeat steps 3a to 3c. 

 

I coughed after inhaling 

– does this matter? 

This may happen. As long 

as the capsule is empty 

you have received enough 

of your medicine. 

 

I felt small pieces of the 

capsule on my tongue – 

does this matter? 

This can happen. It is not 

harmful. The chances of 

the capsule breaking into 

small pieces will be 

increased if the capsule is 

pierced more than once. 

Cleaning the inhaler 

Wipe the mouthpiece 

inside and outside with a 

clean, dry, lint-free cloth to 

remove any powder 

residue. Keep the inhaler 

dry. Never wash your 

inhaler with water. 

Disposing of the inhaler 

after use 

Each inhaler should be 

disposed of after all 

capsules have been used. 
Ask your pharmacist how 

to dispose of medicines 

and inhalers that are no 

longer required. 

 

 

 

7. MARKETING AUTHORISATION HOLDER 
 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/09/594/006-010 

 

  

Cap 

Capsule 

chamber 

Base 

Mouthpiece 

Screen 

Blister 

Side 

buttons 

Inhaler Inhaler base Blister Card 



31 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 

Date of first authorisation: 30 November 2009 

Date of latest renewal: 18 September 2014 

 

 

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/


32 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 



33 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

Name and address of the manufacturer responsible for batch release 

 

Novartis Farmacéutica SA 

Ronda de Santa Maria 158 

08210 Barberà del Vallès, Barcelona 

Spain 

 

Novartis Pharma GmbH 

Roonstraße 25 

D-90429 Nuremberg 

Germany 

 

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. 

 

  



34 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

  



35 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 
  



36 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules 

indacaterol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose (see package leaflet for further information) and gelatin. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Inhalation powder, hard capsules 

 

10 capsules + 1 inhaler 

30 capsules + 1 inhaler 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Do not swallow capsules. 

For use only with the inhaler provided in the pack. 

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 

 

  



37 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

Store in the original blister in order to protect from moisture and do not remove until immediately 

before use. 

 

 

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 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/09/594/001 10 capsules + 1 inhaler 

EU/1/09/594/002 30 capsules + 1 inhaler 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Hirobriz Breezhaler 150 

 

  



38 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



39 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules 

indacaterol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose (see package leaflet for further information) and gelatin. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Inhalation powder, hard capsules 

 

Multipack: 60 (2 packs of 30 capsules and 1 inhaler). 

Multipack: 90 (3 packs of 30 capsules and 1 inhaler). 

Multipack: 300 (30 packs of 10 capsules and 1 inhaler). 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Do not swallow capsules. 

For use only with the inhaler provided in the pack. 

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 

 

  



40 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

Store in the original blister in order to protect from moisture and do not remove until immediately 

before use. 

 

 

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 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/09/594/003 60 capsules + 2 inhalers 

EU/1/09/594/004 90 capsules + 3 inhalers 

EU/1/09/594/005 300 capsules + 30 inhalers 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Hirobriz Breezhaler 150 

 

  



41 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



42 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules 

indacaterol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose (see package leaflet for further information) and gelatin. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Inhalation powder, hard capsules 

 

10 capsules and 1 inhaler. Component of a multipack. Not to be sold separately. 

30 capsules and 1 inhaler. Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Do not swallow capsules. 

For use only with the inhaler provided in the pack. 

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 

  



43 

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

Store in the original blister in order to protect from moisture and do not remove until immediately 

before use. 

 

 

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 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/09/594/003 60 capsules + 2 inhalers 

EU/1/09/594/004 90 capsules + 3 inhalers 

EU/1/09/594/005 300 capsules + 30 inhalers 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Hirobriz Breezhaler 150 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

  



44 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INNER LID OF OUTER CARTON OF UNIT PACK AND OF INTERMEDIATE CARTON OF 

MULTIPACK 

 

 

1. OTHER 

 

1  Insert 

2  Pierce and release 

3  Inhale deeply 

Check  Check capsule is empty 

 

Read the leaflet before use. 

  



45 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules 

indacaterol 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

Inhalation use only. Do not swallow. 

  



46 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF UNIT PACK 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules 

indacaterol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose (see package leaflet for further information) and gelatin. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Inhalation powder, hard capsules 

 

10 capsules + 1 inhaler 

30 capsules + 1 inhaler 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Do not swallow capsules. 

For use only with the inhaler provided in the pack. 

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 

 

  



47 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

Store in the original blister in order to protect from moisture and do not remove until immediately 

before use. 

 

 

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 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/09/594/006 10 capsules + 1 inhaler 

EU/1/09/594/007 30 capsules + 1 inhaler 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Hirobriz Breezhaler 300 

 

  



48 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



49 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules 

indacaterol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose (see package leaflet for further information) and gelatin. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Inhalation powder, hard capsules 

 

Multipack: 60 (2 packs of 30 capsules and 1 inhaler). 

Multipack: 90 (3 packs of 30 capsules and 1 inhaler). 

Multipack: 300 (30 packs of 10 capsules and 1 inhaler). 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Do not swallow capsules. 

For use only with the inhaler provided in the pack. 

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 

 

  



50 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

Store in the original blister in order to protect from moisture and do not remove until immediately 

before use. 

 

 

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 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/09/594/008 60 capsules + 2 inhalers 

EU/1/09/594/009 90 capsules + 3 inhalers 

EU/1/09/594/010 300 capsules + 30 inhalers 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Hirobriz Breezhaler 300 

 

  



51 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC: 

SN: 

NN: 

  



52 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules 

indacaterol 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol. 

 

 

3. LIST OF EXCIPIENTS 

 

Contains lactose (see package leaflet for further information) and gelatin. 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Inhalation powder, hard capsules 

 

10 capsules and 1 inhaler. Component of a multipack. Not to be sold separately. 

30 capsules and 1 inhaler. Component of a multipack. Not to be sold separately. 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Do not swallow capsules. 

For use only with the inhaler provided in the pack. 

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 

 

  



53 

 

9. SPECIAL STORAGE CONDITIONS 

 

Do not store above 30°C. 

Store in the original blister in order to protect from moisture and do not remove until immediately 

before use. 

 

 

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 

 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/09/594/008 60 capsules + 2 inhalers 

EU/1/09/594/009 90 capsules + 3 inhalers 

EU/1/09/594/010 300 capsules + 30 inhalers 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

Medicinal product subject to medical prescription. 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Hirobriz Breezhaler 300 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

  



54 

 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

 

INNER LID OF OUTER CARTON OF UNIT PACK AND OF INTERMEDIATE CARTON OF 

MULTIPACK 

 

 

1. OTHER 

 

1  Insert 

2  Pierce and release 

3  Inhale deeply 

Check  Check capsule is empty 

 

Read the leaflet before use. 

  



55 

 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

 

BLISTERS 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules 

indacaterol 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Novartis Europharm Limited 

 

 

3. EXPIRY DATE 

 

EXP 

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

Inhalation use only. Do not swallow. 

  



56 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 
 



57 

Package leaflet: Information for the user 

 

Hirobriz Breezhaler 150 microgram inhalation powder, hard capsules 

Hirobriz Breezhaler 300 microgram inhalation powder, hard capsules 

indacaterol 

 

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 further questions, ask your doctor or pharmacist. 
- 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 or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 

 

What is in this leaflet: 

1. What Hirobriz Breezhaler is and what it is used for 

2. What you need to know before you use Hirobriz Breezhaler 

3. How to use Hirobriz Breezhaler 

4. Possible side effects 

5. How to store Hirobriz Breezhaler 

6. Contents of the pack and other information 

 

1. What Hirobriz Breezhaler is and what it is used for 

 

What Hirobriz Breezhaler is 

Hirobriz Breezhaler contains the active substance indacaterol which belongs to a group of medicines 

called bronchodilators. When you inhale it, it relaxes the muscles in the walls of the small air passages 

in the lungs. This helps open up the airways, making it easier to get air in and out. 

 

What Hirobriz Breezhaler is used for 

Hirobriz Breezhaler is used to make breathing easier for adult patients who have breathing difficulties 

due to a lung disease called chronic obstructive pulmonary disease (COPD). In COPD the muscles 

around the airways tighten. This makes breathing difficult. This medicine relaxes these muscles in the 

lungs, making it easier for air to get in and out of the lungs. 
 

2. What you need to know before you use Hirobriz Breezhaler 

 

Do not use Hirobriz Breezhaler 

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

 

Warnings and precautions 

Talk to your doctor or pharmacist before using Hirobriz Breezhaler 

 if you have asthma (in this case you should not use Hirobriz Breezhaler). 

 if you have heart problems. 

 if you have epilepsy. 

 if you have thyroid gland problems (thyrotoxicosis). 

 if you have diabetes. 
 

  



58 

During treatment with Hirobriz Breezhaler, 

 Stop using the medicine and tell your doctor 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. 

 Tell your doctor immediately if your COPD symptoms (breathlessness, wheezing, cough) do 
not improve or get worse. 

 

Children and adolescents 

Hirobriz Breezhaler should not be given to children or adolescents below the age of 18 years. 

 

Other medicines and Hirobriz Breezhaler 

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

medicines. 

In particular, please tell your doctor if you are using: 

 medicines for breathing problems that are similar to Hirobriz Breezhaler (i.e. medicines such as 
salmeterol and formoterol). You may be more likely to get side effects. 

 medicines called beta blockers that are used for high blood pressure or other heart problems 
(such as propranolol), or for the eye problem called glaucoma (such as timolol). 

 medicines that lower the amount of potassium in your blood. These include: 
o steroids (e.g. prednisolone), 
o diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide, 
o medicines for breathing problems such as theophylline. 

 

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 using this medicine.  

 

You should not use Hirobriz Breezhaler unless your doctor tells you so. 

 

Ask your doctor or pharmacist for advice before taking any medicine. 

 

Driving and using machines 

It is unlikely that Hirobriz Breezhaler will affect your ability to drive and use machines. 

 

Hirobriz Breezhaler contains lactose 

This medicine contains lactose (milk sugar). 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 Hirobriz Breezhaler 
 

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if 

you are not sure. 

 

How much Hirobriz Breezhaler to use 

 The usual dose is to inhale the content of one capsule each day. Your doctor may tell you to use 
the 150 microgram capsule or the 300 microgram capsule depending on your condition and on 

how you respond to the treatment. Do not use more than your doctor tells you to use. 

 Use your inhaler at the same time each day, the effects last for 24 hours. 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. 

 

  



59 

How to use Hirobriz Breezhaler 

 In this pack, you will find an inhaler and capsules (in blister) that contain the medicine as 
inhalation powder. The Hirobriz Breezhaler inhaler enables you to inhale the medicine 

contained in a capsule. 

 Only use the capsules with the inhaler provided in this pack (Hirobriz Breezhaler inhaler). The 
capsules should remain in the blister until you need to use them. 

 When you start a new pack, use the new Hirobriz Breezhaler inhaler that is supplied in the pack. 

 Dispose of each inhaler after 30 days of use. 

 Do not swallow the capsules. 

 Please read the instructions at the end of this leaflet for more information about how to 
use the inhaler. 

 

If you use more Hirobriz Breezhaler than you should 

If you have inhaled too much Hirobriz Breezhaler or if someone else uses your capsules, tell your 

doctor immediately or go to the nearest emergency unit. Show the pack of Hirobriz Breezhaler. 

Medical attention may be needed. You may notice that your heart is beating faster than usual, or you 

may have a headache, feel drowsy, feel nauseous or have to vomit. 

 

If you forget to use Hirobriz Breezhaler 

If you forget to inhale a dose, inhale just one dose at the usual time the next day. Do not inhale a 

double dose to make up for a forgotten dose. 

 

How long to continue your treatment with Hirobriz Breezhaler 

 Keep using your treatment with Hirobriz Breezhaler for as long as your doctor tells you. 

 COPD is a long-term disease and you should use Hirobriz Breezhaler every day and not only 
when you have breathing problems or other symptoms of COPD. 

If you have questions about how long to continue your treatment with Hirobriz Breezhaler, talk to 

your doctor or pharmacist. 

 

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

 

 

4. Possible side effects 

 

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

 

Some side effects may be serious. Tell your doctor immediately 

 if you get crushing chest pain, (common). 

 if you get high levels of sugar in your blood (diabetes). You will feel tired, very thirsty and 
hungry (without gaining weight) and will pass more urine than usual (common). 

 if you get irregular heart beat (uncommon). 

 if you get symptoms of an allergic reaction such as rash, itching, hives, difficulty breathing or 
swallowing, dizziness (uncommon). 

 if you have difficulty breathing with wheezing or coughing (uncommon). 
 

 

  



60 

Other side effects may include: 

 

Very common side effects (may affect more than 1 in 10 people) 

 cold-like symptoms. You may get all or most of the following: sore throat, runny nose, blocked 
nose, sneezing, coughing, headache. 

 

Common side effects (may affect up to 1 in 10 people) 

 feeling of pressure or pain in the cheeks and forehead (inflammation of the sinuses) 

 runny nose 

 cough 

 sore throat 

 headache 

 dizziness 

 palpitations 

 muscle spasm 

 swollen hands, ankles and feet (oedema) 

 itching/rash 

 chest pain 

 pain in muscles, bones or joints 
 

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

 fast heart beat 

 tingling or numbness 

 muscle pain 
 

 

Some people occasionally cough soon after inhaling the medicine. Cough is a common symptom in 

COPD. If you experience coughing briefly after inhaling the medicine, do not worry. Check your 

inhaler to see if the capsule is empty and that you have received the full dose. If the capsule is empty, 

there is no need for concern. If the capsule is not empty then inhale again as directed. 

 

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 Hirobriz Breezhaler 
 

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 and blister after “EXP”. 

The expiry date refers to the last day of that month. 

Do not store above 30°C. 

Store in the original package in order to protect from moisture and do not remove until immediately 

before use. 

Do not use this medicine if you notice that the pack is damaged or show signs of tampering. 

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. 

 

 

  

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


61 

6. Contents of the pack and other information 

 

What Hirobriz Breezhaler contains 
- Each Hirobriz Breezhaler 150 microgram capsule contains 150 microgram indacaterol as 

indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin. 

- Each Hirobriz Breezhaler 300 microgram capsule contains 300 microgram indacaterol as 
indacaterol maleate. The other ingredients include lactose and the capsule is made of gelatin. 

 

What Hirobriz Breezhaler looks like and content of the pack 

In this pack, you will find an inhaler, together with capsules in blister. The capsules are transparent 

(uncoloured) and contain a white powder. 

 

 Hirobriz Breezhaler 150 microgram capsules have a black product code “IDL 150” printed 

above a black bar and a black company logo ( ) printed below the black bar. 

 Hirobriz Breezhaler 300 microgram capsules have a blue product code “IDL 300” printed 

above a blue bar and a blue company logo ( ) printed below the blue bar. 

 

The following pack sizes are available: 

Carton containing 10 capsules and 1 inhaler. 

Carton containing 30 capsules and 1 inhaler. 

Multipack comprising 2 packs (each containing 30 capsules and 1 inhaler). 

Multipack comprising 3 packs (each containing 30 capsules and 1 inhaler). 

Multipack comprising 30 packs (each containing 10 capsules and 1 inhaler). 

 

Not all pack sizes or strengths may be available in your country. 

 

Marketing Authorisation Holder 

Novartis Europharm Limited 

Vista Building 

Elm Park, Merrion Road 

Dublin 4 

Ireland 

 

Manufacturer 

Novartis Farmacéutica SA 

Ronda de Santa Maria 158 

08210 Barberà del Vallès, Barcelona 

Spain 

 

Novartis Pharma GmbH 

Roonstraße 25 

D-90429 Nuremberg 

Germany 

  



62 

 

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

Authorisation Holder: 

 

België/Belgique/Belgien 
Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Lietuva 
SIA Novartis Baltics Lietuvos filialas 

Tel: +370 5 269 16 50 

 

България 

Novartis Bulgaria EOOD 

Тел.: +359 2 489 98 28 

 

Luxembourg/Luxemburg 
Novartis Pharma N.V. 

Tél/Tel: +32 2 246 16 11 

 

Česká republika 
Novartis s.r.o. 

Tel: +420 225 775 111 

 

Magyarország 

Novartis Hungária Kft. 

Tel.: +36 1 457 65 00 

Danmark 
Novartis Healthcare A/S 

Tlf: +45 39 16 84 00 

 

Malta 

Novartis Pharma Services Inc. 

Tel: +356 2122 2872 

Deutschland 
Novartis Pharma GmbH 

Tel: +49 911 273 0 

 

Nederland 
Novartis Pharma B.V. 

Tel: +31 88 04 52 111 

Eesti 

SIA Novartis Baltics Eesti filiaal 

Tel: +372 66 30 810 

 

Norge 
Novartis Norge AS 

Tlf: +47 23 05 20 00 

Ελλάδα 
Novartis (Hellas) A.E.B.E. 

Τηλ: +30 210 281 17 12 

 

Österreich 
Novartis Pharma GmbH 

Tel: +43 1 86 6570 

España 

Laboratorios Farmacéuticos ROVI, S.A. 

Tel.: +34 91 375 62 30 

 

Polska 

Novartis Poland Sp. z o.o. 

Tel.: +48 22 375 4888 

France 

Novartis Pharma S.A.S. 

Tél: +33 1 55 47 66 00 

 

Portugal 
Novartis Farma - Produtos Farmacêuticos, S.A. 

Tel: +351 21 000 8600 

Hrvatska 

Novartis Hrvatska d.o.o. 

Tel. +385 1 6274 220 

 

România 

Novartis Pharma Services Romania SRL 

Tel: +40 21 31299 01 

Ireland 
Novartis Ireland Limited 

Tel: +353 1 260 12 55 

 

Slovenija 
Novartis Pharma Services Inc. 

Tel: +386 1 300 75 50 

Ísland 

Vistor hf. 

Sími: +354 535 7000 

 

Slovenská republika 

Novartis Slovakia s.r.o. 

Tel: +421 2 5542 5439 

 

  



63 

Italia 
Novartis Farma S.p.A. 

Tel: +39 02 96 54 1 

Suomi/Finland 
Novartis Finland Oy 

Puh/Tel: +358 (0)10 6133 200 

 

Κύπρος 

Novartis Pharma Services Inc. 

Τηλ: +357 22 690 690 

 

Sverige 

Novartis Sverige AB 

Tel: +46 8 732 32 00 

 

Latvija 

SIA Novartis Baltics 

Tel: +371 67 887 070 

 

United Kingdom 

Novartis Pharmaceuticals UK Ltd. 

Tel: +44 1276 698370 

 

 

This leaflet was last revised in 
 

Other sources of information 

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

http://www.ema.europa.eu 



64 

INSTRUCTIONS FOR USE OF HIROBRIZ BREEZHALER INHALER 

 

Please read the full Instructions for Use before using the Hirobriz Breezhaler. 

 

 

 
 

 

Insert Pierce and release Inhale deeply Check capsule is empty 

 
  

 

 
   

 
   

 

 

 

 

 

 

 
Step 1a: 

Pull off cap 

Step 2a: 

Pierce capsule once 

Hold the inhaler upright. 

Pierce capsule by firmly 

pressing both side 

buttons at the same time. 

Step 3a: 

Breathe out fully 

Do not blow into the 

inhaler. 

Check capsule is empty 

Open the inhaler to see if 

any powder is left in the 

capsule. 

 

You should hear a noise 

as the capsule is pierced. 

Only pierce the capsule 

once. 

 

If there is powder left in 

the capsule: 

Close the inhaler. 

Repeat steps 3a to 3c. 

Step 1b: 

Open inhaler 

 
Step 2b: 

Release side buttons 

Step 3b: 

Inhale medicine deeply 

Hold the inhaler as 

shown in the picture. 

Place the mouthpiece in 

your mouth and close 

your lips firmly around 

it. 

Do not press the side 

buttons. 

 
Powder Empty 

remaining 

1 
 

2 
 

3 
 

Check 
 



65 

 

 
 

 Breathe in quickly and as 

deeply as you can. 

During inhalation you 

will hear a whirring 

noise. 

You may taste the 

medicine as you inhale. 

 

Step 1c: 

Remove capsule 

Remove one capsule from 

the blister. 

Do not swallow the 

capsule. 

 

 
Step 3c: 

Hold breath 

Hold your breath for up 

to 5 seconds. 

Remove empty capsule 

Put the empty capsule in 

your household waste. 

 

Close the inhaler and 

replace the cap. 

 
Step 1d: 

Insert capsule 

Never place a capsule 

directly into the 

mouthpiece. 

 

  Important Information 

 Hirobriz Breezhaler 
capsules must always be 

stored in the blister card 

and only removed 

immediately before use. 

 Do not swallow the 
capsule. 

 Do not use the Hirobriz 
Breezhaler capsules 

with any other inhaler. 

 Do not use the Hirobriz 
Breezhaler inhaler to 

take any other capsule 

medicine. 

 Never place the capsule 
into your mouth or the 

mouthpiece of the 

inhaler. 

 Do not press the side 
buttons more than once. 

 Do not blow into the 
mouthpiece. 

 Do not press the side 
buttons while inhaling 

through the mouthpiece. 

 Do not handle capsules 
with wet hands. 

 Never wash your inhaler 
with water. 

 
Step 1e: 

Close inhaler 

 



66 

Your Hirobriz Breezhaler Inhaler pack contains: 

 One Hirobriz Breezhaler inhaler 

 One or more blister cards, each containing either 
6 or 10 Hirobriz Breezhaler capsules to be used 

in the inhaler 

 

 
 

 

 

Frequently Asked 

Questions 

 

Why didn’t the inhaler 

make a noise when I 

inhaled? 

The capsule may be stuck 

in the capsule chamber. If 

this happens, carefully 

loosen the capsule by 

tapping the base of the 

inhaler. Inhale the 

medicine again by 

repeating steps 3a to 3c. 

 

What should I do if there 

is powder left inside the 

capsule? 

You have not received 

enough of your medicine. 

Close the inhaler and 

repeat steps 3a to 3c. 

 

I coughed after inhaling 

– does this matter? 

This may happen. As long 

as the capsule is empty 

you have received enough 

of your medicine. 

 

I felt small pieces of the 

capsule on my tongue – 

does this matter? 

This can happen. It is not 

harmful. The chances of 

the capsule breaking into 

small pieces will be 

increased if the capsule is 

pierced more than once. 

Cleaning the inhaler 

Wipe the mouthpiece 

inside and outside with a 

clean, dry, lint-free cloth to 

remove any powder 

residue. Keep the inhaler 

dry. Never wash your 

inhaler with water. 

Disposing of the inhaler 

after use 

Each inhaler should be 

disposed of after all 

capsules have been used. 
Ask your pharmacist how 

to dispose of medicines 

and inhalers that are no 

longer required. 

 

Cap 

Capsule 

chamber 

Base 

Mouthpiece 

Screen 

Blister 

Side 

buttons 

Inhaler Inhaler base Blister Card 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
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{'Title': '2. what you need to know before you use hirobriz breezhaler', 'Section_Content': 'do not use hirobriz breezhaler - if you are allergic to indacaterol or any of the other ingredients of this medicine (listed in section 6). warnings and precautions talk to your doctor or pharmacist before using hirobriz breezhaler if you have asthma (in this case you should not use hirobriz breezhaler). if you have heart problems. if you have epilepsy. if you have thyroid gland problems (thyrotoxicosis). if you have diabetes. during treatment with hirobriz breezhaler, stop using the medicine and tell your doctor 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. tell your doctor immediately if your copd symptoms (breathlessness, wheezing, cough) do not improve or get worse. children and adolescents hirobriz breezhaler should not be given to children or adolescents below the age of 18 years. other medicines and hirobriz breezhaler tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. in particular, please tell your doctor if you are using: medicines for breathing problems that are similar to hirobriz breezhaler (i.e. medicines such as salmeterol and formoterol). you may be more likely to get side effects. medicines called beta blockers that are used for high blood pressure or other heart problems (such as propranolol), or for the eye problem called glaucoma (such as timolol). medicines that lower the amount of potassium in your blood. these include: o steroids (e.g. prednisolone), o diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide, o medicines for breathing problems such as theophylline. 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 using this medicine. you should not use hirobriz breezhaler unless your doctor tells you so. ask your doctor or pharmacist for advice before taking any medicine. driving and using machines it is unlikely that hirobriz breezhaler will affect your ability to drive and use machines. hirobriz breezhaler contains lactose this medicine contains lactose (milk sugar). if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using this medicine.', 'Entity_Recognition': [{'Text': 'hirobriz breezhaler', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'hirobriz breezhaler', 'Type': 'TREATMENT', 'BeginOffset': 11, 'EndOffset': 30}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 44, 'EndOffset': 52}, {'Id': 5, 'BeginOffset': 56, 'EndOffset': 67, 'Score': 0.867617130279541, 'Text': 'indacaterol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 103, 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{'Title': '3. how to use hirobriz breezhaler', 'Section_Content': 'always use this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure. how much hirobriz breezhaler to use the usual dose is to inhale the content of one capsule each day. your doctor may tell you to use the 150 microgram capsule or the 300 microgram capsule depending on your condition and on how you respond to the treatment. do not use more than your doctor tells you to use. use your inhaler at the same time each day, the effects last for 24 hours. 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. how to use hirobriz breezhaler in this pack, you will find an inhaler and capsules (in blister) that contain the medicine as inhalation powder. the hirobriz breezhaler inhaler enables you to inhale the medicine contained in a capsule. only use the capsules with the inhaler provided in this pack (hirobriz breezhaler inhaler). the capsules should remain in the blister until you need to use them. when you start a new pack, use the new hirobriz breezhaler inhaler that is supplied in the pack. dispose of each inhaler after 30 days of use. do not swallow the capsules. please read the instructions at the end of this leaflet for more information about how to use the inhaler. if you use more hirobriz breezhaler than you should if you have inhaled too much hirobriz breezhaler or if someone else uses your capsules, tell your doctor immediately or go to the nearest emergency unit. show the pack of hirobriz breezhaler. medical attention may be needed. you may notice that your heart is beating faster than usual, or you may have a headache, feel drowsy, feel nauseous or have to vomit. if you forget to use hirobriz breezhaler if you forget to inhale a dose, inhale just one dose at the usual time the next day. do not inhale a double dose to make up for a forgotten dose. how long to continue your treatment with hirobriz breezhaler keep using your treatment with hirobriz breezhaler for as long as your doctor tells you. copd is a long-term disease and you should use hirobriz breezhaler every day and not only when you have breathing problems or other symptoms of copd. if you have questions about how long to continue your treatment with hirobriz breezhaler, talk to your doctor or pharmacist. if you have any further questions on the use of this medicine, ask your doctor or pharmacist.', 'Entity_Recognition': [{'Text': 'hirobriz breezhaler', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 11, 'EndOffset': 24}, {'Text': 'much hirobriz breezhaler', 'Type': 'TREATMENT', 'BeginOffset': 124, 'EndOffset': 148}, {'Text': 'the 150 microgram capsule', 'Type': 'TREATMENT', 'BeginOffset': 253, 'EndOffset': 278}, {'Text': '150', 'Type': 'NUMBER', 'BeginOffset': 257, 'EndOffset': 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{'Title': '4. possible side effects', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '5. how to store hirobriz breezhaler', 'Section_Content': None, 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what hirobriz breezhaler contains - each hirobriz breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate. the other ingredients include lactose and the capsule is made of gelatin. - each hirobriz breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate. the other ingredients include lactose and the capsule is made of gelatin. what hirobriz breezhaler looks like and content of the pack in this pack, you will find an inhaler, together with capsules in blister. the capsules are transparent (uncoloured) and contain a white powder. hirobriz breezhaler 150 microgram capsules have a black product code "idl 150" printed above a black bar and a black company logo ( ) printed below the black bar. hirobriz breezhaler 300 microgram capsules have a blue product code "idl 300" printed above a blue bar and a blue company logo ( ) printed below the blue bar. the following pack sizes are available: carton containing 10 capsules and 1 inhaler. carton containing 30 capsules and 1 inhaler. multipack comprising 2 packs (each containing 30 capsules and 1 inhaler). multipack comprising 3 packs (each containing 30 capsules and 1 inhaler). multipack comprising 30 packs (each containing 10 capsules and 1 inhaler). not all pack sizes or strengths may be available in your country.', 'Entity_Recognition': [{'Text': 'hirobriz breezhaler', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'what hirobriz breezhaler', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 24}, {'Text': 'each hirobriz breezhaler', 'Type': 'TREATMENT', 'BeginOffset': 36, 'EndOffset': 60}, {'Text': '150', 'Type': 'NUMBER', 'BeginOffset': 61, 'EndOffset': 64}, {'Text': '150', 'Type': 'NUMBER', 'BeginOffset': 92, 'EndOffset': 95}, {'Id': 4, 'BeginOffset': 106, 'EndOffset': 117, 'Score': 0.9510186314582825, 'Text': 'indacaterol', 'Category': 'MEDICATION', 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