Oslif Breezhaler: Uses, Dosage & Side Effects
A once-daily long-acting beta-2 agonist (LABA) inhalation powder used for maintenance bronchodilator treatment of chronic obstructive pulmonary disease (COPD) in adults
Oslif Breezhaler is a once-daily inhaled medicine containing indacaterol maleate, a long-acting beta-2 adrenergic agonist (LABA) approved for the maintenance treatment of airflow obstruction in adults with chronic obstructive pulmonary disease (COPD). Supplied as 150 microgram hard capsules used with the single-dose Breezhaler device, it relaxes the smooth muscle surrounding the airways, producing bronchodilation that begins within 5 minutes and lasts approximately 24 hours. Oslif Breezhaler is not a rescue inhaler and must not be used to treat sudden breathing problems or for asthma. It requires a prescription and is intended exclusively for adult patients under the supervision of a physician experienced in managing obstructive airway disease.
Quick Facts: Oslif Breezhaler
Key Takeaways
- Oslif Breezhaler (indacaterol) is a once-daily long-acting beta-2 agonist bronchodilator used for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients – it relaxes airway smooth muscle to make breathing easier.
- The medicine has a rapid onset of action within approximately 5 minutes and a sustained 24-hour duration, allowing simple once-daily dosing delivered as inhalation powder via the single-dose Breezhaler device.
- Oslif Breezhaler is not a rescue inhaler and must never be used to treat sudden breathlessness, acute COPD exacerbations, or asthma; using LABAs as monotherapy in asthma increases the risk of serious asthma-related events including death.
- Common side effects include upper respiratory tract infections, nasopharyngitis, cough, headache, and muscle spasms; serious but uncommon effects include palpitations, hypokalemia, hyperglycemia, and paradoxical bronchospasm.
- Patients with severe cardiovascular disease, uncontrolled hyperthyroidism, severe hypokalemia, prolonged QT interval, or a history of hypersensitivity to indacaterol should use Oslif Breezhaler only after careful specialist assessment; inform your doctor about all medications, particularly beta-blockers, diuretics, and strong CYP3A4 inhibitors.
What Is Oslif Breezhaler and What Is It Used For?
Oslif Breezhaler contains the active substance indacaterol maleate, a novel ultra-long-acting beta-2 adrenergic receptor agonist developed specifically for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Indacaterol belongs to a pharmacological class known as long-acting beta-2 agonists (LABAs), medications that work by stimulating beta-2 adrenergic receptors found on the smooth muscle cells lining the airways of the lungs. When these receptors are activated, the muscle fibers relax, the bronchial tubes widen (bronchodilation), and air can move more freely into and out of the lungs. This reduces the sensation of breathlessness, decreases wheezing, improves exercise capacity, and enhances overall quality of life for patients living with chronic airflow limitation.
What distinguishes indacaterol from earlier LABAs such as salmeterol and formoterol is its unique combination of rapid onset and prolonged duration of action. Clinical pharmacology studies have shown that indacaterol produces measurable bronchodilation within 5 minutes of inhalation – comparable to short-acting beta-2 agonists like salbutamol – while maintaining therapeutic effect for approximately 24 hours. This pharmacokinetic profile allowed the development of a true once-daily LABA, representing an important simplification of COPD maintenance therapy compared with twice-daily alternatives.
Oslif Breezhaler is approved for the maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). COPD is a progressive lung disease characterized by persistent respiratory symptoms and airflow limitation due to airway and alveolar abnormalities, most commonly caused by long-term exposure to noxious particles or gases – particularly cigarette smoke. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) estimates that COPD affects over 390 million people worldwide and is a leading cause of morbidity and mortality. Long-acting bronchodilators such as indacaterol are a cornerstone of GOLD-recommended maintenance therapy because they relieve symptoms, improve exercise tolerance, reduce the frequency of exacerbations, and slow the functional decline associated with the disease.
Oslif Breezhaler is typically indicated for patients who experience ongoing breathlessness on exertion, chronic cough with or without sputum production, and a reduced capacity to perform daily activities because of their lung disease. It is often prescribed in mild to moderate COPD as a single bronchodilator and in more severe disease as part of dual or triple inhaler therapy combined with a long-acting muscarinic antagonist (LAMA) such as tiotropium or glycopyrronium, and/or an inhaled corticosteroid (ICS). The choice of regimen depends on the patient’s symptom burden, exacerbation history, and blood eosinophil count as recommended by GOLD 2025.
The delivery device – the Breezhaler – is a single-dose dry powder inhaler (DPI) specifically engineered to deliver indacaterol efficiently to the lower airways. Each dose is contained in an individual hard gelatin or HPMC (hypromellose) capsule that the patient inserts into the device and pierces before inhalation. This single-capsule design offers several practical advantages: patients receive visual and auditory feedback (the capsule spins audibly and can be seen through the transparent device chamber) that confirms a dose has been delivered, and the device requires relatively low inspiratory flow rates, making it usable by many patients with moderate-to-severe COPD.
It is important to understand that Oslif Breezhaler is not a rescue medicine. It is not designed and not approved to relieve sudden attacks of breathlessness or wheezing. Patients who use Oslif Breezhaler should always have a short-acting bronchodilator (for example, salbutamol/albuterol) available for immediate relief of acute symptoms. Oslif Breezhaler is also not indicated for the treatment of asthma. In asthma, the use of LABAs as monotherapy has been associated with an increased risk of serious asthma-related events, and indacaterol is therefore contraindicated for this use.
Beta-2 adrenergic receptors are located on the smooth muscle of the bronchi and bronchioles. When indacaterol binds to these receptors, it activates adenylyl cyclase, which increases intracellular cyclic AMP (cAMP). Elevated cAMP relaxes airway smooth muscle and inhibits the release of bronchoconstricting mediators from mast cells. The result is widening of the airways, improved airflow, and reduced breathlessness. Indacaterol also has a small anti-inflammatory effect and may reduce plasma exudation and airway wall edema in patients with COPD.
What Should You Know Before Using Oslif Breezhaler?
Before starting Oslif Breezhaler, your doctor will review your medical history in detail, assess your current symptoms, perform spirometry to confirm the diagnosis of COPD, and consider other medicines you are taking. Understanding the contraindications, warnings, and special patient populations is essential to using this medicine safely and effectively.
Contraindications
There are specific circumstances in which Oslif Breezhaler must not be used. These absolute contraindications should always be checked before the first prescription.
- Hypersensitivity: Do not use Oslif Breezhaler if you are allergic to indacaterol, lactose monohydrate, or any of the other excipients listed in section 6 of the summary of product characteristics. Hypersensitivity reactions may include rash, pruritus, angioedema, urticaria, and in rare cases anaphylaxis.
- Asthma without inhaled corticosteroid: Oslif Breezhaler is not indicated for the treatment of asthma. LABAs as monotherapy should never be used in asthma due to the risk of serious asthma-related events including asthma-related death.
- Lactose-containing product: Each capsule contains approximately 24.8 mg of lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Warnings and Precautions
Oslif Breezhaler is a long-acting maintenance medicine. It is not indicated – and must not be used – to treat acute episodes of bronchospasm, sudden shortness of breath, or acute exacerbations of COPD. Patients should always carry a separate short-acting rescue inhaler (such as salbutamol) for rapid relief of unexpected respiratory symptoms. If symptoms worsen or additional doses of rescue medicine are required, seek medical advice promptly, as this may indicate deteriorating disease.
Discuss the following conditions and situations with your doctor before using Oslif Breezhaler. Your doctor may need to adjust the treatment or monitor you more closely.
- Cardiovascular disease: Beta-2 agonists can cause clinically significant cardiovascular effects, including increases in heart rate, blood pressure, or electrocardiographic changes such as flattening of the T-wave, ST-segment depression, and QT-interval prolongation. Use Oslif Breezhaler with particular caution in patients with cardiovascular disorders including coronary insufficiency, recent myocardial infarction, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, or severe hypertension.
- QT prolongation: Indacaterol should be used with caution in patients with known or suspected prolongation of the QT interval, whether congenital or acquired, or those taking medicines known to affect the QT interval (see Drug Interactions).
- Hyperthyroidism: Beta-2 agonists should be used cautiously in patients with thyrotoxicosis, as sympathomimetic effects may be potentiated.
- Diabetes mellitus and hyperglycemia: Indacaterol may cause increases in blood glucose. Patients with diabetes mellitus should have blood glucose monitored more closely after initiation. Episodes of hyperglycemia and, rarely, diabetic ketoacidosis have been reported.
- Hypokalemia: Beta-2 agonists may cause significant hypokalemia (low blood potassium), especially when combined with xanthine derivatives, corticosteroids, non-potassium-sparing diuretics, or hypoxia. The risk is increased during severe COPD exacerbations. Serum potassium may need to be monitored in at-risk patients.
- Paradoxical bronchospasm: As with other inhaled therapies, Oslif Breezhaler may cause paradoxical bronchospasm that can be life-threatening. If this occurs, treatment should be stopped immediately, the patient should be assessed, and an alternative therapy instituted if necessary.
- Hypersensitivity reactions: Immediate hypersensitivity reactions have been reported after administration of indacaterol. If signs suggesting allergic reactions occur – in particular angioedema (difficulty breathing or swallowing, swelling of the tongue, lips and face), urticaria or skin rash – discontinue Oslif Breezhaler immediately and institute alternative therapy.
- Seizure disorders: Use with caution in patients with convulsive disorders, as sympathomimetic stimulation may lower the seizure threshold.
- Severe hepatic impairment: There are no data in patients with severe hepatic impairment. Use should be considered only if the expected benefit outweighs the potential risk.
- Severe renal impairment: Indacaterol has not been studied in patients with severe renal impairment. Cautious use is recommended.
- Deterioration of disease: Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of disease control. In this situation, reassessment of the therapy regimen is required. Oslif Breezhaler should not be used concurrently with other LABAs.
Pregnancy and Breastfeeding
There are no data from the use of indacaterol in pregnant women. Animal studies have not shown direct harmful effects on reproduction at clinically relevant doses. As with other beta-2 agonists, indacaterol may inhibit labor due to a relaxant effect on uterine smooth muscle. Oslif Breezhaler should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus. If you are pregnant, think you may be pregnant, or plan to become pregnant, discuss this with your doctor before starting Oslif Breezhaler.
It is not known whether indacaterol or its metabolites are excreted in human milk. Available pharmacokinetic and toxicological data in animals have shown excretion of indacaterol and metabolites in milk of lactating animals. The use of Oslif Breezhaler by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant.
Fertility studies have shown no adverse effects in rats at exposures substantially higher than the maximum human exposure. There is no information on fertility in humans.
Children and Adolescents
The safety and efficacy of Oslif Breezhaler in children and adolescents below 18 years of age have not been established. COPD as a clinical entity does not typically present before adulthood, and indacaterol is therefore not indicated in this population.
Use in Elderly Patients
No overall differences in safety or efficacy have been observed between elderly patients and younger adults in clinical trials with indacaterol. No dose adjustment is required in elderly patients, although clinicians should remain alert to age-associated comorbidities and concurrent medications that may modify the risk-benefit profile.
Driving and Operating Machinery
Oslif Breezhaler has no or negligible influence on the ability to drive or use machines. However, if you experience dizziness or other effects that may impair alertness, you should refrain from driving or operating machinery until symptoms resolve.
Important Information About Ingredients
Each Oslif Breezhaler capsule contains lactose monohydrate (approximately 24.8 mg) as the carrier for the micronized indacaterol powder. Patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. In practice, the quantity of lactose in a single inhaled dose is small and the risk of systemic reactions is low, but individuals with severe hypersensitivity to cow’s milk protein should be aware that trace contaminants may be present.
How Does Oslif Breezhaler Interact with Other Drugs?
Drug interactions with Oslif Breezhaler arise primarily from pharmacodynamic interactions common to all beta-2 agonists, and from pharmacokinetic interactions affecting indacaterol metabolism via cytochrome P450 3A4 (CYP3A4) and UDP-glucuronosyltransferase 1A1 (UGT1A1). Always inform your doctor and pharmacist about every medicine, herbal supplement, or over-the-counter product you are taking or have recently taken.
Major Interactions
| Interacting Drug / Class | Effect | Clinical Significance |
|---|---|---|
| Other long-acting beta-2 agonists (salmeterol, formoterol, olodaterol, vilanterol) | Additive beta-adrenergic stimulation; increased risk of cardiovascular effects and tremor | Do not combine – use a single LABA only |
| Beta-blockers (propranolol, atenolol, metoprolol, timolol eye drops) | May weaken or abolish the bronchodilator effect of indacaterol; may precipitate severe bronchospasm in COPD | Avoid if possible; if essential (e.g., post-MI), use cardioselective agents with caution |
| Thiazide and loop diuretics (hydrochlorothiazide, furosemide) | Additive potassium-lowering effect; increased risk of hypokalemia and related arrhythmias | Monitor serum potassium; consider potassium-sparing options |
| Methylxanthines (theophylline, aminophylline) | Additive cardiovascular and hypokalemic effects | Use with caution; monitor clinical status and electrolytes |
| Systemic corticosteroids (prednisolone, dexamethasone) | Enhanced hypokalemia, hyperglycemia | Monitor potassium and glucose, especially during exacerbation courses |
| QT-prolonging medications (amiodarone, sotalol, macrolide antibiotics, class III antiarrhythmics, some antipsychotics) | Additive QT prolongation; potential for torsades de pointes | Use with caution; consider baseline and on-treatment ECG in at-risk patients |
| Monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants | Potentiation of cardiovascular effects of sympathomimetics; possible hypertensive response | Use with extreme caution; avoid if possible for 2 weeks after MAOI discontinuation |
Pharmacokinetic Interactions and Minor Interactions
| Interacting Drug / Class | Effect | Clinical Significance |
|---|---|---|
| Strong CYP3A4 and P-gp inhibitors (ketoconazole, itraconazole, ritonavir, clarithromycin) | Approximately 2-fold increase in indacaterol systemic exposure | No dose adjustment required at therapeutic inhaled doses, but use clinical judgment in susceptible patients |
| CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St John’s wort) | Potential reduction in indacaterol plasma levels | Monitor clinical response; dose adjustment generally not required |
| UGT1A1 inhibitors (e.g., atazanavir) | May modestly increase indacaterol exposure | No dose adjustment needed at recommended doses |
| Short-acting beta-2 agonists (salbutamol/albuterol, terbutaline) | Short-term additive bronchodilation; acceptable for rescue use | Routine concurrent use for rescue is permitted |
| Long-acting muscarinic antagonists (tiotropium, glycopyrronium, umeclidinium) | Complementary bronchodilation; often used together | Commonly co-prescribed in dual or triple therapy |
| Inhaled corticosteroids (fluticasone, budesonide, beclomethasone) | No pharmacokinetic interaction; used together in triple therapy | Safe combination for appropriate COPD phenotypes |
Population pharmacokinetic analyses have confirmed that co-administration of indacaterol with strong dual CYP3A4 and P-glycoprotein inhibitors (such as ketoconazole 200 mg twice daily, erythromycin, verapamil, or ritonavir) increases indacaterol systemic exposure by approximately two-fold. Despite this, the overall safety profile at inhaled therapeutic doses remains acceptable and no dose adjustment is required. Nonetheless, clinicians should remain alert to cumulative effects when multiple interacting medicines are prescribed, especially in patients with cardiovascular comorbidities.
What Is the Correct Dosage of Oslif Breezhaler?
Oslif Breezhaler is designed for simple once-daily inhalation. Consistent daily dosing at the same time maintains stable bronchodilation and helps integrate the medicine into the patient’s routine. Always follow the exact instructions provided by your doctor and the patient information leaflet. The medicine should be taken regularly, even on days when symptoms are minimal, because its preventive bronchodilator effect depends on steady-state plasma concentrations.
Adults
Standard Adult Dose (Once Daily)
Recommended dose: One 150 microgram capsule inhaled once daily using the Breezhaler device
Higher strength: One 300 microgram capsule once daily (only when considered beneficial by a physician experienced in COPD management)
Timing: Take at the same time each day to maintain stable 24-hour bronchodilation; morning dosing is often preferred but evening is acceptable
Maximum dose: Do not exceed one capsule in any 24-hour period
If a dose is missed, take the next dose at the usual time the following day. Do not take a double dose to make up for a missed dose.
Recommended Dosing by Patient Group
| Patient Group | Recommended Dose | Special Considerations |
|---|---|---|
| Adults with COPD (standard) | 150 microgram once daily | Usual maintenance dose; assess response at 4–8 weeks |
| Adults with severe COPD (specialist decision) | 300 microgram once daily | Only if 150 mcg is insufficient and benefit outweighs risk |
| Elderly (≥ 75 years) | Same as adult dose | Monitor cardiovascular effects; review concurrent medications |
| Mild to moderate hepatic impairment | No dose adjustment needed | Use standard adult dose |
| Severe hepatic impairment | Limited data; use with caution | Use only if benefit clearly outweighs risk |
| Renal impairment | No dose adjustment needed | Minimal renal excretion; safe for most renal patients |
| Children < 18 years | Not recommended | Safety and efficacy not established |
How to Use the Breezhaler Device Correctly
Correct inhalation technique is critical for effective treatment. Each capsule is a single dose and must be used with the Breezhaler device supplied in every package. Never swallow the capsules. The powder inside the capsule is for inhalation only. Follow these step-by-step instructions:
- Pull off the cap of the Breezhaler inhaler.
- Open the inhaler by holding the base firmly and tilting the mouthpiece until it opens. You will see the capsule chamber.
- Prepare the capsule: Peel away the protective foil on the blister card to expose one capsule. Do not push the capsule through the foil.
- Insert the capsule into the capsule chamber. Never place a capsule directly into the mouthpiece.
- Close the inhaler fully until you hear a click.
- Pierce the capsule by holding the inhaler upright and firmly pressing both side buttons at the same time, once only. You should hear a click as the capsule is pierced. Release the buttons.
- Exhale fully away from the inhaler. Never breathe into the mouthpiece.
- Inhale the dose: Place the mouthpiece between your teeth and close your lips tightly around it. Inhale rapidly, steadily, and as deeply as you can. You should hear a whirring sound as the capsule spins and the powder is dispersed into your airways. A sweet-sour taste is normal.
- Hold your breath for as long as comfortable (ideally 5–10 seconds) while removing the inhaler from your mouth. Then breathe out normally through your nose.
- Check the capsule: Open the chamber and inspect the capsule. If any powder remains, close the inhaler and repeat steps 7–9 to ensure the full dose is delivered.
- Remove and discard the empty capsule. Close the inhaler and replace the cap.
- Rinse your mouth with water after each dose to reduce the risk of dry mouth and oral irritation (do not swallow the water).
Missed Dose
If you forget to take a dose of Oslif Breezhaler, take it as soon as you remember on the same day. However, if it is close to the time of your next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for the missed capsule. Never take more than one capsule per 24-hour period. Missing one dose occasionally is unlikely to cause significant harm, but repeated missed doses will reduce the overall effectiveness of the medicine.
Overdose
Overdose with Oslif Breezhaler is likely to produce exaggerated pharmacological effects typical of beta-2 agonists, including tachycardia, tremor, palpitations, headache, nausea, vomiting, metabolic acidosis, hypokalemia, and hyperglycemia. Symptomatic and supportive treatment is the mainstay of overdose management. Cardioselective beta-blockers may be considered in severe cases, but only under close medical supervision because of the risk of inducing bronchospasm. In case of known or suspected overdose, contact emergency services or your national poison information center immediately.
Keep the capsules in their original blister pack until immediately before use. Do not remove a capsule from the blister until you are ready to inhale the dose, as the powder is sensitive to moisture and may not be effective if exposed to humid air. Always use the Breezhaler device supplied with the medicine. Do not use any other inhaler device. Each Breezhaler device should be discarded after 30 days of use or as directed by your pharmacist.
What Are the Side Effects of Oslif Breezhaler?
Like all medicines, Oslif Breezhaler can cause side effects, although not everyone gets them. Most side effects are mild to moderate in severity and tend to decrease during continued treatment. The safety profile was established in extensive clinical trials involving over 9,000 patients with COPD and has been confirmed by post-marketing surveillance. Side effects are organized below by frequency of occurrence according to standard pharmacovigilance conventions.
Frequency-Based Side Effects
Very Common
May affect more than 1 in 10 people
- Upper respiratory tract infection (common cold-like symptoms including runny or blocked nose and sore throat)
- Nasopharyngitis (inflammation of the nose and throat)
Common
May affect up to 1 in 10 people
- Cough (sometimes a brief cough immediately after inhalation)
- Headache
- Muscle spasms
- Peripheral edema (swelling of the hands, ankles, and feet)
- Dizziness
- Musculoskeletal pain (chest, back, or general)
- Sinusitis (inflammation of the sinuses)
- Pharyngitis (sore throat)
- Rhinitis (inflamed nasal passages)
- Non-cardiac chest pain
- Nasal congestion
Uncommon
May affect up to 1 in 100 people
- Palpitations (awareness of a fast or irregular heartbeat)
- Tachycardia (rapid heartbeat)
- Atrial fibrillation (irregular heart rhythm)
- Ischemic heart disease exacerbation
- Tremor (shaking, especially of the hands)
- Hypersensitivity reactions (including angioedema with swelling of the face, lips, tongue, or throat)
- Paresthesia (tingling sensation)
- Paradoxical bronchospasm (narrowing of the airways immediately after inhalation)
- Oropharyngeal pain including throat irritation
- Dry mouth
- Hyperglycemia (raised blood sugar)
- Diabetes mellitus worsening
- Myalgia (muscle pain)
- Pruritus (itching) and rash
- Non-specific chest discomfort
Rare
May affect up to 1 in 1,000 people
- Severe hypokalemia (low potassium)
- Hypertensive crisis
- Severe anaphylactic reactions
- Prolonged QT interval on ECG
Not Known
Frequency cannot be estimated from available data
- Throat irritation after inhalation
- Generalized pruritus
- Worsening of diabetes mellitus
- Voice alteration (dysphonia)
Understanding Specific Side Effects
Cough after inhalation. A characteristic brief cough lasting a few seconds has been reported in approximately 17–20% of patients immediately after inhalation of indacaterol. This post-inhalation cough is well tolerated, does not appear to be associated with bronchospasm or deterioration of lung function, and typically diminishes with continued use. It does not usually require discontinuation of treatment. However, any cough that is new, worsening, or accompanied by other respiratory symptoms should be reported to your doctor.
Cardiovascular effects. As with all beta-2 agonists, indacaterol may cause modest increases in heart rate, palpitations, and rarely, more significant arrhythmias or exacerbation of pre-existing ischemic heart disease. These effects are generally mild and transient but warrant special vigilance in patients with underlying cardiovascular disease. Report any chest pain, marked palpitations, fainting episodes, or sudden shortness of breath to emergency services promptly.
Metabolic effects. Beta-2 agonists can transiently raise blood glucose and lower serum potassium. In the general COPD population these effects are clinically minor, but they may become significant in patients with poorly controlled diabetes, chronic kidney disease, or concurrent diuretic or corticosteroid therapy. If you have diabetes, continue to monitor your blood glucose as usual and inform your doctor about any new fluctuations.
Paradoxical bronchospasm. Although rare, indacaterol – like other inhaled therapies – can trigger acute narrowing of the airways immediately after inhalation, causing sudden worsening of wheeze or breathlessness. If this occurs, use your short-acting rescue inhaler (salbutamol/albuterol) immediately, discontinue Oslif Breezhaler, and contact your doctor urgently. Alternative therapy will be required.
Hypersensitivity. Immediate hypersensitivity reactions including angioedema have been reported. Seek emergency medical attention if you experience swelling of the tongue, lips, or throat; severe skin rash or urticaria; or difficulty breathing or swallowing that could indicate anaphylaxis.
Contact emergency services or your doctor immediately if you experience: sudden severe shortness of breath or wheezing after a dose; chest pain radiating to the arm, neck, or jaw; fainting or collapse; rapid or irregular heart rhythm with dizziness; severe allergic reaction (swelling of face/throat, difficulty breathing, widespread rash); signs of severe hypokalemia such as muscle weakness, cramps, or palpitations; or rapid deterioration of COPD requiring increased rescue inhaler use.
If you experience any side effects – including those not listed here – tell your doctor, nurse, or pharmacist. You can also report suspected side effects to your national pharmacovigilance authority (for example, the EMA in Europe, the FDA MedWatch program in the United States, the MHRA Yellow Card Scheme in the United Kingdom, or Health Canada’s Canada Vigilance Program) to help ensure ongoing monitoring of the benefit-risk balance of Oslif Breezhaler.
How Should Oslif Breezhaler Be Stored?
Correct storage of Oslif Breezhaler is essential because the inhalation powder is hygroscopic and sensitive to humidity. Improper storage can degrade the product and reduce its clinical effectiveness. Follow these instructions carefully:
- Temperature: Store below 30°C (86°F). Do not freeze. Keep away from direct sunlight, heat sources, or cold drafts.
- Humidity: Capsules must always be stored in the original blister pack to protect them from moisture. Only remove a capsule from the blister immediately before use. Do not transfer capsules to other containers.
- Device care: Keep the Breezhaler device dry. Do not wash it with water. If necessary, wipe the inside and outside of the mouthpiece with a clean, dry cloth to remove residual powder.
- Device lifespan: Each Breezhaler inhaler should be discarded after 30 days of use, or after all capsules in the supplied pack have been used – whichever comes first. A new inhaler is supplied with each pack of capsules.
- Expiry date: Do not use Oslif Breezhaler after the expiry date (EXP) printed on the blister card and outer carton. The expiry date refers to the last day of the stated month.
- Inspection: Do not use a capsule that is broken, discolored, or appears to have been damaged. If in doubt, discard it and use a new one.
- Child safety: Keep this medicine out of the sight and reach of children. Children may mistake the capsules for sweets.
Do not dispose of medicines via wastewater or household waste. Return unused medicines and used Breezhaler devices to your pharmacist for environmentally responsible disposal. These measures help protect the environment and prevent accidental ingestion or misuse.
What Does Oslif Breezhaler Contain?
Active Substance
The active substance is indacaterol, formulated as indacaterol maleate. Each 150 microgram hard capsule contains indacaterol maleate equivalent to 150 micrograms of indacaterol base, while each 300 microgram capsule contains indacaterol maleate equivalent to 300 micrograms of indacaterol base. The powder is a fine, white-to-almost-white micronized material optimized for inhalation deposition in the lower airways.
Excipients (Inactive Ingredients)
- Lactose monohydrate – used as the inhalation-grade carrier powder. Each capsule contains approximately 24.8 mg of lactose monohydrate.
- Capsule shell: Hypromellose (HPMC, hydroxypropyl methylcellulose). The capsules are transparent and colorless, printed with identification codes in black ink.
- Capsule printing ink: Shellac, propylene glycol, black iron oxide (E172), and potassium hydroxide.
The medicine contains no preservatives, no propellants, and no chlorofluorocarbons (CFCs). Dry powder inhaler technology produces no environmental impact from greenhouse gas propellants, which is an additional advantage of the Breezhaler platform.
Package Contents and Appearance
Oslif Breezhaler is supplied as transparent hard capsules containing a white-to-almost-white fine powder. The 150 microgram capsules are marked with the product code and have a specific capsule color coding printed on the shell to distinguish them from the 300 microgram strength. Each carton contains:
- Aluminum/PA/PVC-aluminum blister strips containing the hard capsules
- One single-dose Breezhaler inhalation device (a small plastic inhaler with a transparent chamber, two side buttons for capsule piercing, and a hinged mouthpiece)
- The patient information leaflet with detailed usage instructions and safety information
Package sizes vary by country and market but typically include blister packs corresponding to 30, 60, 90, or 150 capsules, together with the corresponding number of Breezhaler devices.
Marketing Authorization Holder and Manufacturer
Oslif Breezhaler is marketed by Novartis Europharm Limited, headquartered in Ireland. The product was developed by Novartis Pharma AG (Basel, Switzerland) under the centralized EU authorization procedure of the European Medicines Agency (EMA). It is manufactured at licensed Novartis facilities in Europe. The same active ingredient (indacaterol) is also marketed under other brand names in different regions, including Onbrez Breezhaler, Hirobriz Breezhaler, and the discontinued U.S. formulation Arcapta Neohaler.
For questions about the specific batch, manufacturer, or distribution of your pack, contact the Novartis local representative listed in the patient information leaflet, or your pharmacy.
Frequently Asked Questions About Oslif Breezhaler
Oslif Breezhaler (indacaterol) is a long-acting bronchodilator used for the maintenance treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD). It is taken once daily to relax the muscles surrounding the airways, making breathing easier and reducing symptoms such as breathlessness, wheezing, and cough. Oslif Breezhaler is not a rescue medicine and should not be used to treat sudden attacks of breathlessness or an acute worsening of COPD symptoms. It is also not approved for the treatment of asthma.
To use Oslif Breezhaler, open the inhaler by lifting the mouthpiece, place a capsule in the chamber, close the inhaler until you hear a click, and pierce the capsule by firmly pressing both side buttons once, then release. Exhale away from the inhaler, place the mouthpiece in your mouth, tilt your head slightly back, and inhale rapidly and deeply through the inhaler. You should hear a whirring sound as the capsule spins. Hold your breath for up to 5–10 seconds, then exhale. Always rinse your mouth with water after each dose and discard the empty capsule. Never swallow the capsules.
No, Oslif Breezhaler is not approved for the treatment of asthma. Long-acting beta-2 agonists (LABAs) like indacaterol used alone in asthma have been associated with an increased risk of serious asthma-related events, including hospitalization and death. In asthma management, a LABA must always be combined with an inhaled corticosteroid in a single inhaler. Oslif Breezhaler is indicated only for maintenance treatment of airflow limitation in adult patients with chronic obstructive pulmonary disease (COPD).
The most common side effects of Oslif Breezhaler include upper respiratory tract infection (common cold-like symptoms), nasopharyngitis (runny nose and sore throat), cough, headache, and muscle spasms. Some patients may experience a brief paradoxical cough shortly after inhalation, which generally does not require treatment discontinuation. Less common side effects include palpitations, tachycardia, tremor, chest pain, dizziness, peripheral edema, and hyperglycemia (raised blood sugar). Most side effects are mild to moderate and tend to decrease with continued use. Report any troublesome or persistent side effects to your doctor.
Oslif Breezhaler has a rapid onset of action, with measurable bronchodilation detectable within 5 minutes of inhalation. However, the full therapeutic benefit typically develops over the first 1–2 weeks of daily use as steady-state plasma concentrations are reached. Its effect lasts approximately 24 hours, which is why the medication is taken once daily, preferably at the same time each morning or evening. If you notice no improvement in your breathing after 2 weeks of regular use, or if symptoms worsen, contact your doctor for reassessment of your treatment plan.
Yes, Oslif Breezhaler is often used together with other COPD maintenance inhalers such as long-acting muscarinic antagonists (LAMAs) like tiotropium or glycopyrronium, or in combination with inhaled corticosteroids (ICS) for patients with frequent exacerbations or elevated eosinophil counts. However, another long-acting beta-2 agonist (such as salmeterol, formoterol, olodaterol, or vilanterol) should not be used concurrently to avoid cumulative cardiovascular effects. Short-acting rescue inhalers (e.g., salbutamol/albuterol) may still be used as needed for sudden symptoms. Always inform your doctor about every inhaler and medication you are taking.
If you forget to take a dose of Oslif Breezhaler, take it as soon as you remember on the same day. However, if it is almost time for your next scheduled dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed capsule – this increases the risk of cardiovascular and metabolic side effects without any additional bronchodilator benefit. One missed dose is unlikely to cause clinical deterioration, but repeated missed doses will reduce overall treatment effectiveness and may lead to worsening symptoms or an increased risk of exacerbation.
Oslif Breezhaler should be used with caution in patients with significant cardiovascular disease, including coronary artery disease, recent myocardial infarction, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, severe hypertension, or known QT-interval prolongation. While inhaled indacaterol at therapeutic doses has a favorable cardiovascular safety profile overall, all beta-2 agonists can cause modest increases in heart rate and occasional arrhythmias. Your cardiologist and pulmonologist should collaborate to determine whether the benefits outweigh the risks. Report any new chest pain, palpitations, fainting, or sudden breathlessness immediately.
References
- European Medicines Agency (EMA). Oslif Breezhaler (indacaterol) – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- U.S. Food and Drug Administration (FDA). Indacaterol (Arcapta Neohaler) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD – 2025 Report. Available from: goldcopd.org.
- Donohue JF, Fogarty C, Lotvall J, et al. Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium (INHANCE). Am J Respir Crit Care Med. 2010;182(2):155–162. doi:10.1164/rccm.200910-1500OC.
- Kornmann O, Dahl R, Centanni S, et al. Once-daily indacaterol versus twice-daily salmeterol for COPD: a placebo-controlled comparison (INLIGHT-2). Eur Respir J. 2011;37(2):273–279. doi:10.1183/09031936.00045810.
- Dahl R, Chung KF, Buhl R, et al. Efficacy of a new once-daily long-acting inhaled beta-2-agonist indacaterol versus twice-daily formoterol in COPD (INVOLVE). Thorax. 2010;65(6):473–479. doi:10.1136/thx.2009.125435.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
- Joint Formulary Committee. British National Formulary (BNF): Indacaterol. London: BMJ Group and Pharmaceutical Press; 2025. Available from: bnf.nice.org.uk.
- Beier J, Chanez P, Martinot JB, et al. Safety, tolerability and efficacy of indacaterol, a novel once-daily beta-2-agonist, in patients with COPD: a 28-day randomised, placebo controlled clinical trial. Pulm Pharmacol Ther. 2007;20(6):740–749. doi:10.1016/j.pupt.2006.09.001.
- Chapman KR, Rennard SI, Dogra A, et al. Long-term safety and efficacy of indacaterol, a long-acting beta-2-agonist, in subjects with COPD: a randomized, placebo-controlled study (INVIGORATE). Chest. 2011;140(1):68–75. doi:10.1378/chest.10-1830.
- Vogelmeier C, Ramos-Barbon D, Jack D, et al. Indacaterol provides 24-hour bronchodilation in COPD: a placebo-controlled blinded comparison with tiotropium. Respir Res. 2010;11(1):135. doi:10.1186/1465-9921-11-135.
- Yang IA, Brown JL, George J, et al. COPD-X Australian and New Zealand guidelines for the diagnosis and management of chronic obstructive pulmonary disease: 2024 update. Med J Aust. 2024;220(7):355–365.
Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in pulmonology, respiratory medicine, and clinical pharmacology.
Medical Content
iMedic Pulmonology Editorial Team – specialist physicians in respiratory medicine with clinical experience in COPD management and inhaler therapy
Medical Review
iMedic Medical Review Board – independent panel verifying accuracy against EMA SmPC, FDA label, GOLD, and BNF guidelines
Pharmacology Review
iMedic Clinical Pharmacology Team – specialists in drug interactions, pharmacokinetics, and medication safety
Accessibility & SEO
iMedic Digital Health Team – ensuring WCAG 2.2 AAA compliance and optimal search visibility
All content follows the GRADE evidence framework and is reviewed according to international medical guidelines. iMedic receives no commercial funding from pharmaceutical companies.