Rolufta Ellipta (Umeclidinium 55 micrograms Inhalation Powder)
Pre-dispensed dry powder inhaler containing umeclidinium 55 mcg per delivered dose — once-daily maintenance therapy for chronic obstructive pulmonary disease (COPD)
Quick Facts About Rolufta Ellipta
Key Takeaways About Rolufta Ellipta
- Once-daily COPD maintenance: One inhalation each day at the same time delivers 24-hour bronchodilation, making Rolufta Ellipta one of the simplest LAMA inhalers to use consistently
- Not a rescue inhaler: Rolufta Ellipta is not used to relieve sudden shortness of breath; a separate short-acting reliever (e.g. salbutamol) must always be available for acute symptoms
- Effect starts within 15 minutes: The bronchodilator effect begins within 15 minutes of the first dose and lasts for a full 24 hours, improving breathlessness and exercise tolerance in most patients
- Contains lactose with milk proteins: The Ellipta device carries lactose monohydrate as a carrier powder; patients with a severe cow's milk protein allergy should not use this inhaler
- Specific cautions apply: Use with care if you have narrow-angle glaucoma, urinary retention, prostate enlargement, or significant cardiovascular disease, and never combine with another long-acting anticholinergic such as tiotropium
What Is Rolufta Ellipta and What Is It Used For?
Rolufta Ellipta is a prescription dry powder inhaler containing the long-acting muscarinic antagonist (LAMA) umeclidinium, 55 micrograms per delivered dose. It is used as once-daily maintenance therapy in adults with chronic obstructive pulmonary disease (COPD) to relieve breathlessness, reduce flare-ups, and improve exercise tolerance. It is not intended for acute bronchospasm or for monotherapy of asthma.
Rolufta Ellipta is one of the brand names under which the bronchodilator umeclidinium is marketed in Europe by GlaxoSmithKline (GSK); other names for the same medicine in different regions include Incruse Ellipta. The product is delivered through the Ellipta pre-dispensed, multi-dose dry powder inhaler, which the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) authorised after a programme of randomised controlled trials demonstrated sustained improvements in lung function, breathlessness scores, and exacerbation risk in patients with COPD.
COPD is a progressive, largely irreversible airway disease most commonly caused by long-term exposure to tobacco smoke, occupational dust, biomass fuels, or air pollution. It combines features of chronic bronchitis (inflammation and mucus production in the large airways) and emphysema (destruction of alveolar walls with loss of elastic recoil). The result is narrowing and collapse of small airways, air trapping, and shortness of breath that limits everyday activity. COPD is now the third leading cause of death worldwide according to the World Health Organization (WHO), and effective maintenance bronchodilators are the cornerstone of long-term treatment.
The LAMA class to which umeclidinium belongs acts by blocking muscarinic (cholinergic) receptors in airway smooth muscle, thereby inhibiting the constant vagal tone that narrows the bronchi in COPD. Because umeclidinium binds slowly and reversibly to M3 receptors, a single daily dose maintains bronchodilation for at least 24 hours. In the 2025 GOLD (Global Initiative for Chronic Obstructive Lung Disease) treatment algorithm, LAMAs are recommended as initial monotherapy for many patients with symptomatic, stable COPD, and as a core component of dual (LAMA + LABA) or triple (LAMA + LABA + ICS) combination therapy for more severe disease.
Clinically, Rolufta Ellipta is indicated for the symptomatic treatment of adults with COPD. It is not authorised as initial therapy for asthma, because LAMA monotherapy does not address airway inflammation in that disease; it may, however, be used in asthma only as an add-on to an inhaled corticosteroid (ICS) and a long-acting beta-agonist (LABA) under specialist supervision. Rolufta Ellipta is also not a rescue inhaler: it cannot relieve an acute attack of breathlessness, and a short-acting bronchodilator (such as salbutamol or terbutaline) must be available at all times for sudden symptoms.
In pivotal 12- and 24-week studies, umeclidinium 55 mcg once daily produced clinically meaningful improvements in trough forced expiratory volume in 1 second (FEV1) of approximately 115 to 150 mL compared with placebo. Patients reported less breathlessness (measured by the Transitional Dyspnoea Index), improved health status (measured by the St George's Respiratory Questionnaire), and used fewer rescue doses of short-acting bronchodilators. The safety profile was comparable to placebo for most outcomes, and similar to other LAMAs such as tiotropium in head-to-head comparisons.
How Does Umeclidinium Work?
Umeclidinium is a long-acting, competitive, and reversible antagonist of the M1, M2, and M3 muscarinic acetylcholine receptors, with particular functional selectivity for the M3 subtype found on airway smooth muscle. The parasympathetic nervous system releases acetylcholine tonically onto these receptors, activating a signalling cascade that causes smooth muscle contraction, mucous gland secretion, and narrowing of the airway lumen. In COPD this cholinergic tone is pathologically increased, contributing directly to airflow limitation.
By blocking M3 receptors, umeclidinium prevents acetylcholine from binding, which reduces intracellular calcium signalling and produces sustained bronchodilation. Because the drug dissociates very slowly from the M3 receptor compared with the short-acting anticholinergic ipratropium, its clinical effect lasts more than 24 hours, supporting once-daily dosing. Onset of action is rapid: improvements in FEV1 are measurable within 15 minutes of the first dose, peak around 2 to 3 hours, and the trough effect just before the next dose is still clearly above baseline.
Umeclidinium is delivered as a micronised dry powder carried on lactose monohydrate particles. When the patient opens the Ellipta cover, a metered dose is exposed in the mouthpiece, and a single steady inhalation draws the powder into the lungs, where the active drug deposits in the small airways. Systemic absorption of umeclidinium after inhalation is low, with peak plasma concentrations reached in 5 to 15 minutes; the drug is metabolised by CYP2D6 to inactive metabolites and eliminated predominantly in the bile. The long receptor-binding half-life, rather than the short plasma half-life, is what sustains the 24-hour clinical effect.
What Should You Know Before Using Rolufta Ellipta?
Before starting Rolufta Ellipta, confirm the diagnosis of COPD with a doctor, review all current medications and inhalers, and check for relevant medical conditions such as narrow-angle glaucoma, urinary retention, or significant heart disease. Rolufta Ellipta is not a rescue inhaler and must not be used for sudden breathlessness or for asthma monotherapy.
Contraindications
Do not use Rolufta Ellipta if any of the following apply:
- Hypersensitivity: Known allergy to umeclidinium bromide, lactose monohydrate (the carrier), magnesium stearate, or any other listed excipient
- Severe cow's milk protein allergy: The lactose carrier contains trace milk proteins, which have rarely caused severe allergic reactions in patients with confirmed milk protein allergy
- Acute bronchospasm: Rolufta Ellipta is not intended to treat sudden shortness of breath or acute attacks of COPD or asthma – use a short-acting reliever (e.g. salbutamol) instead
- Asthma monotherapy: Rolufta Ellipta should not be used as the only treatment for asthma; in asthma it can be considered only as add-on therapy to an inhaled corticosteroid plus long-acting beta-agonist under specialist supervision
- Children and adolescents: Rolufta Ellipta is not indicated for patients under 18 years of age because COPD does not typically occur in this age group, and safety and efficacy have not been established
If you are uncertain whether you have COPD, asthma, or another lung condition, ask your doctor for a diagnostic review (spirometry, chest imaging, and clinical assessment) before starting or continuing Rolufta Ellipta. Using a LAMA inhaler for the wrong diagnosis can delay appropriate treatment and, in asthma, may increase the risk of severe exacerbations if used without an inhaled corticosteroid.
Warnings and Precautions
Talk to your doctor or pharmacist before using Rolufta Ellipta if you have any of the following conditions. Although systemic absorption from the inhaled route is low, the anticholinergic pharmacology of umeclidinium can affect tissues outside the airway, particularly in susceptible patients.
- Narrow-angle (angle-closure) glaucoma: Anticholinergic bronchodilators can rarely precipitate acute angle-closure glaucoma. Report new eye pain, redness, blurred vision, or seeing halos around lights immediately and seek urgent ophthalmic review
- Urinary retention or prostate enlargement: Umeclidinium can worsen bladder outflow obstruction; men with benign prostatic hyperplasia should monitor for new or worsening difficulty passing urine
- Cardiovascular disease: Patients with unstable ischaemic heart disease, recent myocardial infarction, clinically significant arrhythmias (e.g. tachyarrhythmia, atrial fibrillation), prolonged QT interval, or severe heart failure were excluded from pivotal trials. Such patients should use Rolufta Ellipta only under close medical supervision
- Paradoxical bronchospasm: As with any inhaled medicine, a small minority of patients may experience wheezing, chest tightness, or worsening breathing immediately after a dose. Stop the inhaler and contact your doctor if this occurs
- Severe hepatic impairment: Umeclidinium has not been formally studied in people with severe liver disease. Use with caution and only if the expected benefit clearly outweighs potential risks
- Acute exacerbations: Rolufta Ellipta is not designed for the treatment of an exacerbation of COPD. Worsening symptoms should be managed with a short-acting reliever, increased rescue use, and prompt medical review for possible oral corticosteroids or antibiotics
Patients should also be aware that deteriorating symptoms, such as increasing breathlessness, increased rescue inhaler use, or worsening cough and sputum production, may signal worsening of COPD rather than side effects of the inhaler itself. Regular review with a respiratory nurse or pulmonologist every 6 to 12 months, combined with annual influenza vaccination and one-off pneumococcal vaccination, is part of best-practice COPD management.
Because umeclidinium is a slow-release anticholinergic, some patients notice a mild dry-mouth sensation in the first days of treatment. Rinsing the mouth with water after each dose, keeping a glass of water nearby, and using sugar-free chewing gum or sweets can help reduce this effect and, importantly, also reduces the small risk of candidiasis (oral thrush) when Rolufta Ellipta is used together with an inhaled corticosteroid in a multi-inhaler regimen.
Pregnancy, Breastfeeding, and Fertility
There are no adequate and well-controlled studies of umeclidinium in pregnant women. Animal studies with systemic (not inhaled) administration have not shown clinically relevant adverse effects on the developing fetus at exposures far higher than those obtained with the inhaled dose in humans. Nevertheless, as a general principle, any inhaled medicine should be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus, and under guidance from both a respiratory physician and an obstetrician.
It is not known whether umeclidinium is excreted in human breast milk after inhalation, although systemic exposure is low. A decision to continue or discontinue Rolufta Ellipta during breastfeeding should balance the benefits of maternal treatment against any theoretical risk to the infant. Because well-controlled COPD during pregnancy reduces the risk of preterm birth and low birth weight, abrupt discontinuation is generally not advised without replacing therapy.
There is no evidence that umeclidinium affects male or female fertility at recommended inhaled doses. Patients planning pregnancy who rely on Rolufta Ellipta for symptom control should discuss the ongoing treatment plan with their doctor in advance, rather than stopping therapy unilaterally.
Rolufta Ellipta is a maintenance (controller) inhaler and does not relieve sudden shortness of breath, wheeze, or cough. Always carry your prescribed short-acting reliever inhaler (e.g. salbutamol, terbutaline). If you need your reliever more than usual, if your peak flow is falling, or if your reliever gives less relief than before, contact your doctor or COPD nurse urgently – these are signs of an exacerbation that may require additional treatment.
How Does Rolufta Ellipta Interact with Other Drugs?
Because systemic absorption of inhaled umeclidinium is low, clinically significant drug-drug interactions are uncommon. The most important ones to avoid are combinations with other long-acting anticholinergics and with chronic oral ipratropium. Non-selective beta-blockers, strong CYP2D6 inhibitors, and medicines that prolong the QT interval warrant additional caution.
Drug interactions with Rolufta Ellipta can be grouped into three categories: pharmacodynamic interactions, where another drug adds to or opposes the bronchodilator or anticholinergic effect; pharmacokinetic interactions, where another drug changes the metabolism or elimination of umeclidinium; and class-specific cautions for patients already using inhaled therapies. Most interactions described below are theoretical, based on pharmacology rather than observed clinical events, because systemic exposure from the inhaled dose is small.
The most clinically relevant rule is to avoid duplicating the LAMA class. Rolufta Ellipta should not be prescribed together with another long-acting muscarinic antagonist such as tiotropium (Spiriva), glycopyrronium (Seebri, Enurev), aclidinium (Eklira, Bretaris), or revefenacin. Combining two LAMAs provides no additional bronchodilation but substantially increases systemic anticholinergic side effects, including dry mouth, urinary retention, constipation, and blurred vision. Patients switching between LAMA products should discontinue the previous one on the same day they start Rolufta Ellipta.
Chronic daily use of the short-acting anticholinergic ipratropium should also be avoided, since it occupies the same muscarinic receptors and adds no meaningful benefit to an established LAMA. Ipratropium may, however, be used occasionally for an acute exacerbation under medical advice, as the incremental anticholinergic burden from short-term use is limited.
Combining umeclidinium with a long-acting beta-agonist (LABA) such as vilanterol, salmeterol, formoterol, olodaterol, or indacaterol is pharmacologically complementary and is the basis of widely used fixed-dose combination inhalers. These combinations are associated with greater improvements in lung function and symptom control than either component alone, with no significant increase in adverse events when used at licensed doses.
Known and Potential Drug Interactions
| Drug / Class | Type of Interaction | Clinical Significance | Recommendation |
|---|---|---|---|
| Other long-acting muscarinic antagonists (tiotropium, glycopyrronium, aclidinium, revefenacin) | Pharmacodynamic (class duplication) | Increased anticholinergic adverse effects without added benefit | Do not combine; switch rather than add |
| Ipratropium (chronic use) | Pharmacodynamic (overlapping mechanism) | Additive anticholinergic effects; no efficacy gain | Avoid daily use; short-term use in exacerbation under medical advice only |
| Strong CYP2D6 inhibitors (paroxetine, fluoxetine, bupropion, quinidine) | Pharmacokinetic (reduced metabolism) | Modest increase in systemic umeclidinium; not clinically significant at licensed dose | No dose adjustment required; monitor for anticholinergic effects |
| Oral anticholinergics (tricyclic antidepressants, oxybutynin, antihistamines) | Pharmacodynamic (additive) | Increased dry mouth, urinary retention, constipation, confusion in older adults | Monitor anticholinergic burden; review need for concomitant drugs |
| Non-selective beta-blockers (propranolol, sotalol, timolol eye drops) | Pharmacodynamic (opposing airway effects) | May reduce bronchodilator effect and precipitate bronchospasm | Use cardioselective beta-blocker (e.g. bisoprolol) if beta-blockade required |
| QT-prolonging drugs (e.g. class Ia/III antiarrhythmics, certain antipsychotics) | Theoretical pharmacodynamic | Potential additive effect on cardiac conduction | Use with caution in patients with known QT prolongation; baseline ECG if indicated |
| Long-acting beta-agonists (vilanterol, salmeterol, indacaterol) | Pharmacodynamic (complementary bronchodilation) | Additive efficacy; basis for dual bronchodilator therapy | Often combined; coordinate via prescribing physician |
| Inhaled corticosteroids (fluticasone, budesonide, beclometasone) | Pharmacodynamic (anti-inflammatory) | No adverse interaction; may reduce exacerbations when indicated | Commonly combined in triple therapy; rinse mouth after use |
This list is not exhaustive. Always share an up-to-date list of all prescription medicines, over-the-counter products, herbal remedies, and inhalers with your doctor and pharmacist. Particular care is needed in older adults who may be taking several medicines with anticholinergic properties (e.g. for overactive bladder, allergies, or depression), because the cumulative "anticholinergic burden" has been associated with increased risks of falls, confusion, and cognitive decline.
Moderate alcohol consumption does not directly interact with umeclidinium. Continued tobacco smoking, however, substantially reduces the efficacy of all COPD therapies and accelerates disease progression. Smoking cessation is the single most important intervention in COPD and is strongly recommended alongside any inhaled therapy. Evidence-based smoking-cessation support, including nicotine replacement, varenicline, and behavioural counselling, is compatible with Rolufta Ellipta.
What Is the Correct Dosage of Rolufta Ellipta?
The recommended adult dose of Rolufta Ellipta is one inhalation of 55 micrograms umeclidinium once daily, taken at the same time each day. Do not exceed one inhalation in 24 hours. No dose adjustment is required for age (in adults), mild to severe kidney impairment, or mild to moderate liver impairment. The inhaler is not indicated in children or adolescents.
Dosing accuracy with Rolufta Ellipta is simple because the Ellipta device is pre-dispensed: each time you slide the cover fully, a single 55 mcg dose is prepared automatically, and the dose counter decreases by one. There is no need to measure, prime, or load capsules. However, correct inhaler technique is essential – poor technique is the most common reason for inadequate response to inhaled COPD therapy, and up to 40% of patients use their inhaler incorrectly unless specifically trained.
Adults (18 Years and Older)
Standard Adult Dosage
Dose: One inhalation (55 mcg of delivered umeclidinium) once daily. Take the dose at approximately the same time each day to maintain 24-hour bronchodilation. Do not take a second inhalation on the same day, even if you feel breathless – use your short-acting reliever instead.
Technique: Slide the cover fully until you hear a click, breathe out gently away from the inhaler, place the mouthpiece in your mouth and seal your lips around it, then take one long steady deep breath through your mouth. Hold your breath for 3–4 seconds, remove the inhaler, and breathe out slowly. Close the cover to reset.
Duration: Rolufta Ellipta is a long-term maintenance inhaler. Continue daily use as prescribed, even on days when you feel well, unless your doctor tells you to stop. Discontinuation leads to gradual loss of bronchodilation over 24–72 hours.
Older Adults (Over 65 Years)
Geriatric Dosage Considerations
No dose adjustment is required for patients over 65 years of age, and extensive clinical trial experience includes patients into their 80s. Older patients should, however, receive additional instruction on inhaler technique, because reduced hand strength, joint disease, and impaired inspiratory flow can make any dry powder inhaler harder to use correctly.
If opening the cover is difficult or if inspiratory flow is known to be low (for example in very severe COPD), your doctor may recommend alternative devices (soft-mist or pressurised inhalers with a spacer). The Ellipta device requires a minimum inspiratory flow of approximately 30 L/min for adequate drug delivery, which is achievable by most patients with moderate to severe COPD.
Patients with Kidney Impairment
Renal Impairment Dosage
No dose adjustment is required in patients with mild, moderate, or severe renal impairment. Umeclidinium is predominantly eliminated in the bile rather than the urine, so kidney function has little influence on systemic exposure. Data in patients on haemodialysis are limited, and specialist advice is appropriate for severe cases.
Patients with Liver Impairment
Hepatic Impairment Dosage
No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh A and B). Patients with severe hepatic impairment (Child-Pugh C) have not been studied formally, so Rolufta Ellipta should be used in that group only when the expected benefit clearly outweighs any potential risk, and ideally with specialist respiratory and hepatology input.
Children and Adolescents (Under 18 Years)
Paediatric Use
Rolufta Ellipta is not indicated in children or adolescents under 18 years of age. COPD is a disease of adults with long-term smoke or dust exposure, and children presenting with chronic breathlessness or wheeze should be evaluated for asthma, cystic fibrosis, primary ciliary dyskinesia, or other paediatric lung diseases rather than treated with a LAMA.
In the small subset of adolescents in whom LAMA therapy for severe asthma is considered (usually tiotropium, which has approved paediatric indications in some regions), this decision is made and monitored by a specialist paediatric pulmonologist. Umeclidinium does not currently have an asthma-specific paediatric authorisation.
Missed Dose
If you forget a dose of Rolufta Ellipta, take it as soon as you remember on the same day and then carry on with your next dose at the usual time the following day. Do not take two inhalations in a row to make up for the missed dose. Because receptor occupancy persists beyond 24 hours, one missed dose does not usually cause a noticeable change in symptoms, but repeated lapses will gradually reduce trough lung function. Using a pill-organiser reminder, phone alarm, or linking the inhaler to an established routine (such as brushing teeth in the morning) improves adherence.
Overdose
Inhaling more than one dose of Rolufta Ellipta in a short time is unlikely to cause serious harm in most adults, but may produce troublesome anticholinergic symptoms such as severe dry mouth, blurred vision, rapid heart rate, urinary retention, and confusion. Swallowing the powder is unlikely to produce systemic effects because oral bioavailability is low. Seek urgent medical advice by contacting your local poison control centre, calling emergency services (112 in Europe, 911 in the US), or attending an emergency department if multiple doses have been inhaled or if anticholinergic symptoms are severe. Bring the Ellipta device with you so clinicians can identify the product.
| Patient Group | Recommended Dose | Frequency | Notes |
|---|---|---|---|
| Adults 18–64 years | 55 mcg (one inhalation) | Once daily | Take at the same time every day for stable 24-hour bronchodilation |
| Older adults (≥65 years) | 55 mcg (one inhalation) | Once daily | No dose adjustment; review inhaler technique and inspiratory flow |
| Mild–severe renal impairment | 55 mcg (one inhalation) | Once daily | No dose adjustment; specialist advice for dialysis patients |
| Mild–moderate hepatic impairment | 55 mcg (one inhalation) | Once daily | No dose adjustment (Child-Pugh A–B) |
| Severe hepatic impairment | Individualised | Use only if benefit outweighs risk | Limited data (Child-Pugh C); involve specialist |
| Children & adolescents (<18) | Not indicated | – | Safety and efficacy not established in COPD or asthma |
| Pregnancy or breastfeeding | Individualised | Only if clearly needed | Balance maternal benefit against theoretical fetal/infant risk |
What Are the Side Effects of Rolufta Ellipta?
Most side effects of Rolufta Ellipta are mild and reflect the anticholinergic pharmacology of umeclidinium or localised airway irritation. Common effects include nasopharyngitis, upper respiratory tract infection, sinusitis, cough, headache, and dental pain. Serious but rare effects include paradoxical bronchospasm, acute angle-closure glaucoma, urinary retention, and severe allergic reactions.
Side effects are unwanted reactions that can occur with any medicine, and inhaled LAMAs are no exception. Because systemic exposure of umeclidinium after inhalation is low, most adverse effects are either minor anticholinergic symptoms (dry mouth, taste changes) or localised respiratory-tract events (cough, sore throat, nasopharyngitis). Rare but clinically important effects reflect the anticholinergic class and warrant prompt attention if they occur.
Side-effect frequencies are reported using standard pharmacovigilance categories: very common (affects more than 1 in 10 people), common (1 in 10 to 1 in 100), uncommon (1 in 100 to 1 in 1,000), rare (1 in 1,000 to 1 in 10,000), and very rare (fewer than 1 in 10,000). The frequencies below are consolidated from the EMA Summary of Product Characteristics, FDA label, and published clinical trial data for umeclidinium monotherapy.
Many minor symptoms – particularly dry mouth and a transient cough after inhalation – improve spontaneously within the first 1 to 2 weeks of treatment. Rinsing the mouth with water after each dose, sipping water during the day, and using sugar-free chewing gum or sweets help manage dry mouth. Persistent or severe symptoms should always be discussed with a doctor rather than leading to abrupt discontinuation, as uncontrolled COPD carries its own risks.
Common Side Effects
May affect up to 1 in 10 people
- Nasopharyngitis (common cold symptoms)
- Upper respiratory tract infection
- Urinary tract infection
- Sinusitis
- Cough (often transient after inhalation)
- Headache
- Dental pain (toothache)
- Sore throat (pharyngitis)
- Mild tachycardia (increased heart rate)
Uncommon Side Effects
May affect up to 1 in 100 people
- Hypersensitivity reaction (rash, itch, urticaria)
- Atrial fibrillation
- Idioventricular rhythm
- Supraventricular tachyarrhythmia
- Blurred vision
- Glaucoma (including worsening of known glaucoma)
- Dry mouth and altered taste
- Constipation
- Voice hoarseness (dysphonia)
- Mild peripheral oedema
Rare Side Effects
May affect up to 1 in 1,000 people
- Paradoxical bronchospasm (sudden wheeze after inhalation)
- Acute angle-closure glaucoma
- Urinary retention requiring catheterisation
- Severe allergic reaction, including anaphylaxis
- Angioedema (swelling of face, lips, tongue, or throat)
- Dysuria (pain on passing urine)
- Significant cardiac arrhythmia
Class-Related Considerations
Anticholinergic-class cautions in susceptible patients
- Cumulative anticholinergic burden: In older adults taking multiple anticholinergic drugs for unrelated conditions, the cumulative effect can increase falls, confusion, and cognitive impairment. Medication review by a pharmacist is advised if several anticholinergics are prescribed together.
Signs of a serious allergic reaction (swelling of the face, lips, tongue, or throat; difficulty breathing; widespread hives); sudden wheeze or worsening breathlessness immediately after a dose (possible paradoxical bronchospasm); severe eye pain, redness, blurred vision, or seeing halos (possible acute glaucoma); inability to pass urine (urinary retention); or a rapid, irregular heartbeat with dizziness or chest pain. Stop using Rolufta Ellipta and call your local emergency number or go to the nearest emergency department.
Patients are encouraged to report any suspected adverse reactions to their healthcare professional, who can in turn notify the national pharmacovigilance authority. In the European Union, reports can be submitted through the national competent authority listed in the EudraVigilance system; in the United Kingdom through the Yellow Card Scheme operated by the Medicines and Healthcare products Regulatory Agency (MHRA); and in the United States through MedWatch (FDA). Reporting adverse reactions helps regulators identify rare risks and improve product safety information for all patients.
How Should You Store Rolufta Ellipta?
Store Rolufta Ellipta below 30°C (86°F) in its original sealed foil tray until you are ready to use it. Once the tray is opened, use the inhaler within 6 weeks. Keep it dry and out of reach of children, do not refrigerate or freeze, and do not use after the expiry date printed on the packaging.
Correct storage protects the dry powder from moisture and heat, which can degrade the active drug and make the device unreliable. The Ellipta inhaler is packaged inside a sealed foil tray with a desiccant sachet that keeps the humidity low during transport and shelf storage. The inhaler itself is built to tolerate everyday handling, but the micronised lactose-based powder it contains is hygroscopic – it absorbs water from the air if exposed.
Store the unopened foil tray at room temperature, ideally between 15°C and 25°C but not above 30°C (86°F). Avoid storing the inhaler in places with temperature or humidity extremes: steamy bathrooms, cars parked in direct sunlight, and window sills are all unsuitable. A bedroom shelf, drawer, or kitchen cupboard away from the cooker and kettle is usually ideal. Do not refrigerate or freeze the product; low temperatures can cause condensation inside the device when it returns to room temperature.
Once the foil tray has been opened, the inhaler is exposed to ambient humidity and must be used within 6 weeks. Write the date of opening on the label if it helps you track the 6-week window. A specific "discard-after" date is also present on the device itself. After 6 weeks, discard any remaining doses even if the counter has not reached zero, because the potency of the powder cannot be guaranteed. Most patients using one inhalation per day will finish the 30-dose inhaler within 30 days, comfortably inside the 6-week limit.
Keep Rolufta Ellipta and all medicines out of the reach and sight of children. While accidental inhalation of a single dose is unlikely to cause serious harm in older children, exposure of toddlers to a dry powder inhaler can be frightening and may trigger coughing or choking. If a child accidentally inhales or ingests the product, contact your local poison control centre for advice.
Do not use Rolufta Ellipta after the expiry date stated on the carton and the inhaler. The expiry date refers to the last day of the month indicated. If the inhaler shows visible damage, if the dose counter does not advance when you open the cover, or if you are unsure whether a dose has been delivered, take the device to your pharmacist for assessment.
Do not throw empty or expired inhalers into household waste or recycling bins without consulting local guidance. Many pharmacies operate medicine take-back schemes, and some manufacturers run specific inhaler recycling programmes that separate plastic components, reclaim metal parts, and process the small amount of residual propellant safely. Returning inhalers to a pharmacy is the most environmentally responsible option and avoids accidental exposure to residual drug.
What Does Rolufta Ellipta Contain?
Each inhalation of Rolufta Ellipta delivers 55 micrograms of umeclidinium (as umeclidinium bromide, 65 mcg) as the active ingredient. The only other ingredients (excipients) are lactose monohydrate (which contains trace milk proteins) and magnesium stearate, which act as carrier and flow agents.
The sole pharmacologically active ingredient in Rolufta Ellipta is umeclidinium bromide, a quaternary ammonium muscarinic receptor antagonist with the chemical name (1R,5S)-3-(2-(((R)-2-hydroxy-2,2-diphenylacetyl)oxy)-2-phenylethyl)-8,8-dimethyl-8-azoniabicyclo[3.2.1]octane bromide. Each pre-dispensed blister contains 65 micrograms of umeclidinium bromide, equivalent to 55 micrograms of umeclidinium delivered to the patient after losses in the mouthpiece and device. Umeclidinium is a white to off-white crystalline powder that is practically insoluble in water; the micronised particles are small enough (typically 1–5 micrometres) to penetrate the small airways of the lower respiratory tract.
The inactive ingredients (excipients) in Rolufta Ellipta are:
- Lactose monohydrate: The principal carrier powder in the Ellipta device, making up almost the entire weight of each blister. Lactose is a disaccharide derived from cow's milk, and commercial pharmaceutical-grade lactose contains trace amounts of milk proteins. Patients with a confirmed severe milk protein allergy should therefore not use Rolufta Ellipta, as rare allergic and anaphylactic reactions have been reported. Lactose intolerance (inability to digest dietary lactose) is not a contraindication, because the amount delivered by inhalation is negligible and not metabolised systemically.
- Magnesium stearate: A very small amount of magnesium stearate is used as a flow agent to help the powder dispense and disperse smoothly through the device.
The Ellipta inhaler is a light-grey and light-green plastic device containing two strip foils, each with 7 or 30 blisters depending on the pack size. When the cover is slid fully open, one blister from each strip is pierced and the contents are exposed in the mouthpiece, ready to be inhaled in a single breath. A dose counter on the right-hand side of the device shows the number of doses remaining, turning red once only 10 doses are left. Once the counter reaches zero, the inhaler is empty and should be discarded. The device cannot be refilled or reused.
Patients with known hypersensitivity to any of these ingredients should not use Rolufta Ellipta. If you are unsure whether you have milk protein allergy, ask your doctor or an allergist; a laboratory-confirmed diagnosis is different from non-allergic lactose intolerance, and the distinction is important for inhaler choice.
Rolufta Ellipta is manufactured by GlaxoSmithKline (GSK) to pharmaceutical Good Manufacturing Practice (GMP) standards and is supplied with a patient information leaflet in the local language. The 30-dose pack provides one month of once-daily therapy; a 7-dose pack may be used for treatment initiation or trial periods.
Frequently Asked Questions About Rolufta Ellipta
The bronchodilator effect of Rolufta Ellipta begins within approximately 15 minutes of the first inhalation and reaches peak effect after 2 to 3 hours. Many people notice easier breathing within the first day. Meaningful improvements in daily symptoms, exercise tolerance, and reduction in the need for rescue inhaler use typically become apparent within the first week of daily treatment. Reductions in the frequency of COPD exacerbations develop gradually over several months of continued once-daily use.
No. Rolufta Ellipta is a maintenance (controller) inhaler designed to provide steady bronchodilation across 24 hours, not to relieve a sudden attack. The onset is too slow and the dose is too low for emergency relief. A short-acting bronchodilator such as salbutamol (Ventolin) or terbutaline (Bricanyl) is the recommended rescue medication for acute breathlessness. Carry your reliever inhaler with you at all times, and see your doctor if you are needing it more than twice a week or if symptoms are worsening.
The Ellipta device uses lactose monohydrate (a sugar from cow's milk) as the carrier for the active drug. Commercial lactose contains trace milk proteins. Patients with a confirmed severe cow's milk protein allergy should not use Rolufta Ellipta, as rare anaphylactic reactions have been reported. Lactose intolerance (inability to digest dietary lactose, causing bloating or diarrhoea after dairy) is different and is not a contraindication, because the inhaled amount is negligible and not digested. If you are unsure whether you have allergy or intolerance, consult a doctor or allergist before starting treatment.
If you forget a dose, take it as soon as you remember on the same day, and then carry on with your next dose at the usual time the following day. Do not take two inhalations at once to make up for a missed dose. Because umeclidinium binds slowly to airway receptors and the clinical effect extends beyond 24 hours, one missed dose will rarely produce a noticeable change in your breathing. However, repeated missed doses will gradually reduce your trough lung function and may eventually increase the risk of a flare-up. A simple reminder such as linking the inhaler to brushing your teeth, or using a phone alarm, improves long-term adherence.
Rolufta Ellipta is often used alongside a long-acting beta-agonist (LABA) such as salmeterol, formoterol, or indacaterol, and – if you have frequent exacerbations – with an inhaled corticosteroid (ICS) such as fluticasone or budesonide. These combinations are pharmacologically complementary. You should not, however, combine Rolufta Ellipta with another long-acting muscarinic antagonist (tiotropium/Spiriva, glycopyrronium/Seebri, aclidinium/Eklira) or use chronic daily ipratropium, because this duplicates the same receptor class without adding benefit and increases anticholinergic side effects. Always share the names of every inhaler you use with any prescriber to avoid overlap.
Rolufta Ellipta is not licensed as a monotherapy for asthma. Asthma is fundamentally an inflammatory airway disease, and guidelines from the Global Initiative for Asthma (GINA) require an inhaled corticosteroid (ICS) as the cornerstone of all but the mildest cases. A LAMA such as umeclidinium may be added as a fourth-line treatment on top of ICS + LABA therapy in adults with uncontrolled severe asthma, but this decision should be made by a respiratory specialist. If you have been prescribed Rolufta Ellipta for asthma, make sure you also have an inhaled corticosteroid and a reliever, and do not stop any of them without medical advice.
A mild, usually transient, increase in heart rate and a dry-mouth sensation are the most common anticholinergic effects of inhaled umeclidinium and occur in around 1 in 100 users. Both effects are usually mild, tolerable, and improve within the first 1 to 2 weeks of treatment. Rinsing your mouth with water after each dose, sipping water during the day, and using sugar-free chewing gum help with dry mouth. Significant palpitations, irregular heartbeat, chest pain, or fainting are rare and should prompt immediate medical review. Patients with known arrhythmias should discuss Rolufta Ellipta with their cardiologist before starting.
The Ellipta device does not need routine cleaning and must not be washed or immersed in water, as moisture will damage the powder. If the mouthpiece looks dusty, wipe the outside only with a dry tissue. Store the unopened foil tray below 30°C (86°F), and once opened, use the inhaler within 6 weeks. Keep it dry, upright, and away from direct sunlight or heat. Do not refrigerate or freeze, do not puncture the device, and keep it out of reach of children. When the dose counter reaches zero, return the empty inhaler to a pharmacy for safe recycling or disposal.
References and Sources
This article is based on internationally recognised medical and pharmaceutical guidelines. All information has been reviewed by qualified healthcare professionals and follows evidence-based principles.
- European Medicines Agency (EMA). Rolufta Ellipta: EPAR – Product Information (Summary of Product Characteristics). EMA, 2024. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Incruse Ellipta (umeclidinium inhalation powder) – Prescribing Information. FDA Drug Label Database, 2024. Available at: www.accessdata.fda.gov
- Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease – 2025 Report. GOLD, 2025. Available at: goldcopd.org
- Donohue JF, Maleki-Yazdi MR, Kilbride S, et al. Efficacy and safety of once-daily umeclidinium/vilanterol 62.5/25 mcg in COPD. Respiratory Medicine 2013; 107(10):1538–1546. doi:10.1016/j.rmed.2013.06.001
- Trivedi R, Richard N, Mehta R, Church A. Umeclidinium in patients with COPD: a randomised, placebo-controlled study. European Respiratory Journal 2014; 43(1):72–81. doi:10.1183/09031936.00109313
- Feldman G, Maltais F, Khindri S, et al. A randomized, blinded study to evaluate the efficacy and safety of umeclidinium 62.5 mcg compared with tiotropium 18 mcg in patients with COPD. International Journal of Chronic Obstructive Pulmonary Disease 2016; 11:719–730. doi:10.2147/COPD.S102494
- British National Formulary (BNF). Umeclidinium: prescribing, safety, and monitoring. NICE/BNF, 2024. Available at: bnf.nice.org.uk
- National Institute for Health and Care Excellence (NICE). Chronic obstructive pulmonary disease in over 16s: diagnosis and management (NG115). NICE, 2019 (updated 2024). Available at: www.nice.org.uk/guidance/ng115
- World Health Organization (WHO). Chronic obstructive pulmonary disease (COPD) fact sheet. Geneva: World Health Organization, 2024. Available at: www.who.int
- Vogelmeier CF, Criner GJ, Martinez FJ, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive lung disease: 2017 report. American Journal of Respiratory and Critical Care Medicine 2017; 195(5):557–582.
- Cazzola M, Page CP, Calzetta L, Matera MG. Pharmacology and therapeutics of bronchodilators. Pharmacological Reviews 2012; 64(3):450–504. doi:10.1124/pr.111.004580
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