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umeclidinium

Rolufta Ellipta (previously Rolufta) · ATC code R03BB07

Also known as: Umeklidinyum

Key facts
Active substance
umeclidinium
Drug class
Anticholinergic
ATC code
R03BB07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Rolufta Ellipta 55 micrograms inhalation powder, pre-dispensed
Marketing authorisation holder
GlaxoSmithKline Trading Services Limited
Information as of
2026-10-29

Key facts

Umeclidinium (Rolufta Ellipta) is an inhaled long-acting muscarinic antagonist (LAMA) used as maintenance bronchodilator treatment in COPD.

What it is used for

  • Maintenance bronchodilator treatment to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD).

Dosing

  • One inhalation (55 micrograms) once daily, at the same time each day; this is also the maximum dose.
  • Missed dose: inhale the next dose at the usual time the next day.
  • No dose adjustment in patients aged 65 or older, in renal impairment or in mild or moderate hepatic impairment; use with caution in severe hepatic impairment.
  • Do not shake the inhaler; hold the breath for at least 3-4 seconds after inhaling.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Should not be used in asthma (not studied).
  • Paradoxical bronchospasm, which may be life-threatening – stop immediately.
  • Not for relief of acute symptoms; use an inhaled short-acting bronchodilator. Increasing use signals deterioration.
  • Cardiovascular effects such as atrial fibrillation and tachycardia; caution in severe cardiovascular disorders.
  • Caution in urinary retention and narrow-angle glaucoma; contains lactose.

Side effects

  • Most frequent: nasopharyngitis (6%) and upper respiratory tract infection (5%).
  • Also common: urinary tract infection, sinusitis, headache; uncommon hypersensitivity reactions, dysgeusia; rare eye pain and anaphylaxis; not known: glaucoma, blurred vision.

Interactions

  • Clinically significant interactions are unlikely due to low plasma concentrations.
  • Co-administration with other long-acting muscarinic antagonists is not recommended.
  • Verapamil increased AUC about 1.4-fold; no clinically relevant interaction with P-gp inhibitors expected.

Pregnancy and breastfeeding

  • Use in pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Incruse Ellipta, Rolufta Ellipta
Liechtenstein
Incruse Ellipta, Rolufta Ellipta
Norway
Incruse Ellipta, Rolufta Ellipta

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Rolufta Ellipta (previously Rolufta) – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/rolufta-ellipta-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC R03BB.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.