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roflumilast

Daxas · ATC code R03DX07

Brand names: Daxas, Rofluma, Roflumilast Accord, Roflum Hexal, Roflumila Puren, Roflumilapuren, Roflumilast Abdi, Roflumilast Al, Roflumilast Beta, Roflumilast Elpen, Roflumilast Heumann, Rumixafen, Brolust, Duspas, Roflung

Key facts
Active substance
roflumilast
ATC code
R03DX07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Daxas 250 micrograms tablets · Daxas 500 micrograms film-coated tablets
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-27

Key facts

Roflumilast is a phosphodiesterase-4 inhibitor for maintenance treatment of severe COPD with chronic bronchitis and frequent exacerbations in adults, added to bronchodilators.

What it is used for

  • Maintenance treatment of severe COPD (post-bronchodilator FEV1 less than 50% predicted) with chronic bronchitis
  • Adults with a history of frequent exacerbations, as add-on to bronchodilator treatment
  • Not a rescue medicine for acute bronchospasm

Dosing

  • Start: 250 micrograms once daily for 28 days (sub-therapeutic starting dose to improve tolerability).
  • Then maintenance 500 micrograms once daily; full effect may take several weeks.
  • No dose adjustment in elderly patients or renal impairment.
  • Mild hepatic impairment (Child-Pugh A): use with caution; moderate or severe is contraindicated.
  • Take with water at the same time every day, with or without food.

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Moderate or severe hepatic impairment (Child-Pugh B or C)

Important warnings

  • Weight decrease; check body weight regularly and stop if an unexplained, clinically concerning loss occurs
  • Psychiatric disorders (insomnia, anxiety, depression); rare suicidal ideation and behaviour
  • Not recommended with a history of depression associated with suicidal ideation or behaviour
  • Do not start, or stop, in severe immunological disease, severe acute infection, cancer or immunosuppressive treatment
  • Heart failure NYHA grades 3 and 4 not studied; treatment not recommended

Side effects

  • Most common: diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%), headache (1.7%)
  • Decreased appetite, insomnia, anxiety
  • Also reported: depression, tremor, palpitations, gynaecomastia; rarely suicidal ideation

Interactions

  • CYP1A2/3A4 inhibitors such as enoxacin, cimetidine, fluvoxamine increase PDE4 inhibition; reassess treatment if not tolerated
  • Strong CYP450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin): not recommended
  • Theophylline: concomitant maintenance use not recommended

Pregnancy and breastfeeding

  • Not recommended during pregnancy; women of childbearing age should use effective contraception.
  • Should not be used during breast-feeding.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

  • DaxasAstraZeneca AB · EMEA/H/C/001179

Source: European Medicines Agency (EMA), product information

Austria

  • RoflumaPharmaand Gmbh · 1 register entry
  • Roflumilast AccordAccord Healthcare B.V. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Roflum HexalHexal Ag · 1 register entry
  • Roflumila PurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • RoflumilapurenPuren Pharma Gmbh & Co. Kg · 1 register entry
  • Roflumilast AbdiAbdi Farma Gmbh · 1 register entry
  • Roflumilast AccordAccord Healthcare B.V. · 1 register entry
  • Roflumilast AlAliud Pharma Gmbh · 1 register entry
  • Roflumilast BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Roflumilast ElpenElpen Pharmaceutical Co. Inc. · 1 register entry
  • Roflumilast HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
  • Rumixafen1 A Pharma Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • BrolustARDİ FARMA İLAÇ PAZARLAMA TİC. LTD. ŞTİ. · 2 register entries
  • DuspasABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • RoflungCELTİS İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 12 more European countries
Cyprus
Damirast
Czechia
Rumixafen
Denmark
Firekol
Finland
Firekol
Greece
Damirast
Iceland
Daxas
Liechtenstein
Daxas
Norway
Daxas, Firekol, Roflumilast Accord
Portugal
Roflumilaste Generis
Slovakia
Rumixafen
Spain
Roflumilast Aurovitas
Sweden
Firekol, Roflumilast Accord

EMA – Article 57 product data (EU/EEA), 2026-10-28

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

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Sources

  1. European Medicines Agency. Daxas – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/daxas-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.