Budesonide / Formoterol
BiResp Spiromax, DuoResp Spiromax · ATC code R03AK07
Brand names: BiResp Spiromax, DuoResp Spiromax, Symbicort, Airbufo Forspiro, Bufori Easyhaler, Symbicort Turbohaler, Airbir, Asfogran, Bretfor, Combihale, Fenoster, Foradil Combi, Formega, Forpack, Rolastym …
- Key facts
- Active substance
- Budesonide / Formoterol
- ATC code
- R03AK07
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- BiResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder · BiResp Spiromax 320 micrograms/9 micrograms inhalation powder · DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder · DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder
- Marketing authorisation holder
- Teva Pharma B.V.
- Information as of
- 2026-10-27
Key facts
Budesonide / formoterol is an inhaled combination of a corticosteroid and a long-acting β2 agonist used for asthma and COPD.
What it is used for
- Asthma in adults and adolescents (12 years and older) where a combination of inhaled corticosteroid and long-acting β2 agonist is appropriate
- COPD in adults aged 18 and older with FEV1 < 70% predicted, repeated exacerbations and significant symptoms despite long-acting bronchodilators
Dosing
- Not for initial management of asthma or for only mild asthma; dose individual to severity, titrated to the lowest effective dose
- Lower strength, asthma maintenance: adults 1-2 inhalations twice daily (up to 4 inhalations twice daily), adolescents 1-2 inhalations twice daily
- Lower strength, maintenance and reliever: 2 inhalations per day plus 1 inhalation as needed; not more than 6 inhalations on any single occasion
- Lower strength, COPD: 2 inhalations twice daily
- Higher strength (320/9 micrograms): maintenance only; asthma 1 inhalation twice daily (up to 2 inhalations twice daily), COPD 1 inhalation twice daily
- No special dosing in elderly patients; tapered on discontinuation, not stopped abruptly
Contraindications
- Hypersensitivity to the active substances or the excipient
Important warnings
- Regular reassessment of the dose; a rescue inhaler available at all times
- Increasing use of reliever medication indicates worsening and warrants reassessment
- Paradoxical bronchospasm may occur: discontinue immediately and institute alternative therapy
- Possible impaired adrenal function when transferring from oral steroids
Side effects
- Most common: tremor and palpitations, usually mild and disappearing within a few days
- Common: Candida infections in the oropharynx, pneumonia in COPD patients
- In COPD, skin bruises and pneumonia were more frequent with budesonide than with placebo
Interactions
- Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, HIV protease inhibitors) markedly increase budesonide levels; concomitant use should be avoided
- With potent CYP3A4 inhibitors, maintenance and reliever therapy is not recommended
Pregnancy and breastfeeding
- No clinical data on exposed pregnancies for the combination; no adequate data for formoterol in pregnant women
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.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
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)
- BiResp SpiromaxTeva Pharma B.V. · EMEA/H/C/003890
- DuoResp SpiromaxTeva Pharma B.V. · EMEA/H/C/002348
Source: European Medicines Agency (EMA), product information
Austria
- SymbicortAstrazeneca Oesterreich Gmbh · 4 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Airbufo ForspiroHexal Ag · 1 register entry
- Bufori EasyhalerOrion Corporation · 1 register entry
- Symbicort TurbohalerAstrazeneca Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- AirbirNEUTEC İNHALER İLAÇ SAN. VE TİC. A.Ş. · 8 register entries
- AsfogranGRANDİ İLAÇ SAN. VE TİC. LTD. ŞTİ · 1 register entry
- BretforNOBEL İLAÇ PAZARLAMA VE SAN. LTD. ŞTİ. · 4 register entries
- CombihaleNEUTEC İLAÇ SAN. TİC. A.Ş · 4 register entries
- FenosterWORLD MEDICINE İLAÇ SAN. VE TİC. A.Ş. · 7 register entries
- Foradil CombiARIMED İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- FormegaNEUTEC İLAÇ SAN. TİC. A.Ş · 2 register entries
- ForpackNEUTEC İNHALER İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- RolastymDEVA HOLDİNG A.Ş. · 7 register entries
- SuplairEXELTIS İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- Ventofor Combi FixBİLİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Bufomix Easyhaler, Symbicort
- Bulgaria
- Airbufo® Forspiro®, Буфомикс Изихалер, Ербуфо Форспиро, Симбикорт, Форакорт
- Croatia
- Airbufo Forspiro, Symbicort
- Cyprus
- Bufar Easyhaler, Pulmoton, Symbicort
- Czechia
- Airbufo Forspiro, Budesonidefformoterol Cipla, Bufomix Easyhaler, Symbicort
- Denmark
- Budesonid/Formoterolfumaratdihydrat Cipla, Bufomix Easyhaler, Symbicort
- Estonia
- Airbufo Forspiro, Bufomix Easyhaler, Symbicort
- Finland
- Bufomix Easyhaler, Symbicort
- France
- Budesonide/Formoterol Forspiro Sandoz, Gibiter Easyhaler, Symbicort Rapihaler, Symbicort Turbuhaler
- Greece
- Pulmoresp, Pulmoton, Symbicort
- Hungary
- Bufomix Easyhaler, Pulmalio, Symbicort
- Iceland
- Biresp Spiromax, Bufomix Easyhaler, Duoresp Spiromax, Goresp Digihaler, Pulmoton, Symbicort
- Ireland
- Airbufo Forspiro, Bufomix Easyhaler, Symbicort
- Italy
- Budesonide E Formoterolo Cipla, Budesonide Formoterolo, Fobuler, Gibiter, Sinestic, Symbicort, Symbicortmite Turbohaler
- Latvia
- Airbufo Forspiro, Bufomix Easyhaler, Symbicort
- Liechtenstein
- Biresp Spiromax, Duoresp Spiromax, Goresp Digihaler
- Lithuania
- Bufomix Easyhaler, Symbicort
- Luxembourg
- Bufomix Easyhaler, Symbicort
- Malta
- Airbufo Forspiro, Symbicort
- Netherlands
- Airbufo Forspiro, Budesonide/Formoterolfumaraatdihydraat Cipla, Bufoler Easyhaler, Pulentia, Symbicort
- Norway
- Airbufo Forspiro, Biresp Spiromax, Budesonid/Formoterol Cipla, Bufomix Easyhaler, Duoresp Spiromax, Goresp Digihaler, Symbicort
- Poland
- Airbufo Forspiro, Budesonide + Formoterol Cipla, Bufomix Easyhaler, Oxodil Combo, Symbicort
- Portugal
- Assieme Turbohaler, Budesonida + Formoterol Elpen, Bufomix Easyhaler, Gibiter Easyhaler, Symbicort
- Romania
- Airbufo Forspiro, Symbicort
- Slovakia
- Bufomix Easyhaler, Symbicort
- Slovenia
- Airbufo Forspiro, Bufomix Easyhaler, Symbicort
- Spain
- Budesonida/Formoterol Cipla, Bufomix Easyhaler, Foracort, Gibiter Easyhaler, Rilast, Symbicort
- Sweden
- Airbufo Forspiro, Budesonide/Formoterol Cipla, Bufar Easyhaler, Bufoler Easyhaler, Bufomide, Bufomix Easyhaler, Bufori Easyhaler, Foracort, Gardette, Pulmoton, Respimix Easyhaler, Symbicort
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.
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. BiResp Spiromax – 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/biresp-spiromax-epar-product-information_en.pdf
- European Medicines Agency. DuoResp Spiromax – 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/duoresp-spiromax-epar-product-information_en.pdf
- 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
- 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
- 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.