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Theophylline

Theospirex · ATC code R03DA04

Also known as: Theophyllin, teofilin · Brand names: Theospirex, Afpred Forte-Theo, Bronchoretard, Theophyllin Aristo, Theophyllin Retard Ratiopharm, Theophyllin Stada, Bronkolin, Polteofilin, Teobag, Teofil SR, Teokap SR, Teosel, Xanthium, Theo-24

Key facts
Active substance
Theophylline
Drug class
Xanthines
ATC code
R03DA04
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-27

Key facts

Theophylline is a methylxanthine bronchodilator. Per the US label it is used for chronic asthma and other chronic lung diseases with reversible airflow obstruction.

What it is used for

  • Symptoms and reversible airflow obstruction of chronic asthma
  • Other chronic lung diseases, e.g. emphysema and chronic bronchitis

Dosing

  • Individualise; target peak serum concentration in the 10-20 mcg/mL range
  • Start low and increase slowly, at intervals of no less than 3 days, guided by serum levels
  • Calculate mg/kg doses on ideal body weight
  • Measure serum levels at initiation, before dose increases, with signs of toxicity, and with new illness or changes in co-medication
  • Reduced clearance (e.g. neonates, elderly, heart failure, liver disease, fever) requires dose reduction; schemes in the full text

Contraindications

  • Hypersensitivity to theophylline or other components

Important warnings

  • Extreme caution in active peptic ulcer disease, seizure disorders and cardiac arrhythmias
  • Without dose reduction when clearance is reduced, severe and potentially fatal toxicity can occur
  • Smoking cessation can alter clearance
  • Above 20 mcg/mL: persistent vomiting, cardiac arrhythmias and intractable seizures may occur

Side effects

  • Transient caffeine-like effects: nausea, vomiting, headache, insomnia
  • At high levels: cardiac arrhythmias and seizures, which can be lethal

Interactions

  • Inhibitors of theophylline metabolism (e.g. cimetidine, erythromycin, tacrine) raise levels
  • Stopping inducers (e.g. carbamazepine, rifampin) can raise levels

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 →

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For patients

Patient information (US)

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.

Austria

  • TheospirexGebro Pharma Gmbh · 2 register entries

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

Germany

  • Afpred Forte-TheoGlenwood Gmbh · 1 register entry
  • BronchoretardGlenwood Gmbh · 5 register entries
  • Theophyllin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Theophyllin Retard RatiopharmRatiopharm Gmbh · 1 register entry
  • Theophyllin StadaStadapharm Gmbh · 1 register entry

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

Turkey

  • BronkolinADEKA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • PolteofilinPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • TeobagKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 4 register entries
  • Teofil SRULKAR KİMYA SAN. VE TİC. A.Ş. · 3 register entries
  • Teokap SRNOBEL İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
  • TeoselOSEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
  • XanthiumGALEPHARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

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

USA

  • Theo-24ENDO USA, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28

Brand names in 23 more European countries
Belgium
Xanthium
Bulgaria
Теотард
Croatia
Teotard
Cyprus
Theo-Dur
Czechia
Euphyllin Cr N
Denmark
Theo-Dur, Unixan
Estonia
Teotard
Finland
Retafyllin
France
Dilatrane, Tedralan, Théostat
Greece
Theo-Bros, Theo-Dur, Uniphyllin
Hungary
Theophyllini Fono Vii. Naturland, Theophyllini Fono Viii. Parma, Theospirex
Ireland
Uniphyllin
Latvia
Teotard
Lithuania
Teotard
Luxembourg
Xanthium
Norway
Theo-Dur
Poland
Euphyllin Long, Theophyllinum Tramco, Theospirex
Portugal
Unicontin
Romania
Teotard
Slovakia
Euphyllin Cr N
Slovenia
Teotard
Spain
Elixifilin, Teromol Retard, Theo-Dur
Sweden
Theo-Dur

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

  1. U.S. Food and Drug Administration. Theophylline (Chartwell RX, LLC) – Prescribing Information, 2026-02-06. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1b685384-5d96-46fa-b93b-e96538a2cfe7
  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
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC R03DA.

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.