MedeliX
Start asking

pentosan polysulfate sodium

Elmiron · ATC code G04BX15

Also known as: Pentosanpolysulfat-Natrium · Brand names: Elmiron, Thrombocid, Armiro, Blapas, Elmidam

Key facts
Active substance
pentosan polysulfate sodium
ATC code
G04BX15
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
elmiron 100 mg capsules, hard
Marketing authorisation holder
bene-Arzneimittel GmbH
Information as of
2026-10-27

Key facts

Pentosan polysulfate sodium is a heparin-like polysaccharide with weak anticoagulant activity. It is used to treat bladder pain syndrome with glomerulations or Hunner's lesions in adults.

What it is used for

  • Bladder pain syndrome with glomerulations or Hunner's lesions in adults with moderate to severe pain, urgency and frequency of micturition

Dosing

  • 300 mg/day as one 100 mg capsule three times daily
  • Take with water at least 1 hour before or 2 hours after meals
  • Reassess response every 6 months; stop if no improvement after 6 months
  • No dose adjustment recommended for the elderly or in renal or hepatic impairment (not specifically studied)
  • No data in children and adolescents

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Active bleeding (menstruation is no contraindication)

Important warnings

  • Diagnosis of exclusion: rule out other urologic disorders such as urinary tract infection or bladder cancer
  • Pigmentary maculopathy, especially with long-term use; ophthalmologic examination after 6 months
  • Weak anticoagulant: evaluate for bleeding with invasive procedures, coagulopathy or medicines affecting coagulation
  • History of heparin- or pentosan polysulfate-induced thrombocytopenia: monitor carefully
  • Hepatic or renal insufficiency: careful monitoring

Side effects

  • Most common: headache, dizziness, diarrhoea, nausea, abdominal pain, rectal bleeding
  • Common also infections and influenza
  • Uncommon: anaemia, haemorrhage, thrombocytopenia, photosensitivity, depression

Interactions

  • No interactions with warfarin at therapeutic doses
  • Anticoagulants, heparin derivatives, thrombolytics, antiplatelet agents (including acetylsalicylic acid) or NSAIDs: evaluate for bleeding and adapt the dose if needed

Pregnancy and breastfeeding

  • No data; not recommended during pregnancy
  • 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)

  • Elmironbene-Arzneimittel GmbH · EMEA/H/C/004246

Source: European Medicines Agency (EMA), product information

Germany

  • ThrombocidBene-Arzneimittel Gmbh · 1 register entry

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

Turkey

  • ArmiroARGİS İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • BlapasNOBİS SCİENTİFİC İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • ElmidamBEYMED İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • ElmironAYMED İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry

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

Brand names in 9 more European countries
Czechia
Thrombocid
France
Hemoclar
Hungary
Dimovena, Sp
Iceland
Elmiron
Italy
Fibrase
Liechtenstein
Elmiron
Norway
Elmiron
Portugal
Comfora, Thrombocid
Spain
Thrombocid, Tromboben

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. European Medicines Agency. Elmiron – 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/elmiron-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. 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.