Dear Doctor Letter (Rote-Hand-Brief) on elmiron® (pentosan polysulfate sodium): risk of pigmentary maculopathy
2019.07.18
Active substance: pentosan polysulfate sodium
bene-Arzneimittel GmbH, in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that pigmentary maculopathy has been reported rarely, with pentosan polysulfate sodium, especially after long-term use. During treatment, patients should have regular ophthalmic examination for early detection of pigmentary maculopathy, particularly those taking pentosan polysulfate sodium long-term. Patients should be advised to promptly seek medical advice in case of visual changes such as reading difficulty and slow adjustment to low or reduced light environments.
Download DHPC / Information letter , Download_VeroeffentlichtAm_EN