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Direct Healthcare Professional Communication (DHPC) on Miltefosin (Impavido® 10 mg/50 mg Capsules): new warning about ocular changes, including keratitis

Active substance: miltefosine

The company Paesel und Lorei GmbH & Co. KG informs in coordination with the Federal Institute for Drugs and Medical Devices (BfArM) that in a few case reports complications of the eye (including keratitis) occurred under treatment with miltefosine, in most cases with a treatment duration of more than 28 days. Patients should be advised to contact the prescribing physician immediately in case of eye complaints.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 638KB, File is accessible