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Direct Healthcare Professional Communication (DHPC) on pseudoephedrine: risks of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome

Active substance: pseudoephedrine

The marketing authorisation holders of pseudoephedrine-containing medicines in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that few cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported with the use of pseudoephedrine containing medicines, therefore pseudoephedrine-containing medicines are contraindicated in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease or renal failure, as these conditions increase the risks of PRES or RCVS. Patients should be advised to immediately stop using these medicines and seek medical assistance if signs or symptoms of PRES or RCVS develop.