Notice on the restrictions on the use of medicines containing pseudoephedrine


Based on the recommendations of the European Medicines Agency (EMA), the marketing authorisation holders for medicines containing pseudoephedrine, in cooperation with the Institute for Medicines and Medical Devices, have informed healthcare professionals about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine. In Montenegro, there are several medicines from different manufacturers that contain pseudoephedrine in combination with other active substances, and their use is approved for the treatment of cold and flu symptoms or allergic rhinitis. In the future, these medicines are not to be used in patients with high blood pressure that is severe or uncontrolled, as well as in patients with severe kidney disease, as these conditions increase the risk of the above-mentioned syndromes. Symptoms of PRES and RCVS include severe headache with a sudden onset, feeling sick, vomiting, confusion, seizures and visual disturbances. Once the use of medicines containing pseudoephedrine stops and the appropriate therapy is administered, the symptoms resolve. Cases of PRES and RCVS have not been reported in Montenegro.


The letter on this matter intended for healthcare professionals is available here.


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