The Center recommends updating the instructions for medical use of medicinal products: January 2026 digest

Based on the results of monitoring information published on the official EMA website, in particular PRAC recommendations, the Center recommends that marketing authorization holders make the relevant changes to the instructions for medical use of medicinal products containing the following active substances:

• Vancomycin (vancomycin) Add to the section "Adverse reactions", subsection "Blood and lymphatic system disorders" haemolytic anaemia with frequency "unknown". More details at the link https://surl.lt/ajklgr
• Selegiline (selegiline) Include information on the medicinal interaction between selegiline (selegiline) and serotonin agonists. In addition, the instructions for medical use should be updated by adding impulse control disorders and compulsive behaviour as adverse reactions with frequency "unknown". More details at the link https://surl.li/ltcqwc
• Atenolol (atenolol) Add a warning about the risk of developing severe hypoglycaemia when beta-blockers and sulfonylurea derivatives are used concomitantly. More details at the link https://surl.li/fvgfdc
• Sodium citrate / sodium lauryl sulfoacetate and Sodium citrate / sodium lauryl sulfoacetate / sorbitol Add to the "Adverse reactions" section, subsection "Immune system disorders" an anaphylactic reaction with frequency "unknown". For more details, follow the link https://surl.li/fwdrza
• Rocuronium (rocuronium) Add a warning regarding hypertensive crisis in patients with known or latent pheochromocytoma, and also include information on reactions associated with both the use of rocuronium and the "rocuronium – sugammadex" complex. For more details, follow the link https://surl.li/xfnblz
• Prednisone (prednisone) Add a warning regarding thyrotoxic periodic paralysis in patients with hyperthyroidism and hypokalemia caused by the use of prednisone. For more details, follow the link https://surl.li/eynunh
• Metoprolol (metoprolol) Add a warning regarding the risk of developing severe hypoglycemia with the concomitant use of beta-blockers and sulfonylurea derivatives. For more details, follow the link https://surl.li/mhqnwp

The benefit/risk ratio of medicinal products remains unchanged provided the proposed changes to the instructions for medical use are made.