The alert, coordinated by the Spanish Agency of Medicines and Medical Devices (AEMPS), comes amid a high incidence of respiratory illnesses. The confusion in both reported cases occurred because the syrups marketed in the patients' country of origin contained a paracetamol concentration three times lower than that available in Spain (100 mg/ml).
This discrepancy led to the accidental administration of triple the recommended dose using the same volume, resulting in severe adverse effects. Paracetamol is indicated for the symptomatic treatment of fever and mild to moderate pain, but its precise dosage is crucial.
Administering doses higher than recommended can have serious consequences, including potentially fatal hepatic toxicity. In case of accidental overdose, the AEMPS stresses that the patient must receive immediate medical attention, even if initial symptoms are absent, as they may appear starting from the third day. Warning signs include dizziness, vomiting, jaundice, and abdominal pain.
To prevent errors, the AEMPS recommends that healthcare professionals always prescribe the exact quantity in milliliters based on the drug concentration and the child's weight. Furthermore, it is essential to ensure that parents or caregivers, especially those from other countries, correctly understand the dosage and use the appropriate administration system (dosing syringe or drops), always consulting the pharmacist with any doubts. Official information can be consulted via the SEFV-H.




