Overview
- Digemid updated the technical datasheets and patient inserts for all medicines containing paracetamol across Peru.
- The revisions modify sections on contraindications, warnings and precautions, drug interactions, and adverse reactions.
- Reported cases have chiefly involved patients with severe renal failure, sepsis, malnutrition, or chronic alcoholism during prolonged use.
- Health professionals are advised to stop paracetamol immediately and monitor closely if signs of metabolic acidosis appear, particularly with extended therapy or when combined with flucloxacillin.
- Warning signs include rapid deep breathing, severe respiratory difficulty, somnolence, nausea, and vomiting, and national data record one confirmed case and four compatible reports among 1,838 submissions since 2010.