When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Implementation of change(s) requested by the National Competent Authority following the assessment of the paracetamol pediatric dosing schedule (section 4.2) with subsequent changes to section 4.4 warnings and precautions.
Change in MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire to McNeil Healthcare Ireland Limited, Airton Road, Tallaght, Dublin 24.
Section 4.4 updated to add: Patients with rare hereditary problems of fructose intolerance should not take this medicine.