PIL - Flucloxacillin 125mg/5ml, 250mg/5ml Sugar-free Powder for Oral Solution: Change history
View Patient Information Leaflet (PIL - Flucloxacillin 125mg/5ml, 250mg/5ml Sugar-free Powder for Oral Solution)
Last updated on this site: 20 Jul 2023
Variation Description: To update section 4.5 of the SmPC in line with the PRAC recommendation (EPITT no 19849): Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels. To update sections 2 and 4.4 of the SmPC and to update the PIL to add excipient information for sodium benzoate, sodium and sorbitol. The labelling has also been updated.
PIL sections updated – 2, 3, 4, 5 and 6.
Last updated on this site: 20 Jul 2023
Variation Description: To update section 4.5 of the SmPC in line with the PRAC recommendation (EPITT no 19849): Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels. To update sections 2 and 4.4 of the SmPC and to update the PIL to add excipient information for sodium benzoate, sodium and sorbitol. The labelling has also been updated.
PIL sections updated – 2, 3, 4, 5 and 6.
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Changes: (Updated: 20 Jul 2023)
Variation Description: To update section 4.5 of the SmPC in line with the PRAC recommendation (EPITT no 19849): Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels. To update sections 2 and 4.4 of the SmPC and to update the PIL to add excipient information for sodium benzoate, sodium and sorbitol. The labelling has also been updated.
PIL sections updated – 2, 3, 4, 5 and 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload