PIL - Naproxen 250mg Gastro-resistant Tablets (PL 20075/0619): Change history
View Patient Information Leaflet (PIL - Naproxen 250mg Gastro-resistant Tablets (PL 20075/0619))
Last updated on this site: 05 Sep 2024
To update sections 4.4 and 4.8 of the SmPC in line with PRAC recommendation (PSUSA/02125/202308) regarding adverse reactions DRESS and Fixed Drug Eruption. Consequently, the PIL has been updated.
Last updated on this site: 05 Sep 2024
To update sections 4.4 and 4.8 of the SmPC in line with PRAC recommendation (PSUSA/02125/202308) regarding adverse reactions DRESS and Fixed Drug Eruption. Consequently, the PIL has been updated.
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Changes: (Updated: 2024-09-05T10:38:14.000000Z)
To update sections 4.4 and 4.8 of the SmPC in line with PRAC recommendation (PSUSA/02125/202308) regarding adverse reactions DRESS and Fixed Drug Eruption. Consequently, the PIL has been updated.
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Changes: (Updated: 2024-07-11T14:59:59.000000Z)
Removal of beeswax as an excipient in section 6
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Changes: (Updated: 2023-12-27T15:47:55.000000Z)
Description of update:
To update sections 4.4, 4.7, 4.8, 4.9 and 5.1 of the SmPC fragment following the reference product comparison with the new reference product of Noumed Period Pain Relief 250 mg Gastro-Resistant Tablets. Consequently, the PIL is updated.
PIL sections updated: 2, 3 and 6.
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Changes: (Updated: 2023-06-28T07:47:06.000000Z)
Variation Description: To update sections 4.4 and 4.8 of the SmPC to bring in line with PRAC recommendations (PSUSA/00001270/202204) for Esomeprazole-Naproxen for Tubulointerstitial nephritis. Consequently, the PIL has been updated.
SmPC sections updated – 4.4, 4.8 and 10.
PIL sections updated – 2 and 6.