PIL- Co-codamol 15 mg/500 mg Effervescent Tablets: Change history
View Patient Information Leaflet (PIL- Co-codamol 15 mg/500 mg Effervescent Tablets)
Last updated on this site: 10 Nov 2023
Last updated on this site: 10 Nov 2023
Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.8 and 4.9 in line with the new proposed reference product Solpadol 30mg/500mg Effervescent Tablets (PL 53886/0072, MAH: Opella Healthcare UK Limited). Consequentially, the PIL has been updated. Further editorial updates have been made to the PIL.
PIL sections updated: Introduction, 1, 2, 3, 4 and 6.
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Changes: (Updated: 10 Nov 2023)
Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.8 and 4.9 in line with the new proposed reference product Solpadol 30mg/500mg Effervescent Tablets (PL 53886/0072, MAH: Opella Healthcare UK Limited). Consequentially, the PIL has been updated. Further editorial updates have been made to the PIL.
PIL sections updated: Introduction, 1, 2, 3, 4 and 6.
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Changes: (Updated: 19 May 2023)
Variation Description: 1) To update section 4.4 of the SmPC and section 2 of the PIL to include cautionary warning to patients with myasthenia gravis.
2) To update section 4.4 of the SmPC and section 2 of the PIL to highlight the drug interaction between co-codamol and antidepressants.
3) Typographical amendments to the PIL.
PIL sections updated- Heading, 2, 4, 5 and 6.
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Changes: (Updated: 22 Sep 2022)
initial upload