PIL- Co-codamol 8mg/500mg Effervescent Tablets: Change history
View Patient Information Leaflet (PIL- Co-codamol 8mg/500mg Effervescent Tablets)
Last updated on this site: 03 Oct 2024
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1 and 5.2 of the SmPC and PIL in line with the reference product Co-Codamol 8/500mg Capsules (PL 42176/0007; MAH: Lucis Pharma Limited) dated 03/06/2024. In addition, editorial updates have been made to PIL.
SmPC section 6.1 and the PIL have been updated to remove "anhydrous" from two excipients, in line with the 9th edition Pharmeuropa and section 4.4 of the SmPC has been updated with excipient Sodium and Sorbitol to be in line with the PIL.
Last updated on this site: 03 Oct 2024
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1 and 5.2 of the SmPC and PIL in line with the reference product Co-Codamol 8/500mg Capsules (PL 42176/0007; MAH: Lucis Pharma Limited) dated 03/06/2024. In addition, editorial updates have been made to PIL.
SmPC section 6.1 and the PIL have been updated to remove "anhydrous" from two excipients, in line with the 9th edition Pharmeuropa and section 4.4 of the SmPC has been updated with excipient Sodium and Sorbitol to be in line with the PIL.
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Changes: (Updated: 03 Oct 2024)
To update sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1 and 5.2 of the SmPC and PIL in line with the reference product Co-Codamol 8/500mg Capsules (PL 42176/0007; MAH: Lucis Pharma Limited) dated 03/06/2024. In addition, editorial updates have been made to PIL.
SmPC section 6.1 and the PIL have been updated to remove "anhydrous" from two excipients, in line with the 9th edition Pharmeuropa and section 4.4 of the SmPC has been updated with excipient Sodium and Sorbitol to be in line with the PIL.
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Changes: (Updated: 26 Jun 2023)
Website administration update only- no change to file.
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Changes: (Updated: 16 Jun 2023)
Description of update: To update section 4.4 of the SmPC in line with MHRA request to harmonise product information wording in patients with myasthenia gravis. Consequently, the PIL has been updated.
PIL sections updated: 2, 6.
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Changes: (Updated: 05 Jan 2023)
Initial upload