PIL - Co-codamol 8mg/500mg Effervescent Tablets (PL 20075/0516): Change history
View Patient Information Leaflet (PIL - Co-codamol 8mg/500mg Effervescent Tablets (PL 20075/0516))
Last updated on this site: 22 Apr 2026
SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL have been updated in line with PSUSA/00000851/202503 recommendations for Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), Opioid drug disorder (OUD), and the need to store the product in a safe and secure place. Additional amendments have been made to the SmPC and PIL to align with QRD and to correct typographical errors and grammar.
Date of approval: 20/04/2026
PIL sections updated: Index, 1, 2, 3, 4, 5 and 6
Last updated on this site: 22 Apr 2026
SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL have been updated in line with PSUSA/00000851/202503 recommendations for Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), Opioid drug disorder (OUD), and the need to store the product in a safe and secure place. Additional amendments have been made to the SmPC and PIL to align with QRD and to correct typographical errors and grammar.
Date of approval: 20/04/2026
PIL sections updated: Index, 1, 2, 3, 4, 5 and 6
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Changes: (Updated: 22 Apr 2026)
SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL have been updated in line with PSUSA/00000851/202503 recommendations for Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), Opioid drug disorder (OUD), and the need to store the product in a safe and secure place. Additional amendments have been made to the SmPC and PIL to align with QRD and to correct typographical errors and grammar.
Date of approval: 20/04/2026
PIL sections updated: Index, 1, 2, 3, 4, 5 and 6
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Changes: (Updated: 22 Apr 2026)
Description of update:
SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL have been updated in line with PSUSA/00000851/202503 recommendations for Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), Opioid drug disorder (OUD), and the need to store the product in a safe and secure place. Additional amendments have been made to the SmPC and PIL to align with QRD and to correct typographical errors and grammar.
Date of approval: 20/04/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10.
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Changes: (Updated: 30 Jun 2025)
Description of update: IB, C.I.3.a - PRAC update (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis.
PIL sections updated: 2, 4 and 6.
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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