SmPC- Co-codamol 30/500mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Co-codamol 30/500mg Tablets)
Last updated on this site: 09 Apr 2025
To update sections 4.4, 4.5 and 4.8 of the SmPC in line with
PRAC recommendation (EPITT No 20105). Consequently, the
PIL has been updated.
In addition; the national text for the driving warning in PIL section 2 has been updated in line with MHRA guidelines, there are editorial updates to SmPC section 4.5 and the PIL and QRD updates to the PIL.
Last updated on this site: 09 Apr 2025
To update sections 4.4, 4.5 and 4.8 of the SmPC in line with
PRAC recommendation (EPITT No 20105). Consequently, the
PIL has been updated.
In addition; the national text for the driving warning in PIL section 2 has been updated in line with MHRA guidelines, there are editorial updates to SmPC section 4.5 and the PIL and QRD updates to the PIL.
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Changes: (Updated: 09 Apr 2025)
To update sections 4.4, 4.5 and 4.8 of the SmPC in line with
PRAC recommendation (EPITT No 20105). Consequently, the
PIL has been updated.
In addition; the national text for the driving warning in PIL section 2 has been updated in line with MHRA guidelines, there are editorial updates to SmPC section 4.5 and the PIL and QRD updates to the PIL.
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Changes: (Updated: 21 Feb 2024)
Description of update: To update SmPC sections 4.4 and 5.1 of the SmPC in line with the reference product, Solpadol 30mg/500mg Caplets. Consequently, the PIL has been updated. Additionally, section 4.8 of the SmPC and the leaflet have editorial updates and updates in line with MedDRA and to align the pharmacotherapeutical group naming in section 5.1 of the SmPC with the WHO ATC Index.
SmPC Sections updated: 4.4, 4.8, 5.1 and 10.
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Changes: (Updated: 04 Sep 2023)
New product launch.
Launch date: 01/09/2023.