SmPC - Codeine phosphate Tablets BP 15mg: Change history
View Summary of Product Characteristics (SmPC - Codeine phosphate Tablets BP 15mg)
Last updated on this site: 08 Apr 2026
1. To update sections 4.2, 4.4 and 4.8 of the SmPC and the PIL in line with the MHRA letter - risk of OUD for codeine mono-component medicines.
2. To update sections 4.4, 4.5 and 4.8 of the SmPC and the PIL to implement the wording agreed by the PRAC following the outcome of PSUR procedure (PSUSA/00000843/202501).
Date of approval: 31/03/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
Last updated on this site: 08 Apr 2026
1. To update sections 4.2, 4.4 and 4.8 of the SmPC and the PIL in line with the MHRA letter - risk of OUD for codeine mono-component medicines.
2. To update sections 4.4, 4.5 and 4.8 of the SmPC and the PIL to implement the wording agreed by the PRAC following the outcome of PSUR procedure (PSUSA/00000843/202501).
Date of approval: 31/03/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 08 Apr 2026)
1. To update sections 4.2, 4.4 and 4.8 of the SmPC and the PIL in line with the MHRA letter - risk of OUD for codeine mono-component medicines.
2. To update sections 4.4, 4.5 and 4.8 of the SmPC and the PIL to implement the wording agreed by the PRAC following the outcome of PSUR procedure (PSUSA/00000843/202501).
Date of approval: 31/03/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 31 Oct 2023)
Description of update: To add full product description in SmPC Section 3, Add: `White, circular, biconvex uncoated tablets impressed "C" on one face and the identifying letters "CO" on the reverse.' Only SmPC Section 3 is updated. PIL is not affected.
SmPC sections updated: 3 and 10.
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Changes: (Updated: 22 May 2023)
Variation Description: To register M.3.2.P.7 Container Closure System for 20μ Aluminium/250μ PVC blister packaging. Amendments are also made to 3.2.P.1 and SmPC section 6.5.
Note: 3.2.P.1 and SmPC 6.5 have been updated to remove details of heat seal lacquer.
SmPC section(s) updated– 6.5, 10
No changes to artwork
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Changes: (Updated: 22 Sep 2022)
initial upload