PIL - Codeine Phosphate 15mg, 30mg, 60mg Tablets: Change history
View Patient Information Leaflet (PIL - Codeine Phosphate 15mg, 30mg, 60mg Tablets)
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: 12 Jan 2024)
Description of update: To amend the packaging components without the need to amend the SmPC. Changes notified are: To register the replacement of the leaflet aligning the product description in Section 6 with section 3 of the SmPC. To replace ‘’Codeine Phosphate 15mg Tablets are white, uncoated tablets.’’ with ‘’Codeine Phosphate 15mg Tablets are white, circular, biconvex uncoated tablets impressed "C" on one face and the identifying letters "CO" on the reverse.’’ Additional editorial changes applied in the leaflet: semicolon replaced with colon.
PIL sections updated: 2, 4 and 6.
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Changes: (Updated: 22 Sep 2022)
initial upload