SmPC - Co-codamol 8/500mg Tablets - PL 20075/0702: Change history
View Summary of Product Characteristics (SmPC - Co-codamol 8/500mg Tablets - PL 20075/0702)
Last updated on this site: 07 May 2026
Description of update:
1) To update section 4.4 of the SmPC in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).
2) To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC and sections 2, 3, 4 and 5 PIL in line with PSUSA/00000851/202503 for codeine/paracetamol containing medicines to include the following information: interactions with gabapentinoids, Sphincter of Oddi dysfunction, hyperalgesia, central sleep apnoea (CSA), opioid drug disorder (OUD), storage information. In addition, a spelling has been corrected in SmPC section 4.3 and the leaflet/labelling wording in section 4.4 has been aligned with the current approved text.
Date of approval: 30/04/2026
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8 and 10
Last updated on this site: 07 May 2026
Description of update:
1) To update section 4.4 of the SmPC in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).
2) To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC and sections 2, 3, 4 and 5 PIL in line with PSUSA/00000851/202503 for codeine/paracetamol containing medicines to include the following information: interactions with gabapentinoids, Sphincter of Oddi dysfunction, hyperalgesia, central sleep apnoea (CSA), opioid drug disorder (OUD), storage information. In addition, a spelling has been corrected in SmPC section 4.3 and the leaflet/labelling wording in section 4.4 has been aligned with the current approved text.
Date of approval: 30/04/2026
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 07 May 2026)
Description of update:
1) To update section 4.4 of the SmPC in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).
2) To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC and sections 2, 3, 4 and 5 PIL in line with PSUSA/00000851/202503 for codeine/paracetamol containing medicines to include the following information: interactions with gabapentinoids, Sphincter of Oddi dysfunction, hyperalgesia, central sleep apnoea (CSA), opioid drug disorder (OUD), storage information. In addition, a spelling has been corrected in SmPC section 4.3 and the leaflet/labelling wording in section 4.4 has been aligned with the current approved text.
Date of approval: 30/04/2026
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 06 May 2026)
Description of update: 1) To update section 4.4 of the SmPC in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).
2) To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC and sections 2, 3, 4 and 5 PIL in line with PSUSA/00000851/202503 for codeine/paracetamol containing medicines to include the following information: interactions with gabapentinoids, Sphincter of Oddi dysfunction, hyperalgesia, central sleep apnoea (CSA), opioid drug disorder (OUD), storage information. In addition, a spelling has been corrected in SmPC section 4.3 and the leaflet/labelling wording in section 4.4 has been aligned with the current approved text.
Date of approval: 30/04/2026
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 12 Sep 2025)
IA, B.II.e.1.a.1 – Change in immediate packaging of the finished product – qualitative and quantitative composition – change from Aluminium (9μm)/glassine paper (35g/m2) to Aluminium (25μm)/paper (25g/m2). SmPC Section 6.5 is updated accordingly. [Impl. date = 16/07/2025]
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Changes: (Updated: 03 Jun 2025)
Renewal Approval
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Changes: (Updated: 08 May 2025)
To update sections 4.4, 4.5, 4.8 of the SmPC and the PIL in line with the PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis.
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Changes: (Updated: 10 Apr 2025)
To update sections 4.4, 4.5 and 4.8 of the SmPC to bring in line with the PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis. Consequently, the PIL has been updated.
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Changes: (Updated: 09 Apr 2025)
PRAC update (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis
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Changes: (Updated: 10 Apr 2024)
Description of update: To update section 4.5 of the SPC to bring in line with the Reference product Co-codamol 8/500 Tablets (PL 17780/0510; MAH: Zentiva Pharma UK Limited) dated 16th June 2023.
SmPC Sections updated: 4.5 & 10.
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Changes: (Updated: 19 May 2023)
Variation Description:
1. To update section 4.4 of the SmPC and PIL section 2 to bring in line with the recommendations following MHRA review of myasthenia gravis (SA 19083871).
2. To update section 2 of the PIL in line with the recommendations following MHRA review of CNS depressants (SA 18643283).
The PIL has also been updated to align with the latest QRD template (Version 10.3, 09/2022) as well as the correction of grammar and spelling.
SmPC sections updated- 4.4 and 10.
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Changes: (Updated: 19 May 2023)
Variation Description:
1. To update section 4.4 of the SmPC and PIL section 2 to bring in line with the recommendations following MHRA review of myasthenia gravis (SA 19083871).
2. To update section 2 of the PIL in line with the recommendations following MHRA review of CNS depressants (SA 18643283).
The PIL has also been updated to align with the latest QRD template (Version 10.3, 09/2022) as well as the correction of grammar and spelling.
SmPC sections updated- 4.4 and 10.