SmPC - Co-codamol 8 mg/500 mg effervescent tablets: Change history
View Summary of Product Characteristics (SmPC - Co-codamol 8 mg/500 mg effervescent tablets)
Last updated on this site: 17 Apr 2024
Description of update: To update sections 4.4, 4.5 and 4.9 of the SPC to bring in line with the Reference product, Co-codamol 8/500 Effervescent Tablets - PL 17780/0072 (MAH: Zentiva Pharma UK Limited. Consequently, the leaflet (PIL) is being updated.
SmPC Sections updated: 4.4, 4.5, 4.9 and 10.
Last updated on this site: 17 Apr 2024
Description of update: To update sections 4.4, 4.5 and 4.9 of the SPC to bring in line with the Reference product, Co-codamol 8/500 Effervescent Tablets - PL 17780/0072 (MAH: Zentiva Pharma UK Limited. Consequently, the leaflet (PIL) is being updated.
SmPC Sections updated: 4.4, 4.5, 4.9 and 10.
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Changes: (Updated: 17 Apr 2024)
Description of update: To update sections 4.4, 4.5 and 4.9 of the SPC to bring in line with the Reference product, Co-codamol 8/500 Effervescent Tablets - PL 17780/0072 (MAH: Zentiva Pharma UK Limited. Consequently, the leaflet (PIL) is being updated.
SmPC Sections updated: 4.4, 4.5, 4.9 and 10.
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Changes: (Updated: 10 Apr 2024)
Description of update: To register the additional pack size of 24s in blister packs for Co-codamol 8mg/500mg effervescent tablets, Zipamol PLUS 8mg/500mg effervescent tablets and for Own Label Supplier Boots for Paracetamol & Codeine 500mg/8mg Effervescent Tablets with consequential new cartons pack size 24s and updates to leaflets. Consequential updates are made to SmPC section 6.5. The current approved foils will also be used for the 24s pack. Minor editorial corrections are also made to the existing pack size 32s cartons for Co-codamol 8mg/500mg effervescent tablets and Zipamol PLUS 8mg/500mg effervescent tablets and leaflets.
SmPC Sections updated: 6.5 & 10.
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Changes: (Updated: 19 May 2023)
Variation Description: 1) To update section 4.4 of the SmPC and section 2 of the PIL to include cautionary warning to patients with myasthenia gravis.
2) To update section 4.4 of the SmPC and section 2 of the PIL to highlight the drug interaction between co-codamol and antidepressants.
3) Typographical amendments to the PIL.
SmPC sections updated- 4.4 and 10.