SmPC - Zipamol™ PLUS 8 mg/500 mg Effervescent Tablets: Change history

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.

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.

Variation Description:

To update sections 4.3, 4.4, 4.6, 4.8, 4.9, 5.1, 5.3 and 6.1 of the SmPC in line with reference product Co-codamol 8/500 Effervescent Tablets.

Additionally, the excipient warnings for sodium and sorbitol in SmPC section 4.4 and PIL section 2, have been updated in line with the latest EC guidelines on excipients (EMA/CHMP/302620/2017) and corresponding PRAC recommendations.

SmPC section 6.1. and PIL section 6 have been updated to remove the word ‘anhydrous’ in line with the EP 9th edition, hydrates list.

 SmPC sections updated – 4.3, 4.4, 4.6, 4.8, 4.9, 5.1, 5.3, 6.1 and 10

initial upload