The Medicines and Healthcare products Regulatory Agency (MHRA) has issued advice to pharmacists about batches of soluble or effervescent paracetamol tablets manufactured by Zentiva Pharma UK Limited.

The tablets are taking longer than expected to fully dissolve, resulting in an increase in residue. Medications affected include:

- Zentiva Paracetamol Soluble Tablets PL 17780/0198

- Zentiva Paracetamol Soluble Tablets PL 17780/0162

- Zentiva Co-Codamol 8/500 Effervescent Tablets PL 17780/0072

- Zentiva Co-Codamol 8/500 Effervescent Tablets PL 17780/0511

Affected batch numbers for each medicine can be viewed here in Annex 1, Annex 2 and Annex 3.

The batches listed as ‘not yet distributed’ may also behave in the same way, the MHRA said.

The MHRA considers that there is no patient safety, quality or efficacy risk due to these issues.

It has included them in the notification and the expected distribution dates for these batches will take place from 2 June 2025. These products are fast moving, it says, and the batches listed are expected to be consumed within six months.

It advises healthcare professionals to:

· Tell the patient that there may be an increased length of time required for the tablets to dissolve (approximately five minutes)

· The tablets should be dissolved in a full glass of water (approximately 200 ml) and stirred before drinking

· If after drinking there are residual particles left in the glass, then they should add more water (approximately 100 ml) and stir before drinking

· The effectiveness of the tablets is not affected by this longer dissolving time

· Tell the patient that some tablets may appear to have a slightly rough or uneven surface on one side, but this does not affect the effectiveness of the tablet.

The MHRA has advised patients to continue to take tablets from these batches as prescribed by their healthcare professional and that the effectiveness of the tablets is not affected by this longer dissolving time.

It added that if patients notice a significant change in the tablet appearance or have any other concerns, to contact their pharmacist.

Patients who experience adverse reactions or have any questions about their medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

In March, almost 120,000 packs of Boots Paracetamol were recalled because of a packaging error where they were incorrectly labelled as Aspirin on the foil blister.