Medicines defect noticeMHRA
Paracetamol 500mg Effervescent Tablets defect notice over a labelling error
Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.
Check your product
Only products that match these details are covered. Have your pack in front of you.
2 identifiers listed for this notice.
Paracetamol 500mg Effervescent Tablets
- Product licenceThe PL number on the carton.
- PL 51463/0031
- PL 51463/0032
What to do now
A printing or labelling mistake affects some packs of Paracetamol 500mg Effervescent Tablets.
- Keep taking your medicine unless a healthcare professional tells you otherwise.
- Check the batch number and expiry date on your pack against the list on this page.
- If it matches, your pharmacist can swap it or arrange an alternative.
- Report suspected side effects to the MHRA Yellow Card scheme.
Why it matters. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
Symptoms and when to get help
Look out for
- a side effect you have not had before
- your condition not being controlled as well as usual
Get help urgently
- signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
- if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111
This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.
Replacements and prescriptions
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping.
An affected pack bought over the counter can be returned to where you bought it.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/49). Quoted as issued.
Summary
Kent Pharma UK has identified an error in the Patient Information Leaflet (PIL) for Paracetamol 500mg Effervescent Tablets.
The risk
DMRC reference number DMRC-32772688 Company name
Advice for healthcare professionals
Whilst the correct sodium content per single dosage is provided on the product carton and in the Summary of Product Characteristics (SmPC), healthcare professionals should be aware that the PIL contains incorrect information regarding the sodium content of the maximum daily dosage of product.
When selling or dispensing all batches of this medicine, where possible, advise patients of the correct sodium levels as per the carton. As noted in the PIL, patients should be advised to speak to their pharmacist or doctor if they need effervescent paracetamol on a daily basis for a prolonged period of time, especially if they have been advised to follow a low salt diet.
The leaflet included with Paracetamol 500mg Effervescent Tablets contains incorrect information about the sodium content in the maximum daily dose for this medicine. The correct sodium content per single dose is provided on the product carton. Each tablet contains 438mg of sodium and maximum amount of sodium that would be consumed will be 3504mg sodium, based on taking the maximum of eight (8) paracetamol tablets in 24 hours.
Patients, especially those on low-sodium diets, are advised to consult their healthcare professional if they need effervescent paracetamol over a prolonged period of time.
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Advice for patients
The leaflet included with Paracetamol 500mg Effervescent Tablets contains incorrect information about the sodium content in the maximum daily dose for this medicine. The correct sodium content per single dose is provided on the product carton. Each tablet contains 438mg of sodium and maximum amount of sodium that would be consumed will be 3504mg sodium, based on taking the maximum of eight (8) paracetamol tablets in 24 hours.
Patients, especially those on low-sodium diets, are advised to consult their healthcare professional if they need effervescent paracetamol over a prolonged period of time.
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .
Open the MHRA notice
Questions
Why has Paracetamol 500mg Effervescent Tablets been recalled?
A printing or labelling mistake affects some packs of Paracetamol 500mg Effervescent Tablets. Wrong strengths, expiry dates or dosing instructions on a pack can lead to the medicine being taken incorrectly, even though the medicine itself is fine.
How do I know if my medicine is affected?
Compare the product licence on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.
What should I do now?
Keep taking your medicine unless a healthcare professional tells you otherwise. Check the batch number and expiry date on your pack against the list on this page.
Do I need a new prescription?
The MHRA notice tells pharmacies and healthcare professionals what to do. Patients should keep taking their medicine and ask a pharmacist before stopping. An affected pack bought over the counter can be returned to where you bought it.