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Medicines defect noticeMHRA

Ponstan 250mg Capsules & 500mg Tablets (mefenamic acid) defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batches listed in the tables for Ponstan 250mg capsules and Ponstan Forte 500mg tablets include an out of date PIL, dated March 2020 and January 2021 respectively.

Check your product

Only products that match these details are covered. Have your pack in front of you.

17 identifiers listed for this notice.

  • Ponstan 250mg Capsules & 500mg Tablets (mefenamic acid) 100

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 23I114
    • 23I115
    • 23I120
    • 23I121
    • 23I122
    • 23J153
    • 23J155
    • 23J172
    Product licenceThe PL number on the carton.
    • PL 17736/0006
    • PL 17736/0007
    ExpiryOn the carton, blister or label.
    • Sep-2028
    • Oct-2027
    First distributedOn the product, its label or its packaging.
    • 20Mar2024
    • 25Jan2024
    • 27Mar2024
    • 24Jun2024
    • 22Mar2024

What to do now

The issue with Ponstan 250mg Capsules & 500mg Tablets (mefenamic acid) is information: something on the packaging or leaflet is wrong or missing.

  1. Keep taking your medicine unless a healthcare professional tells you otherwise.
  2. Check the batch number and expiry date on your pack against the list on this page.
  3. If it matches, your pharmacist can swap it or arrange an alternative.
  4. 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

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/40). Quoted as issued.

Summary

Chemidex pharma ltd has informed the MHRA that the patient information leaflet (PIL) in the cartons for the batches listed in the tables for Ponstan 250mg capsules and Ponstan Forte 500mg tablets include an out of date PIL, dated March 2020 and January 2021 respectively.

The risk

DMRC reference number DMRC-31085549 Company name

Advice for healthcare professionals

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing these products. When product from batches included in the tables are supplied or dispensed, please ensure that patients are aware of the missing information.

The electronic versions of the SmPC are up to date and can be accessed via the following links:

Ponstan Capsules 250mg - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Ponstan Forte Tablets 500mg - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk)

Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. This does not affect the quality of the product. There is a warning in the patient information leaflet (PIL) which accompanies the medicine, for the patient to contact their doctor in case of pregnancy. The updated PIL can be accessed via the following link:

Ponstan Capsules 250mg - Patient Information Leaflet (PIL) - (emc) (medicines.org.uk)

Ponstan Forte Tablets 500mg - Patient Information Leaflet (PIL) - (emc) (medicines.org.uk)

If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. If you have concerns about a medicine you may be using, please contact your healthcare professional.

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

Patients should continue to take medicines from the impacted batches as prescribed by your healthcare professional. This does not affect the quality of the product. There is a warning in the patient information leaflet (PIL) which accompanies the medicine, for the patient to contact their doctor in case of pregnancy. The updated PIL can be accessed via the following link:

Ponstan Capsules 250mg - Patient Information Leaflet (PIL) - (emc) (medicines.org.uk)

Ponstan Forte Tablets 500mg - Patient Information Leaflet (PIL) - (emc) (medicines.org.uk)

If you have any concerns about the information provided with your medicine, please speak with your pharmacy team in the first instance. If you have concerns about a medicine you may be using, please contact your healthcare professional.

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 Ponstan 250mg Capsules & 500mg Tablets (mefenamic acid) been recalled?

The issue with Ponstan 250mg Capsules & 500mg Tablets (mefenamic acid) is information: something on the packaging or leaflet is wrong or missing. 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 batch code, product licence, expiry and date code 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?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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