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Medicines defect noticeMHRA

Gepretix 100mg Capsules defect notice over a packaging defect

Packaging or device defectLow riskClass 4

Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.

Check your product

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

14 identifiers listed for this notice.

  • Gepretix 100mg Capsules 30 capsules

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • LF32022A
    • LF32119A
    • LF32120A
    • LF33488A
    • LF33513A
    Product licenceThe PL number on the carton.
    • PL 44081/0009
    ExpiryOn the carton, blister or label.
    • Jul 2025
    • Aug 2025
    • Nov 2025
    First distributedOn the product, its label or its packaging.
    • 27 September 2023
    • 17 October 2023
    • 23 November 2023
    • 04 January 2024
    • 30 January 2024

What to do now

The problem with Gepretix 100mg Capsules is the pack or device, such as a syringe, cap, blister or inhaler.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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/04). Quoted as issued.

Summary

Exeltis UK Limited has informed the MHRA regarding an inconsistency in the Patient Information Leaflet (PIL) packaged in cartons of the specified batches of Gepretix 100mg capsules.

The risk

MDR number MDR 264-01/24 Company name

Advice for healthcare professionals

Healthcare professionals are recommended to reiterate the prescribed dosage to their patients and to ensure that patients follow the dispensing advice. The product quality of Gepretix 100mg capsules is not impacted by this issue, therefore the affected batches are not being recalled.

The manufacturer has confirmed that the batch distributed on 30 January 2024 will be accompanied by a note explaining the issue to supplement dispensing at pharmacies. These batches will not be repackaged to avoid any supply concerns. Exeltis UK Limited have confirmed that all future batches of the product will contain the corrected PIL.

No action is needed from patients. The issue is related to inconsistencies contained within the Patient Information Leaflet of the specified batches of Gepretix 100mg capsules. The quality of the medication itself is not affected. Patients should continue to take medicines from these batches as prescribed by their healthcare professional and as per the advice on the dispensing label.

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

No action is needed from patients. The issue is related to inconsistencies contained within the Patient Information Leaflet of the specified batches of Gepretix 100mg capsules. The quality of the medication itself is not affected. Patients should continue to take medicines from these batches as prescribed by their healthcare professional and as per the advice on the dispensing label.

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 Gepretix 100mg Capsules been recalled?

The problem with Gepretix 100mg Capsules is the pack or device, such as a syringe, cap, blister or inhaler. A faulty cap, seal, syringe or inhaler can mean a missed or wrong dose, or contamination of the product.

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?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

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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