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Medicines defect noticeMHRA

Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV defect notice over a labelling error

Labelling or leaflet errorLow riskClass 4

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.

Check your product

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

7 identifiers listed for this notice.

  • Olmesartan medoxomil 10mg film-coated tablets, Jubilant Pharmaceuticals NV 28 tab/pack

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • MR124001A
    • MR124002A
    • MR224001A
    ExpiryOn the carton, blister or label.
    • 03/2026
    • 04/2026
    First distributedOn the product, its label or its packaging.
    • 02/10/2024
    • 30/09/2024

What to do now

A printing or labelling mistake affects some packs of Olmesartan medoxomil 10mg film-coated tablets, Jubilant.

  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. 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(25)A/37). Quoted as issued.

Summary

Jubilant Pharmaceuticals NV has informed the MHRA that the Patient Information leaflet (PIL) in the cartons for the batches listed in this notification include an outdated PIL.

The risk

DMRC reference number DMRC-34866997 Marketing Authorisation Holder

Advice for healthcare professionals

Healthcare professionals are advised to review the information contained within this notification and take this into account when prescribing this product. When products from batches included in the table are supplied or dispensed, please ensure that patients are aware of the missing information. Please inform the patients that the latest PIL for olmesartan medoxomil film-coated tablets is available. Alternatively, hard copies of the correct PIL will be provided by the Marketing Authorisation Holder upon request, so that any of the affected packs remaining in the dispensary can be supplemented with the correct PIL.

Jubilant can provide printed copy of an updated PIL to HCP’s via safety.uk@lambda-cro.com , or telephone 0800 0668348.

Patients should continue to take medicines from the impacted batch as prescribed by your healthcare professional. This does not affect the quality of the product. There is updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest version of the PIL is available:

The current PIL is missing some information which is presented below:

4. Possible side effects

“Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Olmesartan medoxomil film-coated tablets longer time ago, contact your doctor immediately who will evaluate your symptoms and decide on how to continue your blood pressure medication.”

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 .

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 batch as prescribed by your healthcare professional. This does not affect the quality of the product. There is updated safety information in the latest patient information leaflet (PIL) which accompanies the medicine. The latest version of the PIL is available:

The current PIL is missing some information which is presented below:

4. Possible side effects

“Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Olmesartan medoxomil film-coated tablets longer time ago, contact your doctor immediately who will evaluate your symptoms and decide on how to continue your blood pressure medication.”

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 .

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 Olmesartan medoxomil 10mg film-coated tablets, Jubilant been recalled?

A printing or labelling mistake affects some packs of Olmesartan medoxomil 10mg film-coated tablets, Jubilant. 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, 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?

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.

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