The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a defect notification for three batches of Olmesartan medoxomil film-coated tablets after it was found they contain an outdated patient information leaflet (PIL).

The affected batches are:

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  • Olmesartan medoxomil 10mg film-coated tablets (PL 19156/0097) batch MR124001A – expiry date 03/2026 (first distributed 2 October 2024); batch MR124002A – expiry date 03/2026 (first distributed 30 September 2024)
  • Olmesartan medoxomil 20mg film-coated tablets (PL 19156/0098) batch MR224001A – expiry date 04/2026 (first distributed 2 October 2024)

The affected packs include a PIL revised in September 2021. The latest approved leaflet, dated January 2024, contains updated safety information that is not present in the outdated version.

Missing information includes the addition under section 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.’

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Healthcare professionals are advised to take the defect into account when prescribing and dispensing.

Patients receiving stock from the affected batches should be made aware of the missing information and directed to the latest PIL, available from the MHRA website.

 

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