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Olmesartan Medoxomil 10mg and 20mg PIL error

Missing safety information

August 25th 2023

Tagged: MHRA alert


Accord Healthcare Limited, UK is advising of a PIL error in certain batches of Olmesartan Medoxomil 10mg and 20mg film coated tablets:

Olmesartan Medoxomil 10mg film coated tablets

Batch No Expiry Date Pack Size First Distributed
M2213437 08/2025 2X14T 28/06/2023
M2213708 08/2025 2X14T 09/05/2023
M2213819 08/2025 2X14T 31/03/2023
M2303226 04/2026 2X14T 16/05/2023


Olmesartan Medoxomil 20mg film coated tablets

Batch No Expiry Date Pack Size First Distributed
M2203689 02/2025 2X14T 31/01/2023

In affected batches, the PIL does not include the most up to date safety information regarding the signs and symptoms of liver issues and the need to seek medical advice if they occur.

The information missing from the PILs is included below:

“Section 4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

Although not many people may get them, the following side effects can be serious:
If you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started therapy with Olmesartan Medoxomil a longer time ago, contact your doctor immediately who will evaluate your symptoms and decide on how to continue your blood pressure medication.”

Affected batches are not being recalled.