However, Infarmed advises patients currently taking the medicine not to stop, but to contact their doctor instead. The medicine in question is Salofalk, Mesalazine 300mg prolonged-release gastro-resistant granules, which is sold in boxes of 60 sachets. Infarmed states that this concerns batch L25428A, which is valid until November 2029.

The measure concerns Salofalk, Mesalazine 3000 mg prolonged-release gastro-resistant granules, sold in packs of 60 sachets. According to the circular published by Infarmed, the batch in question is L25428A, valid until November 2029.

The decision was taken because a problem was identified in the product’s serialisation: “a deviation related to the serialisation of this batch was detected”. Infarmed also states that entities holding this batch are prohibited from selling it and must return it.

Salofak contains mesalazine as its active ingredient and is an anti-inflammatory medicine used to treat inflammatory bowel diseases, such as ulcerative colitis. The medicine belongs to the aminosalicylate group and acts on the intestinal mucosa to reduce inflammation.