Pharmacists have been advised to make patients aware of incorrect patient information leaflets (PILs) included in one batch of erythromycin tablets.
The Medicines and Healthcare products Regulatory Agency (MHRA) said in a notification issued yesterday that it had been informed by Amdipharm UK Ltd that the batch included a ‘superseded’ PIL which is ‘missing important updated safety information’.
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The affected product is Erythromycin Stearate BP 250mg Tablets (Erythrocin 250 Tablets), batch number 6104532, with an expiry date of August 2028. The batch was first distributed on 4 September 2024 and has a pack size of 100 tablets.
According to the notification, the PILs in this batch contain superseded information and omit updated safety guidance, including warnings about interactions with lomitapide and corticosteroids, and information on use in pregnancy and breastfeeding.
The omissions stem from a failure to update the leaflet in line with recent recommendations from the Pharmacovigilance Risk Assessment Committee (PRAC).
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However, there is no risk to product quality or safety from the tablets themselves, and pharmacists are advised that they may continue to dispense the affected batch, while also informing patients of the missing safety information and offering the correct PIL where possible.
Patients who experience adverse reactions or have any questions about their medication have been advised to seek medical attention, and to report suspected adverse reactions via the MHRA Yellow Card scheme.
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Erythromycin is an antibiotic widely used to treat chest infections, such as pneumonia, skin conditions, such as acne and rosacea, dental abscesses, and sexually transmitted infections.
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