Omega Pharma Limited has initiated an urgent recall of its Napralief 250mg Gastro-Resistant Tablets after discovering crucial safety and dosage details were omitted from the product packaging.
The precautionary measure affects three specific batches, which consumers can identify by checking for batch numbers B51496, B51497, and B51102 on their medication boxes.
The painkiller, which contains naproxen as its active ingredient, is a non-steroidal anti-inflammatory drug commonly used to treat conditions ranging from muscle and joint pain to period discomfort.
The Medicines and Healthcare products Regulatory Agency has advised anyone with concerns about their medication to seek medical guidance promptly.
Warnings regarding severe allergic reactions are absent on the packaging
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The affected packaging fails to include the essential warning patients must limit their intake to a maximum of three tablets daily, a critical instruction designed to prevent overuse of the medication.
Furthermore, the patient information leaflet lacks proper guidance on the recommended dosing schedule.
On the initial day of treatment, individuals should consume two tablets, with an additional single tablet taken six to eight hours afterwards.
During the second and third days, if treatment remains necessary, patients ought to take one 250mg tablet at intervals of six to eight hours.
The medication should not be used beyond a three-day period.
The leaflet also omits guidance advising patients to undergo an eye examination should they experience any visual disturbances whilst taking the medication.
Warnings regarding severe allergic reactions are absent, including the important notice that such reactions may occur even in individuals who have never previously experienced sensitivity to painkillers.
Patients are not informed that they should notify their doctor if blood or urine tests are required, as treatment may need to cease 48 hours prior to testing.
Additionally, information concerning heart problems and associated risk factors, autoimmune conditions, mixed connective tissue diseases, and potentially serious skin reactions has been excluded from the documentation.
Dr Alison Cave, MHRA Chief Safety Officer, offered reassurance to patients, stating: “Napralief 250mg is considered safe when used in line with the correct dosage instructions. Although small unintentional dosing mistakes are usually not harmful, complete and accurate safety information is essential to help ensure patients use their medicine correctly.”
Healthcare professionals have been instructed to cease supplying affected batches
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She confirmed individuals may continue using the medication provided they adhere to the proper guidelines.
Healthcare professionals have been instructed to cease supplying the affected batches and return the remaining stock to their suppliers.
Patients who experience any suspected adverse effects should report them through the MHRA Yellow Card scheme while also seeking medical attention.