Health chiefs have recalled packs of a popular painkiller due to concerns over patient safety. Napralief, sold by retailers such as Boots and Superdrug, is a brand name for the anti-inflammatory drug naproxen, taken by thousands of Britons to treat conditions including arthritis, gout, period pain, and muscle or bone inflammation.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a recall notice for specific batches manufactured by Omega Pharma Limited. The affected batches, identified by codes B51496, B51497, and B51102 on the packaging, lack vital information regarding potential health risks, including overdose.
The missing patient information leaflet (PIL) includes a warning not to take more than three tablets in one day, which is crucial in preventing overdose. Additionally, the leaflet should contain dosage instructions stating that on the first day, patients should take two tablets, followed by one tablet 6-8 hours later. For the second and third day of treatment, if needed, one tablet (250mg) should be taken every 6-8 hours.
The MHRA also noted that the leaflet for the affected drugs should advise patients to seek an eye examination if they develop vision disturbances. Other missing warnings include that serious allergic reactions can occur even in people with no previous allergy to painkillers, and that patients should inform their doctor if blood or urine tests are needed, as treatment may need to be stopped 48 hours beforehand.
Furthermore, information relating to heart problems and associated risk factors, certain autoimmune or mixed connective tissue diseases, and potential serious skin reactions is also missing. As a result, patients may not receive the full information required to use the medicine safely.
Dr Alison Cave, MHRA Chief Safety Officer, stated: '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.'
Patients can continue to use the medicine safely in line with the correct safety and dosage instructions. They should take two tablets on the first day, followed by one tablet 6-8 hours later. For the second and third day of treatment, if needed, one tablet should be taken every 6-8 hours. Napralief should not be taken for more than three days.
Any patients who have experienced adverse effects from taking the medication have been advised to seek medical advice and report the issue via the MHRA's Yellow Card scheme. Meanwhile, the MHRA has advised healthcare professionals to stop the sale of the affected batches and return stock to their suppliers.
