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Packs of a popular painkiller have been recalled by health chiefs over patient safety concerns.
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 such as arthritis and gout, as well as period pain and muscle or bone inflammation.
But the Medicines and Healthcare products Regulatory Agency (MHRA) say that certain batches are missing vital information regarding potential health risks connected to the medications, including overdose.
For that reason, they have issued a recall notice for the pills, manufactured by Omega Pharma Limited, that have the batch codes B51496, B51497, and B51102 printed on the packaging.
The missing information leaflet includes a warning not to take more than three tablets in one day, which is important in helping to prevent overdose.
‘In addition, the PIL is missing dosage instructions which state that on the first day patients should take two tablets, followed by one tablet 6-8 hours later,’ the MHRA said.
‘For the second and third day of treatment, if needed, one tablet (250mg) should be taken every 6–8 hours.’
The MHRA said the leaflet for the affected drugs should also advise patients to seek an eye examination if they develop vision disturbances.
Packs of a naproxen painkiller have been recalled by health chiefs over patient safety concerns
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.
The MHRA add: ‘In addition, some 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 of these omissions, patients may not receive the full information required to use the medicine safely.
Dr Alison Cave, MHRA Chief Safety Officer, said: ‘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. Patients 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 told to seek medical advice, and lodge a report with 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.
