Patients using the common painkiller Napralief have been issued an urgent warning after safety concerns prompted a recall of specific batches. Omega Pharma Limited is recalling three batches of Napralief 250mg Gastro-Resistant Tablets as a precautionary measure because important safety and dosage information is missing from the patient information leaflet (PIL) and outer carton.
What is Napralief?
Napralief contains naproxen, a non-steroidal anti-inflammatory drug (NSAID) used to treat muscle or joint pain, such as sprains and strains, inflammation from sporting injuries, lower back pain, neck pain, or pain in the wrists or feet. It is also used for period pain.
Affected Batches
Three batches are affected: B51496, B51497, and B51102. Patients should check their packaging for these batch numbers.
Missing Information
The affected cartons lack the instruction that patients must not take more than three tablets a day, a key dosage safety message to prevent overuse. The PIL is also missing dosage instructions: on the first day, patients should take two tablets, followed by one tablet 6-8 hours later. For the second and third day, if needed, one tablet (250mg) should be taken every 6-8 hours.
Additionally, the PIL omits advice that patients should have an eye examination if they develop visual disturbances, warnings that serious allergic reactions can occur even in people with no previous allergy to painkillers, and guidance to inform a doctor if blood or urine tests are needed, as treatment may need to be stopped 48 hours before testing. Information about heart problems and associated risk factors, certain autoimmune or mixed connective tissue diseases, and potential serious skin reactions is also missing.
Official Statement
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.”
Advice for Patients and Healthcare Professionals
Patients experiencing any adverse effects or with questions about their medication should seek medical advice. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme. The MHRA has advised healthcare professionals to stop supplying the affected batches and return all remaining stock to their suppliers.
