Omega Pharma recalls specific Napralief 250 mg tablet batches due to missing dosage and safety information on packaging and patient leaflets, MHRA reports.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
Omega Pharma Limited has initiated a precautionary recall of specific batches of Napralief 250 mg gastro-resistant tablets due to incomplete safety and dosage information on both the patient information leaflet and outer packaging, according to the Medicines and Healthcare products Regulatory Agency (MHRA).
The affected batches, identified as B51496, B51497, and B51102, contain naproxen, a non-steroidal anti-inflammatory drug used to treat musculoskeletal pain such as sprains, strains, back and neck pain, and period pain.
Regulators reported that the outer carton omits a key instruction limiting intake to a maximum of three tablets per day, while the patient leaflet lacks essential dosing guidance, including taking two tablets on the first day followed by one tablet after 6–8 hours, and then one tablet every 6–8 hours on days two and three if needed, with use not exceeding three days.
The leaflet also excludes important safety warnings, including advice to seek an eye examination if visual disturbances occur, information on the risk of serious allergic reactions even in patients without prior sensitivity to painkillers, and guidance to inform healthcare providers before undergoing blood or urine tests, as treatment may need to be stopped 48 hours in advance. Additional omissions relate to cardiovascular risks, autoimmune or connective tissue disorders, and the potential for severe skin reactions, raising concerns that patients may not receive sufficient information for safe use.
MHRA Chief Safety Officer Alison Cave stated that naproxen-containing medicines remain safe when used according to correct dosing instructions, noting that while minor dosing errors are unlikely to cause harm, complete and accurate information is essential.
Patients are advised they may continue using the medicine if they follow the correct dosing schedule, while healthcare professionals have been instructed to stop supplying the affected batches and return remaining stock.
Patients experiencing adverse effects or with concerns should seek medical advice and report suspected side effects through the MHRA Yellow Card Scheme.
Reference
About the Writer
Vennela Reddy, B Pharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.
