Health officials have recalled specific batches of the painkiller Napralief due to missing information concerning potential health risks, including overdose and allergic reactions.

Recall Details

The recall affects batches B51496, B51497, and B51102 of Napralief, a brand name for naproxen. This anti-inflammatory medication is widely used in the UK for conditions like arthritis, gout, menstruation pain, muscle strains, and bone inflammation.

Safety Concerns

The Medicines and Healthcare products Regulatory Agency (MHRA) initiated the recall after discovering that certain batches lack a comprehensive Patient Information Leaflet (PIL). This leaflet is crucial for safe medication use.

Missing Information

The PIL omits vital warnings, including the maximum daily dosage (three tablets within 24 hours) and initial dosage instructions (two tablets on day one, then one every 6-8 hours). It also fails to advise an eye examination for vision disturbances.

Furthermore, the leaflet doesn't detail potential severe allergic reactions, the need to inform doctors before blood/urine tests (medication may need to be stopped 48 hours prior), or risks related to heart problems, autoimmune diseases, and serious skin reactions.

MHRA Guidance

Dr. Alison Cave, MHRA Chief Safety Officer, stated that Napralief 250mg is safe when used correctly. However, she emphasized the importance of complete safety information for responsible use.

Patients currently using the affected batches should adhere to the correct dosage: two tablets on the first day, then one tablet every 6-8 hours, with a maximum of three tablets daily, and not exceeding three days of treatment.

Reporting Adverse Effects

Individuals experiencing adverse effects should seek medical attention and report the incident to the MHRA’s Yellow Card scheme.

Action for Healthcare Professionals

The MHRA has instructed healthcare professionals to stop selling the affected batches and return them to suppliers. This aims to prevent further distribution of potentially unsafe medication.