Key Summary
- The manufacturer recalled three batches of Napralief 250 mg Gastro-Resistant Tablets as a precautionary measure.
- The PIL and carton carried incomplete information regarding the medicine.
- No harm is reported by the patients who had consumed medicines from the specific batches.
Omega Pharma Limited is recalling specific batches of Napralief 250mg Gastro-Resistant Tablets due to the absence of safety and dosage information in the patient information leaflet (PIL) and outer carton.
The drug with the active ingredient naproxen is a non-steroidal anti-inflammatory medicine (NSAID) consumed for muscle or joint pain, inflammation from sporting injuries, lower back pain, neck pain or pain in the wrists or feet, and period pain.
The medicines of batch numbers B51496, B51497 and B51102 are recalled as a precautionary measure to ensure patient safety.
They were recalled as those cartons did not have the guidance that advised patients not to take more than three tablets a day, to prevent overdose.
Along with this, Napralief’s PIL also skipped information that stated that patients should only take two tablets on the first day, followed by one tablet 6 to 8 hours later.
One tablet (250mg) can be consumed every 6 to 8 hours, if needed for the second and third day.
The advice to get patients’ eyes checked in case of any visual disturbances, which could be an allergic reaction to the medicine, along with blood and urine tests are also omitted in the PIL.
There is no information on possibilities of heart problems, certain autoimmune or mixed connective tissue diseases, and serious skin allergies.
“Patients can continue to use the medicine safely in line with the correct safety and dosage instructions,” commented Dr Alison Cave, MHRA chief safety officer.
She added, “Napralief should not be taken for more than three days.”
Although no patient harm is reported, the recall decision advices patients to seek immediate medical help incase of any adverse reactions.
Similarly, health professionals are urged to stop supplying the medicines from these batches and to return the stock to the suppliers.
