LONDON, April 23 -- The government of the United Kingdom issued the following news:

Omega PharmaLimited is recallingspecificbatchesofNapralief 250mg Gastro-Resistant Tabletsas a precautionary measure due toimportant safety and dosage informationbeingmissing fromthe patient information leaflet (PIL) and outer carton.

Napralief250mgcontainsthe active ingredient naproxen and is anon-steroidal anti-inflammatory drug (NSAID) used totreatmuscle or joint pain, such as sprains and strains,inflammationcaused by sporting injuries, lower back pain, neck pain or pain in the wrists or feet. It is also used to treat period pain.

Three batches are affected by this recall. These can beidentifiedby checking the packagingfor batch numbers B51496, B51497, and B51102.

Theaffectedcartonsdo not include the instruction that patients must not take more than three tablets a day, which is a key dosage safety message intended to prevent overuse.

In addition, the PIL is missingdosageinstructionswhich state thaton the first day patients should take two tablets, followed by one tablet 6-8 hours later.For the second and third day oftreatment, ifneeded, one tablet (250mg)should be taken every 6-8 hours.

The PIL is also missing 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.

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 informationrequiredto use the medicine safely.

Dr Alison Cave, MHRA Chief Safety Officer, said: 

"Napralief250mgis considered safe when used in line with the correct dosage instructions. Althoughsmall unintentional dosing mistakesare usually not harmful, completeandaccuratesafety informationis essential to help ensure patients use their medicine correctly.

"Patients cancontinue to use the medicine safely in line with the correct safety and dosageinstructions.Patients shouldtake two tabletson the first day, followed by one tablet 6-8 hours later. For the second and third day of treatment, if needed, onetablet shouldbe taken every 6-8 hours.Napralief should not be taken for more than three days."

Patientsexperiencing any adverse effectsor with questions about their medication should seek medical advice. Anysuspected adverse reactions should also 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.

Notes to editors    

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Please see MHRA's Class3recall for further information.

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The MHRA is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.  

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The MHRA is an executive agency of the Department of Health and Social Care.    

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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.

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