Omega Pharma Limited is
recalling specific batches of Napralief 250mg
Gastro-Resistant Tablets as a precautionary measure due
to important safety and dosage
information being missing from the patient
information leaflet (PIL) and outer carton.
Napralief 250mg contains the active ingredient
naproxen and is a non-steroidal anti-inflammatory drug
(NSAID) used to treat muscle or joint pain, such as
sprains and strains, inflammation caused 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
be identified by checking the packaging for batch
numbers B51496, B51497, and B51102.
The affected cartons do 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
missing dosage instructions which state
that on the first day patients should take two tablets,
followed by one tablet 6-8 hours later. For the second and
third day of treatment, if needed, 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 information required to use the medicine
safely.
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.”
Patients experiencing any adverse effects or with
questions about their medication should seek medical
advice. Any suspected 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 Class 3 recall 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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