|
answer text |
<p>Metamizole is a medicine used in some European Union countries to treat severe
pain and fever. Metamizole magnesium is authorised in Spain, Portugal and Poland (as
a generic medicine and under various brand names including Nolotil in Spain and Portugal
and Pyralgina in Poland). The medicine has not been licensed for use in the United
Kingdom.</p><p>As with all medicines, the safety of metamizole is kept under close
review within the EU. A European review was conducted last year to assess all data
available concerning the maximum daily dose and its contraindications on pregnancy
and breastfeeding. This review was completed in December 2018 and led to agreement
of harmonised information on the maximum dose to be used and that it should not be
used during the third trimester of pregnancy. It was also recommended that use during
breast-feeding should be avoided. As a result, consistent warnings will be available
in the product information for patients and healthcare professionals within each country
where authorised for use.</p><p>A recent evaluation by the European Pharmacovigilance
Risk Assessment Committee noted reports of cases of agranulocytosis (lowered white
blood cell count) which had occurred in UK residents in Spain. Agranulocytosis is
a known risk of metamizole and is described in the product information for healthcare
professionals. However, based on the review of available data, the Spanish Medicines
Agency has taken further action to strengthen the warnings with regards to the risk
of agranulocytosis. We are also aware that in October 2018 a communication was issued
to healthcare professionals in Spain reminding them of this risk and the need to advise
patients of the signs and symptoms and to avoid use in patients who have risk factors
for agranulocytosis.</p><p>All medicines are supplied with information for patients
which contain information on all known side effects and those signs and symptoms which
they need to be aware of. Patients being treated with metamizole medicines who have
any questions or concerns should talk to a healthcare professional.</p><p> </p><p>
</p><p><strong> </strong></p><p><strong> </strong></p>
|
|