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««« IMPORTANT! »»»

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions on the use of codeine-containing medicines for cough and cold in children because of the risk of serious side effects with these medicines, including the risk of breathing problems.

The PRAC recommended specifically that:

  • Codeine should be contraindicated in children below 12 years. This means it must not be used in this patient group.
  • Use of codeine for cough and cold is not recommended in children and adolescents between 12 and 18 years who have problems with breathing.
  • All liquid codeine medicines should be available in child-resistant containers to avoid accidental ingestion.

The effects of codeine are due to its conversion into morphine in the body. Some people convert codeine to morphine at a faster rate than normal, resulting in high levels of morphine in their blood. High levels of morphine can lead to serious effects, such as breathing difficulties.

Read more on the following hyperlink:

PRAC recommends restrictions on the use of codeine for cough and cold in children

 

We would like to inform you that the “Draft proposal for an addendum, on transparency, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014” has been launched on the EMA website for public consultation. Please find the link below for your convenience:

Draft proposal for an addendum, on transparency, to the 'Functional specifications for the European Union portal and EU database to be audited'

Please submit your comments using the template form, which is available through a link in the cover page of this document.

Please forward your comments to This e-mail address is being protected from spambots. You need JavaScript enabled to view it by Wednesday, 18th February 2015.

 

 

PRAC recommends new measures to minimise known heart risks of hydroxyzine-containing medicines Medicines can still be given for their approved uses,
with new restrictions

 EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review of medicines containing the antihistamine hydroxyzine. This follows concerns over the risk of possible effects on heart rhythm with these medicines, which are available in most EU countries. Their approved uses (indications) vary considerably between countries and may include use to treat anxiety disorders, for relief of pruritus (itching), as premedication before surgery, and for treatment of sleep disorders.

More information on this, is included in the hyperlink below.

 

 
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