PRAC News –March 2014
PRAC recommends restricting use of domperidone
The PRAC has recommended a comprehensive review of safe use of domperidone, initiated due to cardiac adverse reactions of these medicines. The PRAC has recommended restrictions in use of these medicines throughout the EU Member States, with regard to use of these medicines to relieve symptoms of nausea and vomiting, restricting the dose and adjusting doses carefully ba weight where it is licensed in children.
There is no medicinal product containing this substance in the Republic of Croatia.
More about restrictions in use of domperidone is accessible on the EMA web pages, or here.
PRAC re-examines diacerein and recommends that it available with restrictions
The PRAC has recommended that diacerein-containing medicinal products remain available in the EU Member States where approved, but with further restrictions due to risk of severe diarrhoea and effects on the liver. These recommendations are the outcome of a re-examination of the PRAC’s November 2013 opinion, which recommended suspension of diacerein. There is no approved diacerein-containing medicinal products in Croatia.
More about restrictions in use of diacerein is accessible on the EMA web pages, or here.
PRAC recommends product information of zolpidem-containing medicinal products be updated with new safety information
The PRAC has recommended inclusion of new safety information in product information for zolpidem-containing medicinal products. New information is aimed at further minimising the known risks of next-morning impaired driving ability and operating machines.
New safety information on safe use of zolpidem will be in shortest time included in the summary of product characteristics and package leaflet of zolpidem-containing medicinal products approved in the Republic of Croatia.
More about new information on safe use of zolpidem is accessible in the EMA web pages, or here.