Prepidil and Propess (dinoprostone) strengthening of product information about the risks of uterine hyperstimulation, uterine rupture and foetal/neonatal death and restriction of usage to qualified health care professionals, to hospitals and clinics.

Summary:

The product information1, Summary of Product Characteristics (SmPC) and Package Leaflet (PIL), of the two medicinal products PREPIDIL and PROPESS have been updated with the following safety information agreed at European level and reported below:

• risks of uterine hyperstimulation and uterine rupture and their serious complications, including foetal and neonatal death.
• restriction of usage to qualified health care professionals and to hospitals and clinics with specialized obstetric units with facilities for continuous monitoring. 
• strengthening of the warning and recommendations regarding the maximum dose (PREPIDIL and PROPESS) and the dosing interval (PREPIDIL only).
• strengthening of the contraindications (PROPESS only) and warnings and precautions for use, including those for concomitant and/or sequential use of dinoprostone and oxytocin.