Revised SPC: Motilium (domperidone) 10mg Film-coated Tablets

SPC revised in line with MHRA advice issued in December to state that efficacy in children less than 12 years of age and in adolescents 12 years of age and older and weighing less than 35 kg has not been established.

SPS commentary:

This follows results from a placebo-controlled study in children younger than 12 years with acute gastroenteritis which did not show any difference in efficacy at relieving nausea and vomiting compared with placebo.


electronic Medicines compendium

Resource links:

MHRA advice