package leaflets
SPC
The indication must be described as
follows: "Traditional herbal medicinal product for use with …
indication …, administered only on the basis of long-standing
use".
Package leaflet and label
Along with a
description of the indication, the following warning must appear
both on the label and in the package leaflet: "Consult your
doctor if your symptoms persist during the use of this medicinal
product or if adverse effects not mentioned in the package leaflet
occur."
In addition, all the requirements relating to labels and package
leaflets for conventional medicinal products (
see Human medicines/Medical package leaflets) also apply to
traditional herbal medicinal products.