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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.

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