Complementary and herbal medicines frequently contain preparations containing ethanol. Particular attention should be paid to the use of these medicinal products in paediatric populations.
In particular, the use of medicinal products containing ethanol in premature and newborn babies, infants and toddlers under 2 years and children aged 2–5 years must be assessed taking into account the individual maturity of the organ system, the route of application (oral, topical, rectal, etc.), possible accumulation of ethanol and the lack of information on potential short and long-term toxicity. The benefits of the use of the medicinal product containing ethanol must outweigh the potential risks.
The requirements for the declaration of active substances and pharmaceutical excipients of human medicinal products (full declaration), which entered into force on 1 January 2019, are being implemented. The excipients of particular interest, which include ethanol, must accordingly be declared as such according to Annex 3 TPLRO[1]. Additional precautionary measures or warnings are listed in the relevant medicinal product information depending on the thresholds according to Annex 3a TPLRO. The intended standard, transparent declaration of medicinal product compositions will support professional individual benefit-risk assessments when prescribing and dispensing medicinal products.
[1] Ordinance of the Swiss Agency for Therapeutic Products on the Licensing Requirements for Therapeutic Products (TPLRO; SR 812.212.22)