Update: Guideline on the excipients warnings to be included in the printed of homeopathic medicines

It is announced that during the meeting of 19 January 2017, the Commission Scientific Technician (CTS) gave a favorable opinion updating the guideline in question was published on 12 December 2016 on the AIFA portal.

This update has considered the fact that, in the guideline of the European Commission "Excipients in the label and package leaflet of medicinal products for human use" (July 2003), the warnings relating to ethanol "about changing the effects of other medicinal products, driving and operating machinery "is expected when the dose exceeds 3 grams of assumptions ethanol.

Considered the appropriateness of the document editing, in order to simplify the text relating to the warnings for such excipient, the guideline has been updated with the introduction of specific information for the 3 g of intake as follows:

"If you take n ml of" ABC "in excess of 3 g of ethanol, this medicine may alter the effects of other medicines and may impair your ability to drive and use machines."

This guideline supersedes the version of December 12, 2016

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