XVI.App1.2. Package leaflet

Location:
XVI.Appendix 1

According to the legislation [DIR Art 8(3)(j), DIR Art 59, REG Art 6(1)] and the Template for the Package Leaflet29 , the package leaflet (PL) (see GVP Annex I) presents information relevant to RMM for the patient in accordance with the SmPC (see XVI.B.2.1.1.) in:

  • PL section 4 ‘Possible Side Effects’: Information on adverse reactions that may occur due to the medicinal product;
  • PL sections 2 ‘What you need to know before you <take/use> ’ and 3 ‘How to <take/use> : Safe use advice regarding dosing and administration, contraindications, interactions, ability to drive and use machines, overdose, warnings and actions to be taken to avoid specific possible adverse reactions or to be taken if specific reactions occur and, if deemed necessary, actions to be taken as a precaution for potential risks, and information on risks of the medicinal product impacting on fertility, pregnancy and lactation, including risks for the embryo/foetus/child due to adverse effects at conception, in utero or during breastfeeding, and actions to be taken to avoid or minimise these risks.

The Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use30 and the Guideline on the Packaging Information of Medicinal Products for Human Use Authorised by the Union31 applies to the PL.

XVI.App1.2.1. Symbols and pictograms

The Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use32 includes guidance on the use of symbols and pictograms to support text in the PL in ways useful to the patient [DIR Art 62], provided the size of the graphic provides for easy legibility and the meaning of the symbol is clear beyond any doubt. Evidence may be required to ensure that their meaning is generally understood and not misleading or confusing

XVI.App1.2.2. Warnings on dark background

The Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use33 includes guidance for particular warnings applying light text on dark background in the PL.