3. Package Leaflet (PL)

1. Package Leaflet (PL)

Just like the SmPC, the Package Leaflet (PL), as mentioned in the introduction, can be considered a key element in medicines information and is mandated by law. The SmPC does not address patients. Many sections are complicated and contain technical terms. Therefore, the legislation requires a PL to be produced. The PL should contain all information from the SmPC that is necessary and useful for the patient. The basic philosophy in producing a PL is that after reading it, the patient will fully understand what the medicine is, what it is used for and how to use it. The doctor (or, in case of a non-prescription medicine, the pharmacist) may well have explained it all. However, back at home, the patient may need to again read the PL to fully understand the medication and how it is used. For example, are there special conditions under which you should not take the medicine? Should you take the medicine with a meal – or on an empty stomach? What are the potential side effects? What if you forget to take a dose?

As regards the legal background, the primary legislation is Directive 2001/83/EC which stipulates:

  • The inclusion in the packaging of all medicinal products of a package leaflet (PL) shall be obligatory. (Art. 58) 
  • The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order …. [it follows the list of items to be included] (Art. 59 (1))
  • The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use. (Art. 59 (3))
  • The PL must be written and designed to be clear and understandable, enabling the users to act appropriately, when necessary, with the help of health care professionals. (Art 63 (2)) [1]

[1] At the time of writing, there are ongoing initiatives to improve the access to the important information in the PL.