The package leaflet
The package leaflet is a notice that informs the user about the medication and its correct use. The package leaflet is part of the medication package. The package leaflet is based on the summary of product characteristics created by the pharmaceutical company for health care professionals. The package leaflet includes information such as:
- What the medication is used for and how
- When the product should not be used
- What kinds of possible adverse reactions the use of the medication may cause
- The effect of other medications on the medicinal product being taken
- The effect of the medication on the ability to operate heavy machinery, such as driving a car
- How the medication should be stored
The Finnish Medicines Agency Fimea or the European Medicines Agency (EMA) approves the information in the summary of product characteristics and the package leaflet during the granting of a marketing authorisation. The information in the package leaflet is updated if necessary. That is why it is important to read the package leaflet before taking the medication, even if you have taken the medication before.
Different pharmaceutical companies might emphasise different things, so the information in the package leaflets of different products might differ slightly even when the active ingredient is the same. However, the information must be based on research, so the package leaflets can be considered reliable sources of basic information.