The Summary of Product Characteristics (SmPC) is a document approved as part of the marketing authorisation of each medicine. It is aimed at healthcare professionals and includes information such as:
- How to use the medicine;
- What the medicine should be used to treat (therapeutic indications);
- Method of administration;
- In what conditions the medicine should not be used (contraindications);
- Special warnings;
- The medicine’s mechanism of action; and
- Any undesirable effects.
The SmPC contains more detail than the Package Leaflet (PL).