Summary of Product Characteristics [SmPC]

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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);
• Dose;
• 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).