What product information for medicinal products is

Summary of Product Characteristics – information for the subscriber and health care professionals

The Summary of Product Characteristics (SmPC) is a document of condensed information concerning the medicinal product and is based on the documentation on quality, manufacturing, preclinical- and clinical studies. The content is dependent on comprehensive regulations and the information is continuously updated for as long as the medicinal product has a marketing authorization.

The package leaflet – information for the user

The package leaflet enclosed in the package is intended for the user of the medicinal product and contains important information about how to use the medicinal product correctly. Information about approved medicinal products in Sweden is also available at our information service Läkemedelsfakta and at Fass.se (in Swedish).

Information in the package leaflet

Before you start using a medicinal product it is important that you read through the package leaflet. The package leaflet provides information about, for example:

• Why the medicinal product is used.
• How the medicinal product is to be used.
• When the medicinal product is not to be used.
• What side-effects the medicinal product might cause.
• Which other medicinal products that could alter the effect of the medicine.
• If the medicinal product might influence the ability to drive a vehicle or use machines.
• If the medicinal product can be used during pregnancy and breast-feeding.

The information in the package leaflet is continuously updated. Therefore, it is advisable to read it through even though you have used the medicinal product before. Physicians sometimes prescribes a medicinal product for another usage or with another dosage than what is described in the package leaflet. In that case you should follow the instructions of your physician.

Differences between package leaflet, Summary of Product Characteristics and Fass text

The information in the package leaflet is intended for the user and it is based on the Summary of Product Characteristics. The Summary of Product Characteristics is the information from the marketing authorisation holder intended for prescribers, health care professionals and pharmacists. Just like the package leaflet it is continuously updated and is available at our information service Läkemedelsfakta.

Both Summary of Product Characteristics and package leaflet are approved by the Swedish Medical Products Agency (Swedish MPA) or the European Medicines Agency (EMA) when the medicinal product is authorized for marketing.

The Fass text for the medicinal product is based on the Summary of Product Characteristics and generally contains the same information although the disposition of text and headings might differ. The Fass texts are published by Läkemedelsindustriföreningen (LIF) and are not assessed or approved by the Swedish MPA.

Labelling – information on the package

The labelling for a medicinal product consists of a labelling text with all written information to be included on the package and an image (mock-up) showing the layout of the package. The information in the labelling text is based on the Summary of Product Characteristics. The approved labelling text and mock-up are not published at the Swedish MPA website.

The package can sometimes also contain a patient card with important information for the patient.