Always read the package leaflet!
The patient information leaflet is provided as a package insert. However, you can also find the current package leaflets for all medicinal products authorised in Austria in the Austrian Medicinal Product Index of the BASG.
Please consult your doctor if
- you notice that you should not take the prescribed medicine because you are suffering from a disease or allergy that is listed among the contraindications.
- the medicine is not compatible with any other medicine that you are taking additionally.
- you notice side effects.
- you want to stop taking the medicine.
- you become pregnant or want to become pregnant during the treatment period.
Before a new medicinal product is authorised, a readability test of the package leaflet must be conducted. In this test, 20 people with different levels of education are asked about different sections of the package leaflet and the answers are recorded. The results of this test are assessed by clinical experts from AGES and the readability, the finding of specific information and the comprehensibility of the package leaflet are evaluated.
For many people, the list of side effects is too long and sometimes it can even put them off from taking or using a medicine. However, for legal reasons all known side effects must be listed with their frequency. Together with the pharmaceutical company, we try to make the chapter as clear as possible. The side effects are usually structured according to their frequency and are sometimes also presented in reader-friendly tables. Furthermore the goal is to use patient-friendly short terms for each medical technical term.
What pharmaceutical companies are not allowed to do
The package leaflet may not be used for advertising. Therefore, only verified and approved information may be contained in the package leaflet; any advertising or unjustified promises of effectiveness are prohibited.
Putting a QR code on the labelling of the package or the package leaflet is possible upon justified request, provided that the underlying contents correspond to the Summary of Product Characteristics (SmPC) and are important for the patient pertaining to e.g. safety issues and do not have an advertising character.
The QR code should preferably be placed in the package leaflet under the heading "Further sources of information".