Instructions for use

Please always read the instructions for use carefully!

The instructions for use (also known as the ‘package insert’) are included with every medicine package.

You can also find the currently valid instructions for use for all medicines approved in Austria online in the Medicines Register of the BASG.

For medicines that have been centrally approved in the EU (approval number begins with EU), you can find the official information in the “Community Register”  of the European Medicines Agency (EMA).

Further information, such as the European Public Assessment Report (EPAR), is available for all centrally authorized medicines on the website of the European Medicines Agency (EMA): https://www.ema.europa.eu/en/medicines.

When should you consult your doctor?

Contact your doctor if any of the following apply:

• You notice that you should not take the medicine because you have a disease or allergy that is listed in section 2 under the headline “Do not take”.
• The medicine is not compatible with another medicine you are also taking.
• You notice side effects.
• You want to stop taking the medicine.
• You are pregnant or want to become pregnant while taking the medicine.

Readability test

Before a new medicine is approved, the package leaflet is also subjected to a readability test. 20 people with different levels of education are asked whether they can understand and find certain sections. These results are evaluated by experts, with a focus on comprehensibility and the findability of important information.

Side effects

Many people find the list of side effects too long or off-putting. However, for legal reasons, all known side effects, including their frequency, must be listed.

Together with the pharmaceutical company, attempts are made to make the section clear and easy to understand: for example, side effects are listed according to frequency and some are presented in easy-to-understand tables.

Attempts are also made to translate medical terms concisely and comprehensibly.

What are pharmaceutical companies not allowed to do?

The package leaflet must not be advertising. Therefore, the package leaflet may only contain verified and approved information — no advertising claims or exaggerated effectiveness.

QR codes

It is generally possible to place a QR code on the packaging, the package leaflet or the summary of product characteristics

However:

• The QR code must refer to content that corresponds to the summary of product characteristics.
• The QR code helps to make the medicine safer to use, e.g. by linking to a video with instructions.
• The QR code must not be promotional.
• The QR code is best placed under the heading ‘Further sources of information’ in the package leaflet.