The package insert (package leaflet)

The package insert – also known as a package leaflet – provides the usage information that has to be contained in all medicinal product packaging. This includes information about the medicinal product (drug) and how it should be used. Among other things, the package insert provides important information about how the medicinal product should be taken and stored as well as warnings about potential side effects or interactions.

The information in the package insert is aimed at people with no medical training. Before a medicinal product is authorized, the information is checked to ensure that it is complete, easy to read and comprehensible. To make it easier to find information, package inserts in Europe always follow the same structure.

Package inserts are also available online. Medicinal product manufacturers are furthermore obliged to provide the package inserts in braille, large print or audio versions for people with visual impairments if necessary.

The package insert contains important information about how to use and store the medicinal product.

In Europe, the information in the package insert always appears in the same order. The most important information includes:

Which active substance is used?

The name of the active pharmaceutical substance often differs from the brand name that appears on the packaging. For example, painkillers labeled with the brand name Aspirin contain the active substance acetylsalicylic acid. The active substance and any auxiliary ingredients are listed on the package insert under point 1. This can be important in the event of an allergy to any particular ingredients. It is also useful to know the active substance if you need to purchase medication when abroad.

How does the medicinal product work?

The package insert details the therapeutic effect of the medicinal product, for example whether it alleviates pain or lowers the blood pressure. The therapeutic indication (area of use) describes the regions or systems of the body that it affects, such as the circulation.

What needs to be considered before using the product?

The package insert details any pre-existing conditions or circumstances that mean that the medicinal product should not be used or should only be used following consultation with a doctor. For example, many medicinal products should not be used during pregnancy or when breastfeeding. The package insert also lists potential interactions that could occur when also taking other medication or consuming certain foods. 

How should the medicinal product be used?

For a medicinal product to work correctly, it must be used as intended. The package insert provides dosage information, i.e. about the amount that should be taken, when it should be taken and for how long it should be taken. For example, some medicinal products should be taken at the same time each day or at certain intervals. 

What side effects are possible?

In addition to their desired effect, medicinal products can also have undesired effects (side effects). These are listed in order of how common they are. If when using a medicinal product you notice any unusual reactions, you can check the package insert to see if these are linked to it. If you notice side effects – in particular serious ones – you should contact your medical practice or a pharmacy.

How should the medicinal product be stored?

Some medicinal products need to be stored in the fridge or can only be kept for a certain period once opened. Information about their storage and the disposal of any leftover product can be found under point 5 of the package insert. 

Who is responsible for the medicinal product?

The package insert also indicates the name and address of the medicinal product’s manufacturer as well as the date on which the information was last revised.

Whether an over-the-counter or a prescription product, it is important to always read the package insert before taking a medicinal product for the first time. This particularly applies if:

• you want to check if the medicinal product is suitable for you – medical practices and pharmacies are not always aware of all your intolerances or circumstances that mean that you should not take a product
• you are unsure how to take a medicinal product or in what dose
• you are taking other medicinal products and want to find out about any potential interactions
• you experience a problem after taking the product and want to check whether it is a known side effect of the medicinal product and how you should respond
• you wish to contact the company that holds the authorization

If you are unsure about anything or there is something in the package insert that you don’t understand, you can consult your doctor or pharmacist. This also applies if you are concerned due to the package insert containing a long list of potential side effects.

It is also useful to re-read the package insert every now and again when taking the same medicinal product for a long time. The information contained is regularly updated.

If you have mislaid or lost a package insert and want to check something, you can usually also find the information online on the manufacturer’s website.

The package inserts for medicinal products authorized in Germany can also be found at pharmnet-bund.de.  

Pharmaceutical companies have to provide braille, large print or audio versions of the package inserts for people who are blind or visually impaired.