It is very important for patients to check for updates to package leaflets each time they receive their medicine. Comparing the date with that on the leaflet received previously will immediately show whether the text has changed.

Most medicine packs contain information for the user, meaning the person taking the medicine or administering it to someone else, such as a child or another person unable to manage their own medicines. This information is provided in the package leaflet, which is usually a loose sheet inside the pack. The leaflet may also form part of the packaging label, often as a peel-back label. In most cases, the package leaflet is in Icelandic.

In addition to the information generally included in package leaflets, leaflets for over-the-counter medicines contain specific instructions for use, taking into account that a doctor has not prescribed the medicine or provided advice on its use.

Packs of unlicensed medicines (medicines dispensed on a special prescription for unlicensed medicines) generally do not contain Icelandic package leaflets, as these medicines have not been granted a marketing authorisation in Iceland. It is therefore particularly important to ask a doctor or pharmacist for information about these medicines.

It is very important to read package leaflets carefully. They contain information on the correct use of the medicine, information that can prevent unnecessary or harmful use, and other information that contributes to its safe use.

The Icelandic Medicines Agency (IMA) encourages healthcare staff to actively explain the usefulness of package leaflets and the importance of reading them carefully before using a medicine. This applies both to patients and, of course, to those administering medicines to others, such as children. Patients have the right to receive the package leaflet before the medicine is used. Icelandic package leaflets for medicines marketed in Iceland are available on the Medicinal Product Information database website.

The importance of package leaflets

When new medicines are marketed, information about their use and safety is monitored particularly closely. Information about new medicines therefore changes rapidly. The importance of package leaflets is also reflected in the growing demand among patients for the latest and best information about medicines they use or are about to use. Informed patients often seek knowledge and are therefore better equipped to participate in decisions about the treatment most suitable for them.

New information about medicines is constantly emerging, both from new studies and because newly marketed medicines may interact with other medicines when taken together. New information also emerges when medicines are used differently from before, for example to treat other diseases or in other patient groups. Package leaflets are therefore updated when new information becomes available, and patients should keep up with these changes. The publication date is stated in the package leaflet, and the latest version is always available on the Medicinal Product Information database website.

Package leaflets should provide the latest and best available information about the medicine, as assessed by experts at the health authorities in Iceland and other EEA countries. The importance of reading the information in package leaflets carefully and thoroughly therefore cannot be overstated. If further information is needed, it is important to consult a doctor or pharmacist.

What information does the package leaflet contain?

Although this overview primarily concerns package leaflets for human medicines, the importance of package leaflets for veterinary medicines must not be underestimated. They contain information that owners of both pets and livestock need to read carefully to ensure the greatest possible safety for the animals and those consuming animal products.

Most package leaflets follow the same structure and are divided into the following sections:

Does the information in package leaflets change, or does the leaflet always stay the same?

Package leaflets are updated as promptly as possible when new information becomes available, for example about the safe use of medicines. Reading a package leaflet only once is therefore far from sufficient for patients receiving long-term treatment.

It is very important for patients to check for updates to package leaflets each time they receive their medicine. Comparing the date with that on the leaflet received previously will immediately show whether the text has changed. It is equally important for patients and healthcare professionals to ensure that, when medicines are administered in hospitals, primary healthcare centres or medical clinics, for example, the patient or their guardian always receives the package leaflet before the medicine is administered.

In addition to being included in medicine packs, package leaflets are published on the Medicinal Product Information database website, where the latest version is always available.

Package leaflets are intended for the people using the medicines, so considerable emphasis is placed on writing them in language users understand, rather than obscure technical language. Leaflets are therefore sometimes revised if the information is found to be insufficiently clear or if changes to their layout are considered necessary to improve understanding. Work is ongoing to improve the presentation of information, the design of package leaflets and other aspects that make them easier to use.

Comments on the content of package leaflets can be submitted to the medicine’s marketing authorisation holder or to lyfjastofnun@lyfjastofnun.is.

Because information in package leaflets changes frequently, each medicine pack must contain the leaflet that was current when the medicine was manufactured. Pharmaceutical companies are responsible for ensuring that all packs contain a package leaflet. This best protects consumers by ensuring that the user receives the leaflet and can check whether new information has become available. It is quick to check whether a leaflet is new, as its date changes whenever its content is revised.

The latest version of the package leaflet is published on the Medicinal Product Information database website and may be more recent than the version inside the medicine pack. Package leaflets play an important and growing role in the information society.

Package leaflets in historical context

The signing of the Agreement on the European Economic Area marked the beginning of a new and very important chapter in providing information about medicines to the public in Iceland, as the EEA Agreement led to the introduction of European Union pharmaceutical legislation in Iceland. This legislation is primarily guided by consumer protection.

Previously, information about medicines in Icelandic was mainly intended for doctors and pharmacists, although medicine reference books for the public were published later. These books quickly became outdated as new medicines entered the market and information about existing medicines changed rapidly. Information about medicines was generally not included in medicine packs. Where it was included, it was not in Icelandic and was sometimes even removed before the medicine was supplied to the user. However, various medicines, particularly those available without a prescription, carried Icelandic labelling and certain warnings.

One of the many significant changes brought about by the EEA Agreement was the requirement for Icelandic package leaflets in all medicine packs. It took many years to implement this change, but Icelandic package leaflets should now be included in all medicine packs supplied to users.

Much has changed since the EEA Agreement entered into force. However, changes to pharmaceutical legislation within the EEA have focused almost exclusively on further improving the safety of medicine users, particularly through substantially better provision of information. Icelandic package leaflets are now also included in packs of most medicines administered to patients in hospitals or medical clinics, such as cancer medicines, vaccines and medicines that suppress or stimulate the immune system and are administered by injection or infusion.

Another significant development is the requirement for certain minimum information to appear in Braille on the packaging of most human medicines. Icelandic package leaflets are published on the Medicinal Product Information database website, where the text can be enlarged if necessary.