Patient information leaflets (PIL) and summaries of product characteristics (SPC) of medicinal products for human use

Each medicine has a patient information leaflet (which is in the packaging of the medicine) and a summary of product characteristics or SPC (designed specifically for healthcare professionals). Both documents were approved at the time of the marketing authorization or the registration of the medicine and constitute the information and the reference for the appropriate and sure prescription, delivery and use of the medicine.

This part of the site enables you to view and print the patient information leaflet and the SPC of the medicines for human use approved in Belgium, whether the medicines are under prescription or not.

The patient information leaflet and the SPC of medicines are made available for information purposes only.

Always consult your doctor or pharmacist before taking any medication.

The objective is to publish the patient information leaflet and the SPC of all medicines for human use authorized in Belgium. The patient information leaflet is available in French, Dutch and German. The SPC in French and Dutch. Appendix V referred to in documents relating to medicinal products authorized through the centralized procedure, contains the details of the system for reporting adverse reactions in each member state. Here attached the data of the Belgian system.

However, it is always possible that the documents concerning some authorized medicines are not available. The absence of a medicine in the list on this site does not mean that it is not authorized or that its use is not recommended. The database of the authorised medicines allows you to check if the sought-for medicine is authorized or registered. If you want to receive the package leaflet or the SPC of an authorized medicine that is not in the list published on this site, you can send an information request to: info.medicines@fagg-afmps.be

On the other hand the fact that the SPC and the patient information leaflet of an authorized medicine indicated as marketed are published on that page does not guarantee that it is currently available or that all the presentations listed in these documents are actually marketed in Belgium.

If the authorisation of a medicinal product is radiated, the patient information leaflet and the SPC of this medicinal product go on being published for a considerable time.

For the medicines that are subject to a parallel import authorisation, please see the patient information leaflet and the SPC of the reference product. Medicines that are subject to a parallel import authorisation are identified by the letters "IP" in the authorisation number and the words "imported by ... " mentioned on their packaging. This information also appears on the patient information leaflet of these medicines.

The publication of the patient information leaflets and the SPC is regularly updated. However there might be a delay between the authorisation date of a new medicine and the date of the publication of the patient information leaflet and the SPC on this site. The patient information leaflets and the SPC may also be subject to changes. You find on this site the latest version of the patient information leaflets and the SPC of the authorized medicines. However, a waiting time is possible between the date of the approval of a modification of the patient information leaflet and/or the SPC of an existing medicine and the date of publication on this site of the amended documents. However if the changes concern essential data for the safe and effective use of a medicine, the documents will be updated as soon as possible. These changes, sometimes successive, also mean that the leaflet enclosed in the packaging of a medicine manufactured before the date of implementation of these changes may be different from that published on this site.

How to search?

1. Enter the name or at least the first 3 letters of the name of the sought-for medicine in the ad hoc adjoining field and click on the magnifier.

2. You get an overview of the data sheet(s) of the medicine or the medicines that match the query, together with the pictograms corresponding to the public leaflet in the three national languages and the SPC in French and Dutch.
If there are no documents available in the column SPC, the SPC and leaflet are identical. You can then find the SPC via the pictogram “leaflet”.

3. Click on the pictogram of the document you want to consult: you can open or save the file and then print it if you wish.

4. To start a new query, click on "Reset" (x) and start again from step 1.

Disclaimer

Despite all the care given to this publication of the patient information leaflets and the SPC of the authorized medicines in Belgium, the FAMHP cannot guarantee the completeness and the conformity of these documents with the approved data at the time of the marketing authorization or registration.

Don't hesitate to send your remarks or comments to info.medicines@fagg-afmps.be.

The FAMHP declines all liability for any direct or indirect damage resulting from the use of this database. The FAMHP also reminds readers that this information in no way replaces the necessary advice of your doctor or pharmacist for any use of a medicine. The FAMHP gives no guarantee that the information included in this database does not violate the right of the intellectual property.