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
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 and marketed 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 and marketed 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 and
marketed medicines are not available. The absence of a medicine in the list on this
site does not mean that it is not marketed or that its use is not recommended.The
of the authorised medicines (click to download) allows you to check
if the sought-for medicine is authorized or registered. If you do not have the Access
program required to view this database or if you want to receive the patient information
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: email@example.com
On the other hand the fact that the SPC and the patient information leaflet of an
authorized medicine 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
If the authorisation of a medicinal product is radiated and/or the commercialisation of a
medicinal product is stopped, 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 date of the marketing launch 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 and marketed 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.
Despite all the care given to this publication of the patient information leaflets
and the SPC of the authorized and marketed 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 firstname.lastname@example.org.
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.