What is a Patient Information Leaflet and why is it useful?
A Patient Information Leaflet (PIL) is the leaflet for patients containing information on taking a medicine, that is included with the medicine packaging. It is written by pharmaceutical companies as a patient version of the Summary of Product Characteristics (SPC). Changes to the PIL after your medicine was packed may mean that the version on medicines.ie may differ from the version found with your medicine. You can compare the “Leaflet prepared or revised date” towards the end of the leaflet in the pack with the version that is on the website to find out if there have been any changes to the information since your medicine was packed.
The Summary of Product Characteristics (SPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
This medicine and its document have not been updated in the last 30 days.
''Company'' may refer to either the Marketing Authorization Holder (MAH), the company responsible for marketing the product in Ireland and/or responsible for uploading documents pertaining to the product onto Medicines.ie. To determine the MAH, please consult the actual submitted documents.