Patient information leaflet
Encyclopedia
Patient information leaflets (PILs) are leaflet
s containing specific information about medical conditions, doses, side effects that packed with medicines to give the user information about the product. PIL is the European version of the Package insert
. The PIL is written by the manufacturing pharmaceutical company and is a patient friendly version of the Summary of Product Characteristics
. All licenced medicines need to carry such a leaflet. There are guidelines that must be followed for producing this document, drawn up by the European Medicines Agency
of the EU.
in November 2005, aimed to replicate these leaflets in more accessible formats, including Braille
, large print and on CD-ROM
. It is a venture by the Royal National Institute of the Blind
, the National Library for the Blind
and Datapharm Communications.
Pamphlet
A pamphlet is an unbound booklet . It may consist of a single sheet of paper that is printed on both sides and folded in half, in thirds, or in fourths , or it may consist of a few pages that are folded in half and saddle stapled at the crease to make a simple book...
s containing specific information about medical conditions, doses, side effects that packed with medicines to give the user information about the product. PIL is the European version of the Package insert
Package insert
A package insert or prescribing information is a document provided along with a prescription medication to provide additional information about that drug.-Responsible agencies:In the United States, the Food and Drug Administration determines the requirements...
. The PIL is written by the manufacturing pharmaceutical company and is a patient friendly version of the Summary of Product Characteristics
Summary of Product Characteristics
The Summary of Product Characteristics is a specific document required within the European Commission before any medicinal product is authorized for marketing. This summary is the definitive description of the product both in terms of its properties, chemical, pharmacological and pharmaceutical...
. All licenced medicines need to carry such a leaflet. There are guidelines that must be followed for producing this document, drawn up by the European Medicines Agency
European Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
of the EU.
Accessibility
The X-PIL service, launched in the UKUnited Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
in November 2005, aimed to replicate these leaflets in more accessible formats, including Braille
Braille
The Braille system is a method that is widely used by blind people to read and write, and was the first digital form of writing.Braille was devised in 1825 by Louis Braille, a blind Frenchman. Each Braille character, or cell, is made up of six dot positions, arranged in a rectangle containing two...
, large print and on CD-ROM
CD-ROM
A CD-ROM is a pre-pressed compact disc that contains data accessible to, but not writable by, a computer for data storage and music playback. The 1985 “Yellow Book” standard developed by Sony and Philips adapted the format to hold any form of binary data....
. It is a venture by the Royal National Institute of the Blind
Royal National Institute of the Blind
RNIB is a UK charity offering information, support and advice to almost two million people in the UK with sight loss.- History :The Royal National Institute of Blind People was founded by Thomas Rhodes Armitage, a successful doctor who suffered from eyesight problems.In 1868 Dr Armitage founded an...
, the National Library for the Blind
National Library for the Blind
The National Library for the Blind was a public library in the United Kingdom, founded 1882, which aimed to ensure that people with sight problems have the same access to library services as sighted people. NLB was taken over by RNIB on 1 January 2007.-Origins:The Lending Library for the Blind...
and Datapharm Communications.
External links
- A library of patient information leaflets for Health Care professionals
- The electronic Medicines Compendium explanation of the headings in the European patient information leaflet.