Patient information leaflets (PILs) are changing...
PILs (patient information leaflets) are improving in quality as a result of new legal obligations on manufacturers to test the documents on potential patients. Testing makes sure that the presentation of the information enables patients to find and understand key messages for safe use of the medicine within the PIL and thereby enable them to use the medicine safely and effectively. To promote this new initiative and share best practice, we are publishing a series of examples below to illustrate improvements and to aid learning. All leaflets associated with this scheme are published with the agreement of the marketing authorisation holder responsible for the medicine to which they relate.
The leaflets in this scheme have been supported by a user test carried out in compliance with article 59(3) of Council Directive 2001/83/EC. However, quality of the information can be assessed in other ways. The Commission on Human Medicines Expert Advisory Group on Patient Information has developed a quality scoring system to help identify by means of a numerical score good quality patient information. Leaflet included in this initiative have scored significantly higher in the new layout and design than previously. Marketing authorisation holders may find it helpful to use this scoring system to help develop better quality patient information leaflets:
Quality criteria for patient information leaflets
(18Kb)
A selection of patient information leaflets demonstrating best practice:
|
Date issued
|
Product
|
|---|---|
| 8 February 2012 | Imodium Instants (244Kb) |
| 7 June 2011 | Capol SixPlus Suspension (82Kb) and Calpol Infant Suspension (78Kb) |
| 13 May 2011 | Cilest (240Kb) |
| 5 November 2010 | Spiriva 18 microgram, inhalation powder, hard capsule (507Kb) |
| 5 November 2010 | Spiriva Respimat 2.5 microgram, solution for inhalation (381Kb) |
| 11 October 2010 | Nexplanon 68 mg (2201Kb) |
| 9 July 2010 | Camcolit 400 mg (59Kb) |
| 9 July 2010 | Camcolit 250 mg (65Kb) |
| 9 July 2010 | Anafranil 10, 25 and 50 mg Capsules and Anafranil 75 mg sustained release Tablets (452Kb) |
| 9 July 2010 | Priadel 200mg and 400mg prolonged release tablets (84Kb) |
| 9 July 2010 | Haldol Tablets (314Kb) |
| 9 July 2010 | Prozac 20 mg hard capsules (168Kb) |
| 9 July 2010 | Prozac 20 mg per 5ml Oral Liquid (170Kb) |
| 9 July 2010 | Cipramil film-coated tablets 10 mg, 20 mg, 40 mg (149Kb) |
| 10 May 2010 | Durogesic DTrans transdermal patches (235Kb) |
| 1 April 2010 | Methotrexate 2.5 mg tablets (57Kb) |
| 26 February 2010 | Human Varicella-Zoster Immunoglobulin 250mg Sterile Solution (130Kb) |
| 27 January 2010 | DDSA amoxicillin capsules 250 mg and 500 mg (40Kb) |
| 11 January 2010 | Concerta XL 27 mg (143Kb) |
| 11 January 2010 | Concerta XL 18 mg (145Kb) |
| 11 January 2010 | Ritalin (467Kb) |
| 17 November 2009 | Arthrotec 75 (1397Kb) |
| 17 November 2009 | Arthrotec 50 (1391Kb) |
| 1 November 2009 | Zocor Heart Pro (388Kb) |
| 28 September 2009 | Isoniazid (39Kb) |
| 28 September 2009 | Rifinah (89Kb) |
| 28 September 2009 | Rifadin (84Kb) |
| 28 September 2009 | Rifater (87Kb) |
| 28 September 2009 | Mycobutin (67Kb) |
| 24 August 2009 | Hyalgan (43Kb) |
| 30 July 2009 | Symbicort (5268Kb) |
| 24 June 2009 | Sulfasalazine (2090Kb) |
| 29 May 2009 | Skelid (66Kb) |
| 30 April 2009 | Caverject (455Kb) |
| 1 April 2009 | Proctofoam HC (2522Kb) |
| 10 March 2009 | NiQuitin Clear patches (1900Kb) |
| 10 March 2009 | NiQuitin Mint Gum (2025Kb) |
| 10 March 2009 | NiQuitin Lozenges (1853Kb) |
| 10 March 2009 | NiQuitin Pre-Quit (1655Kb) |
| 10 March 2009 | Nicorette Gum (178Kb) |
| 10 March 2009 | Nicorette Inhalator (186Kb) |
| 10 March 2009 | Nicorette invisi patch (213Kb) |
| 19 January 2009 | Actonel (risedronate sodium) (463Kb) |
| 19 January 2009 | 4head stick (levomenthol 100% w/w) (69Kb) |
| 23 December 2008 | Tanatril (129Kb) |
| 31 October 2008 | Sertraline (4207Kb) |
| 31 October 2008 | Molipaxin (3212Kb) |
| 31 October 2008 | Amisulpride (97Kb) |
| 17 October 2008 | Telfast (71Kb) |
| 10 September 2008 | Livial (1916Kb) |
| 5 August 2008 | Saw Palmetto Capsules (635Kb) |
| 2 July 2008 | AmBisone (69Kb) |
| 6 June 2008 | Aldactone (1037Kb) |
| 9 May 2008 | Epipen (290Kb) |
| 18 April 2008 | Vicks Sinex Soother Nasal Spray (111Kb) |
| 20 February 2008 | Nicorette Microtab (1180Kb) |
| 29 November 2007 | Lamisil (454Kb) |
| 19 March 2008 | Hedrin (511Kb) |
| 8 November 2007 | Creon 10000 Capsules (68Kb) (78Kb) |
| 8 October 2007 | Andropatch 2.5 mg 24 hours Transdermal Patch (139Kb) |
Any enquiries on this subject area should be directed to patient.information@mhra.gsi.gov.uk
