Chapter Two
22
Table 1. Pre-defined headings in Patient Information Leaflets.
In what follows we look at some relevant similarities and differences
between both documents in terms of functional, structural, and content-
related aspects.
Text function, structure and content
As already indicated, both documents are functional-pragmatic texts,
which primary objective is to convey information on a drug's therapeutic
use for experts and patients respectively (Wright 1999: 85; Dickinson
2003). Regarding the macrostructure SmPCs and PILs represent so-called
controlled documents that are strictly formalized according to a predefined
format following the QRD templates.^4
Both documents are also subject to strict regulations in terms of
content and linguistic realization: in either case the information should be
accurate, up-to-date, and relevant to the respective target group (healthcare
professionals, patients). Furthermore, the information should be presented
in clear and concise language in order to be easily legible and
understandable for the respective target audiences. To this end, SmPCs
adhere to the standardized MeDRA terminology,^5 whereas PILs use
wordings, which comply with defined linguistic standards (see Directive
2001/83/EC, art. 63.2).
(^4) The so-called QRD templates (Quality Review Documents) contain the
mandatory wording for the Product Information document in the Centralized
Procedure. The template texts in all EU languages have been developed in close
collaboration with the respective national authorities. The templates are available
at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_list
ing /document_listing_000134.jsp.
(^5) The Medical Dictionary for Regulatory Activities (MedDRA) is a standardized
medical terminology to facilitate sharing of regulatory information internationally
for medical products used by humans.
What is in this leaflet
- What Telmisartan Teva Pharma is and what it is used for
- What you need to know before you take Telmisartan Teva Pharma
- How to take Telmisartan Teva Pharma
- Possible side effects
- How to store Telmisartan Teva Pharma
- Contents of the pack and other information