Textové pole: PHARMACOLOGY I INFORMATION ABOUT DRUGS 1. Patient information leaflet (PIL) vs
Summary of product characteristics (SPC)

Use the European Medicines Agency website (ema.europa.eu) to answer the following questions and
solve the problems. Find information about medical preparation AVAMYS. On EMA homepage, click on
“Medicines”, “Human”, and then search the product. SPC and PIL can be found in “Product
information”.


                                                SPC

                                                PIL

                                          Number of pages




                                                                Is the information in the document?

                                Give an example of the information
                                          you have found:

                                Is the information in the document?

                                        Mechanism of action

                                                Y/N


                                                Y/N

                                         Pharmacokinetics

                                                Y/N


                                                Y/N

                                        Undesirable effects

                                                Y/N


                                                Y/N

                                            Excipients

                                                Y/N


                                                Y/N

                                         Use in pregnancy

                                                Y/N


                                                Y/N

   Compare and characterize the text of SPC and PIL from the linguistic point of view (e.g., the
                                         terminology used)














                                 For whom is the document intended

                                   healthcare personnel/patients

                                   healthcare personnel/patients



Find SPC of the medicinal product AERINAZE and give an example of the information found:

                                 When the drug should NOT be used?


What is its mechanism of action?


Symptoms of overdose


Plasma proteins binding








Find SPC of the medicinal product VIAGRA and find the information about adverse (undesired)
effects:

                                            Trade name

                                   Very common adverse reactions

                                     Common adverse reactions

                                              VIAGRA











                                          INN of the drug


                                             Incidence

≥ 1 pers. out of

≥ 1 pers. out of             to < 1 pers. out of



2. Database of the Czech State Institute of Drugs Control, MHRA (UK) etc.

Look for the homepage of the Czech State Institute of Drugs Control (www.sukl.cz), UK Medicines and
Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) or drugs.com.
Try to use these databases to find medicinal products with the same active substance:

                                            Trade name

                                          INN of the drug

                                    Products with the same drug

                                              BRUFEN






                                         ZYRTEC or ZIRTEK