The GCC Guidance for Presenting the SPC, PIL and Labeling ...

− In the overall assessment, all available knowledge should be taken into account,including clinical studies and post-marketing surveillance, pharmacological activity,results from non-clinical studies, and knowledge about compounds within the same class.− Efforts should be made to update the recommendations for use during pregnancy andlactation on the basis of increasing human experience in exposed pregnancies whicheventually supersede the animal data.− The following should be mentioned:o Women of childbearing potential / Contraception in males and females.o Pregnancyo Breastfeedingo Fertility− [For Pregnancy and lactation statements see Appendices 3 & 4 ]4.7 Effects on ability to drive and use machines− On the basis of the pharmacodynamic profile, reported Adverse Reactions and/or specificstudies on a relevant target population addressing the performance related to driving orusing machines, specify whether the medicinal product has:a. no or negligible influence;b. minor or moderate influence, orc. major influence on these abilities.Effects of the disease itself on these abilities should not be discussed.Page 22 of 52