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

4.8 Undesirable effects− This section should include all adverse reactions from clinical trials, post-authorizationsafety studies and spontaneous reporting.− Within each frequency grouping, undesirable effects are presented in order of decreasingseriousness.4.9 Overdose− Describe acute symptoms and signs and potential sequelae of different dose levels of themedicinal product based on all available information including accidental intake,mistakes and suicide attempts by patients.− Taking into account all relevant evidence, describe management of overdose in man, e.g.in relation to monitoring or use of specific agonists/antagonists, antidotes or methods toincrease elimination of the medicinal product such as dialysis.5. Pharmacological properties5.1 Pharmacodynamic propertiesDescribe the following:− Pharmacotherapeutic group: {group}, ATC code: {code}. If an ATC code is not yetavailable, this should be mentioned as ‘not yet assigned’.− Mechanism of action (if known).− Pharmacodynamic effects.− Clinical efficacy and safety.5.2 Pharmacokinetic properties− Pharmacokinetic properties of the active substance(s) relevant for the advised dose,strength and the pharmaceutical formulation marketed should be given in this section. IfPage 23 of 52