Monitoring drug safety is of the utmost importance in order to ensure the safe use of medicines and the protection of the health of patients. Patients, health care professionals, pharmaceutical companies and regulatory authorities participate in monitoring the safety profile of the medicine.
Pharmacovigilance is a set of activities related to the detection, assessment, understanding, prevention and treatment in case of side-effects, as well as new information about the harmfulness of medicines. Also, there is a large number of pharmacovigilance activities aimed at reducing the risk of possible side-effects. Each pharmaceutical company has a need and an obligation to establish a pharmacovigilance system through which it monitors the safety profile of the medicines for which it holds a marketing authorisation.
Patients should consult the enclosed patient Information leaflet before using a medicine. It is important that the patient takes the medicine as prescribed in the leaflet, or as recommended by the doctor. A doctor or pharmacist should be notified for further advice if the patient experiences any side-effects.