PDF VI.2 Elements for a Public Summary

Important potential risks Risk What is known Including reason why it is considered a potential risk Use in pregnancy and lactation In babies whose mothers took fluoxetine during

Version Date Safety Concerns Comment  Cerebrovascular adverse effects in elderly patients  Cerebrovascular adverse effects in nonelderly patients  Serotonin syndrome 

EU-Risk Management Plan for Gliclatim, Stada VI.2.4 Summary of safety concerns Important identified risks Risk What is known Preventability Coma due to too low blood sugar

Risk minimisation measures Routine Risk minimization measures: SmPC sections 4.2, 4.3, 4.4, 4.8 and 5.2 Other routine risk minimisation measures: Prescription only medicine

Important potential risks Risk What is known Including reason why it is considered a potential risk Elderly and patients with osteoporosis, diabetes or hypertension

Safety concern Routine risk minimisation measures Additional risk minimisation measures Important identified risks patients suffering from further diseases like cardiac insufficiency

Safety concern Routine risk minimisation measures Additional risk minimisation measures Important identified risks patients suffering from further diseases like cardiac insufficiency

Important potential risks Risk What is known Off-label use None Urinary tract infection None Missing information Risk What is known Interaction with other drugs used to