VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology

pulmonary oedema  Off-label-use  Worsening of sodium retention in patients with congestive heart failure  Severely impaired hepatic function  Increased mortality in burn

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 

Important potential risks Risk What is known Including reason why it is considered a potential risk High blood pressure Hypertension In a dose escalation study in patients on

Concomitant use with other medicines drug-drug interactions When methadone is given concomitantly with drugs acting on the central nervous system such as barbiturates Caution is

If you receive medicines that can cause damage to your Vancomycin is best avoided in individuals at increased risk of hearing damage such as those with existing hearing loss, those

Use in hepatic impairment and in immunocompromised patients The safety and efficacy of sevelamer carbonate has not been established in adult patients with hepatic impairment namely

The product information for ivabradine warns doctors that when blood pressure treatment is modified in chronic heart failure patients treated with ivabradine, their blood pressure