VI.2 Elements for a Public Summary

Version Date Safety Concerns Comment cholesterol, increased triglycerides, or decreased HDLs • Hyperglycemia and diabetes mellitus • Metabolic risk factors 1.2 02/03/2016 Important

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

VI.2.7 Summary of changes to the risk management plan over time Major changes to the Risk Management Plan over time Version Date Safety Concerns Comment 3.0 At time of

Risk What is known Including reason why it is considered a potential risk Risk for the heart and blood vessels in patients with type 2 diabetes There have been patients with heart

N/A Important potential risks Safety concern Summary of Routine Risk Minimisation Activities Summary of Additional Risk Minimisation Activities Severe skin and severe allergic

Risk Management Plan Olopatadine Version 1.0 Page 46 of 59 All information contained in this document is company property and confidential to the regulatory authority.. It must not

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

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