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

Table 3 Summary of Important Identified Risks Risk What is known Preventability Abnormal liver function Abnormal liver function  Effects on the liver, such as abnormal liver blood

The peak age of occurrence is usually between 20 years and 40 years, and typical disease duration is 1–5 years, although this can be greater in many cases.1,2 VI.2.2 Summary of

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 2.0 RMP Version 3.0 17 Nov 2015 Additional risk minimization measures for the risks hepatic toxicity, phototoxicity, Skin cancer including cancer of outermost layers of skin

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

13.3 Part VI.2.5 Summary of additional risk minimization measures by safety concern These additional risk minimization measures are for the following risks:  High blood pressure

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

The risk of a venous thrombosis in women, who are taking combined pills, increases in the following cases: ‐ with increasing age particularly above about 35 years, ‐ if the woman is