Psychiatric disorders: Mood, affect and anxiety disorders insomnia. Musculoskeletal and connective tissue disorders: Muscle spasms. Infections and infestations: Vaginal yeast infection. General disorders and administration site conditions: Fatigue, malaise, application site reactions (e.g. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, abdominal distension. Rarely, hepatocellular carcinoma (prolonged use). unscheduled bleeding, spotting, amenorrhoea), increased risk of cervical and breast cancer, chloasma, cholestasis, gallbladder disease, induced or exacerbated angioedema, retinal vein thrombosis recurrent, persistent or severe headache/migraine, depression increased blood pressure, adverse changes in lipid levels (including serum triglycerides), impaired glucose tolerance, increased thyroxine-binding globulin, sex hormone-binding globulin and cortisol-binding globulin levels. Significant: Bleeding irregularities (e.g. Concomitant use with drug combinations containing ombitasvir/paritaprevir/ritonavir, and dasabuvir. aura) known or suspected breast carcinoma, endometrial carcinoma, or other estrogen- or progestin-dependent cancer, undiagnosed abnormal uterine/genital bleeding active viral hepatitis, severe (decompensated) cirrhosis, liver tumours (benign or malignant). subacute bacterial endocarditis with valvular disease, atrial fibrillation), coronary artery disease, uncontrolled hypertension history of headache/migraine with focal neurological symptoms (e.g. stroke, TIA), thrombogenic valvular or rhythm heart diseases (e.g. obesity, major surgery with prolonged immobilisation, >35 years of age who smoke severe hypertension, severe dyslipoproteinaemia, diabetes mellitus with vascular symptoms) current or history of cerebrovascular disease (e.g. Factor V Leiden mutation and activated protein C -resistance, antithrombin-III-deficiency, protein C and S deficiency hyperhomocysteinaemia, antiphospholipid-antibodies ), patients at high risk of venous and arterial thromboembolism due to the presence of multiple risk factors or 1 serious risk factor (e.g. angina pectoris), known hereditary or acquired predisposition for venous or arterial thrombosis (e.g. DVT, pulmonary embolism), current or history of arterial thromboembolism (e.g. Current or history of venous thromboembolism (e.g.
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