Combined oral contraceptives (COCs) should not be used in the presence of any of the conditions listed as follows. Should any of the conditions appear for the first time during COC use, the product should be stopped immediately.
Presence or risk of venous thromboembolism (VTE): Venous thromboembolism: current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis (DVT) or pulmonary embolism (PE)).
Known hereditary or acquired predisposition for venous thromboembolism, such as APC resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency.
Major surgery with prolonged immobilization (see Warnings).
A high risk of venous thromboembolism due to the presence of multiple risk factors (see Warnings).
Presence or risk of arterial thromboembolism (ATE): Arterial thromboembolism: current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris).
Cerebrovascular disease: current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA).
Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
History of migraine with focal neurological symptoms.
A high risk of arterial thromboembolism due to multiple risk factors (see Warnings) or to the presence of one serious risk factor such as: Diabetes mellitus with vascular symptoms.
Severe hepatic disease as long as liver function values have not returned to normal.
Severe renal insufficiency or acute renal failure.
Presence or history of liver tumors (benign or malignant); Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts).
Undiagnosed vaginal bleeding.
Known or suspected pregnancy.
Hypersensitivity to the active substances or to any of the excipients.