
Description of selected adverse reactions: An increased risk of arterial and venous thrombotic and thrombo-embolic events, including myocardial infarction, stroke, transient ischemic attacks, venous thrombosis and pulmonary embolism has been observed in women using CHCs, which are discussed in more detail in Precautions.
The following serious adverse events have been reported in women using COCs, which are discussed in Precautions: Venous thromboembolic disorders; Arterial thromboembolic disorders; Hypertension; Liver tumours; Crohn's disease, ulcerative colitis, porphyria, systemic lupus erythematosus, herpes gestationis, Sydenham's chorea, haemolytic uremic syndrome, cholestatic jaundice.
The frequency of diagnosis of breast cancer is slightly increased among OC-users. As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC use is unknown. For further information, see Contraindications and Precautions.
In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.
Interactions: Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with oral contraceptives (see Interactions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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