Preparations containing estrogen/progestogen combinations should not be used in the presence of any of the conditions listed below. Should any of the conditions appear for the first time during their use, the product should be stopped immediately.
Concomitant use of another hormonal contraceptive (see Indications/Uses).
Existing or previous venous thrombosis (e.g. deep vein thrombosis, pulmonary embolism).
Personal or family medical history of known, idiopathic venous thromboembolism (VTE) (where the family medical history relates to VTE in a sibling or parent at a relatively early age).
Existing or previous arterial thrombosis (e.g. myocardial infarction) or previous disorders (e.g. angina pectoris and transient ischemic attack).
Existing or previous cerebrovascular accident.
Presence of severe or multiple risk factors for venous or arterial thrombosis (see Precautions), e.g.: diabetes mellitus with vascular symptoms; severe hypertension; severe dyslipoproteinaemia.
Inherited or acquired predisposition for venous or arterial thrombosis, e.g. resistance to activated protein C (APC resistance), antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
Sickle cell anemia.
Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia and/or other disturbances in lipid metabolism.
Severe hepatic disorders (also disorders of the excretory system such as Dubin-Johnson and Rotor syndrome) as long as the liver function values have not returned to normal.
Presence or a history of liver tumors (benign or malignant).
Undiagnosed vaginal bleeding.
History of migraine with focal neurological symptoms.
Smokers (see Precautions).
Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts).
History of idiopathic jaundice of pregnancy, severe pruritus of pregnancy or herpes gestationis, otosclerosis worsening with each pregnancy.
Presence of a desire for pregnancy, pregnancy, breast-feeding.
Hypersensitivity to the active substances or to any of the excipients.
Diane-35 is not for use in men.
This product is contraindicated in women with thrombophlebitis, thromboembolic disorders, or a history of these conditions.