Contraindications : התוויות נגד

4.3    Contraindications

Preparations containing oestrogen/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 with another hormonal contraceptive (see section 4.1)
• Venous thrombosis present or in history (deep venous thrombosis, pulmonary embolism)
• Arterial thrombosis present or in history (e.g. myocardial infarction) or prodromal conditions (e.g.
angina pectoris and transient ischaemic attack).
• Presence or history of cerebrovascular accident
• The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (see section   4.4) such as:
o diabetes mellitus with vascular symptoms
o severe hypertension
o severe dyslipoproteinaemia
• Hereditary or acquired predisposition for venous or arterial thrombosis, such as activated protein C (APC) resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)
• History of migraine with focal neurological symptoms.
• Presence or history of severe hepatic disease e.g. active viral hepatitis and severe cirrhosis, as long as liver function values have not returned to normal.
• Presence or history of liver tumours (benign or malignant).
• Current or history of breast cancer.
• Meningioma or history of meningioma.
• Known or suspected pregnancy (see section 4.6).
• Breast-feeding (see section 4.6).
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.


Diane 35 is contraindicated for concomitant use with the medicinal products containing ombitasvir / paritaprevir / ritonavir or dasabuvir or medicinal products containing glecaprevir/pibrentasvir (see sections 4.4 and 4.5).

Diane 35 is not for use in men.