Contraindications : התוויות נגד

4.3    Contraindications.

Combined hormonal contraceptives (CHCs) should not be used in the following conditions.
Should any of the conditions appear for the first time during CHC use, the product should be stopped immediately.

•     Presence or risk of venous thromboembolism (VTE) o Venous thromboembolism – current VTE (on anticoagulants) or history of (e.g.
deep venous thrombosis [DVT] or pulmonary embolism [PE]) o 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 o Major surgery with prolonged immobilisation (see section 4.4) o A high risk of venous thromboembolism due to the presence of multiple risk factors (see section 4.4)

•     Presence or risk of arterial thromboembolism (ATE) o Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris) o Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g.transient ischaemic attack, TIA) o Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and anti-phospholipid antibodies (anticardiolipin- antibodies, lupus anticoagulant) o History of migraine with focal neurological symptoms.
o A high risk of arterial thromboembolism due to multiple risk factors (see section           4.4) or to the presence of one serious risk factor such as:
 diabetes mellitus with vascular symptoms.
 severe hypertension
 severe dyslipoproteinaemia

•     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.


•     Hypersensitivity to the active substance(s) or to any of the excipients.

Meliane is contraindicated for concomitant use with the medicinal products containing ombitasvir / paritaprevir / ritonavir and dasabuvir, medicinal products containing glecaprevir / pibrentasvir or sofosbuvir / velpatasvir / voxilaprevir (see section 4.5).