Contraindications : התוויות נגד

4.3   Contraindications

Primolut-Nor should not be used in the presence of any of the conditions listed below. Should any of the conditions appear during the use of Primolut- Nor, the use of the product should be stopped immediately.

1.    Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
2.    Known or suspected pregnancy.
3.    Lactation.
4.    Previous idiopathic or current venous thromboembolism (deep vein thrombosis,
pulmonary embolism).
5.    Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction).
6.    Presence or a history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris).
7.    A high risk of venous or arterial thrombosis (see section 4.4)
8.    History of migraine with focal neurological symptoms.
9.    Diabetes mellitus with vascular involvement.
10.   Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
11.   Previous or existing liver tumours (benign or malignant).
12.   Known, past or suspected sex hormone-dependent malignancies, including of the genital organs or breast cancer.
13.   History during pregnancy of idiopathic jaundice or severe pruritus.
14.   Undiagnosed genital bleeding.
15.   Untreated endometrial hyperplasia.

Primolut Nor is contraindicated for concomitant use with the medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see section 4.4 and 4.5).