Contraindications : התוויות נגד

4.3   Contraindications

Combined hormonal contraceptives should not be used in women with any of the conditions below.
Belara should be discontinued immediately if one of these conditions occurs during administration:
•     uncontrolled diabetes mellitus;
•     uncontrolled hypertension or significant increase of blood pressure (values are persistently over 140/90 mmHg);
•     Presence or risk of venous thromboembolism (VTE) •    Venous thromboembolism – currently existing VTE (on anticoagulants) or history of (e.g.
deep venous thrombosis [DVT] or pulmonary embolism [PE]).
•    Known hereditary or acquired predisposition to venous thromboembolism, such as APC- resistance, (including Factor V Leiden mutation), antithrombin-III-deficiency, protein C deficiency, protein S deficiency.
•     Major surgery entailing prolonged immobilization (see section 4.4).
•    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) •    Arterial thromboembolism – current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris).
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•     Cerebrovascular disease – current stroke, history of stroke or prodromal condition (e.g.
transient ischaemic attack, TIA)
•     Known hereditary or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant)
•     History of migraine with focal neurological symptoms
•     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
•     Hepatitis, jaundice, liver function disorders until liver function values have returned to normal.
•     Generalised pruritus, cholestasis, in particular during a previous pregnancy or oestrogen therapy.
•     Dubin-Johnson syndrome, Rotor syndrome, bile-flow disorders.
•     Meningioma or history of meningioma.
•     A history of, or existing, liver tumour.
•     Severe epigastric pain, enlargement of the liver, or symptoms of intra-abdominal haemorrhage (see section 4.8).
•     First occurrence or recurrence of porphyria (all three forms, in particular acquired porphyria).
•     Presence, or a history, of malignant hormone-sensitive tumours, e.g. of the breast or uterus.
•     Severe disorders of lipid metabolism.
•     Pancreatitis or history of such a condition, if associated with severe hypertriglyceridaemia.
•     Symptoms of migraine, when it occurs for the first time, or more frequent occurrence of unusually severe headaches.
•     Acute sensory disorders, e.g. visual or hearing disorders.
•     Motor disorders (particularly paresis).
•     Increase in frequency of epileptic seizures.
•     Severe depression.
•     Otosclerosis deteriorating during previous pregnancies.
•     Unexplained amenorrhoea.
•     Endometrial hyperplasia.
•     Unexplained genital bleeding.

Hypersensitivity to the active ingredients or to any of the excipients listed in section 6.1.

One or more serious risk factors for venous or arterial thrombosis may be a contraindication (see section 4.4).

Concomitant use of Belara with medicines containing ombitasvir/paritaprevir/ritonavir and dazabuvir, medicinal products containing glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir is contraindicated (see sections 4.5).