|||Known or suspected pregnancy.|
|||Active thromboembolic processes or a history thereof.|
|||Diabetes mellitus with vascular involvement.|
|||Presence or history of severe hepatic disease, as long as liver function values have not returned to normal.|
|||Presence or history of liver tumours (benign or malignant).|
|||Known or suspected sex hormone-dependent malignancies.|
|||Hypersensitivity to the active substance or to any of the excipients.|
It has been concluded from epidemiological surveys that the use of oral estrogen/progestogen containing ovulation inhibitors is attended by an increased incidence of arterial and venous thromboembolic diseases. Therefore one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic diseases.
Generally recognised risk factors for venous thromboembolism include a positive personal or family history (venous thromboembolism in a sibling or a parent at a relatively early age), age, obesity, prolonged immobilisation, major surgery or major trauma.
The increased risk of thromboembolism in the puerperium must be considered.
Treatment should be stopped at once if there are symptoms of an arterial or venous thrombotic event or suspicion thereof.
Benign liver tumours and malignant liver tumours have been reported in users of hormonal substances such as the one contained in Primolut N. In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages. A hepatic tumour should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal haemorrhage occur in women taking Primolut N.
Reasons for immediate discontinuation of the tablets
Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches, sudden perceptual disorders (eg disturbances of vision or hearing), first signs of thrombophlebitis or thromboembolic symptoms (for example, unusual pains in or swelling of the legs, stabbing pains on breathing or coughing for no apparent reason), a feeling of pain and tightness in the chest, pending operations (six weeks beforehand), immobilisation (for instance, following accidents), onset of jaundice, onset of anicteric hepatitis, generalised pruritus, significant rise in blood pressure, pregnancy.
|Eye disorders||Visual disturbances|
|General disorders and administration site conditions||Headache, oedema|
|Nervous system disorders||Migraine|
|Respiratory, thoracic and mediastinal disorders||Dyspnoea|
|Skin and subcutaneous tissue disorders||Hypersensitivity reactions (eg rash, urticaria)|