Normens Warnings

If any of the conditions/risk factors mentioned as follows is present or deteriorates while using NORMENS, an individual risk-benefit analysis should be done before NORMENS is started or continued.
It has been concluded from epidemiological surveys that the use of oral oestrogen/progestogen containing ovulation inhibitors is associated by an increased incidence of thromboembolic diseases. Therefore, one should keep the possibility of an increased thromboembolic risk in mind, particularly where there is a history of thromboembolic diseases.
A patient who develops symptoms suggestive of thromboembolic complications should stop treatment immediately. The need for treatment should be reassessed before continuing therapy.
Women with hypertriglyceridemia, or a family history thereof, may be at increased risk of pancreatitis when using COCs while women with hyperlipidaemia are at increased risk of arterial disease.
In rare cases, benign liver tumours, and even more rarely, malignant liver tumours have been reported in users of hormonal substances such as the one contained in NORMENS. In isolated cases, these tumours have led to life-threatening intra-abdominal haemorrhages. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnosis and, if necessary, the preparation should be withdrawn.
NORMENS can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment.
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should minimise exposure to the sun or ultraviolet radiation when taking NORMENS.
Patients who have a history of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Any patient who develops an acute impairment of vision, proptosis, diplopia or migraine headache should be carefully evaluated ophthalmologically to exclude papilloedema or retinal lesions before continuing medication.
Progestogens may cause fluid retention. Special care should be taken when prescribing norethisterone in patients with conditions such as epilepsy, migraine, asthma, cardiac dysfunction and renal dysfunction which might be aggravated by this factor.
If menstrual bleeding should fail to follow a course of NORMENS, or if the patient wishes to postpone menstruation in special circumstances, the possibility of pregnancy must be excluded before a further course is given.