Indication
Dysfunctional bleeding, premenstrual syndrome, cyclical mastopathy, timing of menstruation, endometriosis, menorrhagia.
Dosage & Administration
The tablets are to be swallowed whole with some liquid. The efficacy of RemensTMcould be reduced if the user forgets to take a tablet as directed. The woman should take only the last missed tablet as soon as she remembers and then continue tablet intake at her usual time on the next day. If contraceptive protection is required, additional non-hormonal contraceptive methods should be used. The following dosages are recommended: Dysfunctional uterine bleeding The administration of 1 tablet of RemensTM for three times daily over 10 days, in the majority of cases, leads to the arrest of uterine bleeding that is not associated with organic lesions within 1 to 3 days. Nevertheless, to ensure treatment success, RemensTM must be taken for the full 10 days. About 2 to 4 days after completion of the treatment, withdrawal bleeding will occur with the intensity and duration of normal menstruation. Slight bleeding during tablet-taking Occasionally, slight bleeding may occur after the initial arrest of bleeding. In these cases tablet-taking must not be interrupted or stopped. Missing arrest of haemorrhage, heavy break-through bleeding If the vaginal bleeding does not stop, despite correct tablet intake, an organic cause or an extra-genital factor (e.g. polyps, carcinoma of the cervix uteri or endometrium, myoma, residua of abortion, extrauterine pregnancy, or coagulation disorders) must be considered so that other measures are then mostly required. This applies also in cases where, after initial arrest of haemorrhage, fairly heavy bleeding reoccurs during tablet taking. Prophylaxis against recurrence of dysfunctional bleeding To prevent recurrence of dysfunctional bleeding in patients with anovulatory cycles, it is recommended to administer Norethisterone prophylactically. 1 tablet 1 to 2 times daily from the 16th to the 25th day of the cycle (1st day of the cycle = 1st day of the last bleeding). Withdrawal bleeding occurs a few days after administration of the last tablet. Premenstrual syndrome, cyclical mastopathy Premenstrual symptoms such as headaches, depressive moods, water retention, a feeling of tension in the breasts, may be relieved or alleviated by the administration of one tablet RemensTM 1 - 3 times daily during the luteal phase of the cycle. Timing of menstruation Monthly menstrual bleeding can be postponed with administration of RemensTM However, this method should be restricted to users who are not at risk of pregnancy during the treatment cycle.
Dosage: 1 tablet RemensTM 2 to 3 times daily for not longer than 10 - 14 days, beginning about 3 days before the expected menstruation. Bleeding will occur 2 - 3 days after medication has been stopped. Endometriosis Treatment should begin between the first and fifth day of the cycle with 1 tablet RemensTM twice daily, increasing to 2 tablets twice daily in the event of spotting. If the bleeding ceases, dose reduction to the initial dose should be considered. Treatment is to be continued for at least 4 - 6 months. With uninterrupted daily intake, ovulation and menstruation do not usually occur. After discontinuation of hormone treatment withdrawal bleeding will occur. Menorrhagia (hypermenorrhoea) Treatment with RemensTM 1 tablet 3 times daily from day 5 - 25 of the cycle has been shown to be effective in reducing menstrual blood loss.
Precautions
If any of the conditions/risk factors mentioned below is present or deteriorates, an individual risk-benefit analysis should be done before Norethisterone is started or continued.
Circulatory disorders
It has been concluded from epidemiological surveys that the use of oral oestrogen/progestogencontaining ovulation inhibitors is attended by an increased incidence of thromboembolic diseases. Therefore, one should keep the possibility of an increased thromboembolic risk in mind, particularly when there is a history of thromboembolic disease.Generally recognised risk factors for venous thromboembolism (VTE) include a positive personal or family history (VTE 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 any symptoms of an arterial or venous thrombotic event or suspicion thereof.
Tumours
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 Norethisterone. 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 Norethisterone.
Other
Strict medical supervision is necessary if the patient suffers from diabetes. The requirement for oral anti-diabetics or insulin can change. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultra violet radiation when taking Norethisterone.Patients who have a history of psychiatric depression should be carefully observed and the medicine discontinued if the depression recurs to a serious degree.
Norethisterone also has oestrogenic properties due to its partial conversion to oestrogen, ethinyloestradiol. There were no corresponding oestrogen-related safety-relevant findings during the long period of post-marketing surveillance.
Medical Examination
A complete medical history should be taken and a physical and gynaecological examination should be performed, including the exclusion of pregnancy, prior to the initiation or reinstitution of the use of Norethisterone, guided by the "Contraindications" and "Warnings and Precautions" sections and these should be repeated during the use of Norethisterone. The frequency and nature of these assessments should be adapted to the individual woman, but should generally include special reference to blood pressure, breasts, abdomen and pelvic organs, and should also include cervical cytology.
Reasons for immediate discontinuation of the tablets are
Occurrence for the first time of migrainous headaches or more frequent occurrence of unusually severe headaches; sudden perceptual disorders (e.g. 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 or generalised pruritus (or history of jaundice or severe pruritus during pregnancy); onset of anicteric hepatitis; significant rise in blood pressure; pregnancy.
Use in Pregnancy and Lactation
Use in Pregnancy: The use of Norethisterone during pregnancy is contraindicated. Pregnancy
category D: "Medicines which have caused, are suspected to have caused, or may be expected to
cause, an increased incidence of human foetal malformations or irreversible damage. These
medicines may also have adverse pharmacological effects. Accompanying texts should be consulted
for further details". Use in Lactation: Norethisterone should not be used during lactation.
