Dosage and administration:
The tablets are to be swallowed whole with some liquid. The efficacy of Remens could 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 Remens 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, Remens 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, extra-uterine 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 re-occurs 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 Remens 1 – 3 times daily during the luteal phase of the cycle. Timing of menstruation Monthly menstrual bleeding can be postponed with administration of Remens However, this method should be restricted to users who are not at risk of pregnancy during the treatment cycle. Dosage: 1 tablet Remens 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 Remens 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 Remens 1 tablet 3 times daily from day 5 – 25 of the cycle has been shown to be effective in reducing menstrual blood loss.
Adverse effects are more common during the first months after start of intake of Norethisterone preparations and subside with duration of treatment. In addition to the adverse effects listed in the Warnings and Precautions section, the following undesirable effects have been reported in users of Norethisterone preparations, although a causal relationship could not always be confirmed: Hypersensitivity, reactions, Headache, Migraine, Visual disturbances, Nausea, Dyspnoea, Urticaria, Rash Uterine/Vaginal bleeding including Spotting, Hypo-menorrhoea, Amenorrhoea, and Oedema.