Norethisterone

PRODUCT SCOPE: only this 5 mg tablet SPC is covered. Other norethisterone products on the market, including the page's named brands Primolut N and Utovlan, and the higher-dose and contraceptive products, have their own SPCs, strengths and regimens, and are NOT covered here. §2 (verbatim): 'Each tablet contains 5mg of norethisterone.' §4.1 (verbatim): 'Metropathia haemorrhagica, premenstrual syndrome, postponement of menstruation, endometriosis, menorrhagia, and dysmenorrhoea.' VERBATIM §4.2: 'Metropathia haemorrhagica (dysfunctional uterine bleeding): 1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment. One tablet twice daily from the 19th to the 26th day of the two subsequent cycles should be given to prevent the recurrence of the condition. To ensure treatment success, Norethisterone Tablets must be taken for the full 10 days. Occasionally, slight bleeding may occur after the initial suspension of bleeding. Treatment should not be interrupted or suspended in these cases. If 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 ...' 'Premenstrual syndrome (including premenstrual mastalgia): Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological disturbances may be relieved by the administration of 1-3 tablets daily from the 19th to the 26th day of the cycle. Treatment should be repeated for several cycles.' 'Postponement of menstruation: In cases of too frequent menstrual bleeding, and in special circumstances (e.g., operations, travel, sports) the postponement of menstruation is possible. The dosage is 1 tablet of norethisterone three times daily, starting 3 days before the expected onset of menstruation and continuing for not longer than 10 to 14 days. A normal period should occur 2-3 days after the patient has stopped taking tablets. This method should be restricted to users who are not at risk of pregnancy during the treatment cycle.' 'Endometriosis (pseudo-pregnancy therapy): Treatment should begin between the first and 5th day of the cycle with 1 norethisterone tablet twice daily. In the event of spotting, the dose can be increased to 2 tablets twice daily. If bleeding ceases, dose reduction to the initial dose should be considered. Treatment is to be continued for at least 4 to 6 months. With uninterrupted daily intake, ovulation and menstruation do not usually occur.' 'Menorrhagia (hypermenorrhoea): 1 tablet 2-3 times a day from the 19th to the 26th day of the cycle (counting the first day of menstruation as day 1).' 'Dysmenorrhoea: Functional or primary dysmenorrhoea is almost invariably relieved by the suppression of ovulation. 1 tablet three times daily for 20 days, starting on the fifth day of the cycle (the first day of menstruation counting as day 1). Treatment should be maintained for three to four cycles followed by treatment-free cycles. A further course of therapy may be employed if symptoms return.' 'Paediatric population Not intended for use in children.' 'Method of administration Oral use. The tablets are to be swallowed whole with some liquid.' The SPC prints doses as tablet counts and prints NO maximum daily dose, so no maxDose is written and no milligram total is derived. §4.4 (verbatim): 'If menstrual bleeding should fail to follow a course of norethisterone, or if the patient wishes to postpone menstruation in special circumstances, the possibility of pregnancy must be excluded before a further course is given.' TRUNCATION: §4.2, §4.3 and §4.6 were retrieved in full; the retrieved §4.4 ends part-way through the paragraph on partial metabolisation of norethisterone to ethinylestradiol and §4.5 ends at the laboratory-test sentence, at the source-fetch limit, so monitoring and interactions are partial. In §4.8 the frequency columns were lost in PDF extraction, so no frequencies are stated.