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Indications - Norethisterone is indicated in: Metropathia hemorrhagic (dysfunctional uterine bleeding), Premenstrual syndrome, Postponement of menstruation, Endometriosis & Menorrhagia.

Dosage & Administration - Oral administration. Not intended for use in children. 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. Prophylaxis against recurrence of dysfunctional bleeding: If there are no signs of resumption of normal ovarian function (no rise in the second half of the cycle of the morning temperature, which should be measured daily) recurrence must be anticipated. Cyclical bleeding can be established with 1 tablet twice daily from the 19th to the 26th day of the cycle. 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 2-3 tablets daily from the 19th to the 26th day of the cycle. Treatment should be repeated for several cycles. When treatment is stopped, the patient may remain symptom-free for a number of months. 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. 1 tablet of Norethisterone three times daily, starting 3 days before the expected onset of menstruation. A normal period should occur 2-3 days after the patient has stopped taking tablets. Endometriosis (pseudo-pregnancy therapy): Long-term treatment is commenced on the 5th day of the cycle with 2 tablets of Norethisterone daily for the first few weeks. In the event of spotting, the dosage is increased to 4, and, if necessary, 5 tablets daily. After bleeding has ceased, the initial dose is usually sufficient. Duration of treatment: 4-6 months continuously, or longer if necessary. 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).

Side Effects - Side-effects are more common during the first months after start of intake of Norethisterone, and subside with a duration of treatment. The side-effects are mentioned below: Eye disorders- Visual disturbance GI disorders- Nausea General disorders and administration site- conditions headache, edema Nervous system disorders- Migraine, Respiratory, thoracic and mediastinal disorders- Dyspnoea, Skin and subcutaneous tissue disorders- Hypersensitivity (eg. Rash, urticaria).

Contraindications - Pregnancy Severe disturbances of liver function Dubin-Johnson syndrome Rotor syndrome Previous or existing liver tumours History during pregnancy of idiopathic jaundice, severe pruritus or herpes gestationis Current thromboembolic processes Hypersensitivity to the active substances or to any of the excipients

Others - Pregnancy & Lactation The administration of Norethisterone during pregnancy is contraindicated. Norethisterone should not be used during lactation.