PRIMOLUT N Tablet Ref.[7889] Active ingredients: Norethisterone

Posology

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. One tablet twice daily from the 19th to the 26th day of the two subsequent cycles should be given to prevent recurrence of the condition.

To ensure treatment success, Primolut N 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 so that other measures are then mostly required. This also applies to cases where after an initial suspension of bleeding, fairly heavy bleeding reoccurs during tablet intake.

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. 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. The dosage is 1 tablet of Primolut N 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 of tablet Primolut N 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.

Method of administration

Oral use. The tablets are to be swallowed whole with some liquid.

There have been no reports of ill-effects from overdosage and treatment is generally unnecessary. There are no special antidotes, and treatment should be symptomatic.

5 years.

Not applicable.

30 tablets in aluminium/PVC blisters in a carton.

Keep out of the reach of children.