Posology : מינונים

4.2   Posology and method of administration

Posology
The following dosage schemes are recommended:

•       Dysfunctional bleeding

The administration of 1 tablet Primolut Nor 5 mg twice daily over 10 days leads to the arrest of uterine bleeding not associated with organic lesions within 1-4 days. In individual cases, bleeding diminishes during the first few days after the commencement of tablet-taking and does not stop until about 5-7 days later. For the treatment to be successful, Primolut Nor administration must be continued regularly even after arrest of bleeding (up to a total of 20 tablets Primolut Nor 5 mg).

About 2-4 days after discontinuation of treatment a withdrawal bleeding will occur resembling a normal menstruation in intensity and duration.

•       Slight bleeding during tablet-taking

Occasionally slight bleeding may occur after initial arrest of bleeding. In these cases tablet- taking must not be interrupted.

•       Missing arrest of haemorrhage, heavy breakthrough bleeding

If the bleeding does not stop in spite of regular tablet-taking, an organic cause or an extra- genital factor (e.g. polyps, high-situated carcinoma of the cervix uteri or endometrium, myoma, residua of abortion, extra-uterine pregnancy, thrombopenia, thrombasthenia) must be assumed, so that other measures are called for. This applies also in cases where, after initial arrest of haemorrhage, fairly heavy bleeding recurs within a few days even during tablet-taking.

•       Prevention of recurrence

To prevent recurrence of dysfunctional bleeding, it is recommended to administer Primolut Nor prophylactically during the next three cycles. This applies only to cases where the course of the basal body temperature, which must be measured regularly, points to a monophasic cycle and, hence to a danger of renewed follicular persistence with its sequelae.

1 tablet Primolut Nor 5 mg twice daily from the 19th to the 26th day of the cycle (1st day of the cycle = 1st day of the last bleeding). The withdrawal bleeding occurs some days after administration of the last tablet.

•       Primary and secondary amenorrhoea

In the case of secondary amenorrhoea hormone treatment is to be given at the earliest 8 weeks after the last menstrual period.
In order to induce a menstruation-like bleeding, an estrogen (e.g. Progynon Depot 10 mg) is to be given before the administration of Primolut Nor.

However, before treatment is commenced the presence of a prolactin-producing pituitary tumour should be excluded because, according to the present state of knowledge, the possibility cannot be ruled out that macroadenomas increase in size when exposed to higher doses of estrogen for prolonged periods of time.

•       Commencement of treatment

2 ampoules Progynon Depot 10 mg i.m. on the 1st day of treatment and 1 ampoule Progynon
Depot 10 mg i.m. on the 14th day of treatment, followed by 1 tablet Primolut Nor 5 mg twice daily from the 19th to the 26th day of treatment. Withdrawal bleeding starts about the 28th day.

•       Continuation of treatment (over at least 2-3 cycles)

1 ampoule Progynon Depot 10 mg i.m. on the 6th day and 16th day of the artificial cycle followed by 1 tablet Primolut Nor 5 mg daily from the 19th to the 26th day of the cycle (1st day of bleeding = 1st day of the cycle).

•   An attempt can then be made to stop estrogen treatment and to induce a cyclical bleeding by the administration of 1 tablet primolut-Nor 5 mg daily from the 19th to the     26th of the cycle.

Exception: Patients of whom it can be safely assumed that endogenous estrogen production is insufficient (primary amenorrhoea in gonadal dysgenesia).

Please note: Contraception should be practiced with non-hormonal methods (with the exception of the rhythm and temperature methods). If withdrawal bleeding at regular intervals of about 28 days fails to occur under the therapeutic scheme (see above), pregnancy must be considered despite the protective measures. The treatment must then be interrupted until the situation has been clarified by differential diagnosis.

•       Premenstrual syndrome, mastopathy

Premenstrual symptoms such as headaches, depressive moods, water retention, mastodynia may be relieved or palliated by 1 tablet Primolut Nor 5 mg once or twice daily from the 19th to the 26th day of the cycle.

The remarks under "Please note" for the indication "Primary and secondary amenorrhoea" apply also to this indication.


•       Timing of menstruation
The monthly bleeding can be advanced or postponed if particular circumstances require this.
However, advancement with progestogen-estrogen combinations is definitely to be preferred, because the occurrence of a pregnancy is virtually ruled out by the inhibition of ovulation. As opposed to this, the postponement of menstruation calls for the use of Primolut Nor at a time when the necessary exclusion of pregnancy can be problematical, since Primolut Nor must be given at a time when pregnancy cannot be excluded using the currently available examination methods. Therefore, this method remains restricted to those cases in which there is no possibility of early pregnancy in the cycle concerned.

Dosage: 1 tablet Primolut Nor 5 mg twice daily for not longer than 10-14 days, beginning about 3 days before the expected menstruation. Bleeding will occur 2-3 days after having stopped medication.

•        Endometriosis

Treatment is commenced on the 5th day of the cycle with 1 tablet Primolut Nor 5 mg twice daily, increasing to two 5 mg tablets twice daily in the event of spotting. When the bleeding ceases, the initial dose can be resumed. Duration of treatment is at least 4-6 months. During treatment, ovulation and menstruation do not occur. After discontinuation of hormone treatment a withdrawal bleeding will occur.

Method of administration

The tablets are to be swallowed whole with some liquid.