Posology : מינונים

4.2   Posology and method of administration
Method of administration

Oral administration

Dosage
Pregnant women may not take Androcur. Consequently, pregnancy has to be excluded prior to the start of therapy (see section 4.4). Androcur 10 mg has to be used in combination with a suitable oestrogen or a suitable progestogen-oestrogen combination (combined oral contraceptive ‘pill’), in order to ensure necessary contraceptive protection and to avoid irregular bleeding.

This combination therapy shall be carried out as follows:

Both products have to be started on day 1 of the cycle (day 1 of menstruation).
One Androcur 10 mg tablet has to be taken daily from day 1 to day 15 of the combination therapy. Additionally, from day 1 to day 21, a suitable oestrogen or a suitable progestogen- oestrogen combination has to be taken (combined oral contraceptive ‘pill’).



Day 1 of intake            15          21             1

7 days break

 bleed                                               bleed

Day 1 of menstrual cycle

1 Androcur 10 mg tablet
1 coated tablet of the oestrogen or of the progestogen-oestrogen combination used (oral contraceptive ‘pill’)


Both products have to be started on day 1 of the cycle (day 1 of menstruation). Only women, who are amenorrhoeic, begin immediately with the therapy prescribed by the doctor; in this case, day 1 of intake is considered as day 1 of menstruation and further calculated according to the recommendations.

The first Androcur 10 mg tablet is removed from the field of the calendar pack, which corresponds to the day of the week on which the course is started. Then, one further tablet will be taken each day in direction of the arrow and end with the tablet from the field marked ‘15’. For a further 6 days, only the oestrogen or the progestogen-oestrogen combination (combined oral contraceptive ‘pill’), whichever is being used, will be taken.

During the subsequent seven-day break, withdrawal bleeding will occur. Four weeks after having started taking the tablets, i.e. on the same day of the week, the next combined treatment will be started, irrespective of whether the bleeding has already stopped or is still ongoing.

Since women may not become pregnant while receiving Androcur 10 mg, they must properly adhere to the treatment regimen.

Missed medication

If a dose of Androcur-10 mg has been missed at its usual time, the combination treatment should be continued according to schedule without taking the missed tablet (a double dose should not be taken to make up for the forgotten dose of Androcur 10 mg). The missed dose of Androcur 10 mg can result in reduced efficacy and intermenstrual bleeding.

If the oestrogen or the progestogen-oestrogen combination (combined oral contraceptive ‘pill’), whichever is being used, has been missed at its usual time, they must be taken, at the latest within 12 hours following the usual time. The contraceptive effect becomes questionable if more than 36 hours have elapsed since the previous administration.
Nevertheless, the combination therapy should be continued according to schedule without the missed coated tablet, in order to avoid premature withdrawal bleeding. The advice and recommendations contained in the package leaflet and in the summary of product characteristics (in particular with regard to the contraceptive effect in the event of missing doses) of the oestrogen or the progestogen-oestrogen combination, whichever is being used, have to be followed.

Absence of the withdrawal bleed

If there is no bleed at the end of that particular cycle, pregnancy must be ruled out before tablet taking is resumed.

Length of use

The length of treatment depends upon the type, severity and the individual response to treatment of the virilisation signs. Acne generally responds more quickly to therapy than does hirsutism or alopecia.


If no or only insufficient success has been obtained, in the case of
−      severe acne with at least 6 months of therapy or
−      alopecia and hirsutism with at least 12 months of therapy an increase in the cyproterone-acetate dose may be considered in combination with oestrogen or a suitable oestrogen-progestogen combination.


When therapy has been adequately successful, treatment may be continued with a low- dose cyproterone acetate-oestrogen combination or an anti-androgen sex steroid.
Additional information on special populations

Children and adolescents

Androcur 10 mg may be used in female patients only after completion of puberty. Before the end of puberty, an adverse effect of Androcur 10 mg on the growth in length cannot be completely ruled out. There are no data, which require a dosage adjustment.

The safety and efficacy of Androcur in children and adolescents under 18 years has not been established in clinical trials.

Geriatric Patients

Androcur 10 mg is only indicated in women of childbearing potential.
Patients with liver disease

The use of Androcur 10 mg is contraindicated in patients with liver disease for as long as the liver values have not returned to normal.

Patients with renal impairment

The pharmacokinetics of cyproterone acetate in patients with renal impairment has not been investigated.