Androcur 50 mg 50 Tablets Cyproterone Acetate

1. What is ANDROCUR and what is it used for?

• ANDROCUR is a hormone preparation that blocks the effect of sex hormones produced in men but also found in women in lower amounts. ANDROCUR reduces the level of testosterone hormone in the blood, leading to a decrease in sex drive in men. In patients in whom androgens contribute to the growth of prostate cancer, ANDROCUR reduces this effect.

• There are 50 ANDROCUR tablets in each package.

• There is 50 mg of cyproterone acetate in each tablet.

• ANDROCUR is also available in a package of 30 tablets containing 100 mg of cyproterone acetate.

is offered.

• ANDROCUR is used in the following cases:

In women: In severe androgenization symptoms such as severe hair growth, severe masculine hair loss, acne or severe forms of oily skin.

In men: In order to reduce sexual urges in sexual deviations.

As antiandrogen therapy in inoperable prostate cancer

2. How to use ANDROCUR?

Instructions for proper use and dose/frequency of administration

In women:

Women of childbearing age:

You should not use ANDROCUR if you are pregnant. Therefore, it is necessary to determine that you are not pregnant before starting treatment.

Treatment should be started on the first day of the menstrual period (the first day of bleeding). Only women who do not have menstrual bleeding (amenorrhea) can start ANDROCUR treatment immediately. In this case, the first day of treatment will be considered the first day of menstruation and the recommendations for tablet use will be followed normally.

From the first day of menstruation to the 10th day (10 days in total), 2 tablets of ANDROCUR are used per day. In addition, 1 tablet of DIANE-35 is taken on the 1st-21st days (21 days) to stabilize the menstrual cycle and prevent pregnancy. After a while, the dose can be reduced to half or 1 tablet per day by your doctor.

If periodic combined therapy is used, you should take the tablets at the same time each day.

7-day tablet-free period following 21 days of use of DIANE-35 tablets

and bleeding occurs during this time.

Exactly 4 weeks (28 days) after the start of the first menstrual cycle therapy, the next cycle of combined therapy is started on the exact same day of the week, regardless of whether the bleeding has stopped or not.

If your doctor notices clinical improvement during combination therapy with DIANE-35, he or she may reduce the daily dosage of ANDROCUR to 1 or 1/2 tablet during the first 10 days of combined therapy. DIANE-35 alone may be sufficient. No bleeding

In rare cases, if bleeding does not occur, the tablet is temporarily discontinued and the doctor should be consulted to establish whether pregnancy is present before resuming tablet intake.

Patients who are in the postmenopausal period or have had a hysterectomy

ANDROCUR should be taken alone in postmenopausal or hysterectomy patients. Depending on the severity of the complaints, the average ANDROCUR dosage should be 1 to 1 tablet once daily for 21 days, followed by a 7-day tablet-free interval.

In men:

In order to reduce sexual urges in sexual deviations: Your doctor will determine the appropriate dose for the person.

1. The treatment usually starts by taking 1 tablet of ANDROCUR twice a day.

2. Your doctor may increase the dose to 2 tablets twice a day or even 2 tablets three times a day for a short period.

3. When a satisfactory result is achieved, your doctor will ensure that you take the lowest dose necessary to maintain the effect. Usually two tablets a day are sufficient.

4. While the follow-up dose is adjusted or the use of the preparation is interrupted, your doctor will gradually reduce the dosage. Eventually, your doctor may reduce the daily dose to 1 tablet or tablet per day, with a break every few weeks.

Long-term use of ANDROCUR is necessary to stabilize the therapeutic effect. Your doctor may refer you to psychotherapy during this time.

Antiandrogen therapy in inoperable prostate cancer: The daily dose is 2 tablets ANDROCUR (=200 - 300 mg daily) two or three times a day. When you feel an improvement, do not change the treatment or dosage prescribed by your doctor or discontinue use.

• In combination with GnRH-agonists, against initially rising androgen levels:

1. At the beginning, the daily dose is only 2 tablets of ANDROCUR (= 200 mg per day) twice a day for 5 - 7 days.

2. Following this, 2 tablets of ANDROCUR (= 200 mg per day) are given twice a day for 3-4 weeks, along with a GnRH agonist at the recommended dosage (see the prescription information of the GnRH agonist).

• To treat hot flashes in patients whose testicles were surgically removed and treated with GnRH group drugs:

1. The daily dose is 1-3 tablets of ANDROCUR per day (=50-150 mg per day).

2. If necessary, the dose can be increased up to 2 tablets three times a day (300 mg per day).