Androcur 50 Mg 50 Tab Cyproterone

1. What is ANDROCUR (Cyproterone) and what is it used for?

• ANDROCUR (Cyproterone) is a hormone preparation that blocks the effect of sex hormones produced in men but also found in women in lower amounts. ANDROCUR (Cyproterone) 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 (Cyproterone) tablets in each package.

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

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

is offered.

• ANDROCUR (Cyproterone) 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 (Cyproterone)?

Instructions for proper use and dose/frequency of administration

In women:

Women of childbearing age:

You should not use ANDROCUR (Cyproterone) 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 (Cyproterone) 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 (Cyproterone) 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 (Cyproterone) (=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 (Cyproterone) (= 200 mg per day) twice a day for 5 – 7 days.

2. Following this, 2 tablets of ANDROCUR (Cyproterone) (= 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 (Cyproterone) 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).

Application route and method

ANDROCUR should be swallowed whole with a sufficient amount of water.

different age groups

Use in children
Since there are insufficient data on safety and efficacy, male

It is not recommended for use in children and girls and boys under the age of 18. ANDROCUR should not be given before the end of puberty as it may adversely affect height growth and endocrine function.

effects are unknown.

ANDROCUR 50 can be used in female adolescents only after puberty. There are no data to support the need for dose adjustment.

Use in the elderly
There are no data to support the need for dose adjustment in the elderly.
Special use cases

Renal impairment: There are no data to support the need for dose adjustment in patients with renal impairment.

Hepatic impairment: In patients with ANDROCUR (Cyproterone) hepatic impairment, the liver

should not be used unless function values return to normal.

If you have the impression that the effect of ANDROCUR is too strong or too weak, your doctor or pharmacist

 

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in ANDROCUR.

If any of the following occur, stop using ANDROCUR (Cyproterone) and IMMEDIATELY inform your doctor or go to the nearest hospital emergency department:

• Allergic reactions,

• The rash

• Intra-abdominal bleeding

These are all very serious side effects. If you have one of these, your

You have a serious allergy to ANDROCUR (Cyproterone). You may need emergency medical attention or hospitalization.

If you notice any of the following, tell your doctor immediately or go to the nearest hospital emergency department:

• Osteoclasis,

• Brain tumors (meningioma)

• Benign and malignant liver tumors

• Increased tendency to clot

• Toxic effect on the liver, including jaundice, liver inflammation, liver failure. These are all serious side effects. Emergency medical attention may be required.

Tell your doctor if you notice any of the following:

• Weight gain

• Weight reduction

• Decrease in sexual desire

• Erectile dysfunction

• Depressive state

• Unrest

• Increase in sexual desire

• No ovulation

• No sperm formation

• Breast tenderness

• Breast growth

• Tiredness

• Hot flush

• Doughness of breath

• Anemia

• Perspiration

• Spotting bleeding

These are the mild side effects of ANDROCUR.

Possible side effects are listed below according to their frequency.

Frequency of the following side effects: Very common (> 1/10); common (>1/100 to <1/10); uncommon (> 1/1000 to <1/100); rare (>1/10,000 to <1/1000); very rare (< 1/10,000), based on data from clinical trials.

in women

Benign and malignant tumors

Not known: Benign and malignant liver tumors, benign tumors of the brain (meningioma)

immune system diseases

Not known : Hypersensitivity reaction

Metabolism and nutritional diseases

Not known: increase or decrease in weight

psychiatric disorders

Not known: Depressed mood, restlessness (temporary), decreased sexual desire, increased sexual desire

Skin and subcutaneous tissue diseases

Not known: Rash

Gastrointestinal diseases

Not known: Intra-abdominal (abdominal cavity) bleeding

Reproductive system and breast diseases

Not known: Suppression of ovulation, breast tenderness, spotting bleeding

General-disorders and administration site-related diseases

Not known: Fatigue

Hepato-biliary diseases

Not known: Toxic effect on the liver, including jaundice, liver inflammation, hepatic failure.

Vascular diseases

Not known: increased tendency to clot

Respiratory, thoracic and mediastinal disorders

Not known: shortness of breath

in men

Benign, malignant and unspecified tumors

Very rare: Benign and malignant liver tumors Not known: Tumors in the brain (meningioma)

Blood and lymphatic system diseases

Not known: Anemia

immune system diseases

Rare: Hypersensitivity reaction

Metabolism and nutritional diseases

Common: Weight gain or weight reduction.

psychiatric diseases

Very common: Decreased sexual desire, erectile dysfunction Common: Depressed mood, restlessness (temporary)

Vascular diseases

Not known: increased tendency to clot

Respiratory, thoracic and mediastinal disorders

Common: Shortness of breath

Gastrointestinal diseases

Not known: Intra-abdominal bleeding

Hepato-biliary diseases

Common: Toxic effect on the liver, including jaundice, hepatic inflammation, hepatic failure.

Skin and subcutaneous tissue diseases

Uncommon: rash

Musculoskeletal, connective tissue and bone diseases

Not known: osteoporosis

Reproductive system and breast diseases

Very common: Reversible inhibition of sperm production Common: Breast enlargement in males

General-disorders and administration site-related diseases

Common: Fatigue, flushing, sweating