Androcur

Package Leaflet: Information for the User

Androcur, 50 mg, tablets

Cyproterone acetate

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Androcur and what is it used for
• 2. Important information before taking Androcur
• 3. How to take Androcur
• 4. Possible side effects
• 5. How to store Androcur
• 6. Contents of the pack and other information

1. What is Androcur and what is it used for

Androcur is a hormonal medicine that works by blocking the effects of male sex hormones (androgens, which are also produced in small amounts in the female body). The active substance is cyproterone acetate.
In women, Androcur has a beneficial effect on conditions that are dependent on androgens, such as:
excessive hair growth in hirsutism (male-type hair growth in women), hair loss on the head (androgen-dependent hair loss), and excessive sebum production in acne and seborrhoea.
In addition, during treatment with Androcur, your doctor may prescribe an estrogen-progestogen contraceptive (e.g. Diane-35) for contraceptive protection and to stabilize your menstrual cycle.
During combined therapy, ovarian function is blocked. These changes are reversible after treatment is stopped.
In men, Androcur reduces the level of testosterone (an androgen) in the blood. As a result, it leads to a reduction in sexual desire.
Androgens stimulate the growth of prostate cancer cells. In patients with prostate cancer, Androcur inhibits this effect.

Indications for Use

• Indications in womenSevere symptoms of androgenization, such as high-grade hirsutism, severe androgen-dependent hair loss leading to baldness, severe forms of acne and/or seborrhoea.

In cases of severe androgenization symptoms, cyproterone acetate should be taken at a dose of 50 mg, only when satisfactory results have not been achieved with products containing a lower dose of cyproterone acetate or with other treatment methods.

• Indications in menReduction of sexual desire in sexual deviations. To reduce sexual desire in sexual deviations, cyproterone acetate 50 mg should be taken only when the doctor considers other methods to be inappropriate. Anti-androgen therapy in cases of inoperable prostate cancer.

2. Important Information Before Taking Androcur

When Not to Take Androcur

Do not take Androcur if you have any of the conditions listed below. If any of the conditions listed below occur, inform your doctor before taking Androcur.

Women:

• if you are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of Androcur;
• if you are pregnant or breastfeeding;
• if you have liver disease;
• if you have had jaundice or persistent itching during a previous pregnancy;
• if you have had pruritus of pregnancy;
• if you have Dubin-Johnson syndrome or Rotor syndrome (hereditary liver function disorders with bilirubin excretion impairment from red blood cells);
• if you have or have had liver tumors, whether benign or malignant;
• if you have wasting diseases (diseases that cause atrophy or loss of strength);
• if you have severe chronic depression;
• if you have or have had blood circulation disorders, in particular conditions related to blood clotting (thromboembolic disorders);
• if you have severe diabetes with vascular complications;
• if you have sickle-cell anaemia;
• if you have or have had a benign brain tumor (meningioma). If you are also prescribed an estrogen-progestogen contraceptive (e.g. Diane-35), read the information in the package leaflet of the additional product carefully.

Men:

Reduction of sexual desire in sexual deviations

• if you are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of Androcur;
• if you have liver disease;
• if you have Dubin-Johnson syndrome or Rotor syndrome (hereditary liver function disorders with bilirubin excretion impairment from red blood cells);
• if you have or have had liver tumors, whether benign or malignant (except when they are the result of metastatic prostate cancer);
• if you have wasting diseases (diseases that cause atrophy or loss of strength, except for inoperable prostate cancer);
• if you have severe chronic depression;
• if you have or have had blood circulation disorders, in particular conditions related to blood clotting (thromboembolic disorders);
• if you have severe diabetes with vascular complications;
• if you have sickle-cell anaemia;
• if you have or have had a benign brain tumor (meningioma).

Anti-androgen therapy in cases of inoperable prostate cancer.

• if you are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of Androcur;
• if you have liver disease;
• if you have Dubin-Johnson syndrome or Rotor syndrome (hereditary liver function disorders with bilirubin excretion impairment from red blood cells);
• if you have or have had liver tumors, whether benign or malignant (except when they are the result of metastatic prostate cancer);
• if you have wasting diseases (diseases that cause atrophy or loss of strength, except for inoperable prostate cancer);
• if you have severe chronic depression;
• if you have or have had blood circulation disorders, in particular conditions related to blood clotting (thromboembolic disorders);
• if you have or have had a benign brain tumor (meningioma). Inform your doctor if you have any doubts.

Special Warnings and Precautions

Before starting treatment with Androcur, discuss it with your doctor.

• Androcur is not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy.
• The medicine should not be used before the completion of the growth process, as it may have an adverse effect on growth and the functioning of the immature endocrine system.
• Tell your doctor if you have diabetes, as your anti-diabetic treatment may need to be adjusted. During treatment with Androcur, your diabetes should be closely monitored (see also section "When not to take Androcur").
• There have been reports of anaemia during treatment with Androcur. Therefore, red blood cell count should be regularly monitored.
• Data from animal studies suggest that Androcur may impair the function of adrenal glands when administered in high doses. Therefore, your doctor may order tests to monitor adrenal function during treatment with Androcur.
• A link has been observed between the use of cyproterone acetate and the development of usually benign brain tumors (meningiomas). This risk increases, especially with long-term (several years) use or shorter use of high doses (25 mg per day or higher). If a meningioma is detected, your doctor will stop treatment with cyproterone acetate (see section "When not to take Androcur"). If you experience any symptoms such as vision disturbances (e.g. double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, headache that worsens over time, memory loss, seizures, weakness of arms or legs, inform your doctor immediately. Your doctor will assess the benefit-risk ratio of treatment in postmenopausal women.
• Blood clots (thromboembolic disorders) have been reported in association with the use of Androcur. However, a causal relationship has not been established. Patients who have had blood clots in the past or who have advanced cancer are at increased risk of thromboembolic disorders. Tell your doctor if you have had arterial or venous thrombosis (e.g. deep vein thrombosis), pulmonary embolism, heart attack, or stroke.

Special Warnings for Women

Before starting treatment in women, a thorough gynaecological examination (including breast examination and cervical smear) should be performed and pregnancy should be excluded.
If, during combined treatment with Androcur and an estrogen-progestogen contraceptive prescribed by your doctor (e.g. Diane-35), minor bleeding occurs within the first 3 weeks of taking the tablets, treatment should not be discontinued. However, if bleeding is heavy, you should consult your doctor.
If an estrogen-progestogen contraceptive (e.g. Diane-35) is prescribed as combined therapy, read the information in the package leaflet of the additional product carefully.

Special Warnings for Men

Patients with prostate cancer should inform their doctor if they have had any of the following conditions in the past:

• circulatory disorders, in particular blood clotting (thrombosis) in blood vessels,
• sickle-cell anaemia,
• severe diabetes with vascular complications. Your doctor will consider the appropriateness of prescribing Androcur.

The effect of Androcur prescribed for the indication "reduction of sexual desire in sexual deviations" may be reduced when taken with alcohol.

Androcur and Other Medicines

Tell your doctor about all the medicines you have taken recently, even those that are available without a prescription.
Tell your doctor if you are taking statins (medicines that lower blood fat levels), as some side effects (myopathy or rhabdomyolysis) may be increased when taken with high doses of Androcur.
Also, inform your doctor about the use of liver-acting medicines, such as:

• ketoconazole, itraconazole, clotrimazole (for fungal infections),
• ritonavir (for viral infections),
• rifampicin (for tuberculosis),
• phenytoin (for epilepsy),
• medicines containing St. John's Wort (Hypericum perforatum).

Androcur, when taken in high doses (100 mg 3 times a day), may block certain liver enzymes and thus affect the efficacy of other medicines.

Pregnancy and Breastfeeding

Before taking any medicine, consult your doctor.
Use of Androcur during pregnancy and/or breastfeeding is contraindicated.

Driving and Using Machines

Androcur may cause fatigue, reduced vitality, and impaired concentration.
Androcur contains 105.5 mg of lactose in each tablet.If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to Take Androcur

Tablets should be taken after meals, with a small amount of liquid. Do not take more than 300 mg per day.
If you feel that the effect of Androcur is too strong or too weak, consult your doctor or pharmacist.
Androcur should be taken as directed by your doctor. If you have any doubts, consult your doctor again.

Dosage for Women:

Do not take Androcur if you are pregnant. Therefore, pregnancy should be excluded before starting treatment.
In women of childbearing age, treatment starts on the first day of the cycle (on the first day of menstruation). Only women who are no longer menstruating can start taking Androcur immediately. In this case, the first day of treatment is equated with the first day of the cycle and subsequent recommendations are applied accordingly.
Between the 1st and 10th day of the cycle, take 1 tablet of Androcur (= 100 mg) 2 times a day.
In addition, to stabilize the cycle and provide necessary contraceptive protection, from

• 1st to 21st day of the cycle, patients should take an appropriate estrogen-progestogen contraceptive, e.g. Diane-35.

• ●2 tablets of Androcur
• ●○1 tablet of estrogen-progestogen contraceptive

Women receiving combined therapy in cycles should take the medicines every day at approximately the same time.
After 21 days of taking the estrogen-progestogen contraceptive, a 7-day break in treatment should be taken. During this time, withdrawal bleeding occurs. Exactly 4 weeks (28 days) after starting treatment, i.e. on the same day of the week, the next cycle of combined therapy starts, regardless of whether the withdrawal bleeding has stopped or is still ongoing.
After clinical improvement during combined therapy with Diane-35, your doctor may reduce the daily dose of Androcur to 1 (= 50 mg) or 1/2 tablet (= 25 mg), while still taking the medicine for the first 10 days of combined therapy. It may also be necessary to take only the estrogen-progestogen contraceptive. After menopause, your doctor will reassess the treatment. Long-term use (several years) of Androcur 50 should be avoided (see section "Special Warnings and Precautions").
In postmenopausal women or women who have had a hysterectomy, Androcur may be given as monotherapy, i.e. without the need for additional medicines. Depending on the severity of symptoms, the average dose should be from 1 to 1/2 tablet per day for 21 days, followed by a 7-day break in treatment.
If withdrawal bleeding does not occur
If withdrawal bleeding does not occur, before continuing treatment, consult your doctor to exclude pregnancy.
If you feel that the effect of Androcur is too strong or too weak, consult your doctor or pharmacist.

Dosage for Men:

Reduction of sexual desire in sexual deviations
Your doctor will determine the individual dosage.

• 1. Usually, 1 tablet is taken 2 times a day at the start of treatment.
• 2. It may be necessary to temporarily increase the dose to 2 tablets 2 times a day or even to 2 tablets 3 times a day.
• 3. When a satisfactory treatment result is achieved, your doctor will determine the smallest effective daily dose. Often, 1/2 tablet 2 times a day is sufficient.
• 4. The daily dose should be gradually reduced, e.g. by 1/2 or 1 tablet at intervals of several weeks. To consolidate the treatment effects, it is necessary to take Androcur for a longer period, participating in psychotherapy if possible.

Anti-androgen therapy in cases of inoperable prostate cancer
Take 2 tablets of Androcur 2 to 3 times a day (= 200 to 300 mg per day).
Do not stop treatment or reduce the dose after improvement or disappearance of disease symptoms.

• To reduce the initial increase in male sex hormone levels during treatment with GnRH agonists (gonadotropin-releasing hormone agonists)
• 1. Initially, take 2 tablets of Androcur 2 times a day (= 200 mg per day) for 5-7 days.
• 2. Then, take 2 tablets of Androcur 2 times a day (= 200 mg per day) for 3-4 weeks, in combination with a GnRH agonist at the dose recommended by the marketing authorization holder (see the package leaflet of the GnRH agonist).
• To treat hot flashes in patients treated with GnRH analogues or after orchiectomy
• 1. Take 1 to 3 tablets of Androcur per day (50 to 150 mg per day).
• 2. If necessary, the dose can be increased to 2 tablets 3 times a day (= 300 mg per day).

Patient over 65 years of age
There are no data suggesting the need for a dose adjustment in elderly patients.
Patient with liver impairment
Androcur is contraindicated in patients with liver disease (see section "When not to take Androcur").
Patient with renal impairment
There are no data suggesting the need for a dose adjustment in patients with renal impairment.

Overdose

No serious overdoses with Androcur have been reported.

Missed Dose

Missed dose in women
Do not take a double dose to make up for a missed dose. Take the next tablet at the usual time with the estrogen-progestogen contraceptive.
Women taking combined cycles of Androcur and an estrogen-progestogen contraceptive (e.g. Diane-35) should take the tablets every day at approximately the same time. If you miss a dose of the estrogen-progestogen contraceptive at the usual time, take it within 12 hours. If more than 12 hours have passed since the usual time of taking the tablet, the contraceptive effectiveness may be reduced in this cycle. Refer to the patient information leaflet of the estrogen-progestogen contraceptive for information on contraceptive effectiveness and what to do if you miss a tablet. If withdrawal bleeding does not occur after this cycle, exclude pregnancy before starting the next cycle of treatment.
Missed dose in men
Do not take a double dose to make up for a missed dose.
Take the next tablet at the usual time.
Stopping treatment
After stopping treatment with Androcur, the symptoms of the disease may recur. Do not stop taking the medicine without your doctor's advice. If you want to stop taking the medicine, consult your doctor.
In case of doubts about the use of the medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Androcur can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Inform your doctor immediately if you experience any of the following symptoms:

• general malaise, fever, nausea, vomiting, loss of appetite, itching all over the body, yellowing of the skin and eyes, pale stools, dark urine. These symptoms may indicate toxic liver damage, including hepatitis or liver failure. Liver function disorders, sometimes severe (jaundice, hepatitis, liver damage), have been observed in patients treated with Androcur. Fatal cases have also been reported in patients taking Androcur at a dose of 100 mg and higher. Most of the fatal cases occurred in men with advanced prostate cancer. Liver function disorders are dose-dependent and usually develop within a few months of starting treatment. Therefore, your doctor should monitor liver function before and during treatment, especially if symptoms suggesting toxic liver damage occur. If hepatotoxicity is confirmed, Androcur should be discontinued.
• unusual abdominal symptoms that do not resolve quickly. They may indicate the presence of benign or malignant liver tumors, which can lead to life-threatening bleeding into the abdominal cavity.
• swelling of the leg or foot, burning sensation in the chest, shortness of breath, or sudden weakness. These symptoms may indicate the formation of blood clots (thromboembolic disorders).

The frequency of side effects is defined as::

• very common (affects more than 1 in 10 people),
• common (affects more than 1 in 100 people but less than 1 in 10 people),
• uncommon (affects more than 1 in 1,000 people but less than 1 in 100 people),
• rare (affects more than 1 in 10,000 people but less than 1 in 1,000 people),
• very rare (affects less than 1 in 10,000 people),
• frequency not known (cannot be estimated from the available data).

Very common side effects::

• reversible inhibition of spermatogenesis (men);
• decreased sexual desire (decreased libido in men);
• erectile dysfunction (men).

Common side effects::

• toxic liver damage, including jaundice, hepatitis, liver failure (men);
• weight gain (men);
• weight loss (men);
• depressive mood (men);
• restlessness (transient) (men);
• gynaecomastia (breast growth in men) (men);
• fatigue (men);
• hot flashes (men);
• sweating (men);
• shortness of breath (men).

Uncommon side effects::

• rash (men).

Rare side effects::

• benign brain tumors (meningiomas) (women, men); (see section "When not to take Androcur" and "Special Warnings and Precautions").
• allergic reactions (men).

Very Rare Side Effects:

• benign and malignant liver tumors (men).

Side Effects of Unknown Frequency:

• -benign and malignant liver tumors (women);
• allergic reactions (hypersensitivity) (women);
• weight gain (women);
• weight loss (women);
• depressive mood (women);
• restlessness (transient) (women);
• decreased libido (women);
• increased libido (women);
• blood clots (thromboembolic disorders) (see section "Special Warnings and Precautions") (women, men);
• shortness of breath (women);
• intra-abdominal bleeding (women, men);
• toxic liver damage, including jaundice, hepatitis, liver failure (women);
• rash (women);
• inhibition of ovulation (women);
• breast tenderness (women);
• spotting (women);
• fatigue (women);
• osteoporosis (men);
• anaemia (men).

In women, during combined therapy with an estrogen-progestogen contraceptive such as Diane-35, ovarian function is inhibited, resulting in infertility during treatment. For combined therapy, also refer to the information on side effects in the patient information leaflet of the estrogen-progestogen contraceptive, such as Diane-35.
In men, treatment with Androcur leads to a reduction in sexual desire and potency, as well as inhibition of testicular function. These changes are reversible after treatment is stopped.
After a few weeks of treatment with Androcur, due to its anti-androgenic and anti-gonadotropic effects, spermatogenesis (sperm production) is inhibited. Spermatogenesis gradually returns within a few months after treatment is stopped.
In men, Androcur may cause breast growth (gynaecomastia, sometimes accompanied by breast tenderness). These changes are usually reversible after treatment is stopped.
As with other anti-androgenic medicines, long-term use of Androcur in men may lead to osteoporosis.
Both in women and men, benign brain tumors (meningiomas) have been observed, which have been associated with long-term (several years) use of Androcur at a dose of 25 mg or higher (see section "When not to take Androcur" and "Special Warnings and Precautions").

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel.: + 48 22 49 21 301, Faks: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Androcur

No special precautions for storage are necessary.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Androcur Contains

• The active substance is cyproterone acetate.
• One tablet contains 50 mg of cyproterone acetate.
• The other ingredients are lactose monohydrate, maize starch, povidone K 25, colloidal anhydrous silica, magnesium stearate.

What Androcur Looks Like and Contents of the Pack

Androcur tablets are white or slightly yellowish, round, flat on both sides with a notch on one side and embossed with "BV" within a hexagonal shape on the other side of the tablet. The tablet can be divided into two halves.
The pack contains 2 or 5 blisters of 10 tablets in a cardboard box.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Advanz Pharma Limited
Unit 17, Northwood House
Northwood Crescent
Dublin 9
D09 V504
Ireland
e-mail: [email protected]

Manufacturer

Bayer Weimar GmbH und Co. KG
Döbereinerstrasse 20
99427 Weimar
Germany

Date of Last Revision of the Leaflet: