ANDROCUR 50 mg Таблетки

Содержание инструкции

1. Androcur 50 mg tablets
   1. What is Androcur and what is it used for
   2. What you need to know 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
2. Androcur 100 mg tablets
   1. What is Androcur and what is it used for
   2. What you need to know before you take Androcur
   3. How to take Androcur
   4. Possible side effects
   5. How to store Androcur
   6. Contents of the pack and other information
3. Androcur 300 mg prolonged-release injectable solution for intramuscular use
   1. What is Androcur and what is it used for
   2. What you need to know before using Androcur
   3. How to use Androcur
   4. Possible side effects
   5. How to store Androcur
   6. Contents of the pack and other information

Androcur 50 mg tablets

ciproterone acetate

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Androcur is and what it is used for
• 2. What you need to know before you take 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

The active ingredient of Androcur is cyproterone acetate, which belongs to the group of antiandrogenic hormones.
This medicine is used for the reduction of deviations of sexual instinct in men and for the antiandrogenic treatment of inoperable prostate cancer.
For the reduction of deviations of sexual instinct, you must take cyproterone acetate 50/300 mg only if the doctor considers that other interventions are inadequate.

Important Note:Androcur is not indicated in women.

2. What you need to know before taking Androcur

Do not take Androcur:

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from liver diseases (liver diseases);
• if you suffer from Dubin-Johnson syndrome or Rotor syndrome (rare conditions that manifest with jaundice - yellowish discoloration of the skin and whites of the eyes);
• if you suffer from or have suffered from liver tumors (liver tumors) (except those from metastases of prostate carcinoma);
• if you suffer from debilitating diseases (excluding inoperable prostate carcinoma);
• if you suffer from severe chronic depression;
• if you suffer from or have suffered from thromboembolic processes (the formation of blood clots in blood vessels [thrombosis] or the blockage of a blood vessel by a clot [embolism]);
• if you suffer from severe forms of diabetes with vasculopathy (diabetes that involves the circulation of blood through a disease of the blood vessels themselves);
• if you suffer from sickle cell anemia (red blood cell disease);
• if you have or have had meningioma (brain tumor usually benign).

Warnings and precautions
Consult your doctor or pharmacist before taking Androcur.

Liver
The doctor will perform liver function tests(liver function) before starting the
treatment, at regular intervals during the treatment and whenever you experience symptoms
related to hepatotoxicity (liver damage).
This is because manifestations of direct hepatic toxicity such as jaundice, hepatitis and hepatic
insufficiency have been observed in patients treated with Androcur. At doses equal to or greater than 100 mg
fatal cases have also been reported. Most fatal cases involved male patients with advanced prostate carcinoma.
Hepatotoxicity is related to the dose taken and, in general, occurs several months after the start
of treatment.
If this is confirmed, the administration of Androcur must be discontinued, unless
the hepatotoxicity cannot be attributed to a different cause such as, for example, the presence of
metastases; in this case, it is advisable to continue the treatment with Androcur only if the benefit
perceived outweighs the associated risk.
In addition, very rarely benign and malignant liver tumorshave been observed following the use of Androcur
which can cause life-threatening intra-abdominal bleeding.
If you experience disturbances or abdominal pain that you have never experienced before and that does not go away immediately, inform
your doctor immediately.

Meningiomas(brain tumors usually benign)
The use of cyproterone acetate has been associated with the development of a brain tumor generally
benign (meningioma). The risk increases particularly if you use it for prolonged periods (several
years) or for shorter periods at high doses (25 mg and more per day). If you are diagnosed with a
meningioma, your doctor will stop treatment with cyproterone acetate (see section ‘Do not
take cyproterone acetate’). If you notice symptoms such as visual disturbances (for example double vision or
blurred vision), hearing loss or ringing in the ears, loss of smell, headache that
worsens over time, memory loss, seizures, weakness in the arms or
legs, you should immediately inform your doctor.

Anemia
During treatment with Androcur, cases of anemia have been reported. Therefore, the doctor will perform
periodic checks of the blood count (complete blood test) during treatment.

Diabetes mellitus
If you suffer from diabetes mellitus(the form of diabetes that causes the elimination of excess glucose with the
urine), your doctor will need to carefully monitor your condition as the need for insulin or
oral antidiabetic drugs may change during treatment with Androcur (see also “Do not
take Androcur”).

Adrenal function
The doctor will regularly check the adrenal function(the function of the gland that
produces steroid hormones) during treatment with Androcur, as preclinical data indicate a possible suppression of adrenal function due to the effect of
Androcur administered at high doses.

Shortness of breath
During treatment with Androcur at high doses, you may experience a sensation of shortness
of breath. Even if this generally does not require treatment, inform your doctor if you should
experience this disturbance.

Thromboembolic events(blood clots)
The occurrence of thromboembolic events has been reported in patients treated with Androcur, although
a cause/effect relationship with the medicine has not been established. If you have already had thrombotic and/or thromboembolic events, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke (cerebrovascular event) or advanced-stage tumors,
inform your doctor as there is an increased risk of developing further thromboembolic events.

Other medicines and Androcur
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Tell your doctor especially if you are taking:

• ketoconazole, itraconazole, clotrimazole (medicines used for the treatment of fungal infections), or ritonavir (used for HIV infection); these and other potent CYP3A4 inhibitors may inhibit the metabolism of cyproterone acetate.
• CYP3A4 inducers, such as rifampicin (used for the treatment of tuberculosis), phenytoin (used for the treatment of epilepsy) and products containing Hypericum perforatum(St. John's wort) (used for the treatment of depression); these may reduce the levels of cyproterone acetate.
• HMGCoA inhibitors (statins), used to reduce cholesterol levelsin the blood. Concomitant use with Androcur may increase the risk of rhabdomyolysis (breakdown of skeletal muscle cells) and myopathies (muscle weakness).

If you are taking medicines for the treatment of diabetes, your doctor may adjust the
dosage of this medicine during concomitant treatment with Androcur (see
“Warnings and precautions”).

Androcur with food, drinks and alcohol
In the indication “reduction of deviations of sexual instinct”, the therapeutic efficacy of
Androcur may decrease under the effect of alcohol.

Pregnancy, breastfeeding and fertility
Androcur is not intended for use by women.

Driving and operating machinery
Patients whose activity requires a high degree of attention (for example drivers, machinery operators) must be aware that Androcur can cause asthenia (fatigue) and
reduced vitality and impaired concentration.

Androcur contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Androcur

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

The maximum recommended dose is:300 mg per day.
The tablets should be taken with some liquid after meals.
The tablet can be divided into two equal halves.

Reduction of deviations of sexual drive in men
Generally, treatment begins with 1 Androcur 50 mg tablet twice a day. It may
be necessary to increase the dose to 2 tablets twice a day, or up to 2 tablets
three times a day for a short period of time.
Once a satisfactory result is achieved, an attempt will be made to maintain the therapeutic effect with the
lowest possible dosage. Often half a tablet twice a day is sufficient. When
reaching the maintenance dose or in case of discontinuation of therapy, a gradual reduction of the dosage should be carried out.
To this end, it is recommended to reduce the daily dose by 1 or
better half a tablet at intervals of several weeks.
To stabilize the therapeutic effect, Androcur must be taken for a
prolonged period of time, if possible adopting appropriate psychotherapeutic measures at the same time.

Antiandrogen treatment of inoperable prostate cancer
2 Androcur 50 mg tablets two or three times a day (= 200 - 300 mg), as directed
by your doctor.

Reduction of the initial increase of male sex hormones in combination treatment
with GnRH agonists
If you are being treated with GnRH agonists for the treatment of prostate cancer, to eliminate
the intensification of the disease in the early period of treatment with these medicines, start with
2 Androcur 50 mg tablets twice a day (= 200 mg) for 5 - 7 days, followed by 2
Androcur 50 mg tablets twice a day (= 200 mg) for 3 - 4 weeks together with a GnRH
agonist at the dosage recommended by your doctor.

For the treatment of hot flashes in patients undergoing combination treatment with
GnRH analogs or after orchiectomy (surgical removal of one or both
testicles)
From 1 to 3 Androcur 50 mg tablets per day (= 50 - 150 mg) with a gradual increase in
the dose up to 2 tablets three times a day (= 300 mg) if necessary.

Use in children and adolescents
The use of Androcur is not recommended in children and adolescent males under 18
years of age due to insufficient data on safety and efficacy.
Androcur should not be administered before the end of puberty, due to the possible
negative influence on statural growth and on the still immature endocrine function.

Use in elderly patients
There are no data to indicate the need for dosage adjustment in elderly patients.

Use in patients with impaired liver function (liver function)
The use of Androcur is contraindicated in patients with liver diseases, until
normalization of liver function indices.

Use in patients with impaired renal function
There are no data to indicate the need for dosage adjustment in patients with
impaired renal function.

If you take more Androcur than you should
No harmful effects from excessive doses of the medicine have ever been reported or are predictable.
If you accidentally take an excessive dose of Androcur, immediately inform your
doctor or go to the nearest hospital.

If you stop taking Androcur
Do not stop treatment, or reduce the dose following improvement or disappearance of the symptoms of the
disease.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequent side effects associated with the use of Androcur are decreased libido, erectile
dysfunction and reversible inhibition of spermatogenesis.

The most serious side effectsassociated with the use of Androcur are hepatic toxicity, benign and
malignant liver tumors that can cause intra-abdominal bleeding, and thromboembolic events.
The frequency of side effects is reported below.

Very common side effects(may affect more than 1 in 10 people):

• decreased libido, erectile dysfunction. These changes are reversible after discontinuation of therapy;
• reversible inhibition of spermatogenesis. Recovery of spermatogenesis occurs gradually within a few months of discontinuation of therapy.

Common side effects(may affect up to 1 in 10 people):

• weight gain or loss;
• depressed mood, agitation (temporary);
• shortness of breath (see “Warnings and precautions”);
• hepatic toxicity, including jaundice, hepatitis, hepatic failure (see “Warnings and precautions”);
• gynecomastia (excessive development of male breast tissue), sometimes associated with nipple tenderness, which normally regresses after discontinuation of treatment;
• fatigue, hot flushes, sweating.

Uncommon side effects(may affect up to 1 in 100 people):

• rash (skin eruptions).

Rare side effects(may affect up to 1 in 1,000 people):

• hypersensitivity reaction, i.e. a particularly amplified and violent reaction to the medicine;
• meningioma (see section 2 “Warnings and precautions”);

Very rare side effects(may affect up to 1 in 10,000 people):

• benign and malignant liver tumors (see “Warnings and precautions”).

Side effects with unknown frequency(frequency cannot be estimated based on available data):

• anemia (see “Warnings and precautions”);
• thromboembolic events (no causal relationship with Androcur has been established, see “Warnings and precautions”);
• intra-abdominal bleeding (see “Warnings and precautions”);
• osteoporosis (caused by long-term deprivation of androgens induced by Androcur as well as other antiandrogen treatments).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Androcur

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Androcur contains

• The active ingredient is cyproterone acetate. Each tablet contains cyproterone acetate 50 mg.
• The other ingredients are: corn starch, lactose monohydrate, magnesium stearate, povidone 25, colloidal silicon dioxide.

Description of the appearance of Androcur and contents of the pack
Tablet for oral use.
Tablets from white to slightly yellowish, with a score line on one side and with the letters “BV”
impressed in a regular hexagon on the other.
The tablet can be divided into two equal halves.
Pack of 25 tablets of 50 mg
Pack of 30 tablets of 50 mg
It is possible that not all packs are marketed.

Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17, Northwood House,
Northwood Crescent,
Dublin 9,
D09 V504,
Ireland

Manufacturer
Bayer Weimar GmbH und Co. KG, Germany.

Androcur 100 mg tablets

ciproterone acetate

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Androcur is and what it is used for
• 2. What you need to know before you take 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

The active ingredient of Androcur is cyproterone acetate, which belongs to the group of antiandrogen hormones.
This medicine is used for the antiandrogen treatment of inoperable prostate cancer.

Important Note: Androcur is not indicated in women.

2. What you need to know before you take Androcur

Do not take Androcur:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from liver diseases (liver disease);
• if you suffer from Dubin-Johnson syndrome or Rotor syndrome (rare conditions that manifest with jaundice - yellowish discoloration of the skin and whites of the eyes);
• if you suffer from or have suffered from liver tumors (tumors of the liver) (except those from metastases of prostate cancer);
• if you suffer from debilitating diseases (excluding inoperable prostate cancer);
• if you suffer from severe chronic depression;
• if you suffer from or have suffered from thromboembolic processes (the formation of blood clots in blood vessels [thrombosis] or the blockage of a blood vessel by a clot [embolism]);
• if you suffer from severe forms of diabetes with vasculopathy (diabetes involving blood circulation through a disease of the blood vessels themselves);
• if you suffer from sickle cell anemia (red blood cell disease);
• if you have or have had meningioma (brain tumor usually benign).

Warnings and precautions
Talk to your doctor or pharmacist before taking Androcur.

Liver
The doctor will perform liver function tests(liver function) before starting the
treatment, at regular intervals during treatment and whenever you experience symptoms
related to hepatotoxicity (liver damage).
This is because manifestations of direct hepatic toxicity such as jaundice, hepatitis and hepatic
insufficiency have been observed in patients treated with Androcur. At doses equal to or greater than 100 mg
fatal cases have also been reported. Most fatal cases involved male patients with advanced prostate cancer.
Hepatotoxicity is related to the dose taken and, in general, occurs several months after the start
of treatment.
If this is confirmed, the administration of Androcur must be discontinued, unless
the hepatotoxicity cannot be attributed to a different cause such as, for example, the presence of
metastases; in this case, it is advisable to continue treatment with Androcur only if the perceived benefit
outweighs the associated risk.
In addition, very rarely benign and malignant liver tumorshave been observed following the use of Androcur
which can cause life-threatening intra-abdominal bleeding.
If you experience disturbances or abdominal pain that you have never experienced before and that does not go away immediately, inform
your doctor immediately.

Meningiomas(brain tumors usually benign)
The use of cyproterone acetate has been associated with the development of a brain tumor generally
benign (meningioma). The risk increases particularly if you use it for prolonged periods (several
years) or for shorter periods at high doses (25 mg and more per day). If you are diagnosed with a
meningioma, your doctor will stop treatment with cyproterone acetate (see section ‘Do not
take cyproterone acetate’). If you notice symptoms such as visual 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 in the arms or
legs, you should immediately inform your doctor.”

Anemia
During treatment with Androcur, cases of anemia have been reported. Therefore, the doctor will perform
periodic checks of the blood count (complete blood test) during treatment.

Diabetes mellitus
If you suffer from diabetes mellitus(the form of diabetes that causes the elimination of excess glucose
in the urine), your doctor will need to carefully monitor your condition as the need for
insulin or oral antidiabetic medicines may change during treatment with Androcur
(see also “Do not take Androcur”).

Adrenal function
The doctor will regularly check the adrenal function(the function of the
gland that produces steroid hormones) during treatment with Androcur, as
preclinical data indicate a possible suppression of adrenal function due
to the effect of Androcur administered at high doses.

Shortness of breath
During treatment with Androcur at high doses you may experience a sensation of shortness
of breath. Even if this generally does not require treatment, inform your doctor if you should
experience this disturbance.

Thromboembolic events(blood clots)
The occurrence of thromboembolic events has been reported in patients treated with Androcur, although
a cause-effect relationship with the medicine has not been established. If you have already had thrombotic and/or thromboembolic events, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke (cerebrovascular event) or advanced-stage tumors, inform your doctor as there is an increased risk of developing further thromboembolic events.

Other medicines and Androcur
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those without a prescription.
Tell your doctor particularly if you are taking:

• ketoconazole, itraconazole, clotrimazole (medicines used for the treatment of fungal infections), or ritonavir (used for HIV infection); these and other potent CYP3A4 inhibitors may inhibit the metabolism of cyproterone acetate.
• CYP3A4 inducers, such as rifampicin (used for the treatment of tuberculosis), phenytoin (used for the treatment of epilepsy) and products containing Hypericum perforatum(St. John's wort) (used for the treatment of depression); these may reduce the levels of cyproterone acetate.
• HMGCoA inhibitors (statins), used to reduce cholesterol levelsin the blood. Concomitant use with Androcur may increase the risk of rhabdomyolysis (breakdown of skeletal muscle cells) and myopathies (muscle weakness).

If you are taking medicines for the treatment of diabetes, your doctor may adjust the
dosage of this medicine during concomitant treatment with Androcur (see
“Warnings and precautions”).

Pregnancy, breastfeeding and fertility
Androcur is not intended for use by women.

Driving and operating machinery
Patients whose activity requires a high degree of attention (e.g. drivers, machinery operators) must be aware that Androcur may cause asthenia (fatigue) and
reduced vitality and impaired concentration.

Androcur contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Androcur

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

The recommended dose is:1 tablet of Androcur 100 mg two or three times a day (= 200 - 300 mg).
The tablets should be taken with some liquid after meals.

Reduction of the initial increase of male sex hormones in association treatment
with GnRH agonists
If you are being treated with GnRH agonists for the treatment of prostate cancer, to eliminate
the intensification of the disease in the initial period of treatment with these medicines, start with 1
tablet of only Androcur 100 mg twice a day (= 200 mg) for 5 - 7 days, followed by 1 tablet
of Androcur 100 mg twice a day (= 200 mg) for 3 - 4 weeks together with a GnRH agonist in the
dosage recommended by the doctor.

For the treatment of hot flashes in patients treated with GnRH analogues
or after orchiectomy (surgical removal of one or both testicles)
From half a tablet to one and a half tablets of Androcur 100 mg per day (= 50 - 150 mg) with
gradual dose increase up to 1 tablet three times a day (= 300 mg), if necessary.

Use in children and adolescents
The use of Androcur is not recommended in children and adolescent males under 18
years of age due to insufficient data on safety and efficacy.
Androcur should not be administered before the end of puberty, due to the possible
negative influence on statural growth and still immature endocrine function.

Use in elderly patients
There are no data to indicate the need for dosage adjustment in elderly patients.

Use in patients with impaired liver function (liver function)
The use of Androcur is contraindicated in patients with liver diseases (liver diseases), until
normalization of liver function indices.

Use in patients with impaired renal function
There are no data to indicate the need for dosage adjustment in patients with
impaired renal function.

If you take more Androcur than you should
No adverse effects from overdoses of the medicine have ever been reported or are predictable.
In case of accidental intake of an excessive dose of Androcur, immediately inform
your doctor or go to the nearest hospital.

If you stop taking Androcur
Do not stop treatment, or reduce the dose following improvement or disappearance of the symptoms of the
disease.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequent side effects associated with the use of Androcur are decreased libido, erectile
dysfunction and reversible inhibition of spermatogenesis.

The most serious side effectsassociated with the use of Androcur are hepatic toxicity, benign and
malignant liver tumors that can cause intra-abdominal bleeding and thromboembolic events.
The frequency of side effects is listed below.

Very common side effects(may affect more than 1 in 10 people):

• decreased libido, erectile dysfunction. These changes are reversible after discontinuation of therapy;
• reversible inhibition of spermatogenesis. Recovery of spermatogenesis occurs gradually within a few months of discontinuation of therapy.

Common side effects(may affect up to 1 in 10 people):

• weight gain or loss;
• depressed mood, agitation (temporary);
• shortness of breath (see “Warnings and precautions”);
• hepatic toxicity, including jaundice, hepatitis, hepatic failure (see “Warnings and precautions”);
• gynecomastia (excessive development of male breast tissue), sometimes associated with nipple tenderness, which normally regresses after discontinuation of treatment;
• fatigue, hot flushes, sweating.

Uncommon side effects(may affect up to 1 in 100 people):

• rash (skin eruptions).

Rare side effects(may affect up to 1 in 1,000 people):

• hypersensitivity reaction, i.e. a particularly amplified and violent reaction to the medicine;
• Meningioma (see section 2 “Warnings and precautions”)

Very rare side effects(may affect up to 1 in 10,000 people):

• benign and malignant liver tumors (see “Warnings and precautions”).

Side effects with unknown frequency(frequency cannot be estimated based on available data):

• anemia (see “Warnings and precautions”);
• thrombo-embolic events (no causal relationship with Androcur has been established, see “Warnings and precautions”);
• intra-abdominal bleeding (see “Warnings and precautions”);
• osteoporosis (caused by long-term deprivation of androgens induced by Androcur as well as other antiandrogen treatments).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Androcur

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad.”. The expiry date
refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Androcur contains

• The active ingredient is cyproterone acetate. Each tablet contains cyproterone acetate 100 mg.
• The other ingredients are: corn starch, lactose monohydrate, povidone 25, magnesium stearate.

Description of the appearance of Androcur and contents of the pack
Tablet for oral use.
30 tablets of 100 mg.

Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17, Northwood House,
Northwood Crescent,
Dublin 9,
D09 V504,
Ireland

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

Androcur 300 mg prolonged-release injectable solution for intramuscular use

ciproterone acetate

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Androcur is and what it is used for
• 2. What you need to know before you use Androcur
• 3. How to use 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

The active ingredient of Androcur is cyproterone acetate, which belongs to the group of antiandrogen hormones.
This medicine is used for the antiandrogen treatment of inoperable prostate cancer.

Important Note:Androcur is not indicated in women.

2. What you need to know before using Androcur

Do not use Androcur:

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from liver diseases (liver diseases);
• if you suffer from Dubin-Johnson syndrome or Rotor syndrome (rare conditions that manifest with jaundice - yellowish discoloration of the skin and whites of the eyes);
• if you suffer from or have suffered from liver tumors (tumors of the liver) (except those from metastases of prostate cancer);
• if you suffer from debilitating diseases (excluding inoperable prostate cancer);
• if you suffer from severe chronic depression;
• if you suffer from or have suffered from thromboembolic processes (the formation of blood clots in blood vessels [thrombosis] or the blockage of a blood vessel by a clot [embolism]);
• if you suffer from severe forms of diabetes with vasculopathy (diabetes involving the circulation of blood through a disease of the blood vessels themselves);
• if you suffer from sickle cell anemia (red blood cell disease);
• if you have or have had meningioma (a brain tumor usually benign).

Warnings and precautions
Consult your doctor or pharmacist before using Androcur.

Liver
The doctor will perform liver function tests(liver function) before starting the
treatment, at regular intervals during treatment and whenever you experience symptoms
related to hepatotoxicity (liver damage).
This is because manifestations of direct hepatic toxicity such as jaundice, hepatitis and hepatic
insufficiency have been observed in patients treated with Androcur. Fatal cases have also been reported at doses equal to or greater than 100 mg.
Most fatal cases involved male patients with advanced prostate cancer.
Hepatotoxicity is related to the dose taken and generally occurs several months after the start
of treatment.
If this is confirmed, the administration of Androcur must be discontinued, unless
the hepatotoxicity cannot be attributed to a different cause such as, for example, the presence of
metastases; in this case, it is advisable to continue treatment with Androcur only if the benefit
perceived outweighs the associated risk.
In addition, very rarely benign and malignant liver tumorshave been observed following the use of Androcur
which can cause life-threatening intra-abdominal bleeding.
If you experience new or persistent abdominal discomfort or pain, immediately inform
your doctor.

Meningiomas(brain tumors usually benign)
The use of cyproterone acetate has been associated with the development of a brain tumor generally
benign (meningioma). The risk increases particularly if you use it for prolonged periods (several
years) or for shorter periods at high doses (25 mg and more per day). If you are diagnosed with a
meningioma, your doctor will stop treatment with cyproterone acetate (see section ‘Do not
take cyproterone acetate’). If you notice symptoms such as visual 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 in the arms or
legs, you should immediately inform your doctor.”

Anemia
Cases of anemia have been reported during treatment with Androcur. Therefore, the doctor will perform
periodic checks of the blood count (complete blood test) during treatment.

Diabetes mellitus
If you suffer from diabetes mellitus(the form of diabetes that causes the elimination of excess glucose
in the urine), your doctor will need to carefully monitor your condition as the need for
insulin or oral antidiabetic medicines may change during treatment with Androcur
(see also “Do not use Androcur”).

Adrenal function
The doctor will regularly check the adrenal function(the function of the gland
that produces steroid hormones) during treatment with Androcur, as preclinical data
indicate a possible suppression of adrenal function due to the effect of
Androcur administered at high doses.

Shortness of breath
During treatment with Androcur at high doses, you may experience a sensation of shortness
of breath. Even if this generally does not require treatment, inform your doctor if you should
experience this disturbance.

Thromboembolic events(blood clots)
The occurrence of thromboembolic events has been reported in patients treated with Androcur, although
a causal relationship with the medicine has not been established. If you have already had thrombotic
and/or thromboembolic events, such as deep vein thrombosis, pulmonary embolism,
myocardial infarction, stroke (cerebrovascular event) or advanced-stage tumors, inform your doctor
as there is an increased risk of developing further thromboembolic events.

Other conditions
As with all oily solutions, Androcur must be injected exclusively intramuscularly
(into the muscle) and very slowly. Pulmonary microembolism of oily solutions (the formation of
small clots in the pulmonary arteries) can, in some cases, give rise to signs and symptoms such as cough,
dyspnea (shortness of breath) and chest pain. Other signs and symptoms may appear,
including vasovagal reactions such as malaise, hyperhidrosis (excessive sweating), dizziness, paresthesia
(altered sensitivity) or syncope (fainting). These reactions can occur during
the injection or immediately afterwards and are reversible. Treatment usually consists of supportive measures,
such as oxygen administration.

Other medicines and Androcur
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including over-the-counter medicines.
Tell your doctor particularly if you are taking:

• ketoconazole, itraconazole, clotrimazole (medicines used for the treatment of fungal infections), or ritonavir (used for HIV infection); these and other potent CYP3A4 inhibitors can inhibit the metabolism of cyproterone acetate.
• CYP3A4 inducers, such as rifampicin (used for the treatment of tuberculosis), phenytoin (used for the treatment of epilepsy) and products containing Hypericum perforatum(St. John's wort) (used for the treatment of depression); these can reduce the levels of cyproterone acetate.
• HMGCoA inhibitors (statins), used to reduce cholesterol levelsin the blood. Concomitant use with Androcur may increase the risk of rhabdomyolysis (breakdown of skeletal muscle cells) and myopathies (muscle weakness).

If you are taking medicines for the treatment of diabetes, your doctor may adjust the
dosage of this medicine during concomitant treatment with Androcur (see
“Warnings and precautions”).

Pregnancy, breastfeeding and fertility
Androcur is not intended for use by women.

Driving and operating machinery
Patients whose activity requires a high degree of attention (e.g. drivers, machinery operators) must be aware that Androcur can cause asthenia (fatigue) and
reduced vitality and impaired concentration.

Androcur contains castor oil
This medicine contains castor oil, which can cause severe allergic reactions.

Androcur contains benzyl benzoate
This medicine contains 1855.8 mg of benzyl benzoate per vial, equivalent to 618.6 mg/1 ml.

3. How to use Androcur

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

The recommended dose is1 vial per week in the form of a deep intramuscular injection.
The injections must be administered very slowly (see also “Warnings and
precautions”). Androcur is intended exclusively for intramuscular injection. Particular care
must be taken to avoid intravascular injection (injection into blood vessels).

Use in children and adolescents
The use of Androcur is not recommended in children and adolescent males under 18
years of age due to insufficient data on safety and efficacy.
Androcur should not be administered before the end of puberty, due to the possible
negative influence on statural growth and still immature endocrine function.

Use in elderly patients
There are no data to indicate the need for dosage adjustment in elderly patients.

Use in patients with impaired liver function (liver)
The use of Androcur is contraindicated in patients with hepatopathies (liver diseases), until
normalization of liver function indices.

Use in patients with impaired renal function
There are no data to indicate the need for dosage adjustment in patients with
impaired renal function.

If you use more Androcur than you should
No adverse effects from excessive doses of the medicine have ever been reported or are predictable.
In case of accidental intake of an excessive dose of Androcur, immediately inform
your doctor or go to the nearest hospital.

If you stop taking Androcur
Do not stop treatment, or reduce the dose following improvement or disappearance of the symptoms of the
disease.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequent side effects associated with the use of Androcur are decreased libido, erectile
dysfunction and reversible inhibition of spermatogenesis.

The most serious side effectsassociated with the use of Androcur are hepatic toxicity, benign and
malignant liver tumors that can cause intra-abdominal bleeding, and thromboembolic events.
The frequency of side effects is reported below.

Very common side effects(may affect more than 1 in 10 people):

• decreased libido, erectile dysfunction. These changes are reversible after discontinuation of therapy;
• reversible inhibition of spermatogenesis. Recovery of spermatogenesis occurs gradually within a few months after discontinuation of therapy.

Common side effects(may affect up to 1 in 10 people):

• weight gain or loss;
• depressed mood, agitation (temporary);
• feeling of shortness of breath (see “Warnings and precautions”);
• hepatic toxicity, including jaundice, hepatitis, hepatic failure (see “Warnings and precautions”);
• gynecomastia (excessive development of male breast tissue), sometimes associated with nipple tenderness to the touch, which normally regresses after discontinuation of treatment;
• fatigue, hot flushes, sweating.

Uncommon side effects(may affect up to 1 in 100 people):

• - rash (skin eruptions).

Rare side effects(may affect up to 1 in 1,000 people):

• hypersensitivity reaction, i.e. a particularly amplified and violent reaction to the medicine.
• Meningioma (see section 2 “Warnings and precautions”)

Very rare side effects(may affect up to 1 in 10,000 people):

• benign and malignant liver tumors (see “Warnings and precautions”).

Side effects with unknown frequency(frequency cannot be estimated based on available data):

• anemia (see “Warnings and precautions”);
• oily pulmonary microembolism (see “Warnings and precautions”);
• vasovagal reactions (see “Warnings and precautions”);
• thromboembolic events (no causal relationship with Androcur has been established; see “Warnings and precautions”);
• intra-abdominal bleeding (see “Warnings and precautions”);
• osteoporosis (caused by long-term deprivation of androgens induced by Androcur as well as other antiandrogen treatments).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in
this leaflet. You can also report side effects directly through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Androcur

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Scad”. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Androcur contains

• The active ingredient is cyproterone acetate. Each Androcur vial of 3 ml contains 300 mg of cyproterone acetate in oily solution.
• The other ingredients are: benzyl benzoate, castor oilfor injectable preparations.

Description of the appearance of Androcur and contents of the pack
Prolonged-release injectable solution for intramuscular use.
Clear solution, free from particles.
1 vial of 3 ml

Marketing Authorisation Holder
Advanz Pharma Limited
Unit 17, Northwood House,
Northwood Crescent,
Dublin 9,
D09 V504,
Ireland

Manufacturer
Bayer AG, Muellerstrasse 170-178, D-13353; Berlin (Germany)