ANDROCUR 100 mg * 30 tablets

ANDROCUR 100 mg * 30 tablets

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Price: £ 45.00

Description:
ANDROCUR 100 mg * 30 tablets
Category: Medicines


1. What Androcur is and what it is used for
Androcur is a hormonal product that blocks the effect of androgens - sex hormones that are produced mainly in men, but also in smaller amounts in women. The active substance is cyproterone acetate.

In women, Androcur has a beneficial effect on androgen-dependent conditions, such as excessive hair growth in hirsutism, hair loss (androgenic alopecia) and increased secretion of sebaceous glands, leading to acne and seborrhea.

Also, your doctor may prescribe an estrogen-progestogen-containing contraceptive such as Diane 35 for Androcur treatment to provide contraceptive protection and cycle stabilization. During combination therapy, ovarian function is suppressed. These changes are reversible upon discontinuation of therapy.

In men, Androcur reduces the concentration of testosterone (androgen) in the blood. This in turn leads to a decrease in libido.

Androgens promote the development of prostate cancer. In these patients, Androcur suppresses this effect.

In women, Androcur is used for
Severe signs of androgenization, such as

very severe hirsutism (excessive hair growth)
androgen-induced major hair loss, possibly leading to baldness (severe androgenic alopecia)
 severe forms of acne and / or seborrhea.
In case of severe signs of androgenisation, such as very severe hirsutism (excessive hair growth), androgen-induced severe hair loss, possibly leading to baldness (severe androgenic alopecia), severe acne and / or seborrhea, you should take cyproterone acetate 50 mg only. satisfactory results have not been achieved with drugs containing low doses of cyproterone acetate or with other treatments.

In men, Androcur is used for
Suppression of libido in cases of sexual deviations
When suppressing libido in sexual disorders, you should take cyproterone acetate 50 mg only if your doctor considers that other methods of response are inappropriate.

Antiandrogen therapy in inoperable prostate cancer
2. What you need to know before you take Androcur
Do not take Androcur
If you suffer from any of the conditions listed below, do not take Androcur. If any of these apply to you, tell your doctor before taking Androcur.

For women:
if you are pregnant or breast-feeding;
if you have liver disease;
if you have a history of jaundice or evidence of pruritus during pregnancy;
if you have a history of herpes during pregnancy;
if you suffer from congenital liver disorders with impaired red blood cell pigment secretion called bilirubin (Dubin-Johnson or Rotor syndrome);
if you have or have ever had a benign or malignant liver tumor; .if you have or have ever had a benign brain tumor (meningioma);
if you suffer from a debilitating illness (a disease that causes you to lose weight or lose strength);
if you suffer from severe chronic depression;
if you have or have ever had evidence of circulatory disorders: in practice, conditions associated with thrombosis (blood clot formation), in blood vessels (thromboembolic process);
if you have severe vascular diabetes;
if you have sickle cell anemia;
if you suffer from hypersensitivity (allergy) to cyproterone acetate or any of the other ingredients of Androcur.
If your doctor has prescribed a progestogen-estrogen containing a contraceptive, such as Diane 35 in combination with Androcur, you should also pay attention to the information contained in the Diane 35 package leaflet.

In men
when prescribed to reduce libido in cases of sexual deviations
if you have liver disease;
if you suffer from congenital liver disorders with impaired red blood cell pigment secretion called bilirubin (Dubin-Johnson or Rotor syndrome);
if you have or have ever had a benign or malignant liver tumor;
if you have or have ever had a benign brain tumor (meningioma);
if you suffer from a debilitating illness (a disease that causes you to lose weight or lose strength);
if you suffer from chronic depression;
if you have or have ever had a circulatory disorder: in practice, conditions associated with thrombosis (blood clot formation), in blood vessels (thromboembolic process);
if you have severe vascular diabetes;
if you have sickle cell anemia;
if you are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of Androcur.
when prescribed as antiandrogen therapy in inoperable prostate cancer
if you have liver disease;
if you suffer from congenital liver function problems with impaired red blood pigment called bilirubin (Dubin-Johnson or Rotor syndrome); .if you have or have ever had a benign or malignant liver tumor (only if it is not a metastasis of prostate cancer);
if you have or have ever had a benign brain tumor (meningioma);
if you suffer from a debilitating disease (a disease that causes loss of strength, with the exception of inoperable prostate cancer);
if you suffer from severe chronic depression;
if you have a history or evidence of circulatory disorders: in practice, conditions associated with thrombosis (blood clot formation), in blood vessels (thromboembolic process);
if you are allergic (hypersensitive) to cyproterone acetate or any of the other ingredients of Androcur.
Warnings and precautions
Talk to your doctor before taking Androcur.

Take special care with Androcur
Androcur is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not been established in this age group.

Androcur should not be used before the end of puberty in female children and adolescents, as it may have an adverse effect on growth and on the still unstable hormonal regulation. The safety and efficacy of Androcur have not been established in children and adolescents under 18 years of age.

Tell your doctor if you have diabetes, as there may be a need to change your treatment with antidiabetic medicines. This condition requires close monitoring during Androcur therapy (see also "Do not take Anadrocure").

Cases of anemia have been reported in men during Androcur therapy. Therefore, your doctor will monitor your blood count during treatment.

Data from animal studies suggest that high doses of Androcur may reduce the function of the hormone-producing glands located above the kidneys (adrenal glands). Therefore, your doctor may take some tests to monitor this effect during treatment with Androcur.

Meningioma
The use of cyproterone acetate has been associated with the development of mainly benign brain tumors (meningiomas). The risk increases especially when you use it for a longer time (several years) or for a shorter time with high doses (25 mg per day and higher). If you are diagnosed with meningioma, your doctor will stop your treatment with cyproterone acetate (see section "Do not take cyproterone acetate"). If you notice any symptoms such as a change in vision (eg double vision or blurred vision), hearing loss or tinnitus, loss of smell, headache that gets worse over time, memory loss, seizures, weakness in the arms or legs, you must tell your doctor immediately.

Your doctor will re-evaluate the benefits and risks of Androcur treatment when you enter menopause.

Thrombosis (thromboembolic events) has been reported in patients on Androcur therapy, although no causal relationship has been established. Patients with a history of thrombosis or advanced malignancy are at increased risk of thromboembolism.

Tell your doctor if you have or have ever had arterial or venous thrombosis, pulmonary embolism, heart attack (myocardial infarction) or stroke (cerebrovascular accident).

Specific observation in women
Before starting therapy, it is necessary to perform a general medical and gynecological examination (including breast and cervical smear) in women and to rule out pregnancy.

If "irregular" bleeding occurs during the three weeks of taking the tablets during combination therapy with a progestogen-estrogen-containing contraceptive, the dose should not be stopped. If the bleeding is severe, you should consult a doctor.

In view of the necessary additional use of Diane 35, attention should be paid to all the information contained in the package leaflet of this product.

Specific surveillance in men
If you have been treated for prostate cancer, tell your doctor if you have had in the past:

circulatory disorders (especially blood clot formation)
sickle cell anemia
severe diabetes with vascular changes
If you are being treated for libido suppression in cases of sexual aberration, the effect of Androcur may be reduced under the influence of alcohol.

Other drugs and Androcur
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor especially if you are taking statins (medicines to reduce blood fats), as high doses of Androcur may cause certain side effects (myopathy or rhabdomyolysis) that occur during treatment with statins.

Also, tell your doctor if you are taking other medicines that have an effect on the liver, such as:

ketoconazole, itraconazole, clotrimazole (for fungal infections)
ritonavir (for viral infections)
rifampicin (for tuberculosis)
phenytoin (for epilepsy)
products containing St. John's wort
High doses of Androcur (100 mg, 3 times a day) may block some liver enzymes, which may affect the effect of other medicines.

Pregnancy and lactation
Androcur is contraindicated during pregnancy and lactation.

Driving and using machines
Androcur can cause fatigue and reduced vitality and impair the ability to concentrate.

Important information about some of the ingredients of Androcur
Androcur contains 105.5 mg of lactose in each tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Androcur
Always use this medicine exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

Your doctor will re-evaluate the benefits and risks of Androcur treatment when you enter menopause.
Long-term use (years) of Androcur should be avoided (see section "Warnings and precautions")

Take the tablets with some liquid after a meal. Do not exceed the maximum daily dose of 300 mg.
If you have the impression that the effect of Androcur is too strong or too weak, talk to your doctor or pharmacist.

Dosage in women
Women of childbearing age
If you are pregnant, you should not take Androcur. Therefore, pregnancy should be ruled out before starting therapy.

In women of childbearing potential, treatment begins on the first day of the cycle (the first day of bleeding). Only women with no periods (amenorrhea) can start treatment with Androcur immediately. In this case, the day on which treatment begins is considered the first day of the cycle and the following recommendations are followed.
From the 1st to the 10th day of the cycle (10 days) take 2 tablets of Androcur 50 mg daily with some liquid after meals. In addition, women can take a drug containing progestogen and estrogen, e.g. from the 1st to the 21st day of the cycle 1 tablet daily Diane 35 to obtain the necessary contraception and to stabilize the cycle.
Women on cyclic combination therapy should take the tablet at certain times of the day.

After 21 days, there is a 7-day period during which Diane 35 tablets are not taken and bleeding occurs. Exactly 4 weeks (28 days) after the start of the first treatment cycle, ie, on the same day of the week, the next cycle of combination therapy begins, regardless of whether the bleeding has stopped.

If your doctor finds a clinical improvement during combination treatment with Diane 35, he may reduce the daily dose of Androcur 50 mg in the first 10 days of combination treatment with Diane 35 to 1 or 1/2 tablet. Taking Diane 35 alone may be enough.

No bleeding 
If bleeding does not occur in rare cases, the tablets should not be taken temporarily and your doctor should rule out pregnancy before you start taking them again.

Postmenopausal or hysterectomy patients
In postmenopausal or hysterectomy patients, Androcur can be used on its own. Depending on the severity of the complaints, the average dose should be 1 or 1/2 tablet of Androcur 50 mg, once a day for 21 days, followed by 7 days of tablet-free interval.

If you have the impression that the effect of Androcur is too strong or too weak, talk to your doctor or pharmacist.

Elderly patients (over 65 years)
There are no data to suggest the need for dose adjustment in elderly patients.

Patients with impaired liver function
Do not take Androcur if you suffer from impaired liver function (see section "Do not take Androcur").

Patients with impaired renal function
There are no data to suggest the need for dose adjustment in patients with impaired renal function.

Dosage in men
Suppression of libido in sexual deviations
Your doctor will determine the individual dose.
1. Treatment usually starts with 1 tablet 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 of time.
3. If a satisfactory result is achieved, your doctor will prescribe the lowest possible dose that is needed to maintain the therapeutic effect. It is often enough to take 1/2 tablet twice a day.
4. When switching to a maintenance dose or when you need to stop using it, your doctor will reduce the dose gradually. For this purpose, your doctor will reduce the daily dose by 1 tablet or even better by 1/2 tablet at intervals of several weeks.

In order to stabilize the therapeutic effect, it is necessary to take Androcur for a long period of time. Your doctor will refer you to psychotherapy during this time.

Antiandrogen therapy in inoperable prostate cancer
The daily dose is 2 tablets two to three times a day (= 200-300 mg per day).
Do not change or stop treatment or the dose prescribed by your doctor if you feel better.

To reduce the initially elevated levels of male sex hormones during treatment with GnRH (gonadotropin-releasing hormone) agonists:
1. Initially, the daily dose is 2 tablets of Androcur 50 mg twice a day (= 200 mg per day) for 5-7 days,
2. Then take 2 tablets of Androcur 50 mg twice a day (= 200 mg per day). day), together with a GnRH agonist, at the dose recommended by the MAH for 3-4 weeks (see information on prescribing a GnRH agonist).

For the treatment of hot flushes in patients who are being treated with GnRH analogues or whose testicles have been removed (orchiectomy):
1. The daily dose is 1-3 tablets of Androcur 50 mg daily (50-150 mg per day)
2. If necessary, the dose can be increased to 2 tablets three times a day (300 mg per day).

Elderly patients (over 65 years)
There are no data to suggest the need for dose adjustment in elderly patients.

Patients with impaired liver function
Do not take Androcur if you suffer from impaired liver function (see section "Do not take Androcur").

Patients with impaired renal function
There are no data to suggest the need for dose adjustment in patients with impaired renal function

If you take more Androcur than you should
There are no data on any harmful effects when taking too many Androcur tablets.

If you forget to take Androcur
Omission of tablets in women
Do not take the missed tablet (do not take a double dose to make up for a forgotten tablet). Continue to take your pills as usual during this time with a progestogen-estrogen contraceptive.
If you are on cyclic combination therapy with a contraceptive pill such as Diane 35, you must take the contraceptive pill (along with Androcur) at certain times of the day. If you forget to take a contraceptive at the usual time, you must take it within the next 12 hours at the latest. If more than 12 hours have passed since the usual time of taking the contraceptive pill, the contraceptive effect in this cycle may weaken. Pay special attention to contraceptive reliability in case you miss pills and the recommendations for skipping a pill in the product information of the contraceptive product. If bleeding does not occur after this cycle, it is necessary to rule out pregnancy before resuming the tablets.

Omission of tablets in men
Do not take the missed Androcur tablet (do not take a double dose to make up for a forgotten tablet). Take the next tablet at the usual time.

If you stop taking Androcur
The initial symptoms due to which Androcur was prescribed may worsen. Do not stop taking Androcur unless your doctor tells you to. If you want to stop taking Androcur, you must first discuss it with your doctor.

If you have any further questions on the use of this product, ask 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Tell your doctor immediately if you notice any of the following symptoms:
.General malaise, fever, nausea, vomiting, loss of appetite, itching all over the body, yellowing of the skin and eyes, whitish stools, dark-colored urine. These symptoms may be signs of liver toxicity, including inflammation of the liver (hepatitis) or liver failure.

Hepatic impairment, some of which is severe (jaundice, hepatitis, and hepatic failure), has been observed in patients treated with Androcur. Fatalities have also been reported at doses of 100 mg and above. The most commonly reported cases are in men with advanced prostate cancer. Hepatic impairment is dose-dependent and usually develops several months after starting treatment. Therefore, your doctor should examine your liver function before starting treatment, as well as during therapy, especially if there are any symptoms or signs suggestive of liver toxicity. If liver toxicity is confirmed, your doctor will stop treatment with Androcur, although in men liver toxicity may be explained by something else (eg secondary tumors) and in this case, Your doctor may continue your treatment with Androcur if he sees fit. that the benefits outweigh the risks.

Unusual abdominal pain that does not go away spontaneously in a short time. These symptoms can be caused by benign or malignant tumors, which can lead to life-threatening internal bleeding (intra-abdominal hemorrhage).
Swelling of the calf or legs, chest pain, difficulty breathing and a sudden feeling of weakness. These symptoms may be signs of blood clots (thromboembolic events).
Adverse reactions can occur with a certain frequency, which are defined as follows:
very common: affects more than 1 user in 10
common: occurs in more than 1 in 100 patients, but in less than 1 in 10 patients
uncommon: affects more than 1 in 1,000 patients but less than 1 in 100 patients
rare: affects more than 1 user in 10,000 but less than 1 patient in 1,000
very rare: affects less than 1 in 10,000 patients
with unknown frequency: the frequency cannot be determined from the available data.
Side effects in women
Rare
benign brain tumors (meningiomas) (see section "Do not take Androcur" and "Take special care with Androcur"
Side effects that occur with unknown frequency
benign or malignant liver tumors
allergic reactions (hypersensitivity)
weight gain
weight loss
depressive mood swings
transient anxiety
decreased libido
increased libido
blood clots (see Thromboembolic events - see section "Take special care with Androcur")
difficulty breathing
internal bleeding (intra-abdominal hemorrhage)
hepatic toxicity, including jaundice, inflammation of the liver (hepatitis), liver failure
rash
suppression of ovulation
chest tightness
staining
fatigue
Ovulation is suppressed by combination therapy with a contraceptive such as Diane 35, so there is a risk of infertility.

If your doctor prescribes a medicine such as Diane 35 in combination with Androcur, you should also pay attention to the special side effects warnings in the product information of this additional product.

Occurrence of (multiple) meningiomas has been reported in association with long-term use (several years) of Androcur in daily doses of 25 mg and higher.

Side effects in men
Very common
reversible suppression of sperm formation (spermatogenesis)
decreased libido
inability to get and hold an erection (erectile dysfunction)
Frequent
hepatic toxicity, including jaundice, inflammation of the liver (hepatitis), liver failure
weight gain
weight loss
depressive mood swings
breast augmentation (gynecomastia)
fatigue
hot flashes
sweating
difficulty breathing
Uncommon
rash
Rare
allergic reactions (hypersensitivity)
benign brain tumors (cerebral meningiomas)
Very rare 
benign and malignant liver tumors
Side effects that occur with unknown frequency
internal bleeding (intra-abdominal hemorrhage)
blood clots (see Thromboembolic events - see section "Take special care with Androcur")
osteoporosis
anemia
In male patients on Androcur therapy, libido and potency are reduced and testicular function is suppressed. These changes are reversible upon discontinuation of Androcur therapy.

For several weeks, Androcur suppresses sperm production (spermatogenesis) as a result of antiandrogenic and antigonadotropic action. Spermatogenesis is restored gradually, several months after stopping Androcur treatment.

In men, Androcur can cause swelling of the breasts (so-called gynecomastia, sometimes combined with tenderness to the nipples), which usually goes away after stopping treatment with Androcur.

As with any antiandrogen treatment, long-term treatment with Androcur may lead to osteoporosis.

Benign brain tumors (meningiomas) have been observed with long-term use (several years) of Androcur at doses of 25 mg and higher (see section "Do not take Androcur" and "Take special care with Androcur").

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 via the Bulgarian Medicines Agency:
8
1303 Damyan Gruev Str. Sofia
tel .: +359 2 890 3417
website: www.bda.bg.
By reporting side effects, you can contribute to get more information about the safety of this medicine.

5. How to store Androcur
Keep out of reach of children.
Do not use Androcur after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information
What Androcur contains
The active substance is cyproterone acetate. Each tablet contains 50 mg of cyproterone acetate.
The other ingredients are: lactose monohydrate, corn starch, povidone 25000 colloidal anhydrous silica, magnesium stearate.
What Androcur looks like and contents of the pack
Androcur tablets are white to pale yellow, with a score line on one side and embossed with "BV" in a regular hexagon on the other side. The tablets can be divided into two equal halves.
Androcur is available in blister packs containing 20 or 50 tablets. Not all pack sizes may be marketed. The tablets are round and flat with a diameter of 9 mm.
The tablets are sealed in blisters made of polyvinyl chloride and hot-pressed aluminum foil.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Bayer AG,

Germany

Manufacturers:
Bayer AG,

Germany