50 mg tablets
cyproterone acetate
1. What Androcur is and what it is used for
Androcur is a hormone preparation that blocks the effect of androgens, which are sex hormones that are produced mainly in men but also, to a lesser extent, in women. The active substance is cyproterone acetate.
Men:
Androcur lowers testosterone levels (androgen ) in the blood. This leads to a reduced sexual drive.
For men, Androcur is used for:
- to inhibit the sexual drive in case of sexual deviations and/or abnormally strong sexual drive
In case of inhibition of sexual drive in case of sexual disorders and/or abnormally strong sexual drive in men, cyproterone acetate 50 mg should only be taken if doctors have judged that other treatments are inappropriate.
Women:
Androcur has a beneficial effect on disease states that are linked to the male sex hormones, such as pronounced body hair ( hirsutism ) in women of childbearing age.
For women, Androcur is used to treat:
- pronounced body hair ( hirsutism ) in women of childbearing age
In the case of pronounced hirsutism in women of childbearing potential, cyproterone acetate 50 mg should only be taken when no satisfactory results have been obtained with a lower dose of cyproterone acetate or with other treatments.
To stabilize the menstrual cycle and to protect against pregnancy, the Androcur treatment can be given at the same time as a so-called combined contraceptive pill(contains two hormones: progesterone and estrogen ). During this concomitant treatment, the function of the ovaries is hindered. These changes return after the end of treatment.
2. What you need to know before using Androcur
Do not use Androcur
If you have any of the conditions listed below, do not take Androcur. If any of these apply to you, tell your doctor before taking Androcur.
If you are a man:
- if you are allergic to cyproterone acetate or any of the other ingredients of this medicine (listed in section 6)
- if you have any liver disease
- if you suffer from hereditary disorders of liver function with decreased secretion of pigments from red blood cells, called bilirubin (“Dubin-Johnson syndrome” 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 any disease that leads to severe weight loss
- if you suffer from severe chronic depression
- if you have or have ever had a disease that affects blood circulation; especially those related to thrombosis (blood clots) in the blood vessels (thromboembolic event).
- if you have severe diabetes with vascular changes
- if you have sickle cell anemia (a special form of anemia )
If you are a woman:
- 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 had jaundice or persistent itching during a previous pregnancy
- if you had herpes during a previous pregnancy
- if you have any liver disease
- if you suffer from hereditary disorders of liver function with decreased secretion of pigments from red blood cells, called bilirubin (“Dubin-Johnson syndrome” or “Rotor syndrome”)
- if you have or have had a benign or malignant liver tumor
- if you have or have ever had a benign brain tumor (meningioma)
- if you suffer from any disease that leads to severe weight loss
- if you suffer from severe chronic depression
- if you have or have ever had a disease that affects blood circulation; especially those related to thrombosis (blood clots) in the blood vessels (thromboembolic event).
- if you have sickle cell anemia (a special form of anemia )
- if you have severe diabetes with vascular changes
- if you have had a meningioma (a usually benign tumor of tissue between the brain and the skull). Talk to your doctor if you are unsure.
If your doctor has prescribed a pill at the same time as Androcur to stabilize the menstrual cycle and to protect against pregnancy, you should carefully read the information in the package leaflet of the pill as well.
Take special care with ANDROCUR:
In the treatment of men:
Anemia has been reported during treatment with Androcur. Your doctor will therefore check the number of red blood cells during treatment.
If you are treated with Androcur to inhibit sexual drive, the effect may decrease with concomitant alcohol consumption.
When treating women:
Before starting treatment with Androcur, a thorough medical examination and gynecological examination (which also includes the breasts and a cell sample of the cervix) should be performed, and pregnancy must be ruled out.
If, in connection with treatment with both Androcur and combined oral contraceptives, there is a small irregular bleeding during the three weeks of taking the tablets, do not stop taking them. Contact a doctor if the bleeding is permanent or recurrent.
For concomitant treatment with combined oral contraceptives in the area of use pronounced hair growth in women, the precautionary measures for oral contraceptive treatment should also be taken into account.
When treating men and women:
Androcur is not recommended for use in children and adolescents below 18 years of age as efficacy and safety have not been established in this age group. Androcur should not be given until puberty has ended, as this may have adverse effects on height growth and the development of hormone function.
Tell your doctor if you have diabetes as the dose of one of your insulin or tablets for diabetes may need to be adjusted. This requires careful monitoring during Androcur treatment (see also section “Do not use Androcur”).
Data from animal studies show that high doses of Androcur can lower hormone production from the adrenal glands. Your doctor may therefore perform some tests to check this effect during treatment with Androcur.
The use of cyproterone acetate has been associated with the development of a usually benign brain tumor (meningioma). The risk increases especially when you use the medicine for a longer period of time (several years) or for a shorter period with high doses (25 mg/day or higher). If you are diagnosed with meningioma, your doctor will discontinue your treatment with cyproterone acetate (see section “Do not use Androcur”). If you notice any symptoms such as changes in vision (eg double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, headache that gets worse with time, memory loss, seizures or weakness in the arms and/or legs, you must talk about it immediately for doctors.
Blood clots (thromboembolic events) have been reported in patients using Androcur, although a direct link could not be established. There is an increased risk if the patient has previously had blood clots or in advanced tumor disease.
Tell your doctor if you have had a blood clot, such as deep vein thrombosis, pulmonary embolism ( pulmonary embolism ), heart attack (myocardial infarction), or stroke ( cerebrovascular event).
A feeling of shortness of breath may occur during treatment with high-dose Androcur.
Taking other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Be especially careful to tell your doctor if you are being treated with statins (medicines that lower blood fats). During treatment with statins, effects on muscle tissue ( myopathy and rhabdomyolysis ) may occur. This effect can be enhanced with high- dose Androcur treatment.
Also tell your doctor if you are taking medicines that may affect the liver, such as
- ketoconazole, itraconazole, clotrimazole (antifungal drugs)
- ritonavir (virus infection medicine)
- rifampicin (tuberculosis drug)
- phenytoin (an epilepsy medicine)
- preparations containing St. John’s wort.
Large Androcur- dose s (100 mg three times per day) may prevent certain so-called enzyme action in the liver, which may affect another drug effect.
Pregnancy, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
Androcur must not be used during pregnancy and lactation.
Driving and using machines
Androcur may cause fatigue and decreased strength, which may impair the ability to concentrate.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Important information about some of the ingredients of Androcur
Each tablet contains 105.5 mg of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Androcur
The tablets are taken with some liquid after a meal.
If you have the impression that the effect of Androcur is too strong or too weak, talk to your doctor or pharmacist.
Inhibition of sexual drive in men:
Dose one is determined by a doctor who adapts it individually for you.
- The treatment is usually started with 1 tablet of Androcur twice daily.
- Your doctor may increase the dose one to 2 tablets twice daily, or even 2 tablets 3 times daily for a short period.
- When the desired treatment result has been achieved, the doctor will prescribe the lowest possible dose while maintaining the effect. In general, 2 tablets twice a day is enough.
- When the maintenance dose is determined or when treatment is stopped, your doctor will gradually reduce the dose one. Your doctor will reduce your daily dose by one to 1 tablet every few weeks.
For a stable effect, it is necessary to take Androcur for a long time, possibly together with psychotherapy during this time. Do not take more than the maximum daily dose of 300 mg.
Elderly patients (65 years and older)
Men:
Data indicating that dose adjustment is required for older men are lacking.
Women:
Androcur is used by women of childbearing potential. The treatment of menopausal women has not been studied.
Pronounced hair growth in women of childbearing potential :
If you are pregnant, do not take Androcur. Therefore, pregnancy must be ruled out before starting treatment.
Androcure treatment is started on the 1st day of the menstrual cycle (= the first day of bleeding).
During the 1st – 10th day of the menstrual cycle, take an Androcur tablet twice daily. In addition, to prevent pregnancy and make the menstrual cycle regular, you can also treat it with a combined contraceptive pill from the 1st day of the menstrual cycle. If you are taking both Androcur and birth control pills, take the tablets at about the same time each day.
At the end of the pill cycle, when you either take a break from your birth control pills or take a pill without an active substance (placebo tablets), menstrual-like bleeding may occur.
Exactly 4 weeks (28 days) after the start of treatment and on the exact same day of the week as the previous time, a new treatment period is started with both drugs, regardless of whether the menstrual-like bleeding from the previous pill cycle has stopped or not. When a positive treatment result of the treatment with both of these drugs is achieved, the Androcurdos taken during the first 10 days of the cycle can be reduced to 1 – ½ tablet (50 – 25 mg).
Absence of monthly bleeding
If in rare cases, monthly bleeding does not occur, treatment with Androcur should be temporarily stopped and a doctor consulted. Pregnancy must be ruled out before starting a new course of treatment.
When treating men and women:
Patients with hepatic impairment
Do not use Androcur if you suffer from hepatic impairment (see section: Do not use Androcur)
Patients with renal impairment
There are no data to suggest that dose one needs to be adjusted in patients with renal impairment.
There are no reports of harmful effects after taking too many Androcur tablets.
If you forget to use Androcur
Do not take a double dose of Androcur to make up for a forgotten dose, but continue to take your tablets regularly.
If you as a woman forget to take Androcur, it may lead to intermittent bleeding.
Women:
If you are taking both Androcur and birth control pills, as mentioned above, you should take the birth control pill (with Androcur) at the same time each day. If you forget to take the pill at the usual time, it must be taken within 12 hours at the latest. If more than 12 hours have elapsed from the usual time, the contraceptive pill’s effect on pregnancy may be impaired during that cycle. During treatment with both of these medicines, you should follow the instructions in the package leaflet concerning the contraceptive pill (especially the instructions regarding the preventive effect and the consequences of forgetting the pill ). If the monthly bleeding does not occur after such a cycle, discontinue treatment and consult a physician. Before continuing treatment, it must be determined that you are not pregnant.
If you stop taking Androcur
Problems can get worse if you stop taking Androcur yourself. Therefore, do not stop taking Androcur unless your doctor tells you to. First discuss with your doctor if you want to stop taking Androcur.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you experience any of the following symptoms:
- General malaise, fever, nausea, vomiting, loss of appetite, general itching, yellowish skin and yellowish eyes, light stools, dark urine. These symptoms may be signs of liver toxicity, including inflammation of the liver ( hepatitis ) or liver failure.
Hepatic dysfunction, some severe (jaundice, hepatitis, and hepatic failure), has been observed in patients treated with Androcur. At dose cases of 100 mg or higher, fatal cases have also been reported. Most reported fatal cases were in men with advanced prostate cancer. Hepatic impairment is dose-related and usually develops several months after initiation of treatment. Therefore, your doctor will check your liver function before and during treatment, especially if there are any symptoms that indicate liver toxicity. If you have been diagnosed with liver toxicity, your doctor will stop treatment with Androcur. If you are a man and the liver toxicity can be explained by another cause, your doctor may prescribe further treatment if the benefits of the treatment outweigh the risks. - Unusual pain in the upper abdomen which does not go away on its own within a short time. These symptoms may be signs of benign or malignant liver tumors, which may lead to life-threatening internal bleeding ( intra-abdominal bleeding).
- Swelling of the calf or leg, chest pain, shortness of breath, or a sudden feeling of weakness. These symptoms may be signs of a blood clot (thromboembolic event).
Men:
Very common side effect is ( can occur in more than 1 in 10 )
- temporarily prevented sperm production
- decreased sexual drive (decreased libido )
- inability to get or maintain an erection (erectile dysfunction)
Common side effects are ( may affect up to 1 in 10 )
- liver toxicity, including jaundice, inflammation of the liver ( hepatitis ), liver failure
- weight gain
- weight loss
- Depression
- temporary restlessness
- enlarged breasts ( gynecomastia )
- fatigue
- hot flashes
- sweating
- shortness of breath
Less common side effects are ( may affect up to 1 in 100)
- rash
Rare side effects are ( may affect up to 1 in 1000)
- allergic reactions (hypersensitivity)
- benign brain tumors (meningioma) (see sections “Do not use Androcur” and “Take special care with Androcur”)
Very rare side effects are ( may affect up to 1 in 10 000 users)
- benign and malignant liver tumors
Has been reported ( occurs in an unknown number of users)
- internal bleeding (bleeding in the abdominal cavity)
- the occurrence of blood clots (thromboembolic events) (see section Take special care with Androcur)
- osteoporosis
- anemia
During Androcur treatment, the sexual drive and potency of men are reduced and the function of the testicles is prevented. These changes return after the end of Androcur treatment.
Within a few weeks, the new formation of sperm is inhibited by Androcur. The new formation of the sperm gradually returns within a few months after the Androcur treatment has been completed.
Androcur causes swelling of the mammary glands (so-called gynecomastia, sometimes also soreness in the nipples) which usually goes back when the Androcur treatment is stopped. Long-term treatment with Androcur can, like other antiandrogenic treatments, cause osteoporosis.
Women:
Rare side effects are (may affect up to 1 in 1000)
- benign brain tumors (meningioma) (see sections “Do not use Androcur” and “Take special care with Androcur”)
Has been reported (occurs in an unknown number of users)
- benign and malignant liver tumors
- allergic reaction (hypersensitivity)
- weight gain
- weight loss
- Depression
- temporary restlessness
- decreased sexual drive (decreased libido )
- increased sexual drive (increased libido )
- the occurrence of blood clots (thromboembolic events – see section “Take special care with Androcur”)
- shortness of breath
- internal bleeding (bleeding in the abdominal cavity)
- liver toxicity, including jaundice, inflammation of the liver ( hepatitis ), liver failure
- rash
- prevented ovulation
- sore breasts
- splashing bleeding
- fatigue
In women, the treatment inhibits the function of the ovaries in connection with the use of combined contraceptive pills, which means that the woman cannot become pregnant.
If your doctor prescribes combined oral contraceptives at the same time as Androcur, the information on the side effect of the oral contraceptive in the package leaflet should also be taken into account during treatment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Androcur
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
The medicine 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 to protect the environment.
6. Contents of the packaging and other information
Content declaration:
- The active substance is cyproterone acetate. Each tablet contains 50 mg of cyproterone acetate.
- The other ingredients are lactose monohydrate 111 mg, corn starch, povidone 25,000, silica ( colloidal, anhydrous), magnesium stearate.
What the medicine looks like and the contents of the pack
Androcur tablets are white to slightly yellow, with a notch on one side and the punctuation mark “BV” in a hexagon on the other side. The tablets can be divided into equal parts. The package is available both as a colored glass jar and a blister pack. Both contain 50 tablets. Both packages may not be marketed.
Marketing Authorisation Holder
Bayer AB
Box 606
SE-169 26 Solna
Manufacturer:
Bayer Weimar GmbH und Co KG
994 27 Weimar
Germany
Bayer AG
13353 Berlin
Germany
DELPHARM Little SAS
59452 Lys -lez-Lannoy
France