Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Androcur 50 mg tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Cyproterone acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for What is Androcur? Androcur is a medicine containing cyproterone acetate. It is an anti-androgen therapy. It blocks the actions of male sex hormones (androgens) and reduces the amount of male sex hormones produced by the body. What is Androcur used for? Androcur is used to control sexual desire in men who have an increased sex drive (hypersexuality) and/or sexual deviation. For reduction of drive in sexual deviations, you should only take cyproterone acetate 50 mg, if your doctor considers that other interventions are inappropriate.
What you need to know before you take it
e Androcur
Your doctor may ask you to sign a witnessed agreement to treatment before prescribing Androcur. You may also have a test to check the number and function of your sperm before you start treatment as Androcur can affect this. The overall number of sperm you produce will be reduced and more sperm than usual will be abnormal in shape.
Do not take Androcur If you have: liver diseases (including previous or existing liver tumours, Dubin-Johnson syndrome or Rotor syndrome) any type of cancer (other than cancer of the prostate gland) ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull). You should ask your doctor if you are in doubt wasting diseases (diseases involving an unintended loss of weight or muscle) blood clots (thrombosis or embolism) or have ever had these severe diabetes that affects your blood circulation abnormal red blood cells (sickle-cell anaemia)
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severe depression which you have had for many months
or if: you are allergic to cyproterone acetate or any of the other ingredients of Androcur (listed in section 6) you are under 18 years old or if your testes or bones are not yet fully formed. Warnings and precautions Talk to your doctor or pharmacist before taking Androcur Several blood tests or checks may be required while you are taking this medicine:
liver problems, some of them severe or even fatal, have been reported with cyproterone acetate treatment. Your doctor may arrange for you to have regular liver tests before and during treatment to monitor this and may stop your treatment if necessary. See also section 4.
using medicines such as Androcur has very rarely been linked to the development of benign (non-malignant) liver tumours and with some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway
Use of cyproterone acetate has been linked to the development of a generally benign brain tumour (meningioma). The risk increases especially when you use it for longer duration (several years) or for a shorter duration with high doses (25 mg per day and above). If you are diagnosed with meningioma, your doctor will stop your treatment with cyproterone acetate (see section 'Do not take Androcur'). If you notice any symptoms such as changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs, you must tell your doctor straightaway.
blood clots have been reported in patients taking this medicine which may also be linked to the reason you are receiving Androcur. Tell your doctor if any of the following apply to you, as you may be at an increased risk of getting a blood clot. If you have:
- a history of blood clots, strokes or heart attacks
- cancer
- abnormal red blood cells (sickle-cell anaemia)
- severe diabetes that affects your blood circulation
effects on the blood (anaemia) have been reported rarely during long term treatment with this medicine. See also section 4.
shortness of breath has been reported in patients taking this medicine at high doses (300 mg daily)
Androcur can alter the sugar levels in your blood. If you are diabetic, check your blood sugar levels regularly. Your doctor may alter the dose of medicine used to treat your diabetes
Your doctor will check the function of your adrenal glands, as they may become suppressed during treatment with Androcur. Symptoms may include tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles, abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea.
Other medicines and Androcur Tell your doctor if you are taking, have recently taken or might take any other medicines. Some medicines may stop Androcur from working properly. Also Androcur may change the way other medicines you are taking are broken down in your body.
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Tell your doctor if you take any other medicines regularly, especially: medicines such as rifampicin for the treatment of tuberculosis medicines such as phenytoin used to treat epilepsy or other illnesses products containing the herbal remedy commonly known as St John's wort (Hypericum perforatum) medicines such as ketoconazole, itraconazole, clotrimazole for the treatment of fungal conditions medicines such as ritonavir used to treat HIV infections cholesterol-lowering drugs such as statins. Androcur may make the side effects of statins worse, for example the breakdown of muscle medicines such as glitazones used to treat diabetes. If you are diabetic your doctor may need to alter the dose of medicine required to treat your diabetes. See section 2 'Warnings and precautions'. Androcur with food, drink and alcohol Androcur does not work well in men who regularly drink a lot of alcohol. Driving and using machines You may feel tired and weak during treatment. If affected, do not drive, operate machinery or do anything where these symptoms may put either yourself or others at risk. Important information about some of the ingredients in Androcur Androcur contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, check with your doctor before taking this medicinal product.
How to take it
Androcur Your doctor will decide what dose you will take depending on your treatment. Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The usual dose is 1 tablet twice a day. Once the desired effect is achieved, your dose may be gradually lowered. Take the tablet after your morning and evening meals and swallow it whole with a drink of water.
Androcur is not for use in youths under 18 years old. If you take more Androcur than you should As soon as you can, talk to your doctor who will tell you what you need to do. There have been no reports of serious illness from taking too much Androcur in a single dose. If you forget to take Androcur If you forget to take a dose, take it as soon as you remember and take the next dose when it is due. Do not take a double dose to make up for a forgotten dose. If you stop taking Androcur Do not reduce the dose or stop taking your tablets unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have trouble breathing or swallowing, this may be a sign of a rare allergic reaction – contact your doctor or go to a hospital straight away.
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For information on drinking alcohol while taking this medicine, see under Androcur with food, drink and alcohol in section 2. These are the possible side effects of Androcur, starting with the more common ones: Very common
may affect more than 1 in 10 people reduced sperm count reduced volume of ejaculate
Common
may affect up to 1 in 10 people weight decrease or increase, which can be associated with fluid retention depressed mood restlessness breast swelling sometimes with tenderness hot flushes, sweating tiredness shortness of breath liver problems, some of them severe or even fatal, have been reported with dosages of 100 mg and above of cyproterone acetate. Your doctor may arrange for you to have regular liver tests during treatment to monitor this and may stop your treatment if necessary
Uncommon
may affect up to 1 in 100 people rash
Rare
may affect up to 1 in 1,000 people allergic reaction (possibly causing a rash, itching or more rarely shortness of breath. If you have trouble breathing or swallowing, contact your doctor or go to a hospital straight away) tender lumps in the breasts and oozing of milky fluid from the nipples. These effects usually disappear if treatment is stopped or if the dose of Androcur is reduced meningioma, see also section 2 'Warnings and precautions'
Very rare
may affect up to 1 in 10,000 people benign (non-malignant) liver tumours, see also section 2 'Warnings and precautions' some forms of liver cancer (malignant liver tumours). Liver tumours may lead to bleeding in the abdomen, which can be life-threatening. If you have any new stomach discomfort or pain that does not go away quickly, you must tell your doctor straightaway
Effects of Androcur on sperm After you have been taking this medicine for some months, you may not have any sperm in your ejaculate. You will probably be unable to make anyone pregnant, but note that this does not happen at once. Do not rely on this medicine for contraception at any time. While the overall number of sperm that you produce will be reduced, more of your sperm than usual will be abnormal in shape. Some people think these abnormal sperm might possibly produce abnormal babies. Your doctor will be able to advise you further if you are thinking of having children. Other changes that have been reported include:
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blood clots have been reported in patients taking this medicine but they have not definitely been linked to Androcur. See also section 2 'Warnings and precautions' the occurrence of meningiomas (a generally benign tumour of the tissue layer between the brain and the skull) has been reported in association with longer term use (years) of Androcur at doses of 25 mg per day and above dry skin and improvement in acne temporary patchy loss of body hair, a reduction in hair growth on the body, an increased growth of hair on the head, lightening of hair colour, a female type of pubic hair growth effects on the blood (anaemia) have been reported during long term treatment with this medicine. Your doctor may arrange for you to have regular blood tests during treatment to monitor this thinning of the bones (osteoporosis) tiredness, fatigue, loss of appetite, weight loss, low blood sugar, low blood pressure, dehydration, headache, irritability and depression, aching muscles (often muscle weakness), abdominal pain, a craving for salty foods, feeling or being sick and diarrhoea (suppressed adrenal glands).
After stopping treatment After stopping treatment, the decrease in sex drive, reduction in sperm count and breast swelling will generally go back to normal. 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
How to store it
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 carton after EXP. 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 throw away medicines you no longer use. These measures will help protect the environment.
Contents of the pack and other information
What Androcur contains: the active ingredient is cyproterone acetate. Each tablet contains 50 mg of cyproterone acetate the other ingredients are: maize starch, povidone 25000, magnesium stearate (E572), lactose, silicon dioxide (aerosil) (E551). What Androcur looks like and contents of the pack Each pack of Androcur contains 60 round, white tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
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ADVANZ PHARMA Limited Unit 17, Northwood House, Northwood Crescent, Dublin 9, Ireland D09 V504
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Manufacturer:
Bayer AG Berlin Germany or Bayer Weimar GmbH und Co KG Weimar Germany
This leaflet was last revised in September 2024.
Other formats: To listen or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only) Please be ready to give the following information: Product name Androcur 50 mg
Reference number PL 56734/0016
This is a service provided by the Royal National Institute of the Blind.
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Frequently asked questions about Androcur 50 mg tablets
How do I take Androcur 50 mg tablets?
Androcur 50 mg tablets comes as tablet containing 50mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Androcur 50 mg tablets?
The active substance in Androcur 50 mg tablets is cyproterone acetate.
Are there equivalent medicines to Androcur 50 mg tablets?
Medicines with the same active substance, strength and form include: Cyprostat 50 mg tablet. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Androcur 50 mg tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Androcur 50 mg tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: cyproterone acetate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Control of libido in severe hypersexuality and/or sexual deviation in the adult male.
For reduction of drive in sexual deviations in men, cyproterone acetate 50 mg can be used when other interventions are considered inappropriate.
4.2. Posology and method of administration
Posology
Adults
Generally, treatment is started with 1 tablet Androcur 50 mg twice daily, after the morning and evening meals. The duration of cyproterone acetate treatment should be defined on an individual basis. When a satisfactory result has been achieved, the therapeutic effect should be maintained with the lowest possible dose. When changing the dose or when discontinuing cyproterone acetate, this should be done gradually.
Additional information on special populations
Paediatric population
Androcur is not recommended for use in male children and adolescents below 18 years of age due to a lack of data on safety and efficacy.
Androcur must not be given before the conclusion of puberty since an unfavourable influence on longitudinal growth and the still unstabilised axes of endocrine function cannot be ruled out.
Older people
There are no data suggesting the need for a dosage adjustment in elderly patients.
Patients with hepatic impairment:
The use of Androcur is contraindicated in patients with liver diseases (see section 4.4 and 4.8).
Patients with renal impairment:
The use of Androcur in patients with renal impairment has not been investigated. There are no data suggesting the need for dosage adjustment in patients with renal impairment (see section 5.2).
Method of administration
The tablets are to be taken with some liquid after meals.
For oral administration.
4.3. Contraindications
Androcur must not be used in patients with:
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Liver diseases (including Dubin-Johnson syndrome and Rotor syndrome)
Malignant tumours (except for carcinoma of the prostate)
Previous or existing liver tumours
Wasting diseases (because of transient catabolic action)
A history of or existing thrombosis or embolism
Severe diabetes with vascular changes
Sickle cell anaemia
Severe chronic depression
Meningioma or a history of meningioma.
Androcur should not be given to youths under 18 or to those whose bone maturation and testicular development are incomplete.
4.4. Special warnings and precautions for use
Liver: Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure, has been observed in patients treated with Androcur. At dosages of 100mg and above, cases with fatal outcome have also been reported. Most reported fatal cases were in men with advanced prostatic cancer. Toxicity is dose-related and develops, usually, several months after treatment has begun. Liver function tests should be performed pre-treatment, regularly during treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur. If hepatotoxicity is confirmed, Androcur should be withdrawn, unless the hepatotoxicity can be explained by another cause, e.g. metastatic disease, in which case Androcur should be continued only if the perceived benefit outweighs the risk.
In very rare cases benign and malignant liver tumours, which may lead to life-threatening intra-abdominal haemorrhage have been observed after the use of Androcur. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be considered in the differential diagnosis.
Thromboembolic events: The occurrence of thromboembolic events has been reported patients using Androcur, although a causal relationship has not been established. Patients with previous arterial or venous thrombotic / thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction), with a history of cerebrovascular accidents or with advanced malignancies are at increased risk of further thromboembolic events, and may be at risk of recurrence of the disease during Androcur therapy. See also section 4.3.
Meningiomas: The occurrence of meningiomas (single and multiple) has been reported in association with use of cyproterone acetate primarily at doses of 25 mg and above. The risk of meningioma increases with increasing cumulative doses of cyproterone acetate (see section 5.1). High cumulative doses can be reached with prolonged use (several years) or shorter duration with high daily doses. Patients should be monitored for meningiomas in accordance with clinical practice. If a patient treated with Androcur is diagnosed with meningioma, treatment with Androcur and other cyproterone containing products must be permanently stopped (see section 'Contraindications').
There is some evidence that the meningioma risk may decrease after treatment discontinuation of cyproterone.
Shortness of breaths: Shortness of breath may occur under high-dosed treatment with Androcur. This may be due to the stimulatory effect of progesterone and synthetic progestogens on breathing, which is accompanied by hypocapnia and compensatory alkalosis, and which is not considered to require treatment.
Adrenocortical function: During treatment adrenocortical function should be checked regularly, as preclinical data suggest a possible suppression due to the corticoid-like effect of Androcur with high doses (see section 5.3).
Diabetes mellitus: Strict medical supervision is necessary if the patient suffers from diabetes as Androcur can influence carbohydrate metabolism. Parameters of carbohydrate metabolism should be examined carefully in all diabetics before and regularly during treatment because the requirement for oral antidiabetics or insulin can change. See also section 4.5.
Anaemia: Anaemia has been reported during long-term treatment. Therefore, the red blood count should be checked regularly during treatment.
Lactose: Androcur contains 108.75 mg lactose per tablet. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients who are on a lactose-free diet should take this amount into consideration.
Spermatogenesis: A spermatogram should be recorded before starting treatment in patients of procreative age, as a guard against attribution of pre-existing infertility to Androcur at a later stage. It should be noted that the decline in spermatogenesis is slow, and Androcur should, therefore, not be regarded as a male contraceptive.
Medico-legal considerations: Doctors are advised to ensure that the fully informed consent of the patient to Androcur treatment is witnessed and can be verified.
4.5. Interaction with other medicinal products and other forms of interaction
Diabetes: At high therapeutic cyproterone acetate doses of three times 100mg per day, cyproterone acetate may inhibit CYP2C8 (see below). Thiazolidinediones (i.e. the anti-diabetics pioglitazone and rosiglitazone) are substrates or CYP2C8 (increased blood levels of these anti-diabetics may require dose adjustment).
Chronic alcoholism: Alcohol appears to reduce the effect of Androcur which is of no value in chronic alcoholics.
Other interactions: Clinical interaction studies have not been performed. However, since cyproterone acetate is metabolised by CYP3A4, it is expected that ketoconazole, itraconazole, clotrimazole, ritonavir and other strong inhibitors of CYP3A4 inhibit the metabolism of cyproterone acetate. On the other hand, inducers of CYP3A4 such as rifampicin, phenytoin and products containing St. John's Wort may reduce the levels of cyproterone acetate.
Based on in vitro inhibition studies, an inhibition of the cytochrome P450 enzymes CYP2C8, 2C9, 2C19, 3A4 and 2D6 is possible at high cyproterone acetate doses of 100mg three times per day. (This is three times the maximum total daily dose).
The risk of statin-associated myopathy or rhabdomyolysis may be increased when those HMG-CoA inhibitors (statins) which are primarily metabolised by CYP3A4 are co-administered with high cyproterone acetate doses, since they share the same metabolic pathway.
4.6. Fertility, pregnancy and lactation
Not applicable.
4.7. Effects on ability to drive and use machines
Fatigue and lassitude are common - patients should be warned about this and if affected should not drive or operate machinery.
4.8. Undesirable effects
The most frequently observed adverse drug reactions (ADRs) in patients receiving Androcur are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis.
The most serious ADRs in patients receiving Androcur are hepatic toxicity, benign and malignant liver tumours which may lead to intra-abdominal haemorrhage and thromboembolic events.
The following approximate incidences were estimated from published reports of a number of small clinical trials and spontaneous ADR reports:
- very common: incidence ≥ 1:10
- common: incidence < 1:10 but ≥ 1:100
- uncommon: incidence < 1:100 but ≥ 1:1,000
- rare: incidence < 1:1,000 but ≥ 1:10,000
- very rare: incidence < 1:10,000
- not known (cannot be estimated from available data)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rare:
Meningioma. The occurrence of meningiomas (single and multiple) has been reported in association with use of cyproterone acetate (see section 4.4).
Very rare:
Benign and malignant liver tumours which may lead to life-threatening intra abdominal haemorrhage (see section 4.4).
Blood and the lymphatic system disorders
Not known:
Anaemia during long-term treatment (see section 4.4).
Immune system disorders
Rare:
Hypersensitivity reactions may occur.
Endocrine disorders
Not known:
Suppression of adrenocorticol function.
Metabolism and nutrition disorders
Common:
Changes in bodyweight during long term treatment (chiefly weight gains in association with fluid retention)
Psychiatric disorders
Common:
Depressive moods and restlessness (temporary).
Vascular disorders
Not known:
Thromboembolic events, although a causal relationship has not been established (see section 4.4).
Respiratory, thoracic and mediastinal disorders
Common:
Dyspnoea (see section 4.4).
Hepato-biliary disorders
Common:
Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure has been observed in patients treated with Androcur. At dosages of 100 mg and above, cases with fatal outcome have also been reported. Most reported fatal cases were in men with advanced carcinoma of the prostate. Toxicity is dose related and develops, usually, several months after treatment has begun.
Skin and subcutaneous tissue disorders
Uncommon:
Rash
Not known:
Reduction of sebum production leading to dryness of the skin and improvement of existing acne vulgaris has been reported as well as; transient patchy loss and reduced growth of body hair, increased growth of scalp hair, lightening of hair colour and female type of pubic hair growth.
Musculoskeletal and connective tissue disorders
Not known:
Osteoporosis (due to long-term androgen deprivation).
Reproductive system disorders
Inhibition of spermatogenesis:
Very common:
Sperm count and the volume of ejaculate are reduced.
Infertility is usual, and there may be azoospermia after 8 weeks. There is usually slight atrophy of the seminiferous tubules. Follow-up examinations have shown these changes to be reversible, spermatogenesis usually reverting to its previous state about 3-5 months after stopping Androcur, or in some users, up to 20 months. That spermatogenesis can recover even after very long treatment is not yet known. There is evidence that abnormal sperms which might give rise to malformed embryos are produced during treatment with Androcur.
Gynaecomastia:
Common:
Gynaecomastia (sometimes combined with tenderness to touch of the mamillae) which usually regresses after withdrawal of the preparation.
Rare:
Galactorrhoea and tender benign nodules have been reported.
Symptoms mostly subside after discontinuation of treatment or reduction of dosage.
General disorders and administration site conditions
Common:
Hot flushes, sweating, fatigue and lassitude.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
There have been no reports of ill-effects from overdosage, which it is, therefore, generally unnecessary to treat. There are no specific antidotes and if treatment is required it should be symptomatic.
💬 Ask about this leaflet
Ask anything about Androcur 50 mg tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.