Consumer medicine information

Androcur-100

Cyproterone acetate

BRAND INFORMATION

Brand name

Androcur-100

Active ingredient

Cyproterone acetate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Androcur-100.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Androcur-100.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Androcur-100 against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

WHAT ANDROCUR-100 IS USED FOR

Androcur-100 is an anti-androgen medicine. Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens may help the cancer cells to grow. By blocking these hormones, Androcur-100 may slow or stop the growth of cancer.

Androcur-100 may be used in combination with other medicines or following surgical removal of the testes to treat side effects such as “hot flushes” or “sweats” and to prevent any initial worsening of the disease.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is available only with a doctor’s prescription.

BEFORE YOU TAKE ANDROCUR-100

When you must not take it

Do not take Androcur-100 if you have an allergy to:

  • cyproterone acetate, the active ingredient in Androcur-100
  • any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin

Do not take Androcur-100 if you have any of the following medical conditions:

  • liver disease, previous or existing liver tumours unless they are caused by metastases from prostate cancer (your doctor would have told you if you have this)
  • Dubin-Johnson syndrome or Rotor syndrome (your doctor would have told you if you have either of these conditions)
  • previous or existing benign brain tumour (meningioma)
  • wasting disease (a disease causing muscle loss or loss of strength, with the exception of prostate cancer)
  • severe and persistent depression
  • existing conditions relating to formation of blood clots

Androcur-100 should only be taken by men. It should not be taken by women or children and adolescents below 18 years of age.

Androcur tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Androcur.

Do not take this medicine after the expiry date printed on the pack and blister. The expiry date is printed on the carton and on each blister after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired return it to your pharmacist for disposal.

Do not take this medicine if the packaging is torn or shows signs of tampering. If the packaging is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • diabetes
  • history of blood clotting or sickle cell anaemia
  • osteoporosis, a family history of osteoporosis or risk factors for developing osteoporosis (such as smoking, a diet low in calcium, poor mobility, a slight build or treatment with steroid medicines)

Tell your doctor if fertility after treatment is important. It is recommended that a sperm count is taken to establish fertility before commencing Androcur-100. It can take 3-20 months for fertile sperm production to be re-established after stopping this medicine.

If you have not told your doctor about any of the above, tell them before you start taking Androcur-100.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Androcur-100 may interfere with each other. These include:

  • phenytoin, a medicine used to treat epilepsy
  • medicines used to treat fungal infections, including ketoconazole, itraconazole, clotrimazole
  • ritonavir, a medicine used in the treatment of HIV
  • rifampicin, an antibiotic used to treat infections such as tuberculosis and leprosy
  • St John's wort, a herbal remedy used to treat mood disorders
  • Statins (HMGCoA inhibitors), medicines used to lower cholesterol levels in people with or at risk of cardiovascular disease
  • medicines used to treat diabetes

These medicines may be affected by Androcur-100, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE ANDROCUR-100

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions printed on the pharmacist label, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you the dose that you should take. The usual daily dose is 50-300 mg of Androcur. Your doctor may request you take Androcur with other medicines and/or change your dose during treatment.

Do not alter the dose yourself. Your doctor will advise you if changing the dose is necessary.

Shortness of breath may occur at high doses.

How to take it

Swallow the tablets whole with some liquid after meals.

When to take it

Take your medicine after meals at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it. Missed Androcur-100 tablets may diminish the effectiveness of treatment.

How long to take it

Continue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Androcur-100. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

WHILE YOU ARE TAKING ANDROCUR-100

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Androcur-100.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Your doctor will check your liver function during treatment with Androcur and whenever any symptoms or signs suggesting liver problems are observed.

If you have diabetes, your doctor will monitor you to ensure that you receive the appropriate dose of oral antidiabetic or insulin whilst taking Androcur.

Your doctor will also check your red-blood cell count to ensure you do not become anaemic during treatment with Androcur.

Things you must not do

Do not take Androcur-100 to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how Androcur-100 affects you. This medicine may cause tiredness and can impair the ability to concentrate. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine. If you drink alcohol, tiredness and the ability to concentrate may be worse. The effectiveness of Androcur to reduce abnormal sex drive can also be diminished under the influence of alcohol. Alcohol may prevent Androcur from working as well as it should in reducing abnormal sex drive.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Androcur-100.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • tiredness, fatigue
  • weight change
  • headache
  • depressive mood
  • nausea and other gastrointestinal complaints
  • decreased sexual drive
  • breast pain, change in breast size, breast swelling and/or tenderness
  • breast enlargement in men
  • hot flushes, sweating
  • shortness of breath
  • osteoporosis

If you were fertile before treatment, Androcur-100 will normally prevent sperm production. Fertility is usually regained within a few months of discontinuing therapy.

Androcur-100 will also normally result in the inability to get or maintain an erection (impotence). This ability is usually also regained within a few months of discontinuing therapy.

The above includes the more common side effects of your medicine.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • yellowing of the skin and/or eyes, light coloured bowel motions, dark coloured urine
  • severe upper abdominal pain
  • vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea
  • sudden severe headache, loss of vision, loss of coordination, slurred speech, shortness of breath, chest pain, numbness, heat or swelling in the arms and legs

The above list includes serious side effects that may require medical attention or hospitalisation. Serious side effects are rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may happen in some people.

AFTER TAKING ANDROCUR-100

Storage

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack, they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store Androcur-100 or any other medicine in the bathroom, near a sink or on a window-sill.

Do not leave it in the car. Heat and damp can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Return any unused medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

Androcur-100 tablets are white, capsule shaped tablets, with “LA” markings on the scored side and a hexagon marking on the other side, presented in blisters of 10. Each pack contains 50 tablets.

Ingredients

Active ingredient per tablet:

  • Androcur 100 - 100 mg of cyproterone acetate

Inactive ingredients:

  • lactose monohydrate
  • corn starch
  • povidone
  • magnesium stearate

Supplier

Made in France for:

Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble, NSW 2073

Australian Registration Number

Androcur-100: AUST R 51449

Date of preparation

18 November 2019

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

© Bayer Australia Ltd
All rights reserved

® Registered Trademark of the Bayer Group, Germany

Published by MIMS February 2020

BRAND INFORMATION

Brand name

Androcur-100

Active ingredient

Cyproterone acetate

Schedule

S4

 

1 Name of Medicine

Androcur 100 mg (cyproterone acetate).

6.7 Physicochemical Properties

Cyproterone acetate is a white to pale yellow crystalline powder. M.P. 206-213°C. Cyproterone acetate is very soluble in chloroform and dioxane, freely soluble in acetone and benzene, soluble in ethanol, methanol and ethyl acetate, sparingly soluble in solvent hexane, and almost insoluble in water.

Chemical structure.


CAS number.

427-51-0.

Chemical name.

6-chloro-17α hydroxy-1α, 2α-methylene-pregna-4, 6-diene-3, 20-dione acetate.

Molecular formula.

C24H29ClO4.

Molecular mass.

416.96.

2 Qualitative and Quantitative Composition

Androcur 100 mg tablets.

Each Androcur 100 mg tablet contains 100 mg cyproterone acetate.
Androcur 100 mg tablet contains lactose monohydrate. For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Androcur 100 mg tablets.

Capsule-shaped, white, scored tablets.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Androcur-100 is an antiandrogenic hormone preparation.
Cyproterone acetate inhibits competitively the effect of androgens at androgen-dependent target organs, e.g. it shields the prostate from the effect of androgens originating from the gonads and/or the adrenal cortex. Prostatic carcinoma and its metastases are in general androgen-dependent, cyproterone acetate therefore exerts a direct antiandrogenic action on the tumour and its metastases.
Cyproterone acetate in addition has a progestogenic action exerting a negative feedback effect centrally on the hypothalamic receptors, so leading to a reduction in gonadotropin release, and hence to diminished production of testicular androgens. Treatment with cyproterone acetate in men results in a reduction of sexual drive and potency and inhibition of gonadal function. These changes are reversible following discontinuation of the therapy.
The antigonadotropic effect of cyproterone acetate is also exerted when the substance is combined with LHRH agonists. The initial increase of testosterone provoked by this substance group is decreased by cyproterone acetate.
Prolactin levels can increase slightly under higher doses of cyproterone acetate. Studies showed increased prolactin levels up to 20 nanogram/mL (normal range 5-15 nanogram/mL). There are no data for periods longer than 6 months.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Following oral administration, cyproterone acetate is completely absorbed over a wide dose range.
The ingestion of 100 mg of cyproterone acetate gives maximum serum levels of 239.2 ± 114.2 nanogram/mL at 2.8 ± 1.1 hours. Thereafter, drug serum levels declined during a time interval of typically 24 to 120 hours, with a terminal half-life of 42.8 ± 9.7 h. The total clearance of cyproterone acetate from serum was determined to be 3.8 ± 2.2 mL/min/kg. The absolute bioavailability of cyproterone acetate is unknown. Relative bioavailability was calculated, in a study of eight young women, from a dose-corrected comparison of area under the curves of serum levels after 100 mg oral and 300 mg intramuscular depot administration and was found to be 80 ± 30% when averaged over all volunteers (range 23%-119%).

Distribution.

The major part of circulating cyproterone acetate is bound to serum albumin. In a study in 15 women receiving 2 mg cyproterone acetate in combination with 35 microgram ethinyloestradiol, the free fraction of cyproterone acetate was about 3.5-4%. Because protein binding is non-specific, changes in SHBG (sex hormone binding globulin) levels do not affect the pharmacokinetics of cyproterone acetate.

Metabolism.

Cyproterone acetate is metabolised by various pathways, including hydroxylations and conjugations. The main metabolite in human plasma is the 15β-hydroxy derivative. Some dose parts are excreted unchanged with bile fluid. Phase I metabolism of cyproterone acetate is mainly catalysed by the CYP450 enzyme CYP3A4.

Elimination.

In a study in 6 women administered a 14C labelled dose of 2 mg cyproterone acetate in combination with 50 microgram oestrogen, approximately 30% of the label was found in the urine and 58% in the faeces. The renal and biliary excretion was determined to proceed with a half-life of 1.9 days. Metabolites from plasma were eliminated at a similar rate (half-life of 1.7 days).

Steady state conditions.

According to the long half-life of the terminal disposition phase from plasma (serum) and the daily intake, an accumulation of cyproterone acetate by a factor of about 3 can be expected in the serum during repeated daily administration.

5.3 Preclinical Safety Data

Genotoxicity.

Cyproterone acetate was negative in a standard battery of genotoxicity studies. However, further tests showed that cyproterone acetate was capable of producing hepatocyte DNA adducts in rats, dogs and monkeys (and an increase in DNA-repair activity in rats) in vivo and also in freshly isolated rat and human liver cells in vitro. This DNA-adduct formation occurred at exposures that might be expected to occur in the recommended dose regimens for Androcur. In vivo consequences of cyproterone acetate treatment were the increased incidence of focal, possibly pre-neoplastic, liver lesions in which cellular enzymes were altered in female rats, and an increase of mutation frequency in transgenic rats carrying a bacterial gene as target for mutation. The clinical relevance of these findings presently remains uncertain.

Carcinogenicity.

Long-term animal carcinogenicity studies were performed in rats and mice. In one rat study, an increased incidence of hepatomas was reported at oral dose levels of 50 mg/kg cyproterone acetate and above. In mouse (and a second rat) carcinogenicity studies, increases in benign proliferative changes (nodular hyperplasia) in liver cells of female mice and male and female rats were reported at oral doses of 2 mg/kg. Because of shortcomings in these studies (inadequate pharmacokinetic data and the need to reassess the liver pathology), the carcinogenic potential of cyproterone acetate in animals could not be determined.
Clinical experience and limited epidemiological data available to date do not appear to have supported an increased incidence of hepatic tumours in humans. However, it must be borne in mind that steroidal sex hormones can promote the growth of certain hormone-dependent tissues and tumours.

4 Clinical Particulars

4.1 Therapeutic Indications

Inoperable prostatic carcinoma.

To suppress 'flare' with initial LHRH analogue therapy.
In long-term palliative treatment where LHRH analogues or surgery are ineffective, not tolerated, contraindicated or where oral therapy is preferred.
In the treatment of hot flushes in patients treated with LHRH analogues or who have had orchidectomy.

4.3 Contraindications

Liver diseases.
Dubin-Johnson syndrome, Rotor syndrome.
Previous or existing liver tumours (only if these are not due to metastases from carcinoma of the prostate).
Presence or history of meningioma.
Wasting diseases (with the exception of inoperable carcinoma of the prostate).
Severe chronic depression.
Existing thromboembolic processes.
Hypersensitivity to any of the components of Androcur-100.

4.4 Special Warnings and Precautions for Use

Androcur-100 is for use only in men.
During treatment, liver function, adrenocortical function and red blood cell count should be checked regularly.
As with other antiandrogenic treatments, in male patients long-term androgen deprivation with Androcur-100 may lead to osteoporosis.
In men of procreative age, for whom fertility could be important after conclusion of the medication, it is advisable to make at least one control spermatogram as a precaution before the start of treatment in order to counter any unjustified claims of later infertility as a result of the antiandrogen therapy. Spermatogenesis has taken 3-20 months to return to normal after discontinuing therapy.

Use in hepatic impairment.

Liver.

Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure has been observed in patients treated with cyproterone acetate. At dosages of 100 mg and above, cases with fatal outcome have 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. Liver function tests should be performed pre-treatment, at regular intervals during treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur. If hepatotoxicity is confirmed, Androcur should be withdrawn, unless 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.
Cases of benign and malignant liver tumors 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 included in the differential-diagnostic considerations.

Meningioma.

The occurrence of meningiomas (single and multiple) has been reported in association with long-term use (years) of cyproterone acetate at doses of 25 mg/day and above. If a patient treated with Androcur is diagnosed with meningioma, treatment with Androcur must be stopped (see Section 4.3 Contraindications).

Diabetes.

Strict medical supervision is necessary if the patient suffers from diabetes, because the requirement for oral antidiabetics or insulin can change during Androcur treatment (see Section 4.3 Contraindications).

Shortness of breath.

A sensation of shortness of breath may occur under high-dosed treatment with Androcur. The differential diagnosis in such cases must include the stimulating effect on breathing known for progesterone and synthetic progestogens which is accompanied by hypocapnia and compensatory alkalosis and which is not considered to require treatment.

Thromboembolic events.

The occurrence of thromboembolic events has been reported in patients using Androcur although a causal relationship has not been established. Patients with previous arterial or venous thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or with a history of cerebrovascular accidents or with advanced malignancies are at increased risk of further thromboembolic events.
In patients with a history of thromboembolic processes or suffering from sickle-cell anaemia or from severe diabetes with vascular changes, a careful risk:benefit evaluation must be carried out in each individual case before Androcur-100 is prescribed.

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.

Anaemia.

Anaemia has been reported during treatment with Androcur. Therefore, the red blood cell count should be checked regularly during treatment.

Other conditions.

Androcur tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
The sexual drive-reducing effect of Androcur can be diminished under the influence of alcohol.

Use in the elderly.

See Section 4.2 Dose and Method of Administration.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The requirement for oral antidiabetics or insulin can change.
Although clinical interaction studies have not been performed, since this drug is metabolized 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, e.g. rifampicin, phenytoin and products containing St John's wort may reduce the levels of cyproterone acetate.
The risk of statin-associated myopathy or rhabdomyolysis may be increased when those HMG-CoA inhibitors (statins), which are primarily metabolised by CYP3A4, are coadministered with high therapeutic cyproterone acetate doses since they share the same metabolic pathway.
Based on in vitro CYP450 studies, the recommended clinical doses are likely to inhibit CYP2C8, and an inhibition of the CYP2C9, 2C19, 3A4 and 2D6 is also possible at high therapeutic cyproterone acetate doses of 3 times 100 mg per day.

4.6 Fertility, Pregnancy and Lactation

Androcur-100 is for use only in men.

Effects on fertility.

See Section 4.4 Special Warnings and Precautions for Use; Section 5.1 Pharmacodynamic Properties.
No available data.
No available data.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions reported in clinical trials.

The following adverse reactions have been reported at the approximate frequencies (not necessarily implicating a causal relationship) indicated below.
Very common ≥ 1/10; common ≥ 1/100 and < 1/10; uncommon ≥ 1/1,000 and < 1/100; rare ≥ 1/10,000 and < 1/1,000; very rare < 1/10,000.

General.

Very common: tiredness, weight increase.
Common: headache, depressive moods.

Cardiovascular.

Common: thrombotic phenomena.

Gastrointestinal.

Common: nausea and other gastrointestinal complaints.

Reproductive.

Very common: diminished libido.
Common: mastodynia.

Skin.

Rare: rash.
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.
Over the course of several weeks Androcur-100 gradually impairs spermatogenesis as a result of the antiandrogenic and antigonadotropic actions. Spermatogenesis recovers gradually within several months of discontinuing therapy.
Androcur may lead to gynaecomastia (sometimes combined with tenderness to touch of the breast) which usually regresses after withdrawal of the preparation or reduction of the dose.
As with other antiandrogenic treatments, in male patients long-term androgen deprivation with Androcur may lead to osteoporosis.
In individual cases, disturbances of liver function, some of them severe, have been reported with high-dosed Androcur treatment.
Changes in bodyweight are possible.
Other adverse events reported at a low incidence are: skin discolouration and striae.

Post-marketing information.

The following adverse effects have been reported in users of cyproterone acetate and are based on post-marketing data and cumulative experience with Androcur. The most appropriate MedDRA term to describe a certain adverse reaction is listed in Table 1. Synonyms or related conditions are not listed, but should be taken into account as well.
Under treatment with Androcur-100, sexual drive and potency are reduced and gonadal function is inhibited. These changes are reversible after discontinuation of therapy.
Meningiomas have been reported in association with long-term use (several years) of Androcur doses of 25 mg and above (see Section 4.3 Contraindications; Section 4.4 Special Warnings and Precautions for Use).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems (Australia).

4.2 Dose and Method of Administration

The maximum daily dose is 300 mg.

Inoperable prostatic carcinoma.

Androcur-100 tablets should be taken with some liquid after a meal.

To reduce the initial increase of male sex hormones ('flare') in treatment with LH-RH agonists.

Initially 1 tablet Androcur-100 twice daily (i.e. 200 mg a day) alone for 5-7 days, followed by 1 tablet Androcur-100 twice daily (i.e. 200 mg a day) for 3-4 weeks together with an LHRH agonist in the dosage recommended by the manufacturer.

In long-term palliative treatment of advanced prostate cancer in patients who have not had an orchiectomy.

100 mg (1 tablet Androcur-100) two to three times daily. Treatment should not be interrupted nor the dosage reduced after improvement or remissions have occurred.

To treat hot flushes in patients under treatment with LHRH analogues or who have had orchiectomy.

50 mg-150 mg (half to one and a half tablets) per day with upward titration up to 1 tablet three times daily (300 mg) if necessary.

Children and adolescents.

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.

Use in the elderly.

There are no data suggesting the need for dosage adjustment in elderly patients.

Patients with hepatic impairment.

The use of Androcur is contraindicated in patients with liver diseases.

Patients with renal impairment.

There are no data suggesting the need for dosage adjustment in patients with renal impairment.

4.7 Effects on Ability to Drive and Use Machines

It should be pointed out to patients whose occupation demands great concentration (e.g. road users, machine operators) that Androcur-100 can lead to tiredness and diminished vitality and can impair the ability to concentrate.

4.9 Overdose

There is no clinical experience in overdose. Assessment and symptomatic treatment should be initiated as required.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

In addition to cyproterone acetate, each Androcur 100 mg tablet contains the following inactive ingredients: lactose monohydrate, maize starch, povidone, colloidal anhydrous silica and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Androcur 100 mg tablets are supplied in (PVC/Al) blister pack of 50 tablets.
PBS availability (Authority Required):
Tablets 100 mg - Qty. 50; Rpts. 5.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes