Consumer medicine information




Brand name


Active ingredient





Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Anandron.

What is in this leaflet

This leaflet answers some common questions about Anandron. 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 Anandron against the benefits Anandron is expected to have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What Anandron is used for

Anandron is a medicine for treating prostate cancer in men. It contains the active ingredient Nilutamide.

Anandron belongs to a family of medicines called non-steroidal anti-androgens. These medicines work by blocking the effect of androgen hormones that are naturally produced by your body. Prostate cancer cells are dependent on these hormones, and blocking their effect is intended to stop the growth of the cancer.

Anandron is more effective when used at the same time as other medicines known generally as LHRH agonists or, alternatively, following surgery designed to treat prostate cancer.

Your doctor may have prescribed Anandron for another reason.

Ask your doctor if you have any questions about why Anandron has been prescribed for you. Anandron is available only with a doctor's prescription.

Before you take Anandron

When you must not take it

Anandron must only be taken by men. It is not suitable for women or children.

Do not take Anandron if:

  • you have an allergy to:
    Nilutamide or any of the other ingredients listed at the end of this leaflet (see Product Description).

    Symptoms of an allergic reaction to these medicines may include:
    - asthma, wheezing or shortness of breath
    - swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
    - hives, itching or skin rash
    - fainting
  • you have severe liver problems
  • you have severe breathing problems
  • you have previously taken another anti-androgen medicine for prostate cancer that did not work

If you are not sure whether you should start taking Anandron, contact your doctor.

Return the pack to your pharmacist for replacement if:

  • the packaging is torn or shows signs of tampering
  • the expiry date on the pack has passed.
    If you take Anandron after the expiry date has passed, it may not work as well.

Before you start to take it

Tell your doctor if:

  • you have any allergies to:
    - any other medicines
    - any other substances, such as lactose or corn (maize)
  • you have or have had any of the following medical conditions:
    - liver disease
    - breathing problems
    - any abnormalities of your heart rhythm (in particular have a condition called QTc prolongation)

If you have not told your doctor about any of the above, tell them before you take any Anandron.

Taking other medicines and drinking alcohol

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

Anandron may interfere with some medicines, including the following:

  • warfarin or phenindione (medicines used to stop blood clots)
  • phenytoin (a medicine used to treat epilepsy)
  • propranolol (a medicine used to treat high blood pressure and some other conditions)
  • diazepam or chlordiazepoxide (medicines for anxiety)
  • theophylline (a medicine used to treat asthma)
  • quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide (medicines for the heart)
  • methadone, moxifloxacin, antipsychotics.

Check the labels on your medicines for these drug names or ask your pharmacist for help. Tell your doctor if you are taking any of these medicines before you start taking Anandron.

Some patients being treated with Anandron may have hot flushes or feel unwell after drinking alcohol. This is known as alcohol intolerance and may impair your ability to drive or operate machinery. If this happens, you should not drink alcohol while taking Anandron.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Anandron.

How to take Anandron

How much to take

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

The usual dosage of Anandron is one tablet twice daily (or two tablets once daily) for the first four weeks and then one tablet once daily thereafter.

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

How to take it

You should swallow each tablet whole with some water. Do not chew them.

When to take it

You can take Anandron with or without food.

How long to take it for

Do not take Anandron for longer than your doctor says. If you are not sure how long to take Anandron, ask your doctor.

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 tablets as you would normally. Do not take a double dose to make up for the dose that you missed.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

If you take too much (overdose)

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

While you are taking Anandron

Things you must do

Tell your doctor immediately if you experience any breathing problems or a worsening of a pre-existing breathing problem. Symptoms may include shortness of breath, coughing, chest pain or fever.

Tell your doctor immediately if you experience nausea, vomiting, abdominal pain and jaundice (yellow eyes/skin).

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking Anandron.

Things you must not do

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

Do not take Anandron to treat any other complaints unless your doctor says to.

You should not stop taking Anandron without consulting your doctor first.

Things to be careful of

Be careful driving or operating machinery until you know how Anandron affects you. Anandron may cause dizziness or light-headedness in some people. Make sure you know how you react to Anandron before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy or light-headed. If you drink alcohol, dizziness or light-headedness may be worse.

Side Effects

Anandron helps most people with prostate cancer, but it may have unwanted side-effects in some people.

All medicines may cause side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment for some of the side-effects that have been seen in patients taking Anandron.

Most side effects caused by Anandron happen early in the course of treatment and usually lessen after four weeks when the dose is normally reduced to one tablet daily. The most common side effect affects the eyes and makes it difficult to adapt to darkness. This problem is almost always temporary and may be improved by wearing tinted glasses (eg. sunglasses). Until your eyes get used to darkness, you should not drive at night or through tunnels in bright light.

Tell your doctor if you experience any of the following side effects and it worries you:

  • nausea or vomiting
  • difficulty adapting to changes in light
  • dizziness

Your doctor may be able to adjust your treatment or give you advice to make these side effects less troublesome.

Tell your doctor immediately if you experience any of the following:

  • any new breathing problem or chest pain, or a worsening of a pre-existing breathing problem
  • jaundice (yellow eyes/skin) possibly with nausea, vomiting and abdominal pain
  • allergic reactions such as asthma, wheezing, shortness of breath, swelling of the face, lips or tongue, hives, itching, skin rash or fainting

You may need urgent medical attention for these rare serious side effects.

Other side effects not listed above may occur in some patients, so you should tell your doctor if you feel unwell while taking Anandron.

Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

After using Anandron


Keep your tablets in the blister strip until it is time to take one. If you take the tablets out of the blister strip, they may not keep as well.

Store Anandron tablets in a cool dry place where the temperature stays below 30°C. Do not store them or any other medicine in the bathroom or near a sink. Do not leave the tablets in the car or on window sills. Heat and dampness can destroy some medicines.

Keep Anandron where children cannot reach it. A locked cupboard at least one-and-a-half metres (about 5 feet) above the ground is a good place to store medicines.


If your doctor tells you to stop taking Anandron tablets or if the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

What Anandron looks like

Anandron 150 mg tablets are white to off-white tablets, marked with 168D on one side and RU on the reverse. They come in packs of 30 tablets.


The active ingredient in Anandron tablets is nilutamide. There is 150 mg of nilutamide in every Anandron tablet. Each tablet also contains some inactive ingredients. These are: maize starch, lactose monohydrate, povidone, docusate sodium, magnesium stearate and purified talc.

Anandron does not contain gluten, sucrose, tartrazine or any other azo dyes.


Anandron tablets are distributed by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall No: 1800 818 806

Australian registration number:
AUST R 55059

Date of preparation of this leaflet: April 2020


Published by MIMS June 2020


Brand name


Active ingredient





1 Name of Medicine


2 Qualitative and Quantitative Composition

Nilutamide is a non-steroidal orally-active specific antiandrogen.
Each Anandron tablet contains nilutamide 150 mg as active ingredient.

Excipients with known effect.

Sugars as lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Practically white, biconvex cylindrical tablet, approx. 10 mm in diameter, marked "168D" on one side with company logo "RU" on reverse side.

4 Clinical Particulars

4.1 Therapeutic Indications

Anandron is indicated for the treatment of previously untreated metastatic prostatic carcinoma, in conjunction with surgical or medical castration.
Anandron prevents the disease flare associated with the use of LHRH agonists.

4.2 Dose and Method of Administration

Anandron tablets are taken orally as either a once daily dose or as divided daily doses. To achieve maximum benefits, treatment should begin on the day of medical castration (e.g. using an LHRH agonist) or surgical castration and continue without interruption.
The following dosages are recommended, irrespective of renal function.

Initial treatment.

The dosage for the first four weeks of treatment is 300 mg per day administered either as a once daily dose or as divided doses (e.g. 150 mg twice daily). After four weeks, maintenance treatment should be commenced (see below). Maintenance treatment may be commenced earlier if undesirable effects, especially vomiting or visual effects, occur.

Maintenance treatment.

Immediately following four weeks of initial treatment, the dosage is reduced to 150 mg per day administered as a once daily dose.

4.3 Contraindications

Anandron is contraindicated in the following patients.
Patients who are hypersensitive to nilutamide or any excipient.
Patients with severe hepatic impairment.
Patients with severe respiratory insufficiency.
Patients who have failed to respond to previous hormonal treatment of the cancer.

4.4 Special Warnings and Precautions for Use

The hepatic and respiratory condition of the patient should be checked prior to starting treatment (see Section 4.3 Contraindications). Patients should be advised to promptly report any respiratory symptoms or symptoms suggestive of liver injury which develop during treatment.
In patients with pre-existing respiratory insufficiency, treatment should be interrupted and radiological investigations conducted immediately if any worsening of the degree of dyspnoea occurs.
If any patient develops dyspnoea during treatment, administration of nilutamide should be interrupted and a chest X-ray taken. If the results of the X-ray confirm interstitial pneumonitis, then the treatment should be discontinued to reduce the risk of progression to pulmonary fibrosis and corticosteroid therapy considered in patients with severely impaired gas exchange. Immediate referral to a respiratory unit for investigation and treatment is required for patients experiencing acute respiratory insufficiency.
If clinical signs indicative of hepatitis develop (e.g. nausea, vomiting, abdominal pain, jaundice), transaminase levels (ASAT, ALAT) should be determined. If the transaminase levels are more than three times the upper normal limit, treatment should be discontinued.
Patients should be advised not to interrupt their treatment without medical consultation.

Special populations.

In the two main pivotal studies, the breakdown of patients according to ethnic origin was 737 Caucasian, 95 black, 29 Hispanic, 5 Asian. In a small uncontrolled pilot study conducted in Japan, a higher incidence of interstitial pneumonitis (8 of 47 patients) was reported than in controlled trials conducted elsewhere. Consequently, caution should be exercised when treating patients of this ethnic origin.

Antiandrogen withdrawal syndrome.

In patients treated with an antiandrogen who have disease progression, discontinuation of the antiandrogen may be associated with a withdrawal response. In a subset of patients, discontinuation of antiandrogen treatment decreases PSA values and improves the clinical condition; however the precise mechanism is not clear and it is not known if this translates into prolonged survival.

QT prolongation.

Androgen deprivation therapy may prolong the QT interval. In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval physicians should assess the benefit risk ratio including the potential for torsades de pointes prior to initiating nilutamide. In case of QT prolongation, nilutamide treatment should be discontinued (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions; Section 4.8 Adverse Effects (Undesirable Effects)).

Use in hepatic impairment.

The hepatic condition of the patient should be checked prior to starting treatment (see Section 4.3 Contraindications). Patients should be advised to promptly report any symptoms suggestive of liver injury which develop during treatment.

Use in the elderly.

No data available.

Paediatric use.

Anandron is contraindicated in children.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Due to the effect of nilutamide on certain microsomal enzyme mechanisms, it may reduce the hepatic metabolism of some substances (e.g. oral anticoagulants, phenytoin, propranolol, chlordiazepoxide, diazepam, theophylline) thereby delaying their elimination and increasing blood levels. The dosage of these medicines or others with a similar metabolic pathway may require adjustment if taken with nilutamide.
When an oral anticoagulant is administered concomitantly with nilutamide, blood coagulation tests should be monitored (prothrombin time, INR). The dose of the oral anticoagulant should be adjusted if necessary.
Nilutamide may cause alcohol intolerance in some patients resulting in malaise and vasomotor flushes. In such cases, alcohol should be avoided during treatment.
Since androgen deprivation treatment may prolong the QT interval, the concomitant use of nilutamide with medicinal products known to prolong the QT interval or medicinal products able to induce torsades de pointes such as class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics, etc. should be carefully evaluated. In case of combination with such medicinal products, the QT interval should be closely monitored (see Section 4.4 Special Warnings and Precautions for Use).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Degeneration of testicular germinal epithelium was seen in rats given oral doses of nilutamide at a dose of 10 mg/kg/day for 13 weeks and 5 mg/kg/day for 78 weeks. In addition, in a reproductive study, male rats dosed at 25 mg/kg/day or higher for 30 days and mated to normal females exhibited a reduction in the number of implantations and increased resorptions.
Nilutamide is indicated for male patients only. There are insufficient animal toxicity data to indicate potential risks, and the safety of nilutamide in pregnant women has not been established. Therefore, nilutamide should not be taken during pregnancy.
Nilutamide is indicated for male patients only. There are insufficient animal toxicity data to indicate potential risks, and the safety of nilutamide in lactating women has not been established. Therefore, nilutamide should not be taken by nursing mothers.

4.7 Effects on Ability to Drive and Use Machines

No specific studies have been performed to evaluate the effects of nilutamide on driving performance or the ability to operate machinery. Patients who experience visual disorders should refrain from driving until their eyesight has accommodated to the darkness and should avoid driving at night or through tunnels (see Section 4.8 Adverse Effects (Undesirable Effects), Visual). In case of alcohol intolerance, patients should avoid alcohol before driving or operating machinery.

4.8 Adverse Effects (Undesirable Effects)

Anandron was generally well tolerated by 2,000 patients (including elderly men) treated for periods of up to several years in clinical trials. The most common adverse events (especially nausea, alcohol intolerance, impairment of dark or light adaptation and dizziness) occur early in the course of treatment and usually lessen after one month following dose reduction. The risk of rare but more severe adverse effects may be lessened by careful monitoring.
The following adverse events may be observed during treatment with nilutamide.


Impaired adaptation to darkness affects approximately 25% of treated patients. Symptoms are generally moderate in intensity and may decrease or disappear on continuation of treatment. The problem may be alleviated by wearing tinted glasses (e.g. sunglasses) and is completely reversible following discontinuation of treatment. Treatment discontinuation due to this reaction occurs in only 1 to 2% of patients.


Interstitial lung disease, (including interstitial pneumonitis and pulmonary fibrosis), which may be fatal, has commonly been reported.
Interstitial pneumonitis affects approximately 1 to 2% of treated patients and generally presents as progressive dyspnoea and possibly coughing, chest pain and/or fever usually within the first three months of therapy. Patients presenting with these symptoms should have nilutamide therapy interrupted and a chest X-ray taken to confirm interstitial or alveolo-interstitial changes. Very rarely, the pneumonitis may present as acute respiratory insufficiency, or there may be a progression to this condition if nilutamide treatment is not interrupted at the onset of symptoms. The symptoms usually regress following early discontinuation of treatment with or without corticosteroid therapy.


An increase in transaminases (ALAT, ASAT) has been observed in about 8% of patients treated with nilutamide. This may normalise even on continuing treatment. If the increase exceeds by threefold the upper limit of the normal range, treatment with nilutamide must be stopped. Hepatitis has been reported as an uncommon reaction (see Section 4.4 Special Warnings and Precautions for Use). Rare cases of mixed, hepatocellular and fulminant hepatitis have been reported.


Nausea with or without vomiting has been reported with an incidence of 10-23%, however patients taking the maintenance dosage of 150 mg per day are usually free of these symptoms. Nilutamide does not cause diarrhoea.


Impotence, decrease in libido, hot flushes, body hair loss, sweating and gynaecomastia have been reported as common or very common reactions that are related to the therapeutic effect of nilutamide and also to medical or surgical castration.


In rare cases, aplastic anaemia has been reported. The relationship to nilutamide has not been established.


Frequency unknown: androgen deprivation therapy treatment may lead to QT prolongation (see Section 4.4 Special Warnings and Precautions for Use; Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).


Alcohol intolerance (malaise with vasomotor flushes) has been reported with an incidence of 4-10%.

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

4.9 Overdose

Doses in excess of 300 mg/day may result in undesirable effects such as digestive disorders (nausea and vomiting) and/or vertigo which resolve on stopping or reducing the dose.
In case of overdose, steps should be taken to minimise the absorption of nilutamide (e.g. oral administration of activated charcoal). If vomiting does not occur spontaneously, it should be induced if the patient is alert. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated. As nilutamide is 80-84% protein bound, dialysis may not be of benefit.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anti-androgens, ATC code: L02BB02.

Mechanism of action.

As growth and differentiation of prostate cancer cells are dependent on the presence of adequate concentrations of circulating androgens of testicular and adrenal origin, the primary goal in the systemic treatment of metastatic prostate cancer is the suppression and/or blockade of androgenic stimulation.
Nilutamide is not a cytotoxic drug. Nilutamide acts by competing at the level of the prostatic androgen receptor for binding of endogenous steroids and by inhibiting androgen uptake.
Nilutamide interacts only with the androgen receptor and not with other steroid hormone receptors (oestrogen, progestin, mineralo- or gluco-corticoid), hence it lacks other hormonal or antihormonal activities.
In addition to antagonising the effects of androgens on prostate tissue, nilutamide also acts at other sites which have androgen receptors including the hypothalamus and pituitary. By interrupting the negative feedback of androgens at the hypothalamo-pituitary level, nilutamide induces a secondary increase in gonadotropin and androgen secretion which overcomes part of the blocking effect. It is, therefore, advisable to inhibit testosterone secretion by either surgical or medical castration. Combining nilutamide with surgical (bilateral orchidectomy) or chemical (LHRH agonist) castration provides a more complete androgenic blockade than castration alone, by counteracting the effects of androgens of adrenal origin which are not affected by any means of castration.
There is considerable debate regarding the relative merits of combination versus monotherapy in advanced prostate cancer, summarised by Dalesio et al 1995 in a meta-analysis of trials of maximal androgen blockade (MAB) involving nilutamide, flutamide or cyproterone acetate in combination with surgical or medical castration. While this analysis did not exclude the possibility of a moderate improvement in survival, there was no statistically significant reduction in the annual odds of death in favour of MAB based on the available data. The meta-analysis included the effect of MAB only on mortality, and did not measure other end-points such as time to disease progression.
Nilutamide prevents the disease flare associated with the administration of an LHRH agonist.
In patients with metastatic prostate cancer who received either nilutamide 300 mg/day with an LHRH agonist or placebo with an LHRH agonist, the nilutamide group achieved chemical castration faster and there was significant prevention of the flare phenomenon, decreased serum prostatic acid phosphatase (PAP) and decreased prostate specific antigen (PSA).

Clinical trials.

Evaluated clinical studies include eight randomised trials combining surgical orchidectomy with nilutamide or placebo and three with LHRH agonists and nilutamide or placebo. The two primary studies involving 457 patients randomised to surgical orchidectomy and nilutamide or placebo and 411 patients randomised to LHRH agonist leuprolide and nilutamide or placebo provide the most pertinent data. Both studies demonstrated that patients receiving nilutamide in combination with surgical or medical castration obtain a higher proportion of objective disease regressions, a significant decrease in the incidence of metastatic related pain and related use of analgesia and, particularly in the case of administration of nilutamide in conjunction with LHRH agonists, inhibition of the flare phenomenon. Other potential beneficial effects, however, were inconclusive. While there was a longer progression free survival in patients treated with nilutamide in combination with surgical orchidectomy in one of the primary studies, it was not demonstrated in other evaluated studies. None of the evaluated studies demonstrated a significant improvement in either cancer related or overall survival. A meta-analysis of 1191 patients undertaken of the randomised phase III trials comparing surgical orchidectomy with nilutamide or placebo demonstrated similar results, however there was a significant benefit for nilutamide in terms of time to disease progression.

5.2 Pharmacokinetic Properties


In healthy volunteers, nilutamide was rapidly absorbed following administration of a single oral dose of 100 to 300 mg. The Cmax (0.8-2.3 mg/L) was reached with a Tmax of about 2 hours (range 1.5 to 3.1 hours). Results obtained in patients receiving 150 mg/day show a slightly longer Tmax (2.8 hours) and lower Cmax (0.9 mg/L) and AUC, but the differences are not considered to be significant.
Analysis of blood, urine and faeces samples following a single oral 150 mg dose of [14C]-nilutamide in patients with metastatic prostate cancer showed that the drug is rapidly and apparently virtually completely absorbed and that it yields high and persistent plasma concentrations. During repeat dose treatment of patients, the mean steady-state plasma concentration is 6-7 mg/L for a 300 mg daily dose, and 3-4 mg/L for a 150 mg daily dose. As expected, given the long half-life of nilutamide (56 hours), steady state is achieved by day 14 (on average). The mean plasma concentration is proportional to the dose administered and is unrelated to serum creatinine levels or to the number of daily doses. Studies of one year duration have shown that there is no accumulation with long-term treatment.


At concentrations between 0.32 and 32.1 mg/L, binding of nilutamide to plasma proteins is 80-84% and non-saturable. In whole blood, nilutamide is 36% bound to erythrocytes. Binding to plasma proteins and erythrocytes is constant over the range of therapeutic concentrations observed in patients. These results do not indicate any effects that would cause non-linear pharmacokinetics.

Metabolism and excretion.

The elimination half-life of nilutamide in patients is 56 hours and in healthy volunteers is 43 hours. The half-life of the metabolites is longer (55-126 hours). Nilutamide is almost completely metabolised and the metabolites are primarily excreted into urine as glucuronide and sulfate conjugates. Renal and faecal excretion of the active drug are negligible. Of the 5 metabolites that have been identified, the main four are amino and hydroxymethyl derivatives of nilutamide. Compared to its metabolites, nilutamide shows higher activity and higher plasma concentrations and is thus the main therapeutic agent.

Special populations.

Renal impairment.

There is no evidence that renal impairment with elevated serum creatinine levels (150-600 micromol) affects the pharmacokinetics of nilutamide.

5.3 Preclinical Safety Data


In vitro and in vivo genotoxicity studies, performed with maximum attainable concentrations and dose levels, were negative.


No animal carcinogenicity studies have been carried out with nilutamide. However, a 78 week dietary study in rats showed dose related interstitial cell hyperplasia at all dose levels (from 5 mg/kg/day) and an increased incidence of interstitial cell adenoma of the testis at 45 mg/kg/day.
Carcinogenicity studies with two related anti-androgenic drugs in rats have shown an increased incidence of interstitial cell adenomas. This is due to a sustained elevation of LH levels in these animals consequent to the blockade by the anti-androgen of the testosterone mediated feedback on LH levels.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lactose monohydrate, maize starch, povidone, docusate sodium, magnesium stearate and purified talc.

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

10 and 30 tablets in a PVC-A/Aluminium blister pack.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

The compound is a white to off white powder.

Chemical structure.

Molecular Weight: 317.2.
Chemical Name: 5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl) phenyl]-2,4-imidazolidinedione.

CAS number.


7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes