Eulexin

What EULEXIN is used for

EULEXIN is used in combination with medical castration to treat prostate cancer.

The Prostate Gland

The prostate gland is a walnut-sized gland that surrounds the upper part of the urethra. The urethra is a tube through which urine and sperm exit through the tip of the penis.

The main job of the prostate gland is to produce fluid that nourishes and transports sperm. The gland is vulnerable to two common but unrelated medical problems - enlargement and cancer.

Cancer of the Prostate

Prostate cancer is the most common cancer among Australian men. About 1 in every 10 men will develop the disease in his lifetime. The causes of prostate cancer are unknown but the disease is often responsive to treatment.

Who is at Risk?

Prostate cancer is more common in older men; 80% of men who develop prostate cancer are diagnosed when they are over the age of 65. However, some men develop the disease when they are younger.

What is Maximal Androgen Blockade?

Prostate cancer cells need androgens (male hormones) to grow. There are two sources of androgens in your body: the testes and the adrenal glands (small glands that sit on top of your kidneys). Maximal androgen blockade which combines castration and a medicine called an antiandrogen, is designed to prevent the androgens from both sources reaching and nourishing the cancer cells.

Castration stops the production of testosterone by the testes. Castration can be accomplished either surgically or medically. Surgical castration, called an orchidectomy, is the actual removal of the testes. Medical castration involves taking hormonal drugs known as luteinising hormone-releasing hormone (LHRH) agonists which stop the testes from producing testosterone. Two examples of LHRH agonists are Lucrin (leuprolide) and Zoladex (goserelin acetate). LHRH agonists are given as monthly injections.

While castration "shuts off" the production of testosterone by the testes, it does nothing to stop the androgens produced by the adrenal glands from continuing to nourish the cancer cells.

How EULEXIN works:

To block the adrenal androgens from reaching the cancer cells, your doctor has prescribed EULEXIN, an antiandrogen. EULEXIN is used in combination with medical castration. The combination of medical castration and EULEXIN blocks androgens from all sources; this is called maximal androgen blockade.

Ask your doctor if you have any questions about why EULEXIN has been prescribed for you.

Your doctor, however, may prescribe EULEXIN for another purpose.

This medicine is not addictive.

It is only available with a doctor's prescription.

Before you use EULEXIN

When you must not take it:

Do not take EULEXIN if you are allergic to:

  • flutamide or any of the ingredients listed at the end of this leaflet.

Do not take EULEXIN if you have serious liver problems.

Do not take EULEXIN after the expiry date (EXP) printed on the pack.

Do not take EULEXIN if packaging is torn or shows sign of tampering.

EULEXIN is for use by men only. It should not be taken by women who are pregnant or breast feeding.

Before you start to take it:

You must tell your doctor if:

you are allergic to any other medicines or any food, dyes or preservatives
you have any other medical conditions or health problems
you are pregnant or breast feeding
you have liver problems
you have or have had heart disease, a condition called 'long QT syndrome' or a family history of this heart condition
you have diabetes
you have or have had a history of anaemia, a low red blood cell count
you have low bone mineral density (BMD)
you have osteoporosis or a strong family history of osteoporosis or bone fracture
you consume large quantities of alcohol and/or tobacco
you take medicines to treat epilepsy/fits
you take medicines to reduce the activity of your immune system.

Taking other medicines:

Tell your doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. There may be some interference between EULEXIN and some other medicines, including:

Oral anticoagulants such as warfarin, a medicine used to prevent blood clots.
Theophylline used for asthma
Medicines used to treat irregular heart rhythm e.g. quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, dronedarone, flecainide, propafenone
Medicines that help correct chemical imbalances in the brain which may cause mental illness or behavioural disturbances e.g. chlorpromazine,
Medicines used to treat depression e.g. amitriptyline, nortriptyline
Medicines used to help control pain e.g. methadone
Medicines which treat infection caused by bacteria e.g. erythromycin, clarithromycin, azithromycin, moxifloxacin
Quinine, an antimalarial
Azole antifungals which prevent growth of fungal and yeast organisms
Medicines that help stop nausea and vomiting e.g. ondansetron
Medicines used in the treatment of asthma e.g. salbutamol

How to use EULEXIN

How much to take

Take one tablet by mouth three times a day exactly as directed by your doctor.

When to take it

Taking EULEXIN every 8 hours is the best way of making sure the therapy will block the androgens in your body.

Take one tablet when you first get up, one in the afternoon and one at bedtime. EULEXIN can be taken with or without food.

Do not use meals as a reminder to take EULEXIN because meals are not normally 8 hours apart.

How to take it

Swallow the tablets whole with a full glass of water.

How long to take it

Continue to take EULEXIN regularly, for as long as your doctor tells you to.

Do not stop taking this medicine without first checking with your doctor.

If you forgot to take it

If you forgot to take it, ask your doctor or pharmacist for advice.

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 it as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for advice.

If you take too much (overdose):

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

You may need urgent medical attention.

Keep telephone numbers for these places handy.

While you are using EULEXIN

Things you must do:

Tell your doctor or pharmacist if you are taking any other medicines.

Your doctor may want you to have your blood tested occasionally during your therapy.

Take EULEXIN exactly as your doctor has prescribed.

Tell all doctors, dentists and pharmacists who are treating you that you are taking EULEXIN.

Tell your doctor or pharmacist that you are taking EULEXIN if you are about to be started on any new medicines.

Things you must not do:

Do not stop taking this medicine, or change the dose, without checking with your doctor.

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

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Things to be careful of:

EULEXIN generally does not cause any problems with your ability to drive a car or operate machinery.

However, make sure you know how you react to EULEXIN before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed.

Side Effects

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

All medicines have side effects. Sometimes they are serious, most of the time they are not. Although not all of these side effects may occur, if they do occur they may need medical attention.

Ask your doctor or pharmacist any questions you may have.

Do not be alarmed by this list of side effects.

You may not experience any of them.

Tell your doctor immediately if you notice any of the following symptoms. These may indicate liver disorder, which has been reported very rarely with EULEXIN.

  • itching of the skin
  • dark urine (amber or yellow-green urine is not a cause for concern)
  • nausea, vomiting
  • persistent lack of appetite
  • yellow eyes or skin
  • tenderness in the right upper stomach
  • constant tiredness or "flu-like" symptoms.

Patients receiving the combination of EULEXIN plus medical castration may have:

  • diarrhoea
  • hot flushes (sudden sweating and feelings of warmth)
  • increased breast size
  • nausea (feeling sick)
  • vomiting

Unwanted effects that may occur rarely include:

  • bleeding or bruising more than normal
  • loss of appetite
  • injection site irritation or rash
  • swelling of feet or lower legs
  • shortness of breath
  • muscle ache or twitching
  • high blood pressure
  • liver damage or brain coma from liver illness
  • yellow discolouration of the skin or eyes due to failure to remove bile

Unwanted effects that may occur very rarely include:

  • difficult or labored breathing
  • feeling fatigued
  • excessive thirst and urination
  • unusual weight loss or weight gain
  • nausea and vomiting
  • slow healing cuts or infection
  • blurred vision
  • drowsiness
  • confusion
  • depression
  • anxiety
  • nervousness
  • decrease in sexual desire or sexual ability
  • difficulty sleeping
  • always feeling hungry
  • headaches and feeling dizzy
  • mood swings
  • leg cramps, tingling/numbness in hands and/or feet

Tell your doctor or pharmacist if any of these occur.

In general, patients will experience few additional effects when EULEXIN therapy is added to medical castration.

The following tips may help if you are experiencing diarrhoea:

  • drink plenty of fluids
  • cut down on dairy products
  • try eating smaller food portions
  • eat more carbohydrates
  • in consultation with your doctor, you may also try taking medication to manage diarrhoea.

Since a variety of medications can cause diarrhoea, it is important to tell your physician about all the medicines you take, including those that are non-prescription.

Any therapy that stops the production of male hormones, such as medical or surgical castration, will affect your sex drive. It is important to remember that the reduction of androgen levels may make erection more difficult. If you experience problems, please ask your doctor about available treatment options.

Check with your doctor as soon as possible if you have any problems while taking EULEXIN even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Other side effects not listed above may also occur in some people. If you notice any other side effects, check with your doctor.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using EULEXIN

Storage

Keep it where young children cannot reach it.

Do not store EULEXIN or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Store the tablets at temperature below 25°C in a dry place, away from heat and direct light.

A locked cupboard at least one-and-a-half meters above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using EULEXIN or it has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product Description

What it looks like

EULEXIN is a round, pale yellow tablet with a single score on one side, and an embossed SP logo on the other side. It is available in pack of 100 tablets.

Ingredients

Each tablet contains:

  • flutamide 250 mg
  • lactose anhydrous
  • sodium lauryl sulfate
  • cellulose - microcrystalline
  • starch - pregelatinised maize
  • silicon dioxide
  • magnesium stearate