Flutamide
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about . It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
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 problem
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. 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
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
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, foras long as your doctor tells you to.
Do not stop taking this medicine without first checking with your doctor.
If you forget 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 hot 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)
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
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.
However, the addition of EULEXIN to medical castration will not add to this effect. It is important to remember that the
reduction of androgen levels may make erection more difficult. If you experience problems, please ask you 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 degrees 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
Supplier
Schering-Plough Pty Limited
Level 4, 66 Waterloo Road
North Ryde, NSW 2113
AUSTRALIA
Presentations:
Bottle - AUST R 9988
Blister - AUST R 15471
Date of Preparation
September 2008