Flutamin

contains the active ingredient 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 Flutamin. It does not contain all the information that is known about Flutamin. 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 Flutamin is used for

Flutamin is used together with another medicine (LHRH agonists) to treat cancer of the prostate gland. It is also used to prevent "flare" associated with LHRH agonists use.
Flutamin contains the active ingredient flutamide, which is a non-steroidal antiandrogen. This medicine works by blocking the effects of androgens, male hormones, which prostate cancer cells need to grow.
Ask your doctor if you have any questions about why Flutamin has been prescribed for you.
Your doctor may have prescribed Flutamin for another reason.
Flutamin is available only with a doctor's prescription.
There is no evidence that Flutamin is addictive.
As prostate cancer only occurs in men, this medicine therefore should not be used in women.

Before you take Flutamin

When you must not take it

Do not take Flutamin if you are allergic to medicines containing flutamide or any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.
Do not take Flutamin if you have serious liver problems.
Do not take Flutamin if the expiry date (EXP) printed on the pack has passed.
Do not take Flutamin if the packaging shows signs of tampering or the tablets do not look quite right.
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 are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you have any medical conditions, especially the following:
liver problems.
Your doctor may want to take special care if you have this condition.
Tell your doctor if you are pregnant or breastfeeding.
Flutamin is only for use in men.
If you have not told your doctor about any of the above, tell him/her before you start taking Flutamin.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may be affected by Flutamin, or may affect how well it works. These include:
warfarin, a medicine used to prevent blood clots
theophylline, a medicine used in the treatment of asthma.
Your doctor can tell you what to do if you are taking this medicine.
If you are not sure whether you are taking the above medicine, check with your doctor or pharmacist.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Flutamin.

How to take Flutamin

Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the pack, ask your doctor or pharmacist.

How much to take

The usual dose is one tablet three times a day.

When to take it

Take Flutamin every eight hours.
Flutamin works best when the doses are spaced evenly throughout the day.
Take one tablet when you first get up, one in the afternoon and one at bedtime.
Flutamin can be taken with or without food.
Do not use meals as a reminder to take Flutamin because meals are not normally 8 hours apart.

How to take it

Swallow the tablets with a glass of water.

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

How long to take it for

To properly control your condition, Flutamin must be taken every day, even if you start to feel better.
Keep taking Flutamin for as long as your doctor recommends.
How long to take Flutamin for depends on your response to treatment.

If you take too much (overdose)

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

While you are taking Flutamin

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking Flutamin.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Flutamin.
Visit your doctor regularly for check-ups.
Your doctor may ask you to have blood tests to check your liver, especially during the first 4 months of treatment.
If you need to have any other blood tests, tell your doctor that you are taking Flutamin.
Flutamin may affect the results of some tests.

Things you must not do

Do not stop taking Flutamin, or change the dose, without checking with your doctor.
Do not use Flutamin to treat any other conditions unless your doctor tells you to.
Do not give Flutamin to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Flutamin affects you.
Dizziness and tiredness have been reported in some people.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Flutamin.
Flutamin helps most people with prostate cancer, but it may have unwanted side effects in some people.
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.
The side effects listed in this section have been reported in people receiving treatment with this medicine either alone and/or in combination with a LHRH agonist.
Do not be alarmed by this list of possible 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 Flutamin.
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 Flutamin 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 Flutamin 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 Flutamin 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 your doctor about available treatment options.
Check with your doctor as soon as possible if you have any problems while taking Flutamin even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Tell your doctor if you notice anything that is making you feel unwell.
This is not a complete list of all possible side effects.
Other side effects not listed above may also occur in some people.

After using Flutamin

Storage

Keep Flutamin 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.
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they will not keep well.
Keep Flutamin in a cool dry place, away from direct light where the temperature stays below 30°C.
Do not store Flutamin or any other medicine in the bathroom or near a sink.
Do not leave Flutamin in the car or on window sills.
Heat and dampness can destroy some medicines.

Disposal

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

Product description

What it looks like

Flutamin is a round, yellow, scored tablet marked "FT" over "250" on one side and "G" on the other side.
Flutamin is available in packs of 100 tablets.

Ingredients

The active ingredient in Flutamin is flutamide.
Each Flutamin tablet contains 250 mg of flutamide.
The tablets also contain the following inactive ingredients:
lactose
microcrystalline cellulose
maize starch
pregelatinised maize starch
sodium lauryl sulfate
colloidal anhydrous silica
magnesium stearate.
Flutamin tablets are gluten free.

Supplier

Flutamin is supplied in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
 
Medical Information
Phone: 1800 028 365
 
www.alphapharm.com.au
 
Australian registration number:
Flutamin - AUST R 65675
 
This leaflet was prepared on
30 October 2012.