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Active substance(s): FLUTAMIDE

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250 mg

Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may want to read
it again.
• If you have further questions, ask your doctor
or pharmacist
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Flutamide is and what it is used for.
2. Before you take Flutamide.
3. How to take Flutamide.
4. Possible side effects.
5. How to store Flutamide.
6. Further information.
Flutamide belongs to a group of medicines
called anti-androgens. It blocks the effect of
testosterone (male sex hormone) in the body.
Flutamide is used to treat prostate cancer. It
is usually taken with another medicine (called
a LHRH agonist) that decreases the levels of
testosterone, or after surgical castration.
Do not take Flutamide:
• if you are allergic (hypersensitive) to flutamide
or any of the other ingredients of these tablets.
• Flutamide treats a condition found only in men.
It must not be given to women or children.

Take special care with Flutamide
You should tell your doctor before taking this
medicine if you:
• have liver problems. Your doctor will check your
liver function before and during treatment
• have kidney problems
• have heart disease
• have osteoporosis (brittle bones) as Flutamide
can increase the risk of bone fractures. Your
doctor will measure your bone mineral density
(BMD) to check you are not at risk
• suffer from chest problems such as breathlessness
• are taking Flutamide long-term you may also
have your sperm count checked if it
is appropriate.
Taking other medicines
Tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription, or
the following:
• warfarin, to thin the blood
• theophylline, for breathing problems.
Taking Flutamide with food and drink
You should not drink large quantities of alcohol
while being treated with this medicine. You
should take Flutamide after meals.
Pregnancy and breast-feeding
Flutamide must not be prescribed to women
and therefore must not be given to pregnant or
breast-feeding mothers.
Driving and using machines
Flutamide may cause tiredness or dizziness.
Do not drive or operate machinery if it happens
to you.
Important information about some of the
ingredients of Flutamide
Flutamide Tablets contain lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, such as lactose,
contact your doctor before taking this medicine.

Follow your doctor's instructions exactly. You
should check with your doctor or pharmacist if
you are not sure.
• Take the tablets with a glass of water preferably
after meals.
• Do not chew the tablets.
• The scoreline on the tablets is only to allow
breaking for ease of swallowing. It is not for
dividing tablets into equal doses.
Adults (including elderly) - The usual dose is
one tablet three times daily.
You may also be given another medicine with
your Flutamide called a LHRH agonist. LHRH
agonists (e.g. goserelin, buserelin) are given by
injection. In that case, it is very important that
the two medicines are taken as directed. You
will start your Flutamide treatment at least three
days before taking the LHRH agonist. If you have
had your testicles removed (castrated) you will
not be given a LHRH agonist.
Children - Flutamide must not be given
to children.
Patients with liver problems - If you have liver
problems your doctor will arrange for you to
have regular blood tests.
If you take more Flutamide than you should
You may suffer from methaemoglobinaemia
(where your blood cannot deliver as much
oxygen to your body as normal). Symptoms
can include cyanosis (bluish colouring of the
skin), blood that is darker than usual, headache,
weakness, confusion, chest pain or vomiting.
If you take too much of your medicine, tell
your doctor immediately or go to your nearest
casualty department.

If you forget to take a dose of Flutamide
Take it as soon as you remember unless it is
almost time for your next dose. If this happens,
skip the missed dose and take the next dose on
time. Do not double the dose.
If you stop taking Flutamide
Do not stop taking this medicine, even if you are
feeling well, unless your doctor tells you to.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
Like all medicines, Flutamide can cause side
effects, although not everybody gets them.
Tell your doctor straight away or go to your
nearest hospital casualty department right
away if you have any of the following
side effects:
• allergic reactions such as swelling of the
lips, tongue or face, or difficulty breathing
or swallowing, a rash, swollen itchy skin or a
serious skin reaction causing death of
skin tissue
• liver problems which may cause itching, dark
urine, persistent lack of appetite, yellowing of
the skin or whites of the eyes, abdominal pain
or severe liver damage which could be fatal.
These effects are rare but serious.
Very common side effects (seen in more than
1 in 10 patients) include:
• enlarged or tender breasts
• production of milk from the breasts.
These effects will get better if your dose is
reduced or you are told to stop taking
your medicine.

Common side effects (seen in more than 1 in
100 patients but less than 1 in 10 patients)
• increased appetite
• difficulty sleeping
• sleepiness
• tiredness
• diarrhoea
• feeling sick
• being sick (vomiting)
• brief abnormal liver function.
Rare side effects (seen in more than
1 in 10,000 patients but less than 1 in
1000 patients) include:
• nerve and skin infection caused by the
herpes virus
• swelling
• bruising
• swollen ankles
• lupus-like syndrome (lupus erythematosus
is a disease affecting the skin and can cause
inflammation, a rash on the face, red scaly
patches on the skin)
• loss of appetite
• anxiety
• depression
• dizziness
• blurred vision
• breathing difficulties
• problems with the heart or circulation
• high blood pressure
• constipation
• thirst
• indigestion
• inflammation of the colon
• upset stomach
• heartburn
• abnormal liver function tests
• hives
• itching
• changes in hair growth pattern
• hair loss
• muscle cramps
• reversible increases in blood testosterone levels

• reduced sperm counts
• decreased sex drive
• weakness
• headache
• chest pain
• malaise
• hot flushes.
Very rare side effects (seen in less than 1 in
10,000 patients) include:
• breast cancer
• cough
• sensitivity to sunlight
• sudden kidney failure.
Possible side effects reported when
flutamide has been used in conjunction with
LHRH agonists.
The following side effects have been seen
in patients taking Flutamide together with LHRH
agonist treatment. They could be additional or the
same as above but with a different frequency.
Very common side effects (seen in more than
1 in 10 patients) include:
• hot flushes
• decreased sex drive
• impotence
• feeling sick
• being sick (vomiting)
• diarrhoea.
Rare side effects (seen in more than
1 in 10,000 patients but less than 1 in
1000 patients) include:
• lack of red blood cells which can make the skin
pale and cause weakness or breathlessness
• lack of white blood cells which may cause more
frequent infections
• lack of blood platelets which increases the risk
of bleeding or bruising
• enlarged breasts
• drowsiness
• confusion

16 Mar 2016


• nervousness
• gastrointestinal disorders
• abdominal pain
• rash
• nerve or muscular symptoms
• joint and muscle pain
• reduced bone mineral density or osteoporotic
disorders (these can mean you are more likely
to suffer broken bones)
• painful urination
• changes in how often you urinate
• change in urine colour to amber or yellow-green.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at:
By reporting side effects you can help provide
more information on the safety of this medicine.

Keep this medicine out of the reach and sight of
children. Do not store above 25°C.
Do not use Flutamide after the expiry date
shown on the pack after 'EXP'. The expiry date
refers to the last day of the month. Medicines
should not be disposed of via wastewater or
household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
What Flutamide contains
The active substance is flutamide. Each
tablet contains 250 mg flutamide. The other
ingredients are microcrystalline cellulose, lactose
monohydrate, pre-gelatinised maize starch,
sodium lauryl sulfate, colloidal anhydrous silica,
magnesium stearate.
What Flutamide Tablets look like and contents
of the pack
The tablets are yellow, biconvex in shape and
marked 'FT' score '250' on one side and 'G' on the
other. Flutamide Tablets are available in blister
packs or plastic pots containing 20, 21, 30, 50, 60,
84, 100, 105, 250 or 10 x 21 tablets.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Delpharm Lille SAS, Parc d’activités Roubaix -Est,
22 rue de Toufflers – CS 50070,
59452 Lys-Lez-Lannoy, France

leaflet was last
revised in 04/2016.

16 Mar 2016



Very rare side effects (seen in less than 1 in
10,000 patients) include:
• red blood disorders such as abnormal blood
pigment levels
• raised blood sugar
• worsening of your existing diabetes
• difficulty breathing
• high blood pressure
• lung disease
• cholestatic jaundice (when the flow of bile from
the liver is blocked)
• disease of the brain caused by liver illness
• redness of the skin
• skin ulcers
• eruption of blisters
• raised levels of blood urea and creatinine.


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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.