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FLUTAMIDE TABLETS 250MG

Active substance(s): FLUTAMIDE / FLUTAMIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Flutamide
250 mg Tablets
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. See section 4.

What is in this leaflet

1. What Flutamide is and what it is used for
2. What you need to know before you
take Flutamide
3. How to take Flutamide
4. Possible side effects
5. How to store Flutamide
6. Contents of the pack and other information

1. WHAT FLUTAMIDE IS AND
WHAT IT IS USED FOR
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
may be taken with another medicine (called
a LHRH agonist) that decreases the levels of
testosterone. Flutamide can also be used after
surgical castration.

2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE FLUTAMIDE
Do not take Flutamide:

• if you are allergic to flutamide or any of the
other ingredients of this medicine (listed in
section 6).

Warnings and precautions

Talk to your doctor or pharmacist before
taking Flutamide if you:
• have liver problems. Your doctor will
check your liver function before and
during treatment.
• have kidney problems.
• have heart disease.
• are at risk of osteoporosis such as if you
are a long term smoker or drinker, have
a family history of osteoporosis or are
taking medicines to stop epileptic fits
(antiepileptics) or medicines to relieve
inflammation (corticosteroids) or 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;
at the beginning of your treatment and
then at least on a yearly basis.
• suffer from chest problems such
as breathlessness.
• are diabetic.
• have any heart or blood vessel conditions,
including heart rhythm problems
(arrhythmia), or are being treated with
medicines for these conditions. The risk of
heart rhythm problems may be increased
when using Flutamide.
If you are taking Flutamide long-term you
may also have your sperm count checked if it
is appropriate.
While taking this medicine you should use an
effective barrier method of contraception i.e.
condom when engaging in sexual activity.

Other medicines and Flutamide

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained
without a prescription, especially any of
the following:
• medicines that thin the blood such
as warfarin
• theophylline, for breathing problems
• medicines that may cause damage
to the liver
• medicines that affect the electrical activity
of your heart
• leuprorelin, a medicine used to treat
some cancers

Flutamide treats a condition found only
in men. It must not be given to women
or children.

Description Flutamide 250mg 20/21/30/50/60/84/100/105/250or10x21

Date: 20 Apr 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 564386

SAP No. N/A

Colours

Black

Non-Print
Colours

Glue

Superceded Affiliate Item Code 482346
TrackWise PR No. 564386
MA No. 04569/0338
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 244950
Trackwise Proof No. 6
Glams Proof No. NA
Client Market United Kingdom

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Flutamide might interfere with some
medicines used to treat heart rhythm
problems (e.g. quinidine, procainamide,
amiodarone and sotalol) or might increase
the risk of heart rhythm problems when
used with some other drugs (e.g. methadone
(used for pain relief and part of drug
addiction detoxification), moxifloxacin (an
antibiotic), antipsychotics used for serious
mental illnesses).

Flutamide with alcohol

You should not drink large quantities of
alcohol while being treated with this medicine.

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

If you have had your testicles removed
(castrated) you will not be given a
LHRH agonist.

Use in 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.

Flutamide may cause tiredness, dizziness or
confusion. Do not drive or operate machinery
if it happens to you.

If you take more medicine than you should,
tell your doctor immediately or go to your
nearest hospital emergency department.

Flutamide tablets contain lactose

If you forget to take Flutamide

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.

3. HOW TO TAKE FLUTAMIDE
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
• Take the tablets with a glass of water
preferably after food every 8 hours.
• Do not chew the tablets. If you do, there is
a danger you could overdose because this
medicine will be absorbed into your body
too quickly.
• The score line is only there to help you
break the tablet if you have difficulty
swallowing it whole. It is not for dividing
tablets into equal doses.

Adults (including older people)

The recommended dose is one tablet three
times daily, every 8 hours.
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 either
at the same time as or at least a day before
taking the LHRH agonist.

Description Flutamide 250mg 20/21/30/50/60/84/100/105/250or10x21

Take it as soon as you remember unless it
is almost time for your next tablet. If this
happens, skip the missed tablet and take the
next tablet on time. Do not take a double
dose to make up for a forgotten tablet.

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can
cause side effects, although not everybody
gets them.

Possible side effects if you take
flutamide by itself:
Tell your doctor straight away or go to your
nearest hospital emergency department
right away if you have any of the following
side effects:

Common (may affect up to 1 in 10 people)

• liver disease (hepatitis) which may cause
nausea, vomiting, itching, dark coloured
urine, pale stools, loss of appetite, yellowing
of the skin or whites of the eyes or
abdominal pain

Date: 20 Apr 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 564386

SAP No. N/A

Colours

Black

Non-Print
Colours

Glue

Superceded Affiliate Item Code 482346
TrackWise PR No. 564386
MA No. 04569/0338
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 244950
Trackwise Proof No. 6
Glams Proof No. NA
Client Market United Kingdom

Time: 13:43

1

Page Count

2/4

peel off
glue

Equate CMYK
with

Keyline/Drawing No. C93-B

Main Font Myriad Pro

Body Text Size 11pt

Barcode Info N/A

Dimensions 180 x 315mm

Min Text Size used 11pt

Sign-offs

v1/May 2015

Rare (may affect up to 1 in 1,000 people)

• reactions similar to lupus, which can cause
joint or muscle pain or swelling, fatigue,
general feeling of being unwell, hair loss or
a butterfly shaped rash normally across the
nose and cheeks
• difficulty breathing, shortness of breath,
wheezing or coughing
• diarrhoea containing blood or mucus
which may be signs of inflammation of the
colon (colitis)

Very rare (may affect up to 1 in 10,000 people)
• lumps in your breast tissue
Not known (cannot be estimated from the
available data)
• allergic reactions such as swelling of the
lips, tongue, face or throat causing difficulty
breathing or swallowing, a rash or swollen
itchy skin.
• changes in the electrical activity of the
heart (which may show up in tests which
show how the heart is working known as
'ECG' tests).

• constipation
• thirst
• indigestion or stomach pain
• upset stomach
• heartburn
• hives
• changes in hair growth pattern
• hair loss
• muscle cramps
• reversible increases in blood testosterone
levels as seen in a blood test
• reduced sperm counts as seen in a
fertility test
• decreased sex drive
• unusual weakness (asthenia)
• headache
• chest pain
• general feeling of being unwell
• hot flushes

Very rare (may affect up to 1 in 10,000
people)
• cough
• rash or blisters resulting from skin sensitive
to strong or long periods of sunlight
Possible side effects if you take
flutamide with LHRH agonists

Other side effects include:

Very common (may affect more than 1 in
10 people)
• enlarged, painful or tender breast tissue
• production of milk from the breasts

Common (may affect up to 1 in 10 people)
• increased appetite
• difficulty sleeping
• sleepiness
• tiredness
• diarrhoea
• feeling sick (nausea)
• being sick (vomiting)
• blood tests show abnormal liver function
Rare (may affect up to 1 in 1,000 people)

• painful, itchy fluid filled lumpy skin rash
commonly known as chicken pox or
shingles. This is a sign of nerve or skin
infection caused by the herpes virus
• swelling, especially in the arms, legs, chest
or genitals (also known as fluid retention)
• bruising
• loss of appetite (anorexia)
• anxiety
• depression
• dizziness
• blurred vision
• other problems with the heart or circulation
• high blood pressure

Description Flutamide 250mg 20/21/30/50/60/84/100/105/250or10x21

The following side effects have been seen in
patients taking Flutamide together with LHRH
agonist treatment. They could be additional
side effects or the same as above but seen
more commonly:
Tell your doctor straight away or go to your
nearest hospital emergency department
right away if you have any of the following
side effects:

Rare (may affect up to 1 in 1,000 people)

• lack of white blood cells which may cause
more frequent infections such as fever, sore
throat or mouth ulcers

Very rare (may affect up to 1 in 10,000
people)
• serious skin reactions such as painful red
areas, fluid filled blisters or peeling of layers
of skin
• pale, yellow or bluish colouring of the
skin especially around the lips, blood that
is darker than normal, loss of appetite,
headache, vomiting, weakness, chest pain,
cold or numb hands or feet which are signs
that your blood cannot deliver as much
oxygen to the body as normal
• mood or personality changes,
disorientation, forgetfulness, mental
fogginess. These are signs of a disease of
the brain caused by liver problems

Date: 20 Apr 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 564386

SAP No. N/A

Colours

Black

Non-Print
Colours

Glue

Superceded Affiliate Item Code 482346
TrackWise PR No. 564386
MA No. 04569/0338
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 244950
Trackwise Proof No. 6
Glams Proof No. NA
Client Market United Kingdom

Time: 13:43

1

Page Count

3/4

peel off
glue

Equate CMYK
with

Keyline/Drawing No. C93-B

Main Font Myriad Pro

Body Text Size 11pt

Barcode Info N/A

Dimensions 180 x 315mm

Min Text Size used 11pt

Sign-offs

v1/May 2015

Not known (cannot be estimated from the
available data)
• severe pain or swelling in one of your legs,
sudden severe chest pain that might spread
to your left arm, sudden breathlessness,
sudden cough without an obvious cause,
problems speaking, irregular muscle
movements, sudden severe stomach pain,
weakness, strange feeling or numbness in
any part of the body. This may suggest you
have a blood clot.
Other side effects include:

Very common (may affect more than 1 in
10 people)
• hot flushes
• decreased sex drive
• problems getting or maintaining an erection
• feeling sick (nausea)
• being sick (vomiting)
• diarrhoea

• bleeding or bruising more easily or for a
longer time. These may be signs of a lack of
platelets (blood clotting cells) in the blood
• numbness or lack of sense of touch
• confusion
• nervousness
• nerve or muscle problems
• joint or 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
• skin irritation where the LHRH agonist
was injected
• raised levels of blood urea and creatinine
seen in a blood test

Very rare (may affect up to 1 in
10,000 people)
• raised blood sugar levels
• worsening of existing diabetes

Keep this medicine out of the sight and reach
of children.
Do not store above 25°C.
Do not use this medicine after the expiry date
which is stated on the packaging after 'EXP'. The
expiry date refers to the last day of the month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will help
protect the environment.

6. CONTENTS OF THE PACK
AND OTHER INFORMATION
What Flutamide contains

The active substance is flutamide.
Each tablet contains 250 mg flutamide.
The other ingredients are microcrystalline
cellulose, lactose monohydrate (see section 2
‘Flutamide contains lactose’), pregelatinised
maize starch, sodium laurilsulfate, colloidal
anhydrous silica, magnesium stearate.

What Flutamide tablets look like and
contents of the pack

TBC
212121221

Rare (may affect up to 1 in 1,000 people)

5. HOW TO STORE YOUR MEDICINE

The tablets are yellow, curved on both sides
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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan, Potters Bar,
Hertfordshire, EN6 1TL,
United Kingdom

Manufacturer

Delpharm Lille SAS,
Parc d’activités Roubaix-Est,
22 rue de Toufflers - CS 50070,
59452 Lys-Lez-Lannoy,
France

Reporting of side effects

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

This leaflet was last
revised in 03/2016.

Description Flutamide 250mg 20/21/30/50/60/84/100/105/250or10x21

Date: 20 Apr 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 564386

SAP No. N/A

Colours

Black

Non-Print
Colours

Glue

Superceded Affiliate Item Code 482346
TrackWise PR No. 564386
MA No. 04569/0338
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 244950
Trackwise Proof No. 6
Glams Proof No. NA
Client Market United Kingdom

564386

Time: 13:43

1

Page Count

4/4

peel off
glue

Equate CMYK
with

Keyline/Drawing No. C93-B

Main Font Myriad Pro

Body Text Size 11pt

Barcode Info N/A

Dimensions 180 x 315mm

Min Text Size used 11pt

Sign-offs

v1/May 2015

Expand view ⇕

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.

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