Skip to Content

UK Edition. Click here for US version.

FLUTAMIDE 250 MG TABLETS

Active substance(s): FLUTAMIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
4. Possible side effects

GB 724-8206-APIL
Package leaflet: Information for the user

Like all medicines, this medicin

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

1. What Flutamide Tablets are and what they are
used for
The name of your medicine is Flutamide 250 mg Tablets (referred
to as Flutamide Tablets in this leaflet).
Flutamide Tablets contain the active ingredient flutamide, which
belongs to a group of medicines called non-steroidal
antiandrogens, which stop the effects of male sex hormones.
Flutamide Tablets are used to treat advanced prostate cancer in
men. The prostate is a walnut shaped gland found next to the
bladder. Prostate cancer leads to uncontrolled growth of the
prostate and may also spread to the bones causing pain in the
back, hips and pelvis. Prostate cancer is dependent on male sex
hormones for growth. By stopping the effects of these hormones
it is possible to slow down or shrink the tumour both in the
prostate and areas where it has spread to.

Pregnancy and breast-feeding
Flutamide Tablets should only be used by male patients. The
safety of flutamide in pregnant or breast-feeding women has not
been studied.
Laboratory tests
Your doctor will want to check your blood regularly. Based on
these tests, your doctor may decide that you stop taking
Flutamide Tablets or reduce the dose. If you have any signs of
liver injury such as jaundice (looking yellow), dark urine, itching,
persistent loss of appetite, abdominal pain or flu-like symptoms,
you should stop taking Flutamide Tablets and contact
your doctor immediately.
If you have not undergone castration, either surgical or with
medicines, your doctor may decide to have regular sperm counts
performed.
Driving and using machines
Possible side effects such as tiredness, dizziness and confusion
have been reported with flutamide use which may impair the
ability to drive and use machines. Do not drive or operate
machinery if you are affected in this way.
Flutamide Tablets contain lactose
Flutamide Tablets contain lactose monohydrate, a type of sugar.
If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.

3. How to take Flutamide Tablets
Always take this medicine exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you are not
sure.
The recommended dose
The usual dose is one tablet three times daily.

Your doctor may prescribe these tablets in combination with
other drugs that block male sex hormones called LHRH
(luteinising hormone-releasing hormone) agonists, or after
orchidectomy (an operation on the testes).

You may have also been prescribed another drug called an
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
Tablets treatment at least three days before having the LHRH
agonist.

2. What you need to know before you take
Flutamide Tablets

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

Do not take Flutamide Tablets
• if you are allergic to flutamide or any of the other ingredients of
this medicine (listed in section 6).
• if you are a woman or a child.

These tablets should be taken as instructed, with a glass of
water. Continue to use them for as long as your doctor tells you,
it may be dangerous to stop without his/her advice.

Warnings and precautions
Talk to your doctor before taking Flutamide Tablets
• if you have any liver or kidney problems
• if you suffer from or have a history of heart or blood vessel
disease
• if you 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
• if you suffer from chest problems such as breathlessness
• if you are taking Flutamide Tablets long-term you may also
have your sperm count checked if it is appropriate.
• Flutamide is only for use in male patients. Contraceptive
measures should be taken during treatment.
If any of these apply to you, or you are not sure, tell your doctor.
Other medicines and Flutamide Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines, including any
medicines obtained without a prescription.
This is especially important if you are taking the following
medicines:
• warfarin (or any other blood thinning drugs)
• theophylline (for breathing problems).
Flutamide Tablets with alcohol
Excessive consumption of alcohol should be avoided while
taking Flutamide Tablets

Flutamide Tablets and the elderly
If you are elderly it is particularly important to take this medicine
exactly as directed by your doctor.
Use in children
Flutamide Tablets must not be given to children.
If you take more Flutamide Tablets than you should
If you realize you have taken more Flutamide Tablets than your
doctor has recommended (or if someone else has taken some of
your Flutamide Tablets), contact your doctor right away. If you
cannot reach your doctor, go to the nearest hospital and take the
pack with you.
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 forget to take Flutamide Tablets
If you forget to take a dose, take it as soon as you remember
unless it is nearly time for your next dose. Do not take a double
dose to make up for a forgotten dose.
If you stop taking Flutamide Tablets
Do not stop taking this medicine, even if you are feeling well,
unless your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

Received Date:
26/01/2016
everybody gets them.
CDL JOB No. : not62298
29/01/2016
Required By :

Serious side effects
If you notice any of the followin
and contact your doctor imme
• an allergic reaction to any o
Tablets (such as itching and
tongue and/or throat with d
• problems with your liver (su
PRODUCT NAME: Flutamide
Tabsof250mg
urine, lack
appetite, yello
GB
724-8206-APIL
PIP CODE:
irritability,
changes in the lev
COMPONENT: Leaflet
• 210x347
swellingmm
of legs or any other
SIZE:

MARKET:
Greatside
Britaineffects
Other
PRODUCT SITE:
TBC
Other side effects of Flutamide
SCALE: 100%
COLOURS: Black
Very common (may affect mo
DATE: 27/01/2016
• enlarged and/or tender brea
FONT SIZE:
9 pt
These
effects will get better if y
VERSION NO:
2
VKto stop taking your medici
AMENDED BY: told
PROJECT:
Sovereign Medical

Common (affects less than 1
• brief abnormal liver function
• diarrhoea
• feeling
sick (nausea)
REGULATORY
AUTHORITY
• CONFIRMATION
being sick (vomiting)
APPROVAL
Confirmation that this
has been approved
by
• artwork
increased
appetite
the appropriate market authority (if applicable, e.g.

feeling
tired
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute•thissleepiness
component for sale in the
relevent market.
• difficulty sleeping
Accept Artwork .................................................................

Rare (affects less than 1 in 1
• swelling
Reject Artwork ..................................................................
• chest pain
• dizziness
Signature ..........................................................................
• headache
• abdominal problems such a
Name .................................................................................
• inflammation of the colon
Date ...................................................................................
• heartburn
• constipation (infrequent or d
• itchiness
• bruises
• swollen ankles
• poor appetite
• nerve and skin infection cau
• hot flushes
• weakness
• thirst
• lupus-like syndrome (lupus
affecting the skin and can c
face, red scaly patches on t
• disturbances of vision
• decreased sex drive, decrea
• anxiety
• depression
• breathing difficulties
• problems with the heart or c
• high blood pressure
• hives
• changes in hair growth patte
• muscle cramps
• reversible increases in blood
• malaise

PAGE 1 OF 2

Very rare (affects less than 1
• sensitivity to sunlight
• male breast cancer
• cough
• sudden kidney failure

When Flutamide Tablets are
LHRH agonist
The following side effects have
Flutamide Tablets together wit
could be additional or the sam
frequency.

Very common (may affect mo
• diarrhoea
• feeling sick (nausea)
• being sick (vomiting)

4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Serious side effects
If you notice any of the following, stop taking Flutamide Tablets
and contact your doctor immediately:
• an allergic reaction to any of the ingredients of Flutamide
Tablets (such as itching and/or rash, swelling of the face, lips,
tongue and/or throat with difficulty in swallowing or breathing)
• problems with your liver (such as itching of the skin, dark
urine, lack of appetite, yellow eyes or skin, flu-like symptoms,
irritability, changes in the level of consciousness)
• swelling of legs or any other parts of the body
Other side effects
Other side effects of Flutamide Tablets include:
Very common (may affect more than 1 in 10 people)
• enlarged and/or tender breasts, breast milk production
These effects will get better if your dose is reduced or you are
told to stop taking your medicine.
Common (affects less than 1 in 10 people)
• brief abnormal liver function
• diarrhoea
• feeling sick (nausea)
• being sick (vomiting)
• increased appetite
• feeling tired
• sleepiness
• difficulty sleeping
Rare (affects less than 1 in 1000 people)
• swelling
• chest pain
• dizziness
• headache
• abdominal problems such as indigestion or upset stomach
• inflammation of the colon
• heartburn
• constipation (infrequent or difficult bowel movement)
• itchiness
• bruises
• swollen ankles
• poor appetite
• nerve and skin infection caused by the herpes virus
• hot flushes
• weakness
• thirst
• 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)
• disturbances of vision
• decreased sex drive, decreased sperm production
• anxiety
• depression
• breathing difficulties
• problems with the heart or circulation
• high blood pressure
• hives
• changes in hair growth pattern, hair loss
• muscle cramps
• reversible increases in blood testosterone levels
• malaise
Very rare (affects less than 1 in 10000 people)
• sensitivity to sunlight
• male breast cancer
• cough
• sudden kidney failure
When Flutamide Tablets are taken at the same time as an
LHRH agonist
The following side effects have been seen in patients taking
Flutamide Tablets together with LHRH agonist treatment. They
could be additional or the same as above but with a different
frequency.
Very common (may affect more than 1 in 10 people)
• diarrhoea
• feeling sick (nausea)
• being sick (vomiting)

• hot flushes
• decreased sex drive
• being unable to get an erection (impotence)
Rare (affects less than 1 in 1000 people)
• reduced red blood cell count which can make the skin pale
and cause weakness or breathlessness
• reduced white blood cell count which may cause more
frequent infections
• reduced number of blood platelets which increases the risk of
bleeding or bruising
• muscle or nerve problems
• enlarged breasts
• drowsiness
• confusion
• nervousness
• gastrointestinal disorders
• abdominal pain
• rash
• 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 frequency of urination
• changes in urine colour to amber or yellow-green
Very rare (affects less than 1 in 10000 people)
• red blood disorders such as abnormal blood pigment levels
• 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
• increased blood sugar, worsening of diabetes
• eruption of blisters
• raised levels of blood urea and creatinine
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: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.

5. How to store Flutamide Tablets
Keep this medicine out of the sight and reach of children.
Flutamide Tablets should not be stored above 25°C. Store in a
dry place in the original package.
Do not use the tablets if the strip in which they are packaged is
damaged.
Do not use this medicine after the expiry date that is stated on
the blister strip and the outer carton after EXP. The expiry date
refers to the last day of that 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 Tablets contain
Each Flutamide Tablet contains 250 mg of the active ingredient
flutamide.
The other ingredients are: lactose monohydrate, sodium lauryl
sulphate, microcrystalline cellulose, maize starch, colloidal
anhydrous silica and magnesium stearate.
What Flutamide Tablets look like and the contents of the
pack
Flutamide Tablets are uncoated, have a yellow colour and are
marked FT 250.
Flutamide Tablets are available in blister calendar packs
containing 84 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sovereign Medical, Sovereign House,
Miles Gray Road, Basildon, Essex SS14 3FR.
Manufacturer
Waymade Plc, Sovereign House, Miles Gray Road,
Basildon, Essex SS14 3FR,
This leaflet was last revised in: February 2016

Received Date:
CDL JOB No. :
Required By :

26/01/2016
62298
29/01/2016

PRODUCT NAME: Flutamide Tabs 250mg
GB 724-8206-APIL
PIP CODE:
COMPONENT: Leaflet
SIZE:
210x347 mm
MARKET:
Great Britain
PRODUCT SITE:
TBC
SCALE: 100%
COLOURS: Black
DATE: 27/01/2016
FONT SIZE:
9 pt
VERSION NO:
2
VK
AMENDED BY:
PROJECT:
Sovereign Medical

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, IMB, etc and that Waymade Plc have license
approval to distribute this component for sale in the
relevent market.
Accept Artwork .................................................................
Reject Artwork ..................................................................
Signature ..........................................................................
Name .................................................................................
Date ...................................................................................

PAGE 2 OF 2

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.

Hide