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Active substance(s): FLUTAMIDE

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Patient Information Leaflet

If you forget to take your medicine
If you forget to take a dose, just take the next dose at the usual time,
DO NOT take a double dose.
Like all medicines, Flutamide 250 mg Tablets can cause unwanted
side effects, particularly when you first start taking them, although not
everybody gets them.

Flutamide 250 mg Tablets
Read all of this leaflet carefully before you start taking this
• Please keep this leaflet. You may need to read it again.
• If you have any further questions, please 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 become severe, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Flutamide 250 mg Tablets are and what they are used for.
2. Before you take Flutamide 250 mg Tablets.
3. How to take Flutamide 250 mg Tablets.
4. Possible side effects.
5. How to store Flutamide 250 mg Tablets.
6. Further information.
The name of your medicine is Flutamide 250 mg Tablets. The active
ingredient is flutamide.
Flutamide is an anti-androgen, which means it stops the effects of
male sex hormones.
Flutamide Tablets are used to treat advanced prostate cancer.
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.
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).
Take special care and tell your doctor or pharmacist if:
• you have any liver or kidney problems;
• you suffer from or have a history of heart or blood vessel

Important information about some of the ingredients of
Flutamide Tablets
Tell your doctor before taking this medicine if you have been told that you
have an intolerance to some sugars. This is because Flutamide Tablets
contain lactose, a type of sugar.
Taking other medicines
Tell your doctor if you are taking any other medicines, especially the
• warfarin (or any other blood thinning drugs);
• theophylline (for breathing problems).
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without prescription.
Other special warnings
• If you have not undergone castration, either surgical or with medicines,
your doctor may decide to have regular sperm counts performed.
• 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.
• You should avoid excessive consumption of alcohol.
• Flutamide is only for use in male patients. Contraceptive measures
should be taken during treatment.
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.
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.
Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure. He or
she will tell you how many to take and how often to take them.
The usual dose is one tablet three times daily. If you have also been
prescribed another drug called an LHRH agonist (such as goserelin or
leuprorelin) that blocks the male sex hormones it is best to start taking
Flutamide Tablets at least three days before starting the LHRH agonist.
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.
If you are elderly it is particularly important to take this medicine exactly
as directed by your doctor.
If you take more tablets than you should
If you accidentally take too many tablets, tell your doctor at once or
contact your nearest hospital casualty department. Take your medicine
and this leaflet with you.

Contact your doctor immediately if you experience any of
the following as your Flutamide dose may need to be
reduced or stopped:
· 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 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;
· breathing problems.
If you notice any of the following side effects you should contact
your doctor as soon as possible:
When Flutamide Tablets are taken alone:
Very common (occurs in more than 1 in 10 people)
· enlarged and/or tender male breasts, breast pain, abnormal
breast milk production.
Common (occurs in less than 1 in 10 people)
· liver problems (inflammation of the liver);
· abnormal blood tests;
· loose stools;
· feeling or being sick;
· increased appetite;
· feeling tired;
· difficulty sleeping.
Rare (occurs in less than 1 in 1000 people)
· swelling of the lymph nodes (localised in the
arms, legs, chest, head or genitals leading to
pain and loss of mobility);
· chest pain;
· dizziness;
· headache;
· abdominal problems;
· heartburn;
· constipation (infrequent or difficult bowel movement);
· itchiness;
· bruises;
· poor appetite;
· shingles;
· hot flushes;
· weakness;
· thirst;
· lupus-like syndrome (fever, malaise, joint pains, muscle weakness,
tiredness, etc);
· disturbances of vision;
· decreased sex drive, decreased sperm production;
· anxiety;
· depression.
Very Rare (occurs in less than 1 in 10000 people)
· sensitivity to sunlight;
· male breast cancer.

When Flutamide Tablets are taken at the same time
as an LHRH agonist:
Very common (occurs in more than 1 in 10 people)
· loose stools;
· feeling or being sick;
· hot flushes;
· decreased sex drive;
· being unable to get an erection (impotence).
Uncommon (occurs in less than 1 in 100 people)
· liver problems (inflammation of the liver);
· enlarged and/or tender male breasts.
Rare (occurs in less than 1 in 1000 people)
· abnormal blood tests;
· reduced red blood cell count, reduced white blood cell count,
reduced number of blood platelets;
· muscle, nerve and urinary problems;
· numbness;
· confusion;
· nervousness;
· abdominal problems;
· rash;
· poor appetite;
· increased blood pressure;
· swelling;
· injection site irritation;
· anxiety;
· depression.
Very Rare (occurs in less than 1 in 10000 people)
· lung problems (difficulty breathing);
· change in the colour of urine (dark yellow or greenish-yellow);
· sensitivity to sunlight;
· redness of the skin;
· ulcers;
· skin peeling;
· increased blood sugar, worsening of diabetes.
There have also been reports of blood clot formation inside
blood vessels (thromboembolism).
If any of the side effects becomes severe, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
Flutamide Tablets should be stored below 25°C in a dry place in the
original container. Do not use the tablets if the strip in which they are
packaged is damaged. Do not use after the expiry date that is stated on
the strip and the outer carton.
Return any unused medicine to your pharmacist.
What Flutamide 250 mg Tablets contain
Each tablet contains 250 mg of the active substance, flutamide.
The other ingredients are: lactose monohydrate, sodium lauryl sulphate,
microcrystalline cellulose, maize starch, colloidal anhydrous silica and
magnesium stearate.
What Flutamide 250 mg Tablets look like and the contents of
the pack
The tablets are uncoated, have a yellow colour and are marked FT 250.
Flutamide Tablets are available in packs containing 84 tablets.
Marketing Authorisation Holder and Manufacturer
Waymade Plc trading as Sovereign Medical, Sovereign House,
Miles Gray Road, Basildon, Essex SS14 3FR.
This leaflet does not contain all the available information about
your medicine.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
The information in this leaflet applies only to Flutamide 250 mg Tablets.
This leaflet was last approved in August 2010


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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.