Document: leaflet MAH GENERIC_PL 04569-0338 change

• leaflet MAH GENERIC_PL 04569-0338
• leaflet MAH GENERIC_PL 11311-0525

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FLUTAMIDE TABLETS 250 mg

flutamide

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.

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 is usually taken with another medicine (called a LHRH agonist) that decreases the levels of testosterone, or after surgical castration.

2.    BEFORE YOU TAKE FLUTAMIDE 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.

3. HOW TO TAKE FLUTAMIDE

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.

4. POSSIBLE SIDE EFFECTS

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) include:

•    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

•    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.

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.

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 YOUR 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 'EXP¹. 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.

6.    FURTHER INFORMATION

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.

Manufacturer

Delpharm Lille SAS, Parc d'activites Roubaix -Est, 22 rue de Toufflers - CS 50070,

59452 Lys-Lez-Lannoy, France

This leaflet was last

revised in 04/2016.    845607

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