Flutamide Tablets 250mg
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Flutamide 250mg 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, which are a type of hormone therapy.
Flutamide is used to treat the following:
• Advanced prostate cancer
• As an initial treatment in combination with other hormone therapy medicines known as LHRH agonists (Luteinising-Hormone Release-Hormone)
• Surgically castrated patients
• Patients who have not responded to or cannot tolerate other forms of hormonal manipulation
2 What you need to know before you take Flutamide Do not take Flutamide if:
• You are allergic (hypersensitive) to Flutamide, other anti-androgens or any of the other ingredients of this medicine (listed in section 6)
• You are female. Flutamide is only for use in male patients
Warnings and precautions
Talk to your doctor before taking Flutamide if:
• You suffer from liver problems (your doctor should perform liver function tests before you start treatment, followed by monthly tests for the first four months and periodic tests thereafter, whilst you are taking this medicine)
• You suffer from heart problems, as this medicine may cause fluid retention or ankle swelling (especially if you are prone to these conditions)
• You suffer from kidney problems, as your dose of Flutamide may need to be adjusted
• You have not been medically or surgically castrated as your doctor may perform regular sperm count tests during long-term treatment with Flutamide
• You suffer from an enzyme disorder of the red blood cells (latent or actual G-6-P deficiency)
Other medicines and Flutamide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
Medicines which may interact with or be affected by Flutamide:
• Warfarin or other oral anticoagulants, used to prevent blood clots. Your doctor may need to adjust the dose of your anticoagulant medicine whilst being treated with Flutamide
• Medicines that may harm the liver (such as paracetamol, if given in large doses)
• Steroids
• Theophylline, used for breathing problems
• Leuprolide, used to treat symptoms of advanced prostate cancer (hormone therapy medicines [LHRH agonists])
Taking Flutamide with food and drink and alcohol
Avoid excessive alcohol consumption.
Pregnancy and breast-feeding and fertility
• Flutamide should only be used in male patients.
• Contraceptive measures should be used during treatment.
• If Flutamide is taken by a woman who is pregnant or breast-feeding, the medicine may harm the baby or be present in breast milk.
Driving and using machines
Flutamide may cause tiredness, dizziness and confusion. If affected, do not drive or use machinery. Flutamide contains lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
3 How to take Flutamide
Always take Flutamide exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
These tablets are to be taken orally.
The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Adults
The initial dose is one 250mg tablet 3 times a day at 8 hour intervals.
Used with an LHRH agonist
• When used as initial treatment with an LHRH agonist, the recommended dose of Flutamide is one 250mg tablet 3 times a day.
• Flutamide should be started at least 3 days before starting an LHRH agonist and continued thereafter at the same dose.
• Treatment with Flutamide and an LHRH agonist should begin 8 weeks before radiation therapy and continue through the course of radiation therapy (usually about 8 weeks) i.e. a total of approximately 16 weeks.
If you take more Flutamide than you should
If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. Symptoms of overdose include: abnormally diminished activity (hypoactivity), goose bumps (piloerection), slow breathing, lack of voluntary co-ordination of muscle movements [unsteadiness or clumsiness] (ataxia) and/or tears (lacrimation), loss of appetite (anorexia), tranquilization, being sick (emesis) and blood disorders (methemoglobinemia).
If you forget to take your Flutamide
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Flutamide
It is important that you keep taking Flutamide for as long as your doctor has told 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.
Seek medical advice immediately if you develop the following symptoms:
• Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness
• Swelling of parts of the body (oedema)
• Severe blistering of the skin, mouth, eyes and genitals (epidermal necrolysis)
VERY COMMON SIDE EFFECTS (may affect more than 1 in 10 people):
Flutamide
(These side effects disappear when treatment stops or dose is reduced)
• Excessive development of the male breast (gynaecomastia)
• Breast tenderness
• Milky secretion from the breasts not due to breast-feeding (galactorrhoea)
Flutamide taken with an LHRH agonist
• Hot flushes
• Diarrhoea
• Feeling sick (nausea)
• Being sick (vomiting)
• Decreased sex drive
• Inability to achieve and/or maintain an erection (impotence)
COMMON SIDE EFFECTS (may affect up to 1 in 10 people):
Flutamide
• Feeling sick (nausea)
• Being sick (vomiting)
• Diarrhoea
• Increased appetite
• Tiredness
• Difficulty in sleeping (insomnia)
• Inflammation of the liver (hepatitis) and short-term abnormal liver function
UNCOMMON SIDE EFFECTS (may affect up to 1 in 100 people):
Flutamide taken with an LHRH agonist
• Inflammation of the liver (hepatitis),
• Excessive development of the male breasts (gynaecomastia)
RARE SIDE EFFECTS (may affect up to 1 in 1,000 people):
Flutamide
• Anxiety
• Depression
• Dizziness
• Blurred vision
• Hot flushes
• Decreased sex drive
• Headache
• Feeling thirsty
• Chest pain
• Upset stomach
• Non-specific stomach disorders
• Ulcer-like pain
• Heartburn
• Constipation
• Bruising (ecchymoses)
• Severe itching (pruritus)
• Weakness
• Reduced sperm count
• Generally feeling unwell (malaise)
• Loss of appetite (anorexia)
• Accumulation of fluid, causing swelling often in the arms and/or legs (lymphoedema)
• Herpes zoster virus, (causes shingles in adults and chicken pox in children)
• Inflammation of the skin and/or intestines, joint pain, skin rashes and fever (lupus-like syndrome)
Flutamide taken with an LHRH agonist
• High blood pressure (hypertension)
• Drowsiness
• Depression
• Confusion
• Anxiety
• Nervousness
• Unspecified stomach disorders
• Looking pale and feeling tired (anaemia)
• Decreased number of white blood cells (leukopenia)
• Loss of appetite (anorexia)
• Irritation at site of injection
• Rash
• Muscular problems associated with nerves
• Liver problems including jaundice (yellowing of the skin or whites of the eyes)
• Problems associated with kidneys, bladder and reproductive system
• Reduction in blood platelets, which increases the risk of bleeding or bruising (thrombocytopenia)
• Increased Blood Urea Nitrogen (BUN), detected through blood test
• Increase in serum creatinine (detected through blood test)
• Numbness
VERY RARE SIDE EFFECTS (may affect less than 1 in 10,000 people):
Flutamide
• Lumps in male breasts
• Abnormal sensitivity of the skin to sunlight (photosensitivity)
Flutamide taken with an LHRH agonist
• Skin rashes (erythema)
• Ulcers
• Rash of blisters (bullous eruptions)
• Severe liver disease or damage, or liver failure
• Inflammation of the lungs (interstitial lung disease)
• Abnormal sensitivity of the skin to sunlight (photosensitivity)
• Increase in blood sugar levels (hyperglycaemia)
• Worsening of existing diabetes
• Change in urine colour (to either orange-yellow or yellow-green)
• Lumps in male breasts
• Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic/macrocytic/megalocytic anaemia)
• Blood disorders (methemoglobinemia or sulfhemoglobinemia)
• Shortness of breath or difficulty in breathing (dyspnoea)
OTHER SIDE EFFECTS (frequency not known)
Flutamide
• Kidney failure
• Inflammation of the kidney (interstitial nephritis
• myocardial ischemia
Flutamide taken with an LHRH agonist
• Blood clot which becomes dislodged and is then carried by the blood stream to cause a blockage elsewhere in the body (thromboembolism)
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.
5 How to store Flutamide
• Keep this medicine out of the sight and reach of children.
• Do not use Flutamide after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C. Store in the original package.Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6 Contents of the pack and other information What Flutamide contains:
Each tablet contains 250mg of Flutamide.
The other ingredients are: lactose monohydrate, maize starch, microcrystalline cellulose, sodium lauryl sulfate, colloidal anhydrous silica and magnesium stearate.
What Flutamide looks like and the contents of the pack:
Flutamide are yellowish, round, biconvex, tablets with a score notch on one side.
Flutamide is available in:
Flutamide Tablets are available in packs of 28, 56 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd.
3 Howard Road Eaton Socon St Neots Cambridgeshire PE198ET United Kingdom
Product Licence Number:
PL 11311/0525
This leaflet was last revised in April 2016
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