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BICALUTAMIDE 50 MG TABLETS

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Taking other medicines
You should tell your doctor if you are taking or have taken any of the following medicines
as they may interact with your Bicalutamide Tablets:

PATIENT INFORMATION LEAFLET

Bicalutamide 50 mg Tablets
(bicalutamide)
The name of this medicine is Bicalutamide 50 mg Tablets, which will be referred to as
Bicalutamide Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or pharmacist.

This medicine has been prescribed for you personally and you should 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 gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Bicalutamide Tablets are and what they are used for.
2. Before you take Bicalutamide Tablets.
3. How to take Bicalutamide Tablets.
4. Possible side effects.
5. How to store Bicalutamide Tablets.
6. Further information.







oral anticoagulants (such as warfarin) used to thin the blood
calcium channel blockers (such as verapamil or diltiazem) used to treat high blood
pressure or some heart conditions
cimetidine (used to treat ulcers)
ketoconazole (used to treat fungal infections)
ciclosporin (used to suppress the immune system following transplant surgery).

It may still be all right for you to take Bicalutamide Tablets and your doctor will be able to
decide what is suitable for you.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Women must not take Bicalutamide Tablets.
Driving and using machines
Some people may occasionally feel drowsy when taking Bicalutamide Tablets. If this
happens to you, you should exercise caution if you drive or operate machinery.

1. WHAT BICALUTAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Important information about some of the ingredients of Biaclutamide Tablets
These tablets contain lactose. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.

Bicalutamide Tablets are used to treat prostate cancer.
Bicalutamide is one of a group of medicines called anti-androgens. It has been shown
that the growth of tumours of the prostate gland may be dependent on male
hormones. Since bicalutamide blocks the action of androgens, it can be used to treat
tumours of the prostate gland.

3. HOW TO TAKE BICALUTAMIDE TABLETS

2. BEFORE YOU TAKE BICALUTAMIDE TABLETS

The usual dose for Bicalutamide Tablets is as follows:Adults and elderly men: the dose is one tablet daily. The tablet should be swallowed
whole with plenty of water. Take your tablet at the same time each day.

Do not take Bicalutamide Tablets if you are:

allergic to bicalutamide or to any of the other ingredients in the tablets (these are
listed in section 6, Further Information)

a woman or a child

if you are taking the medicines terfenadine or astemizole (antihistamines) or
cisapride (for some types of indigestion).
Take special care with Bicalutamide Tablets
Before you take Bicalutamide Tablets you should tell your doctor if you:

have liver problems
• have diabetes and are already taking an ‘LHRH analogue’. These include goserelin,
buserelin, leuprorelin and triptorelin.

have been told you have an intolerance to some sugars. Each Bicalutamide Tablet
contains 61 mg of lactose monohydrate.

Dosage
Always take Bicalutamide Tablets exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.

Bicalutamide Tablets are not suitable for use by females.
If you take more Bicalutamide Tablets than you should
If you have accidentally taken more than your prescribed dose, contact your doctor or
pharmacist immediately. Remember to take the pack and any remaining tablets with you.
If you forget to take your dose of Bicalutamide Tablets
Do not worry. Take your dose when you remember and then take your next dose at the
usual time. Do not take two doses at the same time.
If you have any further questions on the use of this product, ask your doctor or pharmacist
for advice.

If any of the above apply to you talk to your doctor who will decide what to do.
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Bicalutamide can cause side effects, although not everybody gets
them.
Allergic reactions:
These are uncommon (affect less than 1 in 100 people). The symptoms can include
sudden onset of:
• Rash, itching or hives on the skin
• Swelling of the face, lips, tongue, throat or other parts of the body
• Shortness of breath, wheezing or trouble breathing
If this happens to you, see a doctor straight away.
Also tell your doctor straight away if you notice any of the following:
Very common (affects more than 1 in 10 people):
• Pain in your abdomen
• Blood in your urine
Common (affects less than 1 in 10 people):
• Yellowing of the skin or whites of your eyes (jaundice). These may be signs of
liver problems or in rare cases (affects less than 1 in 1,000 people) liver failure
Uncommon (affects less than 1 in 100 people):
• Serious shortness of breath or shortness of breath which suddenly gets worse
This may be with a cough or high temperature (fever). These may be signs of an
inflammation of the lungs called ‘interstitial lung disease’
• Hypersensitivity, angioedema (serious allergic reaction which causes swelling of
the face or throat),urticaria (hives)
• Cardiac failure
Other possible side effects:
Very common (affects more than 1 in 10 people)
• Dizziness
• Constipation
• Feeling sick (nausea)
• Swelling and tenderness of your breasts
• Hot flushes
• Feeling weak
• Swelling
• Low levels of red blood cells (anaemia). This may make you feel tired or look pale
Common (affects less than 1 in 10 people)
• Decreased appetite
• Reduced sex drive
• Depression
• Feeling sleepy
• Indigestion
• Wind (flatulence)
• Hair loss
• Hair re-growth or growth of extra hair
• Dry skin
• Itching
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• Skin rash

• Being unable to get an erection (impotence)
• Weight gain
• Chest pain
• Hepatotoxicity, jaundice, raised transaminases.
Your doctor may do blood tests to check for any changes to your blood.
Do not be concerned by this list of possible side effects. You may not get any of them.
If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE BICALUTAMIDE TABLETS
Keep Bicalutamide Tablets out of the sight and reach of children.
Store in the original package to protect the tablets from moisture.
Do not use Bicalutamide Tablets after the expiry date which is stated on the carton after
EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. If you have any
Bicalutamide Tablets left after completing your course of treatment, please return them to
your pharmacist who will dispose of them safely. These measures will help protect the
environment.

6. FURTHER INFORMATION
What Bicalutamide Tablets contain:
The active substance is bicalutamide. Each tablet contains 50 mg of bicalutamide.
The other ingredients are lactose monohydrate, maize starch, sodium lauryl sulphate,
povidone, crospovidone, colloidal anhydrous silica, magnesium stearate, hypromellose,
macrogol and titanium dioxide (E171).
What Bicalutamide Tablets look like and the contents of the pack:
Bicalutamide 50 mg Tablets are white, round, film-coated tablets.
Your medicine is available in blisters containing 28 tablets.
Marketing Authorisation Holder and Manufacturer:
The Product Licence holder is STD Chemicals Ltd, Hillbrow House,
Hillbrow Road, Esher, Surrey, KT10 9NW.
The manufacturer responsible for batch release is Neolab Ltd, 57 High Street,
Odiham, Hants, RG29 1LF.
This information is available in alternative formats upon request.
This leaflet was last revised in July 2011.

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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.

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