Bicalutamide 150 mg Film-Coated Tablets

Bicalutamide 150 Accord is used for the treatment of prostate cancer that has not spread to other parts of the body for which other treatment including surgery is not appropriate.

Bicalutamide 150 Accord should not be administered to you:

• if you are hypersensitive (allergic) to Bicalutamide 150 Accord or any of the other ingredients of Bicalutamide 150 Accord (listed in section 6).
• In women and children
• If you are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole)

Do not take Bicalutamide 150 Accord if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bicalutamide 150 Accord.

Warnings and Precautions

Take special care with Bicalutamide 150 Accord in the following instances: Before taking Bicalutamide 150 Accord tell your doctor, pharmacist or other healthcare professional:

• If you are suffering from any disorder or disease which affects your liver.
• If you are taking any other medicines including those which you have bought. In particular if you are taking oral anti-coagulants (to prevent blood clots).

While you are taking Bicalutamide 150 Accord tell your doctor, pharmacist or other healthcare professional:

• If you experience any problems that could be due to your liver, such as becoming jaundiced (yellowing of the skin and eyes) etc.

Taking Bicalutamide 150 Accord with food and drink:

Do not take Bicalutamide 150 Accord with grapefruit juice as this may affect how Bicalutamide works.

Pregnancy and Breast-feeding:

If you are pregnant or breast-feeding your baby, you should not take Bicalutamide 150 Accord. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

Bicalutamide 150 Accord should not be given to women.

Driving and using machinery:

Do not drive because Bicalutamide 150 Accord could interfere with your ability to drive or use machines. It is not always possible to predict to what extent Bicalutamide 150 Accord may interfere with the daily activities of a patient. Patients should ensure that they do not engage in the above activities until they are aware of the measure to which Bicalutamide 150 Accord affects them.

Important information about some of the ingredients of Bicalutamide 150 Accord:

Lactose

Warning: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Bicalutamide 150 Accord.

Other medicines and Bicalutamide 150 Accord

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Do not share medicines prescribed for you with any other person. Follow your doctor, pharmacist, or other health care professional’s instructions on how to take Bicalutamide 150 Accord and ask them if you are unsure.

If you feel that the effect of Bicalutamide 150 Accord is too strong or too weak, tell your doctor or pharmacist.

The usual dose:

Adults: Take one tablet once a day.

If you receive more Bicalutamide 150 Accord than you should:

In the event of an overdose, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take Bicalutamide 150 Accord:

If you forget to take a dose, then take the dose as soon as possible or take the next dose as usual. Do not take 2 doses at the same time.

Bicalutamide 150 Accord can have side effects. Not all side effects for Bicalutamide 150 Accord are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Bicalutamide 150 Accord, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens:

• severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
• yellow skin and eyes (jaundice). These may be symptoms of liver damage.
• blood in urine
• abdominal pain

Side effects that may occur frequently:

• serious breathlessness, or sudden worsening of breathlessness, possibly with a cough or fever. Some patients taking Bicalutamide 150 Accord get an inflammation of the lungs called interstitial lung disease.

Tell your doctor as soon as possible if any of the following side effects bother you:

• tender or enlarged breast tissue
• hot flushes
• nausea
• itching
• feeling weak
• dizziness
• rash
• dry skin
• chest pain
• loss of appetite
• reduced sex drive
• impotence
• depression
• sleepiness
• indigestion
• flatulence
• loss of hair or hair re-growth
• weight gain
• puffiness / swelling
• reduced heart function, or heart attack

Bicalutamide 150 Accord may also be associated with changes in your blood which may require your doctor to do certain blood tests. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• Store at or below 25 °C.
• Store all medicines out of reach of children.
• Store in original package until use.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).