Do not take Bicalutamide

• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6)
• if you are already taking terfenadine or astemizole (for hay fever or allergy), or cisapride (for stomach disorders).

Bicalutamide should not be taken by women or must not be given to children and adolescents.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bicalutamide

• if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Bicalutamide.
• if you are taking blood thinners or medicines to prevent blood clots
• if your liver function is moderately or severely impaired. The drug should then only be taken after your doctor has carefully considered possible benefits and risks. If this is the case, your doctor will regularly perform tests of liver function (bilirubin, transaminases, alkaline phosphatase). If severe disturbances to liver function develop, treatment with Bicalutamide should be discontinued.
• if you have diabetes and are already taking an “LHRH analogue”. These include goserelin, buserelin, leuprorelin and triptorelin.
• if you have any questions about birth control. You and/or your partner should use birth control while you are taking Bicalutamide and for 130 days after stopping Bicalutamide.

Children and adolescents

Bicalutamide must not be given to children and adolescents.

Other medicines and Biculatamide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Bicalutamide can affect the way other medicines work. Also some other medicines can affect the way Bicalutamide works.

Do not take Bicalutamide if you are already taking any of the following medicines:

• cisapride (for stomach disorders)
• terfenadine or astemizole (for hay fever or allergy).

Bicalutamide might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).

If you take Bicalutamide together with one of the following medicines, the effect of bicalutamide as well as the other medicine may be influenced. Please speak to your doctor before taking any of these medicines together with Bicalutamide:

• warfarin or any similar medicine to prevent blood clots
• ciclosporin (used to suppress your immune system to prevent and treat rejection of a transplanted organ or bone marrow)
• calcium channel blockers (used to treat high blood pressure or some heart conditions)
• cimetidine (used to treat stomach ulcers)
• ketoconazole (used to treat fungal infections of the skin and nails).

Bicalutamide with food and drink

Bicalutamide can be taken before, during or after a meal, but also you can take this medicine without food. The film coated tablet should be swallowed with some water or another liquid.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Bicalutamide is contraindicated in females and must not be given to pregnant women or breast-feeding mothers.

Bicalutamide may have an effect on male fertility which could be reversible.

Driving and using machines

Bicalutamide is unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel drowsy when taking bicalutamide.

If you suffer from drowsiness you would be best advised not to carry out such tasks. However if you still drive a car or use machines you should exercise extra caution.

Sunlight or Ultraviolet (UV) light

Avoid direct exposure to excessive sunlight or UV-light while you are taking Bicalutamide.

Bicalutamide 50 mg film-coated tablets contain lactose

Bicalutamide 50 mg film-coated tablets contain lactose monohydrate, which is a type of sugar.

If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor immediately.