Monday, October 24, 2016

Bicalutamide 150mg (AstraZeneca UK Limited)





Bicalutamide 150 mg



Film-coated Tablets



bicalutamide





What you should know about Bicalutamide 150 mg



The information in this leaflet applies only to your medicine, Bicalutamide 150 mg. Please read it carefully. It gives you important information but it can't tell you everything. If you have any questions, or are not sure about anything, ask your doctor or pharmacist.





What is your medicine?



Bicalutamide 150 mg comes as white film-coated tablets and each tablet contains 150 mg of bicalutamide.

Each tablet contains a number of inactive ingredients, which allow it to be made. These are: lactose monohydrate, sodium starch glycolate, povidone, magnesium stearate, hypromellose, macrogol 300 and titanium dioxide.



Bicalutamide 150 mg comes in blister packs of 28 tablets.



Bicalutamide 150 mg belongs to a group of medicines called antiandrogens. This means that it interferes with some of the actions of androgens (male sex hormones) within the body.





Who has made your medicine?




The Marketing Authorisation for Bicalutamide 150 mg is held by




AstraZeneca UK Limited

600 Capability Green

Luton

LU1 3LU

UK





Bicalutamide 150 mg is manufactured by




AstraZeneca GmBH

Otto-Hahn-Strasse

68723 Plankstadt

Germany






What is your medicine for?



Bicalutamide 150 mg is used to treat prostate cancer.



In early disease, it is used as immediate treatment or commenced after treatment of curative intent.



Bicalutamide 150 mg is also used as monotherapy in patients for whom castration or other medicines are not appropriate or acceptable.





When should Bicalutamide 150 mg not be used?



  • Bicalutamide 150 mg should not be used if you have ever had an allergic reaction to Bicalutamide 150 mg, Casodex 150 mg, Casodex 50 mg or to any particular ingredient.


  • Bicalutamide 150 mg must not be taken by women, including pregnant women or mothers who are breast-feeding their babies.


  • Bicalutamide 150 mg must not be given to children.


  • The tablets are only for you and must never be given to anyone else.




What precautions should be taken with Bicalutamide 150 mg?




Before taking your medicine, tell your doctor if:



  • You are suffering from any disorder or disease which affects your liver.


  • You are taking any other medicines including those which you have bought. In particular, if you are taking oral anticoagulants (to prevent blood clots), some antihistamines (terfenadine or astemizole), cisapride (for some types of indigestion), ciclosporin (to suppress your immune system) or calcium channel blockers (to treat high blood pressure or some heart conditions).


  • You know that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.


  • Your tablets are unlikely to adversely affect your ability to drive a car or to operate machinery.


  • If you go into hospital, let the medical staff know you are taking Bicalutamide 150 mg.


  • Only stop taking your tablets if your doctor tells you.





How should I take my Bicalutamide 150 mg?



  • Follow your doctor's instructions about when and how to take your tablets. Please read the label on the container. Ask your doctor or pharmacist if you are not sure.


  • The usual adult dose is one tablet taken daily.


  • Swallow the tablet whole with a drink of water.


  • Try to take your tablet at the same time each day.


  • You should take Bicalutamide 150 mg as prescribed. However, if you miss a dose do not take an extra dose. Just resume your usual schedule.


  • If you take more than your normal dose, contact your doctor or nearest hospital.


  • Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.




What undesirable events may be experienced with Bicalutamide 150 mg?



Like all medicines, Bicalutamide 150 mg can have side effects.



Contact your doctor or seek medical help immediately if you experience any of the following:




Side effects that are uncommon:



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


  • Severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.


  • Blood in urine.


  • Abdominal pain.


  • Yellow skin and eyes (jaundice). These may be symptoms of liver damage.



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




Side effects that are very common:



  • Tender or enlarged breast tissue




Side effects that are common:



  • Hot flushes


  • Nausea


  • Itching


  • Dry skin


  • Impotence


  • Weight gain


  • Feeling weak


  • Reduced sex drive and reduced fertility


  • Loss of hair or hair regrowth




Side effects that are uncommon:



  • Indigestion


  • Depression



Occasionally, Bicalutamide 150 mg may be associated with changes in your blood (such as abnormal bleeding or bruising), which may require your doctor to do certain blood tests.



Do not be alarmed by this list of possible events. You may not have any of them.



If you notice any side effect not mentioned in this leaflet, please inform your doctor or pharmacist.





How should I store Bicalutamide 150 mg?



  • Do not store above 30°C.


  • Keep your tablets in the container they came in.


  • If your doctor decides to stop your treatment, dispose of your tablets in an appropriate way.


  • Do not take your tablets after the expiry date on the container.


  • Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.



Leaflet updated: April 2008



© AstraZeneca 2008



ONC 08 0011a



P022746







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