Bicalutamide 150mg Film-Coated Tablets
Package leaflet: Information for the user
Package leaflet: Information for the user
Bicalutamide 150mg Film-coated Tablets
Read all of this leaflet carefully before you start using 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: j What Bicalutamide is and what it is used for
^ What you need to know before you take Bicalutamide
^ How to use Bicalutamide 4| Possible side effects How to store Bicalutamide 6| Contents of the pack and other information
j What Bicalutamide is and what it is used for
The growth of prostatic tumours is dependent on stimulation by male hormones (androgens). Bicalutamide contains the active substance bicalutamide, which prevents this stimulation. Bicalutamide is used in adult men for the treatment of locally advanced prostate cancer where there is a high risk that the cancer continues to grow or spread. It can be used alone or in combination with radiotherapy or prostate surgery.
^ What you need to know before you take Bicalutamide
Do not take Bicalutamide if you
• are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• are a woman or a child
• are already taking any medicine containing terfenadine, astemizole or cisapride.
Children and adolescents
Bicalutamide should not be used in children and adolescents.
Other medicines and Bicalutamide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Bicalutamide may affect or be affected by the following medicines;
• ciclosporin, used in transplantation
• calcium channel blockers, to treat high blood pressure
• cimetidine, reduces the amount of acid in your stomach
• ketoconazol, antifungal medicine
• warfarin, anti-coagulant to prevent blood clots
• midazolam, used as sedative
See also section "Do not take Bicalutamide if you".
Pregnancy and breast-feeding
Bicalutamide must not be used by women.
Driving and using machines
Bicalutamide is not likely to affect your ability to drive or use any machines. However, sleepiness may occur during treatment with Bicalutamide. Do not drive and use machines if you are affected.
Bicalutamide contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3| How to use Bicalutamide
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 1 tablet once daily.
The tablets should be swallowed whole with fluids.
If you use more Bicalutamide than you should
If you have taken more medicine than you should, or if for instance a child has taken medicine by accident, please contact your doctor, the hospital or Poison Information Centre to get an opinion of the risk and advice on action to be taken.
Warnings and precautions
Talk to your doctor or pharmacist before using this medicine if you
• have any liver problems (your doctor may decide to do blood tests to check if your liver is working properly while you are taking this medicine).
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If you forget to use Bicalutamide
If you forget a dose, skip the dose and take the next dose as usual. Do not take a double dose to make up for a forgotten tablet.
If you stop using Bicalutamide
Do not stop taking this medicine, even if you are feeling well, unless you are directly instructed to do so by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4| Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor or seek medical assistance immediately if you experience any of the following
Uncommon side effects, (may affect up to 1 in 100
people):
• Severe shortness of breath, possibly coughing or fever. Signs of an inflammation of the lungs called interstitial pneumonia.
• The following allergic reactions (symptoms of angioedema): Swelling of the face, lips, tongue or throat, difficulty in swallowing, hives and trouble breathing.
Other side effects that may occur are:
Very common side effects, (may affect more than 1 in 10 people):
Rash, breast tenderness, enlarged breasts, feeling weak.
Common side effects, (may affect up to 1 in 10 people):
Low levels of red blood cells (anaemia), reduced appetite, reduced sex drive, depression, dizziness, feeling sleepy, hot flushes, pain in the abdomen, constipation, impaired digestion, wind (flatulence), nausea, changes in liver function, yellowing of the skin or eyes (jaundice), hair loss, increased hair growth on the body, dry skin, itching, blood in the urine, impotence, chest pain, swelling (oedema), weight gain.
Rare side effects, (may affect up to 1 in 1,000 people):
Liver failure.
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 Bicalutamide
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6| Contents of the pack and other information
What Bicalutamide contains
• The active substance is bicalutamide 150mg.
• The other ingredients are:
Tablet core: lactose monohydrate, povidone, type A sodium starch glycolate, magnesium stearate. Tablet coating: macrogol 3350, polyvinyl alcohol, talc and titanium dioxide (E 171).
What Bicalutamide looks like and contents of the pack
Appearance:
Bicalutamide 150mg tablets are round, biconvex, white, 10mm in diameter and imprinted with "B 150" on one side.
Blister packs: 28 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegi 76-78 220 HafnarfjorSur Iceland
Manufacturer
Actavis Group PTC ehf.
Reykjavikurvegi 76-78
HafnarfjorSur
IS - 220
Iceland
This leaflet was last revised in September 2014.
If you would like a leaflet with larger text, please contact 01271 385257.
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^actavis
Actavis, Barnstaple, EX32 8NS, UK