Bicalutamide 50 Mg Film-Coated Tablets
B. PACKAGE LEAFLET
Package leaflet: Information for the user
Bicalutamide 50 mg, film-coated tablets
bicalutamide
Read all of this leaflet carefully before you start taking 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
1. What Bicalutamide 50 mg is and what it is used for
2. What you need to know before you take Bicalutamide 50 mg
3. How to take Bicalutamide 50 mg
4. Possible side effects
5. How to store Bicalutamide 50 mg
6. Contents of the pack and other information
1. What Bicalutamide 50 mg is and what it is used for
Bicalutamide 50 mg is a medicine containing the active substance called bicalutamide. This belongs to a group of medicines called ‘antiandrogens’.
• Bicalutamide is used to treat prostate cancer.
• It works by blocking the effects of male hormones such as testosterone.
2. What you need to know before you take Bicalutamide 50 mg Do not take Bicalutamide 50 mg
• if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
• if you are taking terfenadine or astemizole which are used to treat allergies or cisapride which is used to treat heartburn and acid reflux.
• if you are a woman
Bicalutamide 50 mg must not be given to children or adolescents.
Do not take Bicalutamide 50 mg if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bicalutamide 50 mg.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide 50 mg
• if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia), or are being treated with medicines for these conditions. The risk of heart rhythm problems may be increased when using Bicalutamide 50 mg.
• if you have a liver disease. Your doctor may decide to do blood tests to check your liver is working properly while you are taking this medicine.
• if you have diabetes. Treatment with bicalutamide in combination with luteinising hormonereleasing hormone (LHRH) analogues may alter your blood sugar level. Your dosage of insulin and/or oral antidiabetic medicines may need to be adjusted.
if you go into a hospital, tell the medical staff that you are taking Bicalutamide 50 mg.
Children and adolescents
Bicalutamide 50 mg must not be given to children or adolescents.
Other medicines and Bicalutamide 50 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Bicalutamide 50 mg can affect the way other medicines work. Also some other medicines can affect the way Bicalutamide 50 mg works.
• Cyclosporin (used to supress the immune system to prevent and treat rejection of a transplanted organ or bone marrow). This is because bicalutamide may increase the concentration of a substance called creatinine in your plasma and your doctor may take blood samples to monitor this.
• Midazolam (a medicine which is used to relieve anxiety before surgery or certain procedures or as an anaesthetic before and during surgery). You must tell your doctor or dentist you are taking bicalutamide if you need an operation or are very anxious in hospital.
• Terfenadine or astemizole which are used to treat allergies
• Cisapride which is used to treat heartburn and acid reflux (See section 2, Do not take Bicalutamide Synthon 50 mg).
• A type of medicine called a calcium channel blocker eg. diltiazem or verapamil. These are used to treat heart problems, angina and high blood pressure.
• Medicines to thin your blood e.g. warfarin.
• Cimetidine for acid reflux or stomach ulcers
• Ketoconazole an antifungal medicine.
• Bicalutamide 50 mg 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).
Bicalutamide 50 mg with food and drink
The tablets do not need to be taken with food but must be swallowed whole with a glass of water.
Pregnancy and breast-feeding
This medicine must never be taken by women.
Driving and using machines
This medicine should not affect your ability to drive or use machines however some people may feel sleepy while taking this medicine. If you think your medicine is making you feel sleepy you must talk to your doctor or pharmacist before driving or using machines.
Sunlight or Ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV-light while you are taking bicalutamide. Bicalutamide 50 mg 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 take Bicalutamide 50 mg
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your pharmacist if you are not sure.
The recommended dose of this medicine is one tablet, once a day. This must be swallowed whole with a glass of water. Try to take the medicinal product approximately at the same time each day.
You should start taking these tablets at least 3 days before starting treatment with LHRH analogues e.g. gonadorelin, or at the same time as undergoing surgical castration.
If you take more Bicalutamide 50 mg than you should
If you think that you may have taken more tablets than you should, contact your doctor or the nearest hospital as soon as possible. Take with you the remaining tablets or the pack so the doctor can identify what you have taken. He or she may decide to monitor your body function until the effects of bicalutamide have worn off.
If you forget to take Bicalutamide 50 mg
If you think that you may have missed a dose of bicalutamide talk to your doctor or pharmacist. Do not take a double dose to make up for a forgotten dose. Just take the normal dose at the usual time.
If you stop taking Bicalutamide 50 mg
Do not stop taking this medicine even if you are feeling well unless your doctor tells you to.
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.
If you get any of the following symptoms tell your doctor immediately or go to the nearest hospital. Allergic reactions
These are uncommon side effects(may affect up to 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 side effects (may affect more than 1 in 10 people):
• Pain in your abdomen.
• Blood in your urine.
Common side effects (may affect up to 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 (may affect up to 1 in 1,000 people) liver failure.
Uncommon side effects (may affect up to 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’.
Not known side effects (frequency cannot be estimated from the available data):
• Changes in ECG (QT prolongation).
Other possible side effects:
Very common side effects (may affect more than 1 in 10 people)
Dizziness • Constipation • Feeling sick (nausea) • Swelling and tenderness of your breasts • Development of breasts in males • Hot flushes • Feeling weak • Swelling • Low levels of red blood cells (anaemia). This may make you feel tired or look pale
Common side effects (may affect up to 1 in 10 people)
Loss of appetite • Reduced sex drive • Depression • Feeling sleepy • Indigestion • Wind (flatulence) • Hair loss • Hair re-growth or growth of extra hair • Dry skin • Itching • Skin rash • Being unable to get an erection (impotence) • Weight gain • Chest pain • Reduced heart function • Heart attack.
Rare side effects (may affect up to 1 in 1,000 people)
Increased skin sensitivity to sunlight.
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.
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; website: 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 50 mg
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after ‘EXP’. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition.
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 50 mg contains
• The active substance is bicalutamide. Each tablet contains 50 mg bicalutamide.
• The other ingredients in the tablet core are: lactose monohydrate, magnesium stearate, crospovidone, povidone K-29/32, sodium laurilsulfate
The ingredients in the tablet coating are: lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide (E171).
What Bicalutamide 50 mg looks like and contents of the pack
The tablets are white, round, biconvex film-coated tablets, debossed with BCM50 on one side.
They are available in blisters of 5, 7, 10, 14, 20, 28, 30, 40, 50, 56, 80, 84, 90, 98, 100, 140, 200, and 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Manufacturer Synthon BV Microweg 22 6545 CM Nijmegen The Netherlands
Synthon Hispania S.L.
Castello 1
Poligono Las Salinas 08830 Sant Boi de Llobregat Spain
PL 14048/0022; Bicalutamide 50 mg, film-coated tablets
For product information please contact medac UK Scion House
Stirling University Innovation Park Stirling FK9 4NF Phone: 01786 458 086 Fax: 01786 458 032
This leaflet was last revised in April 2016
6/6 M1.3.1 03.BCM.tab50.002.09.UK.6126.01