Bicalutamide 150mg Film-Coated Tablets
PACKAGE LEAFLET
Package leaflet: Information for the patient
Bicalutamide 150 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 150 mg is and what it is used for
2. What you need to know before you take Bicalutamide 150 mg
3. How to take Bicalutamide 150 mg
4. Possible side effects
5. How to store Bicalutamide 150 mg
6. Contents of the pack and other information
1. What Bicalutamide 150 mg is and what it is used for
Bicalutamide 150 mg can be used alone but can also be given as part of a combination treatment to patients that have had their prostate removed. Additionally in combination with radiation therapy for the treatment of prostate cancer, whereby the cancer has spread from the capsule of the prostate gland to the close surrounding tissue. These patients are at high risk for the cancer to spread.
The active ingredient of Bicalutamide 150 mg, bicalutamide, belongs to a group of medicines called nonsteroidal anti-androgens. It blocks the undesired effect of a chemical made by a male sex gland (androgens) and inhibits cell growth in the prostate in this way.
2. What you need to know before you take Bicalutamide 150 mg
Do not take Bicalutamide 150 mg:
- if you are allergic to bicalutamide or any of the other ingredients of Bicalutamide 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 150 mg must not be taken by women or given to children.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide 150 mg.
- 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. If severe disturbances to liver function develop, treatment with bicalutamide should be discontinued.
- if your blood still shows high levels of a certain protein used to detect prostate cancer and the disease is still getting worse, bicalutamide treatment may need to be stopped.
Please tell your doctor if you have any of the following:
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 150mg.
Other medicines and Bicalutamide 150 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you take Bicalutamide 150 mg 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 150 mg:
- warfarin or any similar medicine to prevent blood clots,
- terfenadine or astemizole (for hay fever or allergy),
- cisapride (for stomach disorders),
- cyclosporin (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 150mg 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 150 mg with food and drink
Bicalutamide 150 mg can be taken before, during or after a meal, but also you can take them without food. The film coated tablet should be swallowed with some water or another liquid.
Pregnancy and breast-feeding
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 150 mg is contra-indicated in females and must not be given to pregnant or breastfeeding mothers.
Driving and using machines
Bicalutamide 150 mg is unlikely to adversely affect your ability to drive a car or to operate machinery. However, some people may occasionally feel drowsy after taking Bicalutamide 150 mg. 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.
Bicalutamide 150 mg contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor immediately.
3. How to take Bicalutamide 150 mg
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is one film coated tablet daily. It is better to take the tablet at the same time every day. The film coated tablet should be swallowed with some water or another liquid without being chewed and can be taken with or without food.
Use in children and adolescents
This medicine is not recommended in this age group.
If you take more Bicalutamide 150 mg than you should
If you take more than your normal dose, contact your doctor. In the case of an overdose, contact the nearest hospital immediately. If possible, take your film-coated tablets or the box with you to show the doctor what you have taken.
If you forget to take Bicalutamide 150 mg
If you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you are worried, ask your doctor or pharmacist for advice.
If you stop taking Bicalutamide 150 mg
Do not stop taking your film coated tablets, even if you are feeling well, unless your doctor tells you. 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 help immediately if you experience any of the following serious side effects
Uncommon: (may affect up to 1 in 100 people)
• serious allergic reaction which causes swelling of the face, lips, tongue and/or throat, which may cause difficulties in swallowing or reathing or severe itching of the skin with raised lumps.
• serious breathlessness, or sudden worsening of breathlessness, possibly with a cough or fever. Some patients taking Bicalutamide get an inflammation of the lungs called interstitial lung disease.
Rare: (may affect up to 1 in 1,000 people)
• liver failure.
Other side effects:
Very common: (may affect more than 1 in 10 people)
• rash
• tender or enlarged breast tissue
• weakness.
Common: (may affect up to 1 in 10 people)
• low levels of red blood cells (anaemia). This may make you feel tired or look pale.
• drowsiness, dizziness
• constipation
• feeling sick (nausea)
• abdominal pain
• hot flushes
• discomfort, pain or fullness in the upper abdomen (dyspepsia)
• wind
• dry skin, itching
• chest pain
• swelling
• decreased appetite
• reduced sex drive
• depression
• yellowing of the skin and/or eyes, also called jaundice, liver problems, increase in liver enzymes
• weight increased
• hair loss
• excessive hair growth
• presence of blood in the urine (haematuria)
• impotence (erectile dysfunction).
Rare: (may affect up to 1 in 1,000 people)
• increased skin sensitivity to sunlight
Not known (frequency cannot be estimated from the available data):
• changes in ECG (QT prolongation)
Occasionally, bicalutamide 150 mg may be associated with changes in your blood, which may require your doctor to do certain blood tests.
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 150 mg
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and carton.
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 150 mg contains
- The active substance is bicalutamide.
- The other ingredients are:
Tablet core:
Lactose monohydrate, Povidone K- 25, Sodium starch glycolate Type A, Magnesium Stearate.
Film coating:
Opadry OY-S-9622 which contains Hypromellose 5CP (E464), Titanium dioxide (E171) and Propylene Glycol.
What Bicalutamide 150 mg looks like and contents of the pack
Bicalutamide 150 mg is supplied as white, round, biconvex film coated tablets with a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal parts.
The film coated tablets are packed in blister packs containing 28, 30 and 100 film coated tablets contained in a carton.
UK: 28, 30 and 100 tablets contained in a carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (UK) Limited Building 4, Chiswick Park 566 Chiswick High Road London, W4 5YE United Kingdom
Manufacturer:
Genepharm S.A
18th klm Marathonos Avenue,
153 51 Pallini Attikis Greece
This medicinal product is authorised in the Member States of the EEA under the following names:
IT: Bicalutamide Ranbaxy 150 mg
RO: Bicalutamid Terapia 150mg comprimate filmate
UK: Bicalutamide 150mg Film-coated tablets