Bicalutamide 150 Mg Film-Coated Tablets
Read all of this leaflet carefully before you start taking this
medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Bicalutamide 150 mg is and what it is used for
2. Before you take Bicalutamide 150 mg
3. Howtotake Bicalutamide 150mg
4. Possible side effects
5. Howtostore Bicalutamide 150mg
6. Further information
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 non-steroidal antiandrogens. 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.
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).
Taking 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
Bicalutamide 150 mg is contra-indicated in females and must not be given to pregnant or breast-feeding mothers.
Bicalutamide 150 mg may induce a period of subfertility or infertility in man.
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 dizzy or drowsy after taking Bicalutamide 150 mg. If you suffer from dizziness or 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.
Important information about some of the ingredients of Bicalutamide 150 mg
Bicalutamide 150 mg contains lactose. Ifyou have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor immediately.
Do not take Bicalutamide 150 mg
• if you are allergic (hypersensitive) to bicalutamide or any of the other ingredients of Bicalutamide 150 mg
• if you are already taking terfenadine or astemizole (for hay fever or allergy), or cisapride (for stomach disorders).
Bicalutamide 150 mg should not be taken by women or must not be given to children or adolescents.
Take special care with 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 renal functions is severely impaired. The drug should then only be taken after your doctor has carefully considered possible benefits and risks.
• if you suffer from heart disease. If this is the case, your doctor should regularly monitor your heart function.
• 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.
Taking othermedicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained withouta prescription.
If you take Bicalutamide 150 mg together with one of the following medicines, the effect of bicalutamide as well as the
Always take Bicalutamide 150 mg exactly as your doctor has told you. You should 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.
Children and adolescents
This medicine is not recommended for patients under the age of 18 years.
Ifyou 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.
Ifyou 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.
Ifyou stop taking Bicalutamide 150 mg
Do not stop taking your film coated tablets, even ifyou are feeling well, unless your doctortells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Bicalutamide 150 mg can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Contact your doctor or seek medical help immediately if you experience any of the following serious side effects Very rare (estimated frequency is less than 1 person out of 10,000):
• Liverfailure
• Chest pain (angina) and heart failure (which may be associated with breathlessness, especially on exertion, a fast heart beat, swelling in the limbs and mottling of the skin), irregular heart beat (arrhythmia), abnormal ECG heart tracing.
• Reduction in blood platelets which increases the risk of bleeding or bruising (thrombocytopenia).
Uncommon serious side effects (affecting less than 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 breathing 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.
Tell yourdoctor if any ofthe following side effects botheryou:
Side effects that are very common (estimated frequency is more than 1 person out of 10):
• tenderorenlarged breasttissue
• hotflushes
• impotence (erectile dysfunction), reduced sex drive
Side effects that are common (estimated frequency is less than 1 person out of 10 but more than 1 out of 100):
• sleeplessness
• having frequent loose or liquid bowel movements
• liverchanges
• chills, general pain and swelling
• sweating
• constipation
• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• dizziness
• weightgain
• itching
• feeling weak
• nausea
• pelvic pain
• rash
• excessive hair growth
• diabetes mellitus
Side effects that are uncommon (estimated frequency is less than 1 person out of 100 but more than 1 out of 1000):
• indigestion
• depression
• hairloss
• weight loss
• allergic reactions
• breathlessness or sudden worsening of breathlessness
• abdominal pain
• drowsiness
• needing to urinate during the night
• blood in urine
• inflammation ofthe lungs called interstitial lung disease
• chest pain
• back pain
• neck pain
• headache
• dry mouth
• flatulence
• anorexia
• hyperglycaemia (high blood sugar levels)
• severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing
Side effects that are rare (estimated frequency is less than 1 person out of 1000 but more than 1 out of 10,000)
• dry skin
• vomiting
Occasionally, bicalutamide 150 mg may be associated with changes in your blood, which may require your doctor to do certain blood tests.
If you notice any side effect not mentioned in this leaflet, please inform yourdoctor or pharmacist.
Keep out ofthe reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Bicalutamide 150 mg after the expiry date which is stated on the blister and carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Bicalutamide 150 mg contains
• The active substance is bicalutamide. Each film-coated tablet contains 150mg 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 10, 14, 20, 28, 30, 40, 56, 60, 100 and 150 tablets contained in a carton.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road, Leicester LE30PA, UK
Manufacturer
Genepharm S.A
18th kirn Marathonos Avenue, 153 51 Pallini Attikis, Greece
This medicinal product is authorised in the Member States ofthe EEAunderthefollowing names:
Czech Republic- Bicalutamide Morningside
This leaflet was last approved in September2008.