Bicalutamide 50mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bicalutamide 50 mg Tablets
Bicalutamide
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 you doctor or pharmacist.
In this leaflet:
1. What Bicalutamide 50 mg Tablets are and what they are used for
2. Before you take Bicalutamide 50 mg Tablets
3. How to take Bicalutamide 50 mg Tablets
4. Possible side effects
5. How to store Bicalutamide 50 mg Tablets
6. Further information
1. What Bicalutamide 50 mg Tablets are and what they are used for
Bicalutamide belongs to a group of medicines called anti-androgens. This means that it interferes with some of the actions of androgens (male sex hormones) within the body.
Bicalutamide 50 mg Tablets are used to treat prostate cancer.
2. Before you take Bicalutamide 50 mg Tablets
Bicalutamide must not be taken by women, including pregnant women or mothers who are breast feeding.
Bicalutamide must not be given to children.
Also, do not take Bicalutamide 50 mg Tablets:
- if you are allergic (hypersensitive) to Bicalutamide or any of the other ingredients of Bicalutamide 50 mg Tablets.
Take special care with Bicalutamide 50 mg Tablets:
- if you have liver problems. You should inform your doctor before treatment as he/she needs to take special care.
You have diabetes and are already taking an ‘LHRH analogue’. These include goserelin, buserelin, leuprorelin and triptorelin. If you go into hospital, tell the medical staff that you are taking Bicalutamide.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the following:
• oral anticoagulants (to prevent blood clots)
• terfenadine (an antihistamine)
• astemizole (an antihistamine)
• cisapride (for some types of indigestion)
• ciclosporin (to suppress your immune system)
• calcium channel blockers (to treat high blood pressure or some heart conditions).
• cimetidine (to treat heartburn and stomach ulcers)
• ketoconazole (to treat fungal infections of the skin and nails)
Pregnancy and breast feeding
Bicalutamide must not be taken by women.
You should not take Bicalutamide if you are pregnant or are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Bicalutamide 50 mg Tablets are unlikely to affect your ability to drive or to operate machinery. However, some people may occasionally feel drowsy when taking Bicalutamide. If this happens to you, you should exercise caution when carrying out such tasks.
Important information about some of the ingredients of Bicalutamide 50 mg Tablets
This medicine 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 Tablets
Always take Bicalutamide 50 mg Tablets 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 tablet taken daily.
Swallow the tablet whole with a drink of water.
Bicalutamide 50 mg Tablets can be taken with food or on an empty stomach.
Try to take your tablet at the same time each day.
If you take more Bicalutamide 50 mg Tablets 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 you forget to take a Bicalutamide 50 mg Tablet
You should take Bicalutamide 50 mg Tablets as prescribed. However, if you forget to take your medicine, take your dose when you remember and then take your next dose at the usual time. Don’t take a double dose to make up for a forgotten tablet. If you are worried, ask your doctor or pharmacist for advice.
Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Bicalutamide 50 mg Tablets can cause side effects, although not everybody gets them.
Contact your doctor or seek medical help immediately if you experience any of the following,
these are uncommon side effects (affects less than 1 in 100 people):
• 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
• Severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
Tell your doctor straight away if any of the following side effects bother you:
Very common side effects (affects more than 1 in 10 people):
• pain in your abdomen
• blood in your urine.
Common side effects (affects less than 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 (affects less than 1 in 1,000 people) liver failure.
Other possible side effects:
Very common (affects more than 1 in 10 people)
• dizziness
• constipation
• feeling sick (nausea)
• swelling and tenderness of your breasts
• hot flushes
• feeling weak
• swelling
• low levels of red blood cells (anaemia), this may make you feel tired or look pale.
Common side effects (affects less than 1 in 10 people)
• loss of appetite
• reduced sex drive
• depression
• feeling sleepy
• indigesiton
• 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
Bicalutamide 50 mg Tablets may occasionally be associated with changes in your blood which may require your doctor to do certain blood tests.
Do not be alarmed by this list of possible effects. You may not get any of them.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Bicalutamide 50 mg Tablets
This medicinal product does not require any special storage conditions. Keep out of the reach and sight of children.
Do not use Bicalutamide 50 mg Tablets after the expiry date which is stated on the carton and container/blister strips.
Keep the tablets in the container that they came in.
If your doctor decides to stop treatment, return any left-over tablets to your pharmacist. Only keep them if the doctor tells you to.
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.
6. Further information
What Bicalutamide 50 mg Tablets contain
• The active substance is Bicalutamide 50 mg.
• The other ingredients are:
Lactose monohydrate
Sodium starch glycolate (Type A)
Povidone K-30 Magnesium Stearate Opadry II 85F 18422 white
What Bicalutamide 50 mg Tablets look like and contents of the pack
Bicalutamide 50 mg Tablets are film-coated, white, round, biconvex 7 mm tablets marked with ‘B 50’ on one side.
Pack sizes:
Bicalutamide 50 mg Tablets are supplied in blister packs of 10, 14, 28, 30, 40, 50, 60, 90, or 100 tablets.
Marketing Authorisation Holder:
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturer:
Actavis Nordic A/S 0rnegardsvej 16 DK-2820 Gentoffe Denmark