Patient leaflet - Bicalutamide 150 mg film-coated tablets
1. What Bicalutamide 150 mg Film-coated Tablets is and what it is used for
Bicalutamide 150 mg Film-coated Tablets contains a medicine called bicalutamide. This belongs to a group of medicines called ‘anti-androgens’.
- Bicalutamide 150 mg Film-coated Tablets 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 150 mg Film-coated Tablets
Do not take Bicalutamide 150 mg Film-coated Tablets:
- if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6).
- if you are already taking a medicine called cisapride or certain anti-histamine medicines (terfenadine or astemizole).
- if you are a woman.
Bicalutamide 150 mg Film-coated Tablets must not be given to children.
Do not take Bicalutamide 150 mg Film-coated Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Bicalutamide 150 mg Film-coated Tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Bicalutamide 150 mg Film-coated Tablets:
- if you have problems with your liver. Your doctor may do blood tests before and during your treatment with Bicalutamide 150 mg Film-coated Tablets.
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 150 mg Film-coated Tablets.
- if you are taking Bicalutamide 150 mg Film-coated Tablets, you and/or your partner should use birth control while you are taking Bicalutamide 150 mg Film-coated Tablets and for 130 days after stopping Bicalutamide 150 mg Film-coated Tablets. Talk to your doctor if you have any questions about birth control.
If you go into hospital, tell the medical staff that you are taking Bicalutamide 150 mg Film-coated Tablets.
Children and adolescents
Bicalutamide 150 mg Film-coated Tablets must not be given to children or adolescents.
Tests and checks
Your doctor may do blood tests to check for any changes to your blood.
Other medicines and Bicalutamide 150 mg Film-coated Tablets
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 150 mg Film-coated Tablets can affect the way other medicines work. Also some other medicines can affect the way Bicalutamide 150 mg Film-coated Tablets works.
Do not take Bicalutamide 150 mg Film-coated Tablets if you are already taking any of the following medicines:
- Cisapride (used for some types of indigestion).
- Certain anti-histamines (terfenadine or astemizole).
Bicalutamide 150 mg Film-coated Tablets 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 illness).
Tell your doctor or pharmacist if you are taking any of the following medicines:
- Medicines taken by mouth to prevent blood clots (oral anti-coagulants). Blood thinners or medicines to prevent blood clots. Your doctor may do blood tests before and during your treatment with Bicalutamide 150 mg Film-coated Tablets.
- Ciclosporin (to suppress your immune system).
- Calcium channel blockers (to treat high blood pressure or some heart conditions).
- Cimetidine (for stomach problems).
- Ketoconazole (to treat infections caused by a fungus).
Pregnancy and breast-feeding
Bicalutamide 150 mg Film-coated Tablets must not be given to a woman.
Driving and using machines
Bicalutamide 150 mg Film-coated Tablets is not likely to affect your ability to drive or use any tools or machines. However, some people may occasionally feel sleepy while taking Bicalutamide 150 mg Film-coated Tablets. If this happens to you, ask your doctor or pharmacist for advice.
Sunlight or Ultraviolet (UV) light
Avoid direct exposure to excessive sunlight or UV light while you are taking Bicalutamide 150 mg Film-coated Tablets.
Bicalutamide 150 mg Film-coated Tablets contains lactose.
Lactose is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.
3. How to take Bicalutamide 150 mg Film-coated Tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet each day. Swallow the tablet whole with a drink of water. Try to take your tablet at the same time each day. Do not stop taking this medicine even if you feel well, unless your doctor tells you to.
Use in children and adolescents
Bicalutamide 150 mg Film-coated Tablets must not be given to children.
If you take more Bicalutamide 150 mg Film-coated Tablets than you should
If you take more Bicalutamide 150 mg Film-coated Tablets than you should, talk to a doctor or go to a hospital straight away.
If you forget to take Bicalutamide 150 mg Film-coated Tablets
If you forget to take a dose, skip the missed dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you notice any of the following side effects-you may need urgent medical treatment:
Allergic reactions (uncommon, 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.
Also tell your doctor straight away if you notice any of the following: Common (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 (affects less than 1 in 1,000 people) liver failure.
- Pain in your abdomen.
- Blood in your urine.
Uncommon (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 (frequency cannot be estimated from the available data):
Changes in ECG (QT prolongation).
Other possible side effects :
Very common (may affect more than 1 in 10 people):
- Skin rash.
- Swelling and tenderness of your breasts.
- Feeling weak.
Common (may affect up to 1 in 10 people):
- Hot flushes.
- Feeling sick (nausea)
- Itching.
- Dry skin.
- Problems getting an erection (erectile dysfunction).
- Putting on weight.
- Reduced sex drive and reduced fertility.
- Hair loss.
- Hair re-growth or growth of extra hair.
- Low levels of red blood cells (anaemia). This may make you feel tired or look pale.
- Loss of appetite.
- Depression.
- Feeling sleepy.
- Indigestion.
- Dizziness.
- Constipation.
- Wind (flatulence).
- Chest pain.
- Swelling.
Rare (affects less than 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 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Bicalutamide 150 mg Film-coated Tablets
Keep this medicine out of the sight and reach of children. Keep your tablets in the container they came in.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store below 30°C.
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 Film-coated Tablets contains
The active substance is bicalutamide. Each tablet contains 150 mg of bicalutamide. The other ingredients (excipients) are:
- Tablet core: lactose monohydrate, maize starch, crospovidone, povidone, sodium
lauryl sulphate, colloidal anhydrous silica, magnesium stearate.
- Film coating material: hydroxypropyl methyl cellulose, titanium dioxide (E171), polyethylene glycol 400.
What Bicalutamide 150 mg Film-coated Tablets looks like and contents of the pack
Bicalutamide 150 mg Film-coated tablets are white to off white, circular, biconvex film coated tablets with B150 on one side and plain on the other side. They are available in packs of 10, 20, 30, 40, 50, 80, 90, 100, 200 or 14, 28, 56, 84, 140 and 280 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Torrent Pharma (UK) Ltd, 3rd Floor, Nexus Building 4 Gatwick Road
Crawley West Sussex RH10 9BG United Kingdom
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Ltd.,
9th Floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL.