The name of your medicine is APO-Bicalutamide. It contains the active ingredient bicalutamide.
It is used in combination with other medicines called LHRH agonists to treat advanced prostate cancer and to prevent a side effect of LHRH agonists.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
Bicalutamide is an anti-androgen medicine. Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens may help the
cancer cells to grow.
Bicalutamide interferes with some of the actions of these hormones.
Bicalutamide should only be taken by men.
There is no evidence that this medicine is addictive.
This medicine must not be used in children.
Do not take this medicine if:
In addition, children must not take bicalutamide.
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
2. You have or have had any medical conditions, especially the following:
3. You are planning to start a family. This medicine may affect your fertility
4. You are planning to have surgery or an anaesthetic or are going into hospital.
5. You are currently receiving or are planning to receive dental treatment.
6. You are taking or are planning to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.
Some medicines may interact with bicalutamide. These include:
If you are taking any of these you may need a different dose or you may need to take different medicines.
Other medicines not listed above may also interact with bicalutamide.
Follow carefully all directions given to you by your doctor or pharmacist. Their instructions may be different to the information in this leaflet.
Your doctor or pharmacist will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.
The usual dose for men is one 50 mg tablet each day. This may be reduced if you have severe liver problems.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
Swallow your tablet whole with a full glass of water.
Start taking this medicine when you start taking the other medicines you have been given to treat prostate cancer.
Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
It does not matter if you take it before, with or after food.
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If it is almost time to take your next dose (i.e. less than 12 hours to the next dose), skip the missed dose and take your next dose at the usual time. Otherwise take it as soon as you remember and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for missed doses.
This may increase the chance of unwanted side effects.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Tell your doctor that you are taking this medicine if:
Make sure to always take another prostate cancer medicine (called an LHRH agonist) during the time that you are taking bicalutamide. The two medicines need to work together to have an effect.
Your doctor may do tests to make sure the medicine is working and to prevent side effects.
Go to your doctor regularly for a check-up, and keep any appointments the doctor has made for you.
Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.
Be careful when driving or operating machinery until you know how this medicine affects you.
Some people may feel sleepy, dizzy or weak when taking this medicine.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking bicalutamide or if you have any questions or concerns.
Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Tell your doctor or pharmacist if you notice any of the following and they worry you.
This list includes the more common side effects. Mostly, these are mild:
Tell your doctor as soon as possible if you notice any of the following.
These may be serious side effects. You may need medical attention. Most of these side effects are rare.
If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
These are very serious side effects and are usually very rare. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients.
If you think you are having an allergic reaction to bicalutamide, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging it may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.
APO-Bicalutamide 50 mg tablets are white to off white, round, biconvex, film coated tablets debossed "B50" on one side and plain on other side
Each tablet contains 50 mg of bicalutamide as the active ingredient.
It also contains the following inactive ingredients:
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Bicalutamide is available in blister packs of 28 tablets.
APO-Bicalutamide 50 mg Tablets
AUST R 194683