Consumer medicine information

BICALUTAMIDE-GA

Bicalutamide

Consumer Medicine Information

What is in this leaflet

This leaflet answers some of the common questions people ask about BICALUTAMIDE-GA. It does not contain all the information that is known about BICALUTAMIDE-GA.

It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor will have weighed the risks of you taking BICALUTAMIDE-GA against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What BICALUTAMIDE-GA is used for

BICALUTAMIDE-GA 50mg is used to treat locally advanced prostate cancer.

BICALUTAMIDE-GA is an anti-androgen medicine. Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens can help the cancer cells to grow. Bicalutamide interferes with some of the actions of these hormones.

BICALUTAMIDE-GA must only be taken by men.

You must follow all the directions given to you by your doctor. They can differ from the information in this leaflet.

Your doctor can prescribe this medicine for another use. Always ask your doctor if you need more information.

BICALUTAMIDE-GA is not known to be addictive.

BICALUTAMIDE-GA is only available with a doctor’s prescription.

Before you take BICALUTAMIDE-GA

When you must not take it

Do not take BICALUTAMIDE-GA if you are a woman. Women do not get treated with BICALUTAMIDE-GA.

Do not give BICALUTAMIDE-GA to children. There is no experience of treating children with BICALUTAMIDE-GA.

Do not take BICALUTAMIDE-GA if you are allergic to bicalutamide or any of the other ingredients in BICALUTAMIDE-GA.

Do not take BICALUTAMIDE-GA if you are taking cisapride or the antihistamines, terfenadine and astemizole.

Do not take BICALUTAMIDE-GA after the use by (expiry) date printed on the pack has passed. It may have no effect at all or an unexpected effect if you take it after the expiry date.

Do not take BICALUTAMIDE-GA if the packaging is torn or shows signs of tampering.

Do not use it to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else.

Before you start to take it

You must tell your doctor if:

  1. You have allergies to:
  • bicalutamide, the active ingredient in BICALUTAMIDE-GA
  • any of the other ingredients of BICALUTAMIDE-GA 50mg listed at the end of this leaflet
  • other anti-androgen medicines
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
    If you have an allergic reaction, you may get skin rash, hay fever, or have difficulty breathing or feel faint.
  1. You have liver problems
    If you have problems with your liver, it may not be safe for you to take BICALUTAMIDE-GA.

Taking other medicines

Tell your doctor if you are taking any other medicines, including:

  • Cisapride (see When you must not take it)
  • The antihistamines terfenadine and astemizole (see When you must not take it)
  • Medicines used to prevent blood clots, especially warfarin
  • Midazolam
  • Cyclosporin
  • Medicines used to treat high cholesterol
  • Calcium channel blockers
  • Carbamazepine
  • Quinidine
  • Antiviral medicines for HIV infection
  • Medicines that you buy at the chemist, supermarket or health food shop.

These medicines may affect the way BICALUTAMIDE-GA works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines. If you have not told your doctor about any of these things, tell them before you take any BICALUTAMIDE-GA.

How to take BICALUTAMIDE-GA

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, you must ask your doctor or pharmacist for help.

How much to take

The usual adult does is one 50mg tablet taken each day.

How to take it

Swallow your BICALUTAMIDE-GA tablet whole with a full glass of water.

When to take it

It does not matter if you take BICALUTAMIDE-GA before, with or after food. Take it at about the same time each day.

How long to take it

Continue taking BICALUTAMIDE-GA for as long as your doctor or pharmacist tells you.

If you forget to take it

If you miss a dose take it as soon as you remember, as long as it is 12 hours before the next dose is due.

If it is less than 12 hours to the next dose do not take the dose you have missed.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (Overdose)

Immediately telephone your doctor or pharmacist or the poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much BICALUTAMIDE-GA. Do this even if there are no signs of discomfort or poisoning.

While you are using BICLAUTAMIDE-GA

Things you must do

Be sure to keep all your appointments with your doctor so your progress can be checked.

Tell any other doctors, dentists and pharmacists who are treating you that you are taking BICALUTAMIDE-GA.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking BICALUTAMIDE-GA.

If you go into hospital, please let the medical staff know you are taking BICALUTAMIDE-GA.

Things you must not do

Do not give BICALUTAMIDE-GA to anyone else, even if they have the same condition as you.

Do not take BICALUTAMIDE-GA to treat any other complaints unless your doctor tells you so.

Do not stop taking BICALUTAMIDE-GA, or lower the dosage, without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how BICALUTAMIDE-GA affects you. Some patients may feel dizzy or weak.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking BICALUTAMIDE-GA. BICALUTAMIDE-GA helps people with locally advanced prostate cancer, but it may have unwanted side effects.

All medicines can have side effects. Sometime they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor as soon as possible if you notice any of the following and they worry you:

  • breast tenderness or changes in breast size
  • hot flushes or sweating
  • itching or dry skin
  • increased hairiness or hair loss
  • aches or pains anywhere in your body
  • nausea (feeling sick)
  • constipation
  • weight changes
  • stomach pain
  • unusual tiredness or weakness
  • decrease in your sexual drive
  • inability to get or maintain an erection
  • diarrhoea
  • depression
  • dizziness or light-headedness
  • sleeplessness

These are possible side effects of BICALUTAMIDE-GA.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:

  • frequent urination
  • shortness of breath and dizziness when exercising and looking pale (anaemia)
  • excessive thirst with weight loss, and passing large amounts of urine

These are all serious side effects.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:

  • chest pain
  • yellowing of the skin or eyes and dark coloured urine
  • rash, hives or severe itching of the skin
  • swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing
  • swelling of other parts of the body including hands, feet or ankles
  • serious breathlessness, or sudden worsening of breathlessness, possibly with a cough or fever
  • shortness of breath, wheezing or trouble breathing

These are all serious side effects. You may need urgent medical attention or hospitalisation. Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Some people may get other effects while taking BICALUTAMIDE-GA.

After using BICALUTAMIDE-GA

Storage

Keep your BICALUTAMIDE-GA tablets in the blister foil until it is time to take them. If you take BICALUTAMIDE-GA out of the blister foil, it will not keep well.

Keep it in a cool dry place where the temperature stays below 30°C.

Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it on a window sill or in the car on hot days. Heat and dampness can destroy some medicines.

Keep your medicine where children cannot reach it. A locked cupboard at least 1½ metres above the ground is a good place to store medicines.

Disposal

Ask your pharmacist what to do with any tablets you have left over if your doctor tells you to stop taking them, or you find that the expiry date has passed.

Product description

What it looks like

BICALUTAMIDE-GA 50mg tablets are white to off white, round film-coated, biconvex tablets, engraved with ‘BC 50’ on one face and plain on other.

BICALUTAMIDE-GA tablets are available in blister packs of 28 tablets.

Ingredients

Active ingredient:

  • bicalutamide 50mg

Inactive ingredients:

  • lactose
  • sodium starch glycollate
  • povidone
  • magnesium stearate
  • hypromellose
  • titanium dioxide
  • macrogol 400

BICALUTAMIDE-GA does not contain:

  • added sucrose
  • gluten
  • tartrazine or any other azo dyes.

Supplier

wwww.ascentpharma.com.au

Ascent Pharma Pty Ltd
151-153 Clarendon Street
South Melbourne Vic. 3205

For further information call 1800 554 414

AUST R 129115

This leaflet was prepared in June 2010

Published by MIMS March 2014