What is in this leaflet
This leaflet answers some of the common questions about Bicalutamide Ranbaxy.
It does not contain all the available information.
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 Ranbaxy against the benefits it is expected to 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 Ranbaxy is used for
The name of your medicine is Bicalutamide Ranbaxy. It contains the active ingredient bicalutamide.
Bicalutamide is used in combination with other medicines to treat advanced prostate cancer.
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.
Follow all directions given to you by your doctor.
They may differ from the information in this leaflet.
Your doctor may have prescribed this medicine for another use. Ask your doctor if you want more information.
Bicalutamide Ranbaxy is not addictive.
Before you take Bicalutamide Ranbaxy
When you must not use it
Do not take this medicine if you are a woman.
Women are not normally treated with bicalutamide.
Do not give this medicine to children.
There is no experience of its use in children.
Do not take this medicine if:
- you are allergic to the active ingredient bicalutamide, or any of the other ingredients in Bicalutamide Ranbaxy tablets (see ‘Product Description’ section)
- you are taking cisapride or the antihistamines terfenadine and astemizole.
- the tablets have passed its use-by (expiry) date printed on the pack. It may not work as well if you take it after the expiry date
- 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 use it
You must tell your doctor if:
- you are allergic to:
- Bicalutamide Ranbaxy tablets or any of the ingredients listed at the end of this leaflet (including lactose)
- 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 a skin rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, or have difficulty breathing or feel faint.
- you have liver problems
It may not be safe for you to take bicalutamide if you have problems with your liver.
Taking other medicines
Tell your doctor if you are taking any other medicines, including:
- cisapride (see ‘When you must not use it’)
- the antihistamines terfenadine and astemizole (see ‘When you must not use 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 Ranbaxy 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 Ranbaxy.
How to take Bicalutamide Ranbaxy
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, ask your doctor or pharmacist for help.
How much to take
The usual adult dose is one 50 mg tablet taken each day.
How to take it
Swallow your tablet whole with a full glass of water.
When to take it
Take the tablet(s) at about the same time each day.
Bicalutamide Ranbaxy tablets should be started at the same time as the other medicines you have been given for the treatment of prostate cancer.
It does not matter if you take it before, with or after food.
How long to take it
Continue taking your medicine for as long as your doctor tells you to.
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.
Do this even if there are no signs of discomfort or poisoning.
While you are taking Bicalutamide Ranbaxy
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 Ranbaxy.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Bicalutamide Ranbaxy.
If you go into hospital, let the medical staff know you are taking Bicalutamide Ranbaxy.
Things you must not do
Do not give this medicine to anyone else, even if they have the same condition as you.
Do not take this medicine to treat any other complaints unless your doctor tells you to.
Do not stop taking this medicine, 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 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 Ranbaxy.
Bicalutamide helps people with advanced prostate cancer, but it may have unwanted side effects in a few people.
All medicines can have side effects. Sometimes 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:
- hot flushes or sweating
- breast tenderness or changes in breast size
- itching or dry skin
- increased hairiness or hair loss
- stomach pain or indigestion
- nausea or vomiting
- diarrhoea or constipation
- flatulence (wind)
- dry mouth
- loss of appetite or weight changes
- depression
- unusual tiredness or weakness
- dizziness or light-headedness
- difficulty sleeping
- headache
- chills
- pelvic pain
- decrease in your sexual drive
- inability to get or maintain an erection
These are possible side effects of Bicalutamide Ranbaxy.
Tell your doctor immediately if you notice any of the following:
- 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 side effects may be serious.
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 Ranbaxy.
After using Bicalutamide Ranbaxy
Storage
Keep your tablets in its original packaging until it is time to take them.
If you take the tablets out of the original packaging, it will not keep well.
Keep it in a cool dry place where the temperature stays below 25°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 one-and-a-half 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 the tablets look like
Bicalutamide Ranbaxy 50 mg tablets are white to off-white, round, unscored tablets, engraved “APO” on one side and “BIC” over “50” on the other side. Available in packs of 28 tablets.
Ingredients
Each tablet contains 50 mg of bicalutamide as the active ingredient.
The tablets also contain the following inactive ingredients:
- croscarmellose sodium
- lactose anhydrous
- microcrystalline cellulose
- magnesium stearate
- silica colloidal anhydrous
- hypromellose
- hydroxypropylcellulose
- macrogol 8000
- titanium dioxide
This medicine does not contain added sucrose, gluten, tartrazine or any other azo dyes.
Australian Registration Number
Bicalutamide Ranbaxy 50 mg tablets:
AUST R 139574.
Supplier
Ranbaxy Australia Pty Ltd
Suite 4.02, Level 4, Building D
Talavera Road
North Ryde NSW 2113
Australia
This leaflet was prepared in:
Oct 2008.