Calutex 50 mg
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about Calutex. It does not contain all the information that is known about Calutex.
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 Calutex 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 Calutex is used for
Calutex 50 mg is used in combination with other medicines to treat advanced prostate cancer.
Calutex 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. Calutex interferes with some of the actions of these hormones.
Calutex 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 prescribe this medicine for another use. Ask your doctor if you want more information.
Calutex is not addictive.
Before you use Calutex
When you must not use it
Do not take Calutex if you are a woman. Women are not normally treated with Calutex.
Do not give Calutex to children. There is no experience of its use in children.
Do not take Calutex if you are allergic to bicalutamide or any of the other ingredients in Calutex.
Do not take Calutex if you are taking cisapride or the antihistamines, terfenadine and astemizole.
Do not take Calutex after the use by (expiry) date printed on the pack. It may have no effect at all or an unexpected effect if you take it after the expiry date.
Do not take Calutex 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 use it
You must tell your doctor if:
1.you have allergies to:
bicalutamide, the active ingredient in Calutex
any of the other ingredients of Calutex 50 mg 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 a skin rash, hayfever, or have difficulty breathing or feel faint.
2.you have liver problems
It may not be safe for you to take Calutex 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
medicines used to treat high cholesterol
calcium channel blockers
antiviral medicines for HIV infection
medicines that you buy at the chemist, supermarket or health food shop
These medicines may affect the way Calutex 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 him/her before you take any Calutex.
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.
Swallow your Calutex tablet whole with a full glass of water.
When to take it
Take Calutex at about the same time each day.
Calutex 50 mg 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 Calutex before, with or after food.
How long to take it
Continue taking Calutex 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.
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 Calutex. Do this even if there are no signs of discomfort or poisoning.
While you are using it
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 Calutex.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking Calutex.
If you go into hospital, please let the medical staff know you are taking Calutex.
Things you must not do
Do not give Calutex to anyone else, even if they have the same condition as you.
Do not take Calutex to treat any other complaints unless your doctor tells you to.
Do not stop taking Calutex, or lower the dosage, without checking with your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how Calutex affects you. Some patients may feel dizzy or weak.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Calutex. Calutex 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
loss of appetite or weight changes
unusual tiredness or weakness
dizziness or light-headedness
decrease in your sexual drive
inability to get or maintain an erection
These are possible side effects of Calutex.
Tell your doctor immediately if you notice any of the following:
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.
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 Calutex.
After using Calutex
Keep your Calutex tablets in the blister foil until it is time to take them. If you take Calutex out of the blister foil, 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 1½ metres above the ground is a good place to store medicines.
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.
What Calutex looks like
Calutex 50 mg tablets are white, biconvex film-coated tablets.
Calutex tablets are packed in blister foils of 28 tablets.
Each Calutex 50 mg tablet contains 50 mg of bicalutamide as the active ingredient, plus
sodium starch glycollate
Calutex does not contain added sucrose, gluten, tartrazine or any other azo dyes.
Australian registration numbers
Calutex 50 mg
AUST R 135858
This product is supplied in Australia by:
Sigma Pharmaceuticals (Australia) Pty Ltd
96 Merrindale Drive
Croydon, Vic, 3136
Southern Cross Pharma Pty Ltd
56 Illabunda Drive
Malua Bay, NSW, 2536
ABN 47 094 447 677
Date of Information: 21 August, 2007
Published by MIMS/myDr June 2009
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