Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using ZOLACOS CP?
ZOLACOS CP contains the active ingredient goserelin and bicalutamide. ZOLACOS CP is
used to treat advanced prostate cancer in men. It is not a cure for prostate cancer.
Bicalutamide tablets can also be used to treat disease flare associated with previous
goserelin therapy.
2. What should I know before I use ZOLACOS CP?
Do not use if you have ever had an allergic reaction to ZOLACOS CP or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with ZOLACOS CP and affect how it works.
4. How do I use ZOLACOS CP?
A ZOLADEX implant will be injected under the skin of your stomach every 28 days for
the 3.6 mg strength, or once every 3 months for the 10.8 mg strength.
One 50 mg tablet of COSUDEX is then taken each day for one or three months, as considered
appropriate by your doctor.
5. What should I know while using ZOLACOS CP?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using ZOLACOS CP.
Keep all your appointments with your doctor so your progress can be checked.
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Things you should not do
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Do not give ZOLACOS CP to anyone else, even if they have the same condition as you.
Do not use ZOLACOS CP to treat any other complaints unless your doctor tells you to.
Do not stop taking ZOLACOS CP, or change the dosage, without checking with your doctor.
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Driving or using machines
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Be careful driving or operating machinery until you know how ZOLACOS CP affects you.
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Looking after your medicine
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Keep your tablets in the blister foil until it is time to take them.
Keep the implant in its foil packaging until it is time for administration by your
doctor.
Keep the packaging in a cool dry place where the temperature stays below 25°C.
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6. Are there any side effects?
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. Tell your doctor immediately if you have 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 and shortness
of breath, wheezing or trouble breathing.
Active ingredients: bicalutamide and goserelin
Consumer Medicine Information (CMI)
This leaflet provides important information about using ZOLACOS CP. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ZOLACOS CP.
Where to find information in this leaflet:
1. Why am I using ZOLACOS CP?
ZOLACOS CP contains the active ingredient goserelin and bicalutamide. ZOLACOS CP is a combination pack consisting of an anti-androgen (COSUDEX) medicine
and a Luteinising Hormone Releasing Hormone (LHRH) agonist (ZOLADEX). Androgens such
as testosterone are natural male sex hormones. In some types of prostate cancer, androgens
may help the cancer cells to grow. LHRH agonists reduce the level of testosterone
in men. ZOLACOS CP interferes with some of the actions of these hormones.
ZOLACOS CP is used to treat advanced prostate cancer in men. It is not a cure for
prostate cancer. Bicalutamide tablets can also be used to treat disease flare associated
with previous goserelin therapy.
ZOLACOS CP should only be taken by men.
2. What should I know before I use ZOLACOS CP?
Warnings
Do not use ZOLACOS CP if:
you are a woman or a child.
you are allergic to bicalutamide, goserelin or any of the ingredients listed at the
end of this leaflet.
you are allergic to other anti-androgen medicines or other LHRH agonists.
Always check the ingredients to make sure you can use this medicine.
you are taking cisapride or the antihistamines, terfenadine and astemizole.
Symptoms of an allergic reaction may include:
skin rash
hay fever
difficulty breathing
feeling faint
Check with your doctor if you:
have heart or blood vessel conditions, including heart rhythm problems (arrhythmia),
or are being treated with medicines for these conditions. The risk of you having further
heart rhythm problems may increase if you are taking ZOLACOS CP.
have liver problems. It may not be safe for you to use ZOLACOS CP if you have problems
with your liver.
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
ZOLACOS CP may cause a period of low fertility or infertility whilst you are taking
it and for a period afterwards. NOTE however that you may not be infertile. As ZOLACOS
CP may affect your sperm, effective contraception must be used by you and/or your
partner while you are taking ZOLACOS CP and for at least 130 days after you have stopped
taking ZOLACOS CP.
It is also unlikely that you can father a child while using ZOLACOS CP, but you must
use your normal contraceptive method to make sure.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with ZOLACOS CP and affect how it works.
Tell your doctor if you are taking any other medicines, including:
cisapride (see Warnings)
the antihistamines terfenadine and astemizole (see Warnings)
medicines used to prevent blood clots, especially warfarin as ZOLACOS CP may reduce
their effectiveness which may lead to bleeding and you therefore may need monitoring
midazolam
ciclosporin
medicines used to treat high cholesterol
calcium channel blockers
carbamazepine
quinidine
antiviral medicines for HIV infection
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ZOLACOS CP.
4. How do I use ZOLACOS CP?
How much to take
A ZOLADEX implant will be injected under the skin of your stomach every 28 days for
the 3.6 mg, or once every 3 months for the 10.8 mg strength.
One 50 mg tablet of COSUDEX is then taken each day for one or three months, as considered
appropriate by your doctor.
Swallow your tablet whole with a full glass of water.
When to take ZOLACOS CP
The implant will be administered once a month or once every three months by your doctor.
Take the tablets at about the same time each day.
It does not matter if you take the tablets before, with or after food.
How long to take ZOLACOS CP
Your doctor will tell you how long you will need to be given ZOLACOS CP.
If you forget to use ZOLACOS CP
COSUDEX should be used regularly at the same time each day. If you miss taking a tablet,
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, skip the dose you missed and take your
next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much ZOLACOS CP
If you think that you have used too much ZOLACOS CP, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using ZOLACOS CP?
Things you should do
Be sure to keep all your appointments with your doctor so your progress can be checked.
This is to ensure that your hormone levels will not rise and your illness will not
get worse.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist
that you are taking ZOLACOS CP.
If you go into hospital, please let the medical staff know you are taking ZOLACOS
CP.
Remind any doctor, dentist or pharmacist you visit that you are using ZOLACOS CP.
Things you should not do
Do not give ZOLACOS CP to anyone else, even if they have the same condition as you.
Do not use ZOLACOS CP to treat any other complaints unless your doctor tells you to.
Do not stop taking ZOLACOS CP, or change the dosage, without checking with your doctor.
Do not use ZOLACOS CP if the packaging is torn or shows signs of tampering.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ZOLACOS
CP affects you.
Some patients may feel dizzy or weak.
Looking after your medicine
Keep your tablets in the blister foil until it is time to take them. If you take the tablets out of the blister foil, they will not keep well.
Keep the implant in its foil packaging until it is time for administration by your
doctor.
Keep the packaging in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
You may experience the following side effects:
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Very common (may affect more than 1 in 10 people)
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What to do
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hot flushes or sweating
breast tenderness or changes in breast size
stomach pain or indigestion
nausea or vomiting
diarrhoea or constipation
unusual tiredness or weakness
dizziness or light-headedness
changes in blood pressure
headache
chills
tingling in fingers or toes
decrease in your sexual drive
inability to get or maintain an erection
your testicles getting smaller
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Speak to your doctor if you have any of these very common side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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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
dizziness when exercising and looking pale (anaemia)
frequent urination
excessive thirst with weight loss, and passing large amounts of urine
Tell your doctor immediately if any of these things happen while you are using ZOLACOS
CP:
have trouble passing urine
feel weak in the arms or legs
feel numb in the arms or legs
have pain in the kidneys
have pain in the bones or backbone
These may mean that the cancer is growing.
If you have a tumour in your pituitary gland, ZOLACOS CP may make the tumour bleed
or collapse. This is very rare but causes severe headaches, sickness, loss of eyesight
and unconsciousness.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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ZOLACOS CP lowers the amount of sex hormones in your body so your sex drive will probably
be reduced.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ZOLACOS CP contains
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Active ingredient
(main ingredient)
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bicalutamide and goserelin (as the acetate)
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Other ingredients
(inactive ingredients)
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COSUDEX contains:
lactose monohydrate
sodium starch glycolate
povidone
magnesium stearate (E572)
hypromellose
macrogol 300
titanium dioxide (E171)
ZOLADEX contains:
polyglactin
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Potential allergens
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lactose
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Do not take this medicine if you are allergic to any of these ingredients.
What ZOLACOS CP looks like
ZOLACOS CP contains a syringe with a small pellet containing goserelin and is about
the size of a grain of rice. It can be seen in the "window" halfway up the syringe
and is white or cream coloured.
The tablets are packaged in a blister strip and are white, round film-coated tablets.
One side of the tablet is marked CDX 50 and the other side has an arrow shape.
The tablets are packed in blister foils of 28 tablets.
ZOLACOS CP is available in three different combinations:
1 x Zoladex 3.6 mg implant syringe + 28 (1 month) tablets Cosudex 50 mg (Aust R 125685).
1 x Zoladex 10.8 mg implant syringe + 28 (1 month) tablets Cosudex 50 mg (Aust R 125687).
1 x Zoladex 10.8 mg implant syringe + 84 (3 month) tablets Cosudex 50 mg (Aust R 125687).
Who distributes ZOLACOS CP
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in July 2024.
ZolaCos, Cosudex, Zoladex and Zoladex SafeSystem are registered trademarks of the
AstraZeneca group of companies.
© AstraZeneca 2024
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