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ZOLADEX® 10.8 mg Implant SafeSystem™
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 ZOLADEX 10.8 mg?
ZOLADEX 10.8 mg contains the active ingredient goserelin acetate. ZOLADEX 10.8 mg is used to lower the amount of sex hormones in the body. ZOLADEX 10.8 mg is used to treat prostate cancer in some men.
For more information, see Section 1. Why am I using ZOLADEX 10.8 mg? in the full CMI.
2. What should I know before I use ZOLADEX 10.8 mg?
Do not use if you have ever had an allergic reaction to goserelin acetate or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions or take any other medicines.
For more information, see Section 2. What should I know before I use ZOLADEX 10.8 mg? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with ZOLADEX 10.8 mg and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use ZOLADEX 10.8 mg?
A ZOLADEX 10.8 mg implant will be injected into the skin of your stomach every 3 months.
More instructions can be found in Section 4. How do I use ZOLADEX 10.8 mg? in the full CMI.
5. What should I know while using ZOLADEX 10.8 mg?
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Things you should do |
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Things you should not do |
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Driving or using machines |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using ZOLADEX 10.8 mg? in the full CMI.
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 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 or have a tumour in your pituitary gland which causes severe headaches, sickness, loss of eyesight and unconsciousness. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
ZOLADEX® 10.8 mg Implant SafeSystem™
Active ingredient: goserelin acetate
Consumer Medicine Information (CMI)
This leaflet provides important information about using ZOLADEX 10.8 mg. 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 ZOLADEX 10.8 mg.
Where to find information in this leaflet:
1. Why am I using ZOLADEX 10.8 mg?
ZOLADEX 10.8 mg contains the active ingredient goserelin acetate. ZOLADEX 10.8 mg is a member of the anti-hormonal group of medicines. This means that it affects the levels of various hormones (natural chemicals produced by the body).
ZOLADEX 10.8 mg is used to treat prostate cancer in some men. It is not a cure for prostate cancer. ZOLADEX lowers the amount of sex hormones in the body. In men it reduces the level of testosterone.
2. What should I know before I use ZOLADEX 10.8 mg?
Warnings
Do not use ZOLADEX 10.8 mg if:
- you are allergic to goserelin acetate, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
Symptoms of an allergic reaction may include:
- rash
- hay fever
- difficulty breathing
- feeling faint
Check with your doctor if you:
- have any other medical conditions (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 ZOLADEX 10.8 mg.
- take any medicines for any other conditions
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
ZOLADEX 10.8 mg will not normally be used in females. There is not enough evidence to support its use in women.
It is also unlikely that you can father a child while using ZOLADEX 10.8 mg, but you must use your normal contraceptive method to make sure.
Children
Do not give ZOLADEX 10.8 mg to children.
There is no information on its use in children.
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.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ZOLADEX 10.8 mg.
4. How is ZOLADEX 10.8 mg given?
How much you will be given
- A ZOLADEX 10.8 mg implant will be injected into the skin of your stomach every 3 months.
- The implant is a very small pellet that is given by a special needle and syringe known as SafeSystem. The injection will not hurt very much.
- The pellet is designed to slowly release the medicine into your body over 3 months.
- The ZOLADEX 10.8 mg SafeSystem incorporates a protective needle sleeve that automatically locks in place following administration of the implant to aid in the prevention of needle stick injury.
If you forget to be given ZOLADEX 10.8 mg
Your doctor will make an appointment for your next dose, so you will not forget your next dose.
If you use too much ZOLADEX 10.8 mg
The doctor or nurse giving you ZOLADEX 10.8 mg will be experienced in the use of it, so it is unlikely that you will be given an overdose.
5. What should I know while using ZOLADEX 10.8 mg?
Things you should do
Make sure to keep your appointment for being given ZOLADEX 10.8 mg every 3 months.
If you do not, your testosterone level will rise and the prostate cancer may grow more quickly.
Remind any doctor, dentist or pharmacist you visit that you are using ZOLADEX 10.8 mg.
Things you should not do
- Do not stop being given ZOLADEX 10.8 mg unless you have discussed it with your doctor first.
They will have explained why you need to be given ZOLADEX and for how long.
- Do not use 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 ZOLADEX 10.8 mg affects you.
Looking after your medicine
- Keep 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.
Serious side effects
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Serious side effects |
What to do |
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Tell your doctor immediately if any of these things happen while you are using ZOLADEX 10.8 mg:
These may mean that the cancer is growing. If you have a tumour in your pituitary gland, ZOLADEX 10.8 mg may make the tumour bleed or collapse. This is very rare but causes severe headaches, sickness, loss of eyesight and unconsciousness. |
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. |
You may experience the following side effects:
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Very common (may affect more than 1 in 10 people) |
What to do |
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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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Common (may affect up to 1 in 10 people) |
What to do |
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Speak to your doctor if you have any of these common side effects and they worry you. |
ZOLADEX 10.8 mg 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 ZOLADEX 10.8 mg contains
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Active ingredient |
goserelin (as the acetate) |
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Other ingredients |
polyglactin |
Do not take this medicine if you are allergic to any of these ingredients.
What ZOLADEX 10.8 mg looks like
ZOLADEX 10.8 mg (Aust R 55242) comes in a special syringe, called the SAFESYSTEM, and a siliconised needle.
The small pellet containing ZOLADEX 10.8 mg is about the size of a grain of rice. It can be seen in the "window" half way up the syringe and is white or cream coloured.
Who distributes ZOLADEX 10.8 mg
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone:- 1800 805 342
This leaflet was prepared in May 2024.
Zoladex, Zoladex SafeSystem and SafeSystem are trade marks of the AstraZeneca group of companies.
© AstraZeneca 2024
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