INFORMATION FOR CONSUMERS
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This leaflet answers some of the common questions people ask about Zoladex 10.8. It does not contain all the information that is known about Zoladex 10.8.
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 Zoladex 10.8 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.
Zoladex 10.8 can treat prostate cancer in some men. It is not a cure for prostate cancer and does not work in every patient with prostate cancer.
For endometriosis, Zoladex 10.8 may be used instead of surgery. Zoladex 10.8 is not a cure for Endometriosis. Zoladex 10.8 may be helpful by reducing:
Endometriosis has no connection with any type of cancer.
Fibroids are growths in the womb which are not cancer.
For fibroids, Zoladex 10.8 may be used before surgery. Zoladex 10.8 is not a cure for Uterine Fibroids and may be helpful by reducing:
Your doctor will help you understand the benefits of having Zoladex 10.8 for your particular problem. Ask your doctor for further information if he/she has prescribed this medicine for a different purpose.
Zoladex 10.8 is not addictive.
Zoladex 10.8 is a special preparation of goserelin acetate which is designed to work in the body for 12 to 13 weeks after each injection. Most people will need one injection for each 12 to 13 weeks of treatment. Zoladex 10.8 is otherwise similar to Zoladex 3.6 mg Implant which you may have received in the past. The Zoladex 3.6 mg Implant lasts for only 28 days.
Zoladex 10.8 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). In men it will reduce levels of the male hormone, testosterone. In women it will reduce the levels of the female hormone, oestrogen.
In women, female hormones make the breasts grow, prepare the womb and other sex organs for pregnancy, and increase the sex drive.
In men, male hormones make the testicles grow, assist an erection, and increase the sex drive.
When Zoladex 10.8 lowers sex hormones, all these actions will be reduced. Due to the action of Zoladex 10.8 on hormones, Zoladex 10.8 can treat very different illnesses in both men and women.
When women are treated with Zoladex 10.8, the amount of calcium in their bones decreases over a period of months. Some recovery of this loss can occur when treatment is stopped. A similar condition also happens after the change of life, when the natural production of female sex hormones falls. The link between the loss of calcium while on Zoladex 10.8 and the loss of calcium after the change of life (menopause) is uncertain. However, women who have a family history of osteoporosis and other risk factors should discuss the use of Zoladex 10.8 with their doctor before using Zoladex 10.8.
If you have not told your doctor about any of the above, tell him/her before you receive any Zoladex 10.8.
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.
Do not use Zoladex 10.8 if:
The packaging is torn or shows signs of tampering.
Zoladex 10.8 will be given to you as an injection by your doctor or a nurse.
Zoladex 10.8 comes in a special syringe and needle. A small pellet containing Zoladex 10.8 is injected under the skin. The injection is often at the front of the stomach or to the side of the stomach.
The injection leaves a small pellet underneath your skin. This pellet is designed to give you a dose of Zoladex 10.8 which is released over 12 to 13 weeks. This means your injection will be given every 12 to 13 weeks. Your doctor will tell you for how long you may need to take Zoladex 10.8. It is important that you carry on receiving your Zoladex 10.8 even if feeling well unless your doctor decides it is time for the treatment to stop.
Women should only receive Zoladex 10.8 for a maximum of 6 months.
You should not delay or miss your 12 or 13 weekly Zoladex 10.8. This may lead to the treatment not working.
Tell your doctor if you miss your 12 or 13 weekly treatment of Zoladex 10.8. If you have missed a dose on purpose because you do not like a side effect of the injection, discuss this with your doctor. Talk to your doctor if you do not want to receive any more Zoladex 10.8 injections because of side effects or for any other reason.
Getting too much Zoladex 10.8 is unlikely as overdose is getting more than one Zoladex 10.8 injection in 12 or 13 weeks. If a person received more than one injection in 12 or 13 weeks, Zoladex 10.8 would act for a bit longer. Tell your doctor if you think you have received too much Zoladex 10.8.
Telephone your doctor or the National Poisons and Hazardous Chemicals Information Centre (Ph: 0800 POISON or 0800 764 766) or go to casualty at your nearest hospital immediately if you think that you or anyone else may have taken too much Zoladex 10.8. Even if there are no signs of discomfort or poisoning.
If you are a woman receiving therapy with Zoladex 10.8, barrier methods of contraception such as the condom or diaphragm (cap) should be used. Oral forms of contraception (the "Pill") should not be taken when receiving Zoladex 10.8. If you become pregnant while receiving Zoladex 10.8, tell your doctor immediately.
If you go into hospital, let the medical staff know you are receiving Zoladex 10.8.
If you are about to be started on any new medicine, tell your doctor or pharmacist that you are receiving Zoladex 10.8
You should only stop receiving Zoladex 10.8 if advised to do so by your doctor.
It is unlikely that Zoladex 10.8 will affect your ability to drive a car or to operate machinery.
If you are unsure about any of these points or have further questions please tell your doctor of pharmacist.
Do not be alarmed by the following list of possible side effects. You may not experience any of them.
Zoladex 10.8 begins to work in the two weeks after the first injection. You should expect to notice changes in your body because your sex hormones will fall to low levels.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Zoladex 10.8.
Zoladex 10.8 helps most people with endometriosis, fibroids, or 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 have.
Tell your doctor if you notice any of the following and they worry you.
In the very rare case, when patients receiving Zoladex 10.8 have a tumour in their pituitary gland, Zoladex 10.8 may make the tumour bleed or collapse. This can cause severe headaches, sickness, loss of eyesight and unconsciousness.
These are side effects in both men and women.
Sometimes side effects may be symptoms of the prostate cancer you are being treated for. Therefore you should always tell your doctor if you notice any possible side effect.
For most men, their sex life will be poor during treatment with Zoladex 10.8. You may have a low sex drive. You may not be able to get an erection or father a child. However, Zoladex 10.8 is not a contraceptive for men and should never be used in that way.
You may get hot flushes and sweating. Some men may get swollen or tender, breasts. The testicles may become smaller.
When you first start receiving Zoladex 10.8 you may feel some pain in your bones. If this happens tell your doctor and you may be given something for this.
Very occasionally you may have trouble passing urine or experience lower back pain. If this happens, tell your doctor and you may be given something for this.
Most women get signs of the change of life (menopause) while on Zoladex 10.8 such as:
Formation of ovarian cysts may occur, which may result in pain in some women.
Zoladex 10.8 will usually stop your periods. Some women will have a menstrual period in the first 2 weeks after the first injection of Zoladex 10.8. Rarely, some women may enter their natural menopause when being treated with Zoladex 10.8 and will not resume having periods when the treatment with Zoladex 10.8 stops. In some women, the time it takes for periods to begin again after they stop receiving Zoladex 10.8, can be prolonged.
Vaginal bleeding may occur. If you have fibroids, a slight increase in symptoms such as pain may occur. These effects are usually short-lived and discontinue on continuation of treatment. If symptoms persist or you are uncomfortable, contact your doctor. In addition if you experience excessive nausea, vomiting or thirst, you should tell your doctor. This may indicate possible changes in the amount of calcium in your blood and your doctor may have to do certain blood tests.
Important: This leaflet alerts you to some of the situations when you should call your doctor. Other situations, which cannot be predicted, may arise. Nothing in this leaflet should stop you from calling your doctor or pharmacist with any questions or concerns you have about using Zoladex 10.8.
Keep your Zoladex 10.8 in the original packet. Let your doctor or nurse break the seal.
Keep 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 in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it 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.
Once your doctor has given you the Zoladex 10.8 Implant, he or she will dispose of the syringe and needles. If your Zoladex 10.8 has passed its expiry date, ask your doctor or pharmacist how to dispose of it.
Zoladex 10.8 comes in a special syringe and needle. The small pellet containing Zoladex 10.8 is about the size of a grain of rice. This pellet is located inside the syringe. Zoladex 10.8 comes in packs of one injection.
Zoladex 10.8 contains goserelin acetate. The pellet is made of a combination of two white or cream coloured substances called polyglactins. Polyglactin is like a starch.
AstraZeneca Limited
PO Box 1301, Auckland.
Ph:(09) 623 6300 or 0800 363 200.
Trademarks herein are the property of the AstraZeneca group.
6 July 2000