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ZOLADEX 3.6MG IMPLANT

Active substance: GOSERELIN ACETATE

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When Zoladex is used to treat breast cancer, the following can happen:
• Worsening of the symptoms of your breast cancer at the beginning of treatment. This can include
an increase in pain or an increase in the size of the affected tissue. These effects do not usually last
long and they usually go away as treatment with Zoladex is continued. However, if the symptoms
continue or you are uncomfortable, talk to your doctor.
• Changes in the amount of calcium in your blood. The signs may include feeling very sick, being sick
a lot or being very thirsty. If this happens to you, talk to your doctor as he or she may need to do
blood tests.
When Zoladex is used to treat infertility with another medicine called gonadotrophin, the following
can happen:
• It can have too much of an effect on your ovaries. You may notice stomach pain, swelling of your
stomach, and feeling or being sick. If this happens, tell your doctor straight away.
Do not be concerned by this list of possible side effects. You may not get any of them.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Zoladex
• Your doctor may give you a prescription so that you can get your medicine from the pharmacy and
give it to your doctor when you see him or her again.
• Keep this medicine out of the sight and reach of children.
• Keep it in its original package and do not break the seal.
• Do not store it above 25°C.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers
to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Zoladex 3.6 mg Implant contains
The active substance is goserelin. Each Zoladex 3.6 mg Implant contains 3.6 mg of goserelin.
The other ingredient is lactide/glycolide copolymer which is an inactive substance.
What Zoladex 3.6 mg Implant looks like and contents of the pack
Zoladex 3.6 mg Implant comes as an implant (a very small pellet) in a pre-filled syringe, ready to be
used by the doctor or nurse.
Zoladex 3.6 mg Implant is produced in packs of one implant (injection).
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Zoladex 3.6 mg Implant is held by AstraZeneca UK Limited,
600 Capability Green, Luton, LU1 3LU, UK.
Zoladex 3.6 mg Implant is manufactured by AstraZeneca UK Limited, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, UK.

To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Zoladex 3.6 mg Implant
Reference number
17901/0064
This is a service provided by the Royal National Institute of
the Blind.
This leaflet was last revised in November 2014
© AstraZeneca 2014
Zoladex is a trade mark of the AstraZeneca group of companies.
ONC 14 0041

Package leaflet: Information for the user

P039535

Zoladex ® 3.6 mg Implant
goserelin

Read all of this leaflet carefully before you start using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even
if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Zoladex is and what it is used for
2. What you need to know before you use Zoladex
3. How to use Zoladex
4. Possible side effects
5. How to store Zoladex
6. Contents of the pack and other information
Most of the information in this leaflet applies to both men and women.
• Where information only applies to men, it is shown by the heading Information for men.
• Where information only applies to women, it is shown by the heading Information for women.
1. What Zoladex is and what it is used for
Zoladex contains a medicine called goserelin. This belongs to a group of medicines called ‘LHRH
analogues’.
Use of Zoladex by men
In men, Zoladex is used to treat prostate cancer. It works by reducing the amount of ‘testosterone’
(a hormone) that is produced by your body.
Use of Zoladex by women
In women, Zoladex is used to:
• Treat breast cancer.
• Treat a condition called ‘endometriosis’. This is where cells normally only found in the lining of the
womb (uterus) are found elsewhere in your body (normally on other structures near the womb).
• Treat benign growths in the womb called ‘uterine fibroids’.
• Make the lining of the womb thinner before you have an operation on your womb.
• Help treat infertility (together with other medicines). It helps to control the release of eggs from the
ovaries.
In women, Zoladex works by reducing the amount of ‘oestrogen’ (a hormone) that is produced by
your body.
2. What you need to know before you use Zoladex
Do not use Zoladex:
• if you are allergic to goserelin or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breast-feeding (see the section on ‘Pregnancy and breast-feeding’ below).
Do not have Zoladex if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist
or nurse before having Zoladex.
Warnings and precautions
If you go into hospital, tell the medical staff that you are having Zoladex.
Talk to your doctor, pharmacist or nurse before using Zoladex:
• if you have high blood pressure.
• if you have any heart or blood vessel conditions, including heart rhythm problems (arrhythmia),
or are being treated with medicines for these conditions. The risk of heart rhythm problems may be
increased when using Zoladex.
There have been reports of depression in patients taking Zoladex which may be severe. If you are taking
Zoladex and develop depressed mood, inform your doctor.
Children
Zoladex should not be given to children.

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Information for men
Talk to your doctor, pharmacist or nurse before using Zoladex:
• if you have problems passing urine (water) or problems with your back.
• if you have diabetes.
• if you have any condition that affects the strength of your bones, especially if you are a heavy drinker,
a smoker, have a family history of osteoporosis (a condition that affects the strength of your bones) or
take anticonvulsants (medicines for epilepsy or fits) or corticosteroids (steroids).
Medicines of this type can cause a reduction in bone calcium (thinning of bones).
Information for women
Talk to your doctor, pharmacist or nurse before using Zoladex:
• if you have any condition that affects the strength of your bones, especially if you are a heavy
drinker, a smoker, have a family history of osteoporosis (a condition that affects the strength of your
bones), have a poor diet or take anticonvulsants (medicines for epilepsy or fits) or corticosteroids
(steroids).
Medicines of this type can cause a reduction in bone calcium (thinning of bones). This may improve
when treatment is stopped.
If you are having Zoladex for endometriosis, your doctor may reduce the thinning of the bones by giving
you other medicines as well.
Other medicines and Zoladex
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other
medicines. This includes medicines that you buy without a prescription and herbal medicines.
Zoladex might interfere with some medicines used to treat heart rhythm problems (e.g. quinidine,
procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used
with some other drugs (e.g. methadone (used for pain relief and part of drug addiction detoxification),
moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses).
Pregnancy, breast-feeding and fertility
• Do not have Zoladex if you are pregnant or breast-feeding.
• Do not have Zoladex if you are trying to get pregnant (unless Zoladex is being used as part of a
treatment for infertility).
• Do not use ‘the pill’ (oral contraceptives) while you are having Zoladex. Use barrier methods of
contraception, such as the condom or diaphragm (cap).
Driving and using machines
Zoladex is not likely to affect you being able to drive or use any tools or machines.
3. How to use Zoladex
• The Zoladex 3.6 mg Implant will be injected under the skin on your stomach every four weeks (28 days).
This will be done by your doctor or nurse.
• It is important that you keep having Zoladex treatment, even if you are feeling well.
• Keep having this treatment until your doctor decides that it is time for you to stop.
Your next appointment
• You should be given a Zoladex injection every 28 days.
• Always remind the doctor or nurse to set up an appointment for your next injection.
• If you are given an appointment for your next injection which is earlier or later than 28 days from
your last injection, tell your doctor or nurse.
• If it has been more than 28 days since your last injection, contact your doctor or nurse so that you
can receive your injection as soon as possible.
Information for women
• If you are having Zoladex for uterine fibroids and you have anaemia (low levels of red blood cells or
haemoglobin), your doctor may give you an iron supplement.
• The length of your treatment with Zoladex will depend on what you are having it for:
- To treat uterine fibroids, you should only have Zoladex for up to three months.
- To treat endometriosis, you should only have Zoladex for up to six months.
- To make the lining of your uterus thinner before an operation on your womb, you should only
have Zoladex for one or two months (four or eight weeks).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can happen in men or women:
Allergic reactions:
These are rare. The symptoms can include sudden onset of:
• Rash, itching or hives on the skin.
• Swelling of the face, lips or tongue or other parts of the body.
• Shortness of breath, wheezing or trouble breathing.
If this happens to you, see a doctor straight away.
Other possible side effects:
Very common (may affect more than 1 in 10 people)
• Hot flushes and sweating. Occasionally these side effects may continue for some time (possibly
months) after stopping Zoladex.
• A reduced sex drive.
• Pain, bruising, bleeding, redness or swelling where Zoladex is injected.
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Common (may affect up to 1 in 10 people)
• Thinning of your bones.
• Tingling in your fingers or toes.
• Skin rashes.
• Hair loss.
• Weight gain.
• Pain in the joints.
• Changes in blood pressure.
• Changes in your mood (including depression).
Very rare (may affect up to 1 in 10,000 people)
• Psychiatric problems called psychotic disorders which may include hallucinations (seeing, feeling or
hearing things that are not there), disordered thoughts and personality changes. This is very rare.
• The development of a tumour of the pituitary gland in your head or, if you already have a tumour in
your pituitary gland, Zoladex may make the tumour bleed or collapse. These effects are very rare.
Pituitary tumours can cause severe headaches, feeling or being sick, loss of eyesight and becoming
unconscious.
Not known (frequency cannot be estimated from the available data)
• Changes in your blood.
• Liver problems.
• A blood clot in your lungs causing chest pain or shortness of breath.
• Inflammation of the lungs. The symptoms may be like pneumonia (such as feeling short of breath
and coughing).
• Changes in ECG (QT prolongation).
Information for men
The following side effects can happen in men:
Very common (may affect more than 1 in 10 people)
• Impotence.
Common (may affect up to 1 in 10 people)
• Pain in your lower back or problems passing urine. If this happens, talk to your doctor.
• Bone pain at the beginning of treatment. If this happens, talk to your doctor.
• Reduced heart function or heart attack.
• Swelling and tenderness of your breasts.
• Rises in blood sugar levels.
Information for women
The following side effects can happen in women:
Very common (may affect more than 1 in 10 people)
• Dryness of the vagina.
• A change in breast size.
• Acne has been reported very commonly (often within one month of starting treatment).
Common (may affect up to 1 in 10 people)
• Headaches.
Rare (may affect up to 1 in 1,000 people)
• Small cysts (swellings) on the ovaries which can cause pain. These usually disappear without treatment.
• Some women enter the menopause early during treatment with Zoladex, and their periods do not
return when Zoladex treatment is stopped.
Not known (frequency cannot be estimated from the available data)
• Bleeding from the vagina. This is most likely to happen in the first month after starting Zoladex and
should stop on its own. However, if it continues or you are uncomfortable, talk to your doctor.
• A slight increase in the symptoms of fibroids, such as pain.
When Zoladex is used to treat endometriosis, uterine fibroids, infertility or for thinning of the
uterus lining, the following side effects can also happen:
• Changes in body hair.
• Dry skin.
• Putting on weight.
• Raised levels of a fatty substance known as cholesterol in your blood. This would be seen in a
blood test.
• Inflammation of the vagina and discharge from the vagina.
• Nervousness.
• Disturbed sleep and tiredness.
• Swelling of the feet and ankles.
• Muscle pain.
• Sudden painful muscle tightness (cramp) in your legs.
• Stomach complaints, feeling sick or being sick, diarrhoea and constipation.
• Changes to your voice.
• When used to treat uterine fibroids, a slight increase in the symptoms of fibroids, such as pain.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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