ZOLADEX 3.6MG DEPOT INJECTION

Active substance: GOSERELIN ACETATE

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Zoladex® 3.6 mg Depot Injection
(goserelin)
This medicine is known by the above name but will be referred to as
Zoladex throughout this leaflet.
Package Leaflet: Information for the User
Read all of this leaflet carefully before you start using this
medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or
pharmacist.

This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor, nurse or
pharmacist.
In this leaflet:
1. What Zoladex is and what it is used for
2. Before you are given Zoladex
3. How Zoladex will be given
4. Possible side effects
5. How to store Zoladex
6. Further 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.

Information for women
Check with your doctor or nurse before you have 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.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any
other medicines. This includes medicines that you buy without a
prescription and herbal medicines.
Pregnancy and breast-feeding
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 ZOLADEX WILL BE GIVEN







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. BEFORE YOU ARE GIVEN ZOLADEX
Do not have Zoladex if:
• You are allergic (hypersensitive) to goserelin or any of the other
ingredients of this medicine (listed in Section 6: Further information).
• 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 or pharmacist before having Zoladex.
Zoladex should not be given to children.
Take special care with Zoladex
If you go into hospital, tell the medical staff that you are having Zoladex.
Check with your doctor or nurse before you have Zoladex if:
You have high blood pressure.



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.
Information for men
Check with your doctor or nurse before you have Zoladex if:
• You have problems passing urine (water) or problems with your back.
• You have diabetes.
• 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).

The Zoladex 3.6 mg Depot Injection 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, Zoladex 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:
• Hot flushes and sweating. Occasionally these side effects may continue
for some time (possibly months) after stopping Zoladex.
• A reduced sex drive.
• Thinning of your bones.
• Tingling in your fingers or toes.
• Skin rashes.
• Hair loss.
• Weight gain.
• Pain in the joints.
• Changes in blood pressure.
• Pain, bruising, bleeding, redness or swelling where Zoladex is injected.
• Mood changes (depression)
• In Long term use: Common
• In Short term use: Uncommon









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).
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.

5. HOW TO STORE ZOLADEX
Keep out of the sight and reach of children.
Do not store above 25°C.
You may be given a prescription and asked to collect your injection from
the pharmacy and keep it until you see your doctor. Keep it in the original
package, do not break the seal.
Do not use after the date shown as 'EXP' on the carton.
If the Zoladex become discoloured or show any other signs of deterioration
consult your pharmacist.
If you are told to stop using this medicine return any unused Zoladex
Injection to your pharmacist to be destroyed.

Information for men
The following side effects can happen in men:
• 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.
• Impotence.
• Reduced heart function or heart attack.
• Swelling and tenderness of your breasts.
• Rises in blood sugar levels.

6. FURTHER INFORMATION

Information for women
The following side effects can happen in women:
• 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.
• 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.
• Headaches.
• Dryness of the vagina.
• A change in breast size.
• 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.
• Acne has been reported very commonly (often within one month of
starting treatment).

Zoladex 3.6mg Depot Injection is manufactured by AstraZeneca UK Ltd.,
Silk Road Business Park, Macclesfield, Cheshire SK10 5NA, and is
procured within the EU by the Product Licence holder: Caseview (PL)
Limited, 20 Alliance Court, Alliance Road, London W3 0RB and
repackaged by OPD Laboratories Ltd, Unit 6 Colonial Way, Watford, Herts
WD24 4PR.

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.
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.



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.
If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, nurse or pharmacist.
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 at:
www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the
safety of this medicine.

What is in your injection
The name of your medicine is Zoladex 3.6mg Depot Injection. It contains a
white to cream coloured depot in which the active ingredient Goserelin
acetate, equivalent to 3.6mg Goserelin, is dispersed in a special biodegradable matrix of lactide-glycolide co-polymer.
Zoladex 3.6mg Depot Injection is available in packs containing a single
dose syringe applicator.

PL 13826/0801

POM
Zoladex® 3.6mg Depot Injection
Leaflet revision and issue date (Ref) 30/06/2014

Zoladex and SafeSystem are registered Trade Marks of AstraZeneca
group of companies.
To request a copy of this leaflet in Braille, large print or audio please call
01923 332 796.

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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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