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ZOLADEX 3.6 MG IMPLANT

Active substance(s): GOSERELIN

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Zoladex® 3.6 mg Implant

2878
06.05.16[2]

PATIENT INFORMATION LEAFLET

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)

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.

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

This product is known as the above name but will be referred to as Zoladex
throughout this leaflet.

If you are having Zoladex for endometriosis, your doctor may reduce the
thinning of the bones by giving you other medicines as well.

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

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).

(goserelin acetate)

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.
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

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 3.6mg 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.

Injection site injury (including damage to blood vessels in the abdomen)
has been reported following injection of Zoladex. In very rare cases this has
caused severe bleeding. Contact your doctor immediately if you
experience any of the following symptoms:
- Abdominal pain.
- Abdominal distension.
- Shortness of breath.
- Dizziness.
- Low blood pressure and/or any altered levels of consciousness.
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.
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.
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:
- Keep your medicine in its original package and do not break the seal.
Do not store above 25oC.
- Do not use after expiry date printed on the carton or labelled pack.
- KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
- 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.
- Return any unused or out of date injections to your pharmacist for safe
disposal.
- If the injection shows signs of any deterioration, you should seek the
advice of your pharmacist.
- 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. FURTHER INFORMATION
What Zoladex contains
The active ingredient is goserelin.
Each Zoladex contains goserelin acetate equivalent to 3.6 mg peptide base
in a sustained release implant.
Zoladex also contains the inactive ingredient lactide/glycolide copolymer.
What Zoladex looks like and contents of the pack
Zoladex is available as off-white implant supplied as a single dose pre-filled
SafeSystem™ syringe applicator with a protective sleeve in a sealed pouch
which contains a desiccant.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Zoladex is manufactured by AstraZeneca UK Limited, Silk Road Business
Park, Macclesfield, Cheshire, SK10 2NA, UK and procured from within the
EU by Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close,
Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2878

Leaflet revision and issue date (Ref.) 06.05.16[2]
Zoladex is a trademark of AstraZeneca UK Ltd.

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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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