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ZOLADEX 10.8MG INJECTION

Active substance(s): GOSERELIN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOLADEX® 10.8mg INJECTION
(goserelin)
This product is available as the above but will be referred to as Zoladex throughout
the remainder of this leaflet.
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
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’.
Zoladex is used to treat prostate cancer. It works by reducing the amount of
‘testosterone’ (a hormone) that is produced by your body. Zoladex is a long-acting
form of Zoladex and it is given every 12 weeks.
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 a woman.
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
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 high blood pressure.
• 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).
• 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.
Medicines of this type can cause a reduction in bone calcium (thinning of bones).
If you go into hospital, tell the medical staff that you are having Zoladex.
Children
Zoladex should not be given to children.
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).
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 will be injected under the skin on your stomach every 12 weeks.
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 12 weeks.
• 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 12 weeks from your last injection, tell your doctor or nurse.
• If it has been more than 12 weeks since your last injection, contact your doctor or
nurse so that you can receive your injection as soon as possible.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
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 and 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.
• Thinning of your bones.
• Rises in blood sugar levels.
• Tingling in your fingers or toes.
• Skin rashes.
• Weight gain.
• Pain, bruising, bleeding, redness or swelling where Zoladex is injected.
• Reduced heart function or heart attack.
• Changes in blood pressure.
• Swelling and tenderness of your breasts.
• Changes in your mood (including depression).
Uncommon (may affect up to 1 in 100 people)
• Pain in the joints.
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)
• Hair loss.
• 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).
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 at: 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
• Zoladex should not be stored above 25°C.
• Keep all medicines out of the sight and reach of children.
• Do not use after the expiry date printed on the carton or labelled pack. The expiry
date refers to the last day of that month.
• 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 it in the original package, do not break the seal.
• Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
• If the injection shows signs of any deterioration, you should seek the advice of
your pharmacist.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Your medicine is called Zoladex 10.8mg Injection.
Each Zoladex 10.8mg Injection contains goserelin acetate equivalent to 10.8mg
peptide base in a long-acting sustained release implant.
Also contains lactide/glycolide co-polymer.
Zoladex 10.8mg Injection contains a sterile white to cream coloured, cylindrical
depot in single dose SafeSystem™ syringe applicator with a protective sleeve in a
sealed pouch which contains a dessicant.
Zoladex 10.8mg Injection is available as a single dose SafeSystem™ syringe
applicator.
Manufacturer
This product is manufactured by AstraZeneca UK Ltd., Silk Business Park,
Macclesfield, Cheshire, SK10 5NA and is procured from within the EU and
repackaged by the Product Licence holder who is: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
POM
PL: 15814/0238 Zoladex 10.8mg Injection
Leaflet revision and issue date (Ref.) 28.07.2016.
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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