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ZOLADEX 10.8MG INJECTION

Active substance(s): GOSERELIN / GOSERELIN ACETATE

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Zoladex® 10.8mg Injection /
Zoladex LA® 10.8mg Injection
(goserelin)
This product is available using either of the above names but will be
referred to as Zoladex LA throughout this leaflet.
Package Leaflet: Information for the User
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 LA is and what it is used for
2. What you need to know before you use Zoladex LA
3. How to use Zoladex LA
4. Possible side effects
5. How to store Zoladex LA
6. Contents of the pack and other information

1. WHAT ZOLADEX LA IS AND WHAT IT IS USED FOR
Zoladex LA contains a medicine called goserelin. This belongs to a group
of medicines called ‘LHRH analogues’.
Zoladex LA is used to treat prostate cancer. It works by reducing the
amount of ‘testosterone’ (a hormone) that is produced by your body.
Zoladex LA is a long-acting form of Zoladex and it is given every 12
weeks.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE ZOLADEX LA
Do not use Zoladex LA:
• 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 LA if any of the above apply to you. If you are not
sure, talk to your doctor, pharmacist or nurse before having Zoladex LA.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Zoladex LA:
• 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 LA.
There have been reports of depression in patients taking Zoladex LA
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
LA.
Children
Zoladex LA should not be given to children.
Other medicines and Zoladex LA
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 LA 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 LA is not likely to affect you being able to drive or use any tools
or machines.

3. HOW TO USE ZOLADEX LA
• The Zoladex LA 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 LA 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 LA 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 LA. 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 LA 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 LA 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 LA
Keep out of the sight and reach of children.
Do not store the Zoladex LA above 25°C.
Your doctor may give you a prescription so that you can get your
medicine from your 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.
Do not use after the date shown as 'EXP' on the carton. The expiry date
refers to the last day of that month.
If the Zoladex LA becomes discoloured or shows any other signs of
deterioration consult your pharmacist.
Return any unused or out of date Zoladex LA to your pharmacist to be
destroyed.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines that are no longer
required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
The name of your medicine is Zoladex 10.8mg Injection. It contains a
sterile, white to cream coloured depot in which the active ingredient
Goserelin acetate, equivalent to 10.8mg Goserelin, is dispersed in a
special bio-degradable matrix of lactide-glycolide co-polymer in a
sustained release formulation.
Zoladex LA is available in packs containing a single dose syringe
applicator.
This product is manufactured by AstraZeneca UK Ltd., Silk Road
Business Park, Macclesfield, Cheshire SK10 5NA and is procured from
within the EU by the Product Licence holder who is: Caseview (PL)
Limited, 20 Alliance Court, Alliance Road, London W3 0RB and
repackaged by O.P.D Laboratories Ltd, Unit 6 Colonial Way, Watford,
Herts WD24 4PR.
POM

PL No: 13826/0162
Zoladex 10.8mg Injection / Zoladex LA 10.8mg Injection
Leaflet revision date (ref): 07/07/2015.

Zoladex is a trade mark 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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