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ZOLADEX LA 10.8 MG IMPLANT

Active substance(s): GOSERELIN / GOSERELIN ACETATE / GOSERELIN / GOSERELIN ACETATE / GOSERELIN / GOSERELIN ACETATE

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500000/PL1a
®

Zoladex LA 10.8 mg Implant
(goserelin acetate)
Patient Information Leaflet
The name of your medicine is Zoladex LA 10.8 mg Implant.
Throughout this leaflet it will be referred to as Zoladex LA.
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.

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 10.8 mg Implant 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.

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.

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.

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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

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.

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.

Zoladex LA is a long-acting form of Zoladex and it is given
every 12 weeks.

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.

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.
Continued overleaf

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, 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 LA
• 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.
• 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.
• If you notice any sign of discolouration or deterioration
of your medicine, please tell your pharmacist
immediately.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Zoladex LA 10.8 mg Implant contains
The active substance is goserelin. Each Zoladex LA 10.8 mg
Implant contains 10.8 mg of goserelin.
The other ingredient is lactide/glycolide copolymer which is an
inactive substance.
What Zoladex LA 10.8 mg Implant looks like and contents
of the pack
Zoladex LA 10.8 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 LA 10.8 mg Implant is produced in packs of one
implant (injection).
Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova
Ltd and repackager Ginova UK Ltd, both of St James' House,
8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturer
AstraZeneca UK Limited, Silk Road
Macclesfield, Cheshire, SK10 2NA, UK.

Business

Park,

®

Zoladex LA 10.8 mg Implant
PL No: 18067/0498

POM
th

This leaflet was last revised on 13 February 2017.
®

Zoladex LA and SafeSystem™ are registered trademarks of
AstraZeneca UK Ltd.

To request a copy of this leaflet in
Braille, large print or audio please
call 01622 690172.

500000/PL1a

Expand Transcript

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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