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ZOLADEX LA 10.8MG INJECTION

Active substance(s): GOSERELIN / GOSERELIN ACETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zoladex® LA 10.8mg Injection
(goserelin)

Your medicine is called Zoladex LA 10.8mg Injection but will
be referred to as Zoladex LA throughout 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.
2.
3.
4.
5.
6.

What Zoladex LA is and what it is used for
What you need to know before you use Zoladex LA
How to use Zoladex LA
Possible side effects
How to store Zoladex LA
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.

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 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.

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.

3. How to use Zoladex LA





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)



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The Zoladex LA 10.8 mg Injection 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.

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

Leaflet revision and issue dated (Ref): 18.05.16

You may be given a prescription and asked to get your
medicine from the pharmacy and keep it until you see the
doctor again. Keep it in its original package and don’t break
the seal.

Zoladex® and SafeSystem™ are trademarks of AstraZeneca
group of companies.

Do not store above 25°C.
Keep it in a safe place where children cannot see it or reach
it.
Your medicine should not be used after the expiry date
printed on the carton label. The expiry date refers to the last
day of that month.
If your medicine is not used, take it back to 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. Contents of the pack and other
information
What Zoladex LA contains

Each Zoladex LA pre-filled syringe contains 10.8 mg of
goserelin (as the acetate) in a long acting sustained release
implant.
It also contains lactide/glycolide copolymers, which are
inactive substances.

What Zoladex LA looks like and contents of the pack
Zoladex LA is a cylindrical, off white plug, in a pre-filled
SafeSystem™ syringe contained in a tamper evident sealed
pouch with a ‘Directions for use’ label. The pouch also
contains a white desiccant.

Zoladex LA is available in packs of one implant in a pre-filled
SafeSystem syringe with a protective sleeve.

Manufacturer

Zoladex LA is manufactured by: AstraZeneca UK Ltd,
Macclesfield, Cheshire, UK.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
PL No: 04423/0565

POM

Page 2 of 2

To listen to or request a copy of this leaflet in Braille, large
print or audio please call 01302 365000 and ask for the
Regulatory Department.
Please be ready to give the following information:
Product name: Zoladex LA 10.8 mg Injection
Reference number: 04423/0565

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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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