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ZOLADEX LA 10.8MG INJECTION

Active substance(s): GOSERELIN

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Package leaflet: Information for the user

ZOLADEX® LA 10.8mg INJECTION
(goserelin)
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.
The name of your medicine is ZOLADEX LA
10.8mg INJECTION but will be referred to as
Zoladex LA throughout this leaflet.
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 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
Zoladex LA should not be stored above
25°C. Store in the original container.
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.
You may be given a prescription and
asked to collect your injection from the
pharmacy and keep it until you see your
doctor. Keep it in the original package,
do not break the seal.
If this injection is not required, please
take it back to the pharmacist for safe
disposal. Only keep the injection if your
doctor tells you to.
If the injection becomes discoloured or
shows any other signs of deterioration,
you should consult your pharmacist who
will advise you what to do.
6. Contents of the pack and other
information
What Zoladex LA contains
Your medicine is called Zoladex LA
10.8mg injection.
It contains the active ingredient,
Goserelin acetate, equivalent to 10.8mg
of goserelin and also contains Lactideglycolide co-polymer which is an inactive
substance.
What Zoladex LA looks like and contents
of the pack
Zoladex LA contains a sterile, white to
cream coloured, cylindrical long-acting
sustained release depot.
Zoladex LA is available as a prefilled
SafeSystem single dose syringe
applicator with a protective sleeve.
Manufactured by: AstraZeneca UK Limited,
Silk Road Business Park, Macclesfield,
Cheshire, England.
Procured from within the EU and
repackaged by the Product Licence
holder: B&S Healthcare, Unit 4, Bradfield
Road, Ruislip, Middlesex, HA4 0NU, UK.
®

ZOLADEX LA 10.8mg INJECTION
PL:18799/2787
POM
Leaflet Date: 13.10.2015

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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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