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ZOLADEX LA 10.8MG

Active substance: GOSERELIN

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P039536

Package leaflet: Information for the user

Zoladex LA® 10.8 mg Implant
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.

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).

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

• 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.

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.

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

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.
Other possible side effects:
Very common (may affect more
that 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
There have been reports of
depression in patients taking Zoladex
happens, talk to your doctor.
which may be severe. If you are taking • Bone pain at the beginning of
Zoladex and develop depressed
treatment. If this happens, talk to
mood, inform your doctor.
your doctor.
• Thinning of your bones.
Medicines of this type can cause a
• Rises in blood sugar levels.
reduction in bone calcium (thinning
• Tingling in your fingers or toes.
of bones).
If you go into hospital, tell the medical • Skin rashes.
staff that you are having Zoladex LA. • Weight gain.
• Pain, bruising, bleeding, redness
Children
or swelling where Zoladex LA is
Zoladex LA should not be given to
injected.
children.
• Reduced heart function or heart
Other medicines and Zoladex LA
attack.
Tell your doctor, pharmacist or nurse
• Changes in blood pressure.
if you are taking, have recently taken
• Swelling and tenderness of your
or might take any other medicines.
breasts.
This includes medicines that you buy
• Changes in your mood (including
without a prescription and herbal
depression).
medicines.

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.

To listen to or request a
copy of this leaflet in Braille,
large print or audio please
call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the
following information:
Product name
Zoladex LA 10.8 mg Implant
Reference number
17901/0065
This is a service provided
by the Royal National
Institute of Blind People.
This leaflet was last revised in
November 2014
© AstraZeneca 2014
Zoladex is a trade mark of the
AstraZeneca group of companies.
ONC 14 0042

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.
• Keep it in its original package and
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.
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).
Marketing Authorisation Holder
and Manufacturer
The Marketing Authorisation for
Zoladex LA 10.8 mg Implant is
held by AstraZeneca UK Limited,
600 Capability Green, Luton,
LU1 3LU, UK.
Zoladex LA 10.8 mg Implant is
manufactured by AstraZeneca
UK Limited, Silk Road Business Park,
Macclesfield, Cheshire,
SK10 2NA, UK.

P039536

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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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