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ZOLADEX LA 10.8MG INJECTION SAFESYSTEM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ZOLADEX® LA 10.8MG INJECTION ‘Safe
System™’
(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, nurse or
pharmacist.

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 ‘Safe
System’ but will be referred to as Zoladex LA throughout the
remainder of this leaflet.
What is in this leaflet:
7. What Zoladex LA is and what it is used for
8. What you need to know before you use Zoladex LA
9. How to use Zoladex LA
10. Possible side effects
11. How to store Zoladex LA
12. 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.
3. 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

The Zoladex LA 10.8mg 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.
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 Zoladex LA 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.

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.

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)

Children
Zoladex LA should not be given to children

Uncommon (may affect up to 1 in 100 people)

Pain in the joints

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.

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.

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.

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).

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/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 out of the sight and reach of children.

Do not store it 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 on
the carton.

If your medicine is not used, take it back to your pharmacist.
6. Contents of the pack and other information
What Zoladex LA 10.8mg Implant contains
The active substance is goserelin. Each Zoladex LA 10.8mg
Implant contains 10.8mg of goserelin. The other ingredient is
lactide/glycolide copolymer which is an inactive substance.
What Zoladex LA 10.8mg Implant looks like and contents of
the pack
It contains a sterile white to cream coloured, cylindrical depot in
which the active ingredient Goserelin acetate, equivalent to 10.8
mg Goserelin, is dispersed, in long acting, sustained release
form in a special bio-degradable matrix of lactide-glycolide copolymer.
PL 20774/0729

POM

Manufactured by AstraZeneca UK Limited, Macclesfield
Cheshire SK10 2NA. Procured from within the EU. Product
Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House,
Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by
Maxearn Ltd, Bolton, BL6 4SA.
Leaflet prepared5th August 2015
Zoladex is a registered trademark of AstraZenenca UK Ltd.

PP6/0729/V1

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