ZOLADEX LA 10.8MG DEPOT

Active substance: GOSERELIN ACETATE

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PATIENT INFORMATION LEAFLET FOR ZOLADEX LA 10.8mg DEPOT
(Goserelin acetate)

Read all of this leaflet carefully before you start using this medicine.
• 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor, nurse or pharmacist.
• The name of this medicine is Zoladex LA 10.8mg DEPOT but will be
referred to as Zoladex LA throughout the remainder of this leaflet.
In this leaflet:
1) What Zoladex LA is and what it is used for
2) Before you are given Zoladex LA
3) How Zoladex LA will be given
4) Possible side effects
5) How to store Zoladex LA
6) Further 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) BEFORE YOU ARE GIVEN ZOLADEX LA
Do not have Zoladex LA if:
• You are allergic (hypersensitive) to goserelin or any of the other
ingredients of this medicine (listed in Section 6: Further information).
• 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 or pharmacist before having Zoladex LA.
Zoladex LA should not be given to children.
Take special care with Zoladex LA
Check with your doctor or nurse before you have Zoladex LA if:
• You have problems passing urine (water) or problems with your back.
• You have diabetes.
• You have high blood pressure.
• You suffer from depression.
• 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).
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.
There have been reports of depression in patients taking Zoladex LA
which may be severe. If you are taking Zoladex LA and develop
depressed mood, inform your doctor.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken
any other medicines. This includes medicines that you buy without a
prescription and herbal medicines.
Driving and using machines
Zoladex LA is not likely to affect you being able to drive or use any tools
or machines.

3) HOW ZOLADEX LA WILL BE GIVEN
• 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.
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.
Other possible side effects:
• 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.
• Hot flushes and sweating.
• A reduced sex drive and impotence.
• Thinning of your bones.
• Rises in blood sugar levels.
• Tingling in your fingers or toes.
• Skin rashes.
• Hair loss.
• Weight gain.
• Pain, bruising, bleeding, redness or swelling where Zoladex LA is
injected.
• Pain in the joints.
• Reduced heart function or heart attack.
• Changes in blood pressure.
• Swelling and tenderness of your breasts.
• Mood changes, depression.
• In Long term use: Common
• In Short term use: Uncommon
• 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).
• 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.
Do not be concerned by this list of possible side effects. You may not get
any of them.

If any of the side effects get serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor, nurse or pharmacist.
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 it in its original package and do not break the seal.
• Do not store it above 25°
C.
• KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
• 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) FURTHER INFORMATION
What Zoladex LA 10.8 mg Implant contains
The active ingredient is goserelin.
Each single dose pre-filled syringe applicator contains goserelin acetate
equivalent to 10.8 mg of goserelin base in a long acting sustained
release implant. The other ingredient is lactide-glycolide copolymer which
is an inactive substance.
What Zoladex LA 10.8 mg Depot looks like and contents of the pack
Zoladex LA 10.8mg comes as an implant in a pre-filled syringe
applicator.
Marketing Authorisation Holder and Manufacturer
Zoladex LA 10.8mg Depot is manufactured by AstraZeneca UK Limited,
Silk Road Business Park,
Macclesfield, Cheshire,
SK10 2NA, UK.
It is procured from within the EU by Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, U.K.
Repackaged by XXXXXXXXXXXXXXXXXXXXXXX
PL: 33532/0101 Leaflet code: XXXXXXXXXXXXXXXX
Leaflet Date: 10th May 2012
Zoladex® is a registered trade mark of AstraZeneca group.

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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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