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ZOLADEX LA 10.8 MG IMPLANT

Active substance: GOSERELIN ACETATE

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Zoladex LA® 10.8 mg Implant
(goserelin)

T03531

The name of your medicine is Zoladex LA® 10.8 mg Implant but will be referred to
as Zoladex LA throughout the rest of this leaflet.
Patient Information Leaflet
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.
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 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).
• 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.
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.
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.

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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.
• Changes in your mood (including depression).
• 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.
• Store in the original package.
• 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.
• If the medicine becomes discoloured or shows any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Zoladex LA 10.8 mg Implant contains
Zoladex LA 10.8 mg Implant contains goserelin acetate equivalent to 10.8 mg
peptide 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 Implant looks like and contents of the pack
Zoladex LA 10.8mg Implant contains a small white pellet, in a prefilled single dose
syringe applicator, with a blue safety cap and plunger, and a protective sleeve,
ready to be used by the doctor or nurse.
Zoladex LA 10.8 mg Implant is produced in packs containing one implant in a
prefilled Safe System syringe with a protective sleeve in a sealed pouch which
contains a desiccant.
Manufacture and Product Licence Holder:
This product is manufactured by AstraZeneca UK Limited Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, United Kingdom. It is procured from within the
EU by the Product Licence Holder: Swinghope Ltd, Brandon House, Marlowe Way,
Croydon, CR0 4XS and repackaged by Interport Ltd, Brandon House, Marlowe
Way, Croydon, CR0 4XS.
POM

PL No: 10380/1433

Leaflet revision date: 08/09/2012
Zoladex LA® is a trade mark of the AstraZeneca group of companies.

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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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