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ZOLADEX LA 10.8MG DEPOT

Active substance: GOSERELIN ACETATE

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Patient Information Leaflet

Zoladex® LA 10.8 mg Depot
(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.
®

Your medicine is called Zoladex LA 10.8 mg Depot but throughout
this leaflet will be referred to as Zoladex LA.
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 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, 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 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







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 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 further information
6. Further information
What Zoladex LA 10.8 mg Depot contains
The active substance is goserelin. Each Zoladex LA 10.8 mg
Depot contains 10.8 mg of goserelin (as the acetate) in a long
acting sustained release implant. The other ingredient is
lactide/glycolide copolymer which is an inactive substance.
What Zoladex LA 10.8 Depot looks like and contents of the
pack
Zoladex LA is a Single Dose Safe System syringe applicator with a
protective sleeve in a sealed pouch which contains a desiccant
and is produced in packs of one injection.
Zoladex LA 10.8 Depot is produced in packs of one implant
(injection).
Manufactured by: AstraZeneca UK Limited, Silk Road Business
Park, Macclesfield, Cheshire, SK10 2NA, UK.
Procured from within the EU.
Product Licence Holder: Ecosse Pharmaceuticals Limited,
3 Young Place, East Kilbride G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride, G75 0TD.
PL 19065/0147

POM

This leaflet was revised on 27/02/2015
0147E-5
®is a registered 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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