Medication Guide App

ZOLADEX LA 10.8 MG IMPLANT

Active substance: GOSERELIN ACETATE

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Patient Information Leaflet

Zoladex LA® 10.8 mg Implant
goserelin acetate
Your medicine is called Zoladex LA® 10.8 mg Implant, but throughout this leaflet will be referred to as Zoladex LA.
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 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.
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. Occasionally these side effects may continue for some time (possibly months) after stopping
Zoladex LA.
• 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.
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 in its original package and do not break the seal. Use only if the pouch is undamaged.
Do not store 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 you pharmacist.
6.

Further information

What Zoladex LA 10.8 mg Implant contains
The active substance is goserelin acetate equivalent to 10.8 mg peptide base in a long-acting sustained release implant.
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 with a protective sleeve, ready to
be used by the doctor or nurse.
Zoladex LA 10.8 mg Implant is produced in packs of one implant (injection).
Manufactured by: AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire SK10 2NA, UK.
Procured from with the EU by the Product Licence Holder: Ecosse Pharmaceuticals Limited, 3 Young Place, East Kilbride,
Glasgow, G75 0TD.
Re-packaged by: Munro Wholesale Medical Supplies Limited, 3 Young Place, East Kilbride, Glasgow G75 0TD.
This leaflet was last revised on 20/08/2014
PL 19065/0304
E0304-3
Zoladex LA® is a registered trade mark of the AstraZeneca group of companies

POM

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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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