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Package leaflet: Information for the user

Zoladex LA® 10.8 mg Implant

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.

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.

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.

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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.

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.

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).

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