PACKAGE LEAFLET: INFORMATION FOR THE USER

ZOLADEX® LA 10.8MG INJECTION ‘Safe System™’

(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, nurse or pharmacist.

•    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.

The name of your medicine is called 'Zoladex LA 10.8mg Injection 'Safe System' but will be referred to as Zoladex LA throughout the remainder of this leaflet.

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 10.8mg 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:

Very common (may affect more that 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.

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. Website: www.mhra/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 out of the sight and reach of children.

•    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 other information

What Zoladex LA 10.8mg Implant contains The active substance is goserelin. Each Zoladex LA 10.8mg Implant contains 10.8mg of goserelin. The other ingredients is lactide/glycolide copolymer which is an inactive substance.

What Zoladex LA 10.8mg Implant looks like and contents of the pack

It contains a sterile white to cream coloured, cylindrical depot in which the active ingredient Goserelin acetate, equivalent to 10.8 mg Goserelin, is dispersed, in long acting, sustained release form in a special bio-degradable matrix of lactide-glycolide copolymer.

PL 20774/0729

Manufactured by AstraZeneca UK Limited, Macclesfield Cheshire SK10 2NA. Procured from within the EU. Product Licence holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton,

BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.

Leaflet prepared 20^th April 2015

Zoladex is a registered trademark of AstraZenenca UK Ltd.

PP5/0729/V3