Zoladex 10.8mg Injection
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ZOLADEX® LA 10.8mg INJECTION/ ZOLADEX® 10.8mg INJECTION (Goserelin)
Patient Information Leaflet
This product is known as the above names but will be referred to as Zoladex LA in this 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 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.
• 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
• Zoladex LA 10.8mg injection/Zoladex 10.8mg injection should be stored at a temperature below 25°C in its original container.
• KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use after the expiry date printed on the carton or labelled pack.
• You may be given a prescription and asked to collect your injection from the pharmacy and keep it until you see your doctor. Keep it in the original package, do not break the seal.
• If this injection is not required, please take it back to the pharmacist for safe disposal. Only keep the injection if your doctor tells you to.
• If the injection becomes discoloured or shows any other signs of deterioration, you should consult your pharmacist who will advise you what to do.
6. Further information
Your medicine is called Zoladex LA 10.8mg injection/Zoladex 10.8mg injection.
It contains a sterile white to cream coloured, cylindrical long acting sustained release depot which contains the active ingredient, Goserelin acetate, equivalent to 10.8mg of goserelin and also contains Lactide-glycolide co-polymer which is an inactive substance.
Zoladex LA 10.8mg injection/Zoladex 10.8mg injection is available as a prefilled SafeSystem™ single dose syringe applicator with a protective sleeve.
POM
PL No: 6464/0750
This product is manufactured by AstraZeneca UK Limited, Macclesfield, Cheshire, England and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 01.07.2013
ZOLADEX and SafeSystem trademarks are the property of ASTRAZENECA
V.