Zoladex La 10.8mg Implant
ZOLADEX® LA 10.8MG IMPLANT
(goserelin acetate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 10.8mg Implant is and what it is used for
2. What you need to know before you use Zoladex LA 10.8mg Implant
3. How to use Zoladex LA 10.8mg Implant
4. Possible side effects
5. How to store Zoladex LA 10.8mg Implant
6. Contents of the pack and other information
1. What Zoladex LA 10.8mg Implant is and what it is used for
Zoladex LA 10.8mg Implant contains a medicine called goserelin. This belongs to a group of medicines called 'LHRH analogues'.
Zoladex LA 10.8mg Implant is used to treat prostate cancer. It works by reducing the amount of 'testosterone' (a hormone) that is produced by your body. Zoladex LA 10.8mg Implant 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 10.8mg Implant
Do not use Zoladex LA 10.8mg Implant:
■ 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 10.8mg Implant if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Zoladex LA 10.8mg Implant.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Zoladex LA 10.8mg Implant:
■ 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 10.8mg Implant.
There have been reports of depression in patients taking Zoladex LA 10.8mg Implant which may be severe. If you are taking Zoladex LA 10.8mg Implant 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 10.8mg Implant.
Children
Zoladex LA 10.8mg Implant should not be given to children.
Other medicines and Zoladex LA 10.8mg Implant
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 10.8mg Implant 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 10.8mg Implant is not likely to affect you being able to drive or use any tools or machines.
3. How to use Zoladex LA 10.8mg Implant
■ 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 10.8mg Implant 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 10.8mg Implant. 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 LA 10.8mg Implant.
■ 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 10.8mg Implant 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 10.8mg Implant 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, Website: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Zoladex LA 10.8mg Implant
■ You may be given a prescription and asked to collect your injection from the pharmacy and keep it until you see a doctor.
■ Keep it in the original package, do not break the seal.
■ Do not store above 25°C.
■ KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
■ Do not use this medicine after the expiry date shown on the carton or labelled pack.
■ Return any unused or out of date injections to your pharmacist for safe disposal.
6. Contents of the pack and other information
What Zoladex LA 10.8mg Implant contains
Each Zoladex LA 10.8mg Implant contains goserelin acetate equivalent to 10.8mg peptide base in a sustained release implant. Zoladex LA 10.8mg Implant is dispersed in a special biodegradable matrix of lactide/glycolide copolymer which is an inactive substance.
What Zoladex LA 10.8mg Implant looks like and contents of the pack
Zoladex LA 10.8mg Implant contains a sterile white to cream coloured, cylindrical depot.
Zoladex LA 10.8mg Implant is produced in packs of 1 implant in a prefilled syringe.
Manufacturer
Manufactured by: AstraZeneca UK Limited, Charter Way, Silk Road Business Park, Macclesfield, Cheshire, UK.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
POM
PL No: 21828/0259
Leaflet revision date: 01.08.16
Zoladex® is a registered trademark of the AstraZeneca group of companies.
To request a copy of this leaflet in Braille, large print or audio please call 01302 365000 and ask for the Regulatory Department.
Please be ready to give the following information:
Product name: Zoladex LA 10.8mg Implant
Reference number: 21828/0259
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