Zoladex La 10.8mg Implant
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Zoladex® LA 10.8mg Implant (goserelin acetate)
Your medicine is available using the above name but will be referred to as Zoladex LA throughout the remainder of this leaflet.
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.
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).
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• 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 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.
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), m oxifloxacin (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 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.
POM
• 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).
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.
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.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.
• Do not store above 25°C.
• Keep in a safe place where children cannot see it or reach it.
• Your medicine should be 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 contains
Each implant contains 10.8mg goserelin (as the acetate) in a long lasting sustained release implant as the active ingredient
Also contains lactide/glycolide copolymer as the inactive ingredient.
What Zoladex LA looks like and contents of the pack
Zoladex is a white opaque implant encased in a clear plastic safe-system syringe device with a steel needle, blue plastic needle cap and blue plastic plunger with a removable plastic tag to prevent accidental use of the device with a dessiccant within the pouch.
Zoladex LA is produced in packs of 1 implant (injection).
Manufacturer:
AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK Procured from within the EU and repackaged by: Amimed Direct Ltd, Hendon, London, NW9 6AQ Product Licence Holder:
Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
PL No: 33902/0090
Leaflet revised: 07/07/2015
Zoladex® is a registered trademark of the AstraZeneca group of companies.
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