Zoladex La 10.8 Mg Implant
4. POSSIBLE SIDE EFFECTS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
Zoladex LA® 10.8 mg Implant (goserelin)
Your medicine is called Zoladex LA® 10.8 mg Implant but will be referred to as Zoladex LA throughout this leaflet.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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 10.8 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.
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.
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.
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.
• Keep it in its original package and do not break the seal.
• 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 contains
The active substance is goserelin. Each Zoladex LA 10.8 mg Implant contains goserelin acetate equivalent to 10.8 mg peptide base in a sustained release implant. The other ingredient is lactide/glycolide copolymer which is an inactive substance.
What Zoladex LA looks like and contents of the pack
Zoladex LA comes as an implant in a pre-filled syringe with a Single Dose Safe System containing a light blue cap and a blue safety clip to protect the plunger. The pre-filled syringe has a siliconised stainless steel needle with a needle protection system and is supplied in a sealed pouch which contains a dessicant. Zoladex LA is produced in packs of one implant (injection).
| POM | PL No: 33652/0084 Zoladex LA 10.8 mg Implant
Zoladex LA is manufactured by AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire SK10 2NA, United Kingdom and is procured from within the EU and repackaged on behalf of the PL(PI) holder: Pharmaram Limited, Unit F4 Tom Bill Way, Ivanhoe Business Park, Ashby de la Zouch, Leicestershire LE65 2UY
Zoladex is a trade mark of the AstraZeneca group of companies.
Leaflet revision and issue date (Ref.): 16th September 2016
P-PIL ZOLALA10.8MGX1 (RO) V1