Active ingredient
- goserelin acetate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17901/0064.
Zoladex 3.6mg Implant
Package leaflet: Information for the user
Zoladex® 3.6 mg Implant
goserelin
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 is and what it is used for
2. What you need to know before you use Zoladex
3. How to use Zoladex
4. Possible side effects
5. How to store Zoladex
6. Contents of the pack and other information
Most of the information in this leaflet applies to both men and women.
1. What Zoladex is and what it is used for
Zoladex contains a medicine called goserelin. This belongs to a group of medicines called ‘LHRH analogues’.
Use of Zoladex by men
In men, Zoladex is used to treat prostate cancer. It works by reducing the amount of ‘testosterone’ (a hormone) that is produced by your body.
Use of Zoladex by women
In women, Zoladex is used to:
In women, Zoladex works by reducing the amount of ‘oestrogen’ (a hormone) that is produced by your body.
2. What you need to know before you use Zoladex
Do not use Zoladex:
Do not have Zoladex if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before having Zoladex.
Warnings and precautions
If you go into hospital, tell the medical staff that you are having Zoladex.
Talk to your doctor, pharmacist or nurse before using Zoladex:
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.
Children
Zoladex should not be given to children.
Information for men
Talk to your doctor, pharmacist or nurse before using Zoladex:
Medicines of this type can cause a reduction in bone calcium (thinning of bones).
Information for women
Talk to your doctor, pharmacist or nurse before using Zoladex:
Medicines of this type can cause a reduction in bone calcium (thinning of bones). This may improve when treatment is stopped.
If you are having Zoladex for endometriosis, your doctor may reduce the thinning of the bones by giving you other medicines as well.
Other medicines and Zoladex
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 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).
Pregnancy, breast-feeding and fertility
Driving and using machines
Zoladex is not likely to affect you being able to drive or use any tools or machines.
3. How to use Zoladex
Your next appointment
Information for women
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can happen in men or women:
Allergic reactions:
These are rare. The symptoms can include sudden onset of:
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. In very rare cases this has caused severe bleeding. Contact your doctor immediately if you experience any of the following symptoms:
Other possible side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
Information for men
The following side effects can happen in men:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Information for women
The following side effects can happen in women:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
When Zoladex is used to treat endometriosis, uterine fibroids, infertility or for thinning of the uterus lining, the following side effects can also happen:
When Zoladex is used to treat breast cancer, the following can happen:
When Zoladex is used to treat infertility with another medicine called gonadotrophin, the following can happen:
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
6. Contents of the pack and other information
What Zoladex 3.6 mg Implant contains
The active substance is goserelin. Each Zoladex 3.6 mg Implant contains 3.6 mg of goserelin.
The other ingredient is lactide/glycolide copolymer which is an inactive substance.
What Zoladex 3.6 mg Implant looks like and contents of the pack
Zoladex 3.6 mg Implant comes as an implant (a very small pellet) in a pre-filled syringe, ready to be used by the doctor or nurse.
Zoladex 3.6 mg Implant is produced in packs of one implant (injection).
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Zoladex 3.6 mg Implant is held by
Zoladex 3.6 mg Implant is manufactured by
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Zoladex 3.6 mg Implant
Reference number 17901/0064
This is a service provided by the Royal National Institute of the Blind.
This leaflet was last revised in March 2015
© AstraZeneca 2015
Zoladex is a trade mark of the AstraZeneca group of companies.
ONC 15 0007
Horizon Place, 600 Capability Green, Luton, Bedfordshire, LU1 3LU
+44 (0)1582 838 000
+44 (0)1582 838 003
+44 (0)1582 836 000
0800 783 0033
+44 (0)1582 837 837