Zoladex 3.6mg implant SafeSystem pre-filled syringes

Zoladex prevents the production of certain types of hormones in the body. It is used to treat prostate or breast cancers which are sensitive to hormones. It is not suitable for children or for treating cancers which are not sensitive to hormones. Zoladex is also used in women who are having surgery or other procedures to treat uterine fibroids or other uterine problems. Zoladex is also used to treat endometriosis or as part of a programme of fertility treatment in women.

Other information about Zoladex:

Zoladex is an implant – it will be implanted by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose. If you feel that the medicine is making you feel unwell or you think it is not working, you should talk to someone who is involved in your care.

Your prescriber will advise you when you need to have your injections. It is usually only given every 28 days. It is a good idea to make a note of the date that your next injection is due so that you do not miss any of your appointments.

This medicine will be given to you as an injection. If you have any concerns about this medicine or how this will be given to you, talk to someone who is involved in your medical care.

Having extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems.

In the case of Zoladex, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

Your prescriber will advise you when to stop having your injections.

The medical team will often be responsible for looking after this medicine. However, if you are responsible for looking after this medicine make sure that you store it properly and safely. Check the label and Patient Information leaflet for details or ask a member of your medical team.

In the case of Zoladex:

This medicine will usually be given to you by a health professional. If you have any concerns about this medicine or about the process of taking it you should speak to your doctor, nurse or to the health professional who looks after you.

Zoladex is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore the prescriber may only prescribe this medicine with special care or may not prescribe it at all for a child.

Over time it is possible that Zoladex can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Zoladex has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Very common: More than 1 in 10 people who have Zoladex:

• acne
• breast enlargement
• decreased libido
• hot flushes
• increased sweating
• injection site problems
• vaginal dryness

Common: More than 1 in 100 people who have Zoladex:

• blood pressure changes
• depression
• hair loss
• headaches
• joint pain
• lowering of bone mineral density
• mood changes
• paraesthesiae
• skin rash or rashes
• tumour flare
• tumour pain - at the start of treatment
• weight gain

Uncommon: More than 1 in 1000 people who have Zoladex:

• hypersensitivity reactions
• metabolic problems

Rare: More than 1 in 10,000 people who have Zoladex:

• anaphylactic reactions
• ovarian cyst

Very rare: Fewer than 1 in 10,000 people who have Zoladex:

• pituitary gland problems
• psychosis or psychotic-like behaviour

The frequency of these side-effects is unknown:

• abnormal laboratory test results
• cervical problems
• change of body hairs
• constipation
• diarrhoea
• dry skin
• feeling nervous
• high levels of cholesterol in the blood
• leg cramps
• liver problems
• may affect the results for certain tests
• menopause
• muscle pain or tenderness
• nausea
• oedema of the extremities
• pneumonia
• pulmonary embolism
• sleeping problems
• stomach problems
• tiredness
• vaginal bleeding - this may happen within the first few months of starting treatment with Zoladex. If this continues to happen once Zoladex has been taken for some time you must seek medical advice
• vaginal discharge
• vaginal infection or inflammation
• voice changes
• vomiting
• worsening of fibroids

The following side effects have been reported in people who have Zoladex in combination with gonadotrophin. The reported frequency of these side-effects is rare. :

• ovarian hyperstimulation syndrome

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

There are no known important interactions between Zoladex and other medicines. If you experience any unusual symptoms while having Zoladex and other medicines you should tell your prescriber.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Zoladex.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

In the case of Zoladex:

You should see how this medicine affects you before you judge whether you are safe to drive or operate machinery. If you are in any doubt about whether you should drive or operate machinery, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Zoladex:

Alcohol can interact with certain medicines.

In the case of Zoladex:

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Zoladex:

This medicine is not suitable during pregnancy. It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

If you are planning to become pregnant, you should discuss your personal circumstances with your doctor so that together you can make a decision about what treatment you may need during your pregnancy.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Zoladex:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. Some may be used to prolong the life of the medicine.

Zoladex contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Zoladex before, do not have Zoladex. Talk to your prescriber, pharmacist or nurse as soon as possible.