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The eMC  

Last Updated 23 Apr 2013

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Faslodex 250mg/5ml solution for injection pre-filled syringes

Faslodex (Faz-loh-dex) is a medicine which is used in breast cancer. Faslodex contains fulvestrant. It is supplied by AstraZeneca UK Limited.

The information in this Medicine Guide for Faslodex varies according to the condition being treated and the particular preparation used.

Faslodex 250mg/5ml solution for injection pre-filled syringes

Information specific to Faslodex 250mg/5ml solution for injection pre-filled syringes when used in breast cancer

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Your medicine

Faslodex is used to block the effects of oestrogen hormones in the body. Oestrogen hormones may worsen certain types of breast cancer which occur in women. Faslodex can help to treat these types of cancers by blocking the effects of these hormones. Faslodex is only given to women who have gone through the menopause.

Faslodex is usually given to you 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 unwell or you do not think it is working, then talk to your prescriber or someone involved in your medical care.

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When to take your medicine

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.

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How to take your medicine

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.

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Taking too much of your medicine

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

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

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Stopping your medicine

The person in charge of your care will make the decision about when you should stop this medicine. If you experience any problems while having this medicine, talk to someone who is involved in your medical care.

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Looking after your medicine

As Faslodex will be given to you as an injection, it will usually be stored by the medical team.

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Whether this medicine is suitable for you

Faslodex 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 someone under the age of 18 years.

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

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Side-effects

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 Faslodex:

  • abnormal laboratory test results
  • injection site reactions
  • nausea
  • weakness

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

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

  • injection site problems including bleeding or collection of blood under the skin
  • liver problems
  • vaginal bleeding
  • vaginal discharge
  • vaginal infection

The frequency of these side-effects is unknown:

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 111.

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Taking other medicines

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following types of medicine may interact with Faslodex:

If you are taking Faslodex and one of the above types of medicines, make sure your prescriber knows about it.

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Complementary preparations and vitamins

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 Faslodex.

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.

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Driving and operating machinery

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 Faslodex:

  • this medicine could affect your ability to drive or operate machinery

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.

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Diet

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 Faslodex:

  • there are no specific foods that you must exclude from your diet when having Faslodex
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Alcohol

Alcohol can interact with certain medicines.

In the case of Faslodex:

  • there are no known interactions between alcohol and Faslodex
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Family planning and pregnancy

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 Faslodex:

  • you must not have Faslodex during pregnancy. If you could become pregnant, you must use effective contraception or abstain from penetrative sex while you are being treated with Faslodex

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.

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Breast-feeding

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

In the case of Faslodex:

  • women who are having Faslodex should not breast-feed

Before you have your baby you should discuss breast-feeding with your doctor or midwife. They will help you decide what is best for you and your baby based on the benefits and risks associated with this medicine. 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.

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Ingredients of your medicine

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.

Faslodex contains:

  • benzyl alcohol
  • benzyl benzoate
  • castor oil
  • ethanol 96%

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 Faslodex before, do not have Faslodex. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Faslodex, Version 8, last updated 23 Apr 2013