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The eMC  

Last Updated 25 Mar 2013

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Evorel 100 patches

Evorel (Ev-vor-rel) is a medicine which is used in hormone replacement therapy and preventing osteoporosis in women after the menopause. Evorel contains estradiol. It is supplied by Janssen-Cilag Ltd.

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

There are 4 preparations of Evorel available. If Evorel 100 patches is not the preparation you are looking for, please select from the drop down list below.

Select your preparation (type) of Evorel

Evorel 100 patches

Information specific to Evorel 100 patches when used in hormone replacement therapy

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Your medicine

Evorel contains a hormone which is similar to the hormone oestrogen that is produced by the body. When women go through the menopause, levels of oestrogen become low. This leads to symptoms such as hot flushes, night sweats and dryness of the vagina. Evorel helps to replace the low levels of oestrogen which may help to relieve the symptoms of the menopause. This is known as hormone replacement therapy.

Evorel may also be used to prevent osteoporosis from occurring after the menopause. People with osteoporosis have thin bones and have a higher chance of having bone fractures. Evorel helps to prevent bone loss which may slow down the development of osteoporosis. It is only used when other medicines to prevent osteoporosis are not suitable.

Evorel helps to treat the symptoms of the menopause but it may also increase the chances of getting certain types of cancers and certain heart or circulatory problems.

You and your prescriber will need to weigh up the risks and benefits of hormone replacement therapy. Your prescriber will review your treatment on a regular basis.

Women who are on hormone replacement therapy will be advised by their prescriber to watch out for any symptoms of breast, endometrial or ovarian cancer. They may be advised to regularly examine their breasts for any changes or lumps or report any unusual vaginal bleeding to their prescriber.

Treatment with hormone replacement therapy needs to be tailored to each individual. Sometimes a medicine containing the hormone progesterone will need to be taken as well as Evorel. For more information about different types of hormone replacement therapy, and the risks and benefits of having hormone replacement therapy, you should talk to your prescriber.

Other information about Evorel:

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should use. It also tells you how often you should use your medicine. This is the dose that you and your prescriber have agreed you should use. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

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When to take your medicine

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by the times at which you take other medicines.

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How to take your medicine

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Evorel:

  • detailed advice on how to use Evorel can be found in the Patient Information Leaflet that comes with this medicine
  • Evorel is an oestrogen only patch that has to be worn all the time. It has to be replaced twice a week
  • remove the patch from the wrapper and immediately apply the sticky side of the patch onto a clean, dry and healthy area of the skin. It is best to apply the patch to the stomach below the waistline
  • do not apply the patch on or near the breasts or any area of the skin that is oily, damaged or irritated
  • if the patch falls off, replace it with another new one immediately
  • activities such as bathing or showering should not affect the patch if it has been applied properly. If Evorel falls off during bathing or showering wait until the skin has cooled before applying a new patch
  • after removing your patch there may be some glue or gum left on the skin. You can use baby oil to remove the gum or glue
  • each time you use a new patch you should apply it to a different area of skin

If you are having problems taking this form of Evorel, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

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Taking too much of your medicine

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

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Stopping your medicine

If you are having any problems using your medicine you must speak to your prescriber. If you are not having any problems using this medicine then do not stop using it, even if you feel better, unless advised to do so by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

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Looking after your medicine

The instructions on how you should keep your medicine are on the pharmacy label. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children and pets.

In the case of Evorel:

  • do not store in temperatures above 25°C

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

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Whether this medicine is suitable for you

Evorel 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.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

  • to determine whether or not the medicine is suitable and whether it must be prescribed with extra care
  • to check that this medicine is not having any undesired effects

Over time it is possible that Evorel can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Evorel 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 use Evorel:

  • application site problems such as redness, itching, rashes or oedema

Common: More than 1 in 100 people who use Evorel:

  • breast pain
  • depression
  • diarrhoea
  • feeling dizzy
  • headaches – seek immediate medical advice if you have an unusually bad headache
  • itching
  • joint pain
  • menstrual problems including painful, heavy or long menstrual periods, bleeding or spotting between menstrual periods - some of these problems may happen within the first few months of starting treatment with Evorel or if you forget to apply your patch. If this continues to happen once Evorel has been used for some time or after you have stopped using Evorel you must contact your prescriber
  • migraine – seek immediate medical advice if you get a migraine-type headache for the first time
  • nausea
  • pain
  • skin rash or rashes
  • stomach pain
  • weight gain

Uncommon: More than 1 in 1000 people who use Evorel:

Rare: More than 1 in 10,000 people who use Evorel:

The frequency of these side-effects is unknown:

  • abnormal laboratory test results
  • angioedema
  • dark patches on the face or neck - if you are prone to developing chloasma you should not expose your skin to sunlight or to ultraviolet light while using Evorel
  • dementia – this has only been reported in women over 65 years of age
  • endometrial cancer
  • endometrial hyperplasia
  • fluid retention
  • heart attack
  • high levels of cholesterol or other lipids in the blood which may lead to pancreatitis
  • liver problems including jaundice - you should seek immediate medical advice if you develop jaundice
  • ovarian cancer
  • raised blood pressure
  • some conditions may get worse or return during treatment with Evorel. Examples include: fibroids, endometriosis, endometrial hyperplasia, oestrogen-dependent tumours, breast cancer, thromboembolic problems, raised blood pressure, diabetes, liver problems, gallstones, migraine or headaches, systemic lupus erythematous, epilepsy, asthma, otosclerosis, angioedema or breast problems
  • stroke
  • thromboembolic problems such as pulmonary embolism or deep vein thrombosis seek immediate medical advice if you have a painful and swollen leg or develop breathing difficulties or sudden chest pain

The frequency of these side-effects is unknown and have been reported in women who have taken oestrogens and progestogens :

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.

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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 medicines may interact with Evorel:

The following types of medicine may interact with Evorel:

If you are taking Evorel and one of the above medicines or 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.

Make sure you tell your prescriber the names of all the complementary preparations and vitamins that you are taking or are planning to take.

Your prescriber can then decide whether it is appropriate for you to take combinations that are known to interact.

In the case of Evorel:

If you have been prescribed Evorel you should only take something on the above list on the specific advice of your prescriber or pharmacist.

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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.

Like all medicines Evorel can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, 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 Evorel:

  • there are no specific foods that you must exclude from your diet when using Evorel
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Alcohol

Alcohol can interact with certain medicines.

In the case of Evorel:

  • there are no known interactions between alcohol and Evorel
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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 Evorel:

  • you must not use Evorel during pregnancy. If you could become pregnant, you must use effective non-hormonal contraception or abstain from penetrative sex

It is very important that you seek urgent medical advice if you become pregnant or think you have become pregnant while taking this medicine.

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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 Evorel:

  • women who are breast-feeding must not use this medicine

For information about Evorel and breast-feeding, contact your prescriber.

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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. They are also added to improve the medicine's appearance and to make it easier to use. Some may be used to prolong the life of the medicine.

Evorel contains:

  • adhesive acrylic polymer (Duro-Tak 387-2287)
  • guar gum (meyprogat 90)
  • hostaphan MN19 (polyester film - removed before application)

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 Evorel before, do not use Evorel. Talk to your prescriber, pharmacist or nurse as soon as possible.

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Evorel, Version 7, last updated 25 Mar 2013