Evra transdermal patches

Evra contains two hormones that are similar to the hormones oestrogen and progesterone that are produced by the body. Evra is used to prevent women from becoming pregnant. It works by preventing the release of eggs from the ovary. Evra also changes the lining of the uterus which makes it difficult for an egg to develop and it increases the thickness of vaginal fluid which can stop sperm from reaching an egg.

Evra may increase the chances of developing blood clots or cancers such as cervical or breast cancer. However, it may provide some protection against ovarian and endometrial cancer. You and your prescriber will need to weigh up the benefits and risks of using Evra before you start to use it.

Hormonal contraceptives will only prevent a pregnancy if they are used regularly. Evra needs to be applied once a week. If you want immediate contraceptive cover then start to use Evra on the first day of your menstrual period. If you do not start using Evra on the first day of your menstrual period you will need to take extra contraceptive precautions for at least seven days until Evra starts to work. For more information about starting Evra and if you need to take extra contraceptive precautions ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine.

Once you have started using Evra, you should apply a new patch every seven days for three weeks. After this you should not use a patch for the fourth week. Start using a new patch of Evra immediately after the seven-day patch-free break. This break must not be longer than seven days. During this break you will usually have a withdrawal bleed. If you do not have a withdrawal bleed during the patch-free break and you have used all your patches properly, you are very unlikely to be pregnant. However, if you miss a withdrawal bleed and you have not used your patches correctly or if you miss two withdrawal bleeds in a row you should immediately contact your prescriber or family planning nurse. This is because there is a possibility that you could be pregnant and you must not use Evra during pregnancy.

In certain situations the effectiveness of Evra may be reduced and you will need to take extra contraceptive precautions. These situations include: not applying a new patch on the correct day; the patch either partly or completely falling off; or if you are taking other medicines that interact with Evra. If any of these situations occur you may need to change your routine. For more information on when to take additional contraceptive precautions ask your prescriber, family planning nurse or read the patient information leaflet that comes with your medicine.

Evra does not protect against HIV infections or other sexually transmitted diseases.

Other information about Evra:

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.

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.

In the case of Evra:

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 Evra:

If you are having problems taking this medicine, 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 medicines that are easier for you to take.

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.

If you are not having any problems with this medicine, do not stop using it unless you no longer need this form of contraception or you are advised to stop using it by your prescriber.

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

The instructions on how you should keep your medicine are on the pharmacy label. You should 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.

In the case of Evra:

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.

Evra 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 females under 18 years of age.

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

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

• breast tenderness
• headaches seek immediate medical advice if you keep getting headaches or if you have an unusually bad or prolonged headache
• nausea

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

• acne
• application site problems such as: irritation, redness, itching or rash - you must remove the patch and apply a new patch to another area of skin if you get skin irritation
• breast problems
• diarrhoea
• distension of the stomach
• feeling dizzy
• general feeling of being unwell
• itching
• menstrual problems such as bleeding or spotting in between menstrual periods or heavy or painful menstrual periods. Seek medical advice if you: have not used your patches properly and have missed a withdrawal bleed; do not have two withdrawal bleeds in a row; have spotting or bleeding in between menstrual periods after using Evra for some time or if you have unusual vaginal bleeding
• migraine – seek immediate medical advice if you get a migraine-type headache for the first time
• mood problems including mood changes or anxiety disorders
• muscle spasm
• skin irritation
• skin problems
• skin rash or rashes
• stomach pain - seek immediate medical advice if you suddenly have stomach pain
• tiredness
• uterine problems
• vaginal discharge
• vaginal infections
• vomiting
• weight gain

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

• appetite gain
• certain types of dermatitis
• decreased libido
• difficulty sleeping
• eczema
• fluid retention
• galactorrhoea
• hair loss
• high levels of cholesterol or other lipids in the blood which may lead to pancreatitis
• hypersensitivity reactions
• oedema
• oedema of the extremities
• photosensitivity skin reaction
• pre-menstrual syndrome
• raised blood pressure
• redness of the skin
• urticaria
• vaginal dryness

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

• abnormal laboratory test results
• abnormal taste
• anger
• angioedema
• application site abscess or pustules
• bleeding in the brain
• breast cancer
• breast tumour
• cervical cancer
• cervical problems
• chloasma - this may be permanent. Seek medical advice if you develop chloasma. If you are prone to developing chloasma you should not expose your skin to sunlight or to ultraviolet radiation while using Evra
• colitis
• decreased discharge of milk from the breast
• erythema multiforme
• feelings of frustration
• gallstones
• hypertensive crisis
• increased blood sugar levels
• insulin resistance
• intolerance to contact lenses
• jaundice
• libido increased
• liver problems such as liver tumours - some liver tumours may be fatal. Seek medical advice if you develop pain in the upper part of your stomach
• oedema of the face
• pulmonary embolism
• swelling
• thromboembolic problems such as heart attack, stroke, deep vein thrombosis or pulmonary embolism - some of these problems may be fatal. Seek medical advice if you have: pain or swelling in the leg; eyesight problems; double vision; vertigo; speech problems; problems controlling movements or if you suddenly start to cough, become breathless, collapse or have a seizure; headache; numbness or weakness on one part or one side of your body; sudden chest pain which may spread to the left arm
• uterine fibroids

The frequency of these side-effects is unknown:

• may affect the results for certain tests
• some conditions may occur for the first time, get worse or return during treatment with Evra. If this happens to you, seek immediate medical advice. Examples include: diabetes, jaundice, gallstones, itching, skin rashes, porphyria, systemic lupus erythematosus, blood problems, chorea, Crohn's disease, ulcerative colitis or otosclerosis
• worsening of depression
• worsening of epilepsy

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.

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 Evra:

The following types of medicine may interact with Evra:

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

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 Evra:

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

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

Like all medicines Evra 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.

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 Evra:

Alcohol can interact with certain medicines.

In the case of Evra:

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 Evra:

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

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

In the case of Evra:

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. 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.

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