Do not use EVRA if:
- You are allergic (hypersensitive) to norelgestromin, ethinyl estradiol or any of the other ingredients in EVRA (listed in Section 7 below)
- You have ever had a heart attack or a type of chest pain called ?angina?
- You have ever had a stroke or signs which may lead to stroke. This includes a slight, temporary stroke, without any after effects
- You have high blood pressure(160/100 mmHg or above)
- You have diabetes with damaged blood vessels
- You have bad headaches with neurological symptoms such as changes in vision or numbness in any part of your body (migraine with focal aura)
- You have ever had a blood clot (thrombosis) in your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism) or another part of your body
- You have an illness which runs in your family which affects the clotting of your blood (such as ?protein C deficiency? or ?protein S deficiency?)
- You have very high fat levels in your blood (cholesterol or triglycerides)
- You have an illness which runs in your family which affects fat levels in your blood (called dyslipoproteinemia)
- You have ever had liver tumours or any problem with your liver
- You have ever been told you might have breast cancer or cancer of the womb, cervix or vagina
- You have unexplained vaginal bleeding.
Do not use EVRA if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using EVRA.
Take special care with EVRA
Before using EVRA, you will need to see your doctor for a medical check-up.
Check with your doctor or pharmacist before using EVRA if you have any of the following or they happen or get worse while using EVRA:
- You weigh 90 kg (which is 14 stone 2 lb) or more
- You, or any of your family, have high fat levels in the blood (triglycerides or cholesterol)
- You have high blood pressure or your blood pressure gets higher
- You have a blood problem called porphyria
- You have an immune system problem called ?SLE? (systemic lupus erythematosus)
- You have a blood problem which causes kidney damage called ?HUS? (haemolytic uremic syndrome)
- You have a hearing loss
- You have epilepsy or any other problem that can cause fits (convulsions)
- You have a problem of the nervous system involving sudden movements of the body called ?Sydenham?s chorea?
- You have diabetes
- You have depression
- You have gallstones
- You have liver problems including yellowing of the skin and whites of the eye (jaundice)
- You have an inflammatory illness of your gut (Crohn?s disease or ulcerative colitis)
- You had a skin rash with blisters during pregnancy (called ?herpes gestationis?)
- You have ?pregnancy spots?. These are yellowish-brown patches or spots, especially on your face (called ?chloasma?)
- You think you might be pregnant. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using EVRA.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
Certain medicines and herbal remedies may stop EVRA from working properly. If this happens you could get pregnant.
Tell your doctor if you are taking:
- Medicines for HIV infection (such as ritonavir, nevirapine)
- Medicines for infection (such as rifampicin and griseofulvin)
- Medicines for epilepsy (such as topiramate, barbiturates, phenytoin sodium, carbamazepine, primidone, oxcarbamazepine and felbamate)
- Medicine for high blood pressure in the blood vessels in the lungs (bosentan)
- St. John?s Wort - an herbal remedy used for depression.
If you take any of these medicines, you may need to use another method of birth control (such as a condom, diaphragm or foam). The interfering effect of some of these medicines can last for up to 28 days after you have stopped taking them.
Blood levels of estrogen from EVRA may be increased if you take certain medicines or drink grapefruit juice.
EVRA may make some other medicines less effective, such as:
- medicines containing ciclosporin
- the anti-epileptic lamotrigine (This can increase the risk of fits (seizures)). Ask your doctor or pharmacist for advice before taking any medicine.
Using EVRA with food and drink
It is not expected that food or drink will affect the way EVRA works.
Pregnancy and breast-feeding
- Do not use EVRA if you are pregnant or think you may be pregnant
- Do not use EVRA if you are breast-feeding or planning to breast-feed. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while breast-feeding.
Driving and using machines
You can drive or operate machinery while using EVRA.
Sexually transmitted disease
EVRA will not protect you against HIV infection (AIDS) or any other sexually transmitted disease. These include chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B, syphilis. Always use condoms to protect yourself from these diseases.
- Tell your doctor or the person taking the sample, if you are having a blood or urine test. This is because EVRA may affect some results of the tests.
3. Risks of using combined hormonal contraceptives
The following information is based on information about combined birth control pills. As the EVRA transdermal patch contains similar hormones to those used in combined birth control pills, it is likely to have the same risks. All combined birth control pills have risks, which may lead to disability or death.
It has not been shown that a transdermal patch like EVRA is safer than a combined birth control pill taken by mouth.
Combined hormonal contraceptives and blood clots (thrombosis)
Using combined hormonal contraceptives, including EVRA, increases the chances of getting a thrombosis (blood clots). It is possible that the risk of blood clots in the legs and/or lungs with EVRA is more than the risk with combined birth control pills. This risk of developing blood clots is not affected by how long you use the medicine. The risk returns to normal, a few months after you stop using the medicine.
Blood clots can cause a blockage in a vein or artery and this may make you permanently disabled or even cause death.
- Blood clots can form in a vein in your leg (deep vein thrombosis or DVT) and travel to the lungs. This can cause chest pain and make you breathless or collapse. This is called a ?pulmonary embolism? or PE
- Very rarely, blood clots can form in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke)
- In extremely rare cases, blood clots can happen in other places such as the liver, gut, kidney or eye. Blood clots in the eye may cause loss of eyesight or double vision.
Tell your doctor immediately if you notice any possible signs of a blood clot, such as:
- Pain or swelling in either leg
- Pain in the chest, which may spread to the arm
- Sudden shortness of breath or sudden coughing
- Unusual, severe or long-lasting headache
- Vision problems
- Difficulty speaking
- Feeling dizzy or fainting spells
- Feeling weak or numb on one side or one part of the body
- Difficulty walking or holding things
- Sudden stomach pain If you think you might have any of these, talk to your doctor immediately.
Your chance of getting a blood clot increases:
- As you get older
- If blood clots in blood vessels (veins or arteries) runs in the family
- If you smoke, especially if you are over 35 years of age
- If you stay in bed for many days
- If you are very overweight
- If you have just had a baby, miscarriage or abortion
- If you have had a serious injury, particularly of the leg or hip
- If you have had or are going to have a major operation or need to have bed rest for a long time. Normally you should not use EVRA for two weeks before or two weeks after surgery
- If you have ever had blood clots before
- If you have problems with your blood fats (cholesterol or triglycerides)
- If you have high blood pressure
- If you have heart problems (problems with heart valves, abnormal heart rhythm).
Combined hormonal contraceptives and cancer
Breast cancer has been found more often in women who take combined hormonal contraceptives. However, it is possible that the combined hormonal contraceptive is not the cause of more women having breast cancer. It may be that women taking the combined hormonal contraceptive are examined more often. This might mean that there is a better chance of the breast cancer being noticed. The increased risk gradually goes down after stopping the combined hormonal contraceptive. After 10 years, the risk is the same as for people who have never used the combined hormonal contraceptive.
Cervical cancer also has been found more often in women taking combined hormonal contraceptives. However, this may be due to other causes. These include more sexual partners and sexually transmitted disease.
In rare cases, liver tumours which are not cancer have been found in women taking combined hormonal contraceptives. Even more rarely, liver tumours which are cancer have been found. This can cause bleeding inside the body with very bad pain in the stomach area. If this happens to you, talk to your doctor immediately.