Package Insert: Information for the User

EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patchnorelgestromin/ethinyl estradiol

Important things you should know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.

• They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).

Read this package insert carefully before starting to use this medication, because it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.

• This medication has been prescribed only for you and should not be given to others, as it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. How to use EVRA

1. Possible adverse effects

1. Storage of EVRA

1. Contents of the package and additional information

EVRA contains two types of sex hormones, a progestogen called norelgestromin and an estrogen called ethinyl estradiol.

As it contains two hormones, EVRA is considered a "combined hormonal contraceptive".

It is used to prevent pregnancy.

General Considerations

Before starting to use EVRA, you must read the information about blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood Clots”).

When Not to Use EVRA

You should not use EVRA if you have any of the conditions listed below. If you have any of the conditions listed below, you must inform your doctor. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE) or in other organs;
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies;
• If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”);

• If you have ever had a heart attack or a stroke;

• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of a stroke);
• If you have any of the following diseases that may increase your risk of forming a blood clot in your arteries:

• If you have (or have ever had) a type of migraine called “migraine with aura”;

• If you are allergic to norelgestromin, ethinylestradiol or to any of the other components of this medication (including in section 6);

• If you have ever been told that you may have breast cancer or uterine cancer, cervix (cervical) or vaginal cancer;

• If you have ever had a tumor in your liver or a liver disease for which your liver does not function correctly;

• If you have unexplained vaginal bleeding;

• If you have hepatitis C and are being treated with medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other Medications and EVRA”).

You should not use this medication if you have any of the conditions mentioned above. If you are unsure, consult your doctor, pharmacist or nurse before using this medication.

When to Have Special Care with EVRA

Warnings and Precautions

Before using this medication, your doctor must perform a medical check-up.

Inform Your Doctor if You Suffer from Any of the Following Conditions.

If the condition develops or worsens while you are using EVRA, you must also inform your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);

• If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system);

• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);If you have sickle cell anemia (a hereditary disease of red blood cells);

• If you have high levels of fat in your blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas);
• If you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”);

• If you recently gave birth, you are at greater risk of blood clots. You must ask your doctor how long after delivery you can start taking EVRA;

• If you have superficial thrombophlebitis (inflammation of the veins under the skin);

• If you have varicose veins;

BLOOD CLOTS

The use of a combined hormonal contraceptive like EVRA increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE)

• In arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE)

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or, very rarely, fatal effects.

It is Important to Remember that the Overall Risk of a Harmful Blood Clot Due to EVRA is Small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical assistance if you notice any of the following signs or symptoms.

What Can Happen if a Blood Clot Forms in a Vein?

• The use of combined hormonal contraceptives has been related to an increased risk of blood clots in veins (venous thromboembolism). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.

• If a blood clot forms in a vein in your leg or foot, it may cause deep vein thrombosis (DVT).

• If a blood clot breaks loose from your leg and lodges in your lung, it may cause a pulmonary embolism.

• In rare cases, a blood clot can form in a vein in another organ, such as your eye (retinal vein thrombosis).

When Is the Risk of a Blood Clot in a Vein Greater?

The risk of a blood clot in a vein is greater during the first year of taking a combined hormonal contraceptive for the first time. The risk may be greater also if you start taking a combined hormonal contraceptive again (the same medication or a different medication) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking EVRA, your risk of a blood clot returns to normal in a few weeks.

What Is the Risk of a Blood Clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in your leg or lung (DVT or PE) with EVRA is small.

• Of every 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 may develop a blood clot in a year.

• Of every 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone or norgestimato, about 5-7 may develop a blood clot in a year.

• Of every 10,000 women who are using a combined hormonal contraceptive that contains etonogestrel or norelgestromin like EVRA, between about 6 and 12 women may develop a blood clot in a year.

• The risk of having a blood clot will vary depending on your personal medical history (see “Factors That Increase Your Risk of a Blood Clot” below).

Factors That Increase Your Risk of a Blood Clot in a Vein

The risk of having a blood clot is small, but some conditions increase the risk. Your risk is greater:

• If you are overweight (body mass index or BMI of 30 kg/m2or more);

• If any of your close relatives have had a blood clot in their leg, lung, or other organ at a young age (i.e. before the age of about 50). You may have an inherited blood clotting disorder;

• If you need surgery or spend a lot of time without standing up due to an injury or illness, or if you have your leg in a cast. You may need to stop using EVRA for several weeks before the operation or while you have less mobility. If you need to stop using EVRA, ask your doctor when you can start using it again;

• As you get older (especially over the age of about 35);

• If you have given birth recently.

The risk of a blood clot increases the more conditions you have.

Long flights (>4 hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you suffer from any of the conditions mentioned above, even if you are unsure. Your doctor may decide that you need to stop using EVRA.

If any of the conditions mentioned above change while you are using EVRA, for example, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What Can Happen if a Blood Clot Forms in an Artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors That Increase Your Risk of a Blood Clot in an Artery

It is essential to note that the risk of a heart attack or a stroke due to EVRA is very small, but it may increase:

• With age (over the age of about 35);

• If you smoke. When using a combined hormonal contraceptive like EVRA, you are advised to quit smoking. If you are unable to quit smoking and are over 35, your doctor may advise you to use a different type of contraception;
• If you are overweight;

• If you have high blood pressure;

• If any of your close relatives have had a heart attack or a stroke at a young age (less than about 50). You may also be at greater risk of having a heart attack or a stroke;
• If you or any of your close relatives have high levels of fat in your blood (cholesterol or triglycerides);

• If you have migraines, especially migraines with aura;

• If you have a heart problem (valve disorder, a rhythm disorder called atrial fibrillation);

• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.

If any of the conditions mentioned above change while you are using EVRA, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Psychiatric Disorders:

Some women who use hormonal contraceptives like EVRA have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Also, consult your doctor, pharmacist, or nurse before starting to use EVRA if you have or have had any of the following conditions, or if they develop or worsen during treatment with EVRA:

• Think you may be pregnant;

• Have headaches that worsen or occur more frequently;

• Weigh 90 kg or more (equivalent to 14 st and 2 lb or more);

• Have high blood pressure or a tendency to develop high blood pressure;

• Have any liver disease, including gallstones or inflammation of the gallbladder;

• Have a blood disorder called porphyria;

• Have a nervous disorder that causes sudden, involuntary movements called Sydenham's chorea;

• Had skin eruptions with blisters during pregnancy (“gestational herpes”);

• Have hearing loss;

• Have diabetes;

• Have depression;

• Have epilepsy or any other condition that causes seizures;

• Have liver damage, including yellowing of the skin and the white of the eye (jaundice);

• Have or have had “pregnancy spots”. These are brownish-yellow spots on the skin, especially on the face (called “melasma”). These spots may not disappear completely, even after stopping EVRA. Protect your skin from the sun or ultraviolet radiation. This may help prevent these spots from appearing or worsening.

• Have kidney problems.

If you are unsure if you have any of the conditions mentioned above, consult your doctor or pharmacist before using EVRA.

Sexually Transmitted Infections

This medication does not protect you against HIV (AIDS) or any other sexually transmitted infection. This includes chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, syphilis. Always use condoms to protect yourself against these infections.

Blood Tests

• If you need to have a blood test or urine test, inform your doctor or laboratory staff that you are using EVRA, as hormonal contraceptives can affect some blood test results.

Children and Adolescents

EVRA has not been studied in girls and adolescents under 18 years old. Do not use EVRA in girls and adolescents who have not yet had their first menstrual period.

Other Medications and EVRA

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not use EVRA if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, as it may cause an increase in liver function test results (elevated ALT liver enzyme). Your doctor will prescribe another form of contraception before starting treatment with these medications. EVRA can be restarted, approximately, 2 weeks after completing this treatment. See section “When Not to Use EVRA”.

Certain medications and herbal remedies may interfere with the proper functioning of EVRA.

If this happens, you may become pregnant, or you may experience unexpected bleeding.

These include medications used to treat:

• Some antiretrovirals used to treat HIV/AIDS and hepatitis C (inhibitors of protease and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapina, efavirenz)
• Medications for infections (such as rifampicin and griseofulvin)

• Anticonvulsants (such as barbiturates, topiramato, phenytoin, carbamazepine, primidona, oxcarbazepina, and felbamato)

• Bosentan (a medication used to treat high blood pressure in the blood vessels of the lungs)

• St. John's Wort or Hypericum (a medicinal herb used to treat depression).

If you are using any of the medications mentioned above, you should use another form of contraception (such as condoms, diaphragm, or foam). The effect of some of these medications may last for up to 28 days after stopping their use. Consult your doctor or pharmacist about using another form of contraception if you are using EVRA with any of the medications mentioned above.

EVRA may reduce the effect of some medications, such as:

• Medications that contain ciclosporina

• Lamotrigine used for epilepsy [This may increase the risk of seizures (convulsions)].

Your doctor may need to adjust the dose of the other medication. Consult your doctor or pharmacist before taking any medication.

Pregnancy and Breastfeeding

• Do not use this medication if you are pregnant or think you may be pregnant.

• Stop using this medication immediately if you become pregnant.

• Do not use this medication if you are breastfeeding or plan to breastfeed.

If you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machinery

You can drive or operate machinery while using this medication.

Risks of Using Combined Hormonal Contraceptives

The following information is based on information about combined oral contraceptives. Since the transdermal patch EVRA contains similar hormones to those used in combined oral contraceptives, it is likely that you will have the same risks. The use of any combined oral contraceptive involves risks, which may lead to disability or death.

It has not been demonstrated that a transdermal patch like EVRA is safer than a combined oral contraceptive taken orally.

Combined Hormonal Contraceptives and Cancer

Cervical Cancer

Cervical cancer is also detected more frequently in women who use combined hormonal contraceptives. However, it may be due to other causes, including sexually transmitted infections.

Breast Cancer

Cases of breast cancer have been detected more frequently in women who use combined hormonal contraceptives. However, it is possible that combined hormonal contraceptives are not the cause of more women having breast cancer. This may be due to the fact that women who use combined hormonal contraceptives are examined more frequently. This means that there is a greater chance of breast cancer being detected. The increased risk of breast cancer decreases gradually after stopping treatment with combined hormonal contraceptives. After 10 years, the risk is equal to that of women who have never used combined hormonal contraceptives.

Liver Cancer

Rare cases of non-cancerous tumors in the liver have been found in women taking combined hormonal contraceptives. Even more rarely, cancerous tumors in the liver have been found. This may cause bleeding inside the body with severe pain in the abdominal area.If You Experience This Symptom, Contact Your Doctor Immediately.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.

In case you do not follow these instructions, you may increase the risk of becoming pregnant.

• Consult your doctor or pharmacist if you have any doubts.

• You should have non-hormonal contraceptive methods (such as condoms, diaphragm, or foam) on hand in case you make an error in using the patch.

How many patches to use

• Weeks 1, 2, and 3: Place one patch and leave it for exactly 7 days.

• Week 4: Do not place a patch this week.

If you have not used a hormonal contraceptive during the previous cycle

• You can start using this medication on the first day of your next period.

• If it has been one or more days since the start of your period, consult your doctor about the temporary use of a non-hormonal contraceptive method.

If you switch from oral contraceptive pills to EVRA

If you switch from oral contraceptive pills to this medication:

• Wait until you have your period.

• Place the first patch during the first 24 hours of your period.

If you place the patch after Day 1 of your period, you should:

• Use a non-hormonal contraceptive method simultaneously until Day 8, when you change the patch.

If you do not have your period within 5 days after taking the last oral contraceptive pill, consult your doctor before starting to use this medication.

If you switch from a progestin-only pill, an implant, or an injectable to EVRA

• You can start treatment with this medication on any day after stopping the progestin-only pill, or on the day of implant removal, or on the day of the next injection.
• Place the patch the day after stopping the progestin-only pill, the day of implant removal, or the day of the next injection.
• You should use a non-hormonal contraceptive method simultaneously until Day 8, when you change the patch.

After a spontaneous or induced abortionbefore20 weeks of gestation

• Consult your doctor.

• You can start using this medication immediately.

If you start using this medication when it has been one or more days since the abortion, consult your doctor about the temporary use of a non-hormonal contraceptive method.

After a spontaneous or induced abortionafter20 weeks of gestation

• Consult your doctor.

You can start with this medication 21 days after the abortion or on the first day of your next period, whichever comes first.

After childbirth

• Consult your doctor.

• If you have given birth and are not breastfeeding, do not start using this medication before 4 weeks after delivery.

• If you start using it later than 4 weeks after delivery, use a non-hormonal contraceptive method simultaneously during the first 7 days.

If you have had sex since delivery, wait until you have your first period or consult your doctor to ensure you are not pregnant before starting to use this medication.

If you are breastfeeding

• Consult your doctor.

• Do not use this medication if you are breastfeeding or planning to breastfeed (see also section 2, Pregnancy and lactation).

Important information to follow while using the patch

• Change the EVRA patch on the same day of each week, as it is designed to act for 7 days.

• Do not leave the patch off for more than 7 consecutive days.

• The patches should be worn one at a time.

• Do not cut or manipulate the patch in any way.

• Avoid placing the patch on an area of skin that is red, irritated, or cut.

• The patch should be stuck well to the skin for it to work correctly.

• You should press firmly on the patch until the edges are well stuck.

• Do not apply creams, oils, lotions, powders, or makeup to the area of skin where you will stick the patch or near the area where you will wear the patch. This could cause the patch to come off.
• Do not place a new patch in the same area where the previous patch was removed. If you do, it is more likely to cause irritation.

• Check every day that the patch has not fallen off.

• Do not stop using the patches even if you do not have sex frequently.

How to use the patch:

If you are using EVRA for the first time, wait until the day of your period.

• Place the first patch during the first 24 hours of your period.

• If you place the patch after Day 1 of your period, you should use a non-hormonal contraceptive method until Day 8, when you change the patch.
• The day you place the first patch will be Day 1. The “Patch Change Day” will be this day every week.

Choose a place on your body to put the patch.

• Always place the patch on clean, dry, and hairless skin.

• Place it on the buttock, abdomen, outer arm, or upper back, in an area where it will not rub against tight clothing.
• Never place the patch on the breasts.

If you want to change the “Patch Change Day” to a different day of the week, consult your doctor. You must complete the current cycle and remove the third patch on the correct day. During Week 4, you can choose a new Patch Change Day and place the first patch on that day. In no case should more than 7 consecutive days pass without a patch.

If you want to delay your period, place a patch on Day 22 of Week 4, without respecting the week of rest. You may experience light bleeding or intermenstrual bleeding. Do not use more than 6 consecutive patches (i.e., not more than 6 weeks). When you have used 6 consecutive patches (for 6 consecutive weeks), do not place another patch in Week 7. After 7 days without a patch, place a new patch and start the cycle using this as Day 1. Consult your doctor before deciding to delay your period.

Activities during the day while using the patches

• Normal activities such as bathing, showers, saunas, and exercise should not affect the patch's performance.

• The patch is designed to stay in place during these activities.

• However, it is recommended that you check that the patch has not fallen off after these activities.

If you need to place the patch in a new area of the body on a different day than your “Patch Change Day”

If the patch you are wearing is uncomfortable or causing irritation:

• You can remove it and place a new one in a different area of the body until the next “Patch Change Day”.

• You should only wear one patch at a time.

If you find it difficult to remember to change the patch

• Consult your doctor, pharmacist, or nurse about how to make changing the patch easier. They can also advise you on the use of another contraceptive method.

If the patch starts to come off, the edges lift, or it falls off

Less than a day(up to 24 hours):

• Try to put the patch back on or place a new one immediately.

• No additional contraceptive measures are necessary.

• The “Patch Change Day” should remain the same.

• Do not try to reattach the patch if:
• • the adhesive does not stick

• Do not use any type of adhesive or bandage to hold the patch in place.

• If you cannot reattach the patch, place a new one immediately.

More than a day(24 hours or more) or if you do not know how long:

• Start a new four-week cycle immediately by placing a new patch.

• From now on, there will be a new Day 1 and a new “Patch Change Day”.

• You should use additional non-hormonal contraceptives during the first week of the new cycle.

You can become pregnant if you do not follow these instructions.

If you forget to change the transdermal patch

At the beginning of any patch cycle (Week 1, Day 1):

If you forget to put on the patch, you may be at a very high risk of becoming pregnant.

• You should use non-hormonal contraceptive methods for a week.

• Place the first patch of the new cycle as soon as you remember.

• Now you have a new “Patch Change Day” and a new Day 1.

In the middle of the cycle (Week 2 or 3):

If you forget to change the patch for one or two days (up to 48 hours):

• Place a new patch as soon as you remember.

• The next patch will be placed on the usual “Patch Change Day”.

No additional contraceptive measures are necessary.

For more than 2 days(48 hours or more):

• If you forget to change the patch for more than 2 days, you may become pregnant.

• Start a new four-week cycle as soon as you remember, by placing a new patch.

• From now on, there will be a new “Patch Change Day” and a new Day 1.

• You should use additional non-hormonal contraceptives during the first week of the new cycle.

At the end of the patch cycle (Week 4):

If you forget to remove the patch:

• Remove it as soon as you remember.

• Start the new cycle on the usual “Patch Change Day”, the day after Day 28.

No additional contraceptive measures are necessary.

If you have irregularities or absence of bleeding with EVRA

This medication may cause unexpected vaginal bleeding or losses (spotting) during the weeks of patch use.

• Normally, this stops after the first few cycles.

• Errors in patch use can also cause spotting and light bleeding.

• Continue using this medication and if bleeding persists in subsequent cycles after the first three, consult your doctor or pharmacist.

Although you may not have your period during the week without the EVRA patch (Week 4), you should place a new patch on the usual “Patch Change Day”.

• If you have used this medication correctly and do not have your period, it does not necessarily mean you are pregnant.

• However, if you have two consecutive missed periods, consult your doctor or pharmacist, as you may be pregnant.

If you use more EVRA than you should (more than one EVRA patch at a time)

Remove the patches and consult your doctor immediately.

The use of too many patches can cause:

• Feeling sick (nausea) and being sick (vomiting)

• Vaginal bleeding.

If you interrupt treatment with EVRA

You may have irregular, light, or absent menstruation. This usually occurs in the first three months, especially if your periods were not regular before starting to use this medication.

If you have any other doubts about using this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health change that you think may be due to EVRA, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins [venous thromboembolism (VTE)] or blood clots in the arteries (arterial thromboembolism [ATE]). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to use EVRA”.

Very common side effects (may affect more than 1 in 10 women):

• Headache

• Nausea

• Breast tenderness

Common side effects (may affect up to 1 in 10 women):

• Vaginal yeast infection, sometimes called candidiasis

• Mood changes such as depression, mood swings, or mood fluctuations, anxiety, crying

• Dizziness

• Migraine

• Abdominal pain or swelling

• Vomiting or diarrhea

• Acne, skin rash, skin itching or skin irritation

• Muscle spasms

• Chest problems such as pain, enlargement, or lumps in the chest

• Changes in menstrual cycle, uterine cramps, painful periods, vaginal discharge

• Problems where the patch has been in contact with the skin such as redness, irritation, itching, or rash

• Feeling tired or unwell

• Weight gain

Uncommon side effects (may affect up to 1 in 100 women):

• Allergic reaction, hives

• Swelling due to water retention in the body

• High levels of fats in the blood (such as cholesterol or triglycerides)

• Sleep problems (insomnia)

• Decreased libido

• Eczema, skin redness

• Abnormal milk production in the breast

• Premenstrual syndrome

• Vaginal dryness

• Other problems where the patch has been in contact with the skin

• Swelling

• High blood pressure or increased blood pressure

• Increased appetite

• Hair loss

• Sensitivity to sunlight

Rare side effects (may affect up to 1 in 1,000 women):

Deleterious blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT)

• In the lungs (i.e., PE)

• Heart attack

• Stroke

• Transient ischemic attack (TIA) or temporary symptoms similar to a stroke

• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).

• Breast cancer, cervical cancer, or liver cancer

• Problems in the skin areas where the patch has been applied such as blistering or ulcers

• Benign tumors in the breasts or liver

• Uterine fibroids

• Anger or feeling frustrated

• Increased libido

• Alteration of taste

• Problems with contact lenses

• Sudden and severe increase in blood pressure (hypertensive crisis)

• Inflammation of the gallbladder or colon

• Abnormal cells in the cervix

• Brown spots or patches on the face

• Bile stones or blockage of the bile ducts

• The skin and the white part of the eyes turn yellow

• Abnormal levels of sugar or insulin in the blood

• Swelling of the face, mouth, throat, or tongue

• Rash with red, painful nodules on the skin and legs

• Itching skin

• Rough, flaky, itchy, and red skin

• Suppression of lactation

• Vaginal discharge

• Fluid retention in the legs

• Fluid retention

• Swelling in the arms, hands, legs, or feet.

If you have stomach problems

• The amount of hormones you get from EVRA is not affected by being sick (vomiting) or having diarrhea.

• You do not need to use additional contraceptive measures if you have stomach problems.

You may have spotting or light bleeding or breast tenderness or feel unwell during the first 3 cycles. These symptoms usually go away but if they do not, consult your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label after “CAD”. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light and moisture.

Do not refrigerate or freeze.

Used patches still contain some active hormones. To protect the environment, they must be disposed of carefully. To dispose of the used patch, you must:

• Remove the disposal label from the outside of the package.

• Place the used patch on the label, so that the adhesive covers the shaded area.

• Close the label, keeping the patch inside, and throw it away, keeping it out of the reach of children.

Medicines should not be thrown away through the drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of EVRA

The active principles are norelgestromin and ethinylestradiol. Each transdermal patch of 20 cm2contains 6 mg of norelgestromin and 600 micrograms of ethinylestradiol.

The active principles are released over 7 days, releasing a mean of 203 micrograms of norelgestromin and 34 micrograms of ethinylestradiol every 24 hours.

The other components are: outer layer: low-density pigmented polyethylene coating, inner layer: polyester; intermediate layer: polyisobutylene/polybutene adhesive, crospovidone, polyester non-woven material, lauril lactate; third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.

Appearance of the product and contents of the pack

EVRA is a thin, beige-colored plastic transdermal patch with "EVRA" engraved on it. The adhesive layer is applied to the skin after removing the transparent plastic protective layer.

EVRA is available in the following pack sizes: boxes of 3, 9 or 18 patches in individual foil-lined, perforated plastic pouches, three patches in each pouch.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Janssen-Cilag International NV Turnhoutseweg, 30, B-2340 Beerse, Belgium.

Manufacturer: Janssen-Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update date of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.