EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours Transdermal Patch

Introduction

Package Leaflet: Information for the User

EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patchnorelgestromin/ethinylestradiol

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 having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break 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 the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.

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

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

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

Contents of the package leaflet

1. What is EVRA and what is it used for
2. What you need to know before starting to use EVRA

1. How to use EVRA

1. Possible side effects

1. Storage of EVRA

1. Package contents and additional information

1. What is EVRA and what is it used for

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

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

It is used to prevent pregnancy.

2. What you need to know before starting to use EVRA

General considerations

Before starting to use EVRA, you should 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 you should not 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 should inform your doctor. Your doctor will discuss with you what other form of contraception would be more suitable.

• severe diabetes with blood vessel damage

• very high blood pressure

• very high levels of fat in the blood (cholesterol or triglycerides)

• a condition called hyperhomocysteinemia

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

When you should be careful with EVRA

Warnings and precautions

Before using this medicine, it is necessary for your doctor to perform a medical examination.

Tell your doctor if you suffer from any of the following conditions.

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

BLOOD CLOTS

The use of a combined hormonal contraceptive like EVRA increases your risk of having 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 the veins (which is called "venous thrombosis", "venous thromboembolism", or VTE)

• in the arteries (which is called "arterial thrombosis", "arterial thromboembolism", or ATE)

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

It is essential 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 attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thrombosis). However, these side 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 can cause deep vein thrombosis (DVT).

• If a blood clot moves from your leg and lodges in your lung, it can cause a pulmonary embolism.

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

When is the risk of having a blood clot in a vein higher?

The risk of having a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medicine or a different one) 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 having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having a blood clot in your leg or lung (DVT or PE) with EVRA is small.

• Out of 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 may have a blood clot in a year.

• Out of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 may have a blood clot in a year.

• Out of 10,000 women who use a combined hormonal contraceptive that contains etonogestrel or norelgestromin, like EVRA, about 6-12 may have 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 with EVRA is small, but some conditions increase the risk. Your risk is higher:

• as you get older (especially above about 35 years of age);

The risk of having a blood clot increases with the number of conditions you have.

Long-haul flights (more than 4 hours) may temporarily increase the 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 should stop using EVRA.

If any of the conditions mentioned above change while you are using EVRA, for example, you start smoking, a close relative experiences a thrombosis without a known cause, or you gain a lot of weight, you should 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 stroke due to EVRA is very small, but it can increase:

• with age (above about 35 years of age);

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

If you have one or more of these conditions or if any of them are particularly severe, the risk of having 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 thrombosis without a known cause, or you gain a lot of weight, you should 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 can induce suicidal thoughts. If you experience mood changes and depressive symptoms, you should contact your doctor for further 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 appear or worsen during treatment with EVRA:

• You think you may be pregnant;

• You have headaches that get worse or appear more frequently;

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

• You have high blood pressure or blood pressure that tends to increase;

• You have any gallbladder disease, including gallstones or inflammation of the gallbladder;

• You have a blood disorder called porphyria;

• You have a nervous system disorder that causes sudden movements of the body called "Sydenham's chorea";

• You had skin blisters during pregnancy ("gestational herpes");

• You have hearing loss;

• You have diabetes;

• You have depression;

• You have epilepsy or any other condition that causes seizures;

• You have liver disorders, including yellowing of the skin and the whites of the eyes (jaundice);

• You have or have had "pregnancy spots". These are brownish-yellow spots or patches on the skin, especially on the face;

Enter in the face (called "chloasma"). These spots may not

disappear completely, even after stopping the use of EVRA. Protect your skin from the sun or ultraviolet radiation. This can help prevent these spots from appearing or worsening.

• You have kidney problems.

If you are not sure if you have any of the above conditions, consult your doctor or pharmacist before using EVRA.

Sexually transmitted diseases

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

Lab tests

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

Children and adolescents

EVRA has not been studied in girls and adolescents under 18 years of age. EVRA should not be used 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 recently used, 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 (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive method before starting treatment with these medications. EVRA can be restarted approximately 2 weeks after finishing this treatment. See section "When not to use EVRA".

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

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

These include medications used to treat:

• certain antiretrovirals used to treat HIV/SIDA and hepatitis C virus (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
• medications for infections (such as rifampicin and griseofulvin)

• anticonvulsant medications (such as barbiturics, topiramate, phenytoin, carbamazepine, primidone, oxcarbazepine, and felbamate)

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

• St. John's Wort or hypericum, (a herbal remedy used for depression).

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

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

• medications containing cyclosporine

• 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 using machines

You can drive or use machines 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 to have the same risks. The use of any combined oral contraceptive involves risks, which could lead to disability or death.

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

Combined hormonal contraceptives and cancer

Cervical cancer (cervix)

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

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 would mean that there is a greater chance of breast cancer being detected. The increased risk of having breast cancer decreases gradually after stopping treatment with combined hormonal contraceptives. After ten years, the risk is equal to that of women who have never used combined hormonal contraceptives.

Liver cancer

Rare cases of non-cancerous tumors have been found in the liver in women who take combined hormonal contraceptives. Even more rarely, cancerous tumors have been found in the liver. This can cause bleeding inside the body with severe pain in the stomach area. If you experience this symptom, you should contact your doctor immediately.

3. How to use EVRA

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

Otherwise, 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, diaphragms, or foam) on hand in case you make an error when using the patch.

How many patches to use

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

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

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

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

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

If you switch from an oral contraceptive pill to EVRA

If you switch from an oral contraceptive pill to this medication:

• Wait until you have your menstruation.

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

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

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

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

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

• You can start treatment with this medication on any day after stopping the progestin-only pill, on the day of implant removal, or on the day your next injection is due.
• Place the patch the day after stopping the progestin-only pill, on the day of implant removal, or when your next injection is due.
• You must 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, when you start using this medication, one or more days have passed since the spontaneous or induced abortion, consult your doctor about 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 induced or spontaneous 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, you should not start using this medication before 4 weeks after childbirth.

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

If you have had sexual intercourse since childbirth, wait until you have your first menstruation 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 each week, as it is designed to work for 7 days.

• Never leave the patch on for more than 7 consecutive days.

• Patches should only 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 must be firmly attached to the skin for it to work correctly.

• You must press firmly on the patch until the edges are well attached.

• Do not apply creams, oils, lotions, powders, or makeup to the area of skin where the patch will be applied or near the area where the patch is being worn. This could cause the patch to detach.
• Do not place a new patch on the same area of skin from which the previous patch was just removed. If you do, it is more likely to cause irritation.

• Check every day to ensure the patch has not fallen off.

• Do not stop using the patches even if you do not have frequent sexual intercourse.

How to use the patch:

If it is the first time you are using EVRA, wait until the day you have your menstrual period.

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

• If you place the patch after the first day of your period, you must 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 a place 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 chosen day. In no case should more than 7 consecutive days pass without a patch.

If you want to delay your period, place a patch at the start of Week 4 (Day 22) without observing the week of rest. You may experience light bleeding or intermenstrual spotting. Do not use more than 6 consecutive patches (i.e., no more than 6 weeks). When you have used 6 consecutive patches (for 6 consecutive weeks), do not place another patch during Week 7. After 7 days without wearing a patch, place a new patch and start the cycle using this as Day 1. Consult your doctor before deciding to delay your period.

Daily activities while using the patches

• Normal activities such as bathing, showering, sauna, and exercise should not affect the performance of the patch.

• The patch is designed to stay in place during this type of activity.

• However, it is recommended that you check to ensure the patch has not come off after engaging in these activities.

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

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

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

• You should only wear one patch at a time.

If you have trouble remembering 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 detach, the edges lift, or it falls off

Less than a day(up to 24 hours):

• Try to reattach the patch or place a new patch immediately.

• No other 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.

• it has stuck to itself or another surface.

• it has particles stuck to it.

• it has detached or fallen off for the second time.

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

• If you cannot reattach the patch, you must place a new patch 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, you will have a new Day 1 and a new "Patch Change Day".

• You must 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 start of any patch cycle (Week 1, Day 1):

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

• You must use additional non-hormonal contraceptives for a week.

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

• 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 realize it.

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

No other 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 realize it, by placing a new patch.

• From now on, you will have a new "Patch Change Day" and a new Day 1.

• You must use additional 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 realize it.

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

No additional contraceptives are necessary.

If you experience absence or irregularities in bleeding with EVRA

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

• Normally, this stops occurring 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 cycles after the first three, consult your doctor or pharmacist.

Even if you do not have your period during the week without the EVRA patch (Week 4), you must place a new patch on the usual "Patch Change Day".

• If you have used this medication correctly and do not get 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.

Using 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 3 months, especially if your periods were not regular before starting to use this medication.

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

4. Possible Adverse Effects

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

All women who take 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 you start using EVRA".

Very Common Adverse Effects (may affect more than 1 in 10 women):

• Headache

• Nausea

• Breast tenderness.

Common Adverse Effects (may affect up to 1 in 10 women):

• Vaginal fungal infection, sometimes called candidiasis

• Mood changes such as depression, mood swings or mood changes, 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 bleeding pattern, 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 of tiredness or discomfort

• Weight gain.

Uncommon Adverse 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 sexual desire

• Eczema, skin redness

• Abnormal milk production in the breast

• Pre-menstrual 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 Adverse Effects (may affect up to 1 in 1,000 women):

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

• in a leg or foot (i.e., DVT)

• in a lung (i.e., PE)

• heart attack

• stroke

• mini-stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA)

• 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, cervical or liver cancer

• Problems in the skin areas where the patch has been applied, such as a rash with blisters or ulcers

• Non-cancerous (benign) tumors in the breasts or liver

• Uterine fibroids

• Fury or feeling frustrated

• Increased sexual desire

• Taste disturbance

• Problems with contact lens use

• Sudden 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

• Gallstones or blockage of the bile ducts

• Yellowing of the skin and the whites of the eyes

• Abnormal blood sugar or insulin levels

• Swelling of the face, mouth, throat or tongue

• Red, painful nodules on the shins and legs

• Itching of the skin

• Rough, scaly skin with itching and redness

• Suppression of lactation

• Vaginal discharge

• Fluid retention in the legs

• Fluid retention

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

If you have stomach upset

• 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 upset.

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 of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of EVRA

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

Do not use this medicine after the expiry date that appears on the label after "EXP". The expiry 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 should be disposed of carefully. To dispose of the used patch, you should:

• Peel off the label intended for disposing of the patch from the outside of the pouch.

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

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

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

6. Package Contents and Additional Information

Composition of EVRA

The active ingredients are norelgestromin and ethinylestradiol. Each transdermal patch of 20 cm2 contains 6 mg of norelgestromin and 600 micrograms of ethinylestradiol.

The active ingredients are released over 7 days, releasing an average of 203 micrograms of norelgestromin and 34 micrograms of ethinylestradiol every 24 hours.

The other ingredients are: outer layer: low-density pigmented polyethylene outer layer,

inner layer of polyester; intermediate layer: polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester material, lauryl lactate; third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.

Appearance of the Product and Package Contents

EVRA is a thin, beige, plastic transdermal patch that bears the imprint "EVRA". The adhesive layer is stuck to the skin after removing the transparent plastic protective layer.

EVRA is available in the following package sizes: Boxes of 3, 9 or 18 patches in individual foil pouches, wrapped in sets of three, with a transparent plastic sheet perforated.

Only some package 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.

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu .