Evra

Package leaflet: Information for the user

EVRA 203 micrograms/24 hours + 33.9 micrograms/24 hours transdermal patch

norelgestromin/ethinylestradiol
Important information about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods when used correctly.
• They slightly increase the risk of blood clots forming in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What EVRA is and what it is used for
2. What you need to know before using EVRA
3. How to use EVRA
4. Possible side effects
5. How to store EVRA
6. Contents of the pack and other information

1. What EVRA is and what it is used for

EVRA contains two types of sex hormones, a progestin called norelgestromine and an oestrogen called ethinylestradiol.
Because it contains two hormones, EVRA is known as a "combined hormonal contraceptive".
It is used to prevent pregnancy.

2. What you should know before using EVRA

General information
Before starting to use EVRA, you must read the information about blood clots in section 2. It is
particularly important that you read about the symptoms of a blood clot (see section 2 “Blood
clots”).
Do not use EVRA
Do not use EVRA if you have any of the conditions listed below. If you have any of the
conditions listed below, consult your doctor. Your doctor will discuss with you other methods of
birth control that might be more suitable for your case.

• If you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to have surgery or will be confined to bed for a long period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of a heart attack) or a transient ischaemic attack (TIA) – temporary stroke-like symptoms;
• if you have any of the following diseases, which may increase the risk of clots forming in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you are allergic to norelgestromin, ethinylestradiol, or any of the excipients of this medicine (listed in section 6);
• if you have been told you might have breast cancer or cancer of the uterus, cervix, or vagina;
• if you have had liver tumours or liver disease causing impaired liver function;
• if you have unexplained vaginal bleeding;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (also see section “Other medicines and EVRA”).

Do not use this medicine if you are in any of the situations listed above. If you are unsure, consult
your doctor, pharmacist, or nurse before using this medicine.
When to be especially careful with EVRA
When should you contact a doctor?
Seek urgent medical advice

• if you notice possible signs of a blood clot, which may indicate you have a blood clot in your leg (deep vein thrombosis), in your lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clot (thrombosis)”).

For a description of the symptoms of these serious side effects, see section “How to recognize a
blood clot”.
Warnings and precautions
Before using this medicine, you should visit your doctor for a check-up.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions appear or worsen while you are using EVRA, 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 affecting the body’s natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to have surgery or will be confined to bed for a long period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start using EVRA;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with potential breathing difficulties, contact your doctor immediately. Medicinal products containing estrogens may cause or worsen symptoms of hereditary and acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as EVRA increases the risk of developing a
blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause
serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, or, very rarely, these effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with EVRA
is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.
Are you experiencing any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may only be felt when standing or walking
  • increased warmth in the affected leg
  • skin colour change in the leg, e.g., paleness, redness, or bluish discolouration
• sudden and unexplained shortness of breath or rapid breathing Pulmonary embolism
• sudden cough without an obvious cause, possibly with coughing up blood
• sharp chest pain that may worsen when breathing deeply
• severe mental confusion or dizziness
• rapid or irregular heartbeat
• severe stomach pain

If you are unsure, inform your doctor, as some of these
symptoms, such as cough or breathlessness, may be mistaken
for a milder condition such as a respiratory tract infection (e.g., a
“common cold”).

Symptoms occurring more frequently in one eye: •sudden loss of vision or •blurred vision without pain, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, or heaviness; •crushing sensation or fullness in the chest, arm, or under the breastbone; •feeling of fullness, indigestion, or choking; •discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach; •sweating, nausea, vomiting, or dizziness; •extreme weakness, anxiety, or shortness of breath; •rapid or irregular heartbeat.	Heart attack
sudden numbness or weakness in the face, arm, or leg, especially on one side of the body; •sudden confusion, difficulty speaking or understanding speech; •sudden vision problems in one or both eyes; •sudden difficulty walking, dizziness, loss of balance or coordination; •sudden severe or prolonged headache with no known cause; •loss of consciousness or fainting with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you must still seek urgent medical attention as you may be at risk of another stroke.	Stroke
swelling and pale blue discoloration in a limb; •severe stomach (abdominal) pain.	Blood clots blocking other blood vessels

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 developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of
taking a combined hormonal contraceptive for the first time. The risk may also be higher
when restarting a combined hormonal contraceptive (the same or a different product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not
using a combined hormonal contraceptive.
When you stop using EVRA, the risk of developing a blood clot returns to
normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of venous thromboembolism (VTE) and on the type of combined hormonal contraceptive you are using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with
EVRA is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing etonogrel or norelgestromin, such as EVRA, about 6–12 will develop a blood clot in a year.
• The likelihood of developing a blood clot depends on your medical history (see “Factors that increase the risk of developing a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 women out of 10,000
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone or norgestimate	About 5-7 women out of 10,000
Women who use EVRA	About 6-12 women out of 10,000

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with EVRA is low, but certain conditions can increase it. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are due to undergo surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a plaster cast on your leg. You may need to stop using EVRA several weeks before surgery or during periods of reduced mobility. If you need to stop using EVRA, ask your doctor when you can start again;
• as you get older (especially over 35 years of age);
• if you have given birth within the last few weeks.

The risk of developing a blood clot increases if you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clots, particularly if you have other listed risk factors.
It is important that you inform your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide to stop your use of EVRA.
Inform your doctor if any of the above conditions change while you are using EVRA, for example, if a close relative develops thrombosis without a known cause, or if you gain significant weight.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems—for example, they may lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of EVRA is very low, but it may increase:

• as you get older (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as EVRA, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also be at increased risk of heart attack or stroke;
• if you or a close relative have high levels of fat in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular disorder, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes. If you have more than one of these conditions, or if one of them is particularly severe, the risk of developing a blood clot may be even higher.

Inform your doctor if any of the above conditions change while you are using EVRA, for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight.

Psychiatric disorders
Some women using hormonal contraceptives, including EVRA, have reported depression or depressed mood. Depression can be severe and, in some cases, may lead to suicidal thoughts. If you experience mood changes or symptoms of depression, consult your doctor as soon as possible for further medical advice.

Additionally, consult your doctor, pharmacist, or nurse before using EVRA if you have any of the following conditions, or if any of them develop or worsen:

• if you think you may be pregnant;
• if you have headaches that worsen or occur more frequently;
• if you weigh 90 kg or more;
• if you have high blood pressure or a tendency for your blood pressure to increase;
• if you have gallbladder disease, including gallstones or inflammation of the gallbladder;
• if you have a blood disorder called “porphyria”;
• if you have a nervous system disorder causing sudden involuntary movements of the body called “Sydenham’s chorea”;
• if you had a blistering skin rash during pregnancy (called “herpes gestationis”);
• if you have hearing loss;
• if you have diabetes;
• if you have depression;
• if you have epilepsy or any other condition that may cause seizures;
• if you have liver problems, including yellowing of the skin and whites of the eyes (jaundice);
• if you have or have had “pregnancy mask” (chloasma). These are yellow-brown patches or spots, especially on the face. Such patches may not completely disappear after stopping EVRA. Protect your skin from sunlight or ultraviolet radiation. This may help prevent the appearance or worsening of these patches;
• if you have kidney problems.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before using EVRA.

Sexually transmitted diseases
This medicine will not protect you from HIV (AIDS) or any other sexually transmitted diseases. These include chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. Always use condoms to protect yourself from these diseases.

Medical examinations
If you are due to have a blood or urine test, tell your doctor or the person collecting the sample that you are using EVRA, as hormonal contraceptives can affect some test results.

Children and adolescents
EVRA has not been studied in children and adolescents under 18 years of age. EVRA must not be used in girls and adolescents who have not yet had their first menstrual period.

Other medicines and EVRA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not use EVRA if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in liver function blood tests (elevated liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. You may resume using EVRA approximately 2 weeks after completing treatment. See section “Do not use EVRA”.

Some medicines and herbal remedies may reduce the effectiveness of EVRA. In this case, you may become pregnant or experience unexpected bleeding. These include medicines used to treat:

• certain antiretroviral medicines used for the treatment of HIV/AIDS and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• medicines used to treat infections (such as rifampicin and griseofulvin);
• medicines for the treatment of seizures (such as barbiturates, topiramate, phenytoin, carbamazepine, primidone, oxcarbazepine, and felbamate);
• bosentan (a medicine used to treat high blood pressure in the pulmonary arteries);
• St. John’s wort (Hypericum perforatum) (a herbal remedy used for depression).

If you are taking any of these medicines, you must also use a supplementary contraceptive method (e.g., condom, diaphragm, or spermicidal foam). The interfering effect of some of these medicines may last up to 28 days after you stop taking them. Ask your doctor or pharmacist for advice on another contraceptive method if you are using EVRA together with any of the medicines listed above.

EVRA may reduce the effect of certain medicines such as:

• medicines containing cyclosporine;
• lamotrigine, a medicine used for epilepsy—this may increase the risk of seizures.

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

Pregnancy and breastfeeding

• Do not use this medicine if you are pregnant or think you might be pregnant.
• Stop using this medicine immediately if you become pregnant.
• Do not use this medicine if you are breastfeeding or plan to breastfeed.

If you are pregnant or planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
You may drive and operate machinery while using this medicine.

Risks associated with the use of combined hormonal contraceptives
The following information is based on data regarding combined oral contraceptives. Since the transdermal patch EVRA contains hormones similar to those in combined oral contraceptives, it is likely to carry the same risks. All combined oral contraceptives carry risks that may lead to disability or death.
It has not been proven that a transdermal patch such as EVRA is safer than an orally taken combined hormonal contraceptive pill.

Combined hormonal contraceptives and cancer

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

Breast cancer
Women using combined hormonal contraceptives have been observed to develop breast cancer more frequently than women who do not use them. However, it is possible that combined hormonal contraceptives are not the cause. It may be that women who use combined hormonal contraceptives visit their doctors more frequently, increasing the likelihood of detecting breast cancer. The increased risk of breast cancer gradually decreases after stopping combined hormonal contraceptives. After ten years, the risk of breast cancer is the same as in women who have never used combined hormonal contraceptives.

Liver cancer
Rarely, non-cancerous and even more rarely, cancerous liver tumours have been reported in women using combined hormonal contraceptives. Such tumours may cause internal bleeding and severe abdominal pain. If this occurs, contact your doctor immediately.

3. How to use EVRA

Always use this medicine exactly as instructed by your doctor or pharmacist.

• If you do not, you may have an increased risk of becoming pregnant.
• If you are unsure, consult your doctor or pharmacist.
• Keep other non-hormonal contraceptives (e.g. condoms, spermicidal foam or sponge) available as backup methods in case of user error.

How many patches to use

• Weeks 1, 2, and 3: apply one patch and wear it exactly for seven days.
• Week 4: do not use a patch during this week.

If you have not used any hormonal contraceptive in the previous cycle

• You may start this medicine on the first day of your next cycle.
• If more than one day has passed since the start of your cycle, consult your doctor about temporarily using a non-hormonal contraceptive.

Switching from an oral contraceptive pill to EVRA
If you are switching from an oral contraceptive pill to EVRA:

• Wait for your period.
• Apply the first patch within the first 24 hours of your period.

If the patch is applied after Day 1 of your period:

• Also use a non-hormonal contraceptive until Day 8, when you change the patch.

If your period does not occur within 5 days after taking the last oral contraceptive pill, speak with your doctor before starting this medicine.

Switching from a progestin-only pill, an implant, or an injectable method to EVRA

• You may start this medicine on any day after stopping the progestin-only pill, on the day of implant removal, or on the scheduled date for your next injection.
• On the first day after stopping the progestin-only pill, after implant removal, or on the scheduled date for your next injection, apply the patch.
• Also use a non-hormonal contraceptive until Day 8, when you change the patch.

After a spontaneous or induced abortion before 20 weeks of pregnancy

• Consult your doctor.
• You may start this medicine immediately.

If more than one day has passed since the spontaneous or induced abortion when you start this medicine, consult your doctor about temporarily using a non-hormonal contraceptive.

After a spontaneous or induced abortion after 20 weeks of pregnancy

• Consult your doctor.
• You may choose to start this medicine on Day 21 after the abortion, or on the first day of your menstrual cycle, whichever occurs first.

After childbirth

• Consult your doctor.
• If you have given birth and are not breastfeeding, do not use this medicine before four weeks after delivery.
• If you start more than four weeks after childbirth, use another non-hormonal contraceptive in addition to this medicine for the first 7 days.
• If you have had sexual intercourse after childbirth, wait for your first menstrual cycle or consult your doctor to ensure you are not pregnant before starting this medicine.

If you are breastfeeding

• Consult your doctor.
• Do not use this medicine while breastfeeding or if you intend to breastfeed (see section 2, Pregnancy and breastfeeding).

Important information to consider while using the patch

• Change EVRA on the same day each week. The patch is designed to work over a 7-day period.
• Never go more than 7 consecutive days without wearing a patch.
• Use only one patch at a time.
• Do not cut or tamper with the patch in any way.
• Avoid applying the patch to red, irritated, or cut skin.
• The patch must adhere completely to the skin to work properly.
• Press firmly on the patch until its edges are securely attached.
• Do not use creams, oils, lotions, talc, or makeup on the skin where you are applying the patch or near an applied patch, as this may cause the patch to detach.
• Do not apply a new patch to the exact same skin area as the one you just removed. Doing so increases the risk of irritation.
• Check daily to ensure the patch has not detached.
• Do not stop using patches, even if you have sexual intercourse only rarely.

HOW TO USE THE PATCH
If you are using EVRA for the first time, wait for the day you have your

period.

• Apply the first patch within the first 24 hours of your period.
• If the patch is applied after Day 1 of your period, you must use a non-hormonal contraceptive method until Day 8, when you change the patch.
• The day you apply the first patch will be Day 1. The 'Patch Change Day' will therefore be this same day every week.

Choose a body site to apply the patch.

• Always apply the patch to clean, dry, and hair-free skin.
• Apply the patch to your buttocks, abdomen, outer upper arm, or upper back, in an area not likely to be rubbed by tight clothing.
• Never apply the patch to the breast.

Using your fingers, open the aluminum foil pouch.

• Tear open along the edge (do not use scissors).
• Firmly grasp one corner of the patch and gently remove it from the pouch.
• Note the presence of a transparent protective film on the patch.
• Sometimes patches may stick inside the pouch: be careful not to accidentally remove the transparent protective film while removing the patch.
• Now, as shown in the figure, peel off half of the transparent protective film.
• Avoid touching the adhesive surface.

Apply the patch to the skin.

• Only then, peel off the other half of the protective film.
• Press firmly on the patch with the palm of your hand for 10 seconds.
• Ensure the edges are well adhered.

Wear the patch for 7 days (one week).

• On the 'Patch Change Day' (Day 8), remove the used patch.
• Immediately apply a new patch.
• On Day 15 (Week 3), remove the used patch.

• Apply a new patch.
• In total, there are three weeks during which patches are worn.
• To avoid irritation, do not apply the new patch exactly on the same spot as the previous one.

Do not use any patch during Week 4 (from Day 22 to Day 28).

• You should have your period during this time.
• During this week, you will be protected from pregnancy, but only if you start the next patch on time.

To begin the next four-week cycle:

• Apply a new patch on your regular 'Patch Change Day', i.e. the day after Day 28.
• The exact day your period starts or ends is not important.

If you wish to change your 'Patch Change Day' to another day of the week, discuss this with your doctor.
You must complete the current cycle and remove the third patch on the correct day. During Week 4, you may choose a new 'Patch Change Day' and apply the first patch on that day. Do not go more than 7 consecutive days without wearing a patch.

If you wish to delay your period, apply a patch also at the beginning of Week 4 (Day 22). You may experience spotting or intermenstrual bleeding. Do not wear more than 6 consecutive patches (i.e. for no more than 6 weeks). If you have worn 6 consecutive patches (i.e. for 6 consecutive weeks), do not apply the patch in Week 7. After 7 days without a patch, apply a new patch and restart the cycle, considering that day as Day 1. Consult your doctor before deciding to delay your period.

Daily activities while using the patch

• Normal activities such as bathing, showering, sauna, or exercising should not affect the effectiveness of the patch.
• The patch is designed to stay in place during these activities.
• However, it is recommended to check that the patch has not detached after engaging in these activities.

If you need to apply the patch in a new location on a day different from your 'Patch Change Day'
If the patch you are using becomes uncomfortable or causes irritation:

• you may remove it and replace it with a new patch applied to a different site, up to your next 'Patch Change Day'.
• you must use only one patch at a time.

If you find it difficult to remember to change the EVRA patch

• Talk to your doctor, pharmacist, or healthcare provider about how to make patch changes easier, or about the possibility of using another contraceptive method.

If the patch is coming loose or has detached
For less than one day (up to 24 hours):

• Try immediately to reapply it or apply a new patch right away.
• No additional contraceptive method is needed.
• The 'Patch Change Day' must remain the same.
• Do not reapply a patch if:
  • it no longer adheres
  • it has stuck to itself or another surface
  • foreign materials have adhered to it
  • it has loosened or detached a second time.
• Do not use adhesive tapes or bandages to secure the patch.
• If reapplication is not possible, apply a new patch immediately.

For more than one day (24 hours or longer) or if you are unsure how long it has been:

• Start a new four-week cycle immediately by applying a new patch.
• You will now have a new Day 1 and a new 'Patch Change Day'.
• During the first week of the new cycle, you must also use a non-hormonal contraceptive method.

Pregnancy may occur if you do not follow these instructions.

If you forget to replace the transdermal patch
At the beginning of any patch application cycle (Week 1 (Day 1)):
If you forget to apply the patch, you may be at particularly high risk of becoming pregnant.

• You should therefore use an additional non-hormonal contraceptive method for one week.
• Apply the first patch of the new cycle as soon as you remember.
• You will now have a new 'Patch Change Day' and a new Day 1.

In the middle of the patch cycle (Week 2 or Week 3):
If you forget to replace the patch for one or two days (up to 48 hours):

• Apply a new patch as soon as you remember.
• Apply the next patch on your regular 'Patch Change Day'.

No additional contraception is needed.

For more than two days (48 hours or longer):

• If you forget to replace the patch for more than 2 days, you may become pregnant.
• Start a new four-week cycle as soon as you remember, by applying a new patch.
• You will now have a different 'Patch Change Day' and a new Day 1.
• You must also use a supplementary contraceptive method 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 the patch as soon as you remember.
• Start the next cycle on your regular 'Patch Change Day', i.e. the day after Day 28.

No additional contraception is needed.

If you have no bleeding or irregular bleeding with EVRA
This medicine may cause unexpected vaginal bleeding or spotting during the weeks you wear the patch.

• This usually stops after the first few cycles.
• Errors in patch use may cause spotting or light bleeding.
• Continue using this medicine, and if bleeding persists beyond the first three cycles, consult your doctor or pharmacist.

If your period does not occur during the week you do not wear EVRA (Week 4), continue applying a new patch on your usual 'Patch Change Day'.

• If you are using this medicine correctly and your period is absent, this does not necessarily mean you are pregnant.
• However, if your period is absent for two consecutive cycles, 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 contact your doctor immediately.
Using too many patches may cause:

• Malaise (nausea, vomiting)
• Vaginal bleeding.

If you stop treatment with EVRA
You may experience irregular, light, or no menstrual periods. This generally occurs during the first 3 months, especially if your periods were irregular before starting this medicine.

If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you experience any side effect, especially if it is severe and persistent, or if you notice any change in your health that you think could be due to EVRA, inform your doctor.
Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or possible hives, with difficulty breathing (see also section “Warnings and precautions”).
An increased risk of developing blood clots in the veins [venous thromboembolism (VTE)] or blood clots in the arteries [arterial thromboembolism (ATE)] exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before using EVRA”.

Very common side effects (occur in more than 1 woman in 10):

• Headache
• Nausea
• Breast tenderness

Common side effects (occur in less than 1 woman in 10):

• Vaginal yeast infections, sometimes called candidiasis
• Mood disorders, such as depression, mood changes, mood swings, anxiety, crying
• Dizziness
• Migraine
• Stomach pain or bloated stomach
• Vomiting or diarrhoea
• Acne, skin rash, itching or skin irritation
• Muscle spasms
• Breast problems such as pain, breast enlargement or breast lumps
• Changes in menstrual bleeding patterns, uterine cramps, painful periods, vaginal discharge
• Application site reactions such as redness, irritation, itching or rash
• Feeling tired or generally unwell
• Weight gain

Uncommon side effects (occur in less than 1 woman in 100):

• Allergic reaction, urticaria
• Swelling due to fluid retention
• High levels of fats in the blood (such as cholesterol or triglycerides)
• Sleep disturbance (insomnia)
• Decreased libido
• Eczema, skin redness
• Abnormal production of milk from the breast
• Premenstrual syndrome
• Vaginal dryness
• Other reactions at the patch application site
• Swelling
• High blood pressure or increased blood pressure
• Increased appetite
• Hair loss
• Sensitivity to sunlight

Rare side effects (occur in less than 1 woman in 1,000):

• Harmful blood clots in a vein or artery, for example:
  • in a leg or foot (DVT)
  • in a lung (PE)
  • heart attack
  • stroke
  • mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
  • blood clots in the liver, stomach/intestine, kidneys or eye. The likelihood of developing 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
• Skin problems due to contact with the patch, such as blistering rash or ulcers
• Non-cancerous (benign) tumours of the breast or liver
• Uterine fibroids (uterus)
• Irritability or feeling of frustration
• Increased libido
• Taste disturbance
• Problems when wearing contact lenses
• Sudden and severe increase in blood pressure (hypertensive crisis)
• Inflammation of the gallbladder or colon
• Changes in cervical cells
• Brownish spots or patches on the face
• Gallstones or blockage of the bile duct
• Yellowing of the skin and whites of the eyes
• Abnormal levels of sugar or insulin in the blood
• Severe allergic reaction that may include swelling of the face, lips, mouth, tongue or throat and that may cause difficulty swallowing or breathing
• Skin rash with painful red nodules on the shins and legs
• Itchy skin
• Scaly, peeling, itchy and red skin
• Suppressed lactation
• Vaginal discharge
• Fluid retention in the legs
• Fluid retention
• Swelling of arms, hands, legs or feet

If you have stomach problems

• The amount of hormones released by EVRA should not be affected by vomiting or diarrhoea
• If you have stomach problems, you do not need to use an additional contraceptive method.

You may experience spotting, light bleeding, breast tenderness or feel unwell during the first 3 cycles. This usually resolves, but if it persists, consult your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EVRA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The
expiry date refers to the last day of that month.
Store in the original packaging to protect the patches from light and moisture.
Do not refrigerate or freeze.
Used patches still contain active hormones. To protect the environment, they must be disposed of carefully. To dispose of a used patch, you should:

• lift the label provided for disposal, located on the outside of the sachet.
• place the used patch inside the disposal label, opened in such a way that the adhesive surface covers the shaded area.
• close the label, sealing the used patch inside, and dispose of it out of the reach of children.

Do not throw any medicines down the drain or into household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What EVRA contains
The active substances are norelgestromin and ethinylestradiol. Each 20 cm transdermal patch contains
6 mg of norelgestromin and 600 micrograms of ethinylestradiol. The active substances are released over
a period of 7 days, with an average daily release of 203 micrograms of norelgestromin and 34 micrograms of
ethinylestradiol.
The excipients are: backing layer: outer layer of pigmented low-density polyethylene, inner layer of polyester;
middle layer: polyisobutylene/polybutene adhesive, crospovidone, non-woven polyester fabric, lauryl lactate;
third layer: polyethylene terephthalate (PET) film, polydimethylsiloxane coating.
Description of the appearance of EVRA and package contents
EVRA is a thin beige plastic transdermal patch bearing the printed mark “EVRA”. The adhesive side should be applied to the skin after removal of the transparent protective film.
EVRA is available in the following pack sizes: boxes containing 3, 9 or 18 patches individually packed in reinforced pouches, grouped in threes, wrapped in a perforated transparent plastic film.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Manufacturer:
Janssen Pharmaceutica NV, Turnhoutseweg, 30, B-2340 Beerse, Belgium
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest
Hungary
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.