203 micrograms / 24 hours + 33.9 micrograms / 24 hours transdermal
patch norelgestromin / ethinyl estradiol
Important information about combined hormonal contraceptives:
- They are one of the most reliable contraceptive methods available if used properly.
- The risk of a blood clot in a vein or artery increases slightly, especially during the first year or when combined hormonal contraceptives start to be used again after a break of 4 weeks or longer.
- Pay attention and consult a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).
Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.
- Save this information, you may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others. It can hurt them.
- If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.
In 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 ingredients information
1. What EVRA is and what it is used for
EVRA contains two different sex hormones, a progestogen called norelgestromin and an estrogen called Ethinylestradiol.
Because EVRA contains two hormones, it is called a “combined hormonal contraceptive”.
It is used to prevent pregnancy.
2. What you need to know before using EVRA
Before using EVRA, read the information on blood clots in section 2. You must read the symptoms of blood clots – 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 these conditions, tell your doctor. The doctor will discuss what other type of contraception may be more appropriate.
- if you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs ( pulmonary embolism ), or any other organ
- if you know you have a disease that affects blood clotting – e.g. protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies
- if you need to have an operation or if you stay in bed for a long period of time (see section “Blood clots”)
- if you have (or have had) a heart attack or a stroke (stroke)
- if you have (or have had) angina (a condition that causes severe chest pain and maybe the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)
- if you have any of the following conditions that may increase the risk of a blood clot in your arteries:
- severe diabetes with damaged blood vessels
- very high blood pressure
- a very high level of fat in the blood ( cholesterol or triglycerides )
- a condition called hyperhomocysteinemia
- if you have (or have had) a type of migraine called “migraine with aura”
- if you are allergic to norelgestromin, Ethinyl estradiol, or any of the other ingredients of this medicine (listed in section 6)
- if you have previously been told that you have breast cancer or cancer of the uterus, cervix, or vagina
- if you have previously had liver tumors or any other liver disease that causes your liver to not function properly
- if you have unexplained vaginal bleeding
- if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and EVRA”).
Do not use this medicine if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking this medicine.
Take special care with EVRA
|When should you contact a doctor?|
Seek medical attention immediately if you notice any signs of a blood clot that may mean you have a blood clot in your leg (ie deep vein thrombosis ), a blood clot in your lung (ie pulmonary embolism ), a heart attack, or a stroke (see section “Blood clots” below).To describe the symptoms of these serious side effects, go to “How to recognize a blood clot”.
Warnings and cautions
Before treatment with this medicine, you must check with a doctor.
Tell your doctor if any of the following conditions apply to you.
If the condition occurs or worsens when you use EVRA, you should also consult a doctor.
- if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
- if you have a systemic lupus erythematosus ( SLE – a disease that affects your natural immune system)
- if you have hemolytic uremic syndrome (HUS – a disorder of blood coagulation that leads to kidney failure )
- if you have sickle cell anemia (a hereditary disease of the red blood cells )
- if you have increased blood fats ( hypertriglyceridemia ) or heredity for this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
- if you need to have an operation or if you stay in bed for a long period of time (see section 2 “Blood clots”)
- if you have just given birth, you are at increased risk of getting blood clots. Ask your doctor how soon after giving birth you can start taking EVRA
- if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
- if you have varicose veins.
Using combined hormonal contraceptives such as EVRA increases the risk of blood clots compared to if you do not use these drugs. In rare cases, a blood clot can block the blood vessels and cause serious problems.
Blood clots can form
- in veins (called venous thrombosis, venous thromboembolism, or VTE)
- in the artery (called arterial thrombosis, arterial thromboembolism, or ATE).
It is not always possible to fully recover from blood clots. In rare cases, they can have serious lasting effects and, in very rare cases, be fatal.
It is very important to remember that the overall risk of a dangerous blood clot due to EVRA is small.
HOW TO FEEL A BLOOD CLOTH AGAIN
Seek medical attention immediately if you notice any of the following signs or symptoms.
|Do you experience any of these signs?||What can you possibly suffer from?|
|swelling of a leg or along a vein in the leg or foot, especially if you also get: pain or soreness in the leg that is only felt when you stand or walk increased heat in the affected leg discoloration of the skin on the leg, e.g. pale, red or blue.||Deep vein thrombosis|
|sudden unexplained shortness of breath or rapid breathing sudden cough for no apparent reason that could cause you to cough up blood severe chest pain that may increase with deep breathingsevere instability or dizziness fast or irregular heartbeatsevere pain in the abdomen. If you are not sure, talk to a doctor because some of these symptoms, e.g. cough and shortness of breath, can be mistakenly interpreted as a milder condition such as a respiratory infection (such as a common cold).||Pulmonary embolism|
|Symptoms that usually occur in one eye: immediate loss of vision or blurred vision without pain that can lead to vision loss.||Retinal venous thrombosis (blood clot in the eye)|
|chest pain, discomfort, pressure, heavinesspressure or feeling of fullness in the chest, arm, or below the sternum feeling full, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomensweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breakfast or irregular heartbeat||Myocardial infarction|
|sudden weakness or numbness in the face, arms, or legs, especially on one side of the body sudden confusion, difficulty speaking or understanding sudden vision problems in one or both eyes sudden difficulty walking, dizziness, loss of balance or coordinationsudden, severe or prolonged headache without known cause unconsciousness or fainting with or without seizures. Sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of having a new stroke.||Stroke|
|swelling and slight blue discoloration of an arm or leg severe pain in the abdomen ( acute abdomen).||Blood clots that block other blood vessels|
BLOOD CLOTS IN A FRIEND
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 vein (venous thrombosis ). However, these side effects are rare. They usually occur during the first year of using a combined hormonal contraceptive.
- If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).
- If a blood clot moves from the bone and stays in the lung, it can lead to a pulmonary embolism.
- In very rare cases, a blood clot can form in a vein in another organ such as the eye ( retinal venous thrombosis ).
When is the risk of developing a blood clot in a vein greatest?
The risk of developing a blood clot in a vein is greatest during the first year and the first time you use combined hormonal contraceptives. The risk may also be higher if you start again with a combined hormonal contraceptive (the same product or another product) after a break of 4 weeks or longer.
After the first year, the risk decreases, but it is always slightly higher than if you did not use a combined hormonal contraceptive.
When you stop using EVRA, the risk of a blood clot returns to normal within a few weeks.
How big is the risk of developing 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 the leg or lungs with EVRA is small.
- Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
- Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 develop a blood clot in a year.
- Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norelgestromin such as EVRA, about 6-12 develop a blood clot in a year.
- The risk of a blood clot varies depending on your personal medical history (see “Factors that may increase the risk of a blood clot” below).
|Risk of developing a blood clot during a year|
|Women who do not use combined pills/patches/rings and who are not pregnant||About 2 out of 10,000 women|
|Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate||About 5-7 out of 10,000 women|
|Women using EVRA||About 6-12 out of 10,000 women|
Factors that may increase the risk of a blood clot in a vein
The risk of a blood clot with EVRA is small, but certain conditions increase the risk. The risk is higher:
- if you are overweight (body mass index or BMI over 30 kg / m 2 )
- if someone in your family has had a blood clot in the bone, lung, or another organ at a young age (eg for about 50 years). In this case, you may have a hereditary blood clotting disease
- if you need to have surgery or stay in bed for a long period of time due to an injury or illness, or if your leg is plastered. The use of EVRA may need to be discontinued for several weeks before surgery or while you are less mobile. If you have to stop taking EVRA, ask your doctor when you can start taking it again
- with increasing age (especially if you are over about 35 years old)
- if you gave birth a few weeks ago.
The risk of developing a blood clot increases the more conditions you have.
Air travel (> 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other factors listed here.
You must tell your doctor if you have any of these conditions, even if you are unsure. Your doctor may decide that you must stop taking EVRA.
Talk to your doctor if any of the above conditions change when you use EVRA, e.g. a close relative suffers from a blood clot with an unknown cause or if you gain a lot of weight.
BLOOD CLOTS IN AN ART
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can lead to serious problems. It can e.g. cause a heart attack or stroke.
Factors that may increase the risk of a blood clot in an artery
It is important to know that the risk of a heart attack or stroke due to the use of EVRA is very small but may increase:
- with increasing age (after about 35 years of age)
- if you smoke. When using combined hormonal contraceptives EVRA, you should stop smoking. If you can not stop smoking and are over 35 years old, your doctor may advise you to use another 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 (younger than 50 years). In this case, you may also be at greater risk of a heart attack or stroke
- if you or a close relative have high blood fats ( cholesterol or triglycerides )
- if you get migraines, especially migraines with an aura
- if you have heart problems (valve disease, a heart rhythm disorder called atrial fibrillation )
- if you have diabetes.
If you have more than one of these conditions or if any of them are particularly serious, the risk of developing a blood clot can be even greater.
If any of the above conditions change when you use EVRA, e.g. If you start smoking, a close relative suffers from thrombosis of unknown cause, or you gain a lot of weight, talk to your doctor.
Some women who use hormonal contraceptives, including EVRA, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.
Also talk to your doctor, pharmacist, or nurse before treatment with EVRA if you have any of the following conditions or if a condition occurs or worsens while you are using EVRA:
- if you suspect you are pregnant
- if you have a headache that gets worse or occurs more often
- if you weigh 90 kg or more
- if you have high blood pressure or if your blood pressure increases
- if you have gallbladder disease including gallstones or inflammation of the gallbladder
- if you have a blood disorder called porphyria
- if you have a disease called Sydenham’s Korea which affects the nervous system and causes sudden body movements
- if you have a rash with blisters during pregnancy (so-called herpes gestationis)
- if you have a hearing loss
- if you have diabetes
- if you have depression
- if you have epilepsy or other diseases that can cause seizures (seizures)
- if you have liver problems including yellowing of the skin and whites of the eyes (jaundice)
- if you have or have had so-called “pregnancy spots”. These are yellow-brown pigment spots or dots, especially on the face (so-called chloasma). These spots may not go away completely, even after you stop taking EVRA. Protect your skin from sunlight and ultraviolet radiation. This can help you prevent you from getting such stains or that they get worse
- if you have kidney problems.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking EVRA.
Sexually transmitted diseases
EVRA will not protect against HIV – infection ( AIDS ) or other sexually transmitted diseases, chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, or syphilis. Always use a condom to protect yourself against these diseases.
- If you are going to take a blood or urine sample, tell your doctor or sampling staff that you are using EVRA as hormonal contraceptives may affect certain test results.
Children and young people
EVRA has not been studied in children and adolescents under 18 years of age. EVRA must not be used by children and adolescents who have not yet had their first period.
Other medicines and EVRA
Tell 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 and dasabuvir as this may cause elevated liver function values in blood tests (elevation of the liver enzyme ALT ). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. EVRA can be started again 2 weeks after the end of this treatment. See section “Do not use EVRA”.
Some medicines and herbal medicines may affect the way EVRA works. If this happens, you may become pregnant, or have unexpected bleeding.
These include drugs used to treat:
- certain antiretroviral medicines used to treat HIV / AIDS and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
- medicines for infection (eg rifampicin and griseofulvin)
- anticonvulsants (such as barbiturates , topiramate, phenytoin , carbamazepine, primidone, oxcarbazepine and felbamate)
- bosentan (a medicine for high blood pressure in the blood vessels of the lungs)
- St. John’s wort (herbal medicine for depression). If you are taking any of these drugs, you may need to use another method of contraception (eg condom, diaphragm, or p- foam ). Some of these medicines may impair the effect of EVRA up to 28 days after you stop taking them. If you are using EVRA and any of the above medicines at the same time, ask your doctor or pharmacist to use another type of contraceptive.
EVRA may make some other medicines less effective, for example:
- medicines containing ciclosporin
- lamotrigine, drugs against epilepsy [this may increase the risk of seizures (convulsions)]
Your doctor may need to adjust the dose of one of the other medicines. Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy and breastfeeding
- Do not use this medicine if you are pregnant or think you may be pregnant.
- If you become pregnant, stop taking this medicine immediately.
- Do not use this medicine if you are breast-feeding or intend to breast-feed.
If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine does not affect the ability to drive or use machines.
Risks with combined hormonal contraceptives
The following information is based on information about the contraceptive pill. Because EVRA transdermal patches contain similar hormones to those used in the contraceptive pill, it is likely to carry the same risks. All birth control pills have risks, which can lead to disability or death.
There is no evidence that a transdermal patch such as EVRA is safer than an oral contraceptive pill taken by mouth.
Combined hormonal contraceptives and cancer
Cervical cancer has been found more often in women taking combined hormonal contraceptives. However, this may be due to other causes, including sexually transmitted diseases.
Breast cancer has been found more often in women taking combined hormonal contraceptives. However, the combined hormonal contraceptives may not be the cause of the increased incidence of breast cancer. This may be because women who use combined hormonal contraceptives more often undergo medical examinations. This can lead to an increased chance of detecting breast cancer. The increased risk of breast cancer gradually decreases after stopping treatment with combined hormonal contraceptives. After ten years, the risk is at the same level as in people who have never used combined hormonal contraceptives.
In rare cases, benign liver tumors have been reported in women taking combined hormonal contraceptives and in even more rare cases malignant tumors. This can cause internal bleeding with very severe pain in the abdomen. If you get this, contact your doctor immediately.
3. How to use EVRA
Always use this medicine exactly as your doctor or pharmacist has told you.
- Otherwise, the risk of getting pregnant may increase.
- If you are not sure, talk to your doctor or pharmacist.
- Always have non-hormonal contraceptives (such as condoms, contraceptive foam, or contraceptive pillows) as a spare in case you make a mistake when using the patch.
How many patches to use
- Weeks 1, 2, and 3: Put on a patch and let it sit for exactly seven days.
- Week 4: Do not put on any patches this week.
If you have not used any hormonal contraceptives during your previous menstrual cycle
- You can start with this medicine on the first day of your menstrual cycle.
- If one or more days have passed since menstruation began, consult your doctor about the temporary use of non-hormonal contraceptives.
If you are switching from birth control pills to EVRA
If you are switching from birth control pills to this medicine:
- Wait until you get your period.
- Put on the first patch during the first day of your menstrual cycle.
If the patch is applied after day 1 of your mentoring cycle, you should:
- Use a non-hormonal contraceptive until day 8 when changing patches.
If you do not get your period within 5 days after the last pill, consult your doctor before using this medicine.
If you are switching from birth control pills that contain only progestagen, implants, or injection to EVRA
- You can start with this medicine any day after you stop taking the progestogen-only pill or on the day the implant is removed or the next injection is planned.
- Put on a patch the first day after you stop taking the pill that contains the only progestagen, removed the implant, or when to take your next injection.
- Use a non-hormonal contraceptive until day 8, when changing patches.
After miscarriage or abortion before 20 weeks of pregnancy
- Consult your doctor.
- You can start using this medicine immediately.
If one or more days have passed since the miscarriage or abortion when you start taking this medicine, talk to your doctor about the temporary use of non-hormonal contraceptives.
After miscarriage or abortion after 20 weeks of pregnancy
- Consult your doctor.
- You can start using this medicine on day 21 after the abortion or miscarriage, or on the first day of your next period, whichever comes first.
- Consult your doctor.
- If you have given birth and are not breastfeeding, do not start using this medicine earlier than 4 weeks after giving birth.
- If you start using this medicine more than 4 weeks after delivery, you should use another non-hormonal contraceptive in addition to this medicine for the first 7 days.
- If you have had sex since you gave birth, wait for your first period or consult your doctor to make sure you are not pregnant before using this medicine.
If you are breast-feeding
- Consult your doctor.
- Do not use this medicine if you are breast-feeding or planning to breast-feed (see also section 2 under Pregnancy and breast-feeding).
Important information about the patch
- Change EVRA the same day every week. EVRA is intended to operate for 7 days.
- You should never be without patches for more than 7 days in a row.
- Never use more than one patch at a time.
- Do not cut or alter the patch in any way.
- Do not apply the patch to skin that is red, irritated, or sore.
- To function properly, the patch must adhere firmly to the skin.
- Press the patch until the outer edges are firmly attached.
- Do not use skin cream, oil, lotion, powder, or makeup on the skin where you are going to put a patch or near a patch you are already wearing. This may cause the patch to come off.
- Do not put a new patch on the same spot on the skin as the last patch. Doing so increases the risk of skin irritation.
- Check every day that the patch remains.
- Do not stop using the patches even if you do not have intercourse very often.
If you want to change the “patch change day” to another day of the week, consult your doctor.
You will need to finish the current cycle and remove the third patch on the correct day. During week 4, you can choose a new change day and apply the first patch on this day. It should never go more than 7 days in a row without wearing a patch.
If you want to postpone your period, apply a patch at the beginning of week 4 (day 22) instead of not wearing a patch during week 4. You may experience slight bleeding or breakthrough bleeding. Do not use more than 6 patches (no more than 6 weeks) in a row. When you have worn 6 patches in a row (6 weeks in a row), do not put on any patches in week 7. After a 7-day break without patches, put on a new patch and start again on a new cycle by counting this as Day 1. Consult with a doctor before deciding to postpone menstruation.
Daily activities while using the patch
- Normal activities such as bathing, showering, taking a sauna, or exercising should not affect the effectiveness of the patch.
- The patch is designed to stay in place during this type of activity.
- However, you should always check that the patch has not fallen off after such activities.
If you need to change the placement of the patch to another part of the body on a day other than your “patch change day”
If the patch makes the skin irritated or if it feels uncomfortable:
- Remove the patch and replace it with a new one in another place on the body and leave it until the next “patch change day”.
- You should only use one patch at a time.
If you have difficulty remembering to change patches
- Consult a doctor, pharmacist, or nurse. Maybe they can give you advice that facilitates the patch change or possibly suggest that you switch to another method of contraception.
If the patch comes off, lifts at the edges, or falls off
In less than a day (up to 24 hours):
- Try attaching it again or apply a new patch immediately.
- You do not need any extra contraceptives.
- Keep the same “patch change day”
- Do not try to put the patch back on if:
- it is no longer sticky
- it has stuck to itself or some other surface
- another material has stuck to it
- this is the second time it comes loose or falls off.
- Do not use tape or bandages to hold the patch in place.
- If you cannot reattach the patch, apply a new one immediately.
For more than one day (24 hours or more) or if you do not know how long:
- Immediately start a new four-week cycle by applying a new patch.
- You now have a new day 1 and a new “patch change day”.
- For safety reasons, you must use non-hormonal contraceptives during the first week of your new cycle.
You may become pregnant if you do not follow these instructions.
If you forget to change patches
At the beginning of a patch cycle (week 1 (day 1)):
If you forget to put on your patch, the risk is extra high that you will become pregnant.
- For safety reasons, you must use a non-hormonal contraceptive for one week.
- Put the first patch on your new bike as soon as you remember.
- You now have a new “patch change day” and a new day 1.
In the middle of a patch cycle (week 2 or 3):
If you forget to change the patch for one or two days (up to 48 hours):
- Put on a new patch as soon as you remember.
- Put on the next patch on your regular “patch change day”.
You do not need to use extra contraceptives.
For more than two days (48 hours or more):
- If you forget to change the patch for more than two days, you may become pregnant.
- You must start a new four-week cycle as soon as you remember by applying a new patch.
- You now have another “patch change day” and a new day 1.
- You must use extra contraception during the first week of your new cycle.
At the end of a patch cycle (week 4):
If you forget to remove the patch:
- Take it off as soon as you remember.
- Start the next cycle on your usual “patch change day”, the day after day 28.
You do not need to use extra contraceptives.
If the bleeding does not occur or becomes irregular with EVRA
This medicine may cause unexpected vaginal bleeding or splashing during the weeks you wear the patch.
- This usually stops after the first cycles.
- Using the patches incorrectly can also lead to spotting and spotting.
- Continue to use this medicine and if the bleeding lasts longer than the first three cycles, contact your doctor or pharmacist.
If you do not get your period during the patch-free week (week 4), you should still put on a new patch on your usual “patch change day”.
- If you have used this medicine correctly and you are not getting your period, it does not have to mean that you are pregnant.
- If you miss your period twice in a row, contact 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 a doctor immediately.
Using too many patches can lead to:
- nausea and vomiting
- vaginal bleeding.
If you stop using EVRA
Your bleeding may be irregular, menstruation may be sparse or absent altogether. This usually occurs during the first three months and especially if you had irregular periods before you started using this medicine.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects, especially if they are serious or persistent, or if your health changes and you think they may be due to EVRA, talk to your doctor.
An increased risk of blood clots in the veins [venous thromboembolism (VTE)] or blood clots in the artery are [arterial thrombosis (ATE)] are all women taking hormonal contraceptives combined. For more information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before using EVRA”.
Very common side effects (may affect more than 1 in 10 women):
- Sore breasts.
Common side effects (may affect up to 1 in 10 women):
- Yeast infection in the vagina, sometimes also called cod or candida infection
- Mood problems, including depression and mood swings or mood swings, anxiety, crying mildness
- Abdominal pain or swollen abdomen
- Vomiting or diarrhea
- Acne, rash, itching, or skin irritation
- Muscle cramps
- Problems with the breasts such as chest pain, breast enlargement, or lumps in the breasts
- Changes in the menstrual bleeding pattern, uterine cramps, painful menstruation, discharge from the vagina
- Skin problems at the application site such as redness, irritation, itching, or rash
- Feeling tired or in general
- Weight gain.
Uncommon side effects (may affect up to 1 in 100 women):
- Allergic reactions, hives
- Swelling due to accumulation of water in the body
- High blood fat levels (such as cholesterol or triglycerides )
- Sleep problems (insomnia)
- Decreased interest in sex
- Eczema, redness
- Abnormal breast milk production
- Premenstrual syndrome
- Vaginal dryness
- Other problems in the skin area where the transdermal patch has been sitting
- 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):
- Dangerous blood clots in a vein or artery, eg:
- in one leg or foot (ie DVT)
- in the lungs
- myocardial infarction
- mini-stroke or transient stroke similar symptoms, called transient ischemic attack ( TIA )
- blood clots in the liver, stomach/intestines, kidneys, or eyes.
The risk of developing a blood clot may be higher if you have other conditions that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and the symptoms of a blood clot).
- Breast cancer, uterine or liver cancer
- Skin problems where the patch has been sitting such as skin rash with blisters or sores
- Benign, non-cancerous tumors in your breasts or liver
- Muscle nodules ( fibroids ) in the uterus
- Anger or feelings of frustration
- Increased interest in sex
- Abnormal taste perception
- Problems using contact lenses
- The sudden, sharp rise in blood pressure (hypertensive crisis)
- Inflammation of the gallbladder or colon
- Abnormal cells in the cervix
- Brown spots or spots on the face
- Gallstones are or blockage of the bile duct
- Yellowing of the skin and whites of the eyes
- Abnormal blood sugar or insulin levels
- A severe allergic reaction may include swelling of the face, lips, mouth, tongue, or throat, which may lead to difficulty swallowing or breathing
- Skin rash with sore red bumps on narrow legs and legs
- Itchy skin
- Scaly, flaky, itchy skin and reddening of the skin
- Decreased breastfeeding
- Vaginal discharge
- Fluid retention in the legs
- Fluid accumulation
- Swelling of arms, hands, legs, or feet.
If you experience stomach upset
- The amount of hormone you receive from EVRA should not be affected by vomiting or diarrhea.
- You do not need to use extra contraceptives for stomach upset.
You may experience spotting, spotting, tender breasts, or nausea during the first 3 cycles. These problems usually go away, but if they do not, you should consult a doctor or pharmacist.
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 label after “EXP”. The expiration date is the last day of the specified month.
Store in the original package. Sensitive to light. Moisture sensitive.
Store in a cold place. Do not freeze.
Used patches still contain a certain amount of active hormones. To protect the environment, care must be taken when disposing of the patches. When disposing of a used patch:
- Open the label on the outside of the sachet.
- Place the applied patch under the open-label so that the sticky surface covers the shaded area.
- Seal the label with the applied patch inside and then discard it out of sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
The active substances are norelgestromin and Ethinylestradiol. Each 20 cm2 transdermal patch contains 6 mg norelgestromin and 600 micrograms Ethinylestradiol.
The active substances are released for 7 days and then an average of 203 micrograms of norelgestromin and 34 micrograms of Ethinyl estradiol is released per 24 hours.
The other ingredients are the back layer: an outer layer of low density pigmented polyethylene, an inner layer of polyester; middle layer: self-adhesive polyisobutylene/polybutene, crospovidone, polyester nonwoven fabric, lauryl lactate; third layer: polyethylene terephthalate (PET) film, coated with polydimethylpolysiloxane.
What the medicine looks like and the contents of the pack
EVRA is a thin, beige-colored transdermal patch made of plastic marked with “EVRA”. The sticky, adhesive side is attached to the skin after the transparent plastic protective film has been removed.
EVRA is available in the following pack sizes: Cartons with 3, 9, or 18 patches one-piece packed in foil-lined sachets, packed three and three in transparent perforated plastic film.
Not all 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, 30 Turnhoutseweg, B-2340 Beerse, Belgium.