Ortho Evra
(Ethinyl Estradiol/Norelgestromin)

Prescription Settings Edit

Brand Name Choices

Ortho Evra 0.6/6mg
Ortho Evra 0.6/6mg Extended Release Patches

Marketed as Evra Transdermal Patch 0.6/6mg in United Kingdom

Manufactured by Janssen-Cilag Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Generic Choices

No generic medication is available for Ortho Evra (Ethinyl Estradiol/Norelgestromin)

What Ortho Evra is and what it is used for

EVRA contains two types of sex hormones, a progestogen called norelgestromin and an oestrogen called ethinyl estradiol. Because it contains two hormones, EVRA is called a ‘combined hormonal contraceptive’. It is used to prevent pregnancy.

How to take Ortho Evra

Always use this medicine exactly as your doctor or pharmacist has told you.
• If you do not, you may increase your risk of getting pregnant.
• Check with your doctor or pharmacist if you are not sure.
• Always keep non-hormonal contraceptives (such as condoms, foam or sponge) as a back-up in case you make a mistake when using the patch. How many patches to use
• Weeks 1, 2 & 3: Put on one patch and leave it on for exactly seven days.
• Week 4: Do not put on a patch this week. If you have not used a hormonal contraceptive during your previous cycle
• You may start this medicine on the first day of your next period.
• If one or more days have elapsed since the start of your period, talk to your doctor about temporarily using a non-hormonal contraceptive. If you switch from the oral contraceptive pill to EVRA If you are switching from an oral contraceptive pill to this medicine:
• Wait until you get your menstrual period.
• Put on your first patch during the first 24 hours of your period. If the patch is applied after Day 1 of your period, you should:
• Use a non-hormonal contraceptive until Day 8 when you change your patch. If you do not get your period within 5 days of taking the last contraceptive pill, check with your doctor before starting this medicine. If you switch from the progestogen-only pill, an implant or an injectable to EVRA
• You may start this medicine any day after stopping the progestogen-only pill or on the day of removal of an implant or when the next injection would be due.
• The first day after stopping the progestogen-only pill, removing the implant or when your next injection would be due, put on a patch.
• Use a non-hormonal contraceptive until Day 8, when you change your patch. After miscarriage or abortion before 20 weeks of pregnancy
• Talk to your doctor.
• You may start this medicine right away. If one or more days have elapsed since your miscarriage or abortion when you start this medicine, talk to your doctor about temporarily using a non-hormonal contraceptive. After miscarriage or abortion after 20 weeks of pregnancy
• Talk to your doctor. You may start this medicine on Day 21 following the abortion or miscarriage, or on the first day of your next period, whichever comes first. After delivery
• Talk to your doctor.
• If you’ve had a baby and are not breast-feeding, you should not start using this medicine sooner than 4 weeks after delivery.
• If you start more than 4 weeks after delivery, use another non-hormonal contraceptive in addition to this medicine for the first 7 days. If you’ve had sex since delivery of your baby, wait for your first period or see your doctor to make sure you are not pregnant before starting this medicine. If you are breast-feeding
• Talk to your doctor.
• Do not use this medicine if you are breast-feeding or planning to breast-feed (see also section 2 Pregnancy and breast-feeding). Important information to follow when using the patch
• Change EVRA on the same day of each week. This is because it is designed to work over 7 days.
• Never go without wearing a patch for more than 7 days in a row.
• Only wear one patch at a time.
• Do not cut or tamper with the patch in any way.
• Do not put the patch on skin that is red, irritated or cut.
• To work properly the patch must stick firmly to your skin.
• Press the patch down firmly until the edges stick well.
• Do not use creams, oils, lotions, powder or makeup on the skin where you are placing a patch or near a patch you are wearing. This may make the patch come loose.
• Do not put a new patch on the same area of skin as the old patch. If you do you are more likely to cause irritation.
• Check each day to make sure the patch has not fallen off.
• Keep using the patches even if you do not have sex very often. How to use the patch: If this is the first time you are using EVRA, wait until the day you get your menstrual period.
• Apply your first patch during the first 24 hours of your period
• If the patch is put on after the first day of your period, use a non-hormonal contraceptive until Day 8, when you change your patch
• The day you apply your first patch will be Day 1. Your “Patch Change Day” will be on this day of the week every week. Choose a place on your body to put the patch.
• Always put your patch on clean, dry, hairless skin
• Put it on the buttock, abdomen, upper outer arm or upper back - places where it won’t be rubbed by tight clothing
• Never put the patch on your breasts. Using your fingers, open the foil sachet.
• Open it by tearing it along the edge (do not use scissors)
• Firmly grasp a corner of the patch and gently take it from the foil sachet
• There is a clear protective covering on the patch
• Sometimes patches can stick to the inside of the sachet – be careful not to accidentally remove the clear covering as you remove the patch
• Then peel away half of the clear protective covering (see picture). Try not to touch the sticky surface. Put the patch on your skin.
• Then take off the other half of the covering
• Press down firmly on the patch with the palm of your hand for 10 seconds
• Make sure that the edges stick well. Wear the patch for 7 days (one week).
• On the first “Patch Change Day”, Day 8, take off the used patch
• Put on a new patch immediately.
• On Day 15 (Week 3), take off the used patch
• Put on another new one. This makes a total of three weeks with the patches. To help stop irritation, do not put the new patch on exactly the same area of your skin as your last patch. Do not wear a patch on Week 4 (Day 22 through Day 28).
• You should have your period during this time
• During this week you are protected from getting pregnant only if you start your next patch on time. For your next four week cycle.
• Put on a new patch on your normal “Patch Change Day”, the day after Day 28
• Do this no matter when your period begins or ends. If you want to change your “Patch Change Day” to a different day of the week talk to your doctor. You will need to complete the current cycle and remove the third patch on the correct day. During Week 4, you may pick a new Change Day and apply the first patch on that day. You should never go more than 7 days in a row without wearing a patch. If you want to delay your period, apply a patch at the beginning of Week 4 (Day 22) instead of not wearing a patch on Week 4. You may experience light or breakthrough bleeding. Do not wear more than 6 patches (so not more than 6 weeks) in a row. When you have worn 6 patches in a row (so for 6 consecutive weeks), do not put on a patch in week 7. After 7 days of not wearing a patch, apply a new patch and restart the cycle using this as Day 1. Talk with your doctor before deciding to delay your period. Everyday activities while using the patches
• Normal activities such as having a bath or shower, using a sauna and exercising should not affect how well the patch works.
• The patch is designed to stay in place during these types of activities.
• However, you should check that the patch has not fallen off after doing these activities. If you need to place the patch on a new area on your body on a day other than your “Patch Change Day” If the patch causes irritation or you become uncomfortable wearing it:
• You can take it off and replace it with a new patch in a different place on your body until your next “Patch Change Day”
• You may only use one patch at a time. If you have trouble remembering to change your patch
• Talk to your doctor, pharmacist or nurse. He/she may be able to make patch changing easier for you. He/she may also talk about whether you need to use another method of contraception. If your patch becomes loose, lifts at the edges or falls off For less than one day (up to 24 hours):
• Try to put it on again or put on a new patch immediately.
• Back-up contraception is not needed.
• Your “Patch Change Day” should remain the same.
• Do not try to put a patch back on if:
•it is no longer sticky
•it has become stuck to itself or another surface
•it has other material stuck to it
•it is the second time it has become loose or has fallen off.
• Do not use tapes or wrapping to keep the patch in place.
• If you cannot get a patch back on, put on a new patch immediately. For more than one day (24 hours or more) or if you are not sure for how long:
• Start a new four week cycle immediately by putting on a new patch.
• You now have a new Day 1 and a new “Patch Change Day”.
• You must use non-hormonal contraception as back up for the first week of your new cycle. You may get pregnant if you do not follow these instructions. If you forget to change your patch At the start of any patch cycle (Week 1 (Day 1)): If you forget to put on your patch, you may be at particularly high risk of becoming pregnant.
• You must use non-hormonal contraception as back up for one week.
• Put on the first patch of your new cycle as soon as you remember.
• You now have a new “Patch Change Day” and new Day 1. In the middle of your patch cycle (Week 2 or 3): If you forget to change your patch for one or two days (up to 48 hours):
• You must put on a new patch as soon as you remember.
• Put on your next patch on your normal “Patch Change Day”. No back up contraception is needed. For more than 2 days (48 hours or more):
• If you forget to change your patch for more than 2 days, you may become pregnant.
• You must start a new four week cycle as soon as you remember by putting on a new patch.
• You now have a different “Patch Change Day” and a new Day 1.
• You must use back-up contraception for the first week of your new cycle. At the end of your patch cycle (Week 4): If you forget to take off your patch:
• Take it off as soon as you remember.
• Start your next cycle on your normal “Patch Change Day”, the day after Day 28. No back-up contraception is needed. If you have absent or irregular bleeding with EVRA This medicine may cause unexpected vaginal bleeding or spotting during the weeks when you are wearing the patch.
• This usually stops after the first few cycles.
• Mistakes in using your patches can also cause spotting and light bleeding.
• Continue using this medicine and if the bleeding lasts more than the first three cycles, talk to your doctor or pharmacist. If you do not get your period during the EVRA patch-free week (Week 4), you should still use a new patch on your usual “Patch Change Day”.
• If you have been using this medicine correctly and you do not have a period, this does not necessarily mean that you are pregnant.
• However, if you miss two periods in a row, talk to your doctor or pharmacist as you may be pregnant. If you use more EVRA than you should (more than one EVRA patch at any one time) Take the patches off and talk to a doctor immediately. Using too many patches may cause you to have the following:
• Feeling sick (nausea) and being sick (vomiting)
• Bleeding from the vagina. If you stop using EVRA You may get irregular, little or no menstruation. This usually happens in the first 3 months and especially if your periods were not regular before you started using this medicine. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to EVRA, please talk to your doctor. An increased risk of blood clots in your veins [venous thromboembolism (VTE)] or blood clots in your arteries [arterial thromboembolism (ATE)] is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you use EVRA”.

Very common side effects (may affect more than 1 in 10 women):
• Headache
• Nausea
• Breast tenderness.

Common side effects (may affect up to 1 in 10 women):
• Vaginal yeast infection, sometimes called thrush
• Mood problems such as depression, change in mood or mood swings, anxiety, crying
• Dizziness
• Migraine
• Stomach ache or bloating
• Vomiting or diarrhoea
• Acne, skin rash, skin itching or skin irritation
• Muscle spasms
• Breast problems such as pain, enlargement or lumps in the breast
• Changes in menstrual bleeding pattern, uterine cramps, painful periods, vaginal discharge
• Problems where the patch has been on the skin such as redness, irritation, itching or rash
• Feeling tired or generally unwell
• Weight gain.

Uncommon side effects (may affect up to 1 in 100 women):
• Allergic reaction, hives
• Swelling due to water retention in the body
• High levels of fats in the blood (such as cholesterol or triglycerides)
• Problems sleeping (insomnia)
• Less interest in sex
• Eczema, redness of the skin
• Abnormal breast milk production
• Premenstrual syndrome
• Vaginal dryness
• Other problems where the patch has been on the skin
• Swelling
• High blood pressure or rise in blood pressure
• Increased appetite
• Hair loss
• Sensitivity to sunlight.

Rare side 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 stroke-like symptoms, known as a transient ischaemic attack (TIA)
•blood clots in the liver, stomach/intestine, kidneys or eye. The chance of having a blood clot may be higher if you have any other conditions that increase this risk (See section 2 for more information on the conditions that increase risk for blood clots and the symptoms of a blood clot).
• Breast, cervical or liver cancer
• Problems where the patch has been on the skin such as skin rash with blisters or ulcers
• Non-cancerous (benign) tumours in your breast or liver
• Fibroids in the womb (uterus)
• Anger or feeling frustrated
• Increased interest in sex
• Abnormal taste
• Problems when wearing contact lenses
• Sudden sharp increase in blood pressure (hypertensive crisis)
• Inflammation of the gall bladder or colon
• Abnormal cells in your cervix
• Brown spots or patches on the face
• Gallstones or blockage of the bile duct
• Yellowing of the skin and whites of the eyes
• Abnormal blood sugar or insulin levels
• Swelling of face, mouth, throat, or tongue
• Skin rash with tender red nodules on the shins and legs
• Itchy skin
• Scaly, flaky, itchy and red skin
• Suppressed lactation
• Vaginal discharge
• Fluid retention in legs
• Fluid retention
• Swelling in the arms, hands, legs or feet. If you have an upset stomach
• The amount of hormones you get from EVRA should not be affected by being sick (vomiting) or diarrhoea.
• You do not need to use extra contraception if you have an upset stomach. You may have spotting or light bleeding or breast tenderness or may feel sick during the first 3 cycles. The problem will usually go away but if it doesn’t, check with your doctor or pharmacist.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine

How to Store Ortho 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 expiry date refers to the last day of that month. Store in the original container to protect from light and moisture. Do not refrigerate or freeze. Used patches still contain some active hormones. To protect the environment, the patches should be disposed of with care. To discard the used patch, you should:
• Peel back the disposal label on the outside of the sachet.
• Place the used patch within the open disposal label so that the sticky surface covers the shaded area.
• Close the label sealing the used patch within and discard, keeping out of reach of children. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

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2 to 3 weeks on average

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