Ethinyl estradiol and levonorgestrel (transdermal)

Ethinyl estradiol and levonorgestrel (transdermal) is a combination birth control medicine used to prevent pregnancy.

Ethinyl estradiol and levonorgestrel (transdermal) may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Do not wear more than one skin patch at a time. Never cut a skin patch.

Apply a new skin patch every 7 days for 3 weeks in a row (21 days). Change your patch on the same day of the week, and wear each patch for 7 full days. On Day 22, remove the patch and wait 7 days before applying a new patch. Your patch-free week should not be longer than 7 days.

Apply the patch to clean, dry skin that is not broken or irritated and will not be rubbed by tight clothing (such as a waistband).

You may need to use back-up birth control (such as a condom/diaphragm with spermicide) when you first start using this medicine, or if a patch becomes loose or has been off for longer than 1 day. Read and carefully follow all instructions about what to do if a patch gets loose or falls off, or if you forget to change your patch on time.

If you need major surgery or will be on long-term bed rest, do not wear a skin patch for at least 4 weeks before and 2 weeks after.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding is very heavy, or if you miss 2 or more regular periods.

Store patches at room temperature away from moisture and heat. Do not freeze or refrigerate. Keep each patch in its foil pouch until you are ready to apply it.

After removing a skin patch, fold it in half, sticky side in, and throw it away in a place where children and pets cannot reach it. Do not flush a used patch down the toilet.

You should not use this medicine if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, health problems caused by diabetes (such as damage to your kidneys, eyes, nerves, or blood vessels), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or this medicine, or cancer of the breast, uterus/cervix, or vagina.

Using this medicine can increase your risk of blood clots, stroke, or heart attack (especially if you smoke). You should not use this medicine if you smoke and are over 35 years old.

Using ethinyl estradiol and levonorgestrel can increase your chances of getting blood clots, having a stroke, or having a heart attack. You are at a higher risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight.

Smoking can significantly raise your chances of getting blood clots, having a stroke, or having a heart attack. Your risk goes up as you get older and the more you smoke. You should not use ethinyl estradiol and levonorgestrel if you smoke and are over 35 years old.

Your risk of a serious blood clot may be greater with birth control skin patches than with birth control pills.

You should not use ethinyl estradiol and levonorgestrel if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
• an increased risk of blood clots due to a heart problem or a hereditary blood disorder;
• diabetes (and you are over 35, have high blood pressure, have had diabetes for more than 20 years, or if diabetes has caused damage to your kidneys, eyes, nerves, or blood vessels);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Viekira).

Tell your doctor if you have ever had:

• heart disease, high blood pressure, or if you are prone to having blood clots;
• high cholesterol that is not controlled;
• depression;
• migraine headaches;
• diabetes, gallbladder disease;
• jaundice caused by pregnancy or hormonal birth control;
• hereditary angioedema;
• irregular menstrual cycles; or
• dark patches of skin on your face (chloasma).

Do not use this medicine if you are pregnant. You may need to take a pregnancy test before using ethinyl estradiol and levonorgestrel. Tell your doctor if you think you may be pregnant.

Ethinyl estradiol and levonorgestrel can slow down breast milk production. You should not breastfeed while using this medicine.

Get emergency medical help if you notice signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

ethinyl estradiol and levonorgestrel may lead to serious side effects. Stop using ethinyl estradiol and levonorgestrel and contact your doctor immediately if you experience:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, problems with vision or speech;
• signs of a blood clot--sudden vision loss, sharp chest pain, shortness of breath, coughing up blood, swelling or pain in an arm or leg;
• heart attack symptoms--chest pain or pressure, pain that spreads to your jaw or shoulder, nausea, sweating;
• severe headache, throbbing in your neck or ears;
• jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• a change in the pattern or intensity of migraine headaches; or
• symptoms of depression--sleep issues, weakness, fatigue, mood changes.

Common side effects of ethinyl estradiol and levonorgestrel may include:

• menstrual cramps;
• nausea;
• weight gain;
• headache; or
• skin reactions where a patch was applied--bumps, redness, changes in skin color, itching, rash, dryness, pain, swelling, bleeding.

This is not a complete list of side effects and others may occur. Contact your doctor for medical advice regarding side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Contraception:

Oral tablets: 1 tablet orally once a day at the same time each day in the order directed on the blister packTransdermal System: Four week cycle: Apply 1 patch once a week for 3 consecutive weeks; no patch is to be worn during week 4, cycle is then repeatedComments: -To achieve maximal contraceptive efficacy, tablets should be taken at intervals not exceeding 24 hours.-Tablets may be started on the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start).-The first transdermal system should be applied during the first 24 hours of menstruation. Use: To prevent pregnancy. --Transdermal use is for women with a body mass index (BMI) of less than 30 kg/m2 as those with a BMI of 30 kg/m2 or greater may have reduced efficacy and may be at higher risk for venous thromboembolism events; consider reduced effectiveness in women with a BMI of 25 to less than 30 kg/m2

Usual Pediatric Dose for Contraception:

For postmenarchal females: Oral tablets: 1 tablet orally once a day at the same time each day in the order directed on the blister packTransdermal System: Four week cycle: Apply 1 patch once a week for 3 consecutive weeks; no patch is to be worn during week 4, cycle is then repeatedComments: -To achieve maximal contraceptive efficacy, tablets should be taken at intervals not exceeding 24 hours.-Tablets may be started on the first Sunday after the onset of menstruation (Sunday Start) or on Day 1 of menstruation (Day 1 Start).-The first transdermal system should be applied during the first 24 hours of menstruation. Use: To prevent pregnancy. --Transdermal use is for women with a body mass index (BMI) of less than 30 kg/m2 as those with a BMI of 30 kg/m2 or greater may have reduced efficacy and may be at higher risk for venous thromboembolism events; consider reduced effectiveness in women with a BMI of 25 to less than 30 kg/m2

During your patch-free week, do not go without wearing a patch for longer than 7 days. Missing a dose increases your risk of becoming pregnant and you may need to use back-up birth control. Call your doctor if you miss a period for 2 months in a row.

If you forget to apply a patch at the start of a new cycle:

• Apply a patch as soon as you remember and start a new cycle on that day (3 weeks wearing a weekly patch, 1 week off). Use back-up birth control such as a condom/diaphragm with spermicide during the first week of your new cycle.

If you forget to change your patch during the 3-week wearing time:

• If it has been 24-48 hours since your scheduled patch change, apply a new patch and change it on your regular change day.
• If it has been more than 48 hours since your scheduled patch change, apply a new patch and start a new cycle on that day (3 weeks wearing a weekly patch, 1 week off). Use back-up birth control during the first week.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not smoke while using ethinyl estradiol and levonorgestrel (transdermal), especially if you are older than 35 years of age.

Grapefruit may interact with ethinyl estradiol and levonorgestrel (transdermal) and lead to unwanted side effects. Avoid the use of grapefruit products.

This medicine may cause darkening of your facial skin (chloasma), especially if you've ever had chloasma during a pregnancy. Avoid sunlight or tanning beds. Use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid applying makeup, lotions, powders, or oils to the skin where you apply the patch.

Many drugs can influence how ethinyl estradiol and levonorgestrel work, and some can make hormonal birth control less effective, which may lead to pregnancy. Inform your doctor about all the other medicines you are taking, especially:

• acetaminophen, aprepitant, ascorbic acid (vitamin C), bosentan, levothyroxine, St. John's wort;
• antibiotic or antifungal medicine--fluconazole, griseofulvin, itraconazole, ketoconazole, rifabutin, rifampin, voriconazole;
• antiviral medicine for HIV or hepatitis C--atazanavir, boceprevir, darunavir, efavirenz, etravirine, fosamprenavir, indinavir, lopinavir, nelfinavir, nevirapine, ritonavir, telaprevir, tipranavir;
• cholesterol medicine--atorvastatin, rosuvastatin; or
• seizure medicine--carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, rufinamide, topiramate.

This list is not exhaustive, and many other drugs may affect ethinyl estradiol and levonorgestrel. This includes both prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.