ethinyl estradiol and norelgestromin (transdermal) (Ortho Evra, Xulane, Zafemy)

Brand Names: Ortho Evra, Xulane

Generic Name: ethinyl estradiol and norelgestromin (transdermal)

• What is ethinyl estradiol and norelgestromin transdermal (Ortho Evra, Xulane)?
• What are the possible side effects of ethinyl estradiol and norelgestromin transdermal (Ortho Evra, Xulane)?
• What is the most important information I should know about ethinyl estradiol and norelgestromin transdermal (Ortho Evra, Xulane)?
• What should I discuss with my healthcare provider before using ethinyl estradiol and norelgestromin transdermal (Ortho Evra, Xulane)?
• How should I use ethinyl estradiol and norelgestromin transdermal (Ortho Evra, Xulane)?
• What happens if I miss a dose (Ortho Evra, Xulane)?
• What happens if I overdose (Ortho Evra, Xulane)?
• What should I avoid while using ethinyl estradiol and norelgestromin transdermal (Ortho Evra, Xulane)?
• What other drugs will affect ethinyl estradiol and norelgestromin transdermal (Ortho Evra, Xulane)?
• Where can I get more information (Ortho Evra, Xulane)?

Ethinyl estradiol and norelgestromin contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norelgestromin transdermal (skin patch) is used as contraception to prevent pregnancy.

Ethinyl estradiol and norelgestromin may also be used for purposes not listed in this medication guide.

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

Remove the skin patch and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe headache, pounding in your neck or ears;
• a change in the pattern or severity of migraine headaches;
• swelling in your hands, ankles, or feet;
• a breast lump; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

• breast tenderness;
• darkening of facial skin;
• nausea, vomiting;
• breakthrough bleeding;
• skin irritation, redness, itching, or swelling where the patch was worn;
• headache, menstrual cramps; or
• anxiety, mood changes.

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

Do not use this medicine if you are pregnant or if you have recently had a baby.

You should not use hormonal birth control if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), 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 birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack. Your risk of serious blood clot may be higher with the use of birth control skin patches than with pills.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not use this medicine if you smoke and are older than 35 years of age.

Using hormonal birth control can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of using birth control. Your risk is also high when you restart this medicine after not using for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not use this medicine if you smoke and are over 35 years old.

Your risk of serious blood clot may be higher with the use of birth control skin patches than with the use of birth control pills.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant, or if you miss 2 menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before using this medicine.

You should not use hormonal birth control 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 having blood clots due to a heart problem or a hereditary blood disorder;
• circulation problems (especially if caused by diabetes);
• 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 cancer;
• severe migraine headaches (aura, numbness, vision changes), especially if you are older than 35;
• if you smoke and are over 35 years old; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

Tell your doctor if you have ever had:

• heart problems, high blood pressure, or if you are prone to having blood clots;
• high cholesterol or triglycerides, or if you are overweight;
• depression;
• a seizure or migraine headache;
• liver or kidney disease;
• jaundice caused by pregnancy or birth control pills;
• irregular menstrual cycles; or
• diabetes, gallbladder disease, underactive thyroid.

This medicine can slow breast milk production. Do not use if you are breast-feeding a baby.

Follow all directions on your prescription label. You will apply your first patch on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

Do not wear more than one skin patch at a time. Never cut a skin patch.

Apply the patch to clean, dry skin and press it into place firmly for 10 seconds. Make sure the edges stick well and wear the patch for a full week (7 days). Do not apply the patch to skin that is broken or irritated, or to a skin area that may be rubbed by tight clothing (such as a waistband).

Remove the patch and apply a new one on the same day each week for 3 weeks in a row (21 days). Then remove the patch and do not apply a new one for 7 full days. Your period should start during this time. Do not allow more than 7 days to pass before starting your next 3-week patch cycle.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

While using ethinyl estradiol and norelgestromin transdermal, you will need to visit your doctor regularly.

Check your skin patch every day. If a patch comes loose or falls off, throw it away and apply a new one. You may need to use back-up birth control (condoms with spermicide), if a patch has been off for more than 24 hours. Follow your doctor's instructions.

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 get to it. Do not flush a used patch down the toilet.

QUESTION

Which of the following are methods for contraception? See Answer

If you forget to change your patch at the end of the week, change it as soon as you remember. If it has been 24 hours or longer since your scheduled patch change, apply a new patch and start the cycle over (3 weeks wearing a weekly patch, 1 week off). Do not apply two patches at one time.

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.

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

Do not smoke while using this medicine, especially if you are older than 35 years of age.

Grapefruit may interact with this medicine and lead to unwanted side effects. Avoid the use of grapefruit products.

Avoid using creams, lotions, powders, or other medications on the skin where you apply the patch, or it may not stick to your skin.

This medicine will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Tell your doctor about all your other medicines, especially:

• acetaminophen, ascorbic acid (vitamin C), lamotrigine;
• thyroid medication;
• antifungal medicine--fluconazole, itraconazole, ketoconazole, voriconazole;
• cholesterol-lowering medicines--atorvastatin, rosuvastatin; or
• HIV or AIDS medicines--atazanavir, etravirine, indinavir.

This list is not complete. Other drugs may affect hormonal birth control, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make birth control less effective, which may result in pregnancy. Not all possible interactions are listed in this medication guide.

Your pharmacist can provide more information about ethinyl estradiol and norelgestromin.

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