Norelgestromin/Ethinyl Estradiol Patch

Pronunciation: nor-el-JES-troe-min/ETH-i-nil ES-tra-DYE-ol
Generic Name: Norelgestromin/Ethinyl Estradiol
Brand Name: Ortho Evra

Smoking cigarettes while using Norelgestromin/Ethinyl Estradiol Patch increases the risk of serious heart problems. The risk increases with age (older than 35 years) and with frequent smoking. Patients who use Norelgestromin/Ethinyl Estradiol Patch are strongly advised not to smoke. Do not use Norelgestromin/Ethinyl Estradiol Patch if you are older than 35 years and you smoke.

Women who use Norelgestromin/Ethinyl Estradiol Patch may have a higher risk of developing serious blood clots than women who use birth control pills. Discuss any questions or concerns with your doctor.

Norelgestromin/Ethinyl Estradiol Patch is used for:

Preventing pregnancy. It may also be used for other conditions as determined by your doctor.

Norelgestromin/Ethinyl Estradiol Patch is an estrogen/progestin combination. It works by preventing the release of eggs from the ovaries and thereby preventing pregnancy.

Do NOT use Norelgestromin/Ethinyl Estradiol Patch if:

• you are allergic to any ingredient in Norelgestromin/Ethinyl Estradiol Patch


• you are pregnant or suspect you may be pregnant, have recently given birth, or are breast-feeding


• you have blood clots in the legs, lungs, or eyes, or a history of other blood clotting problems


• you have a history of blood vessel problems of the heart or brain, a heart attack, chest pain, or a stroke


• you have a history of yellowing of the eyes or skin during pregnancy or previous hormonal birth control use


• you have a history of breast cancer; or known or suspected breast cancer or cancer of the uterus, cervix, or vagina; cancer that is estrogen-dependent; or you have unusual vaginal bleeding from an unknown cause


• you have a liver tumor, liver cancer, or active liver disease; severe high blood pressure; blood vessel problems caused by diabetes; certain heart valve problems; or the blood disease porphyria


• you have headaches with neurological symptoms or will be on bed rest for a long period following surgery


• you are taking birth control pills

Contact your doctor or health care provider right away if any of these apply to you.

Before using Norelgestromin/Ethinyl Estradiol Patch:

Some medical conditions may interact with Norelgestromin/Ethinyl Estradiol Patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have high blood pressure; high cholesterol, triglycerides, or calcium levels; or pancreatitis or gallbladder problems; or you are obese


• if you have breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, endometriosis or endometrial carcinomas, uterine fibroids, or irregular or scanty menstrual periods


• if a member of your family has had breast cancer


• if you have liver or kidney problems, heart problems, diabetes, headaches, migraine headaches, epilepsy, or a history of mental depression


• if you smoke, weigh 198 lbs or more, or will be having surgery


• if you have recently given birth or had a miscarriage or abortion


• if you are taking an antibiotic

Some MEDICINES MAY INTERACT with Norelgestromin/Ethinyl Estradiol Patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Azole antifungals (eg, ketoconazole) or HMG-CoA reductase inhibitors (eg, atorvastatin) because they may increase the risk of Norelgestromin/Ethinyl Estradiol Patch's side effects


• Aprepitant, azole antifungals (eg, itraconazole), barbiturates (eg, phenobarbital), bosentan, carbamazepine, felbamate, griseofulvin, HIV protease inhibitors (eg, ritonavir), hydantoins (eg, phenytoin), modafinil, nonnucleoside reverse transcriptase inhibitors (NNRTIs) (eg, nevirapine), oxcarbazepine, penicillins (eg, amoxicillin), rifampin, St. John's wort, tetracyclines (eg, doxycycline), topiramate, or troglitazone because they may decrease Norelgestromin/Ethinyl Estradiol Patch's effectiveness. Alternative forms of birth control are strongly recommended when taking any of these medicines along with this birth control medicine


• Beta-blockers (eg, atenolol), corticosteroids (eg, prednisolone), selegiline, theophyllines (eg, aminophylline), or troleandomycin because the risk of their side effects may be increased by Norelgestromin/Ethinyl Estradiol Patch


• Lamotrigine, morphine, or temazepam because their effectiveness may be decreased by Norelgestromin/Ethinyl Estradiol Patch

This may not be a complete list of all interactions that may occur. Ask your health care provider if Norelgestromin/Ethinyl Estradiol Patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Norelgestromin/Ethinyl Estradiol Patch:

Use Norelgestromin/Ethinyl Estradiol Patch as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Norelgestromin/Ethinyl Estradiol Patch. Talk to your pharmacist if you have questions about this information.


• One patch is usually applied to the skin, worn for 1 week, and then replaced. Follow the dosing schedule carefully.


• Do not open the sealed pouch containing the patch until you are ready to use it. Open the pouch and remove the patch from the protective liner. Apply to an area of clean, dry skin on the lower stomach area below the belly button. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the patch lifts, press down to reapply. Wear only 1 patch at any one time.


• Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on areas where sitting may loosen it. Do not apply to a site that is exposed to sunlight or where the skin is red, irritated, or cut. Do not use creams, oils, powder, or makeup on your skin where you will put a patch or near a patch you are using because it may cause the patch to become loose. Contact with water while bathing, showering, or swimming will not affect the patch.


• When it is time to change the patch, remove it slowly. After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.


• Apply a new patch to a different area to prevent skin irritation. Use a different site when replacing the patch and do not repeat the same site for at least 1 week. If the area around the patch becomes red, itchy, or irritated, remove that patch. Apply a new patch at a different site until your next scheduled patch change. If the irritation continues or becomes worse, notify your doctor promptly.


• If the patch has become loose or has fallen off for less than 1 day, try to reapply it or apply a new patch immediately. No other contraceptive measures are necessary.


• If the patch has become loose or has fallen off for more than 1 day or if you are not sure how long it has been off, apply a new patch to begin a new cycle. In this case, you may not be adequately protected from pregnancy. You must use an additional form of birth control (eg, diaphragm, male condoms, spermicide) until the patch has been in place for 7 days in a row.


• Do not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, if it has other material stuck to it, or if it has previously come loose or fallen off. Do not use any tapes or wraps to keep the patch in place. If you cannot reapply a patch, apply a new patch immediately.


• Check with your doctor before you eat grapefruit or drink grapefruit juice while you use Norelgestromin/Ethinyl Estradiol Patch. Eating grapefruit or drinking grapefruit juice may increase the risk of Norelgestromin/Ethinyl Estradiol Patch's side effects.


• If you forget to change your patch on the scheduled day, follow the directions in the additional patient leaflet that comes with Norelgestromin/Ethinyl Estradiol Patch. You may need to use a backup form of birth control (eg, condoms). If you forget to change your patch on the scheduled day and you are not sure what to do, use an extra form of birth control (eg, condoms) and check with your doctor or pharmacist.

Ask your health care provider any questions you may have about how to use Norelgestromin/Ethinyl Estradiol Patch.

Important safety information:

• Norelgestromin/Ethinyl Estradiol Patch may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Norelgestromin/Ethinyl Estradiol Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Limit alcoholic beverages.


• Norelgestromin/Ethinyl Estradiol Patch may cause dark skin patches on your face (melasma). Avoid the sun, sunlamps, or tanning booths until you know how you react to Norelgestromin/Ethinyl Estradiol Patch. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Norelgestromin/Ethinyl Estradiol Patch may increase the risk of stroke, heart attack, blood clots, high blood pressure, or similar problems. The risk may be greater if you smoke (especially in women older than 35 years).


• The risk of developing a blood clot may be greater with Norelgestromin/Ethinyl Estradiol Patch than with other forms of hormonal birth control (eg, birth control pill). Talk with your doctor about the benefits and risks of Norelgestromin/Ethinyl Estradiol Patch or other forms of hormonal birth control.


• Some antibiotics may decrease Norelgestromin/Ethinyl Estradiol Patch's effectiveness. If you take an antibiotic while you are using Norelgestromin/Ethinyl Estradiol Patch, talk with your doctor or pharmacist. You may need to use an additional form of birth control (eg, condoms) while you take the antibiotic. Discuss any questions or concerns with your doctor.


• Contact your doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.


• Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while using Norelgestromin/Ethinyl Estradiol Patch.


• Follow your doctor's instructions for examining your breasts and report any lumps immediately.


• If you wear contact lenses and you develop problems with them, contact your doctor.


• If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken in these circumstances while you are using Norelgestromin/Ethinyl Estradiol Patch.


• Nonprescription therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.


• Norelgestromin/Ethinyl Estradiol Patch may increase the risk of breast and endometrial cancer.


• Norelgestromin/Ethinyl Estradiol Patch does not stop the spread of HIV and other sexually transmitted diseases (STDs). Use barrier methods of birth control (eg, condoms) if you have HIV infection or an STD. Do not share needles, injection supplies, or items like toothbrushes or razors.


• Diabetes patients - Norelgestromin/Ethinyl Estradiol Patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Norelgestromin/Ethinyl Estradiol Patch may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Norelgestromin/Ethinyl Estradiol Patch.


• Lab tests will be required to monitor therapy. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a Pap test, at least once a year. You should also have periodic mammograms as determined by your doctor. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Norelgestromin/Ethinyl Estradiol Patch is not approved for use in CHILDREN who have not yet had their first menstrual period; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Do not use Norelgestromin/Ethinyl Estradiol Patch if you are pregnant. Avoid becoming pregnant while you are using it. If you miss a menstrual period or think you may be pregnant, contact your doctor right away. Norelgestromin/Ethinyl Estradiol Patch may be found in breast milk. If you are or will be breast-feeding while you use Norelgestromin/Ethinyl Estradiol Patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Norelgestromin/Ethinyl Estradiol Patch:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast tenderness or enlargement; headache; menstrual cramps; mild skin irritation at the application site; nausea; stomach pain, cramps, or bloating; vaginal spotting or breakthrough bleeding; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast lumps; breast pain; calf pain, swelling, or tenderness; changes in vision (eg, double vision, loss of vision); chest pain; confusion; coughing up blood; fainting; mental or mood changes (eg, depression, memory loss); pain, swelling, or tenderness in the stomach; severe headache or vomiting; severe or persistent dizziness; severe or persistent trouble sleeping; severe or persistent vaginal bleeding; slurred speech; sudden shortness of breath; swelling of the hands or feet; symptoms of liver problems (eg, yellowing of the skin or eyes, fever, dark urine, pale stools, loss of appetite); unusual tiredness or weakness; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of Norelgestromin/Ethinyl Estradiol Patch:

Store Norelgestromin/Ethinyl Estradiol Patch at 77 degrees F (25 degrees C) in the original sealed pouch. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Norelgestromin/Ethinyl Estradiol Patch out of the reach of children and away from pets.

General information:

• If you have any questions about Norelgestromin/Ethinyl Estradiol Patch, please talk with your doctor, pharmacist, or other health care provider.


• Norelgestromin/Ethinyl Estradiol Patch is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Norelgestromin/Ethinyl Estradiol Patch. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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