In the U.S.—

• Contraceptive, systemic

Norelgestromin/Ethinyl Estradiol (nor-el-JES-tro-min/ ETH-in-il es-tra-DYE-ole ) contraceptive skin patch is used to prevent pregnancy. Hormones from the patch are absorbed through your skin into your body. It works by stopping a woman's egg from fully developing each month. The egg can no longer accept a sperm and fertilization is prevented.

No contraceptive method is 100 percent effective. Birth control methods such as having surgery to become sterile or not having sex are more effective. Discuss with your health care professional your options for birth control.

Norelgestromin/Ethinyl Estradiol does not prevent AIDS or other sexually transmitted diseases. It will not prevent, hepatitis B. It will not help as emergency contraception, such as after unprotected sexual contact.

ORTHO-EVRA-PATCH is available only with your doctor's prescription, in the following dosage forms:

Transdermal
• Skin patch (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. If you are using the skin patch contraceptive for contraception you should understand how their benefits and risks compare to those of other birth control methods. This is a decision you, your sexual partner, and your doctor will make. For norelgestromin/ethinyl estradiol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to estrogens or progestins. Tell your doctor if you have ever had any unusual or reaction to any other hormones. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Norelgestromin/ethinyl estradiol is not recommended during pregnancy and should be discontinued if you become pregnant or think you are pregnant. In rare cases when hormonal contraceptives have been taken by mistake early in pregnancy, problems to the fetus have not occurred. Be sure you have discussed this with your doctor.

Breast-feeding— It is not known whether norelgestromin/ethinyl estradiol passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking ORTHO-EVRA-PATCH and who wish to breast-feed should discuss this with their doctor.

Children—Studies on ORTHO-EVRA-PATCH have been done only in adult patients, and there is no specific information comparing use of norelgestromin/ethinyl estradiol in children with use in other age groups. ORTHO-EVRA-PATCH should not be used before the start of menstruation.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of norelgestromin/ethinyl estradiol in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking norelgestromin/ethinyl estradiol, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Cyclosporine (e.g., Sandimmune) or
• Prednisolone (e.g., Prelone) or
• Theophylline (e.g., Slo-Phyllin, Theolair-SR)—The amounts of these medicines in your blood may be too high when taken with norelgestromin/ethinyl estradiol.

• Ampicillin or
• Barbiturates (e.g., Amytal, Nembutal) or
• Carbamazepine (e.g., Tegretol) or
• Felbamate (e.g., Felbatol) or
• Griseofulvin (e.g., Fulvicin-P/G) or
• HIV medicines (e.g., Agnerase, Crixivan, Norvir) or
• Oxcarbazepine (e.g., Trileptal) or
• Phenylbutazone (e.g., Butazolidin) or
• Phenytoin (e.g., Dilantin) or
• Rifampin (Rifadin) or
• Topiramate (e.g., Topamax)—Use of these medicines with norelgestromin/ethinyl estradiol may cause your contraceptive to be less effective.

• Hypericum perforatum (e.g., St. John's Wort)—Use of this herbal medicine with norelgestromin/ethinyl estradiol may cause your contraceptive to be less effective or cause vaginal bleeding during your cycle.

• Smoking, tobacco—Smoking may increase the chance of causing serious blood clots, vein, or heart problems.

• Breast cancer—current or suspected diagnosis or
• Breast cancer—personal history or
• Cancer of the uterus or cervix—Use of hormonal contraceptives may make these conditions worse.

• Jaundice during pregnancy or from using hormonal therapy in the past or
• Liver cancer, disease or tumors—Use of hormonal contraceptives may increase the chance of liver problems or make liver conditions worse.

• Diabetes mellitus (sugar diabetes)—Use of hormonal contraceptives may cause an increase, usually only a small increase, in your blood sugar and usually does not affect the amount of diabetes medicine that you take. You or your doctor will want to test for any changes in your blood sugar.

• Depression or
• Gallbladder disease or
• Heart attack or
• Heart disease, now or in the past or
• High blood pressure or
• Stroke, now or in the past—Use of hormonal contraceptives may cause or worsen these conditions.
• Abnormal or unusual vaginal bleeding—This condition may sometimes be treated with hormone contraceptives, but may make this condition worse.
• Migraine headache, new or worse or a new kind of headache—Use of hormonal contraceptives may cause headaches to be worse.
• Obesity—Use of the transdermal patch may be less effective in women with body weight greater than or equal to 198 pounds (90 kilograms).
• Problems with circulation or blood clots, now or in the past or
• Problems with heart valves or
• Surgery with a long period of inactivity—Use of hormonal contraceptives may increase the chance of blood clots and worsen these conditions.

To make using hormonal contraceptives as safe and reliable as possible, you should understand how and when to use them and what effects may be expected.

A paper with information for the patient will be given to you with your filled prescription, and will provide many details concerning the use of hormonal contraceptives. Read this paper carefully and ask your health care professional if you need additional information or explanation.

When you begin using norelgestromin and ethinyl estradiol, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception, such as a condom, spermicide, or diaphragm, for the first 7 days of your first cycle.

Keep each patch in the package until you are ready to use it. Apply the patch to clean, dry skin on the abdomen, upper body, the upper outside part of the arm, or the buttocks. Avoid touching the sticky surface of the patch. Make sure there is no lotion, powder, cream, or make-up on the skin. Apply the patch and then press it with the palm of your hand for 10 seconds to make sure it sticks. Change the location of the patch each time you apply a new one. Do not apply a patch to skin that is injured, broken, or cut. Do not apply a patch to your breasts. Check the patch every day to make sure it is in place.

If the patch comes off partly or all the way, try to apply it again or apply a new patch. If it was loose less than 24 hours, no other form of birth control is needed. If the patch has peeled away for more than 24 hours, apply a new patch and start a new cycle. A second form of birth control should be used.

If the patch is not sticky or has stuck to material or itself, remove it and apply a new patch. Do not hold the patch in place with tape or wraps.

If you are switching from a contraceptive pill to using the patch, start the patch on the first day of your period. If you do not start your period after 5 days, you see your health care professional for a pregnancy test. If you start the patch later than the first day of your period, use a second method of birth control with the patch for the first 7 days.

If you have had a baby and are not breast-feeding, you should wait 4 weeks before you start ORTHO-EVRA-PATCH. If you have not had a period after having your baby, you should make sure you are not pregnant before starting ORTHO-EVRA-PATCH.

If you have a miscarriage or an abortion in the first trimester of your pregnancy, you may start norelgestromin/ethinyl estradiol right away. You do not need a second form of birth control. If you start ORTHO-EVRA-PATCH 5 days or more after the miscarriage or abortion, you should use a second form of birth control with the patch for the first 7 days. If you have a miscarriage or abortion after the first trimester, you should wait 4 weeks before starting ORTHO-EVRA-PATCH

If you have bleeding with the patch in place, continue to use the patches as usual. If the bleeding continues for 2–3 cycles, call your health care professional. If you do not have your period during the time the patch is off stay on your regular schedule and call your health care professional.

If the patch is uncomfortable or causing irritation, change to a new patch in a new location. Change the patch again on your regular schedule. Do not use more than one patch at a time.

When you remove a patch, carefully fold it in half so that it sticks to itself and throw it away. There will still be some hormones on the patch. Do not touch the inside of the patch.

Dosing—

Your health care professional may begin your patch on the first day of your menstrual period (called Day-1 start) or on Sunday (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you forget to change a patch. Do not change your schedule on your own . If the schedule that you have been put on is not convenient, check with your health care professional about changing schedules.

• For transdermal dosage form (skin patch):
  • For contraception (to prevent pregnancy):
    • Adults—Apply 1 patch to the skin and keep it in place for 1 week. Apply a new patch at the beginning of week 2 and again at week 3. Always change the patch on the same day of the week. Do not use a patch during week 4. This is when you will have your period. Start a new patch 7 days after the last patch was removed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Follow your doctor's orders or the directions on the label if you forget to change your patch. The following information includes only some of the ways to handle this. Your health care professional may want you to stop taking the medicine and use other birth control methods for the rest of the month until you have your menstrual period. Then your health care professional can tell you how to begin taking your medicine again.

• If you forget to apply your patch during the 1st week, apply it as soon as possible and start a new cycle. Use a second form of birth control for the first week of the new cycle. You will now have a new patch start day.
• If you forget to change your patch in the 2nd or 3rd week for one or two days, change it as soon as you remember. No other form of birth control is needed.
• If you forget to change your patch in the 2nd or 3rd week for more than two days, change to a new patch and start a new cycle. Use a second form of birth control for the first week of the new cycle
• If you forget to remove your patch at the end of the 3rd week, remove it as soon as possible and then start a new patch on your regular start day. You should never have the patch off for more than 7 days in a row.

Storage—

To store ORTHO-EVRA-PATCH:

• Keep out of the reach of children.
• Store patches in their protective pouches.
• Do not refrigerate.
• Do not freeze.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.