Ortho Evra Patch: Important Information
• Ortho Evra Patch (Ethinyl estradiol) does not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases. • Avoid smoking. It greatly increases the risk of a heart attack, stroke or blood clot formation while using hormonal birth control. • Do not use Ortho Evra Patch if you are pregnant

Ortho Evra Patch: What it is
• Ortho Evra Patch (Ethinyl estradiol) is a form of estrogen and norelgestromin is a form of progesterone. These are both female hormones involved in conception. The ethinyl estradiol and norelgestromin topical patch releases estrogen and progesterone that are absorbed directly through the skin. • Ortho Evra Patch (Ethinyl estradiol) is used to prevent pregnancy. • Ortho Evra Patch (Ethinyl estradiol) may also be used for purposes other than those listed in this medication guide.

Ortho Evra Patch: How to Use
• Use Ortho Evra Patch (Ethinyl estradiol) exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you. • Ortho Evra Patch birth control method uses a 28 day (four week) cycle. One Ortho Evra Patch is applied and kept in place for one week. A new Ortho Evra Patch is applied each week for three weeks in a row (21 total days). You should not apply a Ortho Evra Patch during the fourth week (a one-week break). During the one-week break, you should have your menstrual period. Every new Ortho Evra Patch should be applied on the same day of the week, this will be your 'Patch Change Day'. For example, if you apply the first Ortho Evra Patch on a Monday, all of your patches should be applied on a Monday. • If this is your first time using Ortho Evra Patch and norelgestromin topical patch, wait until the day you start your menstrual period. You may choose either a 'First Day start' or a 'Sunday start'. For the First Day start, apply the first Ortho Evra Patch during the first 24 hours of your menstrual period. For the Sunday start, apply your first Ortho Evra Patch on the first Sunday after your menstrual period starts. The day you apply your first Ortho Evra Patch will be Day 1. Your 'Patch Change Day' will be on this day every week. If the first Ortho Evra Patch is applied after the first 24 hours of the start of a menstrual period (i.e. Sunday start), an extra method of birth control, such as a condoms, spermicide, or diaphragm must be used for the first week of that cycle. • How to apply the Ortho Evra Patch: · Choose a place on your body to put the Ortho Evra Patch. The Ortho Evra Patch can be placed on the buttock, abdomen, upper outer arm, or upper torso in a place where it won't be rubbed by tight clothing. Never put the Ortho Evra Patch on the breasts. To avoid skin irritation, apply each new patch to a different place on the skin. Clean and dry the chosen area of skin. · Open the foil pouch by tearing it along the top edge and one side. Peel the foil pouch apart and open it flat. Using your fingernail, lift one corner of the patch and peel the Ortho Evra Patch, with its clear plastic cover, off the foil liner. · Peel away half of the clear plastic and be careful not to touch the exposed sticky surface of the Ortho Evra Patch with your fingers. Apply the sticky side to the chosen area of skin, then remove the other half of the clear plastic. Press firmly with the palm of your hand for 10 seconds, making sure the edges stick well. Run your finger around the edge of the Ortho Evra Patch to make sure it is sticking properly. Check the Ortho Evra Patch every day to make sure all the edges are sticking. • Wear the Ortho Evra Patch for seven days. On your 'Patch Change Day' (Day 8), remove the used Ortho Evra Patch. The used Ortho Evra Patch still contains some medicine - carefully fold it in half so that it sticks to itself before throwing it away. Apply a new Ortho Evra Patch immediately. To avoid skin irritation, do not apply the new Ortho Evra Patch to the exact same area of skin. • Apply a new patch for week three (on Day 15) on your 'Patch Change Day'. • Do not wear a Ortho Evra Patch on week four (Day 22 through Day 28). Your period should start during this week. • Begin your next four week cycle by applying a new patch on your normal 'Patch Change Day', the day after Day 28 - no matter when your period begins or ends. • Do not apply the Ortho Evra Patch to skin that is red, irritated or cut. Do not use creams, oils, powder, or makeup on the skin where you will put a patch or near a Ortho Evra Patch your are wearing. It may cause the Ortho Evra Patch to become loose. • If a Ortho Evra Patch causes irritation, it can be removed and a new Ortho Evra Patch may be applied to a new location until the next 'Patch Change Day'. Only one Ortho Evra Patch should be worn at a time. • If a Ortho Evra Patch has become loose or fallen off for less than one day, try to reapply it or apply a new patch immediately. Do not use the Ortho Evra 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 become loose or fallen off. No tapes or wraps should be used to keep the patch in place. No back-up contraception is needed. Your 'Patch Change Day' stays the same. • If the patch has fallen off for more than one day or if you are not sure for how long it has been off, you may become pregnant. Start a new four week cycle immediately by putting on a new Ortho Evra Patch. You now have a new 'Day 1' and a new 'Patch Change Day'. You must use another method of birth control such as a condom, spermicide, or a diaphragm for the first week of your new cycle. • Single replacement patches are available through your pharmacist. • If you are switching from the pill (birth control pills, oral contraceptives) to ethinyl estradiol and norelgestromin patches, wait until you get your menstrual period before starting to use the patches. If you do not get your period within five days of taking the last active pill, check with your healthcare professional to be sure that you are not pregnant. • Store the topical Ortho Evra Patch in their protective pouches at room temperature away from moisture and heat. Do not store Ortho Evra Patch in the refrigerator or freezer.

Ortho Evra Patch: Side Effects
• If you experience any of the following serious side effects, stop using ethinyl estradiol and norelgestromin and seek emergency medical attention or contact your doctor immediately: · an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); · sharp chest pain, coughing blood or sudden shortness of breath (possible blood clot in the lung); · pain in the calf (possible blood clot in the leg); · crushing chest pain or heaviness in the chest (possible heart attack); · sudden severe headache or vomiting, dizziness, faintness or problems with vision or speech, weakness or numbness in an arm or leg (possible stroke); · sudden partial or complete loss of vision (possible clot in the eye); · yellowing of the skin or whites of the eyes (jaundice), especially with fever, tiredness, loss of appetite, dark colored urine, or light colored bowel movements (possible liver problems); · severe pain, swelling, or tenderness in the abdomen (gallbladder or liver problems); · irregular vaginal bleeding or spotting that happens in more than 1 menstrual cycle or lasts for more than a few days;; · swelling (edema) of the fingers or ankles; or · severe problems with difficulty sleeping, weakness, lack of energy, fatigue, or a change in mood (possible severe depression). · a lump in a breast. • Other, less serious side effects may be more likely to occur. Continue to use Ortho Evra Patch and norelgestromin and talk to your doctor if you experience · vaginal irritation or infection; · headache; · nausea; · change in appetite; · weight changes; · abdominal cramps or bloating; · breast tenderness or enlargement; · irregular vaginal bleeding or spotting; · changes in menstrual cycles; · slight fluid retention (edema); · spotty darkening of the skin, particularly on the face; · depression; or · intolerance to contact lenses. • It is unclear to what extent hormonal methods of birth control may affect the risk of breast cancer. • Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Ortho Evra Patch: Precautions
• Avoid smoking. It greatly increases the risk of a heart attack, stroke or blood clot formation while using hormonal Ortho Evra Patch • Ortho Evra Patch (Ethinyl estradiol) does not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Ortho Evra Patch: Drug Interactions
• Before taking Ortho Evra Patch (Ethinyl estradiol), talk to your doctor if you are taking any of the following medicines: · a penicillin antibiotic such as amoxicillin (Amoxil, Trimox, Wymox, Augmentin, others), ampicillin (Principen, Omnipen, Totacillin, others), bacampicillin (Spectrobid), carbenicillin (Geocillin), cloxacillin (Cloxapen, Tegopen), dicloxacillin (Dynapen, Dycill, others), nafcillin (Nafcil, Unipen), oxacillin (Bactocill, others), or penicillin (Veetids, Pen Vee K, Bicillin, others); · a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Vibramycin, Vibra-Tabs, others), minocycline (Minocin), or tetracycline (Sumycin, Achromycin, others); · a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); · a seizure or pain medicine such as phenytoin (Dilantin), primidone (Mysoline), ethosuximide (Zarontin), carbamazepine (Tegretol), topiramate (Topamax), oxcarbazepine (Trileptal), felbamate (Felbatol); and others; · griseofulvin (Grisactin, Grifulvin V, Fulvicin PG); · rifampin (Rifadin); or · herbal products containing St. John's wort (Hypericum perforatum). • A dosage adjustment or special monitoring may be required during treatment if you are taking any of the medicines listed above. • Drugs other than those listed here may also interact with Ortho Evra Patch and norelgestromin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Ortho Evra Patch: Missed Dose
• If you forget to change a Ortho Evra Patch at the start of any patch cycle, week one (Day 1), you could become pregnant. You must use back-up contraception, such as a condom, spermicide, or diaphragm for one week. Apply the first Ortho Evra Patch of a new cycle as soon as you remember. You now have a new 'Patch Change Day' and a new Day 1. • If you forget to change a Ortho Evra Patch for one or two days in the middle of your patch cycle, Week two or Week three, apply a new Ortho Evra Patch as soon as you remember. Apply the next Ortho Evra Patch on your normal 'Patch Change Day'. No back-up contraception is needed. • If you forget to change a Ortho Evra Patch for more than two days in the middle of your patch cycle, Week two or Week three, you could become pregnant. Start a new four week cycle as soon as you remember by putting on a new Ortho Evra Patch. You now have a new 'Patch Change Day' and a new Day 1. • If you forget to remove a Ortho Evra Patch at the end of your patch cycle, Week four, 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. • You should never have the Ortho Evra Patch off for more than seven days.

Ortho Evra Patch: If You Can Take Too Much
• An overdose of Ortho Evra Patch (Ethinyl estradiol) is unlikely to occur because the Ortho Evra Patch holding the medicine releases a steady amount of contraceptive hormones. Do not use more than one Ortho Evra Patch at a time. If you do suspect an overdose, or if the Ortho Evra Patch has been ingested, call an emergency room or poison control center for advice. Symptoms of an overdose of combination hormonal contraceptives may include nausea, vomiting, or vaginal bleeding.