Norelgestromin and ethinyl estradiol transdermal system (patient information)

IMPORTANT WARNING:

Cigarette smoking increases the risk of serious side effects from the contraceptive patch, including heart attacks, blood clots, and strokes. This risk is higher for women over 35 years old and heavy smokers (15 or more cigarettes per day). If you use the contraceptive patch, you should not smoke.

Why is this medication prescribed

Norelgestromin and ethinyl estradiol transdermal system (patch) is used to prevent pregnancy. Norelgestromin is a progestin and ethinyl estradiol is an estrogen. Estrogen and progestin are two female sex hormones. Norelgestromin and ethinyl estradiol contraceptive patch works by preventing ovulation (the release of eggs from the ovaries) and by changing the cervical mucus and the lining of the uterus. The contraceptive patch is a very effective method of birth control, but it does not prevent the spread of human immunodeficiency virus [HIV; the virus that causes acquired immunodeficiency syndrome (AIDS)] and other sexually transmitted diseases.

How should this medicine be used

Norelgestromin and ethinyl estradiol transdermal system comes as a patch to apply to the skin. One patch is applied once a week for 3 weeks, followed by a patch-free week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use the contraceptive patch exactly as directed.

If you are just starting to use the contraceptive patch, you may apply your first patch on the first day of your menstrual period or the first Sunday after your period begins. If you apply your first patch after the first day of your menstrual period, you must use a backup method of birth control (such as a condom and/or a spermicide) for the first 7 days of the first cycle.

Always apply your new patch on the same day of the week (the Patch Change Day). Apply a new patch once a week for 3 weeks. During Week 4, remove the old patch but do not apply a new patch, and expect to begin your menstrual period. On the day after Week 4 ends, apply a new patch to start a new 4-week cycle even if your menstrual period has not started or has not ended. You should not go more than 7 days without a patch.

Apply the contraceptive patch to a clean, dry, intact, healthy area of skin on the buttock, abdomen, upper outer arm, or upper torso, in a place where it will not be rubbed by tight clothing. Do not place the contraceptive patch on the breasts or on skin that is red, irritated, or cut. Do not apply makeup, creams, lotions, powders, or other topical products to the skin area where the contraceptive patch is placed. Each new patch should be applied to a new spot on the skin to help avoid irritation.

Do not cut, decorate, or change the patch in any way. Do not use extra tape, glue, or wraps to hold the patch in place.

To use the contraceptive patch, follow these steps:

• Open the foil pouch by tearing it along the edge.
• Peel apart the foil pouch and open it flat.
• Use your fingernail to lift one corner of the patch and peel the patch and its clear plastic liner off the foil liner. *Sometimes patches can stick to the inside of the pouch; be careful not to remove the clear liner as you remove the patch.
• Peel away half of the plastic liner. Avoid touching the sticky surface of the patch.
• Apply the sticky surface of the patch to the skin and remove the other half of the plastic liner. Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the edges stick well.
• After one week, remove the patch from your skin. Fold the used patch in half so that it sticks to itself and throw it away in a trash can that is out of the reach of children and pets. Do not flush the used patch down the toilet.

Check your patch every day to make sure it is sticking. If the patch has been partially or completely detached for less than one day, try to reapply it in the same place immediately. Do not try to reapply a patch that is no longer sticky, that has stuck to itself or another surface, that has any material stuck to its surface or that has loosened or fallen off before. Apply a new patch instead. Your Patch Change Day will stay the same. If the patch has been partially or completely detached for more than one day, or if you do not know how long the patch has been detached, you may not be protected from pregnancy. You must start a new cycle by applying a new patch immediately; the day that you apply the new patch becomes your new Patch Change Day. Use backup birth control for the first week of the new cycle.

If the skin under your patch becomes irritated, you may remove the patch and apply a new patch to a different spot on the skin. Leave the new patch in place until your regular Patch Change Day. Be sure to remove the old patch because you should never wear more than one patch at a time.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before using norelgestromin and ethinyl estradiol contraceptive patch

• tell your doctor and pharmacist if you are allergic to estrogens, progestins, or any other medications.
• tell your doctor if you are using any other type of hormonal birth control, such as pills, rings, injections, or implants. *Your doctor will tell you how and when you should stop using the other type of birth control and start using the contraceptive patch. Do not use any other type of hormonal birth control while you are using the contraceptive patch.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: acetaminophen (APAP, Tylenol); antibiotics such as ampicillin; anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); ascorbic acid (vitamin C); atorvastatin (Lipitor); clofibrate ; cyclosporine (Neoral, Sandimmune); griseofulvin (Fulvicin, Grifulvin, Grisactin); HIV protease inhibitors such as indinavir (Crixivan) and ritonavir (Norvir); medications for seizures such as carbamazepine (Tegretol), felbamate (Felbatol), phenobarbital (Luminal, Solfoton), oxcarbazepine (Trileptal), phenytoin (Dilantin), and topiramate (Topamax); morphine (Kadian, MS Contin, MSIR, others); oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), prednisone (Deltasone), and prednisolone (Prelone); rifampin (Rifadin, Rimactane); temazepam (Restoril); theophylline (Theobid, Theo-Dur); and thyroid medication such as levothyroxine (Levothroid, Levoxyl, Synthroid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor what herbal products you are taking, especially products containing St. John's wort.
• tell your doctor if you have recently had surgery or if you are on bedrest. Also tell your doctor if you have or have ever had a heart attack; a stroke; blood clots in your legs, lungs, or eyes; chest pain due to heart disease; cancer of the breasts, lining of the uterus, cervix, or vagina; vaginal bleeding between menstrual periods; hepatitis (swelling of the liver); yellowing of the skin or eyes, especially while you were pregnant or using hormonal contraceptives; a liver tumor; headaches that happen with other symptoms such as weakness or difficulty seeing or moving; high blood pressure; diabetes that has caused problems with your kidneys, eyes, nerves, or blood vessels; or heart valve disease. Your doctor will probably tell you that you should not use the contraceptive patch.
• tell your doctor if you have recently given birth or had a miscarriage or abortion and if you weigh 198 lbs or more. Also *tell your doctor if anyone in your family has ever had breast cancer and if you have or have ever had breast lumps, fibrocystic disease of the breast (condition in which lumps or masses that are not cancer form in the breasts) or an abnormal mammogram (x-ray of the breasts). Also tell your doctor if you have or have ever had high blood cholesterol and fats; diabetes; asthma; migraines or other types of headaches; depression; seizures; scanty or irregular menstrual periods; or liver, heart, gallbladder, or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using norelgestromin and ethinyl estradiol contraceptive patch, call your doctor immediately. You should suspect that you are pregnant and call your doctor if you have used the contraceptive patch correctly and you have missed two periods in a row, or if you have not used the contraceptive patch correctly and you have missed one period.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using norelgestromin and ethinyl estradiol contraceptive patch. Talk to your doctor about this as soon as your surgery is scheduled because your doctor may want you to stop using the contraceptive patch several weeks before your surgery.
• tell your doctor if you wear contact lenses. If you notice changes in your vision or ability to wear your lenses while using norelgestromin and ethinyl estradiol contraceptive patch, see an eye doctor.
• you should know that when you use the contraceptive patch, the average amount of estrogen in your blood will be higher than it would be if you used an oral contraceptive (birth control pill), and this may increase the risk of serious side effects such as blood clots in the legs or lungs. Two studies were done to learn more about this risk. One study found that women who used contraceptive patches were twice as likely to develop blood clots as women who used oral contraceptives. The other study found that women who used contraceptive patches were no more likely to develop blood clots than women who used oral contraceptives. Talk to your doctor about the birth control method that is best for you.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

If you forget to apply your patch at the start of any patch cycle (Week 1, Day 1), you may not be protected from pregnancy. Apply the first patch of the new cycle as soon as you remember. There is now a new Patch Change Day and a new Day 1. Use a backup method of birth control for one week.

If you forget to change your patch in the middle of the patch cycle (Week 2 or Week 3) for 1 or 2 days, apply a new patch immediately and apply the next patch on your usual Patch Change Day. If you forget to change your patch in the middle of the cycle for more than 2 days, you may not be protected from pregnancy. Stop the current cycle and start a new cycle immediately by applying a new patch. There is now a new Patch Change Day and a new Day 1. Use a backup method of birth control for 1 week.

If you forget to remove your patch at the end of the patch cycle (Week 4), take it off as soon as you remember. Start the next cycle on the usual Patch Change Day, the day after Day 28.

Side effects

Mild side effects

Norelgestromin and ethinyl estradiol contraceptive patch may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• irritation, redness, or rash in the place where you applied the patch
• breast tenderness, enlargement, or discharge
• nausea
• vomiting
• stomach cramps or bloating
• weight gain or weight loss
• change in appetite
• brown or black skin patches
• acne
• swelling of the hands, feet, ankles, or lower legs
• hair loss
• bleeding or spotting between menstrual periods
• changes in menstrual flow
• painful or missed periods
• vaginal itching or irritation
• white vaginal discharge
• difficulty wearing contact lenses

Severe side effects

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• sudden severe headache or vomiting
• speech problems
• dizziness or faintness
• weakness or numbness of an arm or leg
• sudden partial or complete loss of vision
• double vision
• bulging eyes
• sharp or crushing chest pain
• chest tightness
• coughing up blood
• shortness of breath
• calf pain
• severe stomach pain
• sleep problems, mood changes, and other signs of depression
• yellowing of the skin or eyes
• unusual bleeding
• loss of appetite
• extreme tiredness, weakness, or lack of energy
• fever
• dark-colored urine
• light-colored stool
• rash

Norelgestromin and ethinyl estradiol contraceptive patch may increase the risk of developing endometrial and breast cancer, gallbladder disease, liver tumors, heart attack, stroke, and blood clots. Talk to your doctor about the risks of using this medication.

Norelgestromin and ethinyl estradiol contraceptive patch may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, remove all the patches that were applied and call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor and the laboratory. You should have a complete physical examination every year, including blood pressure measurements, breast and pelvic exams, and a Pap test. Follow your doctor's directions for examining your breasts; report any lumps immediately.

Before you have any laboratory tests, tell the laboratory personnel that you use norelgestromin and ethinyl estradiol contraceptive patch, as this medication may interfere with some laboratory tests.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Ortho Evra®

Other names

• birth control patch