IMPORTANT SAFETY INFORMATION

Who should not use ORTHO EVRA^®?

Do not use ORTHO EVRA^® if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from hormonal contraceptives, including death from heart attack, blood clots, or stroke. The risk increases with age and the number of cigarettes you smoke.

You should not use ORTHO EVRA^® if you are pregnant or think you may be pregnant, or if you have any of the following conditions:

• A history of heart attack or stroke
• Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
• A history of blood clots in the deep veins of your legs
• An inherited problem that makes your blood clot more than normal
• Chest pain (angina pectoris)
• Known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina
• Unexplained vaginal bleeding (until your doctor reaches a diagnosis)
• Hepatitis or yellowing of the whites of your eyes or of the skin (jaundice) during pregnancy or during previous use of hormonal contraceptives
• Liver tumor (benign or cancerous)
• Known or suspected pregnancy
• Severe high blood pressure
• Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
• Headaches with neurological symptoms
• Use of oral contraceptives (birth control pills)
• Disease of heart valves with complications
• Need for a prolonged bed rest following major surgery
• An allergic reaction to any of the components of ORTHO EVRA^®

Tell your healthcare professional if you have ever had any of these conditions. Your healthcare professional can recommend a nonhormonal method of birth control.

OTHER CONSIDERATIONS BEFORE USING ORTHO EVRA^®

Hormones from ORTHO EVRA® get into the bloodstream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ORTHO EVRA® than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects. Like pregnancy, hormonal birth control methods increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35 years. This increased risk is highest when you first start using hormonal birth control. Some studies have reported that women who use ORTHO EVRA® have a higher risk of getting a blood clot. Talk with your healthcare provider about your risk of getting a blood clot before deciding which type of birth control is right for you.

It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

• Legs (deep vein thrombosis)
• Lungs (pulmonary embolus)
• Eyes (loss of eyesight)
• Heart (heart attack)
• Brain (stroke)

Call your healthcare professional immediately if any of the side effects listed under “WARNING SIGNALS” occur while you are using ORTHO EVRA® (see below).

What should I tell my healthcare professional before using ORTHO EVRA®?

Tell your healthcare professional if you:

• Smoke
• Are recovering from the birth of a baby
• Are recovering from a second trimester miscarriage or abortion
• Are breastfeeding
• Weigh 198 pounds or more
• Are taking any other medications

Also, tell your healthcare professional if you have or have had:

• Breast nodules, fibrocystic disease of the breast, or an abnormal breast x-ray or mammogram
• Family history of breast cancer
• Diabetes
• Elevated cholesterol or triglycerides
• High blood pressure
• Migraine or other headaches or epilepsy
• Depression
• Gallbladder disease
• Liver disease
• Heart disease
• Kidney disease
• History of scanty or irregular menstrual periods

If you have any of these conditions, you should be checked often by your healthcare professional.

What are the risks of using hormonal contraceptives including ORTHO EVRA^®?

Blood Clots: Like pregnancy, hormonal birth control methods increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age greater than 35 years. This increased risk is highest when you first start using hormonal birth control. Some studies have reported that women who use ORTHO EVRA® have a higher risk of getting a blood clot. Talk with your healthcare provider about your risk of getting a blood clot before deciding which type of birth control is right for you.

It is possible to die or be permanently disabled from a problem caused by a blood clot, such as a heart attack or a stroke. Call your healthcare professional immediately should any of the adverse side effects listed under “WARNING SIGNALS” occur while you are using ORTHO EVRA® (see below).

If you use ORTHO EVRA® and need elective surgery, need to stay in bed for a prolonged illness or injury, or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping ORTHO EVRA® 4 weeks before surgery and not using it for 2 weeks after surgery or during bed rest.

You should also not use ORTHO EVRA® soon after delivery of a baby. It is advisable to wait for at least 4 weeks after delivery if you are not breastfeeding. If you are breastfeeding, you should wait until you have weaned your child before using ORTHO EVRA®.

Heart Attack: Hormonal contraceptives, including ORTHO EVRA®, may increase the risk of developing strokes (blockage or rupture of blood vessels in the brain), angina pectoris, and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability. Smoking and the use of hormonal contraceptives, including ORTHO EVRA®, greatly increase the chances of developing and dying of heart disease. Smoking also greatly increases the possibility of suffering heart attacks and strokes.

Gallbladder Disease: Women who use hormonal contraceptives, including ORTHO EVRA®, probably have a greater risk than nonusers of having gallbladder disease.

Liver Tumors: In rare cases, combination oral contraceptives, including ORTHO EVRA®, can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer. However, liver cancers are rare.

Cancer of the Reproductive Organs and Breasts: Combination hormonal contraceptives, including ORTHO EVRA®, may slightly increase your chance of having breast cancer diagnosed, particularly after using hormonal contraceptives at a younger age. After you stop using hormonal contraceptives, the chances of having breast cancer diagnosed begin to go back down. You should have regular breast examinations by a healthcare professional and examine your own breasts monthly. Tell your healthcare professional if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram. Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormone-sensitive tumor.

WARNING SIGNALS

• Call your doctor immediately if you experience any of these side effects while you are using the ORTHO EVRA^® Patch:

  • Sharp chest pain, coughing blood, or sudden shortness of breath
  • Pain in the calf
  • Crushing chest pain or tightness in the chest
  • Sudden, severe, headache or vomiting, dizziness or fainting, disturbances of vision or speech, or weakness or numbness in an arm or leg
  • Sudden partial or complete loss of vision
  • Breast lumps
  • Severe pain or tenderness in the stomach area
  • Severe problems with sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression)
  • Jaundice or yellowing of the skin or whites of the eyes along with fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements

• What are the possible side effects of ORTHO EVRA^®?
  • Most Common Side Effects: The most common side effects of ORTHO EVRA® include nausea, breast symptoms (discomfort, engorgement, or pain), headache, and problems where the Patch has been on the skin.
  • Skin Irritation: Skin irritation at the site of application. If this occurs, remove the Patch and apply a new Patch at a new location until the next Change Day.
  • Vaginal Bleeding: Irregular vaginal bleeding or spotting may occur. If bleeding occurs in more than a few cycles or lasts for more than a few days, call your healthcare professional.
  • Problems Wearing Contact Lenses: If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your healthcare professional.
  • Fluid Retention: Edema (fluid retention) in the ankles or fingers and/or a rise in blood pressure may occur. Contact your healthcare professional if you experience fluid retention.
  • Melasma: A spotty darkening of the skin, particularly on the face, is possible. This may persist after you stop using ORTHO EVRA®.
  • Other Side Effects: Weight gain, feeling dizzy, migraine, stomach pain or bloating, vomiting, diarrhea, acne, muscle spasms, vaginal infections, tiredness, painful or heavy periods, more frequent periods, uterine cramps, vaginal discharge, and mood problems such as mood swings, depression, or anxiety.

General Precautions

Weight ≥198 lbs: ORTHO EVRA® may be less effective if you weigh 198 lbs or more. If you weight 198 lbs or more, talk to your healthcare professional about which method of birth control may be best for you.

Missed Periods and Use During Pregnancy: If you have used ORTHO EVRA® correctly and miss one menstrual period, continue using your contraceptive Patches for the next cycle but be sure to inform your healthcare professional before doing so. If you have not used ORTHO EVRA® as instructed and missed a menstrual period, or if you missed two menstrual periods in a row, you could be pregnant. Check with your healthcare professional immediately to determine whether you are pregnant. Stop using ORTHO EVRA® if you are pregnant.

There is no conclusive evidence that hormonal contraceptive use causes birth defects when taken accidentally during early pregnancy. Nevertheless, hormonal contraceptives, including ORTHO EVRA®, should not be used during pregnancy. You should check with your healthcare professional about risks to your unborn child from any medication taken during pregnancy.

Breastfeeding: If you are breastfeeding, consult your healthcare professional before starting ORTHO EVRA®. Hormonal contraceptives are passed on to the child in the breast milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, combination hormonal contraceptives may decrease the amount and quality of your breast milk.

Drug Interactions: Hormonal contraceptives may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose.

Some medicines and herbal products may make your hormonal contraceptive less effective, including:

• Barbiturates
• Bosentan
• Carbamazepine
• Felbamate
• Griseofulvin
• Oxcarbazepine
• Phenytoin
• Rifampin
• St. John’s wort
• Topiramate

Blood levels of estrogen from this hormonal contraceptive may be increased if you take certain medicines or drink grapefruit juice. Also, your hormonal contraceptive may make some other medicines less effective. You may need to use a barrier contraceptive when you take medicines or products that can make hormonal contraceptives less effective.

Tell your healthcare professional about all of the medicines you are taking before starting to use the Patch and while you are using the Patch including prescription and nonprescription medicines, vitamins, and herbal and dietary supplements.

Overdosage: Do not use more than one Patch at a time. Overdosage may cause nausea and vomiting. Vaginal bleeding may occur in females. Contact your healthcare professional or pharmacist in case of overdosage.