IMPORTANT SAFETY INFORMATION

Any woman who considers using the contraceptive patch ORTHO EVRA^® should understand the benefits and risks of using this form of birth control. You should discuss the Important Safety Information provided here with your healthcare professional, before you first start using the contraceptive patch ORTHO EVRA^® and during your revisits. You should also follow your healthcare professional's advice with regard to regular checkups.

• 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 non-hormonal 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. The risk of venous thromboembolic events (blood clots in the legs and/or the lungs) may be increased with ORTHO EVRA^® use compared with use of birth control pills. Studies examined the risk of these serious blood clots in women who used either ORTHO EVRA^® or birth control pills containing one of two progestins (levonorgestrel or norgestimate) and 30–35 micrograms of estrogen. Results of these studies ranged from an approximate doubling of risk of serious blood clots to no increase in risk in women using ORTHO EVRA^® compared to women using birth control pills.

You should discuss this possible increased risk with your healthcare professional before using ORTHO EVRA^®. 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 are the risks of using hormonal contraceptives including ORTHO EVRA^®?
  • Blood clots that cause death or serious disability
  • Heart attacks and strokes; smoking while using ORTHO EVRA^® greatly increases the possibility of having a heart attack or stroke
  • Gallbladder disease
  • Benign but dangerous liver tumors
  • Breast and cervical cancer

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, 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 eye along with fever, fatigue, loss of appetite, dark-colored urine or light-colored bowel movements

• 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 breast-feeding
  • 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, 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.

  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 non-prescription medicines, vitamins, herbal and dietary supplements. Especially tell your healthcare professional if you take:

  • barbiturates (for example phenobarbitol)
  • bosentan (Tracleer^®)
  • carbamazepine (Tegretol^® is one brand of this drug)
  • felbamate
  • griseofulvin (Fulvicin^® is one brand of this drug)
  • oxcarbazepine
  • phenytoin (Dilantin^® is one brand of this drug)
  • rifampin
  • St. John's wort (a herbal supplement)
  • topiramate (TOPAMAX^®)

  These medicines/herbal supplements may make your contraceptive less effective and you may need to use a barrier contraceptive when you take these drugs or products.

  Also, tell your healthcare professional if you take lamotrigine (LAMICTAL^®), an anticonvulsant used for epilepsy. This may increase the risk of seizures so your healthcare professional may need to adjust the dose.

  Blood levels of estrogen in ORTHO EVRA^® may be increased if you take certain medicines or drink grapefruit juice while using ORTHO EVRA^®. Also, taking ORTHO EVRA^® with other medicines may make some medicines less effective. You should 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.

  Ask your healthcare professional if you are not sure if any of your medicines are listed above.

• What are the possible side effects of ORTHO EVRA^®?
  • 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. Single replacement patches are available from pharmacies.
  • Irregular vaginal bleeding or spotting. 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 such as change in vision or inability to wear your lenses. If these occur, contact your healthcare professional.
  • Edema (fluid retention) in the ankles or fingers and/or a rise in blood pressure. Contact your healthcare professional if you experience fluid retention.
  • Spotty darkening of the skin (particularly on the face). 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.

  The most common side effects are nausea, breast symptoms (engorgement, pain or discomfort), headache, and problems where the patch has been on the skin.