IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ORTHO TRI-CYCLEN^® LO?

Cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age, with heavy smoking (15 or more cigarettes per day) and in women over 35 years of age. Women who use hormonal contraceptives are strongly advised not to smoke.

Who should not use ORTHO TRI-CYCLEN^® LO?

You should not use ORTHO TRI-CYCLEN^® LO 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, lungs, or eyes, a history of blood clots in the deep veins of your legs, chest pain, 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), 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), or if you plan to have surgery with prolonged bed rest.

Tell your healthcare professional if you have ever had any of these conditions, he/she can recommend a safer method of birth control.

What are the possible side effects of ORTHO TRI-CYCLEN^® LO?

Irregular vaginal bleeding or spotting. If bleeding occurs in more than one cycle 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.
Fluid retention with swelling of the fingers or ankles and may raise your blood pressure. Contact your healthcare professional if you experience fluid retention.
Spotty darkening of the skin (particularly the face). This may persist after you stop using ORTHO TRI-CYCLEN^® LO.
Other side effects include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, vaginal infections and allergic reactions.

Call your doctor immediately if you experience any of these side effects while you are using ORTHO TRI-CYCLEN^® LO:
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 or complete loss of vision, breast lumps, severe pain or tenderness in the stomach area, difficulty in sleeping, weakness, lack of energy, fatigue or change in mood, 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 TRI-CYCLEN^® LO?

Tell your healthcare professional if you: Smoke, are breast-feeding, or 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, a family history of breast cancer, diabetes, elevated cholesterol or triglycerides, high blood pressure, migraine or other headaches or epilepsy, depression, gallbladder, liver, heart or kidney disease, history of light or irregular menstrual periods.

Tell your healthcare professional about all of the medicines you are taking, before starting and while you are using ORTHO TRI-CYCLEN^® LO including prescription and non-prescription medicines, vitamins, herbal and dietary supplements such as:

Barbiturates, bosentan, carbamazepine, phenybutazone, drugs used to treat HIV or AIDS, antibiotics, phenytoin, rifampin, topiramate, St. John’s Wort (a herbal supplement). 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.

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

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Product Information including Boxed Warning.