ORTHO TRICYCLEN

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.

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

• coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;
• a history of a stroke, blood clot, or circulation problems;
• a hormone-related cancer such as breast or uterine cancer;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches; or
• a history of jaundice caused by pregnancy or birth control pills.

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
• high cholesterol or triglycerides, or if you are overweight;
• a history of depression;
• gallbladder disease;
• diabetes;
• seizures or epilepsy;
• a history of irregular menstrual cycles; or
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in this medication can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

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.