HO TRI-CYCLEN [see Drug Interactions (7.1)].
COCs may reduce breast milk production; this is less likely to occur if breastfeeding is well established [see Use in Specific Populations (8.3)].
Women who start COCs postpartum, and who have not yet had a period, should use an additional method of contraception until they have taken an active tablet for 7 consecutive days [see Dosage and Administration (2.2)].
Amenorrhea may occur. Consider pregnancy in the event of amenorrhea at the time of the first missed period. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles [see Warnings and Precautions (5.7)].
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SPL UNCLASSIFIED SECTION
Mfd. by:
Janssen Ortho, LLC
Manati, Puerto Rico 00674
Mfd. for:
Janssen Pharmaceuticals, Inc.
Titusville, New Jersey 08560
© Janssen Pharmaceuticals, Inc. 1998
Revised February 2016
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Patient Information ORTHO-CYCLEN [OR-tho sī-klin] ORTHO TRI-CYCLEN [OR-tho trī-sī-klin] (norgestimate and ethinyl estradiol) Tablets
What is the most important information I should know about ORTHO-CYCLEN or ORTHO TRI-CYCLEN?
Do not use ORTHO-CYCLEN or ORTHO TRI-CYCLEN if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
What is ORTHO-CYCLEN or ORTHO TRI-CYCLEN?
ORTHO-CYCLEN or ORTHO TRI-CYCLEN is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
ORTHO TRI-CYCLEN is also used to treat moderate acne vulgaris in females 15 years of age and older, who have no known history of allergies or problems taking birth control pills, and have started their menstrual cycle ("period"). ORTHO TRI-CYCLEN should only be used to treat acne in women who want to take birth control pills to prevent pregnancy.
How does ORTHO-CYCLEN or ORTHO TRI-CYCLEN work for contraception?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of clinical studies, about 1 out of 100 women may get pregnant during the first year they use ORTHO-CYCLEN or ORTHO TRI-CYCLEN.
The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.
Who should not take ORTHO-CYCLEN or ORTHO TRI-CYCLEN?
Do not take ORTHO-CYCLEN or ORTHO TRI-CYCLEN if you:
smoke and are over 35 years of age
had blood clots in your arms, legs, lungs, or eyes
had a problem with your blood that makes it clot more than normal
have certain heart valve problems or irregular heart beat that increases your risk of having blood clots
had a stroke
had a heart attack
have high blood pressure that cannot be controlled by medicine
have diabetes with kidney, eye, nerve, or blood vessel damage
have certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision, or any migraine headaches if you a
