Low Hormone Birth Control; ORTHO TRI-CYCLEN LO

IMPORTANT SAFETY INFORMATION

Boxed Warning

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.

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    Get to Know ORTHO TRI-CYCLEN® LO


    Do you want a birth control pill that gives you a high level of effectiveness and a low level of hormones? How about one with these benefits and one that may provide more predictable periods? Here's why ORTHO TRI-CYCLEN® LO may be right for you:

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    Oral contraceptives, or “birth control pills” or “the pill,” are used to prevent pregnancy and are more effective than most other nonsurgical methods of birth control. When taken correctly without missing any pills, oral contraceptives are highly effective; however, typical failure rates are 5% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

    Birth control pills do not protect against HIV (AIDS) or other sexually transmitted diseases.

    Get Important Safety Information here. >

    • ORTHO TRI-CYCLEN® LO uses a low dose of hormones while maintaining effective pregnancy prevention.
    Learn more about how ORTHO TRI-CYCLEN® LO works >

    • Janssen Pharmaceuticals, Inc.

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

    Cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use hormonal contraception, including ORTHO TRI-CYCLEN® LO are strongly advised not to smoke.

    What are the risks of using hormonal contraceptives (including ORTHO TRI-CYCLEN® LO?)

    The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:

    • Blood clots in the legs or lungs, heart attacks and stroke (smoking increases the risk of having a heart attack or stroke).
    • Gallbladder disease.
    • Benign but dangerous liver tumors.
    • Breast and cervical cancer.
    • High blood pressure, although blood pressure usually returns to normal when ORTHO TRI-CYCLEN® LO is stopped.


    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 (thrombophlebitis), lungs (pulmonary embolism), or eyes.
    • A history of blood clots in the deep veins of your legs.
    • 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).
    • 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).
    • Severe high blood pressure.
    • Diabetes with complications of the kidneys, eyes, nerves, or blood vessels.
    • Headaches with neurological symptoms.
    • Disease of heart valves with complications.
    • If you plan to have surgery with prolonged bedrest.


    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.



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    ORTHO TRI-CYCLEN® LO contains 25 mcg of estrogen. It contains two female hormones, an estrogen called ethinyl estradiol and a progestin called norgestimate. ORTHO TRI-CYCLEN® LO is a triphasic pill, which means it delivers a different level of progestin each week. The different color pills in your DIALPAK® Tablet Dispenser show that during each of the first 3 weeks, the level of progestin increases.*

    Learn more about how ORTHO TRI-CYCLEN® LO works >

    *Janssen Pharmaceuticals, Inc., clinical study.

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