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 when women who miss pills are included. 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.

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    • ORTHO TRI-CYCLEN® LO uses a low dose of hormones while maintaining effective pregnancy prevention.
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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?)

    For the majority of women, oral contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be fatal or may cause temporary or permanent disability. 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 (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences.
    • In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer. However, liver cancers are rare.
    • High blood pressure, although blood pressure usually returns to normal when the pill is stopped.


    Who should not use oral contraceptives?

    You should not use oral contraceptives 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).
    • Known or suspected pregnancy
    • If you plan to have surgery with prolonged bedrest.


    What are the possible side effects of oral contraceptives?

    • 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) which may persist.
    • 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.

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