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PIMPLES ORTHO-CYCLEN and ORTHO TRI-CYCLEN Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. ORTHO TRI-CYCLEN is indicated for the treatment of moderate acne vulgaris in females, ?15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. PIMPLES
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  Active Ingredients: Norgestimate & Ethinyl Estradiol

Typical Brand Names: ORTHO TRI-CYCLEN/ORTHO-CYCLEN

PIMPLES What Is It Used For?
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This is a tablet that is taken once daily as a form of contraception (to prevent pregnancy), it also has the added benefit of helping to keep your skin beautiful too.

Ortho Tri-Cyclen is typically a good choice for women age 15 or over with mild to moderate acne who have reached menstruation, have no known symptom or condition that would prevent the use of birth control pills, and are unresponsive to topical acne medications.

PIMPLES ORTHO TRI-CYCLENŽ (norgestimate/ethinyl estradiol) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. In addition, it is the only oral contraceptive indicated in the United States for the treatment of moderate acne vulgaris in women 15 years of age or older, who have no known contraindication to oral contraceptive therapy, who desire contraception, who have begun menstruation and who are unresponsive to topical anti-acne medications. It is the first low-dose birth control pill with a noncontraceptive indication since the Pill was introduced over 35 years ago. PIMPLES

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PIMPLES How Is It Used?
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In order to maintain the birth control pill's high level of effectiveness, you need to take the Pill at the same time each day. Select a time that is easy to remember, for instance when you brush your teeth. It provides you with a low daily dose of hormones that prevent pregnancy by keeping any egg from being released. It also thickens the cervical mucus, making it difficult for sperm to enter the uterus. So it's easier for you to prevent pregnancy.

At the same time it actually lowers the level of the hormone in your body that's likely to cause acne. In clinical tests, Ortho Tri-Cyclen has been proven to help reduce mild to moderate acne-nearly nine out of ten women saw improvements in their skin.

PIMPLES Research has demonstrated that ORTHO TRI-CYCLEN decreases the level of a hormone which contributes to the development of acne-producing agents, thus attacking the cause of the acne. In the clinical studies, ORTHO TRI-CYCLEN showed improvement of acne similar to that seen in studies looking at efficacy of benzoyl peroxide and topical or systemic antibiotics. PIMPLES

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PIMPLES Are There Possible Side Effects?
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The most common reported symptoms include nausea, vomiting, bleeding between menstrual periods, breast tenderness, or weight change. These symptoms do not always occur or last.

If they continue or are annoying or troubling to you, check with your doctor. Check with your doctor as soon as you can if you experience continual or recurring unusual vaginal bleeding, a missed menstrual period, dizziness or fainting, swelling of fingers or ankles, headache, or difficulty wearing contact lenses. Contact your doctor immediately if you experience sharp or crushing chest pain, sudden shortness of breath, sudden severe headache or leg pain, yellow skin or eyes, changes in vision, numbness of an arm or leg, or severe stomach pain. If you notice other effects not listed above, contact your doctor, or pharmacist.

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PIMPLES Is It Safe?
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The "Pill" as it is often called is one of the safest birth control methods available. However, it's not for everyone. If you smoke cigarettes while using this medicine it can increase your risk of stroke, heart attack, blood clots, high blood pressure, or other diseases of the heart and blood vessels.

If you have vomiting or diarrhea for any reason, your medicine may not work as well. In such a case it is recommended that you use an additional form of birth control until your next period to avoid pregnancy.

Do not use this medicine if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. This medicine is excreted in breast milk. If you are or will be breast-feeding while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

PIMPLES ORTHO TRI-CYCLEN treats acne with a combination of ethinyl estradiol, a synthetic estrogen, and norgestimate, a progestin. Two randomized, double-blind, placebo-controlled studies demonstrated that improvement of acne was reported during use of ORTHO TRI-CYCLEN in more than 80 percent of the studies' participants treated with ORTHO TRI-CYCLEN. PIMPLES

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PIMPLES What About Interactions With Other Drugs?
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Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin, drugs for epilepsy such as barbiturates (for example, phenobarbital), anticonvulsants such as carbamazepine (TegretolŽ is one brand of this drug), phenytoin (DilantinŽ is one brand of this drug), phenylbutazone, and possibly certain antibiotics. You may need to use additional contraception when you take drugs, which can make oral contraceptives less effective. Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using this medicine. If you wear contact lenses and you develop problems with them, contact your doctor. Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. This medicine may cause dark skin patches on your face. Exposure to the sun may make these patches darker. If patches develop, use a sunscreen or protective clothing when exposed to the sun, sunlamps, or tanning booths.
PIMPLES Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks are increased if you smoke cigarettes. Some studies have reported an increase in the risk of developing breast cancer among women who use oral contraceptives. However, the majority of studies have found no overall increase in this risk. Some studies have reported an increase of developing breast cancer, particularly at a younger age. This increased relative risk appears to be related to duration of use. You should speak to your healthcare professional about how this risk relates to your use of the pill. PIMPLES

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PIMPLES What If I Miss A Dose?
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This medication is to be taken daily at approximately the same time. If you miss a dose of this medicine, take it as soon as you remember. Take your next dose at the regular time. This means you may take 2 doses on the same day, but you should go at least two days being back on your regular schedule of dosing before being sexual.

An alternative is to use another means of birth control after missing a dose, until your next period. If you miss more than 1 dose of this medicine, refer to the patient information that came with this medicine.

PIMPLES ORTHO TRI-CYCLEN, like all oral contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases. For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship please see product package insert for full U.S. prescribing information. PIMPLES

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PIMPLES How Should It Be Stored?
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Store it at room temperature out of reach of children.
PIMPLES Table 1: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States. % of Women Experiencing an % of Women Unintended Pregnancy Continuing Use within the First Year of Use at One Year 3 Method Typical Use 1 Perfect Use PIMPLES

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PIMPLES Anything Else I Should Know?
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Use of this medicine will not prevent the spread of sexually transmitted diseases. If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include restlessness, tremor, rapid breathing, nausea, vomiting, diarrhea, and stomach cramps.
PIMPLES In four clinical trials with ORTHO TRI-CYCLEN, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on ORTHO TRI-CYCLEN, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years. PIMPLES

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NOTE: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.

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