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Ortho Tri-Cyclen

[Noregestimate/Ethinyl Estradiol]

INTRODUCTION

Any woman who considers using oral contraceptives (the birth control pill or the pill) should understand the benefits and risks of using this form of birth control. This patient labeling will give you much of the informa-tion you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this labeling is not a replacement for a careful discussion between you and your health Cigarette smoking increases the risk of serious cardiovascular side effects from oral 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 oral contraceptives are strongly advised not to smoke.

You should discuss the information provided in this labeling with your health care provider, both when you first start taking the pill and during your follow up visits. You should also follow your health care provider's advice with regard to regular check-ups while you are on the pill.

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EFFECTIVENESS OF ORAL CONTRACEPTIVES FOR CONTRACEPTION

Oral contraceptives or "birth control pills" or "the pill" are used to prevent pregnancy and are more effective than other non-surgical methods of birth control. When they are taken correctly, the chance of becoming pregnant is less than 1% (1 pregnancy per 100 women per year of use) when used perfectly, without missing any pills. Typical failure rates are actually 5% per year. The chance of becoming pregnant increases with each missed pill during a menstrual cycle.

In comparison, typical failure rates for other non-surgical methods of birth control during the first year of use are as follows: Implant: <1% Injection: <1% IUD: 1 to 2% Diaphragm with spermicides: 20% Spermicides alone: 26% Vaginal sponge: 20 to 40% Female sterilization: <1% Male sterilization: <1% Cervical Cap with spermicides: 20 to 40% Condom alone (male): 14% Condom alone (female): 21% Periodic abstinence: 25% Withdrawal: 19% No methods: 85%

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