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Ortho-Novum

CONTRAINDICATIONS

Oral contraceptives should not be used in women who currently have the following conditions:
• Thrombophlebitis or thromboembolic disorders
• A past history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebral vascular or coronary artery disease
• Migraine with focal aura
• Known or suspected carcinoma of the breast
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior pill use
• Acute or chronic hepatocellular disease with abnormal liver function
• Hepatic adenomas or carcinomas
• Known or suspected pregnancy
• Hypersensitivity to any component of this product

Ortho-Novum : Full Prescribing Information

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The use of oral contraceptives is associated with increased risks of several serious conditions
including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder
disease, although the risk of serious morbidity or mortality is very small in healthy women without
underlying risk factors. The risk of morbidity and mortality increases significantly in the presence
of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.
Practitioners prescribing oral contraceptives should be familiar with the following information
relating to these risks.

ORTHO-NOVUM products, like all oral contraceptives, do not protect against HIV infection (AIDS) or other sexually transmitted diseases.

What should I discuss with my healthcare provider before taking ORTHO-NOVUM?
• Before taking this medication, tell your doctor if you
· have high blood pressure, angina, or heart disease;
· have had a stroke;
· have a bleeding or blood-clotting disorder;
· have breast, uterine, or another hormone-related cancer;
· have liver disease or a history of jaundice (yellowing of the skin and eyes) caused by use of birth control in the past;
· have undiagnosed, abnormal vaginal bleeding;
· have migraines;
· have asthma; or
· have seizures or epilepsy.
• You may not be able to take birth control pills, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.
• Birth control pills are in the FDA pregnancy category X. This means that birth control pills will cause birth defects in an unborn baby. Hormonal changes during pregnancy can have very serious negative effects on a developing baby. Do not take birth control pills if you are pregnant or if you think you might be pregnant.
• The hormones in birth control pills pass into breast milk and may decrease milk production. Do not take birth control pills without first talking to your doctor if you are breast-feeding a baby.

Ortho-Novum : Full Prescribing Information

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