ORTHO TRI-CYCLEN, introduced in 1992, is the only oral contraceptive cleared in the U.S. 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 also indicated for the prevention of pregnancy in women who elect to use oral contraceptives.

ORTHO TRI-CYCLEN DRUG INFO

IMPORTANT NOTE: The following 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 use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ORAL CONTRACEPTIVES

COMMON BRAND NAME(S): Brevicon, Demulen, Lo/Ovral, Loestrin, Modicon, Nordette, Norinyl, Ortho-Novum, Ovcon, Ovral, Tri-Phasil

WARNING: Smoking cigarettes while using this medication increases your chance of having heart problems. Do not smoke while using this medication. The risk of heart problems increases with age (in women greater than 35 years of age) and with frequent smoking (15 cigarettes per day or greater).

USES: This medication is used to prevent pregnancy or to regulate your menstrual cycle. Certain brands of birth control pills may be used for treating acne or as a "morning after" pill for emergency contraception. Consult your doctor or pharmacist. Use of this medication does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).

HOW TO USE: Take this medication with food or immediately after a meal to prevent stomach upset. Try to take this medication at the same time each day. This may help you to remember to take it. Learn proper use of your particular brand of medication. Follow your dosing schedule carefully. Be sure to ask your doctor or pharmacist if you have any questions. Use a supplemental form of birth control during the first week of taking this medication since it takes a while to be effective. Follow your doctor's directions exactly if this drug is being used as a "morning after" pill.

SIDE EFFECTS: This medication may cause dizziness, headache, lightheadedness, stomach upset, bloating, or nausea. If these effects persist or worsen, contact your doctor. Notify your doctor if you experience: severe depression, groin or calf pain, sudden severe headache, chest pain, shortness of breath, lumps in the breast, weakness or tingling in the arms or legs, yellowing of the eyes or skin. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Before you take this medication, tell your doctor your entire medical history, including family medical history, especially: asthma, high blood pressure, kidney disease, liver heart disease, stroke, history of jaundice (yellowing skin/eyes) or high blood pressure during pregnancy, excessive weight gain or fluid retention during menstrual cycle, blood clots, heart attack, seizures, migraine headaches, breast cancer, high blood level of cholesterol or lipids (fats), diabetes, depression. Depending on strength, this drug may cause a patchy, darkening of the skin on the face (melasma). Higher strengths are more likely to cause melasma. Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. It may take a long time for you to become pregnant after you stop taking birth control pills. Consult your doctor. Do not smoke cigarettes. Birth-control pills slightly increase your risk of strokes, blood clots, high blood pressure, heart attacks, gallbladder disease, vision problems, and liver tumors. Cigarette smoking (especially 15 or more cigarettes daily) and age (women older than 35/smokers or 40/nonsmokers years of age) further increase the risk of stroke, blood clots, high blood pressure and heart attacks. Ask your pharmacist or doctor for a copy of the patient labeling which explains these risks in more detail. Consult your doctor for any questions, including possible use in nonsmokers over 40 years of age. If you are near-sighted or wear contact lenses, you may develop vision problems. Also, your tolerance of the lenses may decrease. Contact your eye doctor if these problems occur. Before having surgery, including dental surgery, tell the doctor that you take birth control pills. This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This medication passes into breast milk. This may affect milk production and may have harmful effects on a nursing infant. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Tell your doctor what prescription and nonprescription drugs you are taking. Drugs that may decrease the effectiveness of the pill include: griseofulvin, many antibiotics (e.g., penicillins, macrolides, tetracyclines, sulfas, cephalosporins), chloramphenicol, many seizure medications (e.g., phenytoin, barbiturates, primidone, carbamazepine), dapsone, rifamycins (e.g., rifampin), modafinil, nevirapine, nelfinavir, ritonavir, St John's wort, troglitazone. Ask your doctor if you should use additional birth control methods while taking any of the drugs mentioned above while taking birth control pills. Also tell your doctor if you use: thyroid hormone drugs, certain benzodiazepines (e.g., diazepam, chlordiazepoxide), prednisone-like drugs, certain antidepressants (e.g., tricyclics), beta-blockers (e.g., metoprolol), "blood thinners" (anticoagulants such as warfarin), insulin. This product can affect the results of certain lab tests (e.g., thyroid). Inform all laboratory personnel that you use this drug. Birth control pills may significantly intensify the effects of alcohol. Consult your doctor or pharmacist about this. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea and vomiting. Females may experience vaginal bleeding.

NOTES: Do not allow anyone else to take this medication. Keep all appointments with your doctor and the laboratory. You should have a complete physical examination, including blood pressure measurements, breast and pelvic examinations, and a PAP test (for vaginal cancer), at least once a year. Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. A manufacturer's fact sheet about this drug should be dispensed with each prescription. Read the information carefully. Ask your doctor or pharmacist any questions you may have.

MISSED DOSE: Missed dose advice differs and depends on the brand used, and the number of doses missed. Refer to the product package information for advice on missed doses. Ask your doctor or pharmacist if you have any questions.

STORAGE: Store at room temperature between 59 and 86 degrees F (between 15 and 30 degrees C) away from moisture and sunlight. Do not store in the bathroom.