Ethinyl estradiol-levonorgestrel Treatment Report

Precautions

Instructions

Side Effects

Interactions

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding).

Do not use this medication if you have:

• a history of a stroke or blood clot;
• circulation problems (especially if caused by diabetes);
• a hormone-related cancer such as breast or uterine cancer;
• abnormal vaginal bleeding;
• liver disease or liver cancer;
• severe high blood pressure;
• severe migraine headaches;
• a heart valve disorder; or
• a history of jaundice caused by birth control pills.

Before using this medication, tell your doctor if you have:

• high blood pressure, heart disease, congestive heart failure, angina (chest pain), or a history of heart attack;
• high cholesterol or if you are overweight;
• a history of depression;
• gallbladder disease;
• diabetes;
• seizures or epilepsy;
• a history of irregular menstrual cycles;
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;
• uterine fibroid tumors;
• varicose veins; or
• tuberculosis.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases—including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

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Missing a pill increases your risk of becoming pregnant.

If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss three "active" pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• a change in the pattern or severity of migraine headaches;
• nausea, stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet; or
• symptoms of depression (sleep problems, weakness, mood changes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;
• breast pain, tenderness, or swelling;
• freckles or darkening of facial skin;
• increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge;
• changes in your menstrual periods, decreased sex drive; or
• headache, nervousness, dizziness, tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

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Some drugs can make birth control pills less effective, which may result in pregnancy. Before using birth control pills, tell your doctor if you are using any of the following drugs:

• acetaminophen (Tylenol) or ascorbic acid (vitamin C);
• prednisolone (Orapred);
• theophylline (Respbid, Theo-Dur);
• cyclosporine (Neoral, Sandimmune, Gengraf);
• St. John's wort;
• an antibiotic;
• seizure medications;
• a barbiturate sedative such as secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or
• HIV or AIDS medications.

This list is not complete and there may be other drugs not listed that can affect birth control pills. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Alesse, Alesse-21, Alesse-28, Aviane, Enpresse, Jolessa, Lessina, Levlen, Levora, Lutera, Lybrel, Min-Ovral 21, Min-Ovral 28, Nordette, Nordette-21, Nordette-28, Portia, Preven EC, Quasense, Seasonale, Seasonique, Sronyx, Tri-Levlen, Triphasil, Triphasil-21, Triphasil-28, Triquilar 21, Triquilar 28, Trivora, ethinyl estradiol-levonorgestrel, levonorgestrel-ethinyl estradiol, Levlite, LoSeasonique, and Trivora-28

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