Levonorgestrel/ethinyl estradiol (By mouth)

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Carefully follow your doctor's instructions about when to start taking your medicine. You may begin taking the pills on the first day of your menstrual period, or on the Sunday after your period begins.
• You may need to use a second form of birth control when you first start using this medicine. Talk with your doctor about your individual situation. Some other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.
• Take this medicine at the same time every day. Birth control pills work best when there is no more than 24 hours between doses. It is very important that you take this medicine on time every day.

If a dose is missed:

• This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully, and call your doctor if you have any questions
• If you miss one pink pill, take it as soon as you can. Then take your next pill at the regular time. This means you may take two pills in one day.
• If you miss two pink pills in a row during Week 1 or 2, take two pills as soon as you can. Take two more pills on the next day. Then go back to your regular schedule of taking one pill every day. Use a second form of birth control until you have been taking pink pills for seven days in a row.
• If you started this medicine on Day 1 of your period and you miss two pink pills in a row during Week 3, throw out the rest of your pills and start a new pack the same day. If you miss three or more pink pills in a row during any week, throw out the rest of your pills and start a new pack the same day.
• If you started this medicine on the Sunday after your period started and you miss two pink pills in a row during Week 3, keep taking one pill every day until the next Sunday. Then throw away the rest of your pills and start a new pack on that same Sunday.
• If you started this medicine on the Sunday after your period started and you miss three or more pink pills in a row during any week, keep taking one pill every day until the next Sunday. Then throw away the rest of your pills and start a new pack on that same Sunday.
• If you miss your pills and change your schedule, you may not have a period for that month. Make sure your doctor knows if you miss your period two months in a row, because you may be pregnant.
• You could have light bleeding or spotting any time you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.
• To prevent a pregnancy, you should use a second form of birth control for the next seven days after you miss a dose. Some other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Warnings While Using This Medicine

• Make sure your doctor knows if you are breast feeding, or have recently been pregnant. Tell your doctor if you have heart disease, high cholesterol, or high triglycerides (lipids). Tell your doctor if you have migraine headaches, diabetes, gallbladder disease, or a history of depression.
• This medicine may increase your risk of certain heart or blood vessel problems. Tell your doctor if you have a history of heart attack, stroke, high blood pressure, congestive heart failure, blood clots, or circulation problems.
• Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.
• This medicine may also increase your risk of certain types of cancer. Talk to your doctor if you have concerns about this risk.
• You might have some light bleeding or spotting when you first start using this medicine. This is usually normal and should not last long. However, if you have heavy bleeding or the bleeding lasts more than seven days in a row, call your doctor's office. You should not have a "normal" menstrual period until you start taking the white pills. The white pills are the last seven pills in your package and do not contain hormones.
• Call your doctor for a pregnancy test if your menstrual period does not start when you take the last seven white pills.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• This medicine will not protect you from getting HIV, AIDS, or other sexually transmitted diseases. If this is a concern for you, talk with your doctor.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Breast changes or lumps.
• Decrease in how much or how often you urinate.
• Chest pain, or coughing up blood.
• Lighter or heavier menstrual periods.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Pain in your upper right stomach.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Sudden or severe headache, problems with vision, speech, or walking.
• Sweating, nausea or vomiting, pain in your chest, jaw, and left arm.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Acne, increased non-scalp hair growth, or darkened skin on your face.
• Breast pain, swelling, or tenderness.
• Migraine headache, or a headache with vision changes or sensitivity to light.
• Mood changes, depression, nervousness, or dizziness.
• Nausea, vomiting, diarrhea, or upset stomach.
• Pain or burning with urination.
• Problems with vision, or trouble wearing contact lenses.
• Vaginal itching or discharge.
• Weight gain or loss, or appetite changes.

Brand Name(s)

Aviane, Trivora-28, Levora-28, Lutera, Enpresse-28, Seasonale, Portia-28, Lessina 28, Levlite 28, Levlen, Nordette-28, Jolessa, Quasense, Sronyx, Seasonique

There may be other brand names for this medicine.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to hormone medicines. Do not use this medicine if you are pregnant, or if you have abnormal vaginal bleeding that has not been checked by a doctor. You should not use this medicine if you have a history of cancer of the breast, ovary, or uterus. Do not use this medicine if you have a history of heart attacks, stroke, or blood clots. You should not use this medicine if you have liver cancer, or a history of jaundice (yellow skin or eyes) caused by pregnancy or birth control pills.

Introduction

Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol), Levonorgestrel (lee-voe-nor-JES-trel)

Prevents pregnancy. This medicine is an oral contraceptive (birth control pill).

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using phenylbutazone (Butazolidin®) or rifampin (Rifadin®, Rimactane®). Tell your doctor if you use seizure medicines such as phenobarbital or phenytoin (Dilantin®). Make sure your doctor knows if you are using any antibiotics such as ampicillin, griseofulvin, or tetracycline.