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

Prevents pregnancy.

Brand Name(s):

Afirmelle, Altavera, Amethia, Amethia Lo, Amethyst, Ashlyna, Aubra, Aubra EQ, Aviane, Ayuna, Balcoltra, Camrese, CamreseLo, Chateal, Chateal EQ

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Read and follow the patient instructions that come with this medicine. Talk to 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 should also use a second form of birth control (including condoms, diaphragms, or contraceptive foams and jellies) when you first start using this medicine.
• Take this medicine at the same time every day. Birth control pills work best when there is no more than 24 hours between doses.
• Missed dose:
  • 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 active 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 active pills in week 1 or 2, take two pills as soon as you can and two more pills the next day. Continue taking one pill a day until you finish the pack. Use another kind of birth control for seven days after you miss a dose.
  • If you miss two active pills in week 3 or three or more active pills in a row in weeks 1, 2, or 3:
    • Day 1 start - Throw out the rest of your pills and start a new pack on the same day.
    • Sunday start - Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day.
    • Use a second form of birth control (including condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy.
  • You could have light bleeding or spotting any time you do not take a pill on schedule. The more pills you miss, the more likely you are to have bleeding.
  • If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Do not use this medicine together with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
• Some medicines can affect how levonorgestrel/ethinyl estradiol works. Tell your doctor if you are using any of the following:
  • Acetaminophen, ascorbic acid (vitamin C), atorvastatin, bosentan, cyclosporine, phenylbutazone, rifampin, St John's wort, theophylline
  • Medicine to treat an infection (including ampicillin, fluconazole, griseofulvin, tetracycline, troleandomycin)
  • Medicine to treat HIV/AIDS (including indinavir, modafinil, ritonavir)
  • Medicine to treat seizures (including carbamazepine, felbamate, lamotrigine, oxcarbazepine, phenobarbital, phenytoin, primidone, topiramate)

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Tell your doctor if you are breastfeeding, or if you have recently been pregnant. Tell your doctor if you have high blood pressure, high cholesterol, diabetes, breast lumps, migraine headache, hereditary angioedema, or a history of depression, epilepsy, gallbladder disease, heart disease, kidney disease, or irregular monthly periods. Tell your doctor if you smoke, wear contact lenses, or if you are having surgery that requires inactivity for a long time.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of cancer (including cancer of the breast, endometrium, ovaries, and cervix)
  • Liver problems (including liver tumor or cancer)
  • Eye or vision problems
  • Gallbladder disease
  • High cholesterol in the blood
  • High blood pressure
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted diseases.
• 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.
• If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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 lumps, pain, swelling, tenderness, or discharge
• Change in how much or how often you urinate
• Chest pain or tightness, trouble breathing, coughing up blood
• Dark urine, pale stools, loss of appetite, yellow skin or eyes
• Heavy vaginal bleeding
• Irregular, late, or missed menstrual periods
• Numbness or weakness in your arm or leg, or on one side of your body
• Pain in your lower leg (calf)
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Vision loss, double or blurred vision

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

• Acne, mild skin rash, or darkened skin on your face
• Changes in appetite
• Contact lens discomfort, changes in vision
• Mild nausea, vomiting, diarrhea, stomach cramps, bloated feeling
• Mood changes, depression, nervousness, or trouble sleeping
• Pain or burning with urination
• Vaginal spotting or light bleeding, itching, discharge

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