Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol), Norethindrone Acetate (nor-ETH-in-drone AS-e-tate)

Prevents pregnancy. Also treats hot flashes during menopause and helps prevent osteoporosis after menopause.

Brand Name(s):

Aurovela 1.5/30, Aurovela 1/20, Aurovela 24 Fe, Aurovela Fe 1.5/30, Aurovela Fe 1/20, Blisovi 24 Fe, Blisovi Fe 1.5/30, Blisovi Fe 1/20, Fyavolv, Hailey 1.5/30, Hailey 24 Fe, Hailey Fe 1.5/30, Hailey Fe 1/20, Jevantique Lo, Jinteli

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet, Dissolving Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Each brand of birth control pills has specific directions. Read and follow the instructions for your prescribed brand. Ask your doctor or pharmacist if you have any questions.
• Take this medicine at the same time each day (with meals or at bedtime). Birth control pills work best when there is no more than 24 hours between doses.
• Disintegrating tablets: Place it on the tongue, allow to dissolve. Drink a full glass of water (8 ounces).
• Use a second form of birth control for the first 7 days of your first cycle of pills. Your body will need at least 7 days to adjust to the new medicine before a pregnancy will be prevented.
• If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, treat this as a missed dose and follow the patient instructions or call your doctor.
• 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 will begin taking the pills on the first day of your menstrual period.
• 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.
  • Use a second form of birth control for the next 7 days after you miss a dose.
  • 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 a pill or change your schedule, you may not have a period that month. Tell your doctor if you miss your period 2 months in a row, because you may be pregnant.
• 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 foods and medicines can affect how ethinyl estradiol/norethindrone works. Tell your doctor if you are using any of the following:
  • Acetaminophen, aprepitant, ascorbic acid (vitamin C), atorvastatin, bosentan, clofibrate, colesevelam, cyclosporine, morphine, phenylbutazone, rosuvastatin, St John's wort, temazepam, theophylline, tizanidine, troglitazone
  • Medicine to treat an infection (including ampicillin, griseofulvin, rifabutin, rifampicin, rifampin, tetracycline)
  • Medicine to treat HIV/AIDS (including boceprevir, telaprevir)
  • Medicine to treat seizures (including carbamazepine, phenobarbital, phenytoin)
  • Thyroid medicines
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. Tell your doctor right away if you think you have become pregnant.
• Tell your doctor if you are breastfeeding, or if you had a baby within 4 weeks before you start using this medicine. Tell your doctor if you have kidney disease, asthma, cervical cancer, diabetes, epilepsy, gallbladder problems, hereditary angioedema, heart or blood vessel disease, high cholesterol, chloasma gravidarum (skin disorder during pregnancy), or a family history of breast cancer or depression. Tell your doctor if you smoke, wear contact lenses, or if you will be having a surgery with a prolonged period of inactivity.
• This medicine may cause the following problems:
  • Increased risk of heart attack, stroke, or blood clots
  • Increased risk of breast, endometrial, ovarian, or cervical cancer
  • 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 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 7 days in a row, call your doctor right away.
• 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
• Chest pain that may spread, trouble breathing, unusual sweating, fainting
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Fast or pounding heartbeat
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sudden and severe stomach pain, nausea, vomiting, lightheadedness
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual, unexpected, or heavy vaginal bleeding

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

• Contact lens discomfort, changes in vision
• Depression, mood changes

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