Ethinyl estradiol/norethindrone acetate (By mouth)
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.
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, Estrostep Fe, Femhrt, Femhrt 1/5, Fyavolv, Gildess 1.5/30, Gildess 1/20, Gildess FE 1.5/30There may be other brand names for this medicine.
When This Medicine Should Not Be Used:This medicine is not right for everyone. Do not use it if you had an allergic reaction to ethinyl estradiol or norethindrone, or if you are pregnant or have unusual vaginal bleeding. Do not use it if you have liver disease (including liver cancer), migraine headaches, breast cancer, or problems with blood clots. Do not use it if you have high blood pressure, certain heart problems, diabetes with kidney, eye, nerve, or blood vessel damage, or if you ever had jaundice (yellow skin or eyes) caused by pregnancy or birth control pills.
How to Use This Medicine:
- 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.
- Your body will need at least 7 days to adjust before a pregnancy will be prevented when you first use this medicine. Use a second form of birth control, including condoms, spermicides, or diaphragms, for the first 7 days of your first cycle of pills.
- Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
- 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.
- Tell your doctor if you miss your period 2 months in a row, because you could be pregnant.
- You may not have a period for that month if you miss more than one dose or change your schedule.
- You could have light bleeding or spotting if you do not take a pill on time. The more pills you miss, the more likely you are to have bleeding.
- 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)
- Other treatments for menopause
- Thyroid replacement medicine
- Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
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 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, heart or blood vessel disease, high cholesterol, 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
- Possible risk of cancer (including cancer of the breast, endometrium, ovaries, or cervix)
- Liver problems
- Changes in vision
- 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 seven days in a row, call your doctor's office.
- 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 check your progress and the effects of this medicine at regular visits. 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 or tightness, trouble breathing, coughing up blood
- Dark urine or pale stools, loss of appetite, yellow skin or eyes
- Fast or pounding heartbeat
- Heavy vaginal bleeding
- Numbness or weakness in your arm or leg, or on one side of your body
- Pain in your lower leg (calf)
- 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
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
Last Updated: 10/10/2019