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

Prevents pregnancy.

Brand Name(s):

Cryselle, Elinest, Low-Ogestrel 28, Turqoz

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 first 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 your pill at the same time every day. Birth control pills work best when there is no more than 24 hours between doses.
• Missed dose:
  • If you miss one white 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. Use a second form of birth control until you have been taking white pills for seven days in a row.
  • If you miss two white 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 white pills for seven days in a row.
  • If you started this medicine on Day 1 of your period and you miss two white 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 white pills in a row during any week, throw out the rest of your pills and start a new pack the same day. Use a second form of birth control until you have been taking white pills for seven days in a row.
  • If you started this medicine on the Sunday after your period started and you miss two white 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. Use a second form of birth control until you have been taking white pills for seven days in a row.
  • If you started this medicine on the Sunday after your period started and you miss three or more white 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. Use a second form of birth control until you have been taking white pills for seven days in a row.
  • 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.
• 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 ethinyl estradiol/norgestrel works. Tell your doctor if you are using any of the following:
  • Acetaminophen, ascorbic acid, cyclosporine, modafinil, morphine, phenylbutazone, salicylic acid, St John's wort, temazepam, theophylline
  • Medicine to lower cholesterol (including atorvastatin, clofibric acid)
  • Medicine to treat an infection (including ampicillin, griseofulvin, itraconazole, ketoconazole, rifabutin, rifampin, tetracycline, troleandomycin)
  • Medicine to treat HIV/AIDS (including indinavir, ritonavir)
  • Medicine to treat seizures (including carbamazepine, felbamate, oxcarbazepine, phenobarbital, phenytoin, primidone, topiramate)
  • Steroid medicine (including dexamethasone, prednisolone)

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 high blood pressure, high cholesterol in the blood, diabetes, breast lumps, or a history of depression, epilepsy, gallbladder disease, heart disease, kidney disease, or irregular monthly periods. Tell your doctor if you smoke or wear contact lenses.
• 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
  • Eye or vision problems
  • Gallbladder disease
  • High cholesterol in the blood
  • High blood pressure
  • Increased risk of ectopic pregnancy (pregnancy outside the uterus)
• 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 a few days in a row, call your doctor.
• 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 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 changes or lumps
• 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)
• 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:

• Acne, mild skin rash, or darkened skin on your face
• Breast tenderness, pain, swelling, or discharge
• Changes in appetite
• Contact lens discomfort changes in vision
• Hair loss or increased hair growth in areas other than the head
• Mild headache, dizziness
• Mild nausea, vomiting, diarrhea, stomach cramps, bloated feeling
• Mood changes, depression, nervousness, trouble sleeping
• 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