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, migraine headaches, breast cancer, or problems with blood clots. Do not use it if you have high blood pressure, certain heart problems, or diabetes with kidney, eye, nerve, or blood vessel damage.

How to Use This Medicine:
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. 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, such as a condom, spermicide, or diaphragm, 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.
  
  • Make sure your doctor knows 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.

• Some foods and medicines can affect how ethinyl estradiol and norethindrone combination works. Tell your doctor if you are also using St John's wort, acetaminophen, aprepitant, aspirin, atorvastatin, boceprevir, bosentan, clofibrate, colesevelam, cyclosporine, morphine, prednisolone, rifabutin, rifampicin, rosuvastatin, telaprevir, temazepam, theophylline, tizanidine, medicine to treat an infection, medicine to treat HIV/AIDS, medicine for seizures, thyroid replacement medicine, or any other medicine that contains hormones, such as other treatments for menopause.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor right away if you think you are pregnant. This medicine could harm your unborn baby if you take it while you are 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.
• This medicine may cause the following problems:
  
  • Higher risk of heart attack, stroke, or blood clots
  • Possible risk of breast or cervical cancer
  • Liver cancers or tumors
  • Changes in vision
  • Gallbladder disease
  • High blood pressure
• You may need to stop using this medicine for a few weeks before and after you have surgery because of the risk of blood clots.
• This medicine will not protect you from HIV/AIDS or other sexually transmitted diseases.
• 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 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
• Chest pain that may spread, unusual sweating, or fainting
• Dark urine or pale stools, loss of appetite, stomach pain, yellow skin or eyes
• Fast or pounding heartbeat
• Numbness or weakness on one side of your body
• Pain in your lower leg (calf)
• Sudden or severe headache, problems with vision, speech, or walking
• Trouble breathing or coughing up blood
• Unusual or unexpected vaginal bleeding or heavy bleeding

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

• Depression, mood changes
• Vision changes or trouble wearing contact lenses

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