Norgestrel (nor-JES-trel)

Prevents pregnancy.

Brand Name(s):

Opill

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. .
• Take your pills at the same time every day.
• If you vomit or have diarrhea within 4 hours of taking this medicine, you should use another method of birth control during the next 48 hours.
• Follow the instructions on the medicine label if you are using this medicine without a prescription.
• 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.
  • If you miss a dose, and it is less than 3 hours from your usual time you take the pill, take the tablet as soon as possible and take the next tablet at your regular schedule.
  • If you miss a dose, and it is more than 3 hours from your usual time you take the pill, take the tablet as soon as possible and take the next tablet at your regular schedule. This means you may take 2 tablets in 1 day. Use a second form of birth control (including condom, spermicide) for 48 hours after restarting the 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.

• Some medicines can affect how norgestrel works. Tell your doctor if you are using bosentan, carbamazepine, efavirenz, phenytoin, rifampin, St John's wort, barbiturates, or medicine to treat HIV/AIDS.
• Take this medicine at least 5 days after using ulipristal acetate. Use another form of birth control (including condom, spermicide) until your next menstrual period.

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 your unborn baby. Tell your doctor right away if you think you have become pregnant.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, diabetes, high cholesterol, or migraine headaches.
• This medicine may cause the following problems:
  • Increased risk of ectopic pregnancy (pregnancy outside the uterus)
  • Cysts in the ovaries
  • Irregular menstrual bleeding
  • Liver problems
• This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including asthma). Tell your doctor if you have any allergies (including an aspirin allergy).
• This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections.
• 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
• Dark urine or pale stools, loss of appetite, stomach pain, nausea, vomiting, yellow skin or eyes
• Heavy vaginal bleeding, irregular or missed menstrual period
• Severe headache, change in vision

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

• Vaginal spotting or light bleeding, itching, or 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