Ethinyl estradiol/norgestimate (By mouth)

Introduction

Ethinyl Estradiol (ETH-i-nil es-tra-DYE-ol), Norgestimate (nor-JES-ti-mate)

Prevents pregnancy and treats acne. This medicine is an oral contraceptive (birth control pill).

Brand Name(s)

Ortho Tri-Cyclen Lo, TriNessa, Tri-Sprintec 28, Sprintec, Ortho Tri-Cyclen, TriNessa 28, Tri-Sprintec, Tri-Previfem, Tri-Lo-Sprintec, Ortho-Cyclen, Previfem, MonoNessa

There may be other brand names for this medicine.

When This Medicine Should Not Be Used

You should not use this medicine if you have had an allergic reaction to ethinyl estradiol or norgestimate. Do not use this medicine if you are pregnant. You should not use this medicine if you have migraine headaches, heart disease, liver disease, or unusual vaginal bleeding. You should not use this medicine if you have breast cancer, liver cancer, or cancer of the uterus. Do not use this medicine if you have ever had a stroke or problems with blood clots.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• The schedule you follow for taking this medicine is different from the schedule for most other birth control pills.
• Unless your doctor tells you to use a different schedule, start taking this medicine on the first Sunday after your menstrual period starts. If your period starts on a Sunday, start taking this medicine on that day. Then continue taking one pill each day in the order they appear in the package.
• It is best to take your pill at the same time every day. Birth control pills work best when there is no more than 24 hours between doses. It is very important that you take this medicine on schedule every day.

If a dose is missed:

• If you miss one active 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.
• If you miss two active pills, take two pills as soon as you can. Then take two pills on the next day. Then go back to your regular schedule of taking one pill every day. Use another kind of birth control until you have been taking active pills for seven days in a row.
• If you miss three or more active pills, do not take the pills you missed. Go back to taking one pill every day, starting with the pill for the day you remember. For example, you may forget or miss taking your pills on Monday, Tuesday, and Wednesday. If this happens, take your Thursday pill (do not take the three you missed) and continue with your regular schedule. Use another kind of birth control until you have been taking active pills for seven days in a row.
• If you miss any inactive pills (green colored pill), throw away the missed pills and go back to your regular schedule.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using barbiturates, carbamazepine (Tegretol®), phenylbutazone, phenytoin (Dilantin®), or rifampin (Rifadin®, Rifamate®). Tell your doctor if you are using ampicillin, griseofulvin, tetracyclines, or topiramate.
• Make sure your doctor knows if you are also using St. John's wort.

Warnings While Using This Medicine

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you are breast feeding. Tell your doctor if you are under the age of 15 years old.
• Make sure your doctor knows if you have diabetes, high blood pressure, high cholesterol or triglycerides in your blood, or obesity.
• This medicine may increase your risk for heart attack, stroke, blood clots, and some forms of cancer. This risk is higher if you are over 35 years old or if you smoke. Talk to your doctor about this risk.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

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, shortness of breath, or coughing up blood.
• Decrease in how much or how often you urinate.
• Irregular or missed menstrual period.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Rapid weight gain.
• Sudden or severe headache, problems with vision, speech, or walking.
• Swelling in your hands, feet, or ankles.
• Yellowing of your skin or the whites of your eyes.

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

• Acne or mild skin rash.
• Breast tenderness.
• Contact lens discomfort.
• Darkening of your skin.
• Excessive growth of hair on your chin and lips.
• Loss of hair.
• Mild nausea or vomiting.

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