Ethinyl estradiol and norgestimate is a combination birth control pill containing female hormones that prevent ovulation (the release of an egg from an ovary). This medicine also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norgestimate is used as contraception to prevent pregnancy. There are many available brands of this medicine. Not all brands are listed on this leaflet.

Ethinyl estradiol and norgestimate may also be used for purposes not listed in this medication guide.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take combination birth control pills if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• circulation problems (especially if caused by diabetes);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (aura, numbness, vision changes), especially if you are older than 35; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

Tell your doctor if you have ever had:

• heart problems, high blood pressure, or if you are prone to having blood clots;
• high cholesterol or triglycerides, or if you are overweight;
• depression;
• a seizure or migraine headache;
• diabetes, gallbladder disease, underactive thyroid;
• liver or kidney disease;
• jaundice caused by pregnancy or birth control pills;
• irregular menstrual cycles; or
• fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

This medicine can slow breast milk production. Tell your doctor if you are breast-feeding.

Use Tri-Previfem (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using birth control pills and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--loss of appetite, upper stomach pain, tiredness, fever, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe headache, pounding in your neck or ears;
• swelling in your hands, ankles, or feet;
• changes in the pattern or severity of migraine headaches;
• a breast lump; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

• stomach pain, gas, nausea, vomiting;
• breast tenderness;
• acne, darkening of facial skin;
• headache, nervousness, mood changes;
• problems with contact lenses;
• changes in weight;
• breakthrough bleeding;
• vaginal itching or discharge; or
• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not smoke while taking birth control pills, especially if you are older than 35 years of age.

Birth control pills will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.