Ethinyl estradiol and norgestimate

Ethinyl estradiol and norgestimate is a combination birth control pill that contains female hormones to stop ovulation (the release of an egg from an ovary). Ethinyl estradiol and norgestimate also changes your cervical mucus and uterine lining, making it more difficult for sperm to reach the uterus and for a fertilized egg to attach to the uterus.

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

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may need to use back-up birth control, like condoms with spermicide, when you first start using this medicine. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the next day. You may get pregnant if you do not take one pill daily.

Some birth control packs have "reminder" pills to help you stay on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using Ethinyl estradiol and norgestimate.

While taking birth control pills, you will need to visit your doctor regularly.

Store this medicine at room temperature away from moisture and heat.

Do not use birth control pills if you are pregnant or if you have recently had a baby.

You should not use birth control pills if you have: uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack.

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

Taking birth control pills can raise your chances of getting blood clots, having a stroke, or experiencing a heart attack. You are at an even higher risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clots is highest during your first year of taking birth control pills. Your risk is also high if you restart birth control pills after not taking them for 4 weeks or longer.

Smoking can significantly increase your risk of blood clots, stroke, or heart attack. Your risk goes up as you get older 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 ethinyl estradiol and norgestimate and inform your doctor immediately 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 starting 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);
• a higher chance of having blood clots due to a heart issue or a genetic 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 evaluated 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 that includes ombitasvir/paritaprevir/ritonavir (Technivie).

Inform your doctor if you have ever had:

• heart problems, high blood pressure, or if you are prone to blood clots;
• high cholesterol or triglycerides, or if you are overweight;
• depression;
• a seizure or migraine headache;
• diabetes, gallbladder disease, or 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 reduce breast milk production. Let your doctor know if you are breast-feeding.

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

Birth control pills may cause serious side effects. Stop using birth control pills and call your doctor right away 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 of ethinyl estradiol and norgestimate 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.

Usual Adult Dose for Contraception:

1 tablet orally once a day

Usual Adult Dose for Acne:

1 tablet orally once a dayComments: Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.

Usual Pediatric Dose for Contraception:

1 tablet orally once a day

Usual Pediatric Dose for Acne:

15 years or older: 1 tablet orally once a dayComments:-Not all preparations are indicated for the treatment of acne; the manufacturer product information should be consulted.-Use should be reserved for the treatment of acne only if the patient desires an oral contraceptive for birth control.Use: For the treatment of moderate acne vulgaris in females at least 15 years of age with no know contraindications to oral contraceptive therapy and who have achieved menarche

Follow the instructions that come with your medicine. Missing a pill increases your risk of becoming pregnant.

If you miss 1 active pill, take 2 pills on the day you remember. Then take 1 pill per day for the rest of the pack.

If you miss 2 active pills in a row in Week 1 or 2, take 2 pills per day for 2 days in a row. Then take 1 pill per day for the rest of the pack. Use back-up birth control for at least 7 days after the missed pills.

If you miss 2 active pills in a row in Week 3, throw out the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 3 active pills in a row in Week 1, 2, or 3, throw out the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss 2 or more pills, you may not have a period during the month. If you miss a period for 2 months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

Other drugs may affect birth control pills, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all your current medicines and any medicine you start or stop using.