Ethinyl estradiol and norethindrone (birth control)

Ethinyl estradiol and norethindrone is a combination birth control pill that contains female hormones. It prevents ovulation, which is the release of an egg from an ovary. This medication also makes changes to 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 norethindrone is used as contraception to prevent pregnancy. Ethinyl estradiol and norethindrone is also used to treat moderate acne in women who are at least 15 years old, have started having menstrual periods, and wish to use birth control pills. There are many brands of ethinyl estradiol and norethindrone available. Not all brands are listed in this leaflet.

Ethinyl estradiol and norethindrone may also be used for reasons not mentioned 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, such as condoms with spermicide, when you first start using this medication. 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 following day. You may get pregnant if you do not take one pill daily.

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

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

You may experience breakthrough bleeding. Tell your doctor if it continues or is very heavy.

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 norethindrone.

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

Store 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.

Smoking, especially if you are older than 35, or taking birth control pills can increase your risk of blood clots, stroke, or heart attack.

Taking birth control pills can raise your chances of getting blood clots, having a stroke, or having a heart attack. You are at greater risk if you have high blood pressure, diabetes, high cholesterol, or are overweight. Your risk of stroke or blood clots is highest during the first year of using birth control pills. Your risk is also high if you start taking birth control pills again after being off them for 4 weeks or longer.

Smoking can raise your risk of blood clots, stroke, or heart attack from birth control pills, especially if you are older than 35.

Do not use if you are pregnant. Stop using ethinyl estradiol and norethindrone and tell your doctor immediately if you become pregnant or if you miss 2 menstrual periods in a row. If you have recently given birth, 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, or heart disease (chest pain, coronary artery disease, history of heart attack, stroke, or blood clot);
• a higher risk of 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 (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills;
• if you smoke and are over 35 years old; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir with or without dasabuvir.

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, or underactive thyroid;
• liver or kidney disease; or
• irregular menstrual cycles, or fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

Ask a doctor if it is safe to breastfeed while using this medicine.

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

This medicine may cause serious side effects. Stop using this medicine and call your doctor right away if you have:

• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure--severe headache, blurred vision, pounding in your neck or ears;
• depression--mood changes, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;
• swelling in your hands, ankles, or feet, or a breast lump; or
• a change in the pattern or severity of migraine headaches.

Common side effects of ethinyl estradiol and norethindrone may include:

• nausea, vomiting;
• breast tenderness, or breakthrough bleeding; or
• headache, or problems with contact lenses.

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 dayComments: To be taken at the same time each day.

Usual Adult Dose for Postmenopausal Symptoms:

1 tablet orally once a dayComments: Not all preparations are indicated for the treatment of vasomotor symptoms due to menopause; the manufacturer product information should be consulted.Use: For the treatment of moderate to severe vasomotor symptoms due to menopause

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.Use: For the treatment of moderate acne vulgaris in females with no known contraindications to oral contraceptive therapy and who have achieved menarche and are unresponsive to topical anti-acne medications

Usual Adult Dose for Prevention of Osteoporosis:

1 tablet orally once a dayComments:-Not all preparations are indicated for the prevention of postmenopausal osteoporosis; the manufacturer product information should be consulted.-When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.Use: For the prevention of postmenopausal osteoporosis

Usual Pediatric Dose for Contraception:

1 tablet orally once a dayComments: To be taken at the same time each 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 and plans to stay on it for at least 6 monthsUse: For the treatment of moderate acne vulgaris in females at least 15 years of age with no known contraindications to oral contraceptive therapy and who have achieved menarche and are unresponsive to topical anti-acne medications

Follow the instructions on your prescription label and read all medication guides or instruction sheets. If you miss a pill, your chance of getting pregnant increases.

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

If you miss 2 active pills in a row during Week 1 or 2, take 2 pills each day for 2 days in a row. Then take 1 pill each 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 during Week 3, throw away the rest of 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 away the rest of the pack and start a new pack that day.

If you miss 3 active pills in a row during Week 1, 2, or 3, throw away the rest of 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 away the rest of the pack and start a new pack that day.

If you miss 2 or more active pills, you might not get your period that month. If you miss your period for 2 months in a row, call your doctor because you could be pregnant.

If you miss a reminder pill, throw it away and continue taking 1 reminder pill each day until the pack is empty.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much may cause nausea or vaginal bleeding.

Do not smoke while taking birth control pills, especially if you are over 35 years old.

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.

Tell your doctor about all your other medicines, especially:

• rifampin;
• troglitazone;
• atorvastatin;
• glecaprevir/pibrentasvir; or
• anticonvulsants (antiepileptics) such as phenobarbital, phenytoin, and carbamazepine.

This list is not complete. Other drugs may affect ethinyl estradiol and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.