Brand Names: Aranelle, Balziva, Brevicon, Estrostep Fe, Femcon FE, Junel 1.5/30, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Loestrin 21 1.5/30, Loestrin 24 Fe, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin FE 1.5/30, Modicon, Necon 0.5/35, Necon 1/35, Necon 7/7/7, Nortrel 0.5/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent

Generic Name: ethinyl estradiol and norethindrone (Pronunciation: ETH in il ess tra DYE ole and nor ETH in drone)

• What is ethinyl estradiol and norethindrone (Ortho-Novum)?
• What are the possible side effects of ethinyl estradiol and norethindrone?
• What is the most important information I should know about ethinyl estradiol and norethindrone?
• What should I discuss with my healthcare provider before taking ethinyl estradiol and norethindrone?
• How should I take ethinyl estradiol and norethindrone?
• What happens if I miss a dose?
• What happens if I overdose?
• What should I avoid while taking ethinyl estradiol and norethindrone?
• What other drugs will affect ethinyl estradiol and norethindrone?
• Where can I get more information?

What is ethinyl estradiol and norethindrone (Ortho-Novum)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication 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 norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

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

Brevicon

round, blue/peach

Leena

Microgestin 1.5-30

round, green, imprinted with WATSON, 631

Microgestin 1-20

round, white, imprinted with WATSON, 630

Microgestin FE 1.5-30

round, green, imprinted with WATSON 075

Microgestin FE 1-20

round, white, imprinted with WATSON 632

Necon 0.5-35-28

round, yellow, imprinted with 507, WATSON

Necon 10-11-28

round, yellow

Necon 1-35-28

round, yellow, imprinted with 508, WATSON

Necon 7-7-7

Norinyl 1-35

round, green, imprinted with 259, WATSON

Zenchent

round, orange, imprinted with WC, 540

What are the possible side effects of ethinyl estradiol and norethindrone?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, bloating, stomach cramps;
• breast pain, tenderness, or swelling;
• freckles or darkening of facial skin;
• increased hair growth, loss of scalp hair;
• changes in weight or appetite;
• problems with contact lenses;
• vaginal itching or discharge;
• changes in your menstrual periods, decreased sex drive; or
• headache, nervousness, dizziness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ethinyl estradiol and norethindrone?

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

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all the prescription and over-the-counter medications you use, including vitamins, minerals and herbal products. Do not start using a new medication without telling your doctor.