Brand Names: Cryselle 28, Lo/Ovral-28, Low-Ogestrel, Ogestrel-28

Generic Name: ethinyl estradiol and norgestrel (Pronunciation: ETH in il ess tra DYE ol and nor JESS trel)

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

What is ethinyl estradiol and norgestrel (Low-Ogestrel)?

Ethinyl estradiol and norgestrel 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 norgestrel is used as contraception to prevent pregnancy.

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

Lo-Ogestrel

white, imprinted with WATSON 847

Ogestrel

round, white, imprinted with 848, WATSON

What are the possible side effects of ethinyl estradiol and norgestrel (Low-Ogestrel)?

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, problems with vision, speech, or balance;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• a change in the pattern or severity of migraine headaches;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• swelling in your hands, ankles, or feet;
• a breast lump; or
• symptoms of depression (sleep problems, weakness, mood changes).

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
• nervousness, dizziness, tired feeling.

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.

What is the most important information I should know about ethinyl estradiol and norgestrel (Low-Ogestrel)?

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 (especially if caused by diabetes), a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, severe high blood pressure, migraine headaches, a heart valve disorder, 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.