Lo/Ovral-28 contains a combination of ethinyl estradiol and norgestrel. Ethinyl estradiol and norgestrel are female hormones that prevent ovulation (the release of an egg from an ovary). Lo/Ovral-28 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.

Lo/Ovral-28 is used as contraception to prevent pregnancy.

Lo/Ovral-28 may also be used for purposes not listed in this medication guide.

Do not use Lo/Ovral-28 if you are pregnant or if you have recently had a baby. You should not take Lo/Ovral-28 if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by Lo/Ovral-28, a heart attack, a stroke, or a blood clot.

You may need to use back up birth control, such as condoms or a spermicide, when you first start using Lo/Ovral-28 or if you miss a dose. Follow your doctor's instructions.

Missing a pill increases your risk of becoming pregnant. Carefully follow the "missed dose" instructions if you forget to take your Lo/Ovral-28.

Some drugs can make Lo/Ovral-28 less effective in preventing pregnancy, including antibiotics, hepatitis C medications, HIV/AIDS medications, seizure medications, or barbiturate sedatives. Tell your doctor about all other medications you use.

Take Lo/Ovral-28 exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using Lo/Ovral-28. 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. Get your prescription refilled before you run out of pills completely.

The 28 day Lo/Ovral pack contains seven "reminder" pills to keep you 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 surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using Lo/Ovral-28.

While taking Lo/Ovral-28, you will need to visit your doctor regularly.

Store Lo/Ovral-28 at room temperature away from moisture and heat.

Lo/Ovral-28 can cause birth defects. Do not use if you are pregnant. 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 Lo/Ovral-28. You should not take Lo/Ovral-28 if you have:

• untreated or uncontrolled high blood pressure;

• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);

• a blood-clotting disorder or circulation problems;

• problems with your eyes, kidneys or circulation caused by diabetes;

• a history of hormone-related cancer such as breast or uterine cancer;

• 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; or

• if you smoke and are over 35 years old.

To make sure you can safely take Lo/Ovral-28, tell your doctor if you have any of these other conditions:

• high blood pressure, varicose veins;

• high cholesterol or triglycerides, or if you are overweight;

• a history of depression;

• underactive thyroid;

• gallbladder disease;

• diabetes;

• seizures or epilepsy;

• a history of irregular menstrual cycles;

• tuberculosis; or

• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in Lo/Ovral-28 can pass into breast milk and may harm a nursing baby. Lo/Ovral-28 may also slow breast milk production. Do not use if you are breast feeding a baby.

Follow the patient instructions provided with Lo/Ovral-28. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant.

If you miss one active pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

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

If you miss two active pills in a row in Week 3,throw out 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 out the rest of the pack and start a new pack that day.

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

If you miss two or more pills, you may not have a period during the month. If you miss a period for two 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. You do not need back-up birth control if you miss a reminder pill.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

Smoking can increase your risk of blood clots, stroke, or heart attack caused by Lo/Ovral-28, especially if you are older than 35.

Lo/Ovral-28 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.

Get emergency medical help if you have any of these signs of an allergic reaction to Lo/Ovral-28: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Lo/Ovral-28 and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body;

• sudden and severe 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;

• sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• a change in the pattern or severity of migraine headaches;

• nausea, upper stomach pain, itching, 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, tired feeling, mood changes).

Less serious Lo/Ovral-28 side effects may include:

• mild nausea (especially when you first start taking this medicine), vomiting, bloating, stomach cramps;

• breast tenderness or swelling, nipple discharge;

• 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; or

• changes in your menstrual periods, decreased sex drive.

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.

Some drugs can make Lo/Ovral-28 less effective, which may result in pregnancy. Before using Lo/Ovral-28, tell your doctor if you are using any of the following drugs:

• bosentan (Tracleer);

• an antibiotic or tuberculosis medication;

• drugs to treat hepatitis C, HIV, or AIDS;

• phenobarbital (Solfoton) and other barbiturates;

• St. John's wort; or

• seizure medications.

Tell your doctor about all other medicines you use, especially:

• dantrolene (Dantrium);

• tizanidine (Zanaflex); or

• tranexamic acid (Cyklokapron, Lysteda).

This list is not complete and other drugs may interact with Lo/Ovral-28. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.