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Seasonale

What is ethinyl estradiol and levonorgestrel

Ethinyl estradiol and levonorgestrel are hormones that affect the ovulatory and menstrual cycle of women. Ethinyl estradiol and levonorgestrel prevent ovulation (the release of an egg from an ovary), therefore preventing the possibility of pregnancy. Seasonale may also inhibit pregnancy by causing the cervical mucous to thicken, which makes it harder for sperm to move toward the uterus, and reducing the likelihood of attachment of a fertilized egg to the uterus.

The extended-cycle formulation of Seasonale has a 91-day treatment cycle, resulting in 4 menstrual periods per year.

Seasonale is used to prevent pregnancy.

Seasonale may also be used for purposes other than those listed in this medication guide.

General medical information about Seasonale

Seasonale does not provide protection from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Take one pill every day at the same time, no more than 24 hours after the last dose. Try to take the pills at a time that you will remember every day--for example just before bed, with a meal, or first thing in the morning.

Avoid smoking cigarettes while taking ethinyl estradiol and levonorgestrel. Smoking greatly increases the risk of heart attack, stroke, and blood clot formation.

Follow your doctor's instructions about using a second form of birth control when you first start taking ethinyl estradiol and levonorgestrel, when you are taking antibiotics or other medications, or if you miss a pill. If you are unsure what to do in any of these cases, talk to your pharmacist, nurse, or doctor about how to ensure that you will not become pregnant.

What you should find out before taking ethinyl estradiol and levonorgestrel

Do not take Seasonale without first talking to your doctor if you:
- smoke;
- have a bleeding or blood-clotting disorder or a history of blood clots;
- have current or past heart or blood vessel disease, heart attack or stroke, uncontrolled high blood pressure, angina (chest pain), problems with heart valves, or irregular heart beats;
- have diabetes;
- current or past liver problems;
- have breast, uterine, or another hormone-related cancer;
- have undiagnosed, abnormal vaginal bleeding; or
- need to have surgery that will require extended bed-rest or immobilization.

Other medical conditions may also affect treatment with ethinyl estradiol and levonorgestrel. Talk to your doctor before taking this medication if you
- have seizures, migraines, or depression;
- have a history of very light or irregular menstrual periods
- have breast nodules, fibrocystic disease of the breast, abnormal breast x-ray or mammogram;
- are obese;
- have high cholesterol, triglycerides, or blood pressure; or
- have gallbladder disease or kidney disease.

You may not be able to take ethinyl estradiol and levonorgestrel, or you may require special monitoring during treatment if you have any of the conditions listed above.

Seasonale is in the FDA pregnancy category X. This means that Seasonale is known to cause birth defects in an unborn baby. Hormonal changes during pregnancy can have very serious negative effects on a developing baby. Do not take Seasonale if you are pregnant or if you think you might be pregnant.

The hormones in Seasonale pass into breast milk and may decrease milk production or affect a nursing baby. Do not take Seasonale without first talking to your doctor if you are breast-feeding a baby.

How should take ethinyl estradiol and levonorgestrel

Take Seasonale exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

The extended-cycle form of Seasonale involves a 91-day treatment cycle resulting in 4 menstrual periods per year (which occurs when you are taking the 7 white pills).

An increase in bleeding or spotting between periods (compared to taking a standard 21- or 28-day birth control pill cycle) is expected to occur. During the first cycle of pills, about 1 in 3 women may have 20 or more days of unplanned bleeding or spotting. This tends to decrease during later cycles. Treatment with Seasonale should not be stopped due to spotting or bleeding. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, contact your healthcare provider.

Take the first pill in a package on the first Sunday after your period begins, even if you are still bleeding. If your period starts on Sunday, take the first pill that day. Use another form of birth control anytime you have sex for the first 7 days you take the pills.

Take one pill every day at the same time, no more than 24 hours after the last dose. Try to take the pills at a time that you will remember every day--for example just before bed, with a meal, or first thing in the morning. Taking the pill at night may help to reduce nausea or headache, which may be side effects.

Your period should occur during the 7 days you are taking the white pills (these pills are inactive and do not contain hormones). If it doesn't, have a pregnancy test before beginning a new package of pills.

After taking the last white pill from a pack, start a new pack the very next day. Do not skip any days.

Follow your doctor's instructions about using a second form of birth control when you first start taking ethinyl estradiol and levonorgestrel, when you are taking antibiotics or other medications, or if you miss a pill. If you are unsure what to do in any of these cases, talk to your pharmacist, nurse, or doctor about how to ensure that you will not become pregnant.

Store Seasonale at room temperature away from moisture and heat.

If you miss a dose:

Missing a pill increases the chance of becoming pregnant. Follow the exact directions on the package information insert concerning missed doses. If you do not have a package information insert, call your pharmacist, doctor, or nurse to find out what to do.

In general:

If you miss one dose, take it as soon as you remember or take two pills at the time of your next regularly scheduled dose. There is little likelihood that ovulation will occur.

If you miss two tablets in a row, take two tablets each for the next two regularly scheduled doses (one missed tablet plus one regularly scheduled tablet for 2 days in a row). There is an increased chance of ovulation and unintended pregnancy. Use an additional form of birth control until you have taken a pill for 7 days in a row.

If you miss three tablets in a row, do not remove the missed tablets from the package, they will not be taken. Take the next pill in the package for the current day. Continue to take one pill per day until the cycle is completed. There is an increased chance of ovulation and unintended pregnancy. Use an additional form of birth control until you have taken a pill for 7 days in a row.You may experience menstrual bleeding during the week following the missed pills.

If you miss any of the 7 white inactive pills, they can be thrown away. Keep taking the scheduled pills until the pack is finished. No back-up method of birth control is needed.

What happens if you overdose:

Death or serious harm is not likely to occur from an overdose of ethinyl estradiol and levonorgestrel. Consult a doctor, an emergency room, or a poison control center for advice.

Symptoms of an overdose may include nausea, vomiting, and menstrual bleeding.

Avoid while taking my ethinyl estradiol and levonorgestrel

Seasonale does not provide protection from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Avoid smoking cigarettes while taking ethinyl estradiol and levonorgestrel. Smoking greatly increases the risk of heart attack, stroke, and blood clot formation.

Possible side effects of ethinyl estradiol and levonorgestrel

If you experience any of the following serious side effects, stop taking Seasonale and seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- possible blood clot in the lung (shortness of breath, coughing up blood, or pain in the chest); the leg (pain, redness, swelling, or numbness of the leg); or the eye (partial or complete loss of vision);
- chest pain or heaviness in the chest (possible heart attack);
- severe headache or vomiting, dizziness or fainting, vision or speech disturbances, weakness or numbness in an arm or leg (may indicate a stroke);
- breast lumps;
- possible liver problems (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

Other, less serious side effects may also occur. Continue to take Seasonale and talk to your doctor if you experience
- breakthrough bleeding or spotting;
- headache;
- nausea or vomiting;
- breast tenderness;
- depression;
- changes in weight or appetite;
- changes in skin color; or
- changes in fit of contact lenses.

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.

What other drugs will affect my ethinyl estradiol and levonorgestrel

Many other drugs may interact with ethinyl estradiol and levonorgestrel. Some interactions (e.g. with certain antibiotics, protease inhibitors, and other medications) may result in decreased effectiveness of the medication and therefore increase the risk of unintended pregnancy. Talk to your doctor or pharmacist before taking any other prescription or over-the-counter medications, including herbal products, while taking ethinyl estradiol and levonorgestrel.

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B
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H
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I
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L
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N
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O
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