SEASONALE

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Generic Name: Seasonale Classification: Women's Health

(These are common indications for Seasonale. There may be additional conditions not listed here. Check with your doctor if you have questions about your specific condition).

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What is the most important information I should know 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 Seasonale. 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 Seasonale, 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.

Seasonale Uses (What is Seasonale):
Seasonale are hormones that affect the ovulatory and menstrual cycle of women. Seasonale 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. This medication does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. Seasonale may also be used for purposes other than those listed in this medication guide.

Who should not take Seasonale:
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 Seasonale. 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.
Seasonale is in the FDA pregnancy category X. Hormonal changes during pregnancy can have very serious negative effects on a developing baby. This means that Seasonale is known to cause birth defects in an unborn 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 Taken:
Take Seasonale exactly as directed by your doctor. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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 Seasonale, 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.

Warnings/Precautions:
If you are breastfeeding, consult your healthcare provider before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. 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 Seasonale. Smoking greatly increases the risk of heart attack, stroke, and blood clot formation.

Possible Side Effects:
Seasonale may cause your blood pressure to rise. A spotty darkening of the skin is possible, particularly of the face. Other, less serious side effects you may experience include nausea and vomiting, change in appetite, breast tenderness, headache, nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections, and allergic reactions. 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.

Missed Dose:
Missing a pill increases the chance of becoming pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. Try not to exceed 24 hours between pills. 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.

Other drugs will affect my Seasonale:
Many other drugs may interact with Seasonale. 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 Seasonale.

Storage:
Store at controlled room temperature 20 -25 degrees C (68 - 77 degrees F). Keep out of the reach of children.

Overdose:
Death or serious harm is not likely to occur from an overdose of Seasonale. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your healthcare provider or pharmacist.

More Information:
Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. You should be reexamined at least once a year.