Seasonale
®
Levonorgestrel
with Ethinyl Estradiol
Important
Note
The following information is intended to supplement, not substitute
for, the expertise and judgment of your physician, pharmacist or
other healthcare professional. It should not be construed to indicate
that use of the drug is safe, appropriate, or effective for you.
Consult your healthcare professional before using this drug.
Use
Seasonale (birth-control pills) are used
to prevent pregnancy. Seasonale tablets are indicated for the prevention
of pregnancy, and used daily as a birth control pill. Seasonale
does not protect against HIV infection or other sexually transmitted
diseases.
Take Seasonale
exactly as directed by your doctor. Seasonale
comes with a patient information leaflet; read it carefully. If
you do not understand these directions, ask your pharmacist, nurse,
or doctor to explain them to you. Take the first pill in the package
on the first Sunday after your period begins (unless otherwise directed
by your doctor). 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). 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.
Side Effects
Bleeding or spotting may occur while taking Seasonale.
Do not stop taking Seasonale if this occurs.
If bleeding or spotting continues for more than 7 days or is heavy,
contact your doctor. If you wear contact lenses and you develop
problems with them, contact your doctor. Seasonale
may cause dark skin patches on your face. Exposure to the sun may
make these patches darker. If patches develop, use a sunscreen or
protective clothing when exposed to the sun, sunlamps, or tanning
booths.
If you experience
the following possible side effects of ethinyl estradiol and levonorgestrel,
stop taking Seasonale and seek emergency
medical attention or contact your doctor immediately: allergic reaction
such as difficulty breathing, closing of the throat, swelling of
the lips, tongue, or face, or hives, possible blood clot in the
lung as indicated by shortness of breath, coughing up blood, or
pain in the chest, the pain, redness, swelling, or numbness of the
leg, or partial/complete loss of vision, chest pain or heaviness
in the chest that could signal possible heart attack, severe headache
or vomiting, dizziness or fainting, speech disturbances, weakness
or numbness in an arm or leg that may indicate stroke, breast lumps,
possible liver problems as indicated by yellowing of the skin or
eyes, nausea, abdominal pain or discomfort, unusual bleeding or
bruising, severe fatigue. In case you experience less serious side
effects, continue to take Seasonale and talk to your doctor: 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 above may occur. Consult your doctor about any side effect
that is unusual and uncomfortable.
Precautions
Smoking while using this medicine may increase your risk of stroke,
heart attack, blood clots, high blood pressure, or other diseases
of the heart and blood vessels. Before using Seasonale, tell your
health care provider about any of the following: if you are pregnant,
planning to become pregnant, or are breastfeeding; if you are taking
any other prescription medicine, nonprescription medicine, herbal
preparation, or dietary supplement; if you have a history of breast
cancer, a family history of breast cancer, or have ever had an abnormal
breast x-ray or mammogram; if you have a history of depression;
if you have a history of migraines or other headaches; if you smoke;
if you have high blood pressure, diabetes, obesity, high cholesterol,
or high triglycerides; if you have a history of scanty or irregular
menstrual periods; if you have any other medical condition.
Under Seasonale's
dosing regimen, the number of expected menstrual periods that a
woman usually experiences are reduced from once a month to about
once every three months. Although Seasonale
users have fewer scheduled menstrual cycles, the data from clinical
trials show that many women, especially in the first few cycles
of use, had more unplanned bleeding and spotting between the expected
menstrual periods than women taking a conventional 28-day cycle
oral contraceptive. Like other available oral contraceptives, Seasonale
is effective for prevention of pregnancy when used as directed.
The risks of using Seasonale are similar
to the risks of other conventional oral contraceptives and include
an increased risk of blood clots, heart attack, and stroke. The
labeling also carries the warning that cigarette smoking increases
the risk of serious cardiovascular side effects from use of combination
estrogen and progestin containing contraceptives.
Since Seasonale
users can expect to have fewer periods, the label also advises women
to consider the possibility that they may be pregnant if they miss
any scheduled periods. Women should discuss contraceptive use and
the precautions and warnings for use of the drug with their doctors.
