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
medication is safe, appropriate, or effective for you. Consult your healthcare professional before using
Seasonale.
What is Seasonale
Seasonale is a
medication is used to prevent pregnancy. Seasonale is a
combination of two types of hormones (levonorgestrel, a
progestin and ethinyl estradiol, an estrogen). Besides
preventing pregnancy, similar birth control pills have been
shown to decrease anemia, painful periods (dysmenorrhea),
ovarian cysts, the number of episodes of pelvic inflammatory
disease, and decrease the occurrence of certain cancers
(uterine, ovarian). Using Seasonale does not protect you or your
partner against sexually transmitted diseases (e.g., HIV,
gonorrhea).
How to Take Seasonale
Begin taking Seasonale on the first Sunday following the
beginning of your period (menstruation). If your period begins
on a Sunday, begin taking Seasonale on that day. Take one
"active" pill (pills that contain the hormones) once daily for
84 days in a row. Following these active pills, you will then
take an "inactive" pill (pills that do not contain the hormones)
once daily for 7 days in a row. After the last inactive pill,
you will repeat the same cycle the very next day, starting again
with an active pill. For Seasonale to be effective you must try
to take Seasonale at the same time each day, not more than 24
hours apart. Pick a time that will be easy for you to remember.
Use an additional form of birth control (e.g., condom or
spermicide) during the first week of taking Seasonale since it
will take a while to be effective. A Patient Information Leaflet
about Seasonale should be dispensed with each prescription. Read
the information carefully. Ask your doctor or pharmacist any
questions you may have regarding Seasonale.
Seasonale Side Effects
Dizziness, headache, stomach upset, bloating, nausea, vomiting,
trouble sleeping, vaginal discomfort/irritation, increased
vaginal discharge, or vaginal bleeding between periods may
occur. If any of these effects persist or worsen, notify your
doctor or pharmacist promptly. Tell your doctor immediately if
any of these serious side effects occur: dark patches on the
skin or face (melasma), weight changes (gain or loss), problem
wearing contact lenses, depression, mental/mood changes. Tell
your doctor immediately if any of these unlikely but serious
side effects occur: chest pain, coughing up blood, shortness of
breath, groin or calf pain/swelling, one-sided weakness, vision
problems/changes, slurred speech, confusion, sudden severe
headache, lumps in the breast, severe stomach/abdominal pain,
tingling/weakness/numbness in the arms/leg, yellowing of eyes or
skin, dark urine. An allergic reaction to Seasonale is unlikely,
but seek immediate medical attention if it occurs. Symptoms of
an allergic reaction include: rash, itching, severe swelling,
severe dizziness, trouble breathing. If you notice other effects
not listed above, contact your doctor or pharmacist.
Seasonale Warning
Smoking cigarettes while using Seasonale increases your chance of
having heart problems. Do not smoke while using Seasonale.
The risk of heart problems increases with age (in women greater
than 35 years of age) and with frequent smoking (15 cigarettes
per day or greater).
Seasonale Precautions
Seasonale should not be used if you have certain medical
conditions. Before using Seasonale, consult your doctor or
pharmacist if you have: history of blood clots (e.g., in the
legs, groin, lungs), history of heart disease or stroke, heart
valve disease, severe high blood pressure, diabetes (especially
affecting the circulation), severe headaches, recent major
surgery, long periods of sitting or lying down (e.g., immobility
such as being bedridden), history of yellowing eyes/skin
(jaundice) during pregnancy or while using birth control pills,
cancer (especially endometrial or breast cancer), undiagnosed
abnormal vaginal bleeding, liver problems, currently pregnant,
heavy tobacco use (if 35 years old or greater). Before using
Seasonale, tell your doctor or pharmacist your medical
history, especially of: high blood pressure, high blood level of
cholesterol or triglycerides (fats), gallbladder problems,
kidney problems, thyroid problems, migraine headaches,
depression, recent pregnancy, smoking, obesity, any allergies
(especially to hormones used in other birth control pills). You
should have your period (withdrawal bleeding) when you are
taking the inactive pills. If bleeding does not occur, contact
your doctor immediately. Your doctor will need to check to see
if you are pregnant. Bleeding or spotting between your periods
may occur while taking Seasonale. If this bleeding
continues for more than 7 days or is heavy, contact your doctor.
Seasonale may cause a patchy, darkening of the skin on the face (melasma).
Sunlight may intensify this darkening and you may need to avoid
prolonged sun exposure and sunlamps. Consult your doctor
regarding use of sunscreens and protective clothing. There may
be a delay in becoming pregnant after you stop taking birth
control pills. Consult your doctor. Birth-control pills slightly
increase your risk of strokes, blood clots, high blood pressure,
heart attacks, gallbladder disease, vision problems, and liver
tumors. Cigarette smoking (especially 15 or more cigarettes
daily) and age (women older than 35/smokers or 40/nonsmokers
years of age) further increase the risk of stroke, blood clots,
high blood pressure and heart attacks. Ask your pharmacist or
doctor for a copy of the patient labeling which explains these
risks in more detail. Consult your doctor for any questions,
including possible use in nonsmokers over 40 years of age. If
you are near-sighted or wear contact lenses, you may develop
vision problems. Also, your tolerance of the lenses may
decrease. Contact your eye doctor if these problems occur. If
you will be having surgery, be confined to a chair or bed for a
long period of time (e.g., a long plane flight), or have
recently delivered a baby, notify your doctor beforehand.
Special precautions may need to be taken in these circumstances
while you are taking Seasonale. Seasonale must not be used
during pregnancy. If you become pregnant or think you may be
pregnant, inform your doctor immediately. Seasonale passes into
breast milk. This may affect milk production and may have
harmful effects on a nursing infant. Consult your doctor before
breast-feeding.
Seasonale Medication Interactions
Seasonale should not be used with the following medications
because very serious interactions may occur: troleandomycin. If
you are currently using any of these medications, tell your
doctor or pharmacist before starting this birth control pill.
Before using Seasonale, tell your doctor or pharmacist of
all prescription and nonprescription products you may use,
especially of: cyclosporine, corticosteroids (e.g., prednisolone),
theophylline, beta-blockers (e.g., metoprolol), thyroid
hormones, temazepam, aspirin, morphine, clofibric acid,
acetaminophen, ascorbic acid (vitamin C), atorvastatin, azole
antifungals (e.g., itraconazole, ketoconazole). Certain
medications can decrease the effectiveness of combination-type
birth control pills by decreasing the amount of birth control
hormones in your system (impaired enterohepatic recirculation or
hepatic induction). This can result in pregnancy. Consult your
doctor or pharmacist for details. Medications that may cause
this effect include: griseofulvin, many antibiotics (e.g.,
penicillins, macrolides, tetracyclines, sulfas, cephalosporins,
chloramphenicol), many seizure medications (e.g., phenytoin,
barbiturates, primidone, carbamazepine, topiramate), dapsone,
rifamycins (e.g., rifampin), modafinil, St. John's wort,
nevirapine, bosentan, aprepitant, certain HIV protease
inhibitors (e.g., amprenavir, nelfinavir, ritonavir). Ask your
doctor if you should use additional reliable birth control
methods while taking any of the medications mentioned above
while also taking birth control pills. Seasonale can affect the
results of certain lab tests (e.g., thyroid). Inform all
laboratory personnel that you use Seasonale. Do not start
or stop any medicine without doctor or pharmacist approval.
Seasonale Overdose
If overdose is suspected, contact your local poison control
center at 1-800-222-1222 (USA) or emergency room immediately.
Symptoms of overdose may include severe nausea, vomiting, and
unusual vaginal bleeding or irregular menstrual periods.
Seasonale Notes
Do not share Seasonale with others. Keep all appointments with
your doctor and the laboratory. You should have a complete
physical examination, including blood pressure measurements,
breast and pelvic examinations, and a PAP test (for vaginal
cancer), at least once a year. Follow your doctor's instructions
for examining your own breasts, and report any lumps
immediately.
Seasonale Missed Dose
If you miss a dose, use it as soon as you remember. Take the
next dose at your regular time. This may mean taking 2 doses on
the same day. If you miss 2 active pills in a row, take 2 pills
on the day you remember and 2 pills the next day. Then return to
1 pill per day dosing. You must use another form of birth
control (e.g., condoms or spermicides) as a back-up for 7 days
after you restart your pills. If you miss 3 or more active pills
in a row, leave the missed pills in the pack. Keep taking 1 pill
every day as indicated on the pack until you complete the pack.
You must use another form of birth control as a back-up for 7
days after you restart your pills. If you miss any of the 7
inactive pills, throw away the missed inactive pill and finish
the rest of the pills in the pack on schedule. You do not need
to use back-up birth control if you miss taking an inactive
pill. If you have any questions about what to do if you miss a
pill, consult your doctor, pharmacist, or the Patient
Information Leaflet available from your pharmacist.
Seasonale Storage
Store at room temperature between 68 and 77 degrees F (20-25
degrees C) away from light and moisture. Do not store in the
bathroom. Keep all medicines away from children and pets.
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