Seasonale Information:
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.
WARNING: Smoking cigarettes while using this
medication increases your chance of having heart problems.
Do not smoke while using this medication. 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).
USES: Seasonale is used to prevent pregnancy.
This medication 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 this medication does not protect you or your partner
against sexually transmitted diseases (e.g., HIV, gonorrhea).
HOW TO USE: Begin taking this medication on the
first Sunday following the beginning of your period
(menstruation). If your period begins on a Sunday, begin
taking this medication 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 this medication to be effective
you must try to take this medication 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 this medication since it will
take a while to be effective. A Patient Information
Leaflet about this drug should be dispensed with each
prescription. Read the information carefully. Ask your
doctor or pharmacist any questions you may have regarding
this medication.
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
this drug 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.
PRECAUTIONS: Seasonale should not be used if
you have certain medical conditions. Before using this
medicine, 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 this medication, 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
this medication. If this bleeding continues for more
than 7 days or is heavy, contact your doctor. This drug
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 this drug. This drug must not be used during
pregnancy. If you become pregnant or think you may be
pregnant, inform your doctor immediately. This medication
passes into breast milk. This may affect milk production
and may have harmful effects on a nursing infant. Consult
your doctor before breast-feeding.
DRUG INTERACTIONS: This drug 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 this medication, 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 drugs 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. Drugs 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 drugs mentioned above
while also taking birth control pills. This product
can affect the results of certain lab tests (e.g., thyroid).
Inform all laboratory personnel that you use this drug.
Do not start or stop any medicine without doctor or
pharmacist approval.
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.
NOTES: Do not share this medication 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.
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.
STORAGE: Store Seasonale 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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