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.
USES: This combination medication is used to prevent pregnancy.
This medication does not protect you or your partner against sexually
transmitted diseases (e.g., HIV, gonorrhea).
HOW TO USE: Take this medication by mouth once daily, preferably
after your evening meal or at bedtime, or as directed by your
doctor. Try to take this medication at the same time each day.
Doing so may help you to remember to take it. It is recommended
to start taking this medication on the first day of your period
(menstrual cycle). If it is not possible to start this treatment
at the start of your period, consult the product information and/or
your doctor or pharmacist for proper instructions. It is recommended
that you use an alternative method of birth control during the
first week of taking this medication until the full benefit of
this drug takes effect.
SIDE EFFECTS: Nausea, vomiting, headache, diarrhea, bleeding between
menstrual periods (spotting), weight gain, acne, stomach cramps,
rash, swelling or bloating, skin spots, breast tenderness, or
difficulty wearing contact lenses may occur. If any of these effects
persist or worsen, notify your doctor promptly. Tell your doctor
immediately if any of these serious side effects occur: dizziness,
flu-like symptoms (e.g., fever, cough, unusual weakness/fatigue,
sore throat, muscle aches), mental/mood changes, trouble sleeping,
hair loss, vaginal infections. Tell your doctor immediately if
any of these unlikely but serious side effects occur: severe headache,
pain in the lower legs or groin, trouble breathing, chest pain,
vision changes, severe stomach pain, one-sided weakness, yellowing
eyes or skin, lumps in the breast. If you notice any other effects
not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Tell your doctor your medical history, especially
of: heart problems, stroke, gallbladder disease, diabetes, high
cholesterol or triglyceride levels, high blood pressure, migraines,
seizures, irregular vaginal bleeding, depression, any allergies.
This medication is not recommended for use if you have the following
medical conditions: liver problems, kidney or adrenal gland problems,
history of blood clots (thrombophlebitis), blood vessel problems
(e.g., cerebral vascular disease, coronary artery disease), history
of certain cancers (especially endometrial or breast cancer),
heavy smoking (especially if older than 35 years of age). If you
are near-sighted or wear contact lenses, you may develop vision
problems or have trouble wearing your contact lenses. Contact
your eye doctor if this occurs. If you stop taking this birth
control medicine and want to become pregnant, it may take a longer
time than is usually seen with women not taking birth control
medicine. Consult your doctor. Do not smoke cigarettes. Birth
control pills combined with smoking cigarettes, especially in
women older than 35 years of age, puts you at a much higher risk
of developing serious health problems than with birth control
pills alone. Consult your doctor or pharmacist for more information.
This medication 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 and has had undesirable
effects on nursing infants. Consult your doctor before breast-
feeding.
DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription
medication you may use, especially: ACE inhibitors (e.g., enalapril,
lisinopril), angiotensin receptor blockers (e.g., losartan, valsartan),
potassium-sparing water pills (e.g., spironolactone, triamterene),
potassium supplements, heparin, NSAIDs (e.g., ibuprofen, naproxen),
atorvastatin, cyclosporine, corticosteroids (e.g., prednisone,
prednisolone) theophylline, ascorbic acid (vitamin C), acetaminophen,
morphine, temazepam, clofibric acid. Tell your doctor if you take
certain drugs that may decrease the effectiveness of this medication,
such as: antibiotics (e.g., tetracyclines, penicillins, cephalosporins),
griseofulvin, rifampin, certain anti-seizure drugs (e.g., carbamazepine,
phenobarbital, phenytoin), St John s wort, phenylbutazone, This
product can affect the result of certain lab tests (e.g., liver
function tests, blood tests). Make sure laboratory personnel and
your doctors know 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 or emergency room immediately. Symptoms of overdose
may include nausea and vomiting.
MISSED DOSE: If you miss a dose, use it as soon as you remember.
If it is near the time of the next dose, take the missed dose
and resume your usual dosing schedule; this may mean taking two
tablets in one day. If you miss two or more doses in a row, use
an alternate birth control method (e.g., condoms, spermicides)
for at least 7 days and consult the product information or your
doctor for a new dosing schedule.
STORAGE: Store at room temperature between 59 and 86 degrees F
(15 and 30 degrees C) away from light and moisture.
