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: This medication is
used to prevent pregnancy or to regulate your menstrual cycle.
Certain brands of birth control pills may be used for treating
acne or as a "morning after" pill for emergency
contraception. Consult your doctor or pharmacist. Use of this
medication does not protect you or your partner against sexually
transmitted diseases (e.g., HIV, gonorrhea).
HOW TO USE: Take this medication
with food or immediately after a meal to prevent stomach upset.
Try to take this medication at the same time each day. This
may help you to remember to take it. Learn proper use of your
particular brand of medication. Follow your dosing schedule
carefully. Be sure to ask your doctor or pharmacist if you
have any questions. Use a supplemental form of birth control
during the first week of taking this medication since it takes
a while to be effective. Follow your doctor's directions exactly
if this drug is being used as a "morning after"
pill.
SIDE EFFECTS: This medication
may cause dizziness, headache, lightheadedness, stomach upset,
bloating, or nausea. If these effects persist or worsen, contact
your doctor. Notify your doctor if you experience: severe
depression, groin or calf pain, sudden severe headache, chest
pain, shortness of breath, lumps in the breast, weakness or
tingling in the arms or legs, yellowing of the eyes or skin.
If you notice other effects not listed above, contact your
doctor or pharmacist.
PRECAUTIONS: Before you take this medication, tell
your doctor your entire medical history, including family
medical history, especially: asthma, high blood pressure,
kidney disease, liver heart disease, stroke, history of jaundice
(yellowing skin/eyes) or high blood pressure during pregnancy,
excessive weight gain or fluid retention during menstrual
cycle, blood clots, heart attack, seizures, migraine headaches,
breast cancer, high blood level of cholesterol or lipids (fats),
diabetes, depression. Depending on strength, this drug may
cause a patchy, darkening of the skin on the face (melasma).
Higher strengths are more likely to cause 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. It may take a long
time for you to become pregnant after you stop taking birth
control pills. Consult your doctor. Do not smoke cigarettes.
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. Before having surgery, including dental surgery,
tell the doctor that you take birth control pills. 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: Tell your
doctor what prescription and nonprescription drugs you are
taking. Drugs that may decrease the effectiveness of the pill
include: griseofulvin, many antibiotics (e.g., penicillins,
macrolides, tetracyclines, sulfas, cephalosporins), chloramphenicol,
many seizure medications (e.g., phenytoin, barbiturates, primidone,
carbamazepine), dapsone, rifamycins (e.g., rifampin), modafinil,
nevirapine, nelfinavir, ritonavir, St John's wort, troglitazone.
Ask your doctor if you should use additional birth control
methods while taking any of the drugs mentioned above while
taking birth control pills. Also tell your doctor if you use:
thyroid hormone drugs, certain benzodiazepines (e.g., diazepam,
chlordiazepoxide), prednisone-like drugs, certain antidepressants
(e.g., tricyclics), beta-blockers (e.g., metoprolol), "blood
thinners" (anticoagulants such as warfarin), insulin.
This product can affect the results of certain lab tests (e.g.,
thyroid). Inform all laboratory personnel that you use this
drug. Birth control pills may significantly intensify the
effects of alcohol. Consult your doctor or pharmacist about
this. 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. Females may experience vaginal bleeding.
NOTES: Do not allow anyone
else to take this medication. 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.
A manufacturer's fact sheet about this drug should be dispensed
with each prescription. Read the information carefully. Ask
your doctor or pharmacist any questions you may have.
MISSED DOSE: Missed dose
advice differs and depends on the brand used, and the number
of doses missed. Refer to the product package information
for advice on missed doses. Ask your doctor or pharmacist
if you have any questions.
STORAGE: Store at room temperature
between 59 and 86 degrees F (between 15 and 30 degrees C)
away from moisture and sunlight. Do not store in the bathroom.
