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.
ORAL CONTRACEPTIVES - BIRTH CONTROL PILLS
COMMON BRAND NAME(S): Brevicon, Demulen, Lo/Ovral, Loestrin, Modicon,
Nordette, Norinyl, Ortho-Novum, Ovcon, Ovral, Tri-Phasil
WARNING: Smoking cigarettes while using Ortho Tri-Cyclen increases
your chance of having heart problems. Do not smoke while using
Ortho Tri-Cyclen. 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: Ortho Tri-Cyclen 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 Ortho Tri-Cyclen does not protect you or your partner against
sexually transmitted diseases (e.g., HIV, gonorrhea).
HOW TO USE: Take Ortho Tri-Cyclen with food or immediately after
a meal to prevent stomach upset. Try to take Ortho Tri-Cyclen
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 Ortho Tri-Cyclen
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: Ortho Tri-Cyclen 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 Ortho Tri-Cyclen, 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.
Ortho Tri-Cyclen 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 Ortho Tri-Cyclen. 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.
