ORTHO
TRI-CYCLEN
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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 ORTHO TRI-CYCLEN.
ORAL CONTRACEPTIVES
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 TAKE ORTHO TRI-CYCLEN:
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 ORTHO TRI-CYCLEN
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, pain the groin or calf, 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, ORTHO
TRI-CYCLEN 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. ORTHO
TRI-CYCLEN 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 ORTHO TRI-CYCLEN. 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 ORTHO TRI-CYCLEN
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.
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