Drug Name: ORTHO
TRI-CYCLEN
IMPORTANT ORTHO TRI-CYCLEN 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 ORTHO TRI-CYCLEN BRAND NAME(S):
Brevicon, Demulen, Lo/Ovral, Loestrin, Modicon,
Nordette, Norinyl, Ortho-Novum, Ovcon, Ovral,
Tri-Phasil
ORTHO TRI-CYCLEN 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).
ORTHO TRI-CYCLEN 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.
ORTHO TRI-CYCLEN 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 of Ortho tri-cyclen not
listed above, contact your doctor or pharmacist.
ORTHO TRI-CYCLEN 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 such
as Ortho tri-cyclen. Consult your doctor. Do not
smoke cigarettes. Birth-control pills like Ortho
tri-cyclen 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.
ORTHO TRI-CYCLEN 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 Ortho
tri-cyclen or any medicine without doctor or pharmacist
approval.
ORTHO TRI-CYCLEN OVERDOSE:
If Ortho tri-cyclen overdose is suspected, contact
your local poison control center or emergency
room immediately. Symptoms of Ortho tri-cyclen
overdose may include nausea and vomiting. Females
may experience vaginal bleeding.
ORTHO TRI-CYCLEN 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 Ortho tri-cyclen leaflet of information carefully.
Ask your doctor or pharmacist any questions you
may have.
MISSED ORTHO TRI-CYCLEN DOSE:
Missed Ortho tri-cyclen dose advice differs and
depends on the brand used, and the number of doses
missed. Refer to the Ortho tri-cyclen product
package information for advice on missed Ortho
tri-cyclen doses. Ask your doctor or pharmacist
if you have any questions about Ortho tri-cyclen.
ORTHO TRI-CYCLEN STORAGE:
Store Ortho tri-cyclen at room temperature between
59 and 86 degrees F (between 15 and 30 degrees
C) away from moisture and sunlight. Do not store
Ortho tri-cyclen in the bathroom.
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