OVRAL 21 & OVRAL 28 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 Ovral 21.
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 Ovral 21
increases your chance of having heart problems. Do
not smoke while using Ovral 21. 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: Ovral 21 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 Ovral 21
does not protect you or your partner against sexually
transmitted diseases (e.g., HIV, gonorrhea).
HOW TO USE: Take Ovral 21 with food or immediately
after a meal to prevent stomach upset. Try to take
Ovral 21 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
Ovral 21 since it takes a while to be effective. Follow
your doctor's directions exactly if Ovral 21 is being
used as a "morning after" pill.
SIDE EFFECTS: Ovral 21 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 Ovral 21, 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, Ovral 21 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.
Ovral 21 must not be used during pregnancy. If you
become pregnant or think you may be pregnant, inform
your doctor immediately. Ovral 21 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 Ovral 21. 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 Ovral 21.
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 Ovral 21 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.
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Ovral 21 & Ovral 28 Drug Information
