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 (women greater
than 35 years of age) and with frequent smoking (15 cigarettes
per day or greater).
USES: This combination hormone
patch is used to prevent pregnancy. It contains hormones similar
to those in birth control pills. The hormones release from
the patch slowly over time. Using this medication patch does
not protect you or your partner against HIV or other sexually
transmitted diseases (STDs).
HOW TO USE: Review the Patient
Information Leaflet. Follow all instructions on how to use
this medication patch and also the best time (during your
menstrual cycle) to start using the patch. If any of the information
is unclear, consult your doctor or pharmacist. Open the patch
container and apply one patch to an area of clean, dry skin
on the buttock, abdomen, upper outer arm, or upper body (torso)
exactly as directed by your doctor. The patch is worn for
7 days. Do not apply the patch to the breast(s), the area
around the breast(s); to red, cut, or irritated skin; or over
other topical products (e.g., make-up, creams, lotions, powders).
After 7 days, remove the old patch and apply a new patch.
Repeat this weekly cycle for 3 weeks (3 patches equal 1 cycle).
After your third patch is removed, you will have one week
without using the patch. Your menstrual cycle (period) usually
should start during the week when you do not use the patch.
If your menstrual cycle (period) does not begin during this
week, consult your doctor. After your 4th week, begin a new
patch cycle, even if you still are experiencing some bleeding
(still having your period). Do not go longer than 7 days without
a patch. Doing so may make this medication less effective.
If the medication patch accidentally comes off, is removed,
or if it becomes detached, apply a new patch. If it is detached
or comes off for longer than 24 hours, or if you are not sure
how long the patch has been detached or removed, use additional
forms of birth control (e.g., condoms, spermicide) for at
least 7 days and continue with the same cycle. After removing
each patch, fold the patch in half so it sticks to itself
and discard it in a trash container. Do not discard or flush
the patches down a toilet. If you weigh more than 198 pounds
(90 kg), this patch may not work as well for you. Make sure
your doctor knows your current weight and ask about which
form of birth control is best for you. If any of this information
is unclear, consult the Patient Information Leaflet or your
doctor or pharmacist.
SIDE EFFECTS: Nausea, vomiting, headache, redness or
itching at the patch application site, dizziness, breast tenderness,
vaginal discomfort/irritation, or stomach cramping/bloating
may occur. If any of these effects persist or worsen, notify
your doctor. Promptly tell your doctor if any of these side
effects occur: dark patches on the skin (melasma), change
in appetite, weight changes (gain or loss), problem wearing
contact lenses. Tell your doctor immediately if any of these
serious side effects occur: unusual vaginal discharge, changes
in vaginal bleeding (e.g., spotting, breakthrough bleeding,
prolonged or complete stoppage of bleeding), swelling, severe
headache, mental/mood changes. Tell your doctor immediately
if any of these unlikely but serious side effects occur: pain
in the groin or lower legs, trouble breathing, rash, chest
pain, stomach pain, vision or eye problems. Tell your doctor
immediately if any of these highly unlikely but very serious
side effects occur: yellowing eyes or skin, dark urine, one-sided
weakness, numbness in the arms/legs, lumps in the breast.
If you notice other effects not listed above, contact your
doctor or pharmacist.
PRECAUTIONS: This medication
is not recommended for use if you have the following medical
conditions: blood circulation problems (e.g., history of blood
clots in the legs or groin), history of heart disease or stroke,
severe high blood pressure, diabetes (especially affecting
the circulation), severe headaches, recent major surgery,
long periods of sitting or lying down (e.g., immobility such
as being bedridden), liver problems, history of yellowing
eyes and skin (jaundice) during pregnancy or while using birth
control pills, cancer (especially endometrial or breast cancer),
undiagnosed abnormal vaginal bleeding, currently pregnant,
heavy tobacco use (if 35 years old or greater). Tell your
doctor your medical history, especially of: high cholesterol
or triglyceride (fat) levels, depression, high blood pressure,
gallbladder problems, thyroid problems, any allergies. Do
not smoke cigarettes. Hormonal birth control (e.g., pills,
injections, devices) products combined with smoking cigarettes
significantly increase your risk for strokes, blood clots,
high blood pressure, and heart attacks; especially in women
older than 35 years of age. Ask your doctor or pharmacist
or consult the patient information leaflet that comes with
this product for more details. Before having surgery, including
dental surgery, tell the doctor(s) that you are using this
product. The drugs in this patch may cause blotchy, dark areas
on your skin (melasma) and sunlight may intensify this effect.
If this occurs, avoid prolonged sun exposure, use a sunscreen,
and wear protective clothing when outdoors. If you are near-sighted
or wear contact lenses, you may develop vision problems or
may have problems wearing your contact lenses. Contact your
eye doctor if these problems occur. This medication device
must not be used in pregnancy. If you become pregnant or think
you may be pregnant, inform your doctor immediately. The medication
from this patch passes into breast milk and may have undesirable
effects on the nursing infant. Consult your doctor before
breast-feeding.
DRUG INTERACTIONS: Tell your
doctor of all prescription and nonprescription medication
you may use, especially: anti-seizure medicine (e.g., carbamazepine,
felbamate, phenobarbital, phenytoin, topiramate), certain
antibiotics (e.g., ampicillin, erythromycin), HIV protease
inhibitors (e.g., indinavir, ritonavir), phenylbutazone, griseofulvin,
atorvastatin, azole antifungals (e.g., itraconazole, ketoconazole),
rifampin, St John's wort, cyclosporine, temazepam, prednisolone,
morphine, theophylline, ascorbic acid (vitamin C), acetaminophen,
aspirin, clofibric acid, modafinil, troglitazone. This product
can affect the results of certain lab tests (e.g., blood tests
such as glucose, clotting factors, or thyroid). Make sure
laboratory personnel and your doctors know you use this product.
Do not start or stop any medicine without doctor or pharmacist
approval.
OVERDOSE: Overdose with this
product is highly unlikely. If overdose is suspected, remove
the patch (or patches) and contact your local poison control
center or emergency room immediately. This medicine device
may be harmful if swallowed. Symptoms of overdose may include:
severe nausea, vomiting, unusual vaginal bleeding or irregular
menstrual periods.
NOTES: Do not share this
medication patch with others. Keep all appointments with your
doctor and when having laboratory tests performed. You should
have a complete physical exam including blood pressure, breast
exams, pelvic exams, and PAP smears at least once a year.
