Ortho
Evra ®
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.