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ORTHO EVRA
ORTHO EVRA ONLINE
Before Using This Medicine
In deciding to use a medicine, the risks of using the medicine
must be weighed against the good it will do. If you are using the
skin patch contraceptive for contraception you should understand
how their benefits and risks compare to those of other birth
control methods. This is a decision you, your sexual partner, and
your doctor will make. For norelgestromin/ethinyl estradiol, the
following should be considered:
Allergies—Tell your doctor if you have ever
had any unusual or allergic reaction to estrogens or progestins.
Tell your doctor if you have ever had any unusual or reaction to
any other hormones. Also tell your doctor and pharmacist if you
are allergic to any other substances, such as foods,
preservatives, or dyes.
Pregnancy—Norelgestromin/ethinyl estradiol
is not recommended during pregnancy and should be discontinued if
you become pregnant or think you are pregnant. In rare cases when
hormonal contraceptives have been taken by mistake early in
pregnancy, problems to the fetus have not occurred. Be sure you
have discussed this with your doctor.
Breast-feeding— It is not known whether
norelgestromin/ethinyl estradiol passes into breast milk. Although
most medicines pass into breast milk in small amounts, many of
them may be used safely while breast-feeding. Mothers who are
taking this medicine and who wish to breast-feed should discuss
this with their doctor.
Children—Studies on this medicine have been
done only in adult patients, and there is no specific information
comparing use of norelgestromin/ethinyl estradiol in children with
use in other age groups. This medicine should not be used before
the start of menstruation.
Teenagers—This medicine may be used for birth
control in teenage females and has not been shown to cause
different side effects or problems than it does in adults. Some
teenagers may need extra information on the importance of taking
norelgestromin/ethinyl estradiol exactly as prescribed.
Older adults—Many medicines have not been
studied specifically in older people. Therefore, it may not be
known whether they work exactly the same way they do in younger
adults or if they cause different side effects or problems in
older people. There is no specific information comparing use of
norelgestromin/ethinyl estradiol in the elderly with use in other
age groups.
Other medicines—Although certain medicines
should not be used together at all, in other cases two different
medicines may be used together even if an interaction might occur.
In these cases, your doctor may want to change the dose, or other
precautions may be necessary. When you are taking norelgestromin/ethinyl
estradiol, it is especially important that your doctor and
pharmacist know if you are taking any of the following:
 | Cyclosporine (e.g., Sandimmune) or
| Prednisolone (e.g., Prelone) or
| Theophylline (e.g., Slo-Phyllin, Theolair-SR)—The amounts
of these medicines in your blood may be too high when taken
with norelgestromin/ethinyl estradiol. |
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| Ampicillin or
| Barbiturates (e.g., Amytal, Nembutal) or
| Carbamazepine (e.g., Tegretol) or
| Felbamate (e.g., Felbatol) or
| Griseofulvin (e.g., Fulvicin-P/G) or
| HIV medicines (e.g., Agnerase, Crixivan, Norvir) or
| Oxcarbazepine (e.g., Trileptal) or
| Phenylbutazone (e.g., Butazolidin) or
| Phenytoin (e.g., Dilantin) or
| Rifampin (Rifadin) or
| Topiramate (e.g., Topamax)—Use of these medicines with
norelgestromin/ethinyl estradiol may cause your contraceptive
to be less effective. |
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| Hypericum perforatum (e.g., St. John's Wort)—Use of this
herbal medicine with norelgestromin/ethinyl estradiol may
cause your contraceptive to be less effective or cause vaginal
bleeding during your cycle. |
| Smoking, tobacco—Smoking may increase the chance of
causing serious blood clots, vein, or heart problems. |
Proper Use of This Medicine
To make using hormonal contraceptives as safe and reliable as
possible, you should understand how and when to use them and what
effects may be expected.
A paper with information for the patient will be given to
you with your filled prescription, and will provide many details
concerning the use of hormonal contraceptives. Read this paper
carefully and ask your health care professional if you need
additional information or explanation.
When you begin using norelgestromin and ethinyl estradiol, your
body will require at least 7 days to adjust before a pregnancy
will be prevented. Use a second form of contraception, such as a
condom, spermicide, or diaphragm, for the first 7 days of your
first cycle.
Keep each patch in the package until you are ready to use it.
Apply the patch to clean, dry skin on the abdomen, upper body, the
upper outside part of the arm, or the buttocks. Avoid touching the
sticky surface of the patch. Make sure there is no lotion, powder,
cream, or make-up on the skin. Apply the patch and then press it
with the palm of your hand for 10 seconds to make sure it sticks.
Change the location of the patch each time you apply a new one. Do
not apply a patch to skin that is injured, broken, or cut. Do not
apply a patch to your breasts. Check the patch every day to make
sure it is in place.
If the patch comes off partly or all the way, try to apply it
again or apply a new patch. If it was loose less than 24 hours, no
other form of birth control is needed. If the patch has peeled
away for more than 24 hours, apply a new patch and start a new
cycle. A second form of birth control should be used.
If the patch is not sticky or has stuck to material or itself,
remove it and apply a new patch. Do not hold the patch in place
with tape or wraps.
If you are switching from a contraceptive pill to using the
patch, start the patch on the first day of your period. If you do
not start your period after 5 days, you see your health care
professional for a pregnancy test. If you start the patch later
than the first day of your period, use a second method of birth
control with the patch for the first 7 days.
If you have had a baby and are not breast-feeding, you should
wait 4 weeks before you start this medicine. If you have not had a
period after having your baby, you should make sure you are not
pregnant before starting this medicine.
If you have a miscarriage or an abortion in the first trimester
of your pregnancy, you may start norelgestromin/ethinyl estradiol
right away. You do not need a second form of birth control. If you
start this medicine 5 days or more after the miscarriage or
abortion, you should use a second form of birth control with the
patch for the first 7 days. If you have a miscarriage or abortion
after the first trimester, you should wait 4 weeks before starting
this medicine
If you have bleeding with the patch in place, continue to use
the patches as usual. If the bleeding continues for 2–3 cycles,
call your health care professional. If you do not have your period
during the time the patch is off stay on your regular schedule and
call your health care professional.
If the patch is uncomfortable or causing irritation, change to
a new patch in a new location. Change the patch again on your
regular schedule. Do not use more than one patch at a time.
When you remove a patch, carefully fold it in half so that it
sticks to itself and throw it away. There will still be some
hormones on the patch. Do not touch the inside of the patch.
Dosing—
Your health care professional may begin your patch on the first
day of your menstrual period (called Day-1 start) or on Sunday
(called Sunday start). When you begin on a certain day it is
important that you follow that schedule, even if you forget to
change a patch. Do not change your schedule on your own .
If the schedule that you have been put on is not convenient, check
with your health care professional about changing schedules.
| For transdermal dosage form (skin patch):
| For contraception (to prevent pregnancy):
| Adults—Apply 1 patch to the skin and keep it in
place for 1 week. Apply a new patch at the beginning
of week 2 and again at week 3. Always change the patch
on the same day of the week. Do not use a patch during
week 4. This is when you will have your period. Start
a new patch 7 days after the last patch was removed.
| Children—Use and dose must be determined by your
doctor. |
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Missed dose—
Follow your doctor's orders or the directions on the label
if you forget to change your patch. The following information
includes only some of the ways to handle this. Your health care
professional may want you to stop taking the medicine and use
other birth control methods for the rest of the month until you
have your menstrual period. Then your health care professional can
tell you how to begin taking your medicine again.
| If you forget to apply your patch during the 1st week, apply
it as soon as possible and start a new cycle. Use a second
form of birth control for the first week of the new cycle. You
will now have a new patch start day.
| If you forget to change your patch in the 2nd or 3rd week
for one or two days, change it as soon as you remember. No
other form of birth control is needed.
| If you forget to change your patch in the 2nd or 3rd week
for more than two days, change to a new patch and start a new
cycle. Use a second form of birth control for the first week
of the new cycle
| If you forget to remove your patch at the end of the 3rd
week, remove it as soon as possible and then start a new patch
on your regular start day. You should never have the patch
off for more than 7 days in a row. |
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Storage—
To store this medicine:
| Keep out of the reach of children.
| Store patches in their protective pouches.
| Do not refrigerate.
| Do not freeze.
| Do not keep outdated medicine or medicine no longer needed.
Ask your health care professional how you should dispose of
any medicine you do not use. Be sure that any discarded
medicine is out of the reach of children. |
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Precautions While Using This Medicine
It is very important that your doctor check your progress
at regular visits to make sure this medicine does not cause
unwanted effects. These visits will usually be every 6 to 12
months, but some doctors require them more often.
Tell the medical doctor or dentist in charge that you are
taking this medicine before any kind of surgery (including dental
surgery) or emergency treatment. Your doctor will decide
whether you should continue taking this medicine.
Norelgestromin/ethinyl estradiol may not work as well for you
if you weigh more than 198 pounds. Talk to your health care
professional about the kind of birth control that is best for you.
Vaginal bleeding of various amounts may occur between your
regular menstrual periods during the first 3 months of use. This
is sometimes called spotting when slight, or breakthrough bleeding
when heavier. If this should occur:
| Continue on your regular dosing schedule.
| The bleeding usually stops within 1 week.
| Check with your doctor if the bleeding continues for more
than 1 week.
| After you have been taking hormonal contraceptives on
schedule and for more than 3 months and bleeding continues,
check with your doctor. |
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Missed menstrual periods may occur:
| If you have not used the patch exactly as scheduled.
Pregnancy must be considered as a possibility.
| If the medicine is not the right strength or type for your
needs. |
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Check with your health care professional if you miss any
menstrual periods so that the cause may be determined.
If you suspect that you may have become pregnant, stop
taking this medicine immediately and check with your doctor.
Check with your doctor before refilling an old prescription,
especially after a pregnancy. You will need another physical
examination and your doctor may change your prescription.
Side Effects of This Medicine
Side Effects of This Medicine
Healthy women who do not smoke cigarettes have almost no chance
of having a severe side effect from using hormonal contraceptives.
For most women, more problems occur because of pregnancy than will
occur from using hormonal contraceptives. But for some women who
have special health problems, hormonal contraceptives can cause
some unwanted effects. Some of these unwanted effects include
heart disease, heart attack, benign (not cancerous) liver tumors,
liver cancer, or blood clots or related problems, such as a
stroke. Although these effects are very rare, they can be serious
enough to cause death. You may want to discuss these effects with
your doctor.
Other health problems that may be affected by using hormonal
contraceptives are high blood pressure, high cholesterol, diabetes
and being overweight.
Smoking cigarettes during the use of hormonal
contraceptives has been found to greatly increase the chances of
these serious side effects occurring. This risk increases with
heavy smoking (15 or more cigarettes a day) or if you are over 35
years old. To reduce the risk of serious side effects, do not
smoke cigarettes while you are taking hormonal contraceptives.
Along with its needed effects, a medicine may cause some
unwanted effects. Although not all of these side effects may
occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the
following side effects occur:
Use with caution around small children. The contraceptive patch
may be a choking hazard if swallowed by a child.
| More common
| Body aches or pain |
| chills; cough; difficulty breathing;
ear congestion; fever; headache; loss of
voice; nasal congestion; runny nose;
sneezing; sore throat; unusual tiredness or
weakness |
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| Symptoms of Overdose
Get emergency help immediately if any of the following
symptoms of overdose occur
| Nausea; vomiting; unusual vaginal bleeding
in women |
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| Frequency unknown
| Anxiety; changes in skin color; chest pain
or discomfort; confusion ; dark urine;
diarrhea; eye pain; dizziness; fainting;
inability to speak; itching; lack or loss of
appetite; light-colored stools;
lightheadedness; nausea; nervousness;
numbness in hands; pain in abdomen; pain in
chest, groin, or legs, especially the calves; pain,
tenderness, or swelling of foot or leg; pain or
discomfort in arms, jaw, back or neck; pounding in
the ears; rash; seizures ; slow or fast
heartbeat; slurred speech; sudden headache;
sudden loss of coordination; sudden, severe weakness
or numbness in arm or leg on one side of the body;
sudden, unexplained shortness of breath; sweating ;
swelling, pain, or tenderness in upper abdominal area;
temporary blindness; unpleasant breath odor;
vision changes; vomiting of blood; yellow eyes
or skin |
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Other side effects may occur that usually do not need medical
attention. These side effects may go away during treatment as your
body adjusts to the medicine. However, check with your doctor if
any of the following side effects continue or are bothersome.
| More Common
| Burning, itching, or redness of skin; menstrual
cramps; pain, soreness, swelling, or discharge from
the breast or breasts; swelling or soreness at patch
site |
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Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your doctor.
| Frequency unknown
| Abdominal cramps or bloating; absent, missed, or
irregular menstrual periods; bloody vaginal
discharge; brown, blotchy spots on exposed skin;
change in amount of vaginal discharge; change in
menstrual flow; decreased amount of breast milk;
discouragement; dry mouth; feeling sad or
empty; increased hunger or thirst; increase or
decrease in weight; increased urination;
irritability; itching of the vagina or outside
genitals ; light vaginal bleeding between periods
and after sexual intercourse; loss of interest or
pleasure ; pain during sexual intercourse;
stopping of menstrual bleeding; swelling;
thick, white curd-like vaginal discharge without odor or
with mild odor; trouble concentrating; trouble
sleeping; unusual vaginal bleeding; vomiting |
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