The package insert of the medicine Evra

the package insert of the medicine Evra. Active principles Ethinyl estradiol and Norelgestromina.

what For?

Evra is indicated as a contraceptive for women.

Contraindications

When should I not use?

Evra should not be used in women who have the following conditions:
thrombophlebitis, thromboembolic disorders, past history of thrombophlebitis of the deep vein or thromboembolic disorders, vascular disease, cerebral or coronary artery, disease heart valve with complications, severe hypertension (persistent values ¡ý 160+/100+ mmhg), diabetes with vascular involvement,
migraine with aura, focal, diagnosis or suspected carcinoma of the breast,
carcinoma of the endometrium or diagnosis or suspicion of other neoplasia is estrogen-dependent, genital bleeding abnormal undiagnosed, cholestatic jaundice of pregnancy or jaundice with prior use of hormonal contraceptive, disease hepatocellular, acute or chronic, with abnormal liver function, adenoma or carcinoma liver, diagnosis or suspected pregnancy, hypersensitivity to any component of the product.

Dosage

How to use?

Method of administration
Evra should be applied on the skin full, clean, dry, in an area without hair
the buttocks, the abdomen, on the face upper, outer arm or upper part of the
back, in a place where there is no friction by tight clothes. Evra should not
be placed on the breasts or on the skin red, irritated or cut. Each
adhesive consecutive Evra should be applied in a different location from the
skin to avoid potential irritation, although it may remain in the same
anatomical region.

The patch should be pressed down firmly until the edges are well
adhered to.

To avoid any interference with the adhesive properties of Evra,
you should not apply makeup, creams, lotions, powders or other products
topics in the area where the adhesive has been or will soon be placed.

it is Recommended that the user check daily if the adhesive is adhered
appropriately.

Dosage
To achieve contraceptive effectiveness maximum, Evra must be used exactly as
as recommended. Only one adhesive must be used every time.

contraception with Evra begins on the first day of menstruation. The day
application of the first adhesive (“the Day 1″/”Start Day”) determines the days
subsequent to the exchange of the adhesive. The “Day Trading” will be the same day of
week, every week (Days 8, 15, 22 of cycle and “Day 1” of the next cycle).

A single adhesive is applied and kept in place for one week (7 days).

Each sticker removed must be immediately replaced by a sticker
again on the same day of the week (“Day Trading”), on the 8th Day and the 15th Day of the
cycle, at any time of the day.

In the fourth week that starts on the “Day 22” of the cycle, the patient will not use the
adhesive.

A new cycle of birth control begins on the day following the end of the week
without adhesive; the next adhesive Evra should be applied even if you do not
has been bleeding or if there is still bleeding.

Under no circumstances should there be the range greater than 7 days without the
adhesive between the treatment cycles. If this interval is greater than 7 days,
there may not be protection against pregnancy, and a nonhormonal contraceptive
should be used concurrently for 7 days. As for the contraceptives
combined oral, the risk of ovulation increases with each day
beyond the recommended period without contraceptive. If there is a relation
sexual during an interval without adhesive that was prolonged, the possibility
fertilization should be considered.

If the Cycle 1 is started after the “Day 1” of the menstrual cycle, a contraceptive
non-hormonal should be used concurrently only during the
the first 7 days of the first cycle of treatment.

If the edges of the adhesive Evra are raised or completely
cool, and remain so, there will be release insufficient
of medicine.

If there is detachment of Evra that even partial:
for less than 1 day (24 hours): the adhesive must be reapplied in the
the same location or replaced with a new patch immediately. There is no
need to use an additional contraceptive. The next adhesive must
be applied in “Day Trading” normal.

for more than a day (24 hours or more) or if the user does not know
when the adhesive is peeled or had the raised edges: the user
may not be protected against pregnancy. The current cycle of contraception
should be stopped and a new cycle should be started immediately
by applying a new patch of Evra. Now there will be a new “Day 1” and a
new “Day Trading”. A non hormonal contraceptive should be used concurrently
only during the first 7 days of the new cycle.

The patch should not be reapplied if you have lost your grip, you are
adhered to itself or another surface, has other material stuck in it or
if you have slipped or fallen previously. If the adhesive cannot be
reapplied, a new patch should be applied immediately. Material adhesives
supplement or tapes should not be used to keep the
adhesive in place.

If the “Days of Exchange” of the adhesive subsequent are delayed:
To the beginning of any cycle (Week 1/Day 1): the user may not be
protected against pregnancy. The first adhesive of the new cycle should be
applied so that the user remember, and there is now a new “Day of
Exchange” and a new “Day 1”. A non hormonal contraceptive should be used
concurrently during the first 7 days of the new cycle. If you have
occurred sexual intercourse during the interval prolonged without adhesive,
the possibility of fertilization should be considered.

In the half of the cycle (Week 2/ Day 8 or Week 3/ Day 15):
for one or two days (up to 48 hours): a new adhesive must be applied
immediately. The next adhesive must be applied in “Day Trading”
normal. There is no need to use an additional contraceptive method.

for more than two days (48 hours or more): the user may not be protected
against the pregnancy. The cycle of contraception should be stopped and a
the new cycle of 4 weeks should be started immediately, with the application
a new adhesive. Now there will be a new “Day 1” and a new “Day
Exchange”. A non hormonal contraceptive should be used concurrently
during the first 7 days of the new cycle.

at The end of the cycle (Week 4/Day 22):
if the adhesive is not removed at the beginning of Week 4 (“Day 22”), the removal of
should be made as soon as possible. The next cycle should be started
in the “Day Trading” normal, which is the day following the “Day 28”. There is no need
use additional contraceptive method.

Under no circumstances should there be interval greater than seven days
without the adhesive between the cycles of use of EVRA. If there are more than 7 days
without the adhesive, THE USER MAY NOT BE PROTECTED AGAINST THE
PREGNANCY and other additional method of contraception, such as condoms or
spermicide with the diaphragm, must be used for seven days. The same
as for the combined oral contraceptives, the risk of ovulation
increases with each day without adhesive beyond the recommended period. If there is
sexual intercourse during such a period that exceeds 7 days without the patch, the
the possibility of fertilization should be considered.

Change “Day Trading”
If the user want to change the “Day Trading”, the current cycle should be completed,
removing the third adhesive on the correct day. During the week without
adhesive, a new “Day Trading” should be selected by applying the first
the adhesive of the next cycle at the desired day. In any case there must be
more than 7 consecutive days without use of the adhesive.

Change of oral contraceptive for Evra
Treatment with Evra should be started on the first day of bleeding
for deprivation. If it does not occur bleeding within 5 days after the decision
the last tablet active (hormone-containing), the possibility of
pregnancy must be excluded before start of treatment with Evra. If the
therapy is initiated after the first day of bleeding for deprivation, a
non hormonal contraceptive should be used concurrently for 7 days.

If the interval after the last active tablet is greater than 7 days, the
the patient may have ovulado, and should be oriented to seek medical advice before
start of treatment with Evra. If you have sex during
this period of non-use of the adhesive, the possibility of fertilization should be
considered.

Use after delivery
For users who decide not to breastfeed, the therapy contraceptive with
Evra should not be started before 4 weeks after the birth.

Use after miscarriage
After the abortion occurred before the 20th week of gestation, Evra* can
be started immediately, not being necessary to adopt another contraceptive method
additional. Ovulation may occur within 10 days after the miscarriage,
without the use of a hormonal contraceptive.

After a miscarriage occurred from the 20th week of gestation, Evra should
be started on Day 21 after abortion or on the first day of the first
spontaneous menstruation, whichever comes first. The incidence of ovulation
on day 21 post-abortion (in the 20th week of pregnancy) is unknown.

Bleeding or “bleeding”
The treatment should be maintained if there is bleeding or
“bleeding” that occur during the use of Evra. This type of bleeding
usually disappears after the first few cycles but if it persists, another
cause in addition to the use of Evra should be considered. The incidence of bleeding
escape or “bleeding” is a clinical and statistically comparable
to that observed with the use of hormonal contraceptives combined oral
containing 20 to 40 mcg of ethinyl estradiol.

If there is no withdrawal bleeding (bleeding that should occur
during the week without any adhesive), the treatment should be continued in the
the next “Day Trading” programmed. If Evra was used correctly, the
absence of withdrawal bleeding is not necessarily an indication
of pregnancy. However, this possibility should be deleted if there are
absence of withdrawal bleeding in 2 consecutive cycles.

general Guidelines
Unlike oral contraceptives, the release of the dose via the transdermal
will not be affected if vomiting occurs or diarrhea.

If the use of the adhesive result in irritation uncomfortable, a new adhesive
can be applied in another place until the next “Day Trading”. Only a
adhesive must be used every time.

Side Effects

What are the evils that can cause me?

adverse reactions that have been associated with the use of hormonal contraceptives, and are, or may be associated with the use of Evra are described below.

severe adverse Reactions neoplasms benign and malignant: liver tumors benign (hepatocellular carcinoma, cancer of uterine cervix, breast cancer, prolactinomas.

nervous System: injuries to neuro eye.

Disorders cardiac: myocardial infarction.

Disorders vascular: hypertension, accidents, stroke, thrombosis of deep vein, arterial thromboembolism, pulmonary thromboembolism and other thromboembolism, migraine headaches.

Disorder hepatobiliary: cholestasis intrahepatic, cholelithiasis.

Disorder in general and at the site of application: headache severe reaction at the site of application.

Other adverse reactions disorders metabolism and nutrition: retention
liquids, change of body weight, reducing tolerance to glucose.

psychiatric Disorders: mood swings, depression, irritability, changes in libido.

Disorders of the nervous system: korea estrogen-induced.

Disorders of eye: change in the curvature of the cornea (change in tolerance to contact lenses).

Disorders vascular: slight elevation of blood pressure.

Disorders gastrointestinal: nausea, vomiting, abdominal cramps, abdominal distension.

Disorders of the skin and subcutaneous tissue: erythema nodosum, rash, pruritus, chloasma, melasma which may persist, erythema multiforme, acne, seborrhea, alopecia.

Disorders of the reproductive system and breasts: intermenstrual bleeding, amenorrhea, absence of withdrawal bleeding, change in the size of fibroids fibroids (leiomyomata), vaginal candidiasis, dysmenorrhea, sensitivity
the breast, galactorrhea, breast pain.

Disorders in general and at the site of application: reaction at application site, headache.

Warnings and Precautions

what should I know before using?

Weight above 90 kg
Studies conducted with Evra suggest that its effectiveness may be
reduced in women weighing over 90 kg compared with
women with lower weight. If your weight is above 90 kg, talk
with your doctor about which birth control method more suitable to
you.

Failure of menstruation, and the use of Evra before or during the beginning of the
pregnancy
It is possible that you may not menstruate regularly during the week without the
use of Evra*. If you used the adhesive correctly and does not menstruated
during a cycle, keep using typically the stickers in the next
cycle, but tell your doctor. If you have not used the Evra correctly and not
menstruated during a cycle or not menstruated in two cycles in a row you
you can be pregnant, and should consult the doctor. Stop the use of Evra if
you are pregnant.

Use during breastfeeding
If you are breastfeeding consult your doctor before starting the use of
Evra. Hormonal contraceptives are transferred to the child through
milk. Few side effects have been observed in children,
including yellowing of the skin (jaundice) and enlargement of the breasts.

in addition, combined hormonal contraceptives may reduce the amount
and the quality of breast milk. If possible, do not use contraceptives
combined hormonal as Evra during the breastfeeding period.

A barrier contraceptive is recommended during this period, a time
that breastfeeding protects only partially from a pregnancy and this
protection decreases significantly over the time of breastfeeding.

When you are not longer breastfeeding, the use of Evra can be considered.

laboratory Tests
If you undergo laboratory tests, tell your doctor because
some blood tests may be affected by hormonal contraceptives.

Overdose

what to do if someone use a larger amount than is recommended?

there have been reported serious side effects after accidental ingestion of large doses of oral contraceptives. the superdose can cause nausea and vomiting.

May occur vaginal bleeding. in the case of suspected superdose, the adhesive transdermal patches must be removed and administered symptomatic treatment.

Attention: this product is a new drug and although the spsquisas have shown efficacy and safety when properly indicated, can occur adverse reactions, unpredictable, not yet described or known. In the case of
suspected adverse reaction, the doctor should be notified.