GENERAL MEDICATION INFORMATION
Seasonale tablets will be available in the Seasonale
Extended-Cycle Tablet Dispenser containing 84 active pink
tablets and 7 white inactive tablets.
Seasonale tablets will be available in the Seasonale
Extended-Cycle Tablet Dispenser containing 84 active pink
tablets and 7 white inactive tablets.
To achieve maximum effectiveness, Seasonale must be taken
exactly as directed and at intervals not exceeding 24 hours.
Ideally, the tablets should be taken at the same time of the
day on each day of active treatment. The dosing regimen for
Seasonale is:
* Take 1 pink tablet daily for 84 consecutive days
* Follow with 7 days of white inactive tablets
* Begin taking Seasonale on the first Sunday after the onset
of menstruation. If menstruation begins on a Sunday, the first
pink tablet is taken that day
* Withdrawal bleeding should occur during the 7 days following
discontinuation of pink active tablets.
Serious as well as minor side effects have been reported
with the use of hormonal contraceptives. Serious risks include
blood clots, stroke, and heart attack. Cigarette smoking
increases the risk of serious cardiovascular side effects,
especially in women over 35 years. Oral contraceptives do not
protect against HIV infection (AIDS) and other sexually
transmitted diseases.
Use of Seasonale provides women with more hormonal exposure
on a yearly basis than conventional monthly oral
contraceptives containing similar strength synthetic estrogens
and progestins (an additional 9 weeks per year). While this
added exposure may pose an additional risk of thrombotic and
thromboembolic disease, studies to date with Seasonale have
not suggested an increased risk of these disorders. The
convenience of fewer menses (4 vs 13 per year) should be
weighed against the inconvenience of increased intermenstrual
bleeding/spotting.
PLEASE CONSULT WITH YOUR PHYSICIAN OR OTHER QUALIFIED
HEALTHCARE PROFESSIONAL BEFORE USING ANY PRODUCT DISCUSSED
HERE OR WITHIN ANY OF OUR OTHER WEB SITES.
Promptly see a qualified healthcare professional if you
have, or suspect that you have, a medical condition. This site
may contain information related to various health, medical and
fitness conditions and their treatment. However, we do not
offer individualized medical diagnosis or patient-specific
treatment advice. You should not use the information contained
herein for diagnosing or treating a medical condition or
disease. You should always consult a qualified healthcare
professional before initiating use of any medicine or other
treatment. Only a qualified healthcare professional can
determine if a product described here, or within any of our
other Web sites, would be appropriate for you to use. Your
qualified healthcare professional is in the best position to
discuss with you the risks and benefits of any treatment,
including prescription drugs, specific to your own medical
condition. Misspellings include seasonal and seasonel birth
control.
Q. Am I a good candidate for SEASONALE®?
A. If you are comfortable having your period just 4 times
a year and do not have any risk factors that prevent you from
taking birth control pills, you may be a good candidate for
SEASONALE®. Only you and your healthcare professional can make
the choice for you to start taking SEASONALE®.
Q. Is it okay to have only 4 pill periods a year?
A. Clinical studies to date have shown no increased health
risks with SEASONALE® compared with a 28-day birth control
pill. Periods experienced on birth control pills (or pill
periods) result only because hormones are stopped during the
last 7 days of your pill cycle. They do not result because of
a need to shed the built up uterine lining. Taking SEASONALE®
maintains the lining of the uterus and avoids buildup. Since
the lining is thin and does not need to be shed each month,
there is no need for a monthly pill period.
Q. Is it okay to switch from another birth control pill
to SEASONALE®?
A. Yes. If you are on another birth control pill, you may
switch to SEASONALE®. Only you and your healthcare
professional, however, can decide if switching to SEASONALE®
is right for you.
Q. Is SEASONALE® safe?
A. SEASONALE® is a combination of low-dose hormones (an
estrogen and a progestin). This combination has been used
safely and effectively in a common 28-day birth control pill
for more than 20 years. SEASONALE® has also been proven safe
and effective in a clinical trial.
Q. Who should not take SEASONALE®?
A. Birth control pills, including SEASONALE®, are not
recommended for women who have experienced heart attack or
stroke; blood clots in the legs, lungs, or eyes; cancer of the
breast or sex organs; or liver tumors. Birth control pills are
also not for women who have chest pain, an inherited tendency
to form blood clots, liver or adrenal disease, or who have
yellowing of the whites of the eyes or skin. Women who smoke,
especially those over 35, should not take birth control pills,
neither should women who are pregnant or have unexplained
vaginal bleeding. If you have diabetes, high cholesterol, high
blood pressure, or kidney disease, you should discuss these
conditions with your healthcare professional before taking any
birth control pill.
Q. Do birth control pills offer any health benefits in
addition to preventing pregnancy?
A. Birth control pills decrease blood flow during pill
periods. With a lighter flow, your body may lose less iron,
and anemia resulting from iron deficiency may then be less
likely to occur. Birth control pills may also reduce painful
periods. In addition, ovarian cysts, ectopic pregnancy, and
noncancerous lumps or cysts of the breasts may occur less
frequently. Birth control pills may reduce the risk of pelvic
inflammatory disease and may reduce the risk of developing
cancers of the ovaries and the lining of the uterus.
About SEASONALE®
Q. How is SEASONALE® different from birth control pills
I've taken in the past?
A. SEASONALE® is a birth control pill that extends your
cycle. With other pills, you will have your pill period once
every 28 days, or 13 times a year. SEASONALE® works like a
28-day birth control pill. Unlike a 28-day birth control pill,
SEASONALE® extends your cycle.
Q. How does SEASONALE® work?
A. Just like other birth control pills, SEASONALE®
prevents pregnancy primarily by stopping your ovaries from
releasing an egg. This is called suppression of ovulation.
SEASONALE® also works in 2 other possible ways to prevent
pregnancy that are similar to other birth control pills.
SEASONALE® thickens the mucus at the opening of your uterus,
to make it difficult for sperm to reach the egg. SEASONALE®
also changes the lining of your uterus (endometrium) to make
implantation less likely.
Q. How quickly will I be protected from pregnancy after
starting SEASONALE®?
A. You should use another method of birth control as a
backup (such as condoms or spermicide) for the first 7 days
after you start your first SEASONALE® Extended-Cycle Tablet
Dispenser.
Q. What is a pill period, and what is the difference
between a pill period and a menstrual period?
A. A pill period is a period that occurs while you are on
a birth control pill. It is different from the menstrual
period of a woman not on a birth control pill. A pill period
results when you stop taking the active pills that contain
hormones for the last 7 days of your pill cycle. A menstrual
period occurs when the lining of the uterus sheds because an
egg was not fertilized and did not implant in the uterus.
Q. If I only get my pill period once every 3 months,
what will it be like?
A. Your pill period on SEASONALE® should not last any
longer than what you would experience on a 28-day birth
control pill. And typically, pill periods tend to be lighter
than menstrual periods.
Q. Will SEASONALE® protect me from HIV infection and
other sexually transmitted diseases?
A. SEASONALE®, like all other birth control pills, does
not protect you from sexually transmitted diseases, including
HIV infection (AIDS). Using a latex condom when you have sex
can reduce the risk of contracting sexually transmitted
diseases.
Q. Is it necessary to take a break every so often from
SEASONALE®?
A. No. There is no medical reason to take a break from any
birth control pill, including SEASONALE®. In fact, taking a
break from your birth control pill may increase your risk of
unintended pregnancy.
What to Expect
Q. Without a monthly pill period, how will I know I'm
not pregnant while taking SEASONALE®?
A. Just like all birth control pills, when taken daily as
directed, SEASONALE® is effective in preventing pregnancy. If
you think you might be pregnant, especially if you have missed
pills, you should contact your healthcare professional.
Q. What if I don't get my pill period while I'm on
SEASONALE®?
A. Some women on birth control pills experience no
bleeding during their pill period. This is called amenorrhea
and can happen with many birth control pills. If you do not
get a pill period, contact your healthcare professional to
confirm you are not pregnant.
Q. Are there any risks associated with taking SEASONALE®?
A. Women who take SEASONALE® receive 9 more weeks of
estrogen and progestin every year than with a same-dose 28-day
birth control pill. While this may increase the chance of
serious health risks, current studies have not shown an
increased risk. Risks with SEASONALE® are similar to those
with all birth control pills. Most side effects are not
serious and those that are occur infrequently. The convenience
of fewer planned menses (4 per year instead of 13 per year)
should be weighed against the inconvenience of increased
intermenstrual bleeding and/or spotting. Serious risks, which
can be life threatening, include blood clots, stroke, and
heart attack. Cigarette smoking increases the risk of serious
side effects, especially if you are over 35. Women who use
birth control pills should not smoke. Some women should not
use birth control pills, including women who have blood clots,
certain cancers, a history of heart attack or stroke, as well
as those who are or may be pregnant. If you are a heavy smoker
and over age 35, you should not take SEASONALE®. Birth control
pills do not protect against HIV infection (AIDS) and other
sexually transmitted diseases.
With SEASONALE®, while you get the convenience of having
only 4 periods a year, you are also likely to have more
breakthrough bleeding and spotting between periods than with a
28-day birth control pill.
Q. Will I experience any side effects with SEASONALE®?
A. Side effects associated with SEASONALE® are similar to
those of other birth control pills. They may include bleeding
between pill periods, headache, nausea, and breast tenderness.
These side effects may decrease over time. In addition, in a
12-month clinical trial, there was no difference in weight
change between women taking SEASONALE® and women taking a
28-day birth control pill. A recent review of clinical studies
involving different birth control pills showed no proof that
birth control pills actually cause an increase in weight.
Q. Will I gain weight with SEASONALE®?
A. Change in weight with SEASONALE® is similar to what you
would experience on a 28-day birth control pill. In a clinical
trial, women taking SEASONALE® did not experience any
noticeable change in their weight. A recent review of clinical
studies involving different birth control pills
showed no proof that birth control pills actually cause an
increase in weight. Every woman is different. Change in weight
usually depends on eating and exercise habits.
Q. Will SEASONALE® help treat my acne?
A. SEASONALE® is not indicated for the treatment of acne.
Q. Will I have spotting or breakthrough bleeding with
SEASONALE®?
A. SEASONALE® offers you the convenience of having just 4
pill periods a year, but you are also likely to have more
spotting and breakthrough bleeding between pill periods than
with a 28-day birth control pill. Breakthrough bleeding may
vary from slight spotting to a flow much like a regular pill
period. These side effects are common during early cycles and
can happen as your body is adjusting to hormones. They should
decrease over time. Breakthrough bleeding usually does not
indicate any serious problems. Even if you have spotting or
breakthrough bleeding, keep taking your pills as scheduled. If
you have bleeding between pill periods for more than 7 days in
a row, contact your healthcare professional.
Q. What is breakthrough bleeding?
A. Breakthrough bleeding is vaginal bleeding, other than
during your menstrual or pill period, that requires sanitary
protection (a pad or tampon). It is common and often occurs as
your body is adjusting to any birth control pill, including
SEASONALE®. If you are concerned, contact your healthcare
professional.
Q. What is spotting?
A. Spotting is light vaginal bleeding, other than during
your menstrual or pill period, that does not require sanitary
protection (a pad or tampon). It is common and often occurs as
your body is adjusting to any birth control pill, including
SEASONALE®. If you are concerned, contact your healthcare
professional.
Q. When should I call my healthcare professional?
A. While taking SEASONALE®, call your healthcare
professional if you experience any symptom that causes you
concern. Call right away if you experience any of the
following: sharp chest pain, coughing up blood, sudden
shortness of breath, calf pain, sudden severe headache or
vomiting, dizziness or fainting, vision or speech
disturbances, numbness in an arm or leg, breast lumps, or
severe stomach pain. If you have missed pills and think you
may be pregnant, contact your healthcare professional.
Q. What if I want to get pregnant?
A. SEASONALE® is a reversible form of birth control, so
once you stop taking SEASONALE®, ovulation should start again.
There may be some delay in becoming pregnant after you stop
using any birth control pill, including SEASONALE®, especially
if you've had irregular menstrual cycles before using a birth
control pill. Birth control pills, including SEASONALE®, do
not cause infertility.
Taking SEASONALE®
Q. How do I start taking SEASONALE®?
A. Take your first pink active pill on the Sunday after
your period starts, even if you are still bleeding. If your
period begins on Sunday, start taking SEASONALE® that same
day. You should use another method of birth control as a
backup (such as condoms or spermicide) for the first 7 days of
your first Extended-Cycle Tablet Dispenser.
Q. How often should I take SEASONALE®?
A. You should take 1 pink active pill every day for 84
days in a row. Then take 1 white inactive pill every day for 7
days. You should take SEASONALE® at the same time every day to
most effectively prevent pregnancy. This may also reduce the
chance of spotting or breakthrough bleeding.
Q. Do I need to take SEASONALE® at the same time every
day?
A. Yes. It's important to take SEASONALE® at the same time
every day. This makes sure you are most effectively protected
from pregnancy. It may also help lessen the chance of spotting
and breakthrough bleeding.
Q. How can I remember to take SEASONALE® every day?
A. The best way to remember to take SEASONALE® every day
is to make it part of your daily routine. Pick a time that's
easy for you to remember, and take SEASONALE® at that time
every day. For example, take SEASONALE® with your breakfast
every morning, with your daily vitamins, or right after you
brush your teeth at night.
Q. What if I forget to take 1 pink pill?
A. If you miss 1 pink active pill, take it as soon as you
remember. Take the next pill at your regular time. This may
mean you will take 2 pills on the same day.
Q. What should I do if I miss 2, 3, or more pink pills?
A. If you miss 2 pink active pills, take 2 pills on the
day you remember. Take 2 pills the next day. Then take 1 pill
a day until you finish your pack. If you miss 3 or more pink
active pills, do not remove the missed pills from your pack.
You are not going to take them. Instead, keep taking 1 pill
every day until you have finished your pack. You may
experience bleeding during the week following your missed
pills. You must use another method of birth control (such as
condoms or spermicide) as a backup for 7 days after you miss 2
or more pink active pills.
Q. What if I forget to take a white pill?
A. Your white pills are inactive (placebo) and do not
contain any hormones. If you miss 1 or more white pills, skip
them and keep taking your white pills as scheduled. When you
start taking your white pills, it is a good time to refill
your SEASONALE® prescription to make sure you don't miss any
of your pink active pills.
Q. Are there any medications I shouldn't take while I'm
taking SEASONALE®?
A. It's important to tell your healthcare professional
about all the medications (prescription, over-the-counter,
vitamins, and herbal supplements) you are currently taking. As
with other birth control pills, if SEASONALE® is taken with
certain other medications, the way either medication works may
be changed.
Q. Will antibiotics reduce the effectiveness of the
pill?
A. Antibiotics may decrease the effectiveness of any birth
control pill, including SEASONALE®. You should use a backup
method of birth control (such as condoms or spermicide) while
you are taking antibiotics or any other drug that may reduce
the effectiveness of your birth control pill. Be sure to tell
your healthcare professional about all the medications
(prescription, over-the-counter, vitamins, and herbal
supplements) you are currently taking.
Q. Can I smoke while taking SEASONALE®?
A. As with other birth control pills, smoking while taking
SEASONALE® can increase your risk for serious side effects
such as heart attack, stroke, and blood clots. Women who use
SEASONALE®, or any birth control pill, should not smoke. If
you are a heavy smoker and over age 35, you should not take
SEASONALE®.
Q. Can I take SEASONALE® right after I have a baby?
A. If you are breast-feeding, you should not take any
combination birth control pill, including SEASONALE®, during
that time. If you decide NOT to breast-feed your baby, you can
safely begin taking SEASONALE® 4 weeks after you give birth.
SEASONALE® tablets are indicated for the prevention of
pregnancy.
Women who take SEASONALE® receive 9 more weeks of estrogen
and progestin every year than with a same-dose 28-day birth
control pill. While this may increase the chance of serious
health risks, current studies have not shown an increased
risk.
Risks with SEASONALE® are similar to those with all birth
control pills. Most side effects are not serious and those
that are occur infrequently. The convenience of fewer planned
menses (4 per year instead of 13 per year) should be weighed
against the inconvenience of increased intermenstrual bleeding
and/or spotting. Serious risks, which can be life threatening,
include blood clots, stroke, and heart attack. Cigarette
smoking increases the risk of serious side effects, especially
if you are over 35. Women who use birth control pills should
not smoke. Some women should not use birth control pills,
including women who have blood clots, certain cancers, a
history of heart attack or stroke, as well as those who are or
may be pregnant. If you are a heavy smoker and over age 35,
you should not take SEASONALE®. Birth control pills do not
protect against HIV infection (AIDS) and other sexually
transmitted diseases.
With SEASONALE®, while you get the convenience of having
only 4 periods a year, you are also likely to have more
breakthrough bleeding and spotting between periods than with a
28-day birth control pill.
PLEASE CONSULT WITH YOUR PHYSICIAN OR OTHER QUALIFIED
HEALTHCARE PROFESSIONAL BEFORE USING ANY PRODUCT DISCUSSED
HERE OR WITHIN ANY OF OUR OTHER WEB SITES. Promptly see a
qualified healthcare professional if you have, or suspect that
you have, a medical condition. This site may contain
information related to various health, medical, and fitness
conditions and their treatment. However, we do not offer
individualized medical diagnosis or patient-specific treatment
advice. You should not use the information contained herein
for diagnosing or treating a medical condition or disease. You
should always consult a qualified healthcare professional
before initiating use of any medicine or other treatment. Only
a qualified healthcare professional can determine if a product
described here, or within any of our other Web sites, would be
appropriate for you to use. Your qualified healthcare
professional is in the best position to discuss with you the
risks and benefits of any treatment, including prescription
drugs, specific to your own medical condition.
