[see zuh nel]
(levonorgestrel and ethinyl estradiol) Tablets
What is the most important
information I should know about SEASONALE?
Do not use SEASONALE if you
smoke cigarettes and are over 35 years old.
Smoking increases your risk of serious
cardiovascular side effects from hormonal birth control pills, including death
from heart attack, blood clots or stroke. This risk increases with age and the
number of cigarettes you smoke.
What is SEASONALE?
SEASONALE is a birth control
pill (oral contraceptive) used by women to prevent pregnancy.
How does SEASONALE work for
Your chance of getting pregnant
depends on how well you follow the directions for taking your birth control
pills. The better you follow the directions, the less chance you have of
Based on the results of
clinical studies, about 1 to 5 out of 100 women may get pregnant during the
first year they use SEASONALE.
The following chart shows the
chance of getting pregnant for women who use different methods of birth
control. Each box on the chart contains a list of birth control methods that
are similar in effectiveness. The most effective methods are at the top of the
chart. The box on the bottom of the chart shows the chance of getting pregnant
for women who do not use birth control and are trying to get pregnant.
Who should not take
Do not take SEASONALE if
- smoke and are over 35 years of
- had blood clots in your arms,
legs, lungs, or eyes
- had a problem with your blood
that makes it clot more than normal
- have certain heart valve
problems or irregular heart beat
- had a stroke
- had a heart attack
- have high blood pressure that
cannot be controlled by medicine
- have diabetes with kidney, eye, nerve, or blood vessel damage
- have certain kinds of severe
migraine headaches with aura, numbness, weakness
or changes in vision, or any migraine headaches if you are over 35 years of age
- have liver problems, including
- have any unexplained vaginal
- are pregnant
- had breast cancer or any cancer
that is sensitive to female hormones
If any of these conditions
happen while you are taking SEASONALE, stop taking SEASONALE right away and
talk to your healthcare provider. Use non-hormonal contraception when you stop
What should I tell my
healthcare provider before taking SEASONALE?
Tell your healthcare
provider if you:
- are pregnant or think you may
- are depressed now or have been
depressed in the past
- had yellowing of your skin or
eyes (jaundice) caused by pregnancy (cholestasis
- are breastfeeding or plan to breastfeed. SEASONALE may
decrease the amount of breast milk you make. A small amount of the hormones in
SEASONALE may pass into your breast milk. Talk to your healthcare provider
about the best birth control method for you while breastfeeding.
Tell your healthcare provider about all the medicines
you take, including prescription and over-the-counter medicines, vitamins
and herbal supplements.
SEASONALE may affect the way other medicines work, and
other medicines may affect how well SEASONALE works.
Know the medicines you take. Keep a list of them to show
your healthcare provider and pharmacist when you get a new medicine.
How should I take SEASONALE?
Read the Instructions for Use at the end of this
What are the possible serious side effects of
- Like pregnancy, SEASONALE may cause serious side
effects, including blood clots in your lungs, heart attack, or a stroke that
may lead to death. Some other examples of serious blood clots include blood
clots in the legs or eyes.
Serious blood clots can happen especially if you smoke, are obese, or are
older than 35 years of age. Serious blood clots are more likely to happen when
- first start taking birth control pills
- restart the same or different birth control pills after
not using them for a month or more
Call your healthcare provider or go to a hospital
emergency room right away if you have:
- leg pain that will not go away
- a sudden, severe headache unlike your usual headaches
- sudden severe shortness of breath
- weakness or numbness in your arm or leg
- sudden change in vision or blindness
- trouble speaking
- chest pain
Other serious side effects include:
- liver problems, including:
- rare liver tumors
- jaundice (cholestasis), especially if you previously had
cholestasis of pregnancy. Call your healthcare provider if you have yellowing
of your skin or eyes.
- high blood pressure. You should see your
healthcare provider for a yearly check of your blood pressure.
- gallbladder problems
- changes in the sugar and fat (cholesterol and
triglycerides) levels in your blood
- new or worsening headaches including migraine
- irregular or unusual vaginal bleeding and spotting
between your menstrual periods, especially during the first 3 months of taking
- possible cancer in your breast and cervix
- swelling of your skin especially around your mouth,
eyes, and in your throat (angioedema). Call your healthcare provider if you
have a swollen face, lips, mouth tongue or throat, which may lead to difficulty
swallowing or breathing. Your chance of having angioedema is higher is you have
a history of angioedema.
- dark patches of skin around your forehead, nose,
cheeks and around your mouth, especially during pregnancy (chloasma). Women
who tend to get chloasma should avoid spending a long time in sunlight, tanning
booths, and under sun lamps while taking SEASONALE. Use sunscreen if you have
to be in the sunlight.
What are the most common side effects of SEASONALE?
- headache (migraine)
- heavier or longer periods, pain with periods
- breast tenderness
- increase in weight
These are not all the possible side effects of SEASONALE.
For more information, ask your healthcare provider or pharmacist.
You may report side effects to the FDA at 1-800-FDA-1088.
What else should I know about taking SEASONALE?
- If you are scheduled for any lab tests, tell your healthcare
provider you are taking SEASONALE. Certain blood tests may be affected by
- SEASONALE does not protect against HIV infection (AIDS)
and other sexually transmitted infections.
How should I store SEASONALE?
- Store SEASONALE at room temperature between 68°F to 77°F
(20°C to 25°C).
- Protect from light.
General information about the safe and effective use
Medicines are sometimes prescribed for purposes other
than those listed in a Patient Information leaflet. Do not use SEASONALE for a
condition for which it was not prescribed. Do not give SEASONALE to other
people, even if they have the same symptoms that you have.
This Patient Information summarizes the most important
information about SEASONALE. You can ask your pharmacist or healthcare provider
for information about SEASONALE that is written for health professionals.
For more information, call 1-888-483-8279
Do birth control pills cause cancer?
Birth control pills do not seem to cause breast cancer.
However, if you have breast cancer now, or have had it in the past, do not use
birth control pills because some breast cancers are sensitive to hormones.
Women who use birth control pills may have a slightly
higher chance of getting cervical cancer. However, this may be due to other
reasons such as having more sexual partners.
What if I want to become pregnant?
You may stop taking the pill whenever you wish. Consider
a visit with your healthcare provider for a pre-pregnancy checkup before you
stop taking the pill.
What should I know about my period when taking
When you take SEASONALE, which has a 91-day extended
dosing cycle, you should have 4 scheduled periods a year (bleeding when you are
taking the 7 white pills). However, you will probably have more bleeding or
spotting between your scheduled periods than if you were using a birth control
pill with a 28-day dosing cycle. During the first SEASONALE 91-day treatment
cycle, about 1 in 3 women may have 20 or more days of unplanned bleeding or
spotting. This bleeding or spotting tends to decrease with time. Do not stop
taking SEASONALE because of this bleeding or spotting. If the spotting
continues for more than 7 days in a row or if the bleeding is heavy, call your
What are the ingredients in SEASONALE?
Active ingredients: Each pink pill contains
levonorgestrel and ethinyl estradiol.
Pink pills: anhydrous lactose NF, FD&C blue no. 1,
FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline
cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF,
and titanium dioxide USP.
White pills: anhydrous lactose NF, hydroxypropyl
methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF.
Instructions For Use
[see zuh nel] (levonorgestrel and ethinyl estradiol tablets)
Important Information about taking SEASONALE
- Take 1 pill every day at the same time. Take the pills in
the order directed on your pill dispenser.
- Do not skip your pills, even if you do not have sex
often. If you miss pills (including starting the pack late) you could get
pregnant. The more pills you miss, the more likely you are to get
- If you have trouble remembering to take SEASONALE, talk
to your healthcare provider.
- When you first start taking SEASONALE, spotting or light
bleeding in between your periods may occur. Contact your healthcare provider if
this does not go away after a few months.
- You may feel sick to your stomach (nauseous), especially
during the first few months of taking SEASONALE. If you feel sick to your
stomach, do not stop taking the pill. The problem will usually go away. If your
nausea does not go away, call your healthcare provider.
- Missing pills can also cause spotting or light bleeding,
even when you take the missed pills later. On the days you take 2 pills to make
up for missed pills (see What should I do if I miss any SEASONALE pills? below),
you could also feel a little sick to your stomach.
- It is not uncommon to miss a period. However, if you miss
a period and have not taken SEASONALE according to directions, or feel like you
may be pregnant, call your healthcare provider. If you have a positive
pregnancy test, you should stop taking SEASONALE.
- If you have vomiting or diarrhea within 3-4 hours of
taking a pink pill, take another pink pill as soon as possible. Continue taking
one pill a day until the 91-day course is finished.
- If you have vomiting or diarrhea for more than 1 day,
your birth control pills may not work as well. Use an additional birth control
method, like condoms or spermicide, until you check with your healthcare
- Stop taking SEASONALE at least 4 weeks before you have
major surgery and do not restart after the surgery without asking your
healthcare provider. Be sure to use other forms of contraception (like condoms
or spermicide) during this time period.
Before you start taking SEASONALE:
- Decide what time of day you want to take your pill. It is
important to take it at about the same time every day.
- Look at your Extended-Cycle Tablet Dispenser. Your Tablet
Dispenser consists of 3 trays with cards that hold 91 individually sealed pills
(a 13-week or 91-day cycle). The 91 pills consists of 84 pink and 7 white
pills. The cards in trays 1 and 2 each contain 28 pink pills (4 rows of 7
pills). See Figure A. The card in tray 3 contains 35 pills consisting of 28
pink pills (4 rows of 7 pills) and 7 white pills (1 row of 7 pills). See Figure
- Also find:
- Where on the first tray in the
pack to start taking pills (upper left corner) and
- In what order to take the pills
(follow the weeks)
- Be sure you have ready at all
times another kind of birth control (such as condoms or spermicide), to use as
a back-up in case you miss pills.
When should I start taking
If you start taking
SEASONALE and you have not used a hormonal birth control method before:
- Take the first pink pill on the
Sunday after your period starts, even if you are still bleeding. If your period
begins on Sunday, start the first pink pill that same day.
- Use another method of birth
control (such as condoms or spermicides) as a back-up method if you have sex
anytime from the Sunday you start your first pink pill until the next Sunday
(first 7 days).
If you start taking
SEASONALE and you are switching from another birth control pill:
- Start your new SEASONALE pack
on the same day that you would start the next pack of your previous birth
- Do not continue taking the
pills from your previous birth control pack.
If you start taking
SEASONALE and previously used a vaginal ring:
- Start using SEASONALE on the
day you would have reapplied the next ring.
If you start taking
SEASONALE and previously used a transdermal patch:
- Start using SEASONALE on the day you would have started a
new cycle (first patch application).
If you start taking SEASONALE and you are switching
from a progestin-only method such as an implant or injection:
- Start taking SEASONALE on the day of removal of your
implant, or on the day when you would have had your next injection.
If you start taking SEASONALE and you are switching
from an intrauterine device or system (IUD or IUS):
- Start taking SEASONALE on the day of removal of your IUD
- You do not need back-up contraception if your IUD or IUS
is removed on the first day (Day 1) of your period. If your IUD or IUS is
removed on any other day, use non-hormonal back-up contraception such as
condoms or spermicide for the first 7 days that you take SEASONALE.
Keep a calendar to track your period: If this is the
first time you are taking birth control pills, read, “When should I
start taking SEASONALE?” above. Follow these instructions for a Sunday
Instructions for using your SEASONALE Extended-Cycle
Tablet Dispenser: Â
- Take pill 1 on the Sunday after your period starts.
To remove your pill from the dispenser, press the pill through the hole in the
bottom of the dispenser. See Figure C.
- If your period starts on a
Sunday, take pill “1” that same day.
- Take 1 pill at about the same time
every day until you have taken the last pill in the tablet dispenser.
- After taking the last white pill on Day 91 from the pill
dispenser, start taking the first pink pill from a new Extended-Cycle Tablet
Dispenser on the very next day (this should be a Sunday). Take the first pill
in the new pack whether or not you are having your period.
- Use non-hormonal back-up contraception such as condoms or
spermicide for the first 7 days of the first cycle that you take SEASONALE.
What should I do if I miss any SEASONALE pills?
If you miss 1 pink pill, follow these steps:
- Take it as soon as you remember. Take the next pill at
your regular time. This means you may take 2 pills in 1 day.
- Then continue taking 1 pill every day until you finish
- You do not need to use a back-up birth control method if
you have sex.
If you miss 2 pink pills in a row, follow these steps:
- Take 2 pills on the day you remember and 2 pills the next
- Then continue to take 1 pill every day until you finish
- You could become pregnant if you have sex in the 7 days
after you miss two pills. You must use a non-hormonal birth control method
(such as a condom or spermicide) as a back-up if you have sex during the first 7
days after you restart your pills.
If you miss 3 or more pink pills in a row, follow
- Do not take the missed pills. Keep taking 1 pill
every day until you have completed all of the remaining pills in the pack. For
example, if you start taking the pill on Thursday, take the pill under
“Thursday” and do not take the missed pills. You may have bleeding during the
week following the missed pills.
- You could become pregnant if you have sex during the days
of missed pills or during the first 7 days after restarting your pills. You must
use a non-hormonal birth control method (such as a condom or spermicide) as a
back-up when you miss pills and for the first 7 days after you restart your
pills. If you do not have your period when you are taking the white pills, call
your healthcare provider because you may be pregnant.
If you have any questions or are unsure about the
information in this leaflet, call your healthcare provider.