(levonorgestrel and ethinyl estradiol tablets)
What is the most important information I s hould know
Do not use QUASENSE 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 QUASENSE?
QUASENSE is a birth control pill (oral contraceptive)
used by women to prevent pregnancy.
How does QUASENSE work for contraception?
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 getting pregnant.
Based on the results of clinical studies, about 1 to 5
out of 100 women may get pregnant during the first year they use QUASENSE.
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 QUASENSE?
Do not take QUASENSE if you:
- smoke and are over 35 years of age
- had blood clots in your arms, legs, lungs, or eyes
- had a problem with your blood that makes it clot more
- 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
- have diabetes with kidney, eye, nerve, or blood vessel
- 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 liver tumors
- take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir,
with or without dasabuvir. This may increase levels of the liver enzyme
“alanine aminotransferase” (ALT) in the blood.
- have any unexplained vaginal bleeding
- are pregnant
- had breast cancer or any cancer that is sensitive to
If any of these conditions happen while you are taking
QUASENSE, stop taking QUASENSE right away and talk to your healthcare provider.
Use non-hormonal contraception when you s top taking QUASENSE.
What should I tell my healthcare provider before
Tell your healthcare provider if you:
- are pregnant or think you may be pregnant
- are depressed now or have been depressed in the past
- had yellowing of your skin or eyes (jaundice) caused by
pregnancy (cholestasis of pregnancy)
- are breastfeeding or plan to breastfeed. QUASENSE may
decrease the amount of breast milk you make. A small amount of the hormones in
QUASENSE 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.
QUASENSE may affect the way other medicines work, and
other medicines may affect how well QUASENSE 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 QUASENSE?
Read the Instructions for Use at the end of this
What are the possible serious side effects of
- Like pregnancy, QUASENSE 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 you:
- 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
- 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 s potting
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 QUASENSE. Use sunscreen if you have to
be in the sunlight.
What are the most common side effects of QUASENSE?
- headache (migraine)
- heavier or longer periods, pain with
- breast tenderness
- increase in weight
These are not all the possible side effects of QUASENSE.
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 QUASENSE?
- If you are scheduled for any lab tests, tell your
healthcare provider you are taking QUASENSE. Certain blood tests may be
affected by QUASENSE.
- QUASENSE does not protect against HIV infection (AIDS)
and other sexually transmitted infections.
How should I store QUASENSE?
- Store QUASENSE at room temperature between 68° to 77°F
(20° 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 QUASENSE for a
condition for which it was not prescribed. Do not give QUASENSE to other
people, even if they have the same symptoms that you have.
This Patient Information summarizes the most important
information about QUASENSE. You can ask your pharmacist or healthcare provider
for information about QUASENSE that is written for health professionals.
For more information, call 1-800-272-5525.
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 QUASENSE, which has a 91-day extended
dosing cycle, you should have 4 scheduled periods a year (bleeding when you are
taking the 7 peach 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 QUASENSE 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 QUASENSE 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 healthcare
What are the ingredients in QUASENSE?
Active ingredients : Each white pill contains
levonorgestrel and ethinyl estradiol.
Inactive ingredients :
White pills: croscarmellose sodium NF, lactose regular
NF, magnesium stearate NF, microcrystalline cellulose NF, and povidone USP.
Peach pills: anhydrous lactose NF, FD&C yellow #6
Lake, lactose monohydrate NF, magnesium stearate NF, and microcrystalline
Instructions For Use
(levonorgestrel and ethinyl estradiol tablets )
Important Information about taking QUASENSE
- 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 pregnant.
- If you have trouble remembering to take QUASENSE, talk to
your healthcare provider.
- When you first start taking QUASENSE, 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 QUASENSE. 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 QUASENSE 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 QUASENSE 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 QUASENSE.
- If you have vomiting or diarrhea within 3-4 hours of
taking a white pill, take another white 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 QUASENSE 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 s tart taking QUASENSE:
- 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 white and 7 peach
pills. The cards in trays 1 and 2 each contain 28 white pills (4 rows of 7
pills). See Figure A. The card in tray 3 contains 35 pills consisting of 28
white pills (4 rows of 7 pills) and 7 peach pills (1 row of 7 pills). See
- 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
When should I start taking QUASENSE?
If you start taking QUASENSE and you have not used a
hormonal birth control method before:
- Take the first white pill on the Sunday after your period
starts, even if you are still bleeding. If your period begins on Sunday, start
the first white 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 white pill until the next Sunday (first 7 days).
If you s tart taking QUASENSE and you are s witching
from another birth control pill:
- Start your new QUASENSE pack on the same day that you would
start the next pack of your previous birth control method.
- Do not continue taking the pills from your previous birth
If you start taking QUASENSE and previously used a
- Start using QUASENSE on the day you would have reapplied
the next ring.
If you start taking QUASENSE and previously used a
trans dermal patch:
- Start using QUASENSE on the day you would have started a
new cycle (first patch application).
If you start taking QUASENSE and you are switching
from a progestin-only method such as an implant or injection:
- Start taking QUASENSE on the day of removal of your
implant, or on the day when you would have had your next injection.
If you start taking QUASENSE and you are switching
from an intrauterine device or system (IUD or IUS):
- Start taking QUASENSE 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 QUASENSE.
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 QUASENSE?” above. Follow these instructions for a Sunday
Instructions for using your QUASENSE Extended-Cycle
- 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
- 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 peach pill on Day 91 from the pill
dispenser, start taking the first white 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 QUASENSE.
What should I do if I miss any QUASENSE pills ?
If you miss 1 white 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 white 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 white pills in a row, follow
these steps :
- 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 peach 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.
This Patient Information and Instructions for Use have
been approved by the U.S. Food and Drug Administration.