(levonorgestrel and ethinyl estradiol tablets, USP)
(lee-voe-nor-JES-trel ETH-in-il es -tra-DIE-ole)
What is the most important information I should know about Introvale™ ?
Do not use Introvale™ 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 Introvale™ ?
Introvale™ is a birth control pill (oral contraceptive) used by women to prevent pregnancy.
How does Introvale™ 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 Introvale™ .
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
Who should not take Introvale™ ?
Do not take Introvale™ 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 than normal
- have certain heart valve problems or irregular heart beat
- had a stroke
- has 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 migrane headaches with aura, numbness, weakness or changes in vision,
or any migrane headaches if your are over 35 years of age
- have liver problems, including liver tumor
- take any Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without
dasabuvir. This may increase levels of the liver enzyme "alanine aminotransferase" (ALT) in the
- have any unexplained vaginal bleeding
- are pregnant
- had breast cancer or any cancer that is sensitive to female hormones
If any of these conditions happen while you are taking Introvale™ , stop taking Introvale™ right
away and talk to your healthcare provider. use non-hormonal contraception when you stop
taking Introvale™ .
What should I tell my healthcare provider before taking Introvale™ ?
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. Introvale™ may decrease the amount of breast milk you
make. A small amount of the hormones in levonorgestrel and ethinyl estradiol may pass into your
breast milk. Talk to your healthcare provider about the best birth control method for you while
Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter
medicines, vitamins and herbal supplements.
Introvale™ may affect the way other medicines work, and other medicines may affect how well
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 Introvale™ ?
Read the Instructions for use at the end of this Patient Information.
What are the possible serious side effects of Introvale™ ?
- Like pregnancy, Introvale™ 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
- sudden severe shortness of breath
- sudden change in vision or blindness
- chest pain
- a sudden, severe headache unlike your usual headaches
- weakness or numbness in your arm or leg
- trouble speaking
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
- gallbladder problems
- changes in the sugar and fat (cholesterol and triglycerides) levels in your blood
- new or worsening headaches including migraine headaches
- irregular or unusual vaginal bleeding and spotting between your mens trual periods,
especially during the first 3 months of taking Introvale™TM.
- 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 if 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 Introvale™ .
Use sunscreen if you have to be in the sunlight.
What else should I know about taking Introvale™ ?
- headache (migraine)
- heavier or longer periods, pain with periods
- breast tenderness
- increase in weight
These are not all the possible side effects of Introvale™ . 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 Introvale™ ?
- If you are scheduled for any lab tests, tell your healthcare provider you are taking Introvale™ .
Certain blood tests may be affected by Introvale™ .
- Introvale™ does not protect against HIV infection (AIDS) and other sexually transmitted
How should I store Introvale™ ?
- Store Introvale™ at room temperature between 68°F to 77°F (20°C to 25°C).
General information about the safe and effective use of Introvale™ .
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
Do not use Introvale™ for a condition for which it was not prescribed. Do not give Introvale™ to
other people, even if they have the same symptoms that you have.
This Patient Information summarizes the most important information about Introvale™ . You can ask your
pharmacist or healthcare provider for information about Introvale™ that is written for health
For more information, call Sandoz Inc. at 1-800-525 8747.
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 Introvale™ ?
When you take Introvale™ , 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 Introvale™ 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 Introvale™ 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 provider.
What are the ingredients in Introvale™ ?
Active ingredients: Each peach pill contains levonorgestrel and ethinyl estradiol.
Peach pills: lactose anhydrous, magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol,
titanium dioxide, talc, iron oxide yellow, iron oxide red and iron oxide black.
White pills: lactose anhydrous, magnesium stearate, povidone, polyvinyl alcohol, polyethylene glycol,
talc and titanium dioxide.
Instructions for Use
(levonorgestrel and ethinyl estradiol tablets , USP)
(lee-voe-nor-JES-trel ETH-in-il es -tra-DIE-ole)
Important Information about taking Introvale™
- 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 Introvale™ , talk to your healthcare TM provider.
- When you first start taking Introvale™ , 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
Introvale™ . 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
Introvale™ 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 Introvale™
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 Introvale™ .
- If you have vomiting or diarrhea within 3 to 4 hours of taking a peach pill, take another peach 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 provider.
- Stop taking Introvale™ 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 Introvale™
- Decide what time of day you want to take your pill. It is important to take it at about the same time
- Look at your Extended-Cycle Blister Cards. Your Tablet Dispenser consists of a Tri-Fold Blister
Card that holds 91 individually sealed pills (a 13-week, or 91-day, cycle). The 91 pills consist of
84 peach pills (active pills with hormones) and 7 white pills (inactive pills without hormone)
arranged in 12 rows of 7 tablets each, labeled weeks “START” through “Week 12” (active pills
with hormones) followed by 1 row of 7 white pills, labeled “Week 13” (inactive pills without
- 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 Introvale™ ?
If you start taking Introvale™ and you have not used a hormonal birth control method before:
- Take the first peach pill on the Sunday after your period starts, even if you are still bleeding. If
your period begins on Sunday, start the first peach 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 peach pill until the next Sunday (first 7 days).
If you start taking Introvale™ and you are switching from another birth control pill:
- Start your new Introvale™ 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 control pack.
If you start taking Introvale™ and previously used a vaginal ring:
- Start using Introvale™ on the day you would have reapplied TM the next ring.
If you start taking Introvale™ and previously used a transdermal patch:
- Start using Introvale™TM on the day you would have started a new cycle (first patch application).
If you start taking Introvale™ and you are switching from a progestin-only method such as an
implant or injection:
- Start taking Introvale™ on the day of removal of your implant, or on the day when you would have
had your next injection.
If you start taking Introvale™ and you are switching from an intrauterine device or system (IUD
- Start taking Introvale™TM on the day of removal of your IUD or IUS.
- 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 Introvale™TM.
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 Introvale™ ?” above. Follow these instructions for a Sunday Start.
Instructions for using your Introvale™ Extended-Cycle Blister Cards:
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 peach pill
from a new Extended-Cycle blister card 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 Introvale™TM.
What should I do if I miss any Introvale™ pills ?
If you miss 1 peach 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 the pack.
- You do not need to use a back-up birth control method if you have sex.
If you miss 2 peach pills in a row, follow these steps:
- Take 2 pills on the day you remember and 2 pills the next day.
- Then continue to take 1 pill every day until you finish the pack.
- 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 peach 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 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
This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug