Introvale is indicated for use by females of reproductive potential to prevent pregnancy.

Introvale is available as round, biconvex, unscored tablets, packaged in a carton of 3 pouches, each pouch contains Extended-Cycle Tablet Blister Pack of 91 tablets, each containing a 13-week supply of tablets in the following order:

• 84 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol; debossed with 212 on the one side and plain on the other side

• 7 green inert tablets debossed with 279 on the one side and plain on the other side.

Introvale is contraindicated in females who are known to have or develop the following conditions:

• A high risk of arterial or venous thrombotic diseases. Examples include females who are known to:

  • Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)].

  • Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions (5.1)].

  • Have cerebrovascular disease [see Warnings and Precautions (5.1)].

  • Have coronary artery disease [see Warnings and Precautions (5.1)].

  • Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)].

  • Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)].

  • Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.4)].

  • Have diabetes mellitus and are over age of 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of > 20 years duration [see Warnings and Precautions (5.7)].

  • Have headaches with focal neurological symptoms, migraine headaches with aura, or over age 35 with any migraine headaches [see Warnings and Precautions (5.8)].

• Current diagnosis of, or history of breast cancer, which may be hormone sensitive [see Warnings and Precautions (5.11)].

• Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis [see Warnings and Precautions (5.2) and Use in Specific Populations (8.6)].

• Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.9)].

• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions (5.3)].

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling:

• Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions (5.1)]

• Vascular events [see Warnings and Precautions (5.1)]

• Liver disease [see Warnings and Precautions (5.2)]

6.2 Postmarketing Experience

Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 2).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use.

Figure 2: Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives

RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

The following adverse reactions have been identified during post-approval use of levonorgestrel and ethinyl estradiol tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal disorders: abdominal distension, vomiting

General disorders and administration site conditions: chest pain, fatigue, malaise, edema peripheral, pain

Immune system disorder: hypersensitivity reactions, including itching, rash, and angioedema

Investigations: blood pressure increased

Musculoskeletal and connective tissue disorders: muscle spasms, pain in extremity

Nervous system disorders: dizziness, loss of consciousness

Psychiatric disorders: insomnia

Reproductive and breast disorders: dysmenorrhea

Skin and subcutaneous tissue disorders: alopecia

Vascular disorders: thrombosis, pulmonary embolism, pulmonary thrombosis

The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested.

Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations.

No drug-drug interaction studies were conducted with levonorgestrel and ethinyl estradiol tablets.

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

Introvale (Levonorgestrel and Ethinyl Estradiol Tablets, USP) is an extended-cycle combination oral contraceptive consisting of 84 white to off-white active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestin and 0.03 mg of ethinyl estradiol, an estrogen, and 7 green inert tablets (without hormones).

The structural formulas for the active components are:

Levonorgestrel is chemically 18,19-Dinorpregn-4-en-20-yn-3-one, 13-ethyl-17-hydroxy-, (17α)-, (-)-.

Ethinyl Estradiol is 19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-.

• Each white to off-white active tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate and polacrilin potassium.

• Each green inert tablet contains the following inactive ingredients: FD&C Blue No. 1 Aluminum Lake, lactose monohydrate, magnesium stearate, polacrilin potassium and yellow oxide of iron.

In a 12-month, multicenter, randomized, open-label clinical trial, 456 women aged 18-40 were studied to assess the safety and efficacy of levonorgestrel and ethinyl estradiol tablets, completing 809 91-day cycles of exposure. The racial demographic of those enrolled was: Caucasian (77%), African-American (11%), Hispanic (7%), Asian (2%), and Other (3%).

There were no exclusions for body mass index (BMI) or weight. The weight range of those women treated was 84 to 304 pounds, with a mean weight of 157 pounds and a median weight of 147 pounds. Among the women in the trial, 63% were current or recent hormonal contraceptive users, 29% were prior users (who had used hormonal contraceptives in the past but not in the 6 months prior to enrollment), and 8% were new starts.

The pregnancy rate (Pearl Index [PI]) in the 397 women aged 18-35 years was 1.98 pregnancies per 100 women-years of use (95% CI: 0.54 to 5.03), based on 4 pregnancies that occurred after the onset of treatment and within 14 days after the last combination pill. Cycles in which conception did not occur, but which included the use of back-up contraception, were not included in the calculation of the PI.

How Supplied

Introvale (Levonorgestrel and Ethinyl Estradiol Tablets, USP) 0.15 mg/0.03 mg is available as round, biconvex, unscored tablets, packaged in a carton of 3 pouches (NDC 70700-208-88); each pouch (NDC 70700-208-87) contains Extended-Cycle Tablet Blister Pack of 91 tablets, each containing a 13-week supply of tablets:

• 84 white to off-white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol: debossed with 212 on the one side and plain on the other side

• 7 green inert tablets debossed with 279 on the one side and plain on the other side

Carton of 3 pouches     NDC 70700-208-88

Storage and Handling

• Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.]

• Protect from light.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Cigarette Smoking

Cigarette smoking increases the risk of serious cardiovascular events from COC use. Women who are over 35 years old and smoke should not use Introvale [see Boxed Warning and Warnings and Precautions (5.1)].

Venous Thromboembolism

The increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions (5.1)].

Use During Pregnancy

Instruct females to stop further intake of Introvale if pregnancy is confirmed during treatment.

Sexually Transmitted Infections

Introvale does not protect against HIV-infection (AIDS) and other sexually transmitted infections.

Dosing and Missed Pill Instructions

• Patients should take one tablet daily by mouth at the same time every day [see Dosage and Administration (2.1)].

• Instruct patients what to do in the event tablets are missed. See “What should I do if I miss any Introvale pills” section of FDA-Approved Instructions for Use [see Dosage and Administration (2.3)].

Need for Additional Contraception

• Postpartum females who start Introvale who have not yet had a period when they start Introvale need to use an additional method of contraception until they have taken a white to off-white tablet for 7 consecutive days [see Dosage and Administration (2.1)].

• There is a need for a back-up or alternative method of contraception when enzyme inducers are used with Introvale [see Drug Interactions (7.1)].

Lactation

Introvale may reduce breast milk production. This is less likely to occur if breastfeeding is well established. When possible, nursing women should use other methods of contraception until they have discontinued breastfeeding [see Use in Specific Populations (8.2)].

Amenorrhea and Possible Symptoms of Pregnancy

Amenorrhea may occur. Because women using Introvale will likely have scheduled bleeding only 4 times per year, advise women to contact their health care provider in the event of amenorrhea with symptoms of pregnancy such as morning sickness or unusual breast tenderness [see Warnings and Precautions (5.9)].

Depression

Depressed mood and depression may occur. Women should contact their healthcare provider if mood changes and depressive symptoms occur, including shortly after initiating the treatment [see Warnings and Precautions (5.10)].

PATIENT INFORMATION

Introvale® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)

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 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. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel. Introvale does not protect against HIV infections (AIDS) and other sexually transmitted infections.

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 pregnant.

Who should not take Introvale?

Do not take Introvale if you:

• smoke and are over 35 years of age

• have or had blood clots in your arms, legs, lungs, or eyes

• had a stroke

• had a heart attack

• have certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart

• have or had a problem with your blood that makes it clot more than normal

• have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessels problems

• have diabetes

  o

  and are over the age of 35

  o

  with high blood pressure

  o

  with kidney, eye, nerve, or blood vessel damage

  o

  for more than 20 years

• 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 or had breast cancer

• have liver problems, including liver tumors

• have any unexplained vaginal bleeding

• 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.

If any of these conditions happen to you 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 scheduled for surgery. Introvale may increase your risk of blood clots after surgery. You should stop taking Introvale at least 4 weeks before you have surgery and not restart Introvale until at least 2 weeks after your surgery.

• 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 Introvale 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 if you have ever had any of the conditions listed in, “Who should not take Introvale” above. Your healthcare provider may recommend another method of birth control.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

Introvale may affect the way other medicines work, and other medicines may affect how well Introvale works.

Some medicines and herbal products may make birth control pills less effective, including:

• barbiturates

• bosentan

• carbamazepine

• felbamate

• griseofulvin

• oxcarbazepine

• phenytoin

• rifampin

• St. John’s wort

• topiramate

Use a back-up or alternative birth control method when you take medicines that may make birth control pills less effective.

Birth control pills may interact with lamotrigine, an anticonvulsant used for epilepsy. This may increase the risk of seizures, so your physician may need to adjust the dose of lamotrigine.

Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone.

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 most serious risks of taking 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:

o

first start taking birth control pills

o

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:

o

leg pain that will not go away

o

sudden severe shortness of breath

o

sudden change in vision or blindness

o

chest pain

o

a sudden, severe headache unlike your usual headaches

o

weakness or numbness in your arm or leg

o

trouble speaking

o

yellowing of your skin or eyes

Other serious side effects include:

• liver problems, including:

  o

  rare liver tumors

  o

  jaundice (cholestasis), especially if you previously had cholestasis of pregnancy.

• high blood pressure. You should see your healthcare provider to check your blood pressure regularly.

• 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 menstrual periods, especially during the first 3 months of taking Introvale.

• depression, especially if you have had depression in the past. Call your healthcare provider immediately if you have any thoughts of harming yourself.

• 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 Introvale. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of Introvale?

• headache (migraine)

• heavier or longer periods, pain with periods

• nausea

• acne

• 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.

• Do not skip any pills, even if you do not have sex often.

• Birth control pills should not be taken during pregnancy. However, birth control pills taken by accident during pregnancy are not known to cause birth defects.

• You should stop Introvale at least four weeks before you have major surgery and not restart it for at least two weeks after the surgery, due to an increased risk of blood clots.

• If you are breastfeeding, consider another birth control method until you are ready to stop breastfeeding. Birth control pills that contain estrogen, like Introvale, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk, but this has not caused harmful effects in breastfeeding infants.

• If you have vomiting or diarrhea, your birth control pills may not work as well. Use another birth control method, like condoms or a spermicide, until you check with your healthcare provider.

How should I store Introvale?

• Store Introvale at room temperature between 20°C to 25°C (68°F to 77°F). Protect from light.

• Keep Introvale and all medicines out of the reach of children.

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 professionals.

For more information, call Xiromed, LLC at 844-XIROMED (844-947-6633).

Do birth control pills cause cancer?

It is not known if hormonal birth control pills cause breast cancer. Some studies, but not all, suggest that there could be a slight increase in the risk of breast cancer among current users with longer duration of use.

If you have breast cancer now, or have had it in the past, do not use hormonal birth control 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 green 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 if I miss my scheduled period when taking Introvale?

You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking green pills). Since scheduled periods are less frequent when you are taking Introvale, notify your healthcare provider that you have missed your period and that you are taking Introvale. Also notify your healthcare provider if you have symptoms of pregnancy such as morning sickness or unusual breast tenderness. It is important that your healthcare provider evaluates you to determine if you are pregnant. Stop taking Introvale if it is determined that you are pregnant.

What are the ingredients in Introvale?

Active ingredients: Each white to off-white pill contains levonorgestrel and ethinyl estradiol.

Inactive ingredients:

White to off-white pills: Lactose monohydrate, magnesium stearate and polacrilin potassium.

Green pills: FD&C Blue No. 1 Aluminum Lake, lactose monohydrate, magnesium stearate, polacrilin potassium and yellow oxide of iron.

Introvale® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)

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 pregnant.

• If you have trouble remembering to take Introvale, talk to your healthcare 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 3-4 hours of taking a white to off-white pill, take another white to off-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 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 every day.

• Look at your Extended-Cycle Tablet Blister Pack. Your Blister Pack consists of 3 trays with cards that hold 91 individually sealed pills (a 13- week or 91-day cycle). The 91 pills consist of 84 white to off-white and 7 green pills. The cards in trays 1 and 2 each contain 28 white to off-white pills (4 rows of 7 pills). See Figure A. The card in tray 3 contains 35 pills consisting of 28 white to off-white pills (4 rows of 7 pills) and 7 green pills (1 row of 7 pills). See Figure B.

• Also find:

  o

  Where on the first tray in the pack to start taking pills (upper left corner) and

  o

  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 white to off-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 to off-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 to off-white pill until the next Sunday (first 7 days).

If you have recently given birth and have not yet had a period, use another method of birth control if you have sex (such as condoms and spermicides) as a back-up method until you have taken Introvale for 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 the next ring.

If you start taking Introvale and previously used a transdermal patch:

• Start using Introvale 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 or IUS):

• Start taking Introvale 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.

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 pack:

Sunday Start:

• 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.

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 blister pack.

• After taking the last green pill on Day 91 from the pill dispenser, start taking the first white to off-white pill from a new Extended-Cycle Blister Pack 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.

What should I do if I miss any Introvale pills?

If you miss 1 white to off-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 the pack.

• You do not need to use a back-up birth control method if you have sex.

If you miss 2 white to off-white 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 white to off-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 green pills, call your healthcare provider because you may be pregnant.

If you miss any of the 7 green pills:

• Throw away the missed pills.

• Keep taking the scheduled pills until the pack is finished.

• You do not need a back-up method of birth control.

Finally, if you are still not sure what to do about the pills you have missed

• Use a back-up method anytime you have sex.

• Keep taking one pill each day until you contact your healthcare provider.

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.

INTROVALE ® is a registered trademark of Xiromed Pharma España, S.L.

Manufactured for:

Xiromed, LLC

Florham Park, NJ 07932

Made in India

Code No.: GUJ-DRUGS/G/28/1297

PI-208-00

Revised: 10/2024

NDC 70700-208-88

RX Only

Introvale® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg)