1 INDICATIONS AND USAGE

Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

Levonorgestrel and ethinyl estradiol tablets USP are available in Extended-Cycle Wallets, each containing a 13-week supply of tablets in the following order:

• 84 pink, round, biconvex, film-coated tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol; debossed with LU on one side and U21 on the other side
• 7 white to off white, round, biconvex, inert tablets debossed with LU on one side and U22 on the other side.

4 CONTRAINDICATIONS

Levonorgestrel and Ethinyl Estradiol Tablets 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)].

5 WARNINGS AND PRECAUTIONS

5.1 Thromboembolic Disorders and Other Vascular Conditions

• Stop levonorgestrel and ethinyl estradiol tablets if an arterial or venous thrombotic/thromboembolic event occurs.
• Stop levonorgestrel and ethinyl estradiol tablets if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
• Discontinue levonorgestrel and ethinyl estradiol tablets during prolonged immobilization. If feasible, stop levonorgestrel and ethinyl estradiol tablets at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
• Start levonorgestrel and ethinyl estradiol tablets no earlier than 4 weeks after delivery, in females who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the likelihood of ovulation increases after the third postpartum week.
• Before starting levonorgestrel and ethinyl estradiol tablets evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy. levonorgestrel and ethinyl estradiol tablets is contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases [see Contraindications (4)].

Arterial Events

COCs increase the risk of cardiovascular events and cerebrovascular events, such as myocardial infarction and stroke. The risk is greater among older women (> 35 years of age), smokers, and females with hypertension, dyslipidemia, diabetes, or obesity.

 

Levonorgestrel and ethinyl estradiol tablets is contraindicated in women over 35 years of age who smoke [see Contraindications (4)]. Cigarette smoking increases the risk of serious cardiovascular events from COC use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked.

• Venous Events
• Use of COCs increases the risk of venous thromboembolic events (VTEs), such as deep vein thrombosis and pulmonary embolism. Risk factors for VTEs include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of COCs [see Contraindications (4)].While the increased risk of VTE associated with use of COCs is well-established, the rates of VTE are even greater during pregnancy, and especially during the postpartum period (see Figure 1). The rate of VTE in females using COCs has been estimated to be 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of a COC and when restarting hormonal contraception after a break of four weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued.
• Figure 1 shows the risk of developing a VTE for females who are not pregnant and do not use oral contraceptives, for females who use oral contraceptives, for pregnant females and for females in the postpartum period. To put the risk of developing a VTE into perspective: If 10,000 females who are not pregnant and do not use oral contraceptives are followed for one year, between 1 and 5 of these females will develop a VTE.

Use of levonorgestrel and ethinyl estradiol tablets provide women with more hormonal exposure on a yearly basis than conventional monthly COCs containing the same strength synthetic estrogens and progestins (an additional 9 weeks of exposure per year). In the clinical trial, one case of pulmonary embolism was reported. Postmarketing adverse reactions of VTE have been reported in women who used levonorgestrel and ethinyl estradiol tablets.

6 ADVERSE REACTIONS

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

7 DRUG INTERACTIONS

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.

8 USE IN SPECIFIC POPULATIONS

10 OVERDOSAGE

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.

11 DESCRIPTION

Levonorgestrel and ethinyl estradiol tablets USP are an extended-cycle combination oral contraceptive consisting of 84 pink, round, biconvex, film-coated, active tablets, each containing 0.15 mg of levonorgestrel USP, a synthetic progestin and 0.03 mg of ethinyl estradiol USP, an estrogen, and 7 white to off white, round, biconvex, inert tablets (without hormones).

The structural formulas for the active components are:

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

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

• Each pink active tablet contains the following inactive ingredients: croscarmellose sodium, FD & C Blue # 1, FD & C Red # 40, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.
• Each white to off white inert tablet contains the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

12 CLINICAL PHARMACOLOGY

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

In a 12-month, multicenter, randomized, open-label clinical trial, 456 women aged 18 to 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 to 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.

16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg are available in Extended-Cycle Wallet of 91 tablets each containing a 13-week supply of tablets which is packed in a pouch (NDC 68180-843-11). Such three pouches are packed in a carton (NDC 68180-843-13).

Each wallet (91 tablets) contains in the following order:

• 84 pink, round, biconvex, film-coated tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol; debossed with LU on one side and U21 on the other side
• 7 white to off white, round, biconvex, inert tablets debossed with LU on one side and U22 on the other side.

• Storage and Handling
• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP Controlled Room Temperature].
• Protect from light.

17 PATIENT COUNSELING INFORMATION

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 levonorgestrel and ethinyl estradiol tablets [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 levonorgestrel and ethinyl estradiol tablets if pregnancy is confirmed during treatment.

Sexually Transmitted Infections

Levonorgestrel and ethinyl estradiol tablets 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 SEASONALE pills" section in FDA-approved Instructions for Use [see Dosage and Administration (2.3)].

Need for Additional Contraception

• Postpartum females who start levonorgestrel and ethinyl estradiol tablets who have not yet had a period when they start levonorgestrel and ethinyl estradiol tablets need to use an additional method of contraception until they have taken a pink 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 levonorgestrel and ethinyl estradiol tablets [see Drug Interactions (7.1)].

Lactation

• Levonorgestrel and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets 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)].

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) - 454 775

INDIA

Revised: September 2023                                          

Patient Information

Levonorgestrel and Ethinyl Estradiol [LEE-voe-nor-JES-trel and EH-thih-nill-ess-tra-DYE-ole] Tablets, 0.15 mg/0.03 mg

What is the most important information I should know about levonorgestrel and ethinyl estradiol tablets?

Do not use levonorgestrel and ethinyl estradiol tablets 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 are levonorgestrel and ethinyl estradiol tablets?

Levonorgestrel and ethinyl estradiol tablet 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. Levonorgestrel and ethinyl estradiol tablet does not protect against HIV infections (AIDS) and other sexually transmitted infections.

How does levonorgestrel and ethinyl estradiol tablet 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 levonorgestrel and ethinyl estradiol tablets.

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 levonorgestrel and ethinyl estradiol tablets?

Do not take levonorgestrel and ethinyl estradiol tablets 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
• and are over the age of 35
• with high blood pressure
• with kidney, eye, nerve, or blood vessel damage
• 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 levonorgestrel and ethinyl estradiol tablets, stop taking levonorgestrel and ethinyl estradiol tablets right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking levonorgestrel and ethinyl estradiol tablets.

What should I tell my healthcare provider before taking levonorgestrel and ethinyl estradiol tablets?

Tell your healthcare provider if you:

• are pregnant or think you may be pregnant
• are scheduled for surgery. Levonorgestrel and ethinyl estradiol tablets may increase your risk of blood clots after surgery. You should stop taking levonorgestrel and ethinyl estradiol tablets at least 4 weeks before you have surgery and not restart levonorgestrel and ethinyl estradiol tablets 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. Levonorgestrel and ethinyl estradiol tablets may decrease the amount of breast milk you make. A small amount of the hormones in levonorgestrel and ethinyl estradiol tablets 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 Levonorgestrel and ethinyl estradiol tablets" 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.

Levonorgestrel and ethinyl estradiol tablets may affect the way other medicines work, and other medicines may affect how well levonorgestrel and ethinyl estradiol tablets work.

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 levonorgestrel and ethinyl estradiol tablets?

Read the Instructions for Use at the end of this Patient Information.

What are the most serious risk of taking levonorgestrel and ethinyl estradiol tablets?

• Like pregnancy, levonorgestrel and ethinyl estradiol tablets 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
• yellowing of your skin or eyes

Other serious side effects include:

• liver problems, including:
  • rare liver tumors
  • jaundice (cholestasis), especially if you previously had cholestasis of pregnancy.
• high blood pressure. You should see your healthcare provider to check of 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 levonorgestrel and ethinyl estradiol tablets.
• 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 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 levonorgestrel and ethinyl estradiol tablets. Use sunscreen if you have to be in the sunlight.

What are the most common side effects of levonorgestrel and ethinyl estradiol tablets?

• 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 levonorgestrel and ethinyl estradiol tablets. 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 levonorgestrel and ethinyl estradiol tablets?

• If you are scheduled for any lab tests, tell your healthcare provider you are taking levonorgestrel and ethinyl estradiol tablets. Certain blood tests may be affected by levonorgestrel and ethinyl estradiol tablets.
• 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 levonorgestrel and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets, 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 levonorgestrel and ethinyl estradiol tablets?

• Store levonorgestrel and ethinyl estradiol tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect from light.
• Keep levonorgestrel and ethinyl estradiol tablets and all medicines out of the reach of children.

General information about the safe and effective use of levonorgestrel and ethinyl estradiol tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use levonorgestrel and ethinyl estradiol tablets for a condition for which it was not prescribed. Do not give levonorgestrel and ethinyl estradiol tablets to other people, even if they have the same symptoms that you have.

This Patient Information summarizes the most important information about levonorgestrel and ethinyl estradiol tablets. You can ask your pharmacist or healthcare provider for information about levonorgestrel and ethinyl estradiol tablets that is written for health professionals.

For more information, call Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or visit our website at www.lupinpharmaceuticals.com.

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 levonorgestrel and ethinyl estradiol tablets?

When you take levonorgestrel and ethinyl estradiol tablets, which have 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 levonorgestrel and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets?

You should consider the possibility that you are pregnant if you miss your scheduled period (no bleeding on the days that you are taking white pills). Since scheduled periods are less frequent when you are taking levonorgestrel and ethinyl estradiol tablets, notify your healthcare provider that you have missed your period and that you are taking levonorgestrel and ethinyl estradiol tablets. 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 levonorgestrel and ethinyl estradiol tablets if it is determined that you are pregnant.

What are the ingredients in levonorgestrel and ethinyl estradiol tablets?

Active ingredients: Each pink pill contains levonorgestrel and ethinyl estradiol.

Inactive ingredients:

Pink pills: croscarmellose sodium, FD & C Blue # 1, FD & C Red # 40, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.

White pills: croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose.

Instructions For Use

Levonorgestrel and Ethinyl Estradiol [LEE-voe-nor-JES-trel and EH-thih-nill-ess-tra-DYE-ole] Tablets

Important Information about taking levonorgestrel and ethinyl estradiol tablets

• Take 1pill every day at the same time. Take the pills in the order directed on your wallet.
• 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 levonorgestrel and ethinyl estradiol tablets, talk to your healthcare provider.
• When you first start taking levonorgestrel and ethinyl estradiol tablets, 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 levonorgestrel and ethinyl estradiol tablets. 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 levonorgestrel and ethinyl estradiol 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 levonorgestrel and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets.
• If you have vomiting or diarrhea within 3 to 4hours 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 provider.
• Stop taking levonorgestrel and ethinyl estradiol tablets at least 4weeks 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 levonorgestrel and ethinyl estradiol tablets:

• 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 Wallet. Your Wallet consist of blister strips that hold 91 individually sealed pills (a 13-week, or 91-day, cycle). The 91 pills consist of 84 pink pills (active pills with hormones) and 7 white pills (inactive pills without hormone).
• Blister strip 1 and 2 each contain 28 pink pills (4 rows of 7 pills). See Figure A.
• Blister strip 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 A.

Figure A

• Also find:
  • Where on the first blister strip in the pack to start taking pills (upper left corner at the start arrow) and
  • In what order to take the pills (follow the weeks and arrow)
• 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 levonorgestrel and ethinyl estradiol tablets?

If you start taking levonorgestrel and ethinyl estradiol tablets 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 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 levonorgestrel and ethinyl estradiol tablets for 7 days.

If you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from another birth control pill:

• Start your new levonorgestrel and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets and previously used a vaginal ring:

• Start using levonorgestrel and ethinyl estradiol tablets on the day you would have reapplied the next ring.

If you start taking levonorgestrel and ethinyl estradiol tablets and previously used a transdermal patch:

• Start using levonorgestrel and ethinyl estradiol tablets on the day you would have started a new cycle (first patch application).

If you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from a progestin-only method such as an implant or injection:

• Start taking levonorgestrel and ethinyl estradiol tablets on the day of removal of your implant, or on the day when you would have had your next injection.

If you start taking levonorgestrel and ethinyl estradiol tablets and you are switching from an intrauterine device or system (IUD or IUS):

• Start taking levonorgestrel and ethinyl estradiol tablets 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 levonorgestrel and ethinyl estradiol tablets.

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 levonorgestrel and ethinyl estradiol tablets?" above. Follow these instructions for a Sunday Start.

Instructions for using your levonorgestrel and ethinyl estradiol tablets Extended-Cycle Wallet:

Sunday Start:

• Take pill 1 on the Sunday after your period starts . To remove your pill from the wallet, press the pill through the hole in the bottom of the wallet.
• 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 wallet.
• After taking the last white pill on Day 91 from the wallet, start taking the first pink pill from a new Extended-Cycle Wallet 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 levonorgestrel and ethinyl estradiol tablets.

What should I do if I miss any levonorgestrel and ethinyl estradiol 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 the pack.
• 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 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 pink 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 miss any of the 7 white 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.

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) - 454 775

INDIA

Revised: September 2023                                                                               ID#: 273192

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg

Rx only

Wallet Label - Extended-Cycle Wallet of 91 tablets

NDC 68180-843-11

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg

Rx only

Pouch Label – Contains Extended-Cycle Wallet of 91 tablets

NDC 68180-843-11

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg

Rx only

Carton Label – Contains 3 Pouches each containing one  Extended-Cycle Wallet of 91 tablets

NDC 68180-843-13