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

Ashlyna® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) are available in extended-cycle tablet dispensers, each containing a 13-week supply of tablets: 84 light blue to blue tablets, each containing 0.15 mg of levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP and 7 light yellow to yellow tablets, each containing 0.01 mg of ethinyl estradiol, USP. The light blue to blue tablets are round, film-coated, biconvex, unscored tablets debossed with “E1” on one side. The light yellow to yellow tablets are round, biconvex, film-coated, unscored tablets debossed with “D8” on one side.

Ashlyna 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:

o

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

o

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

o

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

o

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

o

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)].

o

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

o

Have uncontrolled hypertension or hypertension with vascular disease [see Warnings and Precautions (5.3)].

o

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

o

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 (5.4)].

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 to 1.12 (Figure 3).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 3). 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 to 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 to 10 years of COC use.

Figure 3: 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 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 of 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 disorders: hypersensitivity reaction

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

Respiratory, thoracic and mediastinal disorders: pulmonary embolism, pulmonary thrombosis

Skin and subcutaneous tissue disorders: alopecia

Vascular disorders: 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 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 uterine bleeding in females and nausea.

Ashlyna® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) is an extended-cycle oral contraceptive consisting of 84 light blue to blue tablets each containing 0.15 mg of levonorgestrel, USP a synthetic progestogen and 0.03 mg of ethinyl estradiol, USP and 7 light yellow to yellow tablets containing 0.01 mg of ethinyl estradiol, USP.

The structural formulas for the active components are:

Levonorgestrel, USP

C21H28O2 MW: 312.4

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

Ethinyl Estradiol, USP

C20H24O2 MW: 296.4

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

Each light blue to blue tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin.

Each light yellow to yellow tablet contains the following inactive ingredients: anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 400, polysorbate 80 and titanium dioxide.

In a 12-month, multicenter, randomized, open-label clinical trial, 1,006 women aged 18 to 40 were studied to assess the safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets, completing the equivalent of 8,681 28-day cycles of exposure. The racial demographic of those enrolled was: Caucasian (80%), African-American (11%), Hispanic (5%), Asian (2%), and Other (2%). There were no exclusions for body mass index (BMI) or weight. The weight range of those women treated was 91 to 360 lbs., with a mean weight of 156 lbs. Among the women in the trial, 63% were current or recent hormonal contraceptive users, 26% were prior users (who had used hormonal contraceptives in the past but not in the 6 months prior to enrollment), and 11% were new starts. Of treated women, 14.8% were lost to follow-up, 16.3% discontinued due to an adverse event, and 12.9% discontinued by withdrawing their consent.

The pregnancy rate (Pearl Index [PI]) in women aged 18 to 35 years was 1.34 pregnancies per 100 women-years of use (95% confidence interval 0.54 to 2.75), based on 7 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 backup contraception, were not included in the calculation of the PI. The PI includes patients who did not take the drug correctly.

Product: 50090-2097

NDC: 50090-2097-0 1 KIT in a KIT

Advise the patient to read theFDA-Approved Patient Labeling (Patient Information and Instructions for Use).

Counsel patients about the following information:

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 and ethinyl estradiol tablets [see Boxed Warning and Warnings and Precautions (5.1)].

Venous Thromboembolism

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 interruption in intake) 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 and ethinyl estradiol tablets if pregnancy is confirmed during treatment.

Sexually Transmitted Infections

Levonorgestrel and ethinyl estradiol tablets 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.

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

Need for Additional Contraception

Postpartum females who have not yet had a period when they start levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets need to use an additional method of contraception until they have taken a light blue to blue tablet for 7 consecutive days [see Dosage and Administration (2.1)]. There is a need to use a back-up or alternative method of contraception when enzyme inducers are used with levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets [see Drug Interactions (7.1)].

Lactation

Levonorgestrel and ethinyl estradiol tablets 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. Advise patients to contact a healthcare provider in the event of amenorrhea with symptoms of pregnancy, such as morning sickness or unusual breast tenderness [see Warnings and Precautions (5.9)].

Fertility Following Discontinuation of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets

Resumption of pre-treatment ovarian function is expected, generally within 8 weeks after discontinuation of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets.

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)].

Manufactured by:

Glenmark Pharmaceuticals Limited
Colvale-Bardez, Goa 403513, India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com

March 2023

PATIENT INFORMATION

Ashlyna(ash-lee-na)

(levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets)

What is the most important information I should know about Ashlyna?

Do not use Ashlyna 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 Ashlyna?
Ashlyna is a birth control pill (hormonal contraceptive) used by women to prevent pregnancy. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel.

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

How Does Ashlyna Work for contraception?
Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The more carefully you follow the directions, the less chance you have of getting pregnant.

Based on the results of a single clinical study lasting 12 months, 1 to 3 women, out of 100 women, may get pregnant during the first year they use Ashlyna.

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 Ashlyna?

Do not take Ashlyna if you:

•

smoke and are over 35 years of age

•

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

•

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 vessel problems

•

have diabetes and are over the age of 35; have diabetes with high blood pressure; kidney, eye, nerve, or blood vessel damage; or 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 the age of 35

•

have or had breast cancer

•

have liver disease, including liver tumors

•

have 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.

Birth control pills may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy.

If any of these conditions happen to you while you are taking Ashlyna, stop taking Ashlyna right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Ashlyna.

What should I tell my healthcare provider before taking Ashlyna?

Tell your healthcare provider if you:

•

are pregnant or think you may be pregnant

•

are scheduled for surgery. Ashlyna may increase your risk of blood clots after surgery. You should stop taking Ashlyna at least 4 weeks before you have surgery and not restart Ashlyna 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. Ashlyna may decrease the amount of breast milk you make. A small amount of the hormones in Ashlyna 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 Ashlyna” above. Your healthcare provider may recommend another method of birth control.

Tell your healthcare provider about all medicines and herbal products that you take. 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 Ashlyna?

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

What are the most serious risks of taking birth control pills?

Like pregnancy, birth control pills increase the risk of serious blood clots, especially in women who have other risk factors, such as smoking, obesity, or age over 35 years old. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke. Some examples of serious blood clots are blood clots in the:

•

Legs (thrombophlebitis)

•

Lungs (pulmonary embolus)

•

Eyes (loss of eyesight)

•

Heart (heart attack)

•

Brain (stroke)

Women who take birth control pills may get:

•

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

•

Gallbladder problems

•

Rare cancerous or noncancerous liver tumors

All of these events are uncommon in healthy women.

Call your healthcare provider right away if you have:

•

Persistent leg pain

•

Sudden shortness of breath

•

Sudden blindness, partial or complete

•

Severe pain in your chest

•

Sudden, severe headache unlike your usual headaches

•

Weakness or numbness in an arm or leg, or trouble speaking

•

Yellowing of the skin or eyeballs

What are common side effects of birth control pills?

The most common side effects of birth control pills are:

•

Spotting or bleeding between menstrual periods

•

Nausea

•

Breast tenderness

•

Headache

These side effects are usually mild and usually disappear with time.

Less common side effects are:

•

Acne

•

Less sexual desire

•

Bloating or fluid retention

•

Blotchy darkening of the skin, especially on the face

•

High blood sugar, especially in women who already have diabetes

•

High fat levels in the blood

•

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

•

Problems tolerating contact lenses

•

Weight changes

This is not a complete list of possible side effects. Talk to your healthcare provider if you develop any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

No serious problems have been reported from a birth control pill overdose, even when accidentally taken by children.

What else should I know about taking Ashlyna?

•

If you are scheduled for any lab tests, tell your healthcare provider you are taking Ashlyna. Certain blood tests may be affected by Ashlyna.

•

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 Ashlyna 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 Ashlyna, may decrease the amount of milk you make. A small amount of the pill's hormones pass into breast milk.

•

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 Ashlyna?

•

Store Ashlyna at room temperature between 68°F to 77°F (20°C to 25°C).

•

Keep Ashlyna and all medicines out of the reach of children.

General information about Ashlyna

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Ashlyna for a condition for which it was not prescribed. Do not give Ashlyna to anyone else.

This Patient Information summarizes the most important information about Ashlyna. If you have concerns or questions, ask your healthcare provider. You may also ask your healthcare providers for a more detailed label written for medical professionals.

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 Ashlyna?

When you take Ashlyna, which has a 91-day extended dosing cycle, you should expect to have 4 scheduled periods per year (bleeding when you are taking the 7 light yellow to yellow pills). Each period is likely to last about 3 days. 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 Ashlyna 91-day treatment cycle, about 3 in 10 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 Ashlyna because of this bleeding or spotting. If the spotting continues for more than 7 consecutive days or if the bleeding is heavy, call your healthcare provider.

What if I miss my scheduled period when taking Ashlyna?

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

What are the ingredients in Ashlyna?

Active ingredients:

Light blue to blue tablets: levonorgestrel and ethinyl estradiol

Light Yellow to Yellow tablets: ethinyl estradiol

Inactive ingredients:

Each light blue to blue tablet contains the following inactive ingredients:anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin.

Each light yellow to yellow tablet contains the following inactive ingredients:anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol 400, polysorbate 80 and titanium dioxide.

INSTRUCTIONS FOR USE

Ashlyna (ash-lee-na)

(levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets)

How do I take Ashlyna?

1. Take one pill every day at the same time. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.

2. Many women have spotting or light bleeding or may feel sick to their stomach during the first few months of taking Ashlyna. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn't go away, check with your healthcare provider.

3. 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, you could also feel a little sick to your stomach.

4. If you have trouble remembering to take Ashlyna, talk to your healthcare provider about how to make pill-taking easier or about using another method of birth control.

Before you start taking Ashlyna

1. Decide what time of day you want to take your pill. It is important to take it at about the same time every day.

2. Look at your extended-cycle tablet dispenser. Your tablet dispenser consists of 3 blister cards that hold 91 individually sealed pills (a 13-week or 91-day cycle). The 91 pills consist of 84 light blue to blue and 7 light yellow to yellow pills. Blister cards 1 and 2 each contain 28 light blue to blue pills (4 rows of 7 pills). Blister card 3 contains 35 pills consisting of 28 light blue to blue pills (4 rows of 7 pills) and 7 light yellow to yellow pills (1 row of 7 pills).

3.Also find:

•

Where on the first blister card 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).

4. Be sure you have ready at all times another kind of birth control (such as condoms or spermicides), to use as a back-up in case you miss pills.

If you are switching from another birth control method:

If you have been using a different hormonal method of birth control (such as a different pill, the “patch,” or the “vaginal ring”), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken Ashlyna for 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 Ashlyna for 7 days.

When to start Ashlyna

1. Take the first light blue to blue pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first light blue to blue pill that same day.

2. 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 light blue to blue pill until the next Sunday (first 7 days). If you have been using a different hormonal method of birth control (such as a different pill, the “patch,” or the “vaginal ring”), you need to use another method of birth control (such as condoms or spermicides) each time you have sex after stopping your old method of birth control until you have taken Ashlyna for 7 days.

How to take Ashlyna

1. Take one pill at the same time every day until you have taken the last pill in the tablet dispenser.

•

Do not skip pills even if you are experiencing spotting or bleeding or feel sick to your stomach (nausea).

•

Do not skip pills even if you do not have sex very often.

2. When you finish a tablet dispenser

•

After taking the last light yellow to yellow pill, start taking the first light blue to blue pill from a new extended-cycle tablet dispenser the very next day (this should be on a Sunday) regardless of when your period started.

3. If you miss your scheduled period when you are taking the light yellow to yellow pills, contact your healthcare provider because you may be pregnant. If you are pregnant, you should stop taking Ashlyna.

What to do if you miss pills

If you MISS 1 light blue toblue pill:

1. 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.

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

If you MISS 2 light blue to blue pills in a row:

1. Take 2 pills on the day you remember, and 2 pills the next day.

2. Then take 1 pill a day until you finish the pack.

3. You could become pregnant if you have sex in the 7 days after you miss two pills. You MUST use another birth control method (such as condoms or spermicide) as a back-up for the 7 days after you restart your pills.

If you MISS 3 OR MORE light blue to blue pills in a row:

1. Do not take the missed pills. Keep taking 1 pill every day as indicated on the pack until you have completed all of the remaining pills in the pack. For example: If you resume taking the pill on Thursday, take the pill under “Thursday” and do not take the missed pills. You may experience bleeding during the week following the missed pills.

2. You could become pregnant if you have sex during the days of missed pills or during the first 7 days after restarting your pills.

3. You MUST use a non-hormonal birth control method (such as condoms 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 light yellow to yellow pills, call your healthcare provider because you may be pregnant.

If you MISS ANY of the 7 light yellow to yellow pills:

1. Throw away the missed pills.

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

3. 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

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

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

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Glenmark Pharmaceuticals Limited
Colvale-Bardez, Goa 403513, India

Manufactured for:

Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkpharma-us.com

March 2023