Ashlyna

Ethinyl estradiol and levonorgestrel extended-cycle is a combination drug that contains female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and levonorgestrel extended-cycle is used as contraception to prevent pregnancy.

Ethinyl estradiol and levonorgestrel extended-cycle may also be used for purposes not listed in this medication guide.

Do not use birth control pills if you are pregnant or if you have recently had a baby.

You should not take birth control pills if you have any of the following conditions: uncontrolled high blood pressure, heart disease, a blood-clotting disorder, circulation problems, diabetic problems with your eyes or kidneys, unusual vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you smoke and are over 35, or if you have ever had breast or uterine cancer, jaundice caused by birth control pills, a heart attack, a stroke, or a blood clot.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart this medicine after not taking it for 4 weeks or longer.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take this medicine if you smoke and are over 35 years old.

Do not use if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);
• a blood-clotting disorder or circulation problems;
• problems with your eyes, kidneys or circulation caused by diabetes;
• a history of hormone-related cancer such as breast or uterine cancer;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills; or
• if you smoke and are over 35 years old.

To make sure birth control pills are safe for you, tell your doctor if you have:

• high blood pressure, varicose veins;
• high cholesterol or triglycerides, or if you are overweight;
• a history of depression;
• diabetes, underactive thyroid, gallbladder disease;
• seizures or epilepsy;
• a history of irregular menstrual cycles;
• tuberculosis; or
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast feeding a baby.

Ashlyna is part of the drug class:

• Combination Progesterone and Estrogen Contraceptives

• It is used to prevent pregnancy.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to ethinyl estradiol, levonorgestrel, or any other part of Ashlyna.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have had any of these health problems: Blood clots, blood clotting problem, breast cancer, diseased arteries in the brain, disease of a heart valve with problems, heart disease, chest pain caused by angina, heart attack, stroke, high blood pressure, high cholesterol, a pancreas problem (pancreatitis) due to high blood triglycerides, liver disease, liver tumor, very bad headache or migraine, diabetes that affects blood flow, or tumor where estrogen makes it grow.
• If you have had any of these health problems: Endometrial cancer, cancer of the cervix or vagina, or vaginal bleeding where the cause is not known.
• If you have surgery and need bedrest.
• If you turned yellow during pregnancy or with estrogen-based or hormone contraceptive use.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Ashlyna.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Ashlyna (ethinyl estradiol and levonorgestrel) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ashlyna. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Ashlyna (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg) is indicated for use by women to prevent pregnancy.

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.

How Supplied

Ashlyna tablets (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 blue tablets, each containing 0.15 mg of levonorgestrel USP and 0.03 mg ethinyl estradiol USP, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol USP. The blue tablets are round, film-coated, biconvex, unscored tablets debossed with 'E1' on one side and plain on the other. The yellow tablets are round, biconvex, film-coated, unscored tablets debossed with ‘D8’ on one side and plain on the other.

NDC 68462-646-93                    1 carton containing 2 individual pouches. Inside each pouch is 1 extended-cycle tablet
                                                    dispenser containing 84 blue tablets and 7 yellow tablets.

Storage Conditions

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

Guide for Using Ashlyna (Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets USP, 0.01 mg)

WARNING TO WOMEN WHO SMOKE 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.

Birth control pills help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

What is Ashlyna?
Ashlyna is a birth control pill. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called levonorgestrel.

How Well Does Ashlyna Work?
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 Levonorgestrel and Ethinyl Estradiol Tablets 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.

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 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 blue and 7 yellow pills. Blister cards 1 and 2 each contain 28 blue pills (4 rows of 7 pills). Blister card 3 contains 35 pills consisting of 28 blue pills (4 rows of 7 pills) and 7 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 backup in case you miss pills.

When to Start Ashlyna
1. Take the first blue pill on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the first 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 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 yellow pill, start taking the first 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 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 blue 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 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 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 yellow pills, call your healthcare provider because you may be pregnant.

If you MISS ANY of the 7 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.

Who Should Not Take Ashlyna?

Your healthcare provider will not give you Ashlyna if you have:

• Ever had breast cancer or any cancer that is sensitive to female hormones • Liver disease, including liver tumors • Ever had blood clots in your arms, legs, or lungs • Ever had a stroke • Ever had a heart attack • Certain heart valve problems or heart rhythm abnormalities that can cause blood clots to form in the heart • An inherited problem with your blood that makes it clot more than normal • High blood pressure that medicine can't control • Diabetes with kidney, eye, or blood vessel damage • Certain kinds of severe migraine headaches with aura, numbness, weakness or changes in vision

Also, do not take birth control pills if you:

• Smoke and are over 35 years old • Are pregnant

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.

What Else Should I Know About Taking Ashlyna?

Birth control pills do notprotect you against any sexually transmitted disease, including HIV, the virus that causes AIDS.

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.

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.

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

Consider using another 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.

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.

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 > 35. 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 • 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.

Do Birth Control Pills Cause Cancer?

Birth control pills do not appear to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use birth control pills because some breast cancers are sensitive to hormones.

Women who use birth control pills may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What 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 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 91day 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 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 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.

General Advice About Ashlyna

Your healthcare provider prescribed Ashlyna for you. Do not share Ashlyna with anyone else. Keep Ashlyna out of the reach of children.

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.

Manufactured by:
Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:
Glenmark Generics Inc., USA
Mahwah, NJ 07430

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

March 2014