Patients should be counseled that oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

DESCRIPTION

Twenty-eight (28) white tablets each containing 90 mcg of levonorgestrel (17α)-(–)13-ethyl-17-hydroxy-18, 19-dinorpregn-4-en-20-yn-3-one, a totally synthetic progestogen, and 20 mcg of ethinyl estradiol, (17α)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol. The inactive ingredients present are microcrystalline cellulose, lactose monohydrate, magnesium stearate, croscarmellose sodium, and povidone.

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

Amethyst™ (levonorgestrel and ethinyl estradiol tablets) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Oral contraceptives are highly effective for pregnancy prevention. Table 2 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depend upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.

Table 2: Percentage of Women Experiencing an Unintended Pregnancy During The First Year of Typical Use and The First Year of Perfect Use of Contraception and The Percentage Continuing Use at The End of the First Year. United States.

	% of Women Experiencing an Unintended Pregnancy within the First Year of Use		% of Women Continuing Use at One Year 3
Method (1)	Typical Use 1 (2)	Perfect Use 2 (3)	(4)
Chance 4	85	85
Spermicides 5	26	6	40
Periodic abstinence	25		63
Calendar		9
Ovulation method		3
Sympto-thermal 6		2
Post-ovulation		1
Cap 7
Parous women	40	26	42
Nulliparous women	20	9	56
Sponge
Parous women	40	20	42
Nulliparous women	20	9	56
Diaphragm 7	20	6	56
Withdrawal	19	4
Condom 8
Female (Reality®)	21	5	56
Male	14	3	61
Pill	5		71
Progestin only		0.5
Combined		0.1
IUD
Progesterone T	2.0	1.5	81
Copper T380A	0.8	0.6	78
LNg 20	0.1	0.1	81
Depo-Provera®	0.3	0.3	70
Levonorgestrel Implants (Norplant®)	0.05	0.05	88
Female sterilization	0.5	0.5	100
Male sterilization	0.15	0.10	100

Emergency Contraceptive Pills: The FDA has concluded that certain combined oral contraceptives containing ethinyl estradiol and norgestrel or levonorgestrel are safe and effective for use as postcoital emergency contraception. Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9 

Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10 

Source: Trussell J. Contraceptive efficacy. In: Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowel D, Guest F. Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers; 1998.

1. Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
   
2. Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.
   
3. Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.
   
4. The percents becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.
   
5. Foams, creams, gels, vaginal suppositories, and vaginal film.
   
6. Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.
   
7. With spermicidal cream or jelly.
   
8. Without spermicides.
   
9. The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The FDA has declared the following dosage regimens of oral contraceptives to be safe and effective for emergency contraception: for tablets containing 50 mcg of ethinyl estradiol and 500 mcg of norgestrel 1 dose is 2 tablets; for tablets containing 20 mcg of ethinyl estradiol and 100 mcg of levonorgestrel 1 dose is 5 tablets; for tablets containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel 1 dose is 4 tablets.
   
10. However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

CONTRAINDICATIONS

Amethyst™ (levonorgestrel and ethinyl estradiol tablets) is contraindicated in females who are known to have or develop the following conditions:

• Thrombophlebitis or thromboembolic disorders
  
• History of deep-vein thrombophlebitis or thromboembolic disorders
  
• Cerebrovascular or coronary artery disease (current or past history)
  
• Valvular heart disease with thrombogenic complications
  
• Thrombogenic rhythm disorders
  
• Hereditary or acquired thrombophilias
  
• Major surgery with prolonged immobilization
  
• Diabetes with vascular involvement
  
• Headaches with focal neurological symptoms such as aura
  
• Uncontrolled hypertension
• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
  
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  
• Undiagnosed abnormal genital bleeding
  
• Cholestatic jaundice of pregnancy or jaundice with prior pill use
  
• Hepatic adenomas or carcinomas, or active liver disease
  
• Known or suspected pregnancy
  
• Hypersensitivity to any of the components of Amethyst
• Are receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations (see WARNINGS, Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment).

WARNINGS

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

The use of oral contraceptives is associated with increased risks of several serious conditions including venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke, and transient ischemic attack), hepatic neoplasia, gallbladder disease, and hypertension, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as certain inherited or acquired thrombophilias, hypertension, hyperlipidemias, obesity, diabetes, and surgery or trauma with increased risk of thrombosis (see CONTRAINDICATIONS).

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher doses of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower doses of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population. For further information, the reader is referred to a text on epidemiological methods.

PRECAUTIONS

ADVERSE REACTIONS

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 6).

Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 6). 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 6: Risk of Breast Cancer with Combined Oral Contraceptive Use

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.

An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been associated with the use of oral contraceptives:

• Thromboembolic and thrombotic disorders and other vascular problems (including thrombophlebitis and venous thrombosis with or without pulmonary embolism, mesenteric thrombosis, arterial thromboembolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis, transient ischemic attack)

• Carcinoma of the reproductive organs and breasts

• Hepatic neoplasia/liver disease (including hepatic adenomas or benign liver tumors)

• Ocular lesions (including retinal vascular thrombosis)

• Gallbladder disease

• Carbohydrate and lipid effects

• Elevated blood pressure

• Headache including migraine

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug related (alphabetically listed):

• Acne

• Amenorrhea

• Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms

• Breast changes: tenderness, pain, enlargement, secretion

• Budd-Chiari syndrome

• Cervical erosion and secretion, change in

• Cholestatic jaundice

• Chorea, exacerbation of

• Colitis

• Contact lenses, intolerance to

• Corneal curvature (steepening), change in

• Dizziness

• Edema/fluid retention

• Erythema multiforme

• Erythema nodosum

• Focal nodular hyperplasia

• Gastrointestinal symptoms (such as abdominal pain, cramps, and bloating)

• Hirsutism

• Infertility after discontinuation of treatment, temporary

• Lactation, diminution in, when given immediately postpartum

• Libido, change in

• Melasma/chloasma which may persist

• Menstrual flow, change in

• Mood changes, including depression

• Nausea

• Nervousness

• Pancreatitis

• Porphyria, exacerbation of

• Rash (allergic)

• Scalp hair, loss of

• Serum folate levels, decrease in

• Spotting

• Systemic lupus erythematosus, exacerbation of

• Unscheduled bleeding

• Vaginitis, including candidiasis

• Varicose veins, aggravation of

• Vomiting

• Weight or appetite (increase or decrease), change in

The following adverse reactions have been reported in users of oral contraceptives:

• Cataracts

• Cystitis-like syndrome

• Dysmenorrhea

• Hemolytic uremic syndrome

• Hemorrhagic eruption

• Optic neuritis, which may lead to partial or complete loss of vision

• Premenstrual syndrome

• Renal function, impaired

OVERDOSAGE

Symptoms of oral contraceptive overdosage in adults and children may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue; withdrawal bleeding may occur in females. There is no specific antidote and further treatment of overdose, if necessary, is directed to the symptoms.

NONCONTRACEPTIVE HEALTH BENEFITS

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.

Effects on menses:

      May decrease blood loss and may decrease the incidence of iron-deficiency anemia

      May decrease incidence of dysmenorrhea

Effects related to inhibition of ovulation:

      May decrease incidence of functional ovarian cysts

      May decrease incidence of ectopic pregnancies

Effects from long-term use:

      May decrease incidence of fibroadenomas and fibrocystic disease of the breast

      May decrease incidence of acute pelvic inflammatory disease

      May decrease incidence of endometrial cancer

      May decrease incidence of ovarian cancer

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Amethyst (levonorgestrel and ethinyl estradiol tablets) must be taken exactly as directed and at intervals not exceeding 24 hours. The possibility of ovulation and conception prior to initiation of medication should be considered. Women who do not wish to become pregnant after discontinuation should be advised to immediately use another method of birth control. The dosage of Amethyst is one white tablet daily without any tablet-free interval.

It is recommended that Amethyst tablets be taken at the same time each day.

Initiation of Therapy

Instructions for beginning Amethyst are provided in Table 4 below.

Table 4
Current contraceptive therapy	Amethyst start day	Nonhormonal back-up method of birth control needed when correctly starting Amethyst?
None	Day 1 of patient’s menstrual cycle (during the first 24 hours of her period)	No
21-day COC regimen OR 28-day COC regimen	Day 1 of patient’s withdrawal bleed, at the latest 7 days after her last active tablet	No
Progestin-only pill	Day after taking a progestin-only pill	Yes, for the first 7 days of Amethyst tablet-taking
Implant	Day of implant removal	Yes, for the first 7 days of Amethyst tablet-taking
Injection	Day the next injection is due	Yes, for the first 7 days of Amethyst tablet-taking

If spotting or unscheduled bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her health care professional. The possibility of ovulation increases with each successive day that scheduled white tablets are missed. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered. Hormonal contraception must be discontinued if pregnancy is confirmed.

The risk of pregnancy increases with each tablet missed. For additional patient instructions regarding missed tablets, see the WHAT TO DO IF YOU MISS PILLS section in the DETAILED PATIENT LABELING below.

Amethyst may be initiated no earlier than day 28 postpartum in the nonlactating mother or after a second-trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS concerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.

In the case of first-trimester abortion, if the patient starts Amethyst immediately, additional contraceptive measures are not needed.

HOW SUPPLIED

Amethyst™ (levonorgestrel and ethinyl estradiol tablets, USP 90 mcg levonorgestrel and 20 mcg ethinyl estradiol) is available in a 28 tablet dispenser, arranged in 4 rows of 7 active tablets as follows:

28 round, white, flat face, beveled edge, uncoated tablets debossed with "295" on one side and "WATSON" on the other side (NDC 52544-295-28).

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

References available upon request.

Brands listed are the trademarks of their respective owners.

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Rev. A 12/2021

INFORMATION FOR THE PATIENT

Brief Summary Patient Package Insert

Amethyst™
(Levonorgestrel and Ethinyl Estradiol Tablets, USP
90 mcg/20 mcg)

Rx Only

This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

Oral contraceptives, also known as “birth-control pills” or “the pill,” are taken to prevent pregnancy, and when taken correctly, have a failure rate of approximately 1 to 2% per year (1 to 2 pregnancies per 100 women per year of use) when used without missing any pills. The average failure rate of large numbers of pill users is approximately 5% per year (5 pregnancies per 100 women per year of use) when women who miss pills are included. However, forgetting to take pills considerably increases the chances of pregnancy.

Amethyst is a birth-control pill that is taken every day. When you take Amethyst, the lining of your uterus does not undergo the changes needed for menstruation, and therefore you do not have regular menstrual periods. You are likely to have unscheduled or unplanned bleeding or spotting when you start to use Amethyst. The number of days each month with unscheduled bleeding and spotting usually decreases over time for the majority of women. When using Amethyst, the convenience of having no regular menstrual periods should be weighed against the inconvenience of unscheduled or unplanned breakthrough bleeding and spotting.

For the majority of women, oral contraceptives can be taken safely. However, there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability or death. The risks associated with taking oral contraceptives increase significantly if you:

• smoke 
  
• have high blood pressure, diabetes, high cholesterol, or a tendency to form blood clots, or are obese 
  
• have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice, malignant or benign liver tumors, or major surgery with prolonged immobilization
  
• have headaches with neurological symptoms 

You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.

Although cardiovascular disease risks may be increased with oral contraceptive use in healthy, nonsmoking women over 40 (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.

Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, unscheduled bleeding, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first three months of use.

The serious side effects of the pill occur very infrequently, especially if you are in good health and do not smoke. However, you should know that the following medical conditions have been associated with or made worse by the pill:

1. Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack and angina pectoris) or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences. Women with migraine also may be at increased risk of stroke with pill use.
   
2. Liver tumors, which may rupture and cause severe bleeding. A possible, but not definite, association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.
   
3. High blood pressure, although blood pressure usually returns to normal when the pill is stopped.

The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your health care provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anticonvulsants and some antibiotics, herbal preparations containing St. John’s Wort (Hypericum perforatum), and HIV/AIDS drugs may decrease oral contraceptive effectiveness.

There may be slight increases in the risk of breast cancer among current users of hormonal birth control pills with longer duration of use of 8 years or more.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.

Taking the pill provides some important noncontraceptive benefits. These include less painful menstruation, fewer pelvic infections, and fewer cancers of the ovary and the lining of the uterus.

Be sure to discuss any medical condition you may have with your health care provider. Your health care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it, and the health care provider believes that it is appropriate to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your health care provider.

What You Should Know About Your Menstrual Cycle When You Use Amethyst
You are likely to have unscheduled or unplanned bleeding or spotting when you start to use Amethyst. The number of days each month with bleeding or spotting usually decreases over time in the majority of women. In a study of Amethyst, about 5 out of 10 women had 7 or more days of bleeding or spotting while using their third 28-day pill pack of Amethyst. The number of women with 7 or more days of bleeding or spotting decreased to 3 out of 10 women during the use of their seventh pill pack. Among women who continued to use Amethyst for one year, about 6 out of 10 women had no bleeding or spotting during their last month of use.

Do not stop taking Amethyst because of bleeding or spotting as this will increase your chance of getting pregnant. If the spotting or bleeding continues for more than 7 consecutive days or if the bleeding is heavy, call your health care provider.

Can I Get Pregnant While Taking Amethyst?
You are not likely to get pregnant if you take Amethyst at the same time every day as directed by your health care provider. Because regular monthly bleeding does not occur on Amethyst, it may be difficult to recognize if you get pregnant. If you suspect that you may be pregnant, or if you have symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, you should have a pregnancy test and you should contact your health care professional. Stop taking Amethyst if you are pregnant.

Instructions for the Patient

HOW TO TAKE AMETHYST
Important Points to Remember
Before You Start Taking Amethyst:

1. BE SURE TO READ THESE DIRECTIONS:

Before you start taking Amethyst.

And

Anytime you are not sure what to do.

2. THE RIGHT WAY TO TAKE AMETHYST IS TO 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. See “WHAT TO DO IF YOU MISS PILLS” below.

3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1 to 3 PACKS OF PILLS.

If you feel sick to your stomach, do not stop taking Amethyst. This will usually go away.

If it doesn’t go away, check with your health care professional.

4. MOST WOMEN HAVE SPOTTING OR BLEEDING DURING THE FIRST FEW MONTHS OF TAKING AMETHYST. Do not stop taking your pills even if you are having bleeding or spotting. If the bleeding or spotting lasts for more than 7 consecutive days, talk to your health care provider.

5. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills.

On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.

6. IF YOU VOMIT (within 4 hours after you take your pill), you should follow the instructions for WHAT TO DO IF YOU MISS PILLS. IF YOU HAVE DIARRHEA or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well.

Use a back-up nonhormonal method (such as condoms and/or spermicide) until you check with your health care professional.

7. IF YOU HAVE TROUBLE REMEMBERING TO TAKE AMETHYST, talk to your health care professional about how to make pill-taking easier or about using another method of birth control.

8. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your health care professional.

BEFORE YOU START TAKING AMETHYST

1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take your pill at the SAME TIME every day.

2. LOOK AT YOUR AMETHYST DISPENSER. The pill pack has 28 “active” white pills (with hormones).

3. ALSO FIND:

1) where on the pack to start taking pills, and

2) in what order to take the pills (follow the arrows).

* For use of day labels, see WHEN TO START THE FIRST  PACK OF AMETHYST below.

4. BE SURE YOU HAVE READY AT ALL TIMES:

ANOTHER KIND OF NONHORMONAL BIRTH CONTROL (such as condoms and/or spermicide) to use as a back-up in case you miss pills.

AN EXTRA, FULL PILL PACK.

WHEN TO START THE FIRST  PACK OF AMETHYST

Day 1 Start

1. On Day 1 of your period, peel the day label from the sticker sheet which has the corresponding start day of your period printed on the left hand side; place the label on the dispenser in the designated location. Take your pill daily in the order indicated by the arrows on the dispenser card. Pick a time of day which will be easy to remember and take your pill at the same time every day.

2. Take the first “active” white pill of the first pack during the first 24 hours of your period.

3. You will not need to use a back-up nonhormonal method of birth control, since you are starting the pill at the beginning of your period.

WHAT TO DO DURING THE MONTH

1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.

Do not skip pills even if you are 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 PACK

Start the next pack on the day after your last pill. Do not wait any days between packs.

IF YOU SWITCH FROM ANOTHER BRAND OF COMBINATION PILLS:

When switching from a 21 pill pack: Start Amethyst on the first day of your period (withdrawal bleed). Be sure that no more than 7 days pass between the last day of your 21-day pack and your first Amethyst pill.

When switching from a 28 pill pack (21 active and 7 inactive pills, or 24 active and 4 inactive pills): Start Amethyst on the first day of your period (withdrawal bleed). Be sure that no more than 7 days pass after the last active pill and your first Amethyst pill.

IF YOU SWITCH FROM ANOTHER TYPE OF BIRTH CONTROL

When switching from other types of birth control such as pills containing only a progestin (progestin only pill or POP), an injection, or an implant, your health care professional will provide you with instructions for when to start Amethyst.

WHAT TO DO IF YOU MISS PILLS 

Combination oral contraceptives may not be as effective if you miss pills. Instructions for what to do if you miss pills are provided in the following table.

# of pills missed in a row	What to do when you miss a pill(s)
1 missed pill	• Take the missed pill as soon as you remember. THEN
	• Take the next pill at your regular time. This means you may take 2 pills in 1 day.
	• You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms and/or spermicide) as a back-up for those 7 days.
2 missed pills and remembered on the day of the second missed pill	• Take 2 missed pills on the day you remember. The following day you are back on schedule to take 1 pill a day.
	For example, you take your pills in the morning and you missed 1 pill on Monday and 1 on Tuesday. On Tuesday evening you remembered that you missed your Monday and Tuesday pills. You take the 2 missed pills on Tuesday evening and on Wednesday morning you’re back on schedule and you take 1 pill.
	• You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms and/or spermicide) as a back-up for those 7 days.
2 missed pills and remembered on the day after the second pill is missed	• Take 2 missed pills on the day you remember. The next day you take 2 pills. The following day you are back on schedule to take your pills.
	For example, you take your pills in the morning and you missed 1 pill on Monday and 1 on Tuesday. On Wednesday morning you remembered that you missed your Monday and Tuesday pills. You take the 2 missed pills on Wednesday morning and 2 pills on Thursday morning. On Friday morning you’re back on schedule and you take 1 pill.
	• You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms and/or spermicide) as a back-up for those 7 days.
3 or more missed pills	• Contact your health care professional for further advice. Keep taking one pill every day until you reach your health care professional. Do not take the missed pills.
	• You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms and/or spermicide) as a back-up for those 7 days.

FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED

Use a BACK-UP NONHORMONAL BIRTH-CONTROL METHOD anytime you have sex.

PREGNANCY AFTER STOPPING THE PILL
If you do not desire pregnancy, you should use another method of birth-control immediately after stopping Amethyst. You can get pregnant within days after stopping Amethyst.

For additional information see “Detailed Patient Labeling.”

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Brands listed are the trademarks of their respective owners.

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 12/2021

DETAILED PATIENT LABELING

This product (like all oral contraceptives) is intended to prevent pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

INTRODUCTION

Any woman who considers using oral contraceptives (the “birth-control pill” or “the pill”) should understand the benefits and risks of using this form of birth control. This leaflet will give you much of the information you will need to make this decision and will also help you determine if you are at risk of developing any of the serious side effects of the pill. It will tell you how to use the pill properly so that it will be as effective as possible. However, this leaflet is not a replacement for a careful discussion between you and your health care professional. You should discuss the information provided in this leaflet with him or her, both when you first start taking the pill and during your revisits. You should also follow your health care professional’s advice with regard to regular checkups while you are on the pill.

Amethyst is a birth-control pill that is taken every day. When you take Amethyst, the lining of your uterus does not undergo the changes needed for menstruation, and therefore you do not have regular menstrual periods. You are likely to have unscheduled or unplanned bleeding or spotting when you start to use Amethyst. The number of days each month with unscheduled bleeding and spotting usually decreases over time for the majority of women. When using Amethyst, the convenience of having no regular menstrual periods should be weighed against the inconvenience of unscheduled or unplanned breakthrough bleeding and spotting.

EFFECTIVENESS OF ORAL CONTRACEPTIVES

Oral contraceptives or “birth-control pills” or “the pill” are used to prevent pregnancy and are more effective than other nonsurgical methods of birth control. When they are taken correctly, without missing any pills the chance of becoming pregnant is approximately 1 to 2% per year (1 to 2 pregnancies per 100 women per year of use). Average failure rates are approximately 5% per year (5 pregnancies per 100 women per year of use) when women who miss pills are included. The chance of becoming pregnant increases with each missed pill.

In comparison, average failure rates for other methods of birth control during the first year of use are as follows:

IUD: 0.1 to 2%	Female condom alone: 21%
Depo-Provera® (injectable progestogen): 0.3%	Cervical cap
Norplant® System (levonorgestrel implants): 0.05%	Never given birth: 20%
Diaphragm with spermicides: 20%	Given birth: 40%
Spermicides alone: 26%	Periodic abstinence: 25%
Male condom alone: 14%	No methods: 85%

WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES 

Although cardiovascular disease risks may be increased with oral contraceptive use in healthy, nonsmoking women over 40 (even with the newer low-dose formulations), there are also greater potential health risks associated with pregnancy in older women.

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. This risk increases with age and with the amount of smoking (15 or more cigarettes per day has been associated with a significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should not smoke.

Some women should not use the pill. For example, you should not take the pill if you have any of the following conditions:

• History of heart attack or stroke.
  
• Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes.
  
• History of blood clots in the deep veins of your legs.
  
• Hereditary or acquired blood clotting disorders.
  
• Chest pain (angina pectoris).
  
• Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina, or certain hormonally-sensitive cancers.
  
• Unexplained vaginal bleeding (until a diagnosis is reached by your health care professional).
  
• Liver tumor (benign or cancerous) or active liver disease.
• 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.
• Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill.
  
• Known or suspected pregnancy.
  
• A need for surgery with prolonged bed rest.
  
• Heart valve or heart rhythm disorders that may be associated with formation of blood clots.
  
• Diabetes affecting your circulation.
  
• Headaches with neurological symptoms such as aura.
  
• Uncontrolled high blood pressure.
  
• Allergy or hypersensitivity to any of the components of Amethyst (levonorgestrel and ethinyl estradiol tablets).

Tell your health care professional if you have had any of these conditions. Your health care professional can recommend another method of birth control.

OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES
Tell your health care professional if you or any family member has ever had:

• Breast nodules, fibrocystic disease of the breast, an abnormal breast X-ray or mammogram.
  
• Diabetes.
  
• Elevated cholesterol or triglycerides.
  
• High blood pressure.
  
• A tendency to form blood clots.
  
• Migraine or other headaches or epilepsy.
  
• Depression.
  
• Gallbladder, liver, heart, or kidney disease.
  
• History of scanty or irregular menstrual periods.

Women with any of these conditions should be checked often by their health care professional if they choose to use oral contraceptives. Also, be sure to inform your health care professional if you smoke or are on any medications.

RISKS OF TAKING ORAL CONTRACEPTIVES
Amethyst is a non-cyclic oral contraceptive that provides a low daily dose of estrogen and progestin; however, Amethyst provides women with more hormonal exposure on a yearly basis (13 additional weeks of hormone intake per year) than conventional cyclic oral contraceptives containing the same strength of synthetic estrogens and similar strength of progestins.

1. Risk of Developing Blood Clots
Blood clots and blockage of blood vessels are the most serious side effects of taking oral contraceptives and can cause death or serious disability. In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.

Users of combination oral contraceptives have a higher risk of developing blood clots compared to non-users. This risk is highest during the first year of combination oral contraceptive use.

If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or injury, or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your health care professional about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby or after a midtrimester pregnancy termination. It is advisable to wait for at least four weeks after delivery if you are not breastfeeding. If you are breastfeeding, you should wait until you have weaned your child before using the pill. (See also the section While Breastfeeding in GENERAL PRECAUTIONS.)

The risk of blood clots is greater in users of combination oral contraceptives compared to nonusers. This risk may be higher in users of high-dose pills (those containing 0.05 mg or more of estrogen) and may also be greater with longer use. In addition, some of these increased risks may continue for a number of years after stopping combination oral contraceptives. The risk of abnormal blood clotting increases with age in both users and nonusers of combination oral contraceptives, but the increased risk from the oral contraceptive appears to be present at all ages.

The excess risk of blood clots is highest during the first year a woman ever uses a combined oral contraceptive. This increased risk is lower than blood clots associated with pregnancy. The use of combination oral contraceptives also increases the risk of other clotting disorders, including heart attack and stroke. Blood clots in veins cause death in 1% to 2% of cases. The risk of clotting is further increased in women with other conditions. Examples include: smoking, high blood pressure, abnormal lipid levels, certain inherited or acquired clotting disorders, obesity, surgery or injury, recent delivery or second trimester abortion, prolonged inactivity or bed rest. If possible, combination oral contraceptives should be stopped before surgery and during prolonged inactivity or bed rest.

Cigarette smoking increases the risk of serious cardiovascular events. This risk increases with age and amount of smoking and is quite pronounced in women over 35. Women who use combination oral contraceptives should be strongly advised not to smoke. If you smoke you should talk to your health care professional before taking combination oral contraceptives.

2. Heart Attacks and Strokes
Oral contraceptives may increase the tendency to develop strokes or transient ischemic attacks (blockage or rupture of blood vessels in the brain), and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability.

Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease.

Women with migraine (especially migraine/headache with neurological symptoms such as aura) who take oral contraceptives also may be at higher risk of stroke and must not use combination oral contraceptives (see section WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES).

3. Gallbladder Disease
Oral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens. Oral contraceptives may worsen existing gallbladder disease or accelerate the development of gallbladder disease in women previously without symptoms.

4. Liver Tumor
In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with the pill and liver cancers in two studies in which a few women who developed these very rare cancers were found to have used oral contraceptives for long periods. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.

5. Risk of Cancer
It is not known if hormonal birth control pills causes 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.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives.

6. Lipid Metabolism and Pancreatitis
There have been reports of increases of blood cholesterol and triglycerides in users of combination oral contraceptives. Increases in triglycerides have led to inflammation of the pancreas (pancreatitis) in some cases.

Estimated Risk of Death from a Birth-Control Method or Pregnancy
All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table.

Annual Number of Birth-Related or Method-Related Deaths Associated with Control of Fertility per 100,000 Nonsterile Women, by Fertility-Control Method and According to Age

Method of control and outcome	AGE
	15 to 19	20 to 24	25 to 29		30 to 34	35 to 39	40 to 44
No fertility-control methods*	7.0	7.4	9.1		14.8	25.7	28.2
Oral contraceptives
nonsmoker**	0.3	0.5	0.9	1.9		13.8	31.6
Oral contraceptives
smoker**	2.2	3.4	6.6		13.5	51.1	117.2
IUD**	0.8	0.8	1.0	1.0		1.4	1.4
Condom*	1.1	1.6	0.7	0.2		0.3	0.4
Diaphragm/spermicide*	1.9	1.2	1.2	1.3		2.2	2.8
Periodic abstinence*	2.5	1.6	1.6	1.7		2.9	3.6

* Deaths are birth-related

**Deaths are method-related

In the above table, the risk of death from any birth-control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7 to 26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, except for those women over the age of 40, when the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group.

The suggestion that women over 40 who do not smoke should not take oral contraceptives is based on information from older high-dose pills. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, nonsmoking women over 40 years of age may outweigh the possible risks. Older women, as all women, who take oral contraceptives, should take an oral contraceptive which contains the least amount of estrogen and progestogen that is compatible with the individual patient needs.

WARNING SIGNALS
If any of these adverse effects occur while you are taking oral contraceptives, call your health care professional immediately:

• Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung).
  
• Pain in the calf (indicating a possible clot in the leg).
  
• Crushing chest pain or heaviness in the chest (indicating a possible heart attack).
  
• Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke).
  
• Sudden partial or complete loss of vision (indicating a possible clot in the eye).
  
• Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your health care professional to show you how to examine your breasts).
  
• Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor).
  
• Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression).
  
• Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark-colored urine, or light-colored bowel movements (indicating possible liver problems).

SIDE EFFECTS OF ORAL CONTRACEPTIVES
1. Unscheduled Bleeding and Spotting
Unscheduled bleeding or spotting is likely to occur while you are taking Amethyst. Unscheduled bleeding or spotting occurs most often during the first seven pill packs of Amethyst use. It tends to decrease with subsequent pill packs of use, but may occur after you have been taking Amethyst for some time. In a study of Amethyst, 60% of women had bleeding and/or spotting during the sixth pill pack of use. Bleeding and/or spotting decreased to 48% during pill pack 9, and to 41% during pill pack 13. In this study, the percentage of women who discontinued treatment, at least in part, due to unscheduled bleeding or spotting was 18%.

The following figure shows by pill pack, the percentage of women using Amethyst in a North American study, who experienced unscheduled bleeding or spotting only.

Percentage of Subjects Reporting Bleeding or Spotting Only per Pill Pack

*: The N for each pill pack is the number of subjects with 28 days of data.

Bleeding required sanitary protection; spotting only did not require sanitary protection.

The following figure shows the percentage of women using Amethyst in a North American study who had 4 or more and 7 or more days of bleeding or spotting during each pill pack. During pill pack 2, 67% of women experienced 4 or more days of bleeding or spotting and 54% of these women experienced 7 or more days bleeding or spotting. During the final pill pack of use of Amethyst (pill pack 13), these percentages were 31% and 20%, respectively.

Percentage of Subjects Reporting Greater Than or Equal to 4 or 7 Days of Bleeding and/or Spotting per Pill Pack (Study 313-NA)

*: The N for each pill pack is the number of subjects with 28 days of data.

It is important to continue taking your pills at the same time each day according to your daily routine, even if you are having unscheduled bleeding or spotting. If the unscheduled bleeding and/or spotting continue for an extended period of time (for example, 7 consecutive days) or if the bleeding is heavy, contact your health care professional.

2. Contact Lenses
If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your health care professional.

3. Fluid Retention
Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your health care professional.

4. Melasma
A spotty darkening of the skin is possible, particularly of the face.

5. Other Side Effects
Other side effects may include nausea, breast tenderness, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, vaginal infections, inflammation of the pancreas, and allergic reactions.

If these or any other side effects bother you, contact your health care professional.

GENERAL PRECAUTIONS 
1. Use of Oral Contraceptives Before or During Early Pregnancy
Because regular monthly bleeding does not occur on Amethyst an unexpected pregnancy may be difficult to recognize. If you suspect you may be pregnant, or if you have symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, a pregnancy test should be performed and you should contact your health care professional. Stop taking Amethyst if you are pregnant. Pregnancy is unlikely if the pill is taken as directed.

There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these studies have not been confirmed. Nevertheless, oral contraceptives should not be used during pregnancy. You should check with your health care professional about risks to your unborn child of any medication taken during pregnancy.

2. While Breastfeeding
If you are breastfeeding, consult your health care professional before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk. If possible, do not use oral contraceptives while breastfeeding. You should use another method of contraception since breastfeeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breastfeed for longer periods of time. You should consider starting oral contraceptives only after you have weaned your child completely.

3. Laboratory Tests
If you are scheduled for any laboratory tests, tell your health care professional you are taking birth-control pills. Certain blood tests may be affected by birth-control pills.

4. Drug Interactions
Certain drugs may interact with birth-control pills to make them less effective in preventing pregnancy or cause an increase in unscheduled bleeding. Such drugs include rifampin, drugs used for epilepsy such as barbiturates (for example, phenobarbital) and phenytoin (Dilantin® is one brand of this drug), primidone (Mysoline®), topiramate (Topamax®), carbamazepine (Tegretol® is one brand of this drug), phenylbutazone (Butazolidin® is one brand), some drugs used for HIV or AIDS such as ritonavir (Norvir®), modafinil (Provigil®) and possibly certain antibiotics (such as ampicillin and other penicillins, and tetracyclines), and herbal products containing St. John’s Wort (Hypericum perforatum). You may also need to use a nonhormonal method of contraception during any pill pack in which you take drugs that can make oral contraceptives less effective.

You may be at higher risk for a specific type of liver dysfunction if you take troleandomycin and oral contraceptives at the same time.

You should inform your health care professional about all medicines you are taking, including nonprescription products.

5. Sexually Transmitted Diseases
This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.

What You Should Know About Your Menstrual Cycle When You Use Amethyst
You are likely to have unscheduled or unplanned bleeding or spotting when you start to use Amethyst. The number of days each month with bleeding or spotting usually decreases over time in the majority of women. In a study of Amethyst about 5 out of 10 women had 7 or more days of bleeding or spotting while using their third 28-day pill pack of Amethyst. The number of women with 7 or more days of bleeding or spotting decreased to 3 out of 10 women during the use of their seventh pill pack. Among women who continued to use Amethyst for one year, about 6 out of 10 women had no bleeding or spotting during their last month of use.

Do not stop taking Amethyst because of bleeding or spotting as this will increase your chance of getting pregnant. If the spotting or bleeding continues for more than 7 consecutive days or if the bleeding is heavy, call your health care provider.

Can I Get Pregnant While Taking Amethyst?
You are not likely to get pregnant if you take Amethyst at the same time every day as directed by your health care provider. Because regular monthly bleeding does not occur on Amethyst, it may be difficult to recognize if you get pregnant. If you suspect that you may be pregnant, or if you have symptoms of pregnancy such as nausea/vomiting or unusual breast tenderness, you should have a pregnancy test and you should contact your health care professional. Stop taking Amethyst if you are pregnant.

HOW TO TAKE AMETHYST

Important Points to Remember
Before You Start Taking Amethyst:

1. BE SURE TO READ THESE DIRECTIONS:

Before you start taking Amethyst.

And

Anytime you are not sure what to do.

2. THE RIGHT WAY TO TAKE AMETHYST IS TO 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. See “WHAT TO DO IF YOU MISS PILLS” below.

3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1 to 3 PACKS OF PILLS.

If you feel sick to your stomach, do not stop taking Amethyst. This will usually go away.

If it doesn’t go away, check with your health care professional.

4. MOST WOMEN HAVE SPOTTING OR BLEEDING DURING THE FIRST FEW MONTHS OF TAKING AMETHYST. Do not stop taking your pills even if you are having bleeding or spotting. If the bleeding or spotting lasts for more than 7 consecutive days, talk to your health care provider.

5. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills.

On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.

6. IF YOU VOMIT (within 4 hours after you take your pill), you should follow the instructions for WHAT TO DO IF YOU MISS PILLS. IF YOU HAVE DIARRHEA or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well.

Use a back-up nonhormonal method (such as condoms and/or spermicide) until you check with your health care professional.

7. IF YOU HAVE TROUBLE REMEMBERING TO TAKE AMETHYST, talk to your health care professional about how to make pill-taking easier or about using another method of birth control.

8. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your health care professional.

BEFORE YOU START TAKING AMETHYST

1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take your pill at the SAME TIME every day.

2. LOOK AT YOUR AMETHYST DISPENSER. The pill pack has 28 “active” white pills (with hormones).

3. ALSO FIND:

1) where on the pack to start taking pills, and

2) in what order to take the pills (follow the arrows).

* For use of day labels, see WHEN TO START THE FIRST PACK OF AMETHYST below.

4. BE SURE YOU HAVE READY AT ALL TIMES:

ANOTHER KIND OF NONHORMONAL BIRTH CONTROL (such as condoms and/or spermicide) to use as a back-up in case you miss pills.

AN EXTRA, FULL PILL PACK.

WHEN TO START THE FIRST PACK OF AMETHYST

Day 1 Start      
1. On Day 1 of your period, peel the day label from the sticker sheet which has the corresponding start day of your period printed on the left hand side; place the label on the dispenser in the designated location. Take your pill daily in the order indicated by the arrows on the dispenser card. Pick a time of day which will be easy to remember and take your pill at the same time every day.

2. Take the first “active” white pill of the first pack during the first 24 hours of your period.

3. You will not need to use a back-up nonhormonal method of birth control, since you are starting the pill at the beginning of your period.

WHAT TO DO DURING THE MONTH

1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.

Do not skip pills even if you are 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 PACK

Start the next pack on the day after your last pill. Do not wait any days between packs.

IF YOU SWITCH FROM ANOTHER BRAND OF COMBINATION PILLS:
When switching from a 21 pill pack: Start Amethyst on the first day of your period (withdrawal bleed). Be sure that no more than 7 days pass between the last day of your 21-day pack and your first Amethyst pill.

When switching from a 28 pill pack (21 active and 7 inactive pills, or 24 active and 4 inactive pills): Start Amethyst on the first day of your period (withdrawal bleed). Be sure that no more than 7 days pass after the last active pill and your first Amethyst pill.

IF YOU SWITCH FROM ANOTHER TYPE OF BIRTH CONTROL
When switching from other types of birth control such as pills containing only a progestin (progestin only pill or POP), an injection, or an implant, your health care professional will provide you with instructions for when to start Amethyst.

WHAT TO DO IF YOU MISS PILLS

Combination oral contraceptives may not be as effective if you miss pills. Instructions for what to do if you miss pills are provided in the following table.

# of pills missed in a row	What to do when you miss a pill(s)
1 missed pill	• Take the missed pill as soon as you remember. THEN
	• Take the next pill at your regular time. This means you may take 2 pills in 1 day.
	• You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms and/or spermicide) as a back-up for those 7 days.
2 missed pills   and remembered on the day of the second missed pill	• Take 2 missed pills on the day you remember. The following day you are back on schedule to take 1 pill a day.
	For example, you take your pills in the morning and you missed 1 pill on Monday and 1 on Tuesday. On Tuesday evening you remembered that you missed your Monday and Tuesday pills. You take the 2 missed pills on Tuesday evening and on Wednesday morning you’re back on schedule and you take 1 pill.
	• You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms and/or spermicide) as a back-up for those 7 days.
2 missed pills   and remembered on the day after the second pill is missed	• Take 2 missed pills on the day you remember. The next day you take 2 pills. The following day you are back on schedule to take your pills.
	For example, you take your pills in the morning and you missed 1 pill on Monday and 1 on Tuesday. On Wednesday morning you remembered that you missed your Monday and Tuesday pills. You take the 2 missed pills on Wednesday morning and 2 pills on Thursday morning. On Friday morning you’re back on schedule and you take 1 pill.
	• You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms and/or spermicide) as a back-up for those 7 days.
3 or more missed pills	• Contact your health care professional for further advice. Keep taking one pill every day until you reach your health care professional. Do not take the missed pills.
	• You COULD BECOME PREGNANT if you have sex during the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms and/or spermicide) as a back-up for those 7 days.

FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED

Use a BACK-UP NONHORMONAL BIRTH-CONTROL METHOD anytime you have sex.

KEEP TAKING ONE PILL EACH DAY until you can reach your health care professional.

PREGNANCY DUE TO PILL FAILURE

The incidence of pill failure resulting in pregnancy is approximately 1 to 2% per year (1 to 2 pregnancies per 100 women per year of use) if taken every day as directed, but the average failure rate is approximately 5% per year (5 pregnancies per 100 women per year of use) including women who do not always take the pill exactly as directed without missing any pills. If you do become pregnant, the risk to the fetus is minimal, but you should stop taking your pills and discuss the pregnancy with your health care professional.

PREGNANCY AFTER STOPPING THE PILL
If you do not desire pregnancy, you should use another method of birth-control immediately after stopping Amethyst. A pregnancy can occur within days after stopping Amethyst.

There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill.

There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy.

OVERDOSAGE
Overdosage may cause nausea, vomiting, breast tenderness, dizziness, abdominal pain, and fatigue/drowsiness. Withdrawal bleeding may occur in females. In case of overdosage, contact your health care professional or pharmacist.

OTHER INFORMATION
Your health care professional will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care professional believes that it is appropriate to postpone it. You should be reexamined at least once a year. Be sure to inform your health care professional if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health care professional, because this is a time to determine if there are early signs of side effects of oral contraceptive use.

Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth-control pills.

HEALTH BENEFITS FROM ORAL CONTRACEPTIVES
In addition to preventing pregnancy, some information suggests that the use of oral contraceptives provide certain other benefits. The benefits are:

• Decreased blood loss, and less iron may be lost. Therefore, anemia due to iron deficiency is less likely to occur.
  
• Pain or other cycle-related symptoms may occur less frequently.
  
• Ovarian cysts may occur less frequently.
  
• Ectopic (tubal) pregnancy may occur less frequently.
  
• Noncancerous cysts or lumps in the breast may occur less frequently.
  
• Acute pelvic inflammatory disease may occur less frequently.
  
• Oral contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus.

If you want more information about birth-control pills, ask your health care professional or pharmacist. They have a more technical leaflet called the Professional Labeling which you may wish to read.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Brands listed are the trademarks of their respective owners.

Distributed by:

Actavis Pharma, Inc.

Parsippany, NJ 07054 USA

Rev. A 12/2021

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 52544-295-28
Rx Only
Amethyst
(Levonorgestrel and
Ethinyl Estradiol Tablets, USP,
90 mcg/20 mcg)