Generic name: Levonorgestrel and Ethinyl Estradiol

What is Amethyst?

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.

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.

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

Amethyst (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.

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.

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.

Who should not take Amethyst?

Cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from oral contraceptive use. The 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 contraceptive should not smoke.

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.

What should I tell my healthcare provider before taking Amethyst?

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.

Before you start taking Amethyst

Be sure to read the directions before you start taking your pills and anytime you are not sure what to do.

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. At your Amethyst dispenser. The pill pack has 28 “active” white pills (with hormones).

3. Also find:

  • where on the pack to start taking pills, and
  • in what order to take the pills (follow the arrows).
Packet Diagram
* For use of day labels, see WHEN TO START THE FIRST 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 Amethyst pack.

How should I take Amethyst?

1. 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.

2. 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.

3. 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.

4. 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.

5. If you vomit (within 4 hours after you take your pill), you should follow the instructions for “What to do if you miss pills” below. 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.

6. 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.

7. If you have any questions or are unsure about the information in this guide, call your health care professional.

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 ), 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 below.

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.

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.

What are the possible side effects of Amethyst?

Most side effects of the pill are not serious. The most common such effects are:

  • nausea
  • vomiting
  • unscheduled bleeding
  • weight gain
  • breast tenderness
  • 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:

  • 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.
  • 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.
  • 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.

Various studies give conflicting reports on the relationship between breast cancer and oral contraceptive use.

Oral contraceptive use may slightly increase your chance of having breast cancer diagnosed, particularly if you started using hormonal contraceptives at a younger age.

After you stop using hormonal contraceptives, the chances of having breast cancer diagnosed begin to go down, and disappear 10 years after stopping use of the pill. It is not known whether this slightly increased risk of having breast cancer diagnosed is caused by the pill. It may be that women taking the pill were examined more often, so that breast cancer was more likely to be detected.

You should have regular breast examinations by a health care professional and examine your own breasts monthly. Tell your health care professional if you have a family history of breast cancer or if you have had breast nodules or an abnormal mammogram. Women who currently have or have had breast cancer should not use oral contraceptives because breast cancer is usually a hormone-sensitive tumor.

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.

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.

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.

What are the ingredients in Amethyst?

Active Ingredients: Levonorgestrel and Ethinyl Estradiol

Inactive Ingredients: Microcrystalline Cellulose, Lactose Monohydrate, Magnesium Stearate, Croscarmellose Sodium , Povidone K30

Source: National Library of Medicine. Last updated December 2, 2017.