My Way

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of levonorgestrel, there are no specific foods that you must exclude from your diet when receiving this medication.

Before having the intrauterine device (IUD) placed, tell your doctor if you:

• have had a heart attack
• have had a stroke
• were born with heart disease or have problems with your heart valves
• have problems with blood clotting or take medicine to reduce clotting
• have high blood pressure
• recently had a baby or if you are breastfeeding
• have diabetes (high blood sugar)
• use corticosteroid medications on a long-term basis
• have severe migraine headaches

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

You may use the intrauterine device (IUD) when you are breastfeeding if more than six weeks have passed since you had your baby. If you are breastfeeding, the IUD is not likely to affect the quality or amount of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported among women using progestin-only birth control pills.

First, your healthcare provider will examine your pelvis to find the exact position of your uterus. Your healthcare provider will then clean your vagina and cervix with an antiseptic solution, and slide a thin plastic tube containing the intrauterine device (IUD) into your uterus. Your healthcare provider will then remove the plastic tube, and leave the IUD in your uterus. Your healthcare provider will cut the threads to the right length. Placement takes only a few minutes during an office visit.

You may experience pain, bleeding or dizziness during and after placement. If these symptoms do not pass 30 minutes after placement, the IUD may not have been placed correctly. Your healthcare provider will examine you to see if the IUD needs to be removed or replaced.

You should check that the IUD is in proper position by feeling the removal threads. You should do this after each menstrual period. First, wash your hands with soap and water. Feel for the threads at the top of your vagina with your clean fingers. The threads are the only part of the IUD you should feel when it is in your uterus. Be careful not to pull on the threads. If you feel more than just the threads, the IUD is not in the right position and may not prevent pregnancy. Call your healthcare provider to have it removed. If you cannot feel the threads at all, ask your healthcare provider to check the IUD is still in the right place. In either case, use a non-hormonal birth control method (such as condoms or spermicide) until otherwise advised by your healthcare provider.

Call your healthcare provider if you have any questions or concerns. Otherwise, you should return to your healthcare provider for a follow-up visit 4 to 12 weeks after the IUD is placed to make sure that it is in the right position.

Tampons may be used with the IUD.

Call your healthcare provider if you have any concerns about this medication. Be sure to call if you:

• think you are pregnant
• have pelvic pain or pain during sex
• have unusual vaginal discharge or genital sores
• have unexplained fever
• might be exposed to sexually transmitted diseases (STDs)
• cannot feel the IUD threads
• develop very severe or migraine headaches
• have yellowing of the skin or whites of the eyes. These may be signs of liver problems.
• have a stroke or heart attack
• or your partner becomes HIV positive
• have severe vaginal bleeding or bleeding that lasts a long time

The intrauterine device (IUD) contains 52 mg of levonorgestrel. Initially, levonorgestrel is released at a rate of approximately 20 mcg/day. This rate decreases over time to half that amount after 5 years.

Levonorgestrel-releasing intrauterine system contains a total of 52 mg levonorgestrel and is available in a carton of one sterile unit. Each hormone-releasing system is packaged together with an inserter in a thermoformed blister package with a peelable lid.

It is supplied sterile, and is sterilized with ethylene oxide. Do not resterilize. For single use only. Do not use if the inner package is damaged or open. Insert before the end of the month shown on the label.

In the U.S.

• My Way
• Next Choice
• Plan B
• Plan B One-Step

In Canada

• Option 2

Available Dosage Forms:

• Tablet

Therapeutic Class: Contraceptive, Progestin

Pharmacologic Class: Progestin

This section provides information on the proper use of a number of products that contain levonorgestrel. It may not be specific to My Way. Please read with care.

Use this medicine exactly as directed by your doctor or follow the instructions on the package. This medicine is for occasional use as emergency birth control. It should not replace your regular birth control method. You may use this medicine at any time during your monthly period.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Plan B One-Step® is available as an over-the-counter medicine for any woman of childbearing potential.

If you vomit within 2 hours after taking this medicine, call your doctor right away. Your doctor may prescribe another tablet for you.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For emergency contraception:
  • For oral dosage form (Plan B One-Step® tablets):
    • Adults and teenagers—One tablet taken as soon as possible and not more than 72 hours (3 days) after unprotected sex or after failure of another birth control method.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check you closely to make sure this medicine is working properly and does not cause unwanted effects.

Although you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. Your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Call your doctor right away if you have severe lower abdominal or stomach pain 3 to 5 weeks after taking this medicine. You may have a pregnancy outside of the uterus (womb), which is called an ectopic pregnancy. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

You may have some blood spotting a few days after taking this medicine. If the bleeding continues for more than 1 week, check with your doctor right away.

This medicine may make your next monthly period later than expected by a few days. If your next period after taking this medicine is more than 1 week late, check with your doctor right away for a pregnancy test.

This medicine will not protect you from getting HIV/AIDS or other sexually transmitted infections. If this is a concern for you, talk with your doctor.

Your regular birth control method such as birth control pills or patch may not work as well while you are using this medicine. After using this medicine, you must use two forms of birth control. Use birth control pills or patch together with another form of birth control, such as a condom, diaphragm, or contraceptive foam or jelly, during any other times that you have sex in the same monthly period you used this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Applies to levonorgestrel: oral tablet

Other dosage forms:

• intradermal implant, intradermal kit
• intrauterine insert extended release

Along with its needed effects, levonorgestrel (the active ingredient contained in My Way) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking levonorgestrel:

• Heavy or light menstrual bleeding

• Absent missed or irregular menstrual periods
• cramps
• irregular menstruation
• pain
• pain in the pelvis
• stopping of menstrual bleeding

Some side effects of levonorgestrel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• dizziness
• headache
• nausea
• tenderness of the breasts
• unusual tiredness or weakness
• vomiting

• Diarrhea