Levonorgestrel is a female hormone that can cause changes in your cervix and uterus. Levonorgestrel intrauterine system or intrauterine device (IUD) is placed in the uterus where it slowly releases the hormone.

Levonorgestrel intrauterine system is used to prevent pregnancy. Mirena is also used to treat heavy menstrual bleeding in women who choose to use an intrauterine form of birth control.

Levonorgestrel does not contain estrogen and should not be used as emergency birth control.

Levonorgestrel intrauterine system may also be used for purposes not listed in this guide.

Do not use during pregnancy. Tell your doctor right away if you become pregnant.

Levonorgestrel intrauterine system is a small, flexible, T-shaped plastic device to be inserted into the uterus by a health-care provider. The Mirena brand intrauterine systems may be left in place for up to 8 years after it is inserted if it is being used for pregnancy prevention, the Liletta brand intrauterine systems may be left in place for up to 8 years after it is inserted, the Kyleena brand intrauterine systems may be left in place for up to 5 years after it is inserted, and the Skyla brand intrauterine system may be left in place for up to 3 years after it is inserted. If you still want to use an intrauterine system to prevent pregnancy after this time has passed, your healthcare provider can insert a new system as soon as the old system is removed. The intrauterine systems may be removed by a doctor any time that you want to become pregnant or want to use a different form of birth control. If the Liletta brand or Mirena brand intrauterine system is used to treat heavy menstrual bleeding, it may be left in place for up to 5 years after it is inserted.

Your doctor will tell you the best time to have the levonorgestrel intrauterine system inserted. Depending on the timing, you may need to use a non-hormonal birth control method such as condoms and spermicide for 7 days to prevent pregnancy if sexual intercourse occurs. Your intrauterine system may be inserted immediately after a first-trimester miscarriage or abortion. If you have given birth, had a miscarriage, or had a second-trimester abortion, your intrauterine system should not be inserted until at least 6 weeks have passed and a physical exam shows that your uterus has recovered from the pregnancy.

You will need to have your intrauterine system removed in your health-care provider's office or clinic. You may experience some of these symptoms during and after the removal: sweating, pale skin, fast heartbeat, fainting, dizziness, cramping, and bleeding.

You will need to have your intrauterine system inserted in your health-care provider's office or clinic. Your health-care provider may tell you to take a nonprescription pain reliever prior to your appointment to help decrease cramping during and after the placement. You may experience some of these symptoms during and after the placement: sweating, pale skin, fast heartbeat, fainting, dizziness, cramping, and bleeding. Tell your health-care provider if your cramping is severe or if these symptoms last for longer than 30 minutes. Your health-care provider will check you to be sure that your system has been placed correctly.

Call your doctor if you experience severe pain during the first few hours after your intrauterine system is inserted. This may be a sign of a serious infection.

Your health-care provider will place your intrauterine system into your uterus, but will leave two threads dangling through your cervix. You should check for these threads once a month so that you will know whether your intrauterine system is still in place. To check for the threads, you should wash your hands with soap and water. Then, reach up to the top of your vagina with clean fingers to feel the threads. If you cannot feel the threads or if you feel any part of the intrauterine system other than the threads, your intrauterine system may not be in place and may not prevent pregnancy. If this happens, call your doctor and use a non-hormonal birth control method such as condoms and spermicide to prevent pregnancy until you are seen by your doctor.

You will need a follow-up appointment with your health-care provider 4-6 weeks after your intrauterine system is inserted to be sure that your system is properly in place. After this appointment, you will need to be examined once every year or more often if you have any problems or concerns.

If your levonorgestrel intrauterine system must be removed, talk to your doctor about the best time to remove it. You are not protected from pregnancy once your intrauterine system is removed, so if you do not want to become pregnant, you will need to be sure that you have effective birth control as soon as your intrauterine system is removed. If you plan to have your intrauterine system replaced with a new intrauterine system, you can have the old system removed and the new system inserted at any time during your menstrual cycle. If you have chosen to use a different form of birth control instead of your intrauterine system and you have regular menstrual cycles, you should have the system removed during the first 7 days after your menstrual period begins and begin using your new form of birth control right away. If you have chosen to use a different form of birth control and you do not have regular cycles, you do not menstruate at all, or you are not able to have your intrauterine system removed during the first 7 days of your menstrual period, you should start using your new form of birth control 7 days before your intrauterine system is removed.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

The levonorgestrel IUD is inserted through the vagina and placed into the uterus by a doctor.

You may feel pain or dizziness during insertion of the IUD, and you may have minor vaginal bleeding. Tell your doctor if these symptoms last longer than 30 minutes.

The IUD should not interfere with sexual intercourse, wearing a tampon or menstrual cup, or using other vaginal medications.

Your doctor should check the IUD after a few weeks to make sure it is still in place. You will also need annual pelvic exams and Pap smears.

You may have irregular periods for 3 to 6 months. Your flow may be lighter or heavier, and your periods may stop after several months. Tell your doctor if you do not have a period for 6 weeks or if you think you might be pregnant.

The IUD may come out by itself. After each menstrual period, make sure you can still feel the removal strings at the opening of your cervix.

Call your doctor at once if you cannot feel the strings, or if you think the IUD has slipped lower or has come out of your uterus, especially if you also have pain or bleeding. Use a non-hormone method of birth control (condom, diaphragm, cervical cap, or contraceptive sponge) to prevent pregnancy until your doctor is able to replace the IUD.

If you need to have an MRI (magnetic resonance imaging), tell your caregivers ahead of time that you have an IUD in place.

Your IUD may be removed at any time you decide to stop using birth control. Mirena must be removed at the end of the 8-year wearing time, and Liletta must be removed after 6 years. Kyleena must be removed after 5 years, and Skyla must be removed after 3 years. Your doctor can insert a new device if you wish to continue using this form of birth control. Only your doctor should remove the IUD. Do not attempt to remove the device yourself.

If you decide to use a different method of birth control, you may need to start using it a week before your IUD is removed.

An IUD can increase your risk of developing a serious pelvic infection, which may threaten your life or your future ability to have children. Ask your doctor about this risk.

Do not use during pregnancy. If left in place during pregnancy, this IUD could cause severe infection, miscarriage, premature birth, or death of the mother. The hormone in the IUD may also cause unwanted effects in a female newborn.

Tell your doctor right away if you become pregnant. If you continue the pregnancy, watch for signs such as fever, chills, cramps, vaginal bleeding or discharge.

You should not use this device if you are allergic to levonorgestrel, silicone, silica, silver, barium, iron oxide, or polyethylene, or if you have:

• abnormal vaginal bleeding that has not been checked by a doctor;

• an untreated or uncontrolled pelvic infection (vaginal, cervical, uterine);

• endometriosis or a serious pelvic infection following a pregnancy or abortion in the past 3 months;

• pelvic inflammatory disease (PID), unless you had a normal pregnancy after the infection was treated and cleared;

• uterine fibroid tumors or conditions that affect the shape of the uterus;

• past or present cancer of the breast, cervix, or uterus;

• liver disease or liver tumor (benign or malignant);

• a condition that weakens your immune system, such as AIDS, leukemia, or IV drug abuse;

• if you have another intrauterine device (IUD) in place;

• if you had an abortion or miscarriage in the past 6 weeks; or

• if you gave birth to a baby in the past 6 weeks.

Tell your doctor if you have ever had:

• high blood pressure, heart problems, a heart attack, or a stroke;

• bleeding problems;

• migraine headaches; or

• a vaginal infection, pelvic infection, or sexually transmitted disease.

Tell your doctor if you are breastfeeding.

Since the IUD continuously releases a low dose of levonorgestrel, missing a dose does not occur when using this form of levonorgestrel.

An overdose of levonorgestrel released from the intrauterine system is very unlikely to occur.

Unless your doctor tells you otherwise, continue your normal diet.

Avoid having more than one sex partner. The IUD can increase your risk of developing a serious pelvic infection, which is often caused by sexually transmitted disease. Levonorgestrel intrauterine system will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom may help protect from these diseases.

Call your doctor if your sex partner develops HIV or a sexually transmitted disease, or if you have any change in sexual relationships.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy.

The IUD may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. Your doctor may need to surgically remove the device.

Levonorgestrel intrauterine system may cause serious side effects. Call your doctor at once if you have:

• severe cramps or pelvic pain, pain during sexual intercourse;

• extreme dizziness or light-headed feeling;

• severe migraine headache;

• heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;

• pale skin, weakness, easy bruising or bleeding, fever, chills, or other signs of infection;

• jaundice (yellowing of the skin or eyes); or

• sudden numbness or weakness (especially on one side of the body), confusion, problems with vision, sensitivity to light.

Common side effects of levonorgestrel intrauterine system may include:

• pelvic pain, painful or irregular menstrual periods, changes in bleeding patterns or flow;

• vaginal swelling, itching or infection;

• temporary pain, bleeding, or dizziness during insertion of the IUD;

• ovarian cysts (pelvic pain that disappears within 3 months);

• stomach pain, nausea, vomiting, bloating;

• headache, migraine, depression, mood changes;

• back pain, breast tenderness or pain;

• weight gain, acne, oily skin, changes in hair growth, loss of interest in sex; or

• puffiness in your face, hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect levonorgestrel, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor.

If you have a Skyla or Kyleena brand intrauterine system, tell your doctor and the radiology staff that you have one of these types of intrauterine system before you undergo a magnetic resonance imaging (MRI) scan.

Ask your pharmacist any questions you have about levonorgestrel intrauterine system.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.