Levonorgestrel intrauterine system

Levonorgestrel is a female hormone that can cause changes in your cervix, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus. Levonorgestrel intrauterine system is a plastic device that is placed in the uterus where it slowly releases the hormone to prevent pregnancy for 3 to 5 years.

Levonorgestrel intrauterine system is used to prevent pregnancy for up to 5 years. You may use this device whether you have children or not. Mirena is also used to treat heavy menstrual bleeding in women who choose to use an intrauterine form of birth control.

Levonorgestrel is a progestin hormone and does not contain estrogen. The intrauterine device (IUD) releases levonorgestrel in the uterus, but only small amounts of the hormone reach the bloodstream. Levonorgestrel intrauterine system should not be used as emergency birth control.

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

An intrauterine device 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 your personal risk.

Do not use this IUD during pregnancy. This device can cause severe infection, miscarriage, premature birth, or death of the mother if left in place during pregnancy. Tell your doctor right away if you become pregnant. If you choose to continue a pregnancy that occurs while using a levonorgestrel intrauterine system, watch for signs of infection such as fever, chills, flu symptoms, 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, or bladder);

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

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

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

• past or present breast cancer, known or suspected cervical or uterine cancer;

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

• a recent abnormal Pap smear that has not yet been diagnosed or treated;

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

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

To make sure levonorgestrel is safe for you, tell your doctor if you have ever had:

• high blood pressure, heart disease or a heart valve disorder;

• a heart attack or stroke;

• a bleeding or blood-clotting disorder;

• migraine headaches; or

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

You should not use this IUD if you are breast-feeding a baby younger than 6 weeks old. This IUD may be more likely to form a hole or get embedded in the wall of your uterus if you have the device inserted while you are breast-feeding.

Avoid having more than one sexual 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 is the only way to help protect yourself from these diseases.

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

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.

The levonorgestrel 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.

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;

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

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

• signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• pelvic pain, vaginal itching or infection, irregular menstrual periods, changes in bleeding patterns or flow;

• stomach pain, nausea, vomiting, bloating;

• headache, depression, mood changes;

• back pain, breast tenderness or pain;

• weight gain, acne, 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.