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Brand Names: Mirena

Generic Name: levonorgestrel intrauterine system (Pronunciation: LEE voe nor JES trel)

• What is levonorgestrel intrauterine system (Mirena)?
• What are the possible side effects of levonorgestrel intrauterine system (Mirena)?
• What is the most important information I should know about levonorgestrel intrauterine system (Mirena)?
• What should I discuss with my healthcare provider before taking levonorgestrel intrauterine system (Mirena)?
• How is levonorgestrel intrauterine system used (Mirena)?
• What happens if I miss a dose (Mirena)?
• What happens if I overdose (Mirena)?
• What should I avoid while using levonorgestrel intrauterine system (Mirena)?
• What other drugs will affect levonorgestrel intrauterine system (Mirena)?
• Where can I get more information?

What is levonorgestrel intrauterine system (Mirena)?

Levonorgestrel is a female hormone. This hormone can cause changes in your cervical mucus and uterine lining, 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 contains the hormone levonorgestrel. This device is placed in the uterus where it slowly releases the hormone to prevent pregnancy for up to 5 years. Levonorgestrel intrauterine system is meant for use in a woman who has had at least one child and is in a stable sexual relationship with someone who has no other sexual partners.

Levonorgestrel intrauterine system is also used in women who have heavy menstrual bleeding and choose to use an intrauterine form of birth control.

Levonorgestrel is a progestin hormone and does not contain estrogen. The intrauterine device releases levonorgestrel into the uterus, but only small amounts of the hormone reach your blood stream.

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

What are the possible side effects of levonorgestrel intrauterine system (Mirena)?

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 intrauterine device 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. If the device embeds in or perforates the uterine wall, your doctor may need to surgically remove the device.

Call your doctor at once if you have a serious side effect such as:

• severe cramps or pelvic pain;
• extreme dizziness, feeling like you might pass out;
• heavy or ongoing vaginal bleeding, vaginal sores, vaginal discharge that is watery, foul-smelling discharge, or otherwise unusual;
• severe pain in your side or lower stomach;
• pale skin, weakness, easy bruising or bleeding;
• fever, chills, or other signs of infection;
• pain during sexual intercourse;
• sudden numbness or weakness, especially on one side of the body;
• sudden or severe headache, 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.

Less serious side effects may include:

• irregular menstrual periods, changes in bleeding patterns or flow;
• breakthrough bleeding, or heavier menstrual bleeding during the first few weeks after device insertion;
• back pain;
• headache, nervousness, mild dizziness;
• nausea, vomiting, bloating;
• breast tenderness or pain;
• weight gain, acne, changes in hair growth;
• mood changes, loss of interest in sex;
• mild itching, skin rash; or
• puffiness in your face, hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about levonorgestrel intrauterine system (Mirena)?

You should not use this medication if you have abnormal vaginal bleeding, an uncontrolled pelvic infection, a condition that affects the shape of the uterus, past or present breast cancer, a liver problem, cervical or uterine cancer, a weak immune system, if you have recently had a serious pelvic infection following a pregnancy or abortion, or if you already have an intrauterine device (IUD) in place.

You also should not use this medication if you have a history of pelvic inflammatory disease (unless you have had a normal pregnancy after the infection was treated and cleared), a recent abnormal Pap smear that has not yet been diagnosed or treated, or if you do not have an exclusive sexual partner.

Before using the levonorgestrel intrauterine device, tell your doctor if you have diabetes, a bleeding or blood-clotting disorder, a vaginal infection, pelvic infection, or sexually transmitted disease, high blood pressure, heart disease, or a heart valve disorder.

Serious side effects of the intrauterine system include severe cramps or pelvic pain, heavy or ongoing vaginal bleeding, unusual vaginal discharge, pale skin, easy bruising or bleeding, fever, chills, sudden numbness or weakness, severe headaches, or jaundice (yellowing of the skin or eyes).

Only your doctor should remove the levonorgestrel intrauterine system. Do not attempt to remove the device yourself.

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