Levonorgestrel Treatment Report

Precautions

Instructions

Side Effects

Interactions

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 and about ways to help prevent a pelvic infection.

You should not use this medication if you are allergic to levonorgestrel, silicone, or polyethylene, or if you have:

• abnormal vaginal bleeding;
• an untreated or uncontrolled pelvic infection (vaginal, uterine, or bladder);
• 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;
• liver disease or liver tumor (benign or malignant);
• known or suspected cervical or uterine cancer;
• 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;
• if you have another intrauterine device (IUD) in place; or
• if you do not have an exclusive sexual partner.

You may need special tests to safely use a levonorgestrel intrauterine device if you have:

• diabetes;
• a bleeding or blood-clotting disorder;
• a vaginal infection, pelvic infection, or sexually transmitted disease; or
• high blood pressure, heart disease or a heart valve disorder.

Your doctor may ask about your partner’s medical and sexual history before prescribing a levonorgestrel intrauterine device for you.

The levonorgestrel intrauterine system should not be used during pregnancy. This device can cause severe infection, miscarriage, premature birth, or death of the mother if it is left in place during pregnancy. Tell your doctor right away if you become pregnant while using the intrauterine system.

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. Contact your doctor at once if you have any of these symptoms.

If you have recently had a baby and are breast-feeding, wait until your baby is at least 6 weeks old before you start using the intrauterine system.

Avoid having sexual intercourse with more than one partner. Also avoid having sexual intercourse with a partner who has other sexual partners besides you. The intrauterine device 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.

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

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

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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.

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Tell your doctor about all other medications you use, especially:

• insulin;
• a blood thinner such as warfarin (Coumadin); or
• steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

This list is not complete and there may be other drugs that can interact with the levonorgestrel intrauterine system. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Mirena, Norplant System, Plan B, and levonorgestrel

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