This product is a small, flexible device that is placed in the womb (uterus) to prevent pregnancy. It is used in women who desire reversible birth control that works for a long time (up to 5 years). The device works by slowly releasing a hormone (levonorgestrel) that is similar to a certain substance made by a woman's body.

This product is only intended for women who have previously given birth and have only one sexual partner. It is not meant for women with a history of certain infections/conditions (e.g., pelvic inflammatory disease, sexually transmitted disease, a certain problem pregnancy called ectopic pregnancy). For more information, consult your doctor.

The use of this medication device does not protect you or your partner against sexually transmitted diseases (e.g., HIV, gonorrhea).

Carefully read all of the information provided by your doctor, and ask any questions you may have about this product or other birth control methods that may be right for you.

Read the Patient Information Leaflet provided by your pharmacist before this medication device is inserted and each time it is re-inserted. The leaflet contains very important information about side effects and when it is important to call your doctor. If you have any questions, consult your doctor or pharmacist.

This product is inserted into your uterus by a properly trained health care professional, usually once every 5 years or as determined by your doctor. The medication in the device is slowly released into the body over a 5-year period.

Have a follow-up appointment 4-12 weeks after insertion of this product to check that it is still correctly in place.

If you still desire birth control after 5 years, the medication device may be replaced with a new one. The medication device may also be removed at any time by a properly trained health care professional.

Learn all the instructions on how and when to check this product and its proper positioning in your body, and make sure you understand the problems that may occur with this product. See also Precautions section.

Irregular vaginal bleeding (e.g., spotting), cramps, headache, nausea, breast pain, acne, rash, hair loss, weight gain, or decreased interest in sex may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication device because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication device do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: lack of menstrual period, unexplained fever, chills, trouble breathing, mental/mood changes (e.g., depression, nervousness), vaginal swelling/itching, painful intercourse.

Tell your doctor immediately if any of these unlikely but serious side effects occur: migraine/severe headache, vomiting, tiredness, fast/pounding heartbeat.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: prolonged or heavy vaginal bleeding, unusual vaginal discharge/odor, vaginal sores, abdominal/pelvic pain or tenderness, lumps in the breast, yellowing eyes/skin, dark urine, persistent nausea, trouble urinating.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this medication device, tell your doctor or pharmacist if you are allergic to levonorgestrel, or to any other progestins (e.g., norethindrone, desogestrel); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication device should not be used if you have certain medical conditions. Before using this product, consult your doctor or pharmacist if you have: current known or suspected pregnancy, previous ectopic pregnancy, uterus problems (e.g., cancer, endometriosis, fibroids, pelvic inflammatory disease-PID), other IUD (intrauterine device) still in place, vaginal problems (e.g., infection), breast cancer, liver disease/tumors, any condition that affects your immune system (e.g., AIDS, leukemia).

Before using this product, tell your doctor your medical history, especially of: bleeding problems (e.g., menstrual changes, clotting problems), heart problems (e.g., congenital valve conditions), high blood pressure, migraine headaches, stroke, diabetes.

If you have diabetes, this medication may make it harder to control your blood sugar levels. Monitor your blood sugar regularly as directed by your doctor. Tell your doctor the results and any symptoms such as increased thirst/urination. Your anti-diabetic medication or diet may need to be adjusted.

This medication device may sometimes come out by itself or move out of place. This may result in unwanted pregnancy or other problems. After each menstrual period, check to make sure it is in the right place. Talk to your doctor about how to check your device. If it comes out or you cannot feel its threads, call your doctor promptly, and use a backup birth control method such as condoms.

If you or partner has any other sexual partners, this medication device may no longer be a good choice for pregnancy prevention. If you or your partner becomes HIV positive, or if you think you may have been exposed to any sexually transmitted disease, contact your doctor immediately. You should consider having this device removed.

This medication device must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor immediately. If you have just given birth and are not breast-feeding, or if you have had a pregnancy loss or abortion after the 3 months of pregnancy, wait at least 6 weeks (or as directed by your doctor) before using this medication device. Consult your doctor about the problems that may occur during pregnancy while using this product.

Levonorgestrel passes into breast milk. Consult your doctor before breast-feeding.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication device, tell your doctor of all prescription and nonprescription medications you may use, especially of: "blood thinners" (e.g., warfarin), birth control taken by mouth or applied to the skin (patch), certain drug used for varicose vein treatment (sodium tetradecyl sulfate), drugs that affect your immune response (e.g., corticosteroids such as prednisone).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose with this medication is very unlikely because of the way the drug is released from this device. Consult your doctor or pharmacist for more information.

Do not share this medication with others.

Keep all appointments with your doctor and the laboratory. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.

Not applicable.

Before use, store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep all medications and medical devices away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised June 2010. Copyright(c) 2010 First Databank, Inc.