This product is a small, flexible device that is placed in the womb (uterus) to prevent pregnancy. It is used by women who want to use a reversible birth control method that works for a long time (up to 5 years). It is also used to treat heavy menstrual bleeding in women who choose to use this birth control method. The device slowly releases a hormone (levonorgestrel) that is similar to a hormone that women normally make. This device and hormone helps prevent pregnancy.

Using this product does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

Read the Patient Information Leaflet if available from your pharmacist before you start using this product. If you have any questions, ask your doctor or pharmacist.

This device is placed in your uterus by a health care provider during an in-office visit. It is left in place for up to 5 years. Schedule a follow-up visit 4 to 6 weeks after the device is placed to make sure it is still in the proper position.

Ask your doctor if you need to use a backup form of birth control for the first 7 days after this device is placed to prevent pregnancy until the device has enough time to work.

This device may sometimes move out of place or come out by itself. After each menstrual period, check to make sure it is in the proper position. Learn how to carefully check the position of this device from the Patient Information Leaflet and/or your health care provider. If it comes out or if you cannot feel the threads, contact your doctor promptly and use a backup form of non-hormonal birth control (such as condoms, spermicide) to prevent pregnancy until otherwise directed by your doctor.

If you wish to continue this method of birth control after 5 years, the used device may be removed and replaced with a new one. Either way, the used device should be removed after 5 years. Your health care provider can remove this device whenever you want to stop using this method of birth control.

Pain, bleeding, or dizziness during and after placement of the device may occur. Cramps, irregular menstrual periods, and vaginal bleeding between periods (spotting) may occur, especially during the first few weeks of use. Headache, nausea, breast tenderness, or weight gain may also occur. If any of these effects last or get worse, tell your doctor promptly.

After your body adjusts to this product, it is normal to have fewer bleeding days during your menstrual periods, and some women stop having periods altogether. This will not affect your ability to become pregnant after stopping use of this product.

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

Tell your doctor right away if you have any serious side effects, including:

• stomach/abdominal pain
• vomiting
• lumps in the breast
• mental/mood changes (such as new/worsening depression)
• unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding, missed periods)
• dark urine
• yellowing eyes/skin
• unusual headaches (including headaches with vision changes/lack of coordination, worsening of migraines, sudden/very severe headaches)

Using an intrauterine device (IUD) may increase your risk for a rare but serious pelvic infection (pelvic inflammatory disease-PID), which can cause permanent damage to sex organs and infertility. The risk is greater in women who have multiple sexual partners, or infection with a sexually transmitted disease (STD), or who have had PID in the past (see also Precautions section). Tell your doctor right away if you experience symptoms of PID, including:

• unexplained fever/chills
• lower abdominal/pelvic pain
• pain during sexual intercourse
• genital sores
• unusual vaginal discharge

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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 or at www.fda.gov/medwatch.

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 (such as 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.

Before using this product, tell your doctor or pharmacist your medical history, especially of:

• recent pregnancy
• current breastfeeding
• bleeding/blood disorders
• high blood pressure
• abnormal breast exam
• cancer (especially endometrial or breast cancer)
• depression
• diabetes
• severe headaches/migraines
• heart problems (such as heart valve disease, irregular heartbeat, previous heart attack)
• liver disease (including tumors)
• previous pregnancy outside the uterus (ectopic pregnancy)
• stroke
• unexplained vaginal bleeding
• uterus problems (such as fibroids, pelvic inflammatory disease-PID)
• conditions that weaken the immune system/increase the risk of infection (such as HIV, leukemia, IV drug abuse)

If you or partner have other sexual partners, this device may not be the best birth control method for you. If you or your partner get a sexually transmitted disease (including HIV, gonorrhea, chlamydia), contact your doctor right away. Ask your doctor if you should continue to use this device for birth control.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Also, if you are going to have an MRI test, tell testing personnel that you are using this device. They may need to adjust your MRI test.

This device should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

Levonorgestrel passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication device may be harmful if swallowed. If someone has swallowed it and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

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 breasts, and report any lumps right away. Keep all medical and lab appointments. Consult your doctor for more details.

Not applicable.

Before use, store at room temperature. 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.