HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using this product. The leaflet contains very important information about this device. 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 12 weeks after the device is placed to make sure it is still in the proper position.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 an additional 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.
SIDE EFFECTS: 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 persist or worsen, 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 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 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.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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