When This Medicine Should Not Be Used:
This device is not right for everyone. Do not use it if you had an allergic reaction to levonorgestrel, are pregnant, have liver disease or a liver tumor, or have breast cancer. Tell your doctor if you have had any problems, infections, or other conditions that affected your reproductive system. There are many problems that could make an IUD a bad choice for you, including if you have fibroids, unexplained bleeding, a uterus that has an unusual shape, a recent infection, pelvic inflammatory disease, abnormal Pap test, ectopic pregnancy, cancer or suspected cancer, or an existing IUD.

How to Use This Medicine:
Device

• The IUD is usually inserted by your doctor during your monthly period. You will need to see your doctor 4 to 6 weeks after the IUD is placed and then once a year.
• Your IUD has a string or "tail" that is made of plastic thread. About one or two inches of this string hangs into your vagina. You cannot see this string, and it will not cause problems when you have sex. Check your IUD after each monthly period. You may not be protected against pregnancy if you cannot feel the string or if you feel plastic. Do the following to check the placement of your IUD:
  
  • Wash your hands with soap and warm water. Dry them with a clean towel.
  • Bend your knees and squat low to the ground.
  • Gently put your index finger high inside your vagina. The cervix is at the top of the vagina. Find the IUD string coming from your cervix. Never pull on the string. You should not be able to feel the plastic of the IUD itself. Wash your hands after you are done checking your IUD string.
• Your doctor will need to replace your IUD after 3 years for Liletta™ or Skyla™, or after 5 years for Mirena®. You will also need to have it replaced if it comes out of your uterus.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Tell your doctor if you are using a blood thinner (including warfarin).

Warnings While Using This Medicine:

• Tell your doctor if you are breastfeeding, or you have had a baby, miscarriage, or abortion in the past 3 months. Tell your doctor if you have heart or blood circulation problems, including a history of heart valve problems, heart disease, blood clotting problems, stroke, heart attack, or high blood pressure. Tell your doctor if you have problems with your immune system or have had surgery on your female organs (especially fallopian tubes).
• There is a small chance that you could get pregnant when using an IUD, just as there is with any birth control. If you get pregnant, your doctor may remove your IUD to lower the risk of miscarriage or other problems.
• This medicine may cause the following problems:
  
  • Increased risk of ectopic pregnancy (pregnancy outside the uterus)
  • Increased risk of a serious infection called pelvic inflammatory disease (PID)
  • Increased risk for ovarian cysts
  • Perforation (hole in the wall of your uterus), which can damage other organs
• You might have some spotting and cramping during the first weeks after the IUD has been inserted. These symptoms should decrease or go away within a few weeks up to 6 months.
• You could have less bleeding or even stop having periods by the end of the first year. Call your doctor if you have a change from the regular bleeding pattern after you have had your IUD for awhile, such as more bleeding or if you miss a period (and you were having periods even with your IUD).
• An IUD can slip partly or all of the way out of your uterus. If this happens, use condoms or another form of birth control, and call your doctor right away.
• This IUD will not protect you from HIV/AIDS, herpes, or other sexually transmitted diseases.
• If you have the Skyla IUD™, tell your healthcare provider before you have an MRI test.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Abdominal or pelvic pain, tenderness, or cramping that is sudden or severe
• Chest pain, problems with speech or walking, numbness or weakness in your arm or leg or on one side of your body
• Heavy bleeding from your vagina
• Pain during sex, or if your partner feels the hard plastic of the IUD during sex
• Severe headache, vision changes
• Vaginal discharge has a bad smell, fever, chills, sores on your genitals

If you notice these less serious side effects, talk with your doctor:

• Acne or other skin changes
• Breast pain
• Change in bleeding pattern after the first few months
• Dizziness or lightheadedness after IUD is placed
• Mild itching around your vagina and genitals

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088