Uses of Liletta:

• It is used to prevent pregnancy.
• It is used to treat heavy bleeding during monthly periods (menstruation).

What do I need to tell my doctor BEFORE I take Liletta?

• If you are allergic to Liletta (52 MG) (levonorgestrel (IUD)); any part of Liletta (52 MG) (levonorgestrel (IUD)); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are pregnant or may be pregnant. Do not use Liletta (52 MG) (levonorgestrel (IUD)) if you are pregnant.
• If you have an IUD (intrauterine device) in place.
• If you have any of these health problems: Active liver disease, chlamydia or gonorrhea, endometritis after a birth, genital tract infection, infected abortion in the last 3 months, liver tumor, pelvic infection, uterine or cervical tumor or growth, uterine problems like uterine fibroids, or untreated cervicitis or vaginitis.
• If you have unexplained vaginal bleeding.
• If you have ever had any of these health problems: Breast cancer, cancer where hormones make it grow, or pelvic inflammatory disease.
• If you have a weak immune system, you use or abuse IV drugs, or you have a disease that may cause a weak immune system like HIV.
• If you or your partner have sex with more than one person.

This is not a list of all drugs or health problems that interact with Liletta (52 MG) (levonorgestrel (IUD)).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Liletta (52 MG) (levonorgestrel (IUD)) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Liletta?

• Tell all of your health care providers that you take Liletta (52 MG) (levonorgestrel (IUD)). This includes your doctors, nurses, pharmacists, and dentists.
• Ovarian cysts may rarely happen. Most of the time, these go back to normal in 2 to 3 months. Sometimes, ovarian cysts can cause pain and the need for surgery. Talk with the doctor.
• If you get pregnant while taking Liletta (52 MG) (levonorgestrel (IUD)), the chance of pregnancy outside of the uterus (ectopic pregnancy) may be raised. Talk with your doctor.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through having sex. Do not have any kind of sex without using a latex or polyurethane condom. If you have questions, talk with your doctor.
• If you are having an MRI, talk with your doctor.
• Life-threatening infection can happen within a few days after Liletta (52 MG) (levonorgestrel (IUD)) was put in. Call your doctor right away if you have fever or pain where Liletta (52 MG) (levonorgestrel (IUD)) was placed.
• Very bad health problems and the need for surgery can happen if Liletta (52 MG) (levonorgestrel (IUD)) goes through the uterus. Most of the time, this happens when this drug is put in but can happen at any time during use. The chance is raised if Liletta (52 MG) (levonorgestrel (IUD)) is put in while you are breast-feeding. This medicine may also not prevent pregnancy if this happens. If you have questions, talk with your doctor.
• This medicine may raise the chance of a health problem called pelvic inflammatory disease (PID). The chance may be higher if you or your partner have sex with other partners. PID can lead to other health problems like not being able to get pregnant, surgery, or rarely death. Talk with your doctor.
• Vaginal bleeding, spotting, or cramps may happen for 3 to 6 months after Liletta (52 MG) (levonorgestrel (IUD)) has been put in. If these signs do not go away or are very bad, call your doctor right away.
• If you cannot feel the string or you think Liletta (52 MG) (levonorgestrel (IUD)) has come out, call your doctor. You may get pregnant if Liletta (52 MG) (levonorgestrel (IUD)) comes out. Use another kind of birth control like a condom until you see your doctor.
• Periods may stop in some women after 1 year of using Liletta (52 MG) (levonorgestrel (IUD)). Periods will go back to normal when Liletta (52 MG) (levonorgestrel (IUD)) is taken out. If you do not have a period for 6 weeks when Liletta (52 MG) (levonorgestrel (IUD)) is in place, call your doctor.
• You may need to have a pregnancy test before Liletta (52 MG) (levonorgestrel (IUD)) is put in. If you have questions, talk with your doctor.
• If you think you may be pregnant while Liletta (52 MG) (levonorgestrel (IUD)) is in place, call your doctor right away. Very bad and sometimes deadly health problems can happen when Liletta (52 MG) (levonorgestrel (IUD)) is removed or if it is left in place during pregnancy. This includes loss of fertility, infections, and loss of the unborn baby. Talk with your doctor about the risks of getting pregnant while Liletta (52 MG) (levonorgestrel (IUD)) is in place.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Liletta) best taken?

Use Liletta (52 MG) (levonorgestrel (IUD)) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine will be given to you by a doctor.
• Follow up with the doctor as you have been told.
• Check to see if Liletta (52 MG) (levonorgestrel (IUD)) is in place as you have been told by your doctor or read the package insert.
• Based on when Liletta (52 MG) (levonorgestrel (IUD)) is put in, you may need to use a non-hormone type of birth control like condoms to prevent pregnancy for some time. Follow what your doctor has told you to do about when to have Liletta (52 MG) (levonorgestrel (IUD)) put in and using a non-hormone type of birth control.
• If Liletta (52 MG) (levonorgestrel (IUD)) is being removed and you do not want to get pregnant, talk with your doctor. You will need to use another kind of birth control like a condom the week before it is removed.
• This medicine is not for use as emergency birth control. Talk with the doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Chest pain or pressure.
• Stomach pain.
• Pelvic pain.
• Vaginal bleeding that is not normal.
• Vaginal itching or discharge.
• Fever or chills.
• A lump in the breast or breast soreness.
• Painful sex.
• Yellow skin or eyes.
• Depression or other mood changes.
• Genital sores.
• Some pain, bleeding, dizziness, or other reactions may happen when Liletta (52 MG) (levonorgestrel (IUD)) is put in. Talk with your doctor right away if these do not go away 30 minutes after Liletta (52 MG) (levonorgestrel (IUD)) is put in or if you have other reactions like seizures, slow heartbeat, or passing out.

What are some other side effects of Liletta?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pimples (acne).
• Headache.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Liletta?

• If you need to store Liletta (52 MG) (levonorgestrel (IUD)) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Liletta (52 MG) (levonorgestrel (IUD)), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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