Levonorgestrel-Releasing System, Intrauterine

What are other names for this medicine?

Type of medicine: intrauterine contraceptive

Generic and brand names: levonorgestrel-releasing intrauterine system; Mirena

What is this medicine used for?

This device, called an IUD, or intrauterine device, is inserted by your healthcare provider into the uterus to provide birth control.

It releases a tiny amount of the hormone levonorgestrel into the lining of your uterus. It provides birth control for up to 5 years. If birth control is desired beyond 5 years, you will need a new IUD.

The IUD is recommended for women who:

• have had at least 1 child
• are in a mutually monogamous relationship (one sexual partner)
• have no history of pelvic inflammatory disease (PID)
• have no history of ectopic pregnancy (a pregnancy in any other place other than the uterus such as in the fallopian tubes).

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• an allergy to levonorgestrel, silicone, or polyethylene
• a stroke
• breast cancer
• liver disease
• migraines or other severe headaches
• a bleeding disorder or are taking medicine that reduces the chance of blood clots forming such as warfarin (Coumadin)
• a weakened immune system from diseases such as leukemia, AIDS, or HIV
• abnormal vaginal bleeding
• an abnormal Pap smear
• an abnormal uterus (fibroids)
• bacterial vaginosis (vaginal infection with discharge, odor, pain, itching, or burning)
• diabetes
• heart disease
• high blood pressure
• high cholesterol
• pain or inflammation in your uterus, tubes, or ovaries (pelvic inflammatory disease or PID)
• postpartum endometritis (infection) or an infected abortion in the past 3 months
• vaginal or uterine tumors
• past problems with an IUD

Tell your healthcare provider if you or your partner have more than one sexual partner. Your risk of developing pelvic inflammatory disease is higher if you have more than one sexual partner, especially while you have an IUD in place.

Tell your healthcare provider if you have recently had a baby or are breast-feeding.

Females of childbearing age: Do not use this device during pregnancy because it can harm the baby. Do not breast-feed while the IUD is in place without your healthcare provider's approval.

How do I use it?

The IUD is inserted by a healthcare provider. You will need regular checkups while the IUD is in place.

Read the information sheet that comes in the medicine package. You will be asked to sign a special form saying you have read the information.

The insertion is done on the 7th day after you start your menstrual period, or immediately after a first-trimester abortion. It can be replaced at any time during a menstrual cycle. The IUD should not stay in the uterus after 5 years.

Fainting, cramps, or having a slow heartbeat are common side effects during insertion.

Check for the IUD strings every month after each menstrual period. Contact your healthcare provider if the IUD moves out of place or if you cannot feel the strings. To check that the IUD is still in place:

• Wash your hands thoroughly.
• Squat and, using your middle finger, find the cervix high in the vagina.
• The IUD strings should hang down from the cervix. (Never pull on the strings).

What should I watch out for?

This form of birth control does not protect against sexually transmitted diseases, AIDS, or HIV.

If you become pregnant with this IUD in your uterus, the IUD must be removed. Contact your healthcare provider right away if you think you are pregnant. If you become pregnant with the IUD in place and it cannot be removed or you choose not to remove it, you risk miscarriage, infection in the uterus, premature labor and delivery, and birth defects in the infant. Talk to your healthcare provider about this.

Be sure to contact your healthcare provider right away if you have any severe pain that starts right after insertion of the IUD.

You may get pelvic inflammatory disease (PID) after the insertion of the IUD. PID can cause tubal damage leading to ectopic pregnancy. Symptoms of PID include heavy bleeding, bleeding that lasts a long time during your menstrual period, unusual vaginal discharge, abdominal or pelvic pain or tenderness, chills, and fever. If you develop these symptoms, contact your healthcare provider right away.

During the first few weeks that you have this IUD, you may have more bleeding and spotting days, cramps, and irregular menstrual bleeding patterns. If you bleed a lot or if cramps become severe, contact your healthcare provider right away.

Your healthcare provider may want to examine you within 3 months of the insertion of the IUD to be sure that everything is normal.

Diabetics: The IUD may change your normal glucose level. Your healthcare provider may want you to check your glucose level frequently using a home-testing machine.

What are the possible side effects?

Along with its needed effects, the IUD may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the device. Tell your healthcare provider if you have any side effects that continue or get worse.

Serious (report these to your healthcare provider right away): Fever; chills; muscle or joint pain; yellowish skin or eyes; vaginal discharge; prolonged or heavy bleeding during your period; abdominal or pelvic pain or tenderness; sores in or around your vagina; missed periods.

Other: Headache, depression, nervousness, nausea, vomiting, acne, skin disorder, chest infection, back pain, abdominal pain, breast pain, weight gain, stuffy nose, decreased sex drive.

What products might interact with this medicine?

When you use this device with medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antiseizure medicines such as phenytoin (Dilantin) and carbamazepine (Tegretol)
• barbiturates such as phenobarbital, butabarbital (Butisol), and pentobarbital (Nembutal)
• nevirapine (Viramune)
• rifampin (Rifadin, Rimactane)
• St. John's wort

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.

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