The following are serious but uncommon side effects of Mirena: Pelvic inflammatory disease (PID).

Some IUD users get a serious pelvic infection called pelvic inflammatory disease.

PID is usually sexually transmitted.

You have a higher chance of getting PID if you or your partner have sex with other partners.

PID can cause serious problems such as infertility, ectopic pregnancy or constant pelvic pain.

PID is usually treated with antibiotics.

More serious cases of PID may require surgery.

A hysterectomy (removal of the uterus) is sometimes needed.

In rare cases, infections that start as PID can even cause death.

Tell your health care provider right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, or fever.

Life-threatening infection.

Life-threatening infection can occur within the first few days after Mirena is placed.

Call your health care provider if you develop severe pain within a few hours after placement.

Embedment.

Mirena  may adhere to the uterine wall.

This is called embedment.

If embedment occurs, Mirena may no longer prevent pregnancy and you may need surgery to have it removed.Perforation.

Mirena may go through the uterus.

This is called perforation.

If your uterus is perforated, Mirena may no longer prevent pregnancy.

It may move outside the uterus and can cause internal scarring, infection, or damage to other organs, and you may need surgery to have Mirena removed.

Common side effects of Mirena include:Discomfort during placement.

Dizziness, faintness, bleeding or cramping may occur during placement.

This is common.

Let your health care provider know if the cramping is severe.

Expulsion.

Mirena may come out by itself.

This is called expulsion.

You may become pregnant if Mirena comes out.

If you notice that Mirena has come out, use a backup birth control method like condoms and call your health care provider.Missed menstrual periods.

About 2 out of 10 women stop having periods after 1 year of Mirena use.

The periods come back when Mirena is removed.

If you do not have a period for 6 weeks during Mirena use, contact your health care provider.Changes in bleeding.

You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months.

Sometimes the bleeding is heavier than usual at first.

However, the bleeding usually becomes lighter than usual and may be irregular.

Call your health care provider if the bleeding remains heavier than usual or if the bleeding becomes heavy after it has been light for a while.

Cyst on the ovary.

Approximately 12% (12 out of 100) of women using Mirena develop a cyst on the ovary.

These cysts usually disappear on their own in a month or two.

However, cysts can cause pain and sometimes cysts will need surgery.

This is not a complete list of possible side effects with Mirena.

For more information, ask your health care provider.

Call your doctor for medical advice about side effects.

You may report side effects to the manufacturer at 1-888-842-2937, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.When should I call my health care provider? Call your health care provider if you have any concerns about Mirena.

Be sure to call if you think you are pregnant have pelvic pain or pain during sex have unusual vaginal discharge or genital sores have unexplained fever might be exposed to sexually transmitted diseases (STDs) cannot feel Mirena 's threads develop very severe or migraine headaches have yellowing of the skin or whites of the eyes.

These may be signs of liver problems.

have a stroke or heart attack or your partner becomes HIV positive have severe vaginal bleeding or bleeding that lasts a long time miss a menstrual period General advice about prescription medicines Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.

This leaflet summarizes the most important information about Mirena.

If you would like more information, talk with your health care provider.

You can ask your health care provider for information about Mirena that is written for health providers.© 2008, Bayer HealthCare Pharmaceuticals Inc.

All rights reserved.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470This patient information booklet was updated July 2008.Fill out the following checklist.

Your answers will help you and your health care provider decide if Mirena is a good choice for you.Do you have any of these conditions? YesNoDon’t know— will discuss with my health care provider Abnormalities of the uterus ??? Acquired immune deficiency syndrome (AIDS) ??? Anemia or blood clotting problems ??? Bleeding between periods ??? Cancer of the uterus or cervix ??? History of other types of cancer ??? Steroid therapy (for example, prednisone)??? Possible pregnancy ??? Diabetes ??? Ectopic pregnancy in the past ??? Fainting attacks ??? Genital sores ??? Heart disease ??? Heart murmur ??? Heavy menstrual flow ??? Hepatitis or other liver disease ??? Infection of the uterus or cervix ??? IUD in place now or in the past ??? IV drug abuse now or in the past ??? Leukemia ??? More than one sexual partner ??? A sexual partner who has more than one sexual partner ??? Pelvic infection ??? Abortion or miscarriage in the past 2 months ??? Pregnancy in the past 2 months ??? Severe menstrual cramps ??? Severe Headache??? Sexually transmitted disease (STD), such as gonorrhea or chlamydia ??? Stroke??? Abnormal Pap smear ??? Unexplained genital bleeding ??? Uterine or pelvic surgery ??? Vaginal discharge or infection ??? HIV infection ??? Breastfeeding ??? High blood pressure??? Manufactured for:Bayer HealthCare Pharmaceuticals Inc.Wayne, NJ 07470Manufactured in Finland1-866-647-3646© 2008, Bayer HealthCare Pharmaceuticals Inc.All rights reserved.