Brief Summary Of Patient Information

(Consult Patient Insert tor complete patient riformaticn)

For more information about Mirena, visit

Mirena does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women's health. If you have any questions about Mirena, ask your healthcare provider. You should also learn about other birth control methods to choose the one that is best for you.

Who might use Mirena?

You might choose Mirena if you:

• Want birth control that provides a low chance of getting pregnant [less than 1 in 100)

• Want birth control that is reversible

• Want a birth control method that does not require taking it dally

• Have had at least one child

• Want treatment for heavy periods and want to use a birth control method that is placed in the uterus to prevent pregnancy.

Who should not use Mirena?

Do not use Mirena If you:

• Might be pregnant

• Have had a serious pelvic infection called pelvic Inflammatory disease (PID) unless you have had a normal pregnancy after the Infection went away

• Have an untreated pelvic infection now

• Have had a serious pelvic infection in the past 3 months after a pregnancy

• Can get infections easily. For example, if you have:

More than one sexual partner or your partner has more than one partner Problems with your Immune system Intravenous drug abuse.

• Have or suspect you might have cancer of the uterus or cervix

• Have bleeding from the vagina that has not been explained

• Haveliverdiseaseorlivertumor

• Have breast cancer now or in the past or suspect you have breast cancer

• Have an intrauterine device in your uterus already

• Have a condition of the uterus that changes the shape of the uterine cavity, such as large fibroid tumors

• Arealler^tolevonorgestrel,silicone,orpotyethytene.

Before having Mirena placed, tell your healthcare provider it you:

• Have had a heart attack

• Were bom with heart disease or have problems with your heart valves

• Have problems with blood clotting or take medicine to reduce clotting

• Have high blood pressure

• Recently had a baby or if you are breast feeding

• Have diabetes (high blood sugar)

» Use oorticosterotd medications on a long-term basis

• Have severe migraine headaches How is Mirena placed?

First, your healthcare provider will examine your pelvis to find the exact position of your uterus. Your healthcare provider will then clean your vagina and cervix wfth an antiseptic solution, and slide a thin plastic til» containing Mirena into your uterus Your healthcare provider will then remove the plastic tube, and leave Mirena in your uterus. Your healthcare provider will cut the threads to the rigfit length Placement takes only a few minutes during an office visit.

You may experience pain, bleeding or dizziness during and after placement If these symptoms do not pass 30 minutes after placement, Mirena may not have been placed correctly Your healthcare provider will examine you to see If Mirena needs to be removed or replaced.

Should I check that Mirena Is In the proper position?

Yes, you should check 1hat Mirena is in proper position by feeling the removal threads. You should do this after each menstrual period. First, wash your hands with soap and water Feel tor the threads at the top of your vagina with your dean fingers. The threads are the only part of Mirena you should feel when Mirena is in your uterus. Be careful not to pull on the threads If you feel more than just the threads, Mirena is not In the right position and may not prevent pregnancy. Call your healthcare provider to have it removed. If you cannot feel the threads at all, ask your healthcare provider to check that Mirena is still in the right place In either case, use a non-hormonal birth control method (such as condoms or spermicide) until otherwise advised by your healthcare provider

How soon after placement of Mirena should I return to my healthcare provider?

Call your healthcare provider if you have any questions or concerns (see "When should I call my healthcare provider") Otherwise, you should return to your healthcare provider for a follow-up visit 4 to 12 weeks after Mirena is placed to make sure that Mirena is in the right position

What If i become pregnant while using Mirena?

Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using Mirena, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy.

Ectopic pregnancy is a medical emergency that often requires surgery Ectopic pregnancy can cause internal bleeding, infertility, and even death There are also risks if you get pregnant while using Mirena and the pregnancy is in the uterus, Severe infection, miscarriage, premature delivery, and even death can occur with pregnancies that continue with an intrauterine device (IUD), Because of this, your healthcare provider may try to remove Mirena, even though removing it may cause a miscarriage. If Mirena cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy. !f you continue your pregnancy, see your healthcare provider regularly Call your healthcare provider right away if you get flu-Ike symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina These may be signs of infection it is not known if Mirena can cause long-term effects on (he fetus if it stays in place during a pregnancy.

How will Mirena change my periods?

For the first 3 to 6 months, your monthly period may become Irregular and the number of bleeding days may increase at first. You may also have frequent spotting or light bleeding. A few women have heavy bleeding during this time. After your body adjusts, the number of bleeding days is likely to lessen, and you may even find that your periods stop altogether. In some women with heavy bleeding, the total blood loss per cycle progressively decreases with continued use. The number of spatting and bleeding days may initially increase but then typically decreases in the months that follow.

Is It safe to breast-feed while using Mirena?

You may use Mirena when you are breastfeeding if more than six weeks have passed since you had your baby. If you are breastfeeding, Mirena is not likely to aftect the quality or amount Of your breast milk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported among women using progestln-onty birth control pills.

What are the possible side effects of using Mirena?

Mirena can cause serious side effects including:

• Pelvic inflammatory disease (PID). Some IUD users get a serious peMc Infection called peMc inflammatory disease PID is usually sexually transmitted You have a higher chance of getting PID if you or your partner have sax with other partners. PID can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away 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 healthcare provider right away it you have any ot 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 healthcare provider if you develop severe pain within a few hours after Mirena is placed.

■ Embedment. Mirena may become attached to the uterine wall. This Is called embedment. If embedment happens, 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:

• Pain, bleeding or dizziness during and after placement. If these symptoms do not stop 30 minutes after placement, Mirena may not have been placed correctly. Your healthcare provider will examine you to see if Mirena needs to be removed or replaced.

• Expulsion. Mirena may come out by itself. This is called expulsion You may become pregnant If Mirena comes out. If you notioe that Mirena has come out, use a backup birth oorrtrol method like condoms and call your healthcare provider.

■ Missed menstmal periods. About 2 out of 10 women stop having periods after 1 year of Mirena use. If you do not have a period for 6 weeks during Mirena use, call your healthcare provider When Mirena is removed, your menstrual periods will come back.

■ 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 healthcare provider if the bleeding remains heavier than usual or if the bleeding becomes heavy after it has been igfrt for a while.

• Cyst on theovary, About 12 out of 100 women using Mirena develop a cyst on the ovary, These cysts usually dsappear 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 healthcare provider.

Call your doctor for medical advice about side effects. You may report side effects to the manufacturer at 1-888-&42-2937, or FDA at 1-800-FDA-1088 or

After Mirena has been placed, when should I call my healthcare provider?

Call your healthcare 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.

• Cannot feel Mirena's threads.

• Develop very severe or migraine headaches.

• Have yellowing of the skin or whites ot 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.

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 healthcare provider. You can ask your healthcare provider for information about Mirena that is written for health providers,

© 2009, Bayer Healthcare Pharmaceuticals Inc. Ail rights reserved,

Manufactured for

Bayer HeaithCare Pharmaceuticals Inc. Wayne, NJ 07470

Patient Information Leaflet

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