Info

you need birth control that helps simplify your life

Consider Mirena?

Mirena is birth control you don't have to think about taking every day, every month, or even every year. It's a small intrauterine contraceptive made of soft, flexible plastic that's put in place by your healthcare provider during an office visit and all you have to do is check the threads of Mirena once a month.

• Over 99% effective at preventing pregnancy for as long as you want for up to What else should you five years. In fact, it's one of the most efficacious forms of birth control know about Mirena? • When you choose to have Mirena removed, you can try to get pregnant immediately

• Keeps hormone levels steadier and lower than the Pill

Indications & Usage: Mirena (levonorgestrel-releasing intrauterine system) is a hormone-releasing system placed in your uterus to prevent pregnancy for up to 5 years.

Important safety information about Mirena: Only you and your healthcare provider can decide if Mirena is right for you. Mirena is recommended for women who have had a child. Do not use Mirena if you have a pelvic infection, get infections easily or have certain cancers. Less than 1 % of users get a serious infection called pelvic inflammatory disease. Talk to your healthcare provider about problems related to this condition. Mirena may attach to or go through the wall of the uterus and cause other problems, if Mirena comes out, use back-up birth control and call your healthcare provider. In the unlikely event you get pregnant while using Mirena, seek emergency care because continuing pregnancy with an intrauterine device may result in loss of pregnancy or loss of fertility. Ovarian cysts may occur and usually disappear. Bleeding and spotting may increase in the first few months and continue to be irregular. Periods may become shorter, lighter or even stop. Mirena does not protect against HIV or STDs. For important risk and use information, please see reverse side.

To team more about Mirena, call 1-877-MIRENA-2 or visit www.mirena-us.com

VMirena"

(levonorgestrei-reEeasing intrauter'ne system)

Keep life simple.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch, or call 1-800-FDA-1088.

BRIEF SUMMARY OF PATIENT INFORMATION Mirena* (Mur-a-nah) (levonorgestrel-releasing intrauterine system)

Mirena is used to prevent pregnancy. Mirena does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs).

Read the full Patient Information carefully before you decide il Mirena is rig hi lor you, 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.

What is Mirena?

Mirena is a hormone-releasing system placed in your uterus to prevent pregnancy for up to 5 years. Mirena is T-shaped. It is made of flexible plastic and contains a progestin hormone called levonorgestrel. Levonorgestrel is a progestin hormone often used in birth control pilts; however, unlike many birth control pills, Mirena does not contain an estrogen, Mirena releases the hormone into the uterus. Only small amounts of the hormone enter your blood,

Two threads are attached to the stem of Mirena. The threads are the only part of Mirena you can feel when Mirena is in your uterus.

What it I need birth control lor more than 5 years?

You must have Mirena removed after 5 years, hut your healthcare provider can insert a new Mirena during the same office visit if you clwose to continue using Mirena.

What it I change my mind about birth control and want to become pregnant in less than 5 years?

Your healthcare prouder can remove Mirena at any time. You may become pregnant as soon as Mirena is removed. About 8 out of 10 women who want to become pregnant win become pregnant some time In the first year after Mirena is removed-Haw does Mirena work?

It is not known exactly how Mirena works. Mirena may work in several ways, It may thicken your cervical mucus, thin the lining of your uterus, inhibit sperm movement and reduce sperm survival. Mirena may stop release of your egg from your ovary, but this is not the way it works in most cases, Most likely, these actions work together to prevent pregnancy.

How well (foes Mirena work?

The following chart shows the chance of getting pregnant for women who use different methods ot birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are in the box at the top of the chart. Mirena, an intrauterine device, Is in the box at ttie top of the chart. The box on the bottom ot the cliart slwws the chance of getting pregnant for women who do not use birth control and are trying to get pregnant-

Fewer than 1 pregnancy per 100 women in one year

10-20 pregnancies per 100 women in one year

85 or more pregnancies per 100 women In one year_

Fewer Pregnancies

Implants Injections

Intrauterine devices Sterilization

Birth control pills Skin patch Vaginal ring with hormones

Condoms Diaphragm

No sex during the most fertile days of the monthly cycle Spermicide Withdrawal

More Pregnancies

No birth control

Who might use Mirena?

You might choose Mirena if you

* need birth control that is highly effective

• need birth control that is reversible

• need birth control that is easy to use

* have had at least one baby

(PID) unless you have had a normal

Who should not use Mirena?

Do not use Mirena If you

• might be pregnant

• have had a serious pelvic infection called pelvic inflammatory c pregnancy after the infection went away

• have an untreated pelvic infection now

• nave 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 you r partner has more than one partner - proble ms with your imrnu ne system

* leukemia

* intravenous drug abuse

• have or suspect you mig ht have cancer ot the uterus or cervix

• have bleeding from the vagina that has not been explained

• have liver disease or liver tu mor

• have breast cancer now or in the pas! 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

• are allergic to levonorgesirel, silicone, or polyethylene Tell your healtticare prouder if you

• recently had a baby or if you are breast feeding

• have diabetes (hig h blood sugar)

• were horn with heart disease or have problems with your heart valves

• have problems with blood dotting or take medicine to reduce clotting

• have high blood pressure How is Mirena placed?

First, your healthcare provider will examine your pelvis to find the exact position of your uterus, Your healfhcare provider will then clean your vagina and cervix with an antiseptic solution, and slide a thin plastic lube containing Mirena into your uterus, Your healthcare provider will then remove the plastic tube, and leave Mirena in your uter us. Your healthcare provider will cut the threads to the right length. Placement takes only a few mi nutes du ring an office visit.

Some women may experience pain, bleeding and/or dizziness during and after placement. If these symptoms do not pass within half an hour while in a resting position, Mirena may not have been correctly placed. It necessary, your healthcare provider will examine you to determine it Mirena needs to be removed.

Should I check that Mirena is in the proper position?

Yes, you should check that Mirena is in proper position by feeling the removal threads. You should do this after each penod. First, wash your hands with soap and water. Feel for the threads at the top of your vagina with your clean fingers. Ttie threads are the only part of Mirena you should feel when Mirena is in your uterus. Be careful not to pull on the threads. It 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 il removed, If you cannot feel the threads at ail, 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 lo my healthcare provider? Call your healthcare provider if you have any question or concerns (see "When to call your healthcare provider"), Otherwise, you should retur n 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.

Can I use tampons with Mirena?

Tampons may be used with Mirena.

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 an 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 benefiis and risks of continuing the pregnancy.

If you continue your pregnancy, see your healthcare provider regularly, Call your healthcare provider right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina These may he signs of infection.

We do not know if Mirena can cause long-term effects on the fetus if it slays in place during a pregnancy. How will Mirena change my periods?

For the first 3 to 6 months, your monthly period may become irregular. You may also have frequent spotting or I ight bleeding, A few women have heavy bleed ing d uring this time, After your body adj usts, the number of bleed ing days is likely to decrease, and you may even find that your periods stop altogether, Is it sale 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 affect the quality or amount of your breast milk or the health otyour nursing baby,

Wjil Mirena interfere will» sexual intercourse?

Neither you nor your partner should feel Mirena during intercourse, as Mirena is placed in the uterus, not in the vagina Sometimes male partners feel the threads.

What are the possible side effects ot using Mirena?

The following are serious but uncommon side effects of Mirena:

* Pelvic mtiammatoty disease (PID). Some IUD users gel a serious pelvic Infection called pelvic inflammatory disease. PID is usually sexually transmitted. You have a iigter 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 healihcare provider right away if you have any of these sigre 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 alter 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, If 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 healthcare provider know if the cramping is severe,

* Expulsion, Mi re na may come out by itself, This is called expulsion, You may become p reg narit if Mirena comes out. If you notice that Mirena has come out, use a backup birth control method like condoms and call your healthcare provider.

* Missed menstrual periods. About 2 out of 10 women slop 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 healthcare provider,

■ Changes in bleeding. You may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. Sometimes the bleed ing 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 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 lisi 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 1-888842-2937, or FDA at 1-800-FDA-1088 or www.fda.gcw/mBdwaicli. When should I call my healihcare 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 (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 you r 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 healthcare provider. You can ask your healthcare provider for information about Mirena that is written for health providers.

© 2008, Bayer Healthcare Pharmaceuticals Inc. All rights reserved. ___ Manufactured for:

ffi Bayer HealthCare Pharmaceuticals

Bayer HeaifhCare Pharmaceuticals Inc. Wayne, NJ 07470

Manufactured in Roland Telephone number: 1-888-842-2937 This patient Information booklet was updated July 2008.

81179515 6795102BS J u ly 2008

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