Welcome to Mirena. The Mirena Handbook: A Personal Guide to Your New Mirena. mirena.com. Mirena is the #1 prescribed IUD * in the U.S.

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1 Mirena is the #1 prescribed IUD * in the U.S. Welcome to Mirena The Mirena Handbook: A Personal Guide to Your New Mirena *Intrauterine Device Supported by SHS data

2 INDICATIONS FOR MIRENA Mirena (levonorgestrel-releasing intrauterine system) is a hormone-releasing intrauterine device (IUD) that prevents pregnancy for up to 5 years. Mirena also treats heavy periods in women who choose intrauterine contraception. IMPORTANT SAFETY INFORMATION If you have a pelvic infection, get infections easily, or have certain cancers, don t use Mirena. Less than 1% of users get a serious pelvic infection called pelvic inflammatory disease (PID). If you have persistent pelvic or stomach pain or if Mirena comes out, tell your healthcare provider (HCP). If Mirena comes out, use back-up birth control. Mirena may attach to or go through the uterus and cause other problems. Pregnancy while using Mirena is uncommon but can be life threatening and may result in loss of pregnancy or fertility. Ovarian cysts may occur but usually disappear. Bleeding and spotting may increase in the first 3 to 6 months and remain irregular. Periods over time usually become shorter, lighter, or may stop. Mirena does not protect against HIV or STDs. Only you and your HCP can decide if Mirena is right for you. Mirena is available by prescription only. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call FDA You had Mirena placed now what? You ve joined millions of women who have used IUDs. So, what comes next tomorrow, the next day, one month from today? What can you expect as your body adjusts to Mirena? This information is here to help you, whether you re new to Mirena or considering having Mirena placed again. Either way, use this resource as much as you need. And don t forget to read the enclosed Full Prescribing Information in the back cover pocket. Contents: Indications and Important Safety Information...2 Day one with Mirena...4 Looking ahead with Mirena... 6 Mirena What ifs?...10 Possible common side effects...14 To learn more about Mirena, visit www. 2 For important risk and use information about Mirena, please see the Full Prescribing Information. 3

3 Day one with Mirena Starting something new can be intimidating, but your first day with Mirena doesn t have to be. We put together the following information to let you know what the first day may be like and explain some of the basics about Mirena. What should you expect immediately after placement? Everyone is different, and some women may experience discomfort or spotting during or after placement. Cramps, dizziness, and/or some bleeding may occur and are common side effects. Let your healthcare provider know if your side effects are severe or last more than 30 minutes, as Mirena may not have been properly placed. How can you be sure Mirena is properly in place? Once it s placed, check the threads of Mirena once a month to make sure it s positioned correctly. Your healthcare provider should show you how. When you re doing your monthly checks at home, call your healthcare provider if you have trouble finding the threads. And in the meantime, you should use a back-up birth control method like condoms and spermicide. How often should you see your healthcare provider once Mirena is in place? You should visit your healthcare provider once in the first 4 to 6 weeks after having Mirena placed. After that, Mirena can be checked by your healthcare provider once a year as part of your routine exam. Call your healthcare provider if you have any questions or concerns. Please see Important Safety Information about Mirena on page 2. For important risk and use information about Mirena, please see the Full Prescribing Information. Insider Tip: Think about calling to make your 4- to 6-week appointment now, while it s fresh in your mind. 4 5

4 Looking ahead with Mirena Wondering what s next? The information on the following pages will give you an idea of what you may be able to expect now that you ve had Mirena placed. Will your periods change now that you have Mirena? With Mirena, your periods may change over time. For the first 3 to 6 months Your monthly period may increase. You may also experience frequent spotting or light bleeding, especially in the first 3 to 6 months. A few women have heavy bleeding during this time. Call your healthcare provider if the bleeding remains heavier than usual As your body adjusts to Mirena The number of bleeding and spotting days is likely to decrease, though your period may remain irregular. You may even find that your periods stop altogether as long as Mirena is in place. Call your healthcare provider if the bleeding becomes heavy after it has been light for a while About 20% of women will have no period at all after 1 year of Mirena use. If it has been 6 weeks or longer since your last period, contact your healthcare provider to rule out the possibility of pregnancy. Your periods should return once Mirena is removed Please see Important Safety Information about Mirena on page 2. For important risk and use information about Mirena, please see the Full Prescribing Information. 6 Model used for illustrative purposes only. If you re using Mirena to also reduce heavy periods In some women with heavy bleeding, the total blood loss per cycle progressively decreases with continued use. The number of bleeding and spotting days may initially increase but then typically decreases in the months that follow. In a clinical trial of Mirena in women with heavy periods, the majority had an 80% reduction in bleeding as early as 3 months and a greater than 90% reduction at 6 months 7

5 Will your partner be able to feel Mirena during intercourse? Mirena is placed in the uterus, not in the vagina, so neither you nor your partner should feel Mirena during intercourse. Sometimes your partner feels the threads. If this occurs, talk to your healthcare provider. Can Mirena protect you from HIV or other STDs (sexually transmitted diseases)? Mirena does not protect against HIV or other STDs. So, if while using Mirena you think you and your partner might be at risk of getting an STD, use a condom and call your healthcare provider. Can you still use tampons? Yes, you can still use tampons after Mirena is placed. Just be sure to change each tampon with care so as not to pull the threads of Mirena when removing it. Please see Important Safety Information about Mirena on page 2. For important risk and use information about Mirena, please see the Full Prescribing Information. 8 9

6 Your healthcare provider is the best source for information about Mirena and birth control in general, but this section can help answer some of the most common questions women have about Mirena. What if you want to try to get pregnant? Mirena can be removed by your healthcare provider at any time during a routine office visit, and you can try to become pregnant right away. So, if you decide you want to try to have a child, simply make an appointment with your healthcare provider to have Mirena removed. Within a year of having Mirena removed, about 8 out of 10 women succeed at becoming pregnant. Insider Tip: Talk with your healthcare provider about replacing your Mirena before your scheduled appointment to have your current Mirena removed. He or she can then place your new Mirena during the same office visit. Mirena What ifs? What if you want to breastfeed 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 of your nursing baby. However, isolated cases of decreased milk production have been reported among women using progestin-only birth control pills. The risk of Mirena becoming attached to (embedded) or going through the wall of the uterus is increased if Mirena is inserted while you are breastfeeding. What if you need birth control for more than 5 years? Mirena must be removed after 5 years. If you want to continue using Mirena after those 5 years, you can talk with your healthcare provider about having another one placed. 10 Please see Important Safety Information about Mirena on page 2. For important risk and use information about Mirena, please see the Full Prescribing Information. 1111

7 What if you become pregnant while using Mirena? Call your healthcare provider right away if you think you are pregnant. If you get pregnant while you are 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. 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 be signs of infection. It is not known if Mirena can cause long-term effects on the fetus if it stays in place during a pregnancy. 12 Please see Important Safety Information about Mirena on page 2. For important risk and use information about Mirena, please see the Full Prescribing Information. 13

8 Possible 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. Please see Important Safety Information about Mirena on page 2. For important risk and use information about Mirena, please see the Full Prescribing Information. Expulsion. Mirena may come out by itself. This is called expulsion. You may become pregnant if Mirena comes out. If you think that Mirena has come out, use a backup birth control method like condoms and spermicide and call your healthcare provider. Missed menstrual 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 increases after it has been light for a while. Cysts on the ovary. About 12 out of 100 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 side effects with Mirena. For more information, ask your healthcare provider. Call your healthcare provider for medical advice about side effects. You may report side effects to the manufacturer at , or at FDA-1088 or

9 Please see Important Safety Information about Mirena on page 2. For important risk and use information about Mirena, please see the Full Prescribing Information. A simple way to keep track You probably keep track of dinner plans, birthdays, and many other things. Now that you ve had Mirena placed, you may want to consider keeping track of your periods for a little while, too. As your body adjusts to your new birth control, you may experience some changes. Monitoring those changes (or lack of them) and keeping a record will help you and your healthcare provider track your experience with Mirena. See the Mirena diary inside for an easy way to track your periods. Insider Tip: Use the enclosed diary to keep track of your periods for 3 to 6 months and remember to take it with you to your next appointment with your healthcare provider

10 More questions about Mirena? Call the Bayer Women s Health Hotline: :30am - 8:00pm EST, Monday - Friday or visit www. Please see Important Safety Information about Mirena on page 2. For important risk and use information about Mirena, please see the Full Prescribing Information. BAYER, the Bayer Cross, and Mirena are registered trademarks of Bayer Bayer. Whippany, NJ All rights reserved. PP-150-US-0742 Printed in USA/June 2017