Safety Information

Only you and your healthcare provider can decide if Mirena (levonorgestrel-releasing intrauterine system) is right for you. As the two of you discuss your options, there are a number of things you should consider like your general health, current or past health conditions, sexual history and the possibility that you'd like to have more children in the future.

Mirena is not appropriate for women who:

• 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
• Have liver disease or a liver tumor
• 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
• Are allergic to levonorgestrel, silicone or polyethylene

Tell your healthcare provider if you:

• Have had a heart attack
• Have had a stroke
• Were born 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 breastfeeding
• Have diabetes (high blood sugar)
• Use corticosteroid medications on a long-term basis
• Have severe migraine headaches

Some serious but uncommon side effects of Mirena include:

• Pelvic Inflammatory Disease (PID) Use of Mirena (levonorgestrel-releasing intrauterine system) and other IUDs have been associated with an increased risk of PID. The percentage of women who develop PID while using Mirena is less than 1%. The risk is highest shortly after placement—especially within the first 20 days—and if you have a vaginal infection at the time of placement. After the first 20 days, the risk of PID is reduced.
  
  PID is an infection of the uterus and other organs of the upper reproductive system. It is caused by bacterial infections that are usually sexually transmitted, such as gonorrhoea or chlamydia, that travel beyond the vagina and cervix into the uterus and other organs in the reproductive system. The risk of PID is greater if you or your partner have sex with multiple partners. If not treated quickly and appropriately, PID can lead to serious problems, including infertility, ectopic pregnancy or constant pelvic pain. 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.
  
  Before placement of Mirena, be sure to tell your healthcare provider if you have signs of a vaginal infection or PID. Signs of PID include long-lasting or heavy bleeding, unusual vaginal discharge, abdominal or pelvic pain or tenderness, or painful sex, chills or fever.
  
  After placement, contact your healthcare provider if any of these symptoms listed above occur and persist.
• A rare life-threatening infection like sepsis may occur within the first few days after Mirena is placed. As of September 2006, 9 sepsis cases out of an estimated 9.9 million Mirena users had been reported. Call your healthcare provider immediately if you experience severe pain or unexplained fever after Mirena is placed.
• Embedment is when Mirena attaches to the uterine wall. If embedment occurs, Mirena may no longer prevent pregnancy and you may need surgery to have it removed.
• Perforation. Mirena may go through (perforate) the uterine wall. If your uterus is perforated. Mirena may no longer prevent pregnancy. It may move outside the uterus and can cause scarring, infection or damage to other organs. Surgery may be needed to have Mirena removed. The risk of perforation is increased in breastfeeding women.

Possible common side effects of Mirena include:

• Missed menstrual periods. About 2 out of 10 women stop having periods after 1 year of Mirena (levonorgestrel-releasing intrauterine system) use. Your periods come back when Mirena is removed. If you do not have a period for 6 weeks during Mirena use, contact your healthcare provider to rule out pregnancy.
• Expulsion. Mirena may come out by itself and no longer prevent pregnancy. Symptoms of partial or complete expulsion may include bleeding, pain and an increase in menstrual flow. If this occurs, Mirena may be replaced within 7 days of a menstrual period after pregnancy has been ruled out. If you notice Mirena has come out, use a back-up form of birth control like condoms and call your healthcare provider.

More than 10% of Mirena users may experience:

• Discomfort during placement. Dizziness, bleeding or cramping may occur during placement. This is common. Let your healthcare provider know if the cramping is severe.
• Changes in bleeding. Your period may become irregular and you may have bleeding and spotting between menstrual periods, especially during the first 3 to 6 months. A few women have heavy bleeding during this time. After your body adjusts, periods usually get lighter and the number of bleeding days is likely to decrease, but may remain irregular. Or you may even find that your periods stop altogether. In which case, you should contact your healthcare provider to rule out pregnancy.
  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.
• Pelvic and/or abdominal pain. Talk to your healthcare provider if the pain is persistent.
• Cyst on the ovary.These cysts may develop as long Mirena is in place. They are generally harmless and usually disappear in a month or two. However, cysts can cause pain and may sometimes require surgery.

Between 5% and 10% of Mirena users may experience:

• Headache/Migraine
• Acne
• Depressed mood
• Heavy or prolonged menstrual bleeding

Less than 5% of Mirena users may experience:

• Vaginal discharge
• Breast pain or tenderness
• Nausea
• Nervousness
• Inflammation of cervix, vulva or vagina
• Pelvic pain during your period
• Back pain
• Weight increase
• Decreased sex drive
• Pain during intercourse
• Anaemia
• Unusual hair growth or loss
• Skin irritations (such as hives, rash, eczema or itching)
• Feeling bloated
• Swelling of hands and feet
• Expulsion

Every individual responds differently to medication, so talk to your healthcare provider about your individual risk factors and to see if Mirena is right for you.

Mirena (levonorgestrel-releasing intrauterine system) does not protect against STDs (sexually transmitted diseases) or HIV. So, if while using Mirena you think you or your partner might be at risk of getting an STD, use a condom and call your healthcare provider.

What if I become pregnant while using Mirena?

Less than 8 in 1,000 women (0.8%) become pregnant over the course of the five years using Mirena. One risk of becoming pregnant using Mirena is called ectopic pregnancy, when the pregnancy is not in the uterus. It may occur in the fallopian tubes. Signs of ectopic pregnancy may include unusual bleeding or abdominal pain. Ectopic pregnancy is an emergency that requires immediate medical attention and often surgery. Ectopic pregnancy can cause internal bleeding, infertility and even death. Call your healthcare provider right away if you think that you're pregnant.

There are also risks if you become 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.

Indications & Usage

Mirena (levonorgestrel-releasing intrauterine system) is a hormone-releasing system placed in your uterus to prevent pregnancy for as long as you want for up to 5 years. Mirena also treats heavy periods in women who choose intrauterine contraception.

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.

• Don’t 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. If you have persistent pelvic or abdominal pain, see your healthcare provider.
• 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.
• Although uncommon, pregnancy while using Mirena 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.

Available by prescription only