20 micrograms / 24 hours, intrauterine insert
Levonorgestrel
What Mirena is and what it is used for
Mirena is used as:
- Contraceptive
- Treatment of abnormally abundant menstrual bleeding
- Protection to prevent unwanted growth of the uterine lining in women who use estrogen replacement therapy during menopause
Children and young people
Mirena is not for use before the first menstrual period ( menarche ).
Mirena is a T-shaped uterine insert that, after insertion into the uterus, releases the hormone et levonorgestrel. The T-shape means that the insert adapts well to the shape of the uterus. On the vertical part of the white T-structure, there is a hormone capsule that releases the hormone. Two brown socket wires are attached to the lower end of the vertical part.
Levonorgestrel, the active ingredient in Mirena, is a synthetic hormone similar to the corpus luteum hormone, a hormone produced by the body. Mirena’s hormone capsule releases levonorgestrel directly into the uterine lining in low doses (20 micrograms per 24 hours). The insert prevents pregnancy by affecting the mucous membrane so that it is not prepared for pregnancy and by making the secretions in the cervix thicker, which makes it difficult for the sperm to enter the uterus. The insert also affects the motility of the sperm inside the uterus so that fertilization is prevented.
What you need to know before you use Mirena
General notes
| Before you can start using your Mirena, the midwife/doctor will ask you some questions about your own and your immediate relatives’ medical history. This leaflet describes several situations where Mirena should be removed or when Mirena’s reliability may be impaired. In such situations, you should either refrain from having intercourse or use other non-hormonal contraceptives, such as condoms or any other barrier method. Do not use the rhythm method (safe periods) or the temperature method. These methods can be unreliable, as Mirena affects the monthly changes in body temperature and cervical secretions. Mirena, like other hormonal contraceptives, does not protect against HIV infection ( AIDS ) or other sexually transmitted diseases. |
Do not use Mirena:
- if you are pregnant or think you may be pregnant
- if you have a tumor that is dependent on progestogen (a type of hormone ), such as breast cancer
- if you have ongoing or recurrent inflammation you are in the abdomen
- if you have an infection of the cervix
- if you have an infection in the abdomen
- if you have an infection in the uterus after childbirth
- if you have had an infection in the womb after an abortion within the last three months
- if you have a condition that may increase the risk of infection
- if you have cell changes in the cervix
- if you have cancer or suspected cancer of the cervix or uterus
- if you have unexplained bleeding from the uterus
- if you have a congenital or acquired malformation of the uterus including fibroids if this affects the uterine cavity
- if you have an ongoing liver disease or liver tumor
- if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor/midwife before using Mirena.
If you are using Mirena in conjunction with estrogen replacement therapy, see also the estrogen package leaflet.
Contact a doctor/midwife if you have any of the following conditions or if any of the following conditions occur for the first time when you use Mirena. The doctor/midwife can then decide whether Mirena should continue to be used or taken out.
- migraine or asymmetric vision loss, which may be a sign of temporary blockage of the blood supply to the brain (transient cerebral ischemia )
- very severe headache
- jaundice (skin, whites of the eyes and / or nails turn yellow)
- sharp rise in blood pressure
- severe vascular disease such as stroke or heart attack
- acute blood clot in vein / veins with symptoms such as pain and swelling in one extremity , usually in one leg, sudden chest pain, difficulty breathing.
Your doctor/midwife also needs to know if you have any heart disease, as there is a risk of heart infection.
Because levonorgestrel may affect glucose metabolism, you should check your blood sugar if you are diabetic but it is not usually necessary to change your diabetes treatment while using Mirena.
Irregular bleeding can mask certain symptoms and signs of polyps or cancer of the uterine lining. Consult a doctor or midwife.
Mirena is not a first-line method for women who have undergone menopause and have a reduced uterus.
Medical examination
A gynecological examination should be performed to determine the location and size of the uterus. An examination before insertion may also include a cell sample, an examination of the breasts and, if necessary, other tests, for example for genital infections, including sexually transmitted diseases.
Mirena is not suitable as a “day after” method against unwanted pregnancy.
Infection is
The insertion tube protects the insert against bacteria in connection with the insertion. There is an increased risk of genital infection immediately and during the first month after insertion in copper insert users and a similar risk can not be ruled out for Mirena. Having multiple sexual partners increases the risk of genital infection. If you get a genital infection when using Mirena, it should be treated as soon as possible. Abdominal infections can affect fertility and increase the risk of future ectopic pregnancies (ectopic pregnancy). As with other gynecological and surgical procedures, severe infection or sepsis can occur in extremely rare cases after insertion of the uterus.
If acute infection is severe or does not improve within a few days despite treatment, as well as in recurrent genital infections or infection of the uterine lining, Mirena should be removed.
Contact your doctor/midwife immediately if you experience persistent abdominal pain, fever, pain during intercourse, or abnormal bleeding.
Ejection
Muscle contractions in the uterus during menstruation can sometimes displace the insert or repel it completely. This is more likely to occur if you are overweight at the time of insertion or if you have had heavy periods in the past. If the insert is displaced, it may not work as intended and therefore the risk of pregnancy is higher. If the post is rejected, you are no longer protected against pregnancy.
Any signs of expulsion are pain and abnormal bleeding, but Mirena can also be expelled without you noticing. As Mirena reduces the amount of menstruation, and increased menstrual bleeding may be a sign of expulsion.
You should check the threads with your fingers e.g. in connection with your showering. See also section 3 “How to use Mirena – How do I know if Mirena is in place?”. If you notice anything that indicates an ejection of the insert or if you cannot feel the threads, use another form of contraception (such as a condom) and contact your healthcare provider.
Perforation / Damage to the uterine wall
Damage to the uterine wall can occur, usually during the insertion of Mirena. An injury is sometimes not discovered until after a while. If Mirena gets stuck outside the uterine cavity, it does not effectively protect against pregnancy and should be removed as soon as possible. Surgery may be needed to remove Mirena.
The risk of damage to the uterine wall is increased in breastfeeding women and in women where the insertion is made up to 36 weeks after delivery, and may be increased in women where the uterus is fixed and bent backward (retro-reflected uterus). If you suspect that you have suffered an injury to the uterine wall, contact your doctor/midwife immediately for advice and remind them that you have a Mirena inserted, especially if it is not the same person who inserted it.
Possible signs and symptoms of damage to the uterine wall may include:
- severe pain (such as menstrual cramps) or more pain than expected
- heavy bleeding (after insertion)
- pain or bleeding that continues for more than a few weeks
- sudden changes in your bleeding pattern
- pain during intercourse
- that you no longer know Mirena’s threads (see section 3 “How to use Mirena – How do I know if Mirena is in place?”)
Breast cancer
Available data show that Mirena does not increase the risk of breast cancer in menstruating women under 50 years of age. The risk of getting breast cancer can neither be confirmed nor rejected when Mirena is used as protection to prevent unwanted growth of the uterine lining in women who use estrogen replacement therapy during menopause. This is because there are not enough data from studies on Mirena.
Excessive pregnancy
Pregnancy is very rare in women who use Mirena. If you still become pregnant while using Mirena, the risk of the fetus being outside the womb (so-called ectopic pregnancy) is increased. With the correct use of Mirena, about 1 in 1,000 women per year suffer from ectopic pregnancy. The proportion is lower than in women who do not use contraception (where about 3 to 5 out of 1000 women per year are affected). Women who have previously had an ectopic pregnancy performed surgery on the fallopian tubes or had a genital infection have a greater risk of getting an ectopic pregnancy. Ectopic pregnancy is a serious condition that requires immediate treatment. The following signs may indicate that you have an ectopic pregnancy and you should contact a doctor immediately:
- Your period has stopped and you then have a constant painful bleeding
- Diffuse or severe pain in the abdomen
- Normal pregnancy symptoms, but you also have bleeding and dizziness.
Dizziness
Some women feel dizzy right after Mirena is inserted. This is a normal physical reaction. You should then rest for a while after the deposit.
Enlarged follicles (ovary)
Since the preventive effect of the insert is mainly due to its effect on the uterus, ovulation is not affected infertile women. Sometimes, however, the normal regeneration of the follicle is delayed and the development continues. Although most of these follicles do not cause any symptoms, some can cause abdominal pain or intercourse pain. Sometimes medical treatment is required but usually, they disappear on their own within 2-3 months.
Mental disorders
Some women who use hormonal contraceptives, including Mirena, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.
Contact a doctor/midwife if any of the following occur:
- you can no longer feel the threads
- you can feel the lower part of the post
- you think you may be pregnant
- you have persistent abdominal pain, fever or abnormal discharge
- you or your partner feel pain or discomfort during intercourse
- you get sudden changes in your bleeding pattern (eg if you normally have little or no menstrual bleeding and you instead start to have persistent bleeding or pain or start bleeding heavily)
- if you have other medical problems such as migraines or severe headaches that are recurring and you suddenly have visual disturbances, jaundice or high blood pressure .
Additional information on specific patient groups
Elderly (over 65 years)
Mirena has not been studied in women over 65 years of age.
Patients with liver disease
Mirena should not be used in women with liver disease or liver tumors (see section 2 “Do not use Mirena”).
Patients with kidney problems
Mirena has not been studied in women who have kidney problems.
Other medicines and Mirena
Tell your healthcare provider if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Pregnancy
Mirena should not be used if you are pregnant or think you may be pregnant.
Pregnancy is very rare in women who use Mirena.
Some women (about 20%) do not menstruate when they use Mirena. It does not have to mean that you are pregnant if you do not get your period. If you do not menstruate for 6 weeks and have other signs of pregnancy (eg nausea, fatigue, sore breasts), you should see a doctor/midwife for examination and pregnancy test.
If you become pregnant with Mirena on the spot, you should see a doctor or midwife immediately to remove Mirena. Taking out Mirena can cause a miscarriage. However, if Mirena is left in place during pregnancy, not only does the risk of miscarriage increase but also the risk of premature birth. If Mirena can not be taken, talk to a doctor or midwife about the benefits and risks of continuing the pregnancy, and the effects the hormone can have on the baby’s development.
Breast-feeding
Mirena can be used during breastfeeding 6 weeks after the baby is born. A small amount of the hormone in Mirena ends up in breast milk (approximately 0.1% of the total dose ), but it is unlikely that infants older than 6 weeks can be affected. Mirena does not seem to affect either the amount or the quality of breast milk.
Consult your doctor/midwife or pharmacist before taking any medicine while breastfeeding.
Driving and using machines
Mirena has no known effects affecting the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mirena contains barium sulphate
Mirena’s T-skeleton contains barium sulfate, which makes the insert visible on X-ray examination.
How to use Mirena
How effective is Mirena?
As a contraceptive, Mirena is at least as effective as of today’s most effective copper coils. Clinical studies show that about 2 out of 1000 women who use Mirena become pregnant during the first year. The risk of pregnancy may increase with ejection or perforation (see section 2 “Ejection” and “Perforation / Damage to the uterine wall”).
When treating abnormally abundant menstrual bleeding, Mirena gives a strong reduction of the bleeding already after three months. Some users do not get a period at all.
When should Mirena be deployed?
The insert can be inserted within 7 days after the start of menstruation. The insert can also be inserted immediately after an abortion in the first trimester if genital infections can be ruled out. The insert should be inserted when the uterus has returned to its normal size after delivery and not earlier than 6 weeks after delivery (see section 2 “What you need to know before using Mirena – Perforation / Damage to the uterine wall”). Mirena can be replaced with a new post at any time during the menstrual cycle. When Mirena is used to protect the uterine lining during estrogen treatment during menopause, it can be used at any time in a woman who is not bleeding or during the last days of menstruation or bleeding.
It is strongly recommended that Mirena is only inserted by a doctor/midwife with previous experience of inserting Mirena.
How is Mirena deployed?
After a gynecological examination, the doctor/midwife inserts an instrument called a speculum into the vagina and the cervix is wiped with an antiseptic solution. The insert is then inserted into the uterus via a thin, flexible plastic tube.
After Mirena is inserted, you will receive a patient card from your doctor/midwife for future examinations. Bring this card for all return visits.
Should Mirena be checked regularly?
Mirena should be checked 4-12 weeks after deposit and thereafter regularly, at least once a year. Your doctor/midwife decides how often and what type of check-ups are required in your case.
Bring the patient card that you received from your doctor/midwife for all return visits.
How long can Mirena be used?
The same Mirena can be used for 6 years when used as a contraceptive (to prevent pregnancy) and for 5 years when used to treat abnormally abundant menstrual bleeding or as protection to prevent unwanted growth of the uterine lining in women who use estrogen replacement therapy during menopause. , then the post must be removed. If you wish to continue treatment, a new Mirena must be inserted.
Can Mirena cause pain or discomfort?
You can feel the deposit but it usually does not hurt much. In some cases, local anesthesia may be needed.
Some women experience pain and dizziness after insertion. If these symptoms do not disappear after half an hour of rest, it is possible that the insert is not seated correctly and if necessary the insert is removed. Some women may experience pain (such as menstrual cramps) during the first few weeks after insertion. You should contact your doctor/midwife again if you have severe pain or if the pain continues for more than 3 weeks after the insertion of the insert.
How long should I wait to have intercourse after the deposit?
For your body to rest, it is best to wait a few days after the deposit before you have intercourse. However, Mirena protects against pregnancy as soon as it is inserted.
Does Mirena affect intercourse?
Neither you nor your partner senses the post during intercourse. If any of you should do so, intercourse should be avoided until a doctor/midwife has checked that the insert is correct.
Does Mirena affect menstruation?
All women of childbearing potential using Mirena have an altered bleeding pattern.
In the first 3-6 months after insertion, irregular bleeding is common. This is completely normal, but the bleeding pattern after this period should be fairly regular and the amount of bleeding should have decreased significantly. The irregular bleeding pattern may be more frequent and last longer if the woman uses Mirena to treat heavy menstruation. You will likely have a gradual decrease each month in the number of bleeding days and the amount of blood. For some women, menstruation disappears completely.
If menstruation stops completely, it depends on the effect the hormone has on the uterine lining. About 20% of women of childbearing age become bleeding-free over time. Your hormone levels remain normal, even though your period may have stopped. When the insert is removed, menstruation returns to normal.
Even in women who use Mirena in combination with estrogen therapy, irregular bleeding is common during the first 3-6 months. About 40% of menopausal women become bleeding-free.
For all Mirena users, if the irregular bleeding persists after 6 months, you should contact your doctor/midwife, as well as if you experience bleeding after a period of missed or sparse menstruation.
Can you use a tampon or menstrual cup?
The use of sanitary napkins is recommended. If tampons or menstrual cups are used, you should change them carefully so that you do not pull on Mirena’s threads. If you think you have pulled Mirena out of position (see section 2 “Contact a doctor/midwife if any of the following occur” for possible signs), avoid intercourse or use a barrier method as a contraceptive (such as a condom) and contact a doctor/midwife.
How do I know if Mirena is in place?
You can check for yourself if the threads are in place. Carefully insert a finger into the vagina and feel for the threads in the back of the vagina near the opening to the uterus.
Do not pull the threads because then you can accidentally pull out Mirena. If you can not feel the threads, it may indicate that an ejection or damage to the uterine wall has occurred. In this case, you should use extra protection, a barrier method (such as a condom), and consult your doctor.
If you want to get pregnant or want to have Mirena withdrawn for other reasons?
Your doctor/midwife can remove the insert at any time and it is then possible for you to become pregnant. Removing the post is usually a painless procedure. Fertility returns to normal after Mirena is removed.
If you want to avoid pregnancy, Mirena should not be taken after the seventh day of the menstrual cycle (monthly period) unless another contraceptive is used (eg a condom) for at least 7 days before removal. If you have irregular menstruation (menstruation) or no menstruation, you should use a barrier method as a contraceptive for 7 days before withdrawal and until your period returns. A new Mirena can also be inserted immediately after the old one is removed. In such cases, no additional protection is required.
Can I get pregnant when I stop using Mirena?
Yes. Once Mirena has been removed, fertility is back to normal. You may become pregnant during the first menstrual cycle once Mirena has been removed.
If you have any further questions on the use of this product, ask your doctor/midwife or pharmacist.
Possible side effects
Like all medicines, Mirena can cause side effects, although not everybody gets them.
Very common (may affect more than 1 user in 10) :
- Headache
- Abdominal and pelvic pain
- Changes in the bleeding pattern such as increased or decreased menstrual bleeding, splashing bleeding, shorter or longer menstrual periods, prolonged interval between bleeding or no bleeding at all
- Vulvovaginitis ( inflammation of the external genitalia or vagina )
- Relocations
Common (may affect up to 1 in 10 people):
- Depression
- Decreased sex drive
- Migraine
- Dizziness
- Nausea
- Acne
- Hirsutism (heavy body hair)
- Back pain
- Inflammation of the upper genitals
- Cysts on the ovaries
- Menstrual cramps
- Chest pain
- Ejection of the insert from the uterus (in whole or in part)
- Weight gain.
Uncommon (may affect up to 1 in 100 people):
- Alopecia (hair loss)
- Chloasma (brown pigmented spots on the face) and / or severe pigmentation of the skin
- Perforation of the uterus / damage to the uterine wall
Has been reported (occurs in an unknown number of users):
- Hypersensitivity ( allergic reaction ), including rash, hives and angioedema (characterized by sudden swelling of eg eyes, mouth and throat)
- Increased blood pressure
- Blood poisoning has occurred after insertion of the uterine insert.
The partner can feel the pulling threads during intercourse.
If you become pregnant while using Mirena, there is a risk that the fetus is outside the womb (see section 2 “Outbreaks of pregnancy”).
The following side effects have been reported with the introduction or withdrawal of Mirena
Pain and bleeding when inserting and removing the insert, dizziness, or fainting in connection with inserting the insert (vasovagal reaction). Insertion/withdrawal can trigger a seizure in patients with epilepsy.
How to store Mirena
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is levonorgestrel 52 mg.
- Other ingredients are:
- polydimethylsiloxane elastomer
- silica, colloidal , anhydrous
- polyethylene
- barium sulphate
- iron oxide (E 172)
Pack sizes
The package contains a sterile uterine insert.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Bayer AB
Box 606
SE-169 26 Solna
Manufacturer :
Bayer Oy
Passionate 47
20210 Turku
Finland