Mirena

Leaflet accompanying the packaging: information for the user

Mirena, 20 micrograms/24 hours, intrauterine therapeutic system
Levonorgestrel

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Mirena is and what it is used for

2. Important information before using Mirena

3. How to use Mirena

4. Possible side effects

5. How to store Mirena

6. Contents of the packaging and other information

1. What Mirena is and what it is used for

Mirena is an intrauterine therapeutic system in the shape of a "T", which, after insertion, releases the hormone levonorgestrel into the uterus. The "T" shape ensures that the system fits into the uterus. The white system contains a reservoir that holds the active substance, levonorgestrel. Two brown threads are attached to the loop at the lower end of the system, which are used to remove the system from the uterus.
Mirena is used to prevent pregnancy (contraceptive effect) and to treat heavy menstrual bleeding (of unknown cause).

2. Important information before using Mirena

General notes
Before inserting the Mirena system, your doctor will ask you a few questions about your health and the health of your close relatives.
This leaflet describes several situations in which it is necessary to remove the Mirena system or when the effectiveness of the system may be reduced. In such situations, you should either abstain from sexual intercourse or use additional non-hormonal contraceptive methods, such as a condom or another mechanical method. You should not use the calendar method or temperature measurement. These methods may be ineffective because Mirena affects the monthly changes in body temperature and cervical mucus.
Mirena, like other hormonal contraceptives, does not protect against HIV (AIDS) or other sexually transmitted diseases.

Mirena should not be inserted if any of the following conditions are present:

• if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6)
• pregnancy or suspected pregnancy
• tumors that are dependent on the action of progesterone, such as breast cancer
• existing or recurring inflammatory conditions of the pelvic organs (infections of the female reproductive organs)
• cervicitis
• lower genital tract infections
• postpartum endometritis
• infections of the uterus after abortion in the last 3 months
• conditions that promote the development of infection
• abnormal cervical cells
• cancer or suspected cancer of the cervix or uterus
• unexplained abnormal uterine bleeding
• abnormalities in the cervix or uterus, including fibroids, if they deform the uterine cavity
• active liver disease or liver tumor

Warnings and precautions

Before starting to use the Mirena system, you should consult your doctor.
Consult your doctor, who will decide whether to remove the Mirena system or not, if any of the following conditions occur for the first time while using the Mirena system:

• migraine, asymmetric visual field defects or other symptoms that may be signs of transient cerebral ischemia (temporary blockage of blood flow to the brain)
• severe headache
• jaundice (yellowing of the skin, whites of the eyes, and/or nails)
• significant increase in blood pressure
• severe arterial disease, such as stroke or heart attack
• acute venous thromboembolic disease.

The Mirena system should be used with caution in women with congenital heart defects or heart valve defects that increase the risk of endocarditis.
In women with diabetes who use the Mirena system, blood glucose levels should be monitored.
Irregular bleeding may mask some symptoms and signs of endometrial polyps or cancer, and in these cases, diagnostic tests should be considered.

Medical examination/consultation

The examination before inserting the Mirena system may include a cervical smear as well as other tests, such as infection screening, including sexually transmitted diseases if necessary, and a pregnancy test. A gynecological examination should be performed to determine the position and size of the uterus.
The Mirena system is not a suitable contraceptive method for emergency use (post-coital contraception, emergency contraception).
Infections
The applicator tube helps protect the Mirena system from microbial contamination during insertion. The Mirena applicator has been designed to reduce the risk of infection. Nevertheless, there is an increased risk of infection shortly after insertion and during the first month after insertion of the Mirena system. Pelvic infections in women using the Mirena system are often related to sexually transmitted diseases. The risk of infection increases with multiple sexual partners. Pelvic infections must be properly treated, as they can affect fertility and increase the risk of ectopic pregnancy. The Mirena system should be removed in case of recurring endometritis or pelvic infections, if there are acute and severe infections or if they do not resolve after a few days of treatment.
In extremely rare cases, shortly after insertion of the intrauterine therapeutic system, severe infection or sepsis (a very severe infection that can be life-threatening) may occur.
You should contact your doctor immediately if you experience persistent lower abdominal pain, elevated body temperature, pain during sexual intercourse, and unusual vaginal bleeding.
Expulsion
Uterine contractions during menstrual bleeding may sometimes cause the system to move or be expelled. This is more likely if the woman is overweight at the time of insertion or if she has had heavy menstrual bleeding in the past. If the system is not in its proper position, it may not work as intended, and the risk of pregnancy increases. Expulsion of the system results in loss of protection against pregnancy.
Possible symptoms of expulsion include vaginal bleeding or abdominal pain, but Mirena may also be expelled without symptoms. Since the Mirena system reduces menstrual bleeding, the intensity of these bleedings may be a sign of expulsion or displacement of the system.
It is recommended to check with your fingers (e.g., during bathing) whether the threads are in the correct position. See also section 3 "How to use Mirena - Self-checking of the correct position of the Mirena system". If symptoms occur that may indicate expulsion of the system or if the threads cannot be felt in the cervix, you should use other contraceptive methods (such as condoms) and contact your doctor.
Perforation of the uterus
Perforation or damage to the uterine wall may occur, most often during insertion, although it may only be detected later. A Mirena system that has moved outside the uterine cavity is not effective in preventing pregnancy and should be removed as soon as possible. Removal of the system may require surgery. The risk of perforation is higher in breastfeeding women and within 36 weeks after delivery; this risk may also be increased in women with a permanently retroverted uterus (uterus tilted backwards). If you suspect perforation of the uterus, you should contact your doctor and inform them that you have a Mirena system, especially if it is not the doctor who inserted the system.
Possible signs and symptoms of perforation may include:

• severe pain (like menstrual cramps) or pain stronger than expected
• severe bleeding (after insertion)
• pain or bleeding that lasts longer than a few weeks
• sudden changes in your periods
• pain during sexual intercourse
• inability to feel the Mirena threads (see section 3 "How to use Mirena - Self-checking of the correct position of the Mirena system")

Ectopic pregnancy
Getting pregnant while using the Mirena system is very unlikely. However, if you get pregnant while using the Mirena system, the risk of ectopic pregnancy is relatively increased. In about 1 in 1000 women who properly used the Mirena system, an ectopic pregnancy occurred within a year of use. This is less than in women who do not use any contraceptive methods (about 3 to 5 in 1000 women per year). In women who have had an ectopic pregnancy before, who have had tubal surgery, or who have had pelvic infections, there is an increased risk of ectopic pregnancy.
Ectopic pregnancy is a serious condition that requires immediate medical attention.
Symptoms that may indicate an ectopic pregnancy and require immediate medical attention include:

• missed menstrual periods, followed by persistent bleeding or pain
• dull or severe abdominal pain
• typical symptoms of pregnancy with concurrent bleeding and dizziness. Weakness Some women may experience dizziness after insertion of the Mirena system. This is a normal physiological reaction. The doctor will recommend resting for a while after insertion of the Mirena system.

Ovarian cysts enclosing a mature ovum in the ovary
The contraceptive properties of the Mirena system are related to its local action, so in women of childbearing age, menstrual cycles are usually ovulatory and ovulation occurs. Sometimes, an unruptured follicle does not regress for a while and may enlarge. In most cases, these enlarged follicles do not cause symptoms, although they may cause pelvic pain or pain during sexual intercourse. Such enlarged ovarian follicles usually resolve on their own, but may also require medical intervention.

Mental disorders

Some women using hormonal contraceptives, including Mirena, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts.
If you experience mood changes and symptoms of depression, you should contact your doctor as soon as possible to receive further medical advice.

Mirena and other medicines

Since the mechanism of action of the Mirena system is primarily local, taking other medicines should not increase the risk of pregnancy during use of this system.
However, it is recommended that you tell your doctor about all medicines you have taken recently, including those that are available without a prescription.

Pregnancy, breastfeeding, and fertility

Pregnancy

Mirena should not be used during pregnancy or if pregnancy is suspected.
Very rarely, a woman may become pregnant while the Mirena system is in place. However, if the Mirena system moves out of place, contraceptive protection is reduced, and other contraceptive methods should be used until a doctor's visit.
During use of the Mirena system, some women may experience amenorrhea (absence of menstruation) after a while. Absence of menstruation does not always mean pregnancy. If menstruation has stopped and other signs of pregnancy are present (e.g., nausea, fatigue, breast tenderness), you should see a doctor for an examination and a pregnancy test.
If you become pregnant while using the Mirena system, you should contact your doctor immediately to have the system removed. Removal of the system may cause miscarriage. However, leaving the Mirena system in place during pregnancy may increase the risk not only of miscarriage but also of preterm birth. If the Mirena system cannot be removed, you should discuss the benefits and risks of continuing the pregnancy with your doctor. If the pregnancy continues, it should be monitored closely by your doctor, and you should inform your doctor immediately if you experience symptoms such as abdominal cramps, abdominal pain, or fever.
Mirena contains a hormone called levonorgestrel, and there have been isolated reports of its effects on the genital organs of girls exposed to levonorgestrel released from an intrauterine device left in the uterus.

Breastfeeding

Mirena can be used during breastfeeding. Levonorgestrel passes into breast milk in small amounts (about 0.1% of the levonorgestrel dose may pass into the baby's body through breast milk). After 6 weeks postpartum, use of the Mirena system has no harmful effect on the growth and development of the baby.
It has not been found that progestogen-only contraceptives affect the amount and quality of milk.
Hormonal contraception is not recommended as a first-line method during breastfeeding; only non-hormonal methods are recommended. Second-line methods are progestogen-only contraceptives, such as the Mirena system. The daily dose and blood levels of levonorgestrel are lower than with other hormonal contraceptives.

Fertility

Removal of the Mirena system restores the woman's fertility.
If you are pregnant, breastfeeding, or think you may be pregnant, or plan to become pregnant, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No effects of the Mirena system on the ability to drive and use machines have been found.

Important information about some ingredients of Mirena

The T-shaped frame of the Mirena system contains barium sulfate, which allows the system to be visible on X-ray.

3. How to use Mirena

Efficacy of the Mirena system

The contraceptive efficacy of the Mirena system is the same as that of the most effective copper-containing intrauterine device. In clinical trials, about 2 pregnancies per 1000 women using the Mirena system were found in the first year.
In the treatment of heavy menstrual bleeding of unknown cause, the intensity of bleeding decreases after 3 months of using the Mirena system. In some women, menstruation may even stop.

When to insert the Mirena system

Starting to use the Mirena system

• Before inserting the Mirena system, you should make sure that you are not pregnant.
• The Mirena system should be inserted within 7 days of the start of menstrual bleeding. If the Mirena system is inserted during these days, it will work immediately and prevent pregnancy.
• If it is not possible to insert the Mirena system within 7 days of the start of menstrual bleeding or if menstruation occurs at an unpredictable time, the system can be inserted at any time. In this case, you should not have sexual intercourse without using contraception from the last menstrual period and before insertion, and you should have a negative pregnancy test result. Additionally, Mirena may not prevent pregnancy immediately in a reliable manner. Therefore, you should use a barrier method of contraception (e.g., condoms) or abstain from sexual intercourse for 7 days after insertion of the Mirena system.
• The Mirena system is not suitable for use as emergency contraception (post-coital contraception).

How to insert the Mirena system

The Mirena system should only be inserted by a doctor or other qualified medical personnel with experience in inserting the system.
After performing a gynecological examination, a speculum is inserted into the vagina, and the cervix is rinsed with an antiseptic solution. Then, the intrauterine system is inserted into the uterus using a thin, flexible plastic tube (applicator). If necessary, the cervix can be locally anesthetized before insertion.
Some people may experience pain and dizziness after insertion of the system. If these symptoms do not resolve within half an hour while the patient is in a lying position, it may indicate that the system is not inserted correctly. An examination should be performed, and if necessary, the system should be removed.
After insertion of the Mirena system, the patient should receive a reminder card from the doctor, which should be brought to each scheduled visit.

When to contact your doctor

Your doctor should check the presence of the system within 4 to 12 weeks after insertion and then regularly check the presence of the system at least once a year. Your doctor will determine individually how often and what follow-up examinations should be performed. You should bring the reminder card for the patient, received from the doctor, to each scheduled visit.
In addition, you should contact your doctor if:

• the threads in the vagina are not palpable
• the lower part of the system is palpable
• you suspect you are pregnant
• you experience persistent abdominal pain, fever, or unusual vaginal discharge
• you or your partner experience pain or discomfort during sexual intercourse
• you experience sudden changes in your menstrual cycle (e.g., scant or absent menstrual periods, followed by persistent bleeding or pain)
• you experience other health problems, such as migraine headaches or severe headaches that recur, sudden vision problems, jaundice, or increased blood pressure
• any of the conditions listed in section 2 "Important information before using Mirena" occur. Remind your doctor that you have a Mirena system, especially if it is not the doctor who inserted the system.

Duration of use of the Mirena system

The Mirena system prevents pregnancy (has a contraceptive effect) for 8 years after insertion. If you use the Mirena system for this purpose, the system should be removed or replaced no later than 8 years after insertion.
The Mirena system is effective for 5 years after insertion in the treatment of heavy menstrual bleeding (of unknown cause). If you use Mirena for this purpose, the system should be removed or replaced when heavy menstrual bleeding returns or no later than 8 years after insertion. If you wish, a new system can be inserted after removal of the previous one.

If you want to have the Mirena system removed to become pregnant or for other reasons

Your doctor can easily remove the system at any time, and it is then possible to become pregnant.
Removal of the system is usually painless. After removal of the Mirena system, fertility returns.
Continuing contraception after removal of the system
If you do not plan to become pregnant, the Mirena system should not be removed after the 7th day of the menstrual cycle (unless other contraceptive methods are used, such as condoms) for at least 7 days before removal. If you have irregular menstrual periods or do not have menstrual periods, you should use mechanical methods of contraception for at least 7 days before removal and until menstrual bleeding resumes. Alternatively, a new system can be inserted immediately after removal of the previous one, and no additional protection is required. If you do not want to continue using the same method, you should ask your doctor for advice on other proven contraceptive methods.

Can you become pregnant after stopping the use of Mirena?

Yes. Removal of the Mirena system does not disrupt fertility. You can become pregnant during the first menstrual cycle after removal of the Mirena system.

Does the Mirena system affect menstrual bleeding?

Mirena affects the menstrual cycle. The system can cause various changes in menstruation, such as spotting (minor blood loss), shorter or longer menstrual bleeding, scant or heavy menstrual bleeding, or its absence.
In many women, during the first 3 to 6 months after insertion of the Mirena system, in addition to menstrual bleeding, frequent spotting or minor bleeding occurs. In some women, menstrual bleeding may become heavier or longer than usual. You should inform your doctor if these symptoms do not resolve, especially if they do not resolve on their own.

Is the absence of menstrual bleeding a normal condition?

Yes, when using the Mirena system. Absence of menstruation is a sign of the effect of the hormone on the uterine lining. There is no monthly thickening of the uterine lining. Therefore, there is nothing to be expelled with menstrual blood. This does not have to be a sign of menopause or pregnancy. Hormone levels remain normal.
In fact, the absence of menstruation can be a great benefit for a woman's health.

Pregnancy diagnosis

Becoming pregnant while using the Mirena system is unlikely, even if menstrual bleeding does not occur.
If menstrual bleeding has not occurred for 6 weeks and this causes concern, a pregnancy test can be performed. If the result is negative, there is no need for further testing, unless other symptoms of pregnancy are present, such as nausea, fatigue, or breast tenderness.

Can the Mirena system cause pain or discomfort?

Some women experience pain (like menstrual cramps) for a few weeks after insertion of the system. You should see your doctor or visit a clinic again if you experience severe pain or if pain persists for more than 3 weeks after insertion of the Mirena system.

Effect of the Mirena system on sexual intercourse

Neither you nor your partner should feel the system during sexual intercourse. However, if you do feel it, you should avoid sexual intercourse until your doctor has checked that the system is still in the correct position.

How soon after insertion of the system can you have sexual intercourse?

To allow your body to rest, it is recommended to wait about 24 hours after insertion of the system before having sexual intercourse. Depending on when in your menstrual cycle the Mirena system is inserted, you may need to use emergency contraception (e.g., condoms) or abstain from sexual intercourse for the first 7 days after insertion (see section 3 "How to use Mirena - When to insert the Mirena system").

Using tampons or menstrual cups

It is recommended to use sanitary pads. If you use tampons or menstrual cups, you should change them carefully to avoid pulling on the Mirena system threads. If you think the Mirena system has been displaced from its correct position (see "When to contact your doctor" with possible symptoms), you should avoid sexual intercourse or use mechanical contraception (such as condoms) and contact your doctor.

What happens if the Mirena system is expelled

Rarely, but it is possible, that the Mirena system may be expelled from the uterus without your knowledge during menstrual bleeding. If menstrual bleeding is heavier than usual, it may mean that the Mirena system has been expelled through the vagina. It is also possible for the Mirena system to be partially expelled from the uterus (you or your partner may notice this during sexual intercourse). If the Mirena system is completely or partially expelled, it does not protect against pregnancy.

Self-checking of the correct position of the Mirena system

You can check yourself whether the threads of the system are in the correct position. To do this, you should carefully insert your finger into the vagina and check the presence of the threads near the cervix.
Do not pull on the threads, as this can cause unintentional removal of the system. If you do not feel the threads, it may mean that the system has been expelled from the uterus or that the uterus has been perforated. In this case, you should use mechanical contraception (e.g., condoms) and contact your doctor.

4. Possible side effects

Like all medicines, Mirena can cause side effects, although not everybody gets them.
In addition to the possible side effects listed in other sections (e.g., section 2 "Important information before using Mirena"), the following side effects are possible, divided by body system and frequency of occurrence:
Very common side effects:may occur in more than 1 in 10 people
Reproductive system and breast disorders

• uterine or vaginal bleeding, including spotting, infrequent menstruation, or absence of menstruation
• mild ovarian cysts (see section 2: "enlarged ovarian follicles")

Common side effects:may occur in less than 1 in 10 people
Psychiatric disorders

• depressed mood or depression
• anxiety
• decreased libido

Nervous system disorders

• headache

Vascular disorders

• dizziness

Gastrointestinal disorders

• abdominal pain
• nausea

Skin and subcutaneous tissue disorders

• acne

Musculoskeletal and connective tissue disorders

• back pain

Reproductive system and breast disorders

• pelvic pain
• painful menstruation
• leukorrhea
• vulvovaginitis
• breast tenderness
• breast pain
• expulsion of the intrauterine therapeutic system

Investigations

• weight gain

Uncommon side effects:may occur in less than 1 in 100 people
Nervous system disorders

• migraine

Gastrointestinal disorders

• abdominal distension

Skin and subcutaneous tissue disorders

• hirsutism (male-type hair growth in women)
• hair loss (alopecia)
• pruritus (severe itching)
• erythema (skin inflammation)
• chloasma (yellow-brown spots on the skin) or intense skin discoloration

Reproductive system and breast disorders

• perforation (puncture) of the uterus
• pelvic inflammatory disease (infection of the upper female reproductive organs, organs above the cervix)
• endometritis (inflammation of the uterine lining)
• cervicitis - normal smear class II Papanicolaou in cytological examination (cervicitis)

General disorders and administration site conditions

• edema

Rare side effects:may occur in less than 1 in 1000 people
Skin and subcutaneous tissue disorders

• urticaria
• angioedema

If you become pregnant while using the Mirena system, there is a risk that the pregnancy will be ectopic (see section 2: "Ectopic pregnancy").
After insertion of the intrauterine therapeutic system, cases of sepsis (a very severe infection that can be life-threatening) have been reported.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Mirena

Store in a place inaccessible to children.
Storage: There are no special precautions for storage of the medicine.
Do not insert Mirena after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Mirena contains

• The active substance of the medicine is levonorgestrel. One intrauterine therapeutic system contains 52 mg of levonorgestrel.
• The other ingredients of the medicine are: polydimethylsiloxane elastomer; anhydrous colloidal silica; polyethylene; barium sulfate; iron oxide.

What Mirena looks like and what the packaging contains
Pack size: one sterile-packed intrauterine therapeutic system for intrauterine use.

Marketing authorization holder

Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Manufacturer

Bayer Oy
Pansiontie 47
20210 Turku
Finland
To obtain more detailed information, you should contact your doctor or a representative of the marketing authorization holder:
Bayer Sp. z o.o.
Al. Jerozolimskie 158
02-326 Warsaw
tel. +48 22 572 35 00
If you have any further questions, you should consult your doctor or pharmacist.

Date of last revision of the leaflet: May 2024

Other sources of information

Detailed and up-to-date information about this product can be obtained by scanning the QR code attached to the patient leaflet, packaging, and patient reminder card using a smartphone. The same information is also available at the following URL: www.pi.bayer.com/mirena/pl and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (RPL (ezdrowie.gov.pl)).
[QR code for the patient leaflet, to be added at the national level]
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The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR INSERTION

MIRENA

20 micrograms/24 hours, intrauterine therapeutic system
Levonorgestrel

The system can only be inserted by a doctor under aseptic conditions.

The Mirena system is supplied with an applicator in a sterile package, which should not be opened until immediately before insertion. The product should not be re-sterilized. The Mirena system is for single use only. It should not be used if the inner package is damaged or opened. It should not be inserted after the expiry date (sterility date) of the product, month, and year stated on the label.
Information on the timing of insertion is given in the Mirena summary of product characteristics.
The Mirena system is supplied with a patient reminder card in the outer package. The patient reminder card should be completed and given to the patient after insertion of the system.

Preparation for insertion

• Examine the patient to rule out contraindications for the use of the Mirena system (see Summary of Product Characteristics, section 4.3, and "Medical examination, consultation" in section 4.4).
• Insert a speculum into the vagina to visualize the cervix; then thoroughly clean the cervix and vagina with an antiseptic solution.
• If necessary, use an assistant.
• Grasp the anterior lip of the cervix with a surgical hook or other type of forceps to immobilize the uterus. If the uterus is retroverted, it may be more appropriate to grasp the posterior lip. To straighten the cervical canal, gentle traction can be applied to the forceps. The forceps should remain in place and gentle traction should be maintained during insertion.

Advance the uterine sound through the cervical canal to the uterine fundus and measure the depth and direction of the uterine cavity and verify the absence of any uterine anomalies (e.g., septum, submucous fibroids) and any previously inserted intrauterine contraceptive devices that have not been removed. If difficulties arise, consider dilation of the cervix.
If dilation of the cervix is necessary, consider using analgesics and/or a paracervical block.

Insertion

• 1. First, open the completely sterile packaging (Figure 1). Then, maintain sterility and wear sterile gloves.

• 2. Move the slider forward, in the direction indicated by the arrow, until the end, to load the Mirena system into the tube (Figure 2).

IMPORTANT! Do not move the slider downwards, as this may cause premature release of the Mirena system. Once the Mirena system is released, it cannot be reloaded into the applicator.

• 3. Holding the slider in the extreme position, set the upperedge of the stop so that it corresponds to the actual measurement of the uterine depth (Figure 3).

• 4. Holding the slider in the extremeposition, insert the applicator through the cervix until the stop is about 1.5-2.0 cm from the uterine cervix (Figure 4).

IMPORTANT!Do not try to force the applicator into place. If necessary, dilate the cervical canal.

• 5. While holding the applicator in a fixed position, move the slider to the markto open the horizontal arms of Mirena (Figure 5). Wait 5-10 seconds for the horizontal arms to open completely.

• 6. Gently move the applicator towards the bottom of the uterus until the stop touches the cervix. Mirena is now in the position at the bottom of the uterus (Figure 6).

• 7. While holding the applicator in place, release Mirena by pulling the slider completely downwards(Figure 7). While holding the slider in the extreme lower position, gently pull out the applicator. Cut the threadsso that they are about 2-3 cm long and protruding from the cervix.

IMPORTANT!If there is suspicion that the system is not in the correct position, check the position (e.g., by ultrasound examination). If the system is not in the correct position in the uterine cavity, it should be removed. A removed system should not be reinserted.

Removal/Replacement

Information on removal and/or replacement is contained in the Summary of Product Characteristics for Mirena.
The Mirena system
is removed by gently
pulling on the remaining
threads with forceps
(Figure 8).
Immediately after
removing one Mirena
system, another can
be inserted.
After removing the Mirena
system, it should be
evaluated to ensure that
it has not been damaged
and has been completely
removed.