Mirena

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Mirena

52 mg, 20 micrograms/24 hours, intrauterine therapeutic system

Levonorgestrel

You should carefully read the contents of the 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 a 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 the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Mirena and what is it 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 is Mirena and what is it used for

Mirena is a T-shaped intrauterine therapeutic system that releases the hormone levonorgestrel into the uterus after insertion. The T-shape ensures that the system fits into the uterus. The white system has a container with the active substance levonorgestrel in the vertical part. Two brown threads are attached to the loop at the bottom of the system, which are used to remove the system from the uterus. Mirena is used to prevent pregnancy (contraceptive effect) and to treat excessive menstrual bleeding (of unknown origin).

2. Important information before using Mirena

General notes Before using the Mirena system, the doctor will ask the patient a few questions about her health and the health of her close relatives. This leaflet describes several situations in which it is necessary to remove the Mirena system or when its effectiveness may be reduced. In such cases, 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. They may prove to be ineffective, as 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 the patient is allergic to levonorgestrel or any of the other components 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 uterus
• active liver disease or liver tumor

Warnings and precautions

Before starting to use the Mirena system, you should consult a doctor. Consult a 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 tests, 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 use in emergency situations (post-coital contraception). Infections The applicator tube helps protect the Mirena system from microbial contamination during insertion. The Mirena system applicator has been designed to reduce the risk of infection. However, there is an increased risk of infection shortly after insertion and during the first month after insertion of the Mirena system. Pelvic inflammatory disease in women using the Mirena system is often associated with sexually transmitted diseases. The risk of infection increases with multiple sexual partners. Pelvic inflammatory disease must be properly treated, as it can affect fertility and increase the risk of ectopic pregnancy. The Mirena system should be removed in case of recurring inflammatory conditions of the endometrium or pelvic organs, if there are acute and severe inflammatory conditions or if they do not resolve after a few days of treatment. In extremely rare cases, a severe infection or sepsis (a very severe infection that can be fatal) may occur shortly after insertion of the intrauterine therapeutic system. You should contact your doctor immediately if you experience persistent abdominal pain, elevated body temperature, pain during sexual intercourse, or unusual vaginal bleeding. Expulsion The 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 place, 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 can also be expelled without being noticed. 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 Perforation or damage to the uterine wall may occur, most often during insertion, although it may only be detected later. A Mirena system that is outside the uterus is not effective in preventing pregnancy and should be removed as soon as possible. Surgery may be necessary to remove the system. 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 uterine wall, 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 more severe pain 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 Pregnancy while using the Mirena system is very unlikely. However, if a woman becomes pregnant while using the Mirena system, the risk of ectopic pregnancy is relatively increased. About 1 in 1000 women who properly used the Mirena system experienced an ectopic pregnancy 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 in the past, who have had tubal surgery, or who have had pelvic inflammatory disease, 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:

• cessation of menstrual bleeding, followed by persistent bleeding or pain
• dull or severe pain in the lower abdomen
• typical symptoms of pregnancy with concurrent bleeding and dizziness

Lightheadedness Some women may experience dizziness after insertion of the system. This is a normal physiological reaction. The doctor will recommend resting for a while after insertion of the Mirena system. Enlarged ovarian follicles surrounding the maturing egg 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, the unruptured follicle does not regress for a while and may enlarge. In most cases, these enlarged follicles do not cause any 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 mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for further medical advice.

Mirena and other medicines

Since the mechanism of action of the Mirena system is primarily local, taking other medicines is unlikely to increase the risk of pregnancy during use of this system. However, you should 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 is displaced, 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 cessation of menstrual bleeding after a while. Absence of menstrual bleeding does not always mean pregnancy. If menstrual bleeding has stopped and other signs of pregnancy occur (e.g., nausea, fatigue, breast tenderness), you should consult a doctor for an examination and a pregnancy test. If a woman becomes pregnant while using the Mirena system, she should contact her doctor immediately to have the system removed. Removal may cause miscarriage. However, leaving the Mirena system in place during pregnancy may increase not only the risk of miscarriage but also the risk 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 a doctor, and you should immediately inform your doctor if you experience symptoms such as abdominal cramps, abdominal pain, or fever. Mirena contains a hormone called levonorgestrel, and there have been individual reports of its effects on the genital organs of female infants exposed to levonorgestrel released from the intrauterine device remaining 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 infant'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 infant. 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 contraceptive methods, such as the Mirena system. The daily dose and blood levonorgestrel levels are lower than with other hormonal contraceptive methods.

Fertility

Removal of the Mirena system restores normal fertility in women. 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 components of the Mirena system:

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

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 excessive menstrual bleeding of unknown origin, the intensity of bleeding decreases after 3 months of using the Mirena system. In some women, menstrual bleeding 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 the patient is 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 the Mirena system is inserted more than 7 days after the start of menstrual bleeding or if menstrual bleeding occurs at an unpredictable time, the system may be inserted at any time. In this case, you should not have sexual intercourse without using contraception from the last menstrual bleeding and before insertion, and you should have a negative pregnancy test result. Additionally, Mirena may not prevent pregnancy immediately and reliably. 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).

Starting to use the Mirena system after childbirth

• The Mirena system can be inserted after childbirth, when the uterus has returned to its normal size, but not earlier than 6 weeks after childbirth (see section 2: "Important information before using Mirena - Perforation of the uterine wall").
• See also "Starting to use the Mirena system" above to find out what else you need to know about the timing of insertion.

Starting to use the Mirena system after abortion The Mirena system can be inserted immediately after an abortion in the first trimester, provided that there is no infection of the genital tract. Mirena will then work immediately. Replacing the Mirena system The system can be replaced with a new one at any time during the menstrual cycle. Mirena will then work immediately. Changing from another contraceptive method (e.g., combined hormonal contraceptives, implant)

• The Mirena system can be inserted immediately if there is justified certainty that the patient is not pregnant.
• If more than 7 days have passed since the start of menstrual bleeding, you should abstain from sexual intercourse or use additional contraceptive protection for the next 7 days.

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 a gynecological examination, a speculum is inserted into the vagina, and the cervix is rinsed with an antiseptic solution. The intrauterine system is then 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 has been inserted incorrectly. 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 a doctor

The doctor should check the presence of the system within 4 to 12 weeks after its insertion and then regularly check the presence of the system at least once a year. The doctor will determine individually how often and what control tests should be performed. You should bring the reminder card for the patient, received from the doctor, to each scheduled visit. Additionally, you should contact a doctor if:

• the threads in the vagina are not palpable
• the lower part of the system is palpable
• pregnancy is suspected
• persistent abdominal pain, fever, or unusual vaginal discharge occurs
• the woman or her partner experiences pain or discomfort during sexual intercourse
• sudden changes in the menstrual cycle occur (e.g., menstrual bleeding is scarce or absent, and then persistent bleeding or pain occurs, or intense bleeding starts)
• other health problems occur, such as migraine headaches or severe headaches that recur
• 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 the patient uses 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 excessive menstrual bleeding (of unknown origin). If the patient uses Mirena for this purpose, the system should be removed or replaced when excessive menstrual bleeding returns or no later than 8 years after insertion. If the patient wishes, a new system can be inserted after removal of the previous one.

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

A doctor can easily remove the system at any time, and then it is 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 returns. You can also have a new system inserted immediately after removal of the previous one, and in this case, 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 the Mirena system

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 menstrual bleeding, such as spotting (minor blood loss), shorter or longer menstrual bleeding, scarce or intense 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 more intense or longer than usual. You should inform your doctor, especially if these symptoms do not resolve. In general, it is possible to gradually reduce the number of days of bleeding and the amount of blood lost each month. In some women, menstrual bleeding may eventually stop completely. Since the Mirena system usually reduces the intensity of bleeding, many women experience an increase in hemoglobin levels in the blood. After removal of the system, menstrual bleeding returns to normal.

Is the absence of menstrual bleeding a normal state

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

Diagnosing pregnancy

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 occur, 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 consult your doctor or 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 the patient nor her partner should feel the system during sexual intercourse. However, if they do, you should avoid sexual intercourse until the doctor checks whether the system is still in the correct position.

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

To allow the body to rest, it is recommended to wait about 24 hours after insertion of the system before having sexual intercourse. Depending on when in the menstrual cycle the Mirena system is inserted, it may be necessary 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 so as not to pull on the Mirena system threads. If you think the Mirena system has been displaced from its correct position (see "When to contact a doctor" with possible symptoms), you should avoid sexual intercourse or use mechanical contraception (such as condoms) and contact your doctor.

What happens when the Mirena system is expelled

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

Self-checking of the correct position of the Mirena system

A woman can check herself 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. You should not pull on the threads, as this can cause the system to be unintentionally removed. If the threads are not felt, it may indicate that the system has been expelled from the uterus or that the uterine wall has been perforated. You should then 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
Disorders of the reproductive system and breast

• 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
• nervousness
• decreased libido

Nervous system disorders

• headache

Vascular disorders

• dizziness

Gastrointestinal disorders

• abdominal pain
• nausea

Skin and subcutaneous tissue disorders

• acne

Musculoskeletal, connective tissue, and bone disorders

• back pain

Reproductive system and breast disorders

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

Diagnostic tests

• weight gain

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

• migraine

Gastrointestinal disorders

• abdominal bloating

Skin and subcutaneous tissue disorders

• hirsutism (male-type hair growth in women)
• hair loss (alopecia)
• pruritus (severe itching)
• rash (skin inflammation)
• chloasma (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)
• 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

• rash
• urticaria

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

Reporting side effects

If you experience any side effects, including any side effects 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 of the 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mirena

Store in a place inaccessible to children. Storage: No special storage temperature instructions. Store in the original packaging. Do not insert Mirena after the expiration date stated on the packaging. The expiration 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; polydimethylsiloxane tubing (contains 30-40% anhydrous colloidal silica); polyethylene; barium sulfate; black iron oxide (E 172).

What Mirena looks like and what the packaging contains

Package size: one sterile packaged intrauterine therapeutic system for intrauterine use. For more detailed information, you should contact your doctor, the marketing authorization holder, or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Bayer AG Kaiser-Wilhelm-Allee 1 51373 Leverkusen Germany

Manufacturer

Bayer Oy Pansiontie 47 20210 Turku Finland

Parallel importer:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o. ul. Zbąszyńska 3 91-342 Łódź Authorization number in Romania, the country of export: 7842/2015/01 Parallel import authorization number: 180/20 If you have any further questions, you should consult your doctor or pharmacist.

Date of approval of the leaflet: 01.07.2025

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