Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Mirena
52 mg, 20 micrograms/24 hours, intrauterine system
Levonorgestrel
Please read this leaflet carefully before using the medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Mirena is and what it is used for
Important information before using Mirena
How to use Mirena
Possible side effects
How to store Mirena
Contents of the pack and other information

1. What Mirena is and what it is used for

Mirena is a T-shaped intrauterine system that, once inserted, releases the hormone levonorgestrel into the uterine cavity. The T-shape ensures proper fitting of the system within the uterus. The drug reservoir containing levonorgestrel is located in the vertical shaft of the white system. Attached to loops at the lower end of the stem are two brown threads used for removing the system from the uterus.

Mirena is used for contraception (prevention of pregnancy) and for the treatment of heavy menstrual bleeding (of unknown cause).

Children and adolescents
Mirena is not indicated for use before the onset of menstruation (first menstrual period).

2. Important information before using Mirena

General notes
Before inserting the Mirena system, your doctor will ask you several questions about your health and the health of your immediate family members.
This leaflet describes several situations in which the Mirena system must be removed 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. Do not use the rhythm method or temperature measurement. These may be ineffective because Mirena affects monthly body temperature changes and cervical mucus patterns.
Mirena, like other hormonal contraceptive products, does not protect against HIV (AIDS) infection or other sexually transmitted diseases.

Do not use Mirena if any of the following conditions apply:

if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6)
pregnancy or suspected pregnancy
hormone-dependent tumours, e.g. breast cancer
existing or recurrent pelvic inflammatory disease (infections of the female reproductive organs)
cervicitis (inflammation of the cervix)
lower genital tract infections
postpartum endometritis (inflammation of the uterine lining after childbirth)
uterine infection following abortion within the last 3 months
conditions predisposing to infection
abnormal cervical epithelial cells
cancer or suspected cancer of the cervix or uterine corpus
unexplained abnormal uterine bleeding
abnormalities of the cervix or uterine cavity, including fibroids, if they distort the uterine cavity
active liver disease or liver tumour.

Warnings and precautions
Consult your doctor before starting to use the Mirena system.
Contact your doctor, who will decide whether to remove the Mirena system, if any of the following conditions occur for the first time during use:

migraine, asymmetric visual field defects, or other symptoms that may indicate transient ischaemic attack (temporary blockage of blood flow to the brain)
exceptionally severe headache
jaundice (yellowing of the skin, whites of the eyes, and/or nails)
marked increase in blood pressure
severe arterial disease, such as stroke or myocardial infarction
acute venous thromboembolic disease.

Use Mirena with caution in women with congenital heart defects or valvular heart disease that increase the risk of endocarditis.
In diabetic women using the Mirena system, blood glucose levels should be monitored.
Irregular bleeding may mask symptoms and signs of endometrial polyps or cancer, and diagnostic investigations should be considered in such cases.

Medical examination/consultation
The examination prior to insertion of the Mirena system may include a cervical smear test and other tests, such as screening for infections, including sexually transmitted infections if necessary, and a pregnancy test. A gynaecological examination should be performed to determine the position and size of the uterine cavity.
The Mirena system is not an appropriate contraceptive method for emergency contraception (post-coital 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 immediately after insertion and during the first month following insertion of the Mirena system. Pelvic infections in women using Mirena are often associated with sexually transmitted diseases. The risk of infection increases with sexual contact with multiple partners. Pelvic infections must be properly treated, as they may affect fertility in the future and increase the risk of ectopic pregnancy. The Mirena system should be removed in cases of recurrent endometritis or pelvic inflammatory disease if there are severe and acute inflammatory conditions or if they do not resolve within a few days of treatment.
In extremely rare cases, immediately after insertion of an intrauterine therapeutic system, severe infection or sepsis (a very serious infection that may be fatal) may occur.
Contact your doctor immediately if you experience persistent lower abdominal pain, elevated body temperature, pain during sexual intercourse, or abnormal vaginal bleeding.

Spontaneous expulsion
Uterine muscle contractions during menstrual bleeding may sometimes cause displacement or expulsion of the system. This is more likely if the woman is overweight at the time of insertion or has previously experienced heavy menstrual bleeding. If the system is displaced, it may not function properly, thereby increasing the risk of pregnancy. Expulsion of the system results in loss of contraceptive protection.
Possible symptoms of expulsion include vaginal bleeding or lower abdominal pain, but Mirena may also be expelled unnoticed. Since Mirena reduces the amount of menstrual bleeding, increased bleeding may be a sign of expulsion or displacement of the system.
It is recommended to check manually (e.g. during bathing) whether the threads are in the correct position. See also section 3 "How to use Mirena", subsection "Self-checking the correct position of the Mirena system". If symptoms indicating expulsion occur or if the threads cannot be felt at the cervical opening, use other contraceptive methods (such as condoms) and contact your doctor.

Uterine perforation
Perforation or damage to the uterine wall may occur, most commonly during insertion, although it may only be detected later. A Mirena system located outside the uterine cavity is ineffective in preventing pregnancy and should be removed as soon as possible. Surgical intervention may be required to remove the Mirena system. The risk of perforation is higher in women who are breastfeeding and within 36 weeks after childbirth; the risk may also be increased in women with a persistently retroverted uterus (retroversion of the uterus). If you suspect uterine perforation, contact your doctor and inform them that you have a Mirena system in place, especially if this is not the doctor who inserted it.
Possible signs and symptoms of perforation may include:

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

Ectopic pregnancy
Pregnancy during use of the Mirena system is very unlikely. However, if a woman becomes pregnant while using Mirena, the probability of ectopic pregnancy is relatively increased. Approximately 1 in 1000 women who correctly use the Mirena system experience an ectopic pregnancy within one year of use.
This is less than in women who do not use any contraceptive methods (about 3 to 5 per 1000 women per year). Women who have previously had an ectopic pregnancy, tubal surgery, or pelvic infection have an increased risk of ectopic pregnancy. Ectopic pregnancy is a serious condition requiring immediate medical attention. Symptoms that may indicate ectopic pregnancy and require immediate medical consultation include:

cessation of menstrual bleeding followed by persistent bleeding or pain
dull or very severe pain in the lower abdomen
typical pregnancy symptoms accompanied by bleeding and dizziness.

Fainting
Some women may experience dizziness after insertion of the Mirena system. This is a normal physiological response. Your doctor may recommend resting for a short time after insertion of the Mirena system.

Enlarged ovarian follicles
The contraceptive properties of the Mirena system are related to its local action; therefore, in women of reproductive age, menstrual cycles are usually ovulatory and follicular rupture occurs. Occasionally, an unruptured follicle does not regress for some time and may enlarge. In most cases, these enlarged follicles cause no symptoms, although they may cause pelvic pain or pain during intercourse. Such enlarged ovarian follicles usually regress spontaneously but may sometimes require medical intervention.

Psychiatric disorders
Some women using hormonal contraceptives, including Mirena, have reported depression or depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, 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 should not increase the risk of pregnancy during use of this system. However, it is recommended to inform your doctor about all medicines you are currently taking, including those available without a prescription.

Pregnancy, breastfeeding and effects on fertility

Pregnancy
Mirena must not be used during pregnancy or if pregnancy is suspected.
Very rarely, a woman may become pregnant while the Mirena system is correctly positioned. However, if the system becomes displaced, contraceptive protection is reduced, and other contraceptive methods should be used until you see your doctor.
During use of the Mirena system, menstrual bleeding may cease in some women after some time. Absence of menstrual bleeding does not always indicate pregnancy. If menstrual bleeding stops and other signs of pregnancy occur (e.g. nausea, fatigue, breast tenderness), consult your doctor for examination and take a pregnancy test.
If a woman becomes pregnant while using the Mirena system, contact your doctor immediately for removal of the system. 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 premature delivery. If the Mirena system cannot be removed, discuss the benefits and risks of continuing the pregnancy with your doctor. If the pregnancy continues, it should be closely monitored by a doctor, and you should immediately inform your doctor if symptoms such as abdominal cramps, abdominal pain, or fever occur.
Mirena contains a hormone called levonorgestrel, and there have been isolated reports of effects on the genital organs of girls exposed to levonorgestrel released from an intrauterine device remaining in the uterine cavity.

Breastfeeding
Mirena may be used during breastfeeding. Levonorgestrel passes into breast milk in small amounts (approximately 0.1% of the levonorgestrel dose may pass from milk into the infant's body). Six weeks after childbirth, use of the Mirena system has no harmful effect on the infant's growth and development. Anticonceptive products containing only progestogens have not been shown to affect the quantity or quality of breast milk.

Hormonal contraception is not recommended as the first-choice method during breastfeeding; non-hormonal contraceptive methods are recommended. Progestogen-only contraceptive methods, such as the Mirena system, are considered second-line options. The daily dose and blood concentration of levonorgestrel are lower than with other hormonal contraceptive methods.

Fertility
Removal of the Mirena system restores normal fertility in women.
If you are pregnant or breastfeeding, suspect you are pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines
No effect of the Mirena system on the ability to drive or operate machinery has been observed.

Important information about certain ingredients of the Mirena system
The T-shaped frame of the Mirena system contains barium sulfate, which allows the system to be visible on X-ray imaging.

3. How to use Mirena

Effectiveness of Mirena
The contraceptive effectiveness of Mirena is comparable to that of the most effective copper intrauterine devices. In clinical studies, approximately 2 pregnancies per 1000 women using Mirena were observed during the first year.
In the treatment of heavy menstrual bleeding of unknown origin, the intensity of bleeding decreases within 3 months of using Mirena. In some women, menstruation may even stop completely.

When should Mirena be inserted?
Starting use of Mirena

Before inserting Mirena, it must be confirmed that the patient is not pregnant.
Mirena should be inserted within 7 days from the start of menstrual bleeding. If Mirena is inserted during this period, it will be effective immediately and will prevent pregnancy.
If Mirena cannot be inserted within 7 days from the onset of menstrual bleeding, or if menstruation occurs at unpredictable times, Mirena may be inserted at any time. In such cases, sexual intercourse without contraception since the last menstrual period must be avoided, and a negative pregnancy test result must be obtained before insertion. Additionally, Mirena may not provide immediate reliable protection against pregnancy. Therefore, a barrier method of contraception (e.g., condoms) should be used, or sexual intercourse should be avoided for the first 7 days after insertion.
Mirena is not suitable for use as emergency contraception (post-coital contraception).

Starting use of Mirena after childbirth

Mirena may be inserted after delivery once 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 use of Mirena" above for additional information on timing of insertion.

Starting use of Mirena after miscarriage
Mirena may be inserted immediately after a first-trimester miscarriage, provided there is no genital tract infection. Mirena will then be effective immediately.

Replacing Mirena
Mirena may be replaced with a new device at any time during the menstrual cycle. The new Mirena will be effective immediately.

Switching from another contraceptive method (e.g., combined hormonal contraceptives, implant)

Mirena may be inserted immediately if it is reasonably certain that the patient is not pregnant.
If more than 7 days have passed since the start of menstrual bleeding, sexual intercourse should be avoided or additional contraceptive protection used for the next 7 days.

Method of inserting Mirena
Mirena should be inserted only by a physician or other healthcare professional experienced in intrauterine device insertion.
After a gynecological examination, a speculum is inserted into the vagina and the cervix is cleaned with an antiseptic solution. The intrauterine device is then placed into the uterus using a thin, flexible plastic tube (the inserter). If necessary, the cervix may be locally anesthetized before insertion.
In some individuals, pain and dizziness may occur after insertion. If these symptoms persist for more than half an hour in a patient lying down, this may indicate incorrect placement of the device. An examination should be performed and, if necessary, the device should be removed.
After insertion, the patient should receive a reminder card from the physician, on which follow-up examination dates are recorded. This card should be brought to every scheduled visit.

When to contact a physician
The physician should check the presence of Mirena 4 to 12 weeks after insertion and will then perform regular checks at least once a year. The physician will determine individually how often and what follow-up examinations are needed. The reminder card provided by the physician should be brought to every scheduled visit.
Additionally, contact a physician if:

the threads are not palpable in the vagina
the lower part of the device is felt
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., periods become light or absent, followed by persistent bleeding or pain, or heavy bleeding starts)
other health problems occur, such as migraine headaches or severe recurring headaches, sudden vision problems, jaundice, or high blood pressure
any of the conditions listed in section 2. "Important information before using Mirena" occur.

Remind your physician that you have Mirena inserted, especially if it is not the physician who originally inserted it.

Duration of use of Mirena
Mirena provides contraceptive protection for 8 years after insertion. If Mirena is used for this purpose, it should be removed or replaced no later than after 8 years.
Mirena is effective for 5 years after insertion in the treatment of heavy menstrual bleeding (of unknown origin). If Mirena is used for this purpose, it should be removed or replaced when heavy menstrual bleeding returns, or no later than after 8 years. If desired, a new device may be inserted immediately after removal of the previous one.

If Mirena is to be removed to allow pregnancy or for another reason
A physician can easily remove Mirena at any time, after which pregnancy becomes possible. Removal is usually painless. Fertility returns after removal of Mirena.

Continuation of contraception after removal of Mirena
If pregnancy is not planned, Mirena should not be removed after the 7th day of the menstrual cycle unless another method of contraception (e.g., condoms) is used for at least 7 days before removal. If a woman has irregular or absent menstruation, mechanical contraception should be used for at least 7 days before removal and until the return of menstrual bleeding. Alternatively, a new device may be inserted immediately after removal of the previous one, in which case no additional protection is required. If the patient does not wish to continue with the same method, she should consult her physician about other reliable contraceptive methods.

Can pregnancy occur after stopping use of Mirena?
Yes. Removal of Mirena does not impair fertility. Pregnancy can occur during the first menstrual cycle after removal of Mirena.

Does Mirena affect menstrual bleeding?
Mirena affects the menstrual cycle. It may cause various changes in menstruation, such as spotting (light bleeding), shorter or longer bleeding, light or heavy bleeding, or absence of bleeding.
In many women, during the first 3 to 6 months after insertion of Mirena, frequent spotting or light bleeding may occur between periods. In some women, menstrual bleeding may become heavier or last longer than usual. In such cases, the physician should be informed, especially if symptoms persist.

Generally, the number of bleeding days and the amount of blood lost each month may gradually decrease. In some women, menstruation may eventually stop completely. Since menstrual bleeding usually becomes lighter during use of Mirena, many women experience an increase in hemoglobin concentration in the blood.
After removal of Mirena, menstruation returns to normal.

Is absence of bleeding normal?
Yes, when using Mirena. Absence of menstruation is a result of the hormone's effect on the endometrium. Monthly thickening of the endometrial lining does not occur. Therefore, there is nothing to be shed as menstrual blood. This does not necessarily indicate menopause or pregnancy. Hormone levels remain normal.
In fact, absence of menstruation may be a significant health benefit for women.

Diagnosis of pregnancy
Pregnancy during use of Mirena is unlikely, even in the absence of menstrual bleeding.
If menstrual bleeding has not occurred for six weeks and this causes concern, a pregnancy test may be performed. If the result is negative, no further testing is needed unless other signs of pregnancy are present, such as nausea, fatigue, or breast tenderness.

Can Mirena cause pain or discomfort?
Some women experience pain (similar to menstrual cramps) during the first few weeks after insertion. A physician or clinic should be consulted if severe pain occurs or if pain persists for more than 3 weeks after insertion.

Effect of Mirena on sexual intercourse
Neither the woman nor her partner should feel Mirena during sexual intercourse. If either does feel it, sexual intercourse should be avoided until a physician checks whether the device is still in the correct position.

How soon after insertion can sexual intercourse occur?
To allow the body to rest, it is advisable to wait approximately 24 hours after insertion before having sexual intercourse. However, Mirena provides immediate protection against pregnancy right after insertion.

Use of tampons or menstrual cups
Sanitary pads are recommended. If tampons or menstrual cups are used, they should be changed carefully to avoid pulling on the Mirena threads. If the patient suspects that Mirena has been displaced (see section "When to contact a physician" for possible symptoms), sexual intercourse should be avoided or mechanical contraception (such as condoms) should be used, and the patient should contact her physician.

What happens if Mirena is spontaneously expelled?
Rarely, Mirena may be expelled without the patient's knowledge during menstrual bleeding. If menstrual bleeding is heavier than usual, this may indicate that Mirena has been expelled through the vagina. Partial expulsion of Mirena from the uterine cavity is also possible (the woman or her partner may notice this during sexual intercourse). If Mirena is completely or partially expelled, it does not protect against pregnancy.

Self-checking for correct placement of Mirena
A woman may check herself whether the Mirena threads are in the correct position. To do this, insert a finger gently into the vagina and feel for the threads near the cervix.
Do not pull on the threads, as this may accidentally remove the device. If the threads cannot be felt, this may indicate expulsion or perforation of the uterus. In such cases, mechanical contraception (e.g., condoms) should be used and a physician should be contacted immediately.

4. Possible adverse effects

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Like all medicines, Mirena may cause adverse effects, although not everyone will experience them.
In addition to the possible adverse effects mentioned in other sections (e.g. section 2. "Important information before using Mirena"), the following possible adverse effects are listed below by affected body system and frequency of occurrence:

Very common: may occur in 1 out of every 10 patients
Disorders of the reproductive system and breast

Uterine or vaginal bleeding, including spotting, infrequent menstruation or absence of menstruation
Benign ovarian cysts (see section 2. "Enlarged ovarian follicles surrounding the maturing egg cell in the ovary")

Common: may occur in 1 to 10 out of every 100 patients
Psychiatric disorders

Depressed mood or depression
Nervousness
Decreased libido

Disorders of the nervous system

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
Vulvitis or vaginitis
Breast tenderness
Breast pain
Expulsion of the intrauterine delivery system

Investigations

Weight gain

Uncommon: may occur in 1 to 10 out of every 1,000 patients
Disorders of the nervous system

Migraine

Gastrointestinal disorders

Abdominal distension

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Skin and subcutaneous tissue disorders

Hirsutism (excessive hair growth in a male pattern in women)
Hair loss (alopecia)
Pruritus (intense itching)
Rash (skin inflammation)
Chloasma (yellowish-brown skin patches) or intense skin pigmentation

Reproductive system and breast disorders

Uterine perforation (puncture of the uterine wall)
Pelvic inflammatory disease (infection of the upper female genital tract, organs located above the cervix)
Endometritis (inflammation of the uterine lining)
Cervicitis – normal Papanicolaou class II smear in cytological examination (inflammation of the cervix)

General disorders and administration site conditions

Edema (swelling)

Rare: may occur in 1 to 10 out of every 10,000 patients
Skin and subcutaneous tissue disorders

Rash
Urticaria

If a woman becomes pregnant while using Mirena, there is a risk that the pregnancy will be ectopic (see section 2. "Ectopic pregnancy").
Cases of sepsis (a very severe infection that may be life-threatening) have been reported following insertion of the intrauterine delivery system.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Mirena

Keep out of the sight and reach of children.
No special temperature requirements for storage. Store in the original
packaging.
Do not use Mirena after the expiry date stated on the package. The expiry date refers to the last day of the stated month.
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Medicines must not be disposed of via the sewage system or household waste bins. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Mirena contains

The active substance is levonorgestrel. One intrauterine system contains 52 mg of levonorgestrel.
Other components are: polydimethylsiloxane elastomer, polydimethylsiloxane tubing (containing 30-40% colloidal silicon dioxide); T-body composition: polyethylene (containing 20-24% barium sulfate); threads composition: polyethylene, iron oxide black (E 172) below 1%.

What Mirena looks like and contents of the pack
Pack size: one sterile packaged intrauterine system for intrauterine use.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Romania, country of export:
Bayer AG, Kaiser-Wilhelm-Allee 1, 51373 Leverkusen, Germany
Manufacturer:
Bayer Oy, Pansiontie 47, 20210 Turku, Finland
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Romania, country of export: 7842/2015/01
Parallel import licence number: 242/23
If you have any further questions, please consult your doctor, pharmacist, or nurse.
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