Package leaflet: Information for the user

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 carefully all of this leaflet before use, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor, pharmacist or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Contents of the leaflet

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 which, once inserted, releases the hormone levonorgestrel into the uterine cavity. The T-shape ensures the system fits properly within the uterine cavity. The white vertical part of the system contains a reservoir with the active substance, levonorgestrel. 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 (to prevent 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 bleeding).

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 condoms or other mechanical methods. You should not use the calendar 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 infections.
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)
cervical inflammation
lower genital tract infections
postpartum endometritis
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
Before starting to use the Mirena system, consult your doctor.
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.

The Mirena system should be used with caution in women with congenital heart defects or heart valve abnormalities that increase the risk of endocarditis.
In women with diabetes using the Mirena system, blood glucose levels should be monitored.
Irregular bleeding may mask symptoms and signs of endometrial polyps or cancer; in such cases, diagnostic investigations should be considered.
Medical examination/consultation
A pre-insertion examination for 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 uterine position and uterine cavity size.
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 the Mirena system are often associated with sexually transmitted infections. 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, especially if acute and severe symptoms occur or do not resolve after several days of treatment.
In extremely rare cases, immediately after insertion of an intrauterine therapeutic system, a severe infection or sepsis (a very serious infection that may be fatal) may occur.
You should 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 out of place, it may not function as intended, thereby increasing the risk of pregnancy. Expulsion of the system results in loss of contraceptive protection.
Possible signs of expulsion include vaginal bleeding or lower abdominal pain, but Mirena may also be expelled unnoticed. Because Mirena reduces menstrual flow, increased bleeding may be a sign of expulsion or displacement of the system.
It is recommended to check by finger (e.g. during bathing) whether the threads are in the correct position. See also section 3, "How to use Mirena – Self-checking the correct position of the Mirena system". If symptoms indicating expulsion occur or if the threads cannot be felt near the cervical os, you should use alternative 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 not be detected until later. A Mirena system located outside the uterine cavity will not prevent 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 inserted, especially if this is not the doctor who performed the insertion.
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").

Breast cancer
Women using oral contraceptive pills have a slightly increased risk of developing breast cancer. This risk returns to age-appropriate levels within 10 years after stopping the pill.
Some scientific studies suggest a slightly increased risk of breast cancer with the use of levonorgestrel-releasing intrauterine devices, such as Mirena, while other studies do not indicate an increased risk. If you have any doubts, consult your doctor.
Ectopic pregnancy
Pregnancy while using the Mirena system is very unlikely. However, if a woman becomes pregnant while using Mirena, the likelihood of ectopic pregnancy is relatively increased. Approximately 1 in 1,000 women using Mirena correctly will 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 1,000 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.
Enlarged ovarian follicles surrounding the maturing egg
The contraceptive properties of the Mirena system are primarily due to its local action; therefore, in women of reproductive age, menstrual cycles are usually ovulatory and follicular rupture occurs. Occasionally, the unruptured follicle does not regress 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 the Mirena system, 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, you should inform your doctor about all medicines you are currently taking, including those obtained 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 alternative contraceptive methods should be used until you see your doctor.
During use of the Mirena system, menstruation may cease in some women after some time. Absence of menstruation does not always indicate pregnancy.
If menstruation has ceased and other signs of pregnancy are present (e.g. nausea, fatigue, breast tenderness), you should see a doctor for examination and take a pregnancy test.
If a woman becomes pregnant while using the Mirena system, she should contact her 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 preterm 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 inform your doctor immediately 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 female infants 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 into the infant's body via milk). After 6 weeks postpartum, use of the Mirena system has no harmful effect on infant growth and development. No adverse effects of progestogen-only contraceptives on the quantity and quality of breast milk have been observed.
Hormonal contraception is not recommended as a first-choice method during breastfeeding; non-hormonal contraceptive methods are recommended. Progestogen-only 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.
If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and operating machinery
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 visualized during X-ray examination.

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 were observed during the first year of using Mirena.
In the treatment of heavy menstrual bleeding of unknown origin, a reduction in bleeding intensity is observed as early as 3 months after starting 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 woman is not pregnant.
Mirena should be inserted within 7 days from the start of menstrual bleeding. If Mirena is inserted within this time frame, it will be effective immediately and will prevent pregnancy.
If Mirena cannot be inserted within 7 days from the onset of menstruation, or if menstruation occurs unpredictably, it may be inserted on any day. In such cases, unprotected sexual intercourse must be avoided from the last menstrual period onward, and a negative pregnancy test must be confirmed before insertion. Additionally, Mirena may not provide reliable contraceptive protection immediately. Therefore, a barrier method of contraception (e.g., condoms) should be used, or sexual intercourse should be avoided during the first 7 days after Mirena 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 postpartum (see section 2: "Important information before using Mirena – Uterine perforation").
See also "Starting use of Mirena" above for further 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 there is reasonable assurance that the woman is not pregnant.
If more than 7 days have passed since the start of menstrual bleeding, abstinence or additional contraceptive protection should be used for the next 7 days.

Method of inserting Mirena
Mirena should only be inserted by a physician or other healthcare professional experienced in intrauterine device insertion.
Following a gynecological examination, a speculum is inserted into the vagina and the cervix is cleaned with an antiseptic solution. The intrauterine system is then placed into the uterus using a thin, flexible plastic tube (the inserter). If necessary, local anesthesia of the cervix may be administered prior to insertion.
Some individuals may experience pain and dizziness after insertion. If these symptoms do not resolve within half an hour while the patient remains lying down, this may indicate improper placement of the device. An examination should be performed and, if necessary, the device should be removed.
After Mirena insertion, the patient should receive an information card from the physician, where follow-up examination dates are recorded. This card should be brought to every scheduled visit.

When to contact a doctor
The physician should check for the presence of Mirena 4 to 12 weeks after insertion, and then perform regular checks at least once a year. The physician will determine individually how frequently follow-up examinations should be performed. The patient should bring the information card received from the physician to every scheduled visit. Additionally, contact a doctor if:

The threads are not detectable 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 begins)
Other health problems occur, such as migraine headaches or recurrent severe headaches, sudden vision problems, jaundice, or increased blood pressure
Any of the conditions listed in section 2 "Important information before using Mirena" occur

Inform any physician that you have Mirena inserted, especially if it is not the physician who originally inserted the device.

Duration of use of Mirena
Mirena prevents pregnancy (provides contraceptive effect) for up to 8 years after insertion. If Mirena is used for this purpose, it should be removed or replaced no later than 8 years after insertion.
Mirena is effective for 5 years after insertion in the treatment of heavy menstrual bleeding of unknown origin. If Mirena is used for this reason, it should be removed or replaced when heavy menstrual bleeding returns, or no later than 8 years after insertion. 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 Mirena removal.

Continuation of contraception after Mirena removal
If pregnancy is not planned, Mirena should not be removed after the 7th day of the menstrual cycle unless another contraceptive method (e.g., condoms) has been used for at least 7 days prior to 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 contraceptive 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 you become pregnant after stopping use of Mirena?
Yes. Removal of Mirena does not impair fertility. Pregnancy can occur during the first menstrual cycle after Mirena removal.

Does Mirena affect menstrual bleeding?
Mirena affects the menstrual cycle and may cause various changes in menstruation, such as spotting (light bleeding), shorter or longer bleeding periods, light or heavy bleeding, or absence of bleeding.
In many women, during the first 3 to 6 months after Mirena insertion, 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 Mirena typically reduces menstrual flow, many women experience an increase in hemoglobin levels in the blood.
After Mirena removal, menstruation returns to its normal pattern.

Is absence of bleeding normal?
Yes, when using Mirena. Absence of menstruation is due to the hormonal effect on the endometrium. There is no monthly thickening of the endometrial lining, so 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 some women.

Diagnosis of pregnancy
Pregnancy during Mirena use is unlikely, even in the absence of menstrual bleeding.
If menstruation does not occur for six weeks and this causes concern, a pregnancy test may be performed. If the result is negative, no further testing is necessary 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 confirms that 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 engaging in sexual intercourse. Depending on when during the menstrual cycle Mirena is inserted, emergency contraception (e.g., condoms) may be required, or sexual intercourse should be avoided for the first 7 days after insertion (see section 3 "How to use Mirena – When should Mirena be inserted?").

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 doctor" 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, but possibly, Mirena may be expelled without the woman'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 no longer provides protection against pregnancy.

Self-checking for correct placement of Mirena
A woman may check herself whether the Mirena threads are in place. 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 inadvertently remove the device. If the threads are not felt, this may indicate expulsion of the device from the uterus or uterine perforation. In such cases, mechanical contraception (e.g., condoms) should be used and a physician should be contacted immediately.

4. Possible side effects

Like all medicines, Mirena may 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"), below are possible side effects categorized by affected body systems and their frequency of occurrence:

Very common side effects: may occur in more than 1 out of 10 women

Reproductive system and breast disorders

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 side effects: may occur in less than 1 out of 10 women

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 and connective tissue 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 system

Investigations

Increased body weight

Uncommon side effects: may occur in less than 1 out of 100 women

Nervous system disorders

Migraine

Gastrointestinal disorders

Abdominal distension

Skin and subcutaneous tissue disorders

Hirsutism (male-pattern body hair growth 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 side effects: may occur in less than 1 out of 1000 women

Skin and subcutaneous tissue disorders

Rash
Urticaria (hives)

If a woman becomes pregnant while using Mirena, there is an increased risk of ectopic pregnancy (see section 2. "Ectopic pregnancy").

Cases of sepsis (a very severe infection which may be fatal) have been reported after insertion of the intrauterine system.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse.

Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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

Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Mirena

Keep the medicine out of the sight and reach of children.
No special storage conditions are required.
Do not insert the Mirena system after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 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.
The other ingredients are: polydimethylsiloxane elastomer, polydimethylsiloxane tubing containing colloidal anhydrous silica, T-body composition: polyethylene containing 20–24% barium sulfate, threads composition: polyethylene, iron oxide.

What Mirena looks like and contents of the pack
Pack size: one, sterile packaged intrauterine system for intrauterine use.
For more detailed information, please consult your doctor, the marketing authorisation holder, or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
Bayer Hispania, S.L., Av. Baix Llobregat 3-5, 08970 Sant Joan Despí (Barcelona), Spain
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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Spanish marketing authorisation number, country of export: 885905.4
Parallel import authorisation number: 304/20
If you have any further questions, please consult your doctor or pharmacist.