Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Mirena (Mirena)
52 mg, 20 micrograms/24 hours, intrauterine system
Levonorgestrel
Mirena and Mirena are the same brand names of the same medicinal product written in Polish and Bulgarian languages, respectively.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same as yours.
If you experience any adverse reactions, 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 an intrauterine system in the shape of a "T", which, once inserted, releases the hormone levonorgestrel into the uterine cavity. The "T" shape ensures proper fit within the uterine cavity. The white system contains a drug reservoir in its vertical stem, which holds levonorgestrel. Attached to the loop 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 etiology).

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 that of your immediate family.
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. Do not use the rhythm method or temperature measurement. These methods 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) or other sexually transmitted infections.
Do not insert 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 (cervicitis)
lower genital tract infections
postpartum endometritis
uterine infection following miscarriage 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 or not, if any of the following conditions occur for the first time during use of the Mirena system:

migraine, asymmetric visual field defects, or other symptoms which 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, blood glucose levels should be monitored during use of the Mirena system.
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 medical 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 uterus.
The Mirena system is not an appropriate contraceptive method for emergency contraception (post-coital contraception).
Infections
The insertion tube helps protect the Mirena system from microbial contamination during insertion. The Mirena inserter 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 diseases. The risk of infection increases with sexual intercourse 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 acute and severe inflammatory conditions occur or do not resolve after a few days of treatment.
In extremely rare cases, severe infection or sepsis (a very serious infection that may be fatal) may occur shortly after insertion of the intrauterine therapeutic system.
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 had heavy menstrual bleeding. If the system is displaced, 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. Since the Mirena system reduces menstrual flow, 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 – 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 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 be detected only later. The 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 inserted, especially if it is not the doctor who inserted it.
Possible signs and symptoms of perforation may include:

severe pain (like menstrual cramps) or pain more intense 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 – 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 the Mirena system, the likelihood of ectopic pregnancy is relatively increased. Approximately 1 in 1000 women who correctly use the Mirena system experience an ectopic pregnancy per year of use. This is less than in women who do not use any contraceptive method (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 attention include:

cessation of menstrual bleeding, followed by persistent bleeding or pain
dull or 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 reaction. Your doctor may recommend resting for a short time after insertion of the Mirena system.
Ovarian cysts
The contraceptive effect of the Mirena system is primarily local, so in women of reproductive age, menstrual cycles are usually ovulatory and the ovarian follicle ruptures. Occasionally, the unruptured follicle does not regress for some time and may enlarge. In most cases, these enlarged ovarian cysts cause no symptoms, although they may cause pelvic pain or pain during intercourse. Such enlarged ovarian cysts usually resolve spontaneously but may sometimes require medical intervention.
Psychiatric disorders
Some women using hormonal contraceptives, including Mirena, have reported depression or low 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 Mirena 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, 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), you should see your doctor for examination and undergo 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 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 contact 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 breast milk). Six weeks after delivery, use of the Mirena system has no harmful effect on the infant's growth and development. Contraceptive products containing only progestogens have not been shown to affect the quantity or quality of breast milk.
Hormonal contraception is not recommended as a first-choice method during breastfeeding; non-hormonal contraceptive methods are recommended. Progestogen-only contraceptive methods, such as the Mirena system, are considered second-choice 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 visible during X-ray imaging.

3. How to use Mirena

Effectiveness of the Mirena system
The contraceptive effectiveness of the Mirena system 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 the Mirena system.
In the treatment of heavy menstrual bleeding of unknown origin, bleeding intensity decreases within 3 months of starting use of the Mirena system. In some women, menstruation may even stop completely.

When should the Mirena system be inserted?
Starting use of the Mirena system

Before inserting the Mirena system, it must be confirmed that the woman is not pregnant.
The Mirena system should be inserted within 7 days from the start of menstrual bleeding. If inserted during this time, the system will be effective immediately and will prevent pregnancy.
If insertion cannot occur within 7 days from the onset of menstrual bleeding, or if menstruation occurs unpredictably, the system may be inserted on any day. In such a case, sexual intercourse without contraception should be avoided since the last menstrual bleeding, and a negative pregnancy test must be obtained 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 insertion of the Mirena system.
The Mirena system is not suitable for use as emergency contraception (post-coital contraception).

Starting use of the Mirena system after childbirth

The Mirena system 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 – Uterine perforation").
See also "Starting use of the Mirena system" above for additional information on the timing of insertion.

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

Replacement of the Mirena system
The system may be replaced with a new one on any day of the menstrual cycle. The Mirena will then be effective immediately.

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

The Mirena system may be inserted immediately if it is reasonably certain that the woman 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 should be used for the next 7 days.

Method of inserting the Mirena system
The Mirena system should only be inserted by a physician or other qualified healthcare professional experienced in the insertion of such systems.
After performing 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 before 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 incorrect placement of the system. 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 physician, on which follow-up examination dates will be recorded. This card should be brought to every scheduled visit.

When to contact a doctor
The physician should check for the presence of the system 4 to 12 weeks after insertion, and thereafter should regularly check its presence at least once a year. The physician will determine individually how often and what follow-up examinations are required. The reminder card provided by the physician should be brought to every scheduled visit.
Additionally, contact a doctor if:

the threads are not felt in the vagina
the lower part of the system 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 stop, then suddenly heavy bleeding or pain occurs, or intense bleeding starts)
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 the Mirena system occur.

Remind your doctor that you have the Mirena system in place, especially if it is not the doctor who inserted it.

Duration of use of the Mirena system
The Mirena system prevents pregnancy (exerts contraceptive effect) for 8 years after insertion. If the patient uses Mirena for this reason, the system should be removed or replaced no later than after 8 years.
The Mirena system is effective for 5 years after insertion in the treatment of heavy menstrual bleeding (of unknown origin). If the patient uses Mirena for this reason, the system should be removed or replaced when heavy menstrual bleeding returns, or no later than after 8 years. If desired, a new system may be inserted immediately after removal of the previous one.

If you wish to remove the Mirena system to become pregnant or for another reason
A physician can easily remove the system at any time, after which pregnancy becomes possible. Removal is usually painless. Fertility returns after removal of the Mirena system.

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

Can you become pregnant after stopping use of the Mirena system?
Yes. Removal of the Mirena system does not impair fertility. Pregnancy can occur 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 may cause various changes in menstruation, such as spotting (light blood loss), 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 the Mirena system, frequent spotting or light bleeding occurs in addition to menstrual bleeding. In some women, menstrual bleeding may become heavier or last longer than usual. In such cases, the physician should be informed, especially if these symptoms do not resolve.
Generally, a gradual reduction in the number of bleeding days and the amount of blood lost each month is possible. In some women, menstruation may eventually stop completely. Since menstrual bleeding usually decreases during use of the Mirena system, many women experience an increase in hemoglobin concentration in the blood.
After removal of the system, menstruation returns to normal.

Is absence of bleeding normal?
Yes, when using the Mirena system. Absence of menstruation is a result of the hormone's effect on the endometrium. Monthly thickening of the endometrium does not occur. Therefore, there is no tissue to be shed through menstrual bleeding. 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
Becoming pregnant while using the Mirena system is unlikely, even if there is no 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 symptoms of pregnancy are present, such as nausea, fatigue, or breast tenderness.

Can the Mirena system cause pain or discomfort?
Some women experience pain (similar to menstrual cramps) during the first few weeks after insertion of the system. A follow-up visit to the doctor or clinic is recommended if severe pain occurs 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 woman nor her partner should feel the system during sexual intercourse. However, if either does feel it, sexual intercourse should be avoided until a doctor checks whether the system 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 in the menstrual cycle the Mirena system is inserted, emergency contraception (e.g., condoms) may be necessary, or sexual intercourse should be avoided for the first 7 days after insertion (see section 3 "How to use Mirena – When should the Mirena system 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 the Mirena system 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 doctor.

What happens if the Mirena system is spontaneously expelled?
Rarely, but possibly, the Mirena system may be expelled without the woman's knowledge during menstrual bleeding. If menstrual bleeding is heavier than usual, this may indicate that the Mirena has been expelled through the vagina. Partial expulsion of the Mirena system from the uterine cavity is also possible (the woman or her partner may notice this during sexual intercourse). If the Mirena is completely or partially expelled, it no longer protects against pregnancy.

Self-checking for correct placement of the Mirena system
A woman may check herself whether the system's 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 system. If the threads cannot be felt, this may indicate expulsion of the system from the uterus or uterine perforation. In such cases, mechanical contraception (e.g., condoms) should be used and the woman should contact her doctor.

4. Possible adverse effects

Like all medicines, the Mirena medicine can cause adverse effects, although they do not occur in everyone.

In addition to the possible adverse effects listed in other sections (e.g. section 2, Important information before using Mirena), below are possible adverse effects listed according to the body system involved and their frequency of occurrence:

Very common adverse 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
benign ovarian cysts (see section 2: "enlarged ovarian follicles")

Common adverse 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 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 delivery system

Investigations

weight increase

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

migraine

Gastrointestinal disorders

abdominal distension

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 (penetration 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 (cervical inflammation)

General disorders and administration site conditions

swelling

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

rash
urticaria

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

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor, pharmacist, or nurse.
Adverse 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.
Adverse effects can also be reported to the marketing authorization holder or parallel importer.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Mirena

Keep the medicine out of the sight and reach of children.
Storage: No special storage instructions apply.
Do not insert Mirena after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist what to do with 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: elastomer polydimethylsiloxane; polydimethylsiloxane tubing (containing colloidal anhydrous silica); T-body (composed of polyethylene containing 20-24% barium sulfate); threads (composed of polyethylene, iron oxides (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 Bulgaria, the country of export:
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany
Manufacturer:
Bayer Oy
Pansiontie 47
20210 Turku
Finland
Parallel importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing authorisation number in Bulgaria, the country of export: 9800344
Parallel import authorisation number: 407/24
If you have any further questions, please consult your doctor or pharmacist.