Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Mirena
52 mg, 20 micrograms/24 hours, intrauterine therapeutic system
Levonorgestrel
Please read the entire leaflet carefully before use, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual only. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. 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 therapeutic system which, once inserted, releases the hormone levonorgestrel into the uterine cavity. The T-shape ensures proper fitting of the system within the uterus. The vertical stem contains a drug reservoir holding levonorgestrel. Attached to the loop at the lower end of the stem are two threads, used for removal of 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 bleeding).

2. Important information before using Mirena

General information
Before using 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. Do not use fertility awareness-based methods or temperature monitoring. These may be ineffective because Mirena affects monthly body temperature changes and cervical mucus changes.
Like other hormonal contraceptive products, Mirena 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;
existing or recurrent 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 uterus;
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);
unusually 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 myocardial infarction;
acute venous thromboembolic disease.

The Mirena system should be used with caution in women with congenital heart defects or valvular heart disease 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, 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 uterine position and size of the uterine cavity.
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 Mirena. Pelvic infections in women using Mirena are often associated with sexually transmitted diseases. The risk of infection increases with sexual intercourse with multiple partners. Pelvic infections must be adequately 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 within a few days of treatment.
In extremely rare cases, shortly after insertion of an intrauterine delivery 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, fever, 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 protection against pregnancy.
Possible symptoms of expulsion include vaginal bleeding or lower abdominal pain, but Mirena may also be expelled unnoticed. Since Mirena reduces menstrual flow, increased bleeding may be a sign of expulsion or displacement.
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 for correct placement 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.
Perforation of the uterine wall
Perforation or damage to the uterine wall may occur, most commonly during insertion, although it may not be detected until 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 Mirena. 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 – Self-checking for correct placement 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 likelihood of ectopic pregnancy is relatively increased. Approximately 1 in 1000 women using Mirena correctly experience an ectopic pregnancy per 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 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 advise you to rest for a while after insertion.
Ovarian cysts
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, an unruptured follicle may persist for some time and 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 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
Because the mechanism of action of Mirena 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 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 alternative contraceptive methods should be used until you see your doctor.
During use of Mirena, menstrual bleeding may cease in some women after some time. Absence of menstrual bleeding does not always indicate pregnancy. If menstruation 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 Mirena, contact your doctor immediately for removal of the system. Removal may result in 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 contact your doctor immediately if symptoms such as abdominal cramps, abdominal pain, or fever occur.
Mirena contains the hormone levonorgestrel, and there are 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). Six weeks after childbirth, use of the Mirena system has no harmful effect on the infant’s growth and development. Anticontraceptive 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 methods such as Mirena 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 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 Mirena
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 equivalent to that of the most effective copper-containing intrauterine devices. In clinical studies, approximately 2 pregnancies per 1000 women using the Mirena system were observed during the first year.
In the treatment of heavy menstrual bleeding of unknown origin, bleeding intensity decreases already after 3 months of using the Mirena system. In some women, menstruation may even cease 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 patient is not pregnant.
The Mirena system should be inserted within 7 days from the start of menstrual bleeding. If inserted during this period, the system will be effective immediately and will prevent pregnancy.
If insertion cannot occur within 7 days after the onset of menstrual bleeding, or if menstruation occurs at unpredictable times, the system may be inserted on any day. In such cases, sexual intercourse without contraception should be avoided since the last menstrual period, and a negative pregnancy test result 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 for 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 postpartum (see section 2: "Important information before using Mirena – Uterine perforation").
See also "Starting use of the Mirena system" above for additional information about 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.

Replacing 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 there is reasonable assurance that the patient 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 the Mirena system
The Mirena system should only be inserted by a physician or other qualified medical professional experienced in its insertion.
Following a gynecological examination, a speculum is inserted into the vagina and the cervix is cleansed 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.
In some individuals, pain and dizziness may occur after insertion. If these symptoms do not resolve within half an hour in a patient remaining in a lying position, 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 the presence of the system 4 to 12 weeks after insertion, and thereafter will monitor its presence regularly at least once a year. The physician will determine individually how often and which follow-up examinations are required. The patient reminder card received from the physician should be brought to every scheduled visit.
Additionally, contact a doctor if:

The threads are not palpable 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 absent, then suddenly persistent bleeding or pain occurs, or heavy bleeding begins)
Other health problems occur, such as migraine headaches or severe recurring 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.

Inform 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 action) for 8 years after insertion. If the patient uses Mirena for this purpose, the system should be removed or replaced no later than 8 years after insertion.
The Mirena system is effective for 5 years after insertion in the treatment of heavy menstrual bleeding (of unknown 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 8 years after insertion. 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 desired, 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 prior to removal. If a woman has irregular or absent menstruation, mechanical contraceptive methods should be used for at least 7 days before removal and until return of menstrual bleeding. Alternatively, a new system 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 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 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 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 typically 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 endometrial lining does not occur. Therefore, there is no tissue to be shed with menstrual blood under natural conditions. 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.

Pregnancy diagnosis
Becoming pregnant while using the Mirena system is unlikely, even in the absence of menstrual bleeding.
If menstruation 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 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. 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.

Effect of the Mirena system on sexual intercourse
Neither the woman nor her partner should feel the system during sexual intercourse. 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 best 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
The use of sanitary pads is 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 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 spontaneous expulsion of the Mirena system occurs?
Rarely, but possibly, the Mirena system 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 the system 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 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 inadvertently remove the system. If the threads are not 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 patient should contact her doctor.

4. Possible adverse reactions

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

Very common adverse reactions: may occur in more than 1 out of 10 women
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 reactions: 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, 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 system

Investigations

weight gain

Uncommon adverse reactions: may occur in less than 1 out of 100 women
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 (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 – Pap smear showing normal class II according to Papanicolaou classification (cervical inflammation)

General disorders and administration site conditions

edema (swelling)

Rare adverse reactions: may occur in less than 1 out of 1,000 women
Skin and subcutaneous tissue disorders

rash
urticaria (hives)

If a woman becomes pregnant while using Mirena, there is an increased risk 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 system.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Mirena

Keep this medicine out of the sight and reach of children.
Store below 30°C. Protect from moisture.
Do not insert Mirena after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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, polyethylene, barium sulfate, iron oxide black (E 172).

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 physician, the marketing authorisation holder, or the parallel importer.
Marketing authorisation holder in Greece, the country of export:
Bayer Hellas ABEE
Agisilaou 6-8, 151 23 Marousi, Attica, Greece
Manufacturer:
Bayer Oy
Pansiontie 47, 20210 Turku, Finland
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11, 03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorisation number in Greece, the country of export: 20731/1-4-2008
46275/25-6-2009
Parallel import authorisation number: 730/15