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 this leaflet carefully before using this medicine because it contains
important information for the patient.

Keep this leaflet as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Mirena is and what it is used for
What you need to know 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 shaped like the letter "T", which, once inserted, releases the hormone levonorgestrel into the uterine cavity. The "T" shape ensures the system fits properly within the uterine cavity. The vertical part of the white system contains a reservoir holding 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 remarks
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. 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) or other sexually transmitted infections.

Do not use Mirena if any of the following 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 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 tumours.

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)
marked increase in blood pressure
severe arterial disease, such as stroke or myocardial infarction
acute venous thromboembolic disease.

Mirena 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; diagnostic evaluation should be considered in such cases.

Medical examination/consultation
The examination prior to insertion of Mirena 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.
Mirena 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 is 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 infections. The risk of infection increases with multiple sexual 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, especially if acute and severe symptoms occur or do not resolve after several 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.
Seek immediate medical attention if you experience persistent lower abdominal pain, elevated body temperature, pain during sexual intercourse, or abnormal vaginal bleeding.

Spontaneous expulsion
Uterine 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 as intended, increasing the risk of pregnancy. Expulsion results in loss of contraceptive protection.
Possible symptoms 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.
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 suggesting 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 not be detected until later. Mirena located outside the uterine cavity is not effective 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 breastfeeding women 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 Mirena 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 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 contraceptives have a slightly increased risk of developing breast cancer. This risk returns to age-appropriate levels within 10 years after stopping oral contraceptives.
Some scientific studies suggest a slightly increased risk of breast cancer with the use of a levonorgestrel-releasing intrauterine system such as Mirena, while other studies do not indicate an increased risk. If in doubt, consult your doctor.

Ectopic pregnancy
Pregnancy during use of Mirena 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 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 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 Mirena. This is a normal physiological reaction. Your doctor may recommend resting for a while after insertion.

Enlarged ovarian follicles surrounding the maturing egg cell
The contraceptive properties of Mirena 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 may enlarge. In most cases, these enlarged follicles are asymptomatic, although they may cause pelvic pain or pain during intercourse. Such enlarged ovarian follicles usually resolve 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 Mirena is primarily local, taking other medicines should not increase the risk of pregnancy during use. 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 Mirena is correctly positioned. However, if Mirena becomes displaced, contraceptive protection is reduced and alternative contraceptive methods should be used until you see your doctor.
During use of Mirena, menstruation may stop 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), see your doctor for examination and take a pregnancy test.
If you become pregnant while using Mirena, contact your doctor immediately for removal of the system. Removal may cause miscarriage. However, leaving Mirena in place during pregnancy may increase not only the risk of miscarriage but also the risk of preterm delivery. If Mirena 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 via breast milk). After 6 weeks postpartum, use of Mirena has no harmful effect on infant 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. Methods containing only progestogens, 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 Mirena restores normal fertility.

If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning 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 components of Mirena:
The T-shaped frame of Mirena contains barium sulfate, which allows the system to be visible during X-ray examination.

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 intrauterine device. In clinical studies, approximately 2 pregnancies per 1000 women using the Mirena system were observed during the first year.
In the treatment of excessive menstrual bleeding of unknown origin, bleeding intensity decreases already after 3 months of using the Mirena system. In some women, menstruation may even stop completely.
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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 the Mirena system is inserted during this time, it will be effective immediately and will prevent pregnancy.
If the Mirena system cannot be inserted 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 period, and a negative pregnancy test result must be confirmed before insertion. Furthermore, Mirena may not reliably prevent pregnancy 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 after childbirth (see section 2: "Important information before using Mirena – Perforation of the uterine wall").
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.

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 there is reasonable assurance that the patient is not pregnant.
If more than 7 days have passed since the start of menstrual bleeding, abstinence from sexual intercourse or additional contraceptive protection should be used for the next 7 days.

Method of inserting the Mirena system
The Mirena system should be inserted only by a physician or other medical professional experienced in its 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.
In some individuals, pain and dizziness may occur 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 are recorded. This card should be brought to every scheduled visit.
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When to contact a physician
The physician should check for the presence of the system 4 to 12 weeks after insertion, and subsequently perform regular checks at least once a year. The physician will determine individually how often and what type of follow-up examinations are needed. The patient should bring the reminder card received from the physician to every scheduled visit. Additionally, contact the physician 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 absent, then suddenly persistent bleeding or pain occurs, or heavy bleeding begins)
other health problems arise, 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 Mirena" occur.

Remind the physician that you have the Mirena system inserted, especially if it is not the physician who originally 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 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 excessive menstrual bleeding (of unknown origin). If the patient uses Mirena for this reason, the system should be removed or replaced when excessive menstrual bleeding recurs, or no later than after 8 years. If desired, a new system may be inserted after removal of the previous one.

If you wish to remove the Mirena system to become pregnant or for another reason
The physician can easily remove the system at any time, after which pregnancy becomes possible. Removal of the system 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 prior to 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 return of menstrual bleeding. Alternatively, a new system may be inserted immediately after removal of the previous one, in which case additional contraception is not 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 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?
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The Mirena system affects the menstrual cycle. It 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 insertion of the Mirena system, frequent spotting or slight bleeding may occur 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 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 sign of the hormone's effect on the endometrium. Monthly thickening of the endometrial lining does not occur. Therefore, there is nothing to be shed through menstrual bleeding under normal 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.

Diagnosis of pregnancy
Becoming pregnant while using the Mirena system is unlikely, even if there are no menstrual periods.
If menstrual bleeding 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 visit to the physician 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 patient nor her partner should feel the system during sexual intercourse. However, if either does feel it, sexual intercourse should be avoided until a physician checks whether the system is still in the correct position.

How soon after insertion of the Mirena system 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
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 system threads. If the patient suspects that the Mirena system 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 the Mirena system is spontaneously expelled?
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 the Mirena system has been expelled through the vagina. Partial expulsion of the Mirena system from the uterine cavity is also possible (the patient or partner may notice this during sexual intercourse). If the Mirena system is completely or partially expelled, it does not protect against pregnancy.

Self-checking for correct placement of the Mirena system
A woman can check herself whether the system threads are in the correct position. To do this, she should gently insert a finger into the vagina and check for the presence of threads near the cervix.
Do not pull on the threads, as this may inadvertently 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 physician should be contacted immediately.
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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 use of Mirena"), the possible side effects listed below are categorized by body parts affected and frequency of occurrence:

Very common side effects: may occur in more than 1 in 10 women
Reproductive system and breast disorders

Uterine or vaginal bleeding including spotting, infrequent menstruation or absence of periods
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 in 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
Vulvitis or vaginitis
Breast tenderness
Breast pain
Expulsion of the intrauterine system

Investigations

Weight gain

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

Migraine

Gastrointestinal disorders

Abdominal distension

Skin and subcutaneous tissue disorders

Hirsutism (excessive male-pattern body hair growth in women)
Hair loss (alopecia)
Itching (pruritus)
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

Swelling

Rare side effects: may occur in less than 1 in 1,000 women
Skin and subcutaneous tissue disorders

Rash
Urticaria

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

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse.
Side effects can also 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
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Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Mirena

Keep out of the sight and reach of children.
Store in the original packaging to protect from light.
Do not insert the Mirena system 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. These measures help protect the environment.

6. Contents of the packaging and other information

What Mirena contains

The active substance is levonorgestrel. One intrauterine system contains 52 mg of levonorgestrel.
Other components of the medicine are: elastomer polydimethylsiloxane, tubing polydimethylsiloxane (containing anhydrous colloidal 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, sterilely 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 the Netherlands, country of export:
Bayer B.V., Siriusdreef 36, 2132 WT Hoofddorp, the Netherlands
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
Dutch, country of export, marketing authorisation number: RVG 16681
Parallel import authorisation number: 40/26
If you have any further questions, please consult your doctor or pharmacist.
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