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 delivery system
Levonorgestrel
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
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 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 an intrauterine delivery system in the shape of a "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 stem of the white system contains a reservoir holding 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 (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 notes
Before inserting the Mirena system, your doctor will ask you several questions about your health and the health 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.
Like other hormonal contraceptives, Mirena does not protect against HIV infection (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
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
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 of the system:

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)
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.
Women with diabetes using the Mirena system should have their blood glucose levels 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 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 the position and size of the uterine cavity.
The Mirena system is not an appropriate contraceptive method for emergency use (post-coital contraception, emergency 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. Despite this, there is an increased risk of infection immediately after insertion and during the first month following insertion of the Mirena system. Pelvic infections in women using Mirena are often associated with sexually transmitted diseases. The risk of infection increases with sexual contact with multiple partners. Pelvic inflammatory disease must be adequately treated, as it 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 several days of treatment.
In extremely rare cases, immediately after insertion of an intrauterine therapeutic system, severe infection or sepsis (a very serious infection that may be fatal) may occur.
Contact your doctor immediately if you experience persistent lower abdominal pain, elevated body temperature, pain during sexual intercourse, or abnormal vaginal bleeding.
Spontaneous expulsion
Uterine muscle contractions during menstrual bleeding may sometimes cause displacement or expulsion of the system. This is more likely if the woman is overweight at the time of insertion or has previously experienced heavy menstrual bleeding. If the system is 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 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 for correct placement of the Mirena system". If symptoms indicating expulsion occur or 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 only be detected later. A Mirena system located outside the uterine cavity is ineffective in preventing pregnancy and must 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 (uterine retroversion). 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 inserted the system.
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 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 probability of ectopic pregnancy is relatively increased. Approximately 1 in 1000 women who correctly use the Mirena system experience an ectopic pregnancy within one year of use. This is less than in women who do not use any contraceptive method (approximately 3 to 5 per 1000 women per year). Women who have previously had an ectopic pregnancy, tubal surgery, or pelvic inflammatory disease 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 briefly after insertion of the Mirena system.
Enlarged ovarian follicles surrounding the maturing egg cell
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 for some time and may enlarge. In most cases, these enlarged follicles cause no symptoms, although they may cause pelvic pain or pain during intercourse. Such enlarged ovarian follicles usually 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
Since the mechanism of action of the Mirena system is primarily local, taking other medicines should not increase the risk of pregnancy during use of this system. However, it is recommended to inform your doctor about all recently taken medicines, 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.
It is very rare, but possible, for a woman to 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, 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 perform a pregnancy test.
If a woman becomes pregnant while using the Mirena system, contact your doctor immediately for removal of the system. Removal may cause miscarriage. However, leaving the Mirena system in place during pregnancy may increase not only the risk of miscarriage but also the risk of 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 immediately inform your doctor if symptoms such as abdominal cramps, abdominal pain, or fever occur.
Mirena contains a hormone called levonorgestrel, and there have been isolated reports of effects on the genital organs of 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 childbirth, 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; only non-hormonal contraceptive methods are recommended. Second-choice methods include progestogen-only contraceptives such as the Mirena system. The daily dose and blood concentration of levonorgestrel are lower than with other hormonal contraceptive methods.
Fertility
Removal of the Mirena system restores normal fertility in women.
If you are pregnant or breastfeeding, suspect you 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 and 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 equivalent to that of the most effective copper 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 idiopathic excessive menstrual bleeding, a reduction in bleeding intensity is observed as early as 3 months after starting Mirena. 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 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 at any time. In such cases, sexual intercourse without contraception must be avoided from the last menstrual period until insertion, and a negative pregnancy test must be obtained prior to 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 on 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. In such cases, Mirena will be effective immediately.

Replacing the Mirena system
The system may be replaced with a new one at any time during the menstrual cycle. 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 onset 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 healthcare professional experienced in intrauterine device insertion.
After a gynecological examination, a speculum is inserted into the vagina and the cervix is cleaned with an antiseptic solution. The intrauterine device is then placed into the uterus using a thin, flexible plastic tube (the inserter). If necessary, 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.

When to contact a physician
The physician should check for the presence of the system 4 to 12 weeks after insertion and will subsequently perform regular checks at least once a year. The physician will determine individually how often and which follow-up examinations are required. The patient reminder card provided by the physician should be brought to every scheduled visit.

Additionally, contact a physician if:

the threads are not palpable in the vagina
the lower part of the 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, followed by persistent bleeding or pain, or sudden onset of heavy bleeding)
other health problems arise, 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 physician that you have the Mirena system in place, especially if it is not the physician who inserted it.

Duration of use of the Mirena system
The Mirena system provides contraceptive protection for 8 years after insertion. If the patient is using 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 idiopathic excessive menstrual bleeding. If the patient is using Mirena for this indication, the system should be removed or replaced when excessive menstrual bleeding recurs, or no later than 8 years after insertion. A new system may be inserted immediately after removal of the previous one, if desired.

If the Mirena system is to be removed to allow pregnancy 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 contraceptive method (e.g., condoms) is used for at least 7 days prior to removal. If the woman has irregular or absent 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 no additional protection is required. If the patient does not wish to continue with the same method, she should consult her physician for advice on 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 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 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 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, 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 cease completely. Because 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 its normal pattern.

Is absence of bleeding normal?
Yes, when using the Mirena system. Absence of menstruation is a result of the hormonal effect on the endometrium. Monthly thickening of the endometrial lining does not occur. Therefore, there is no tissue to be shed during menstruation. This does not necessarily indicate menopause or pregnancy. Hormone levels remain within normal ranges.
In fact, absence of menstruation may be a significant health benefit for women.

Diagnosis of pregnancy
Pregnancy during use of the Mirena system 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 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 physician 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 physician confirms that the system is still correctly positioned.

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 the Mirena system is inserted, emergency contraception (e.g., condoms) may be needed, 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 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, 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 Mirena system from the uterine cavity is also possible (the woman or her partner may notice this during intercourse). If 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 inadvertently remove the system. If the threads cannot be felt, this may indicate expulsion or uterine perforation. In such cases, mechanical contraception (e.g., condoms) should be used and the physician should be contacted immediately.

4. Possible adverse reactions

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

In addition to the possible adverse reactions mentioned in other sections (e.g. section 2: Important information before using Mirena), below are listed possible adverse reactions categorized by affected body systems and frequency of occurrence:

Very common adverse reactions: may occur in more than 1 in 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 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 increase

Uncommon adverse reactions: may occur in less than 1 in 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
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 adverse reactions: may occur in less than 1 in 1000 women
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 system.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please inform your doctor, pharmacist or nurse.
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, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the responsible entity or parallel importer.
Reporting adverse reactions 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 temperature requirements for storage.
Keep in the original packaging.
Do not use Mirena 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. This will help protect the environment.

6. Contents of the pack and other information

What Mirena contains

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

What Mirena looks like and contents of the pack
Pack size: one sterile packaged intrauterine system for intrauterine use.
For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Romania, country of export:
Bayer AG
Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany
Manufacturer:
Bayer Oy
Pansiontie 47
20210 Turku
Finland
Parallel importer:
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
02-224 Warsaw
Marketing authorisation number in Romania, country of export: 7842/2015/01
Parallel import authorisation number: 393/24
If you have any further questions, please consult your doctor or pharmacist.