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
Levonorgestrelum
Please read all of this 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 questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 a T-shaped intrauterine delivery system which, once inserted, releases the hormone levonorgestrel into the uterine cavity. The T-shape ensures proper fit within the uterine cavity. In the vertical shaft of the white system there is a reservoir containing the active substance, 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 (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 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, as these may be ineffective because Mirena affects monthly body temperature changes and cervical mucus patterns.
Like other hormonal contraceptive products, Mirena does not protect against HIV (AIDS) or other sexually transmitted infections.

Do not use Mirena if any of the following conditions apply:

if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6)
pregnancy or suspected pregnancy
hormone-dependent tumours, e.g. breast cancer
existing or recurrent pelvic inflammatory disease (infections of the female reproductive organs)
cervical inflammation (cervicitis)
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 the Mirena system should be removed, if any of the following conditions occur for the first time during use:

migraine, asymmetric visual field defects, or other symptoms that may indicate transient ischaemic attack (temporary blockage of blood flow to the brain)
exceptionally severe headache
jaundice (yellowing of the skin, whites of the eyes, and/or nails)
marked increase in blood pressure
severe arterial disease, such as stroke or myocardial infarction
acute venous thromboembolic disease

The Mirena system should be used with caution in women with congenital heart defects or 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 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. 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 use immediately after unprotected sexual intercourse (post-coital, 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. 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 Mirena are often associated with sexually transmitted diseases. The risk of infection increases with multiple sexual partners. Pelvic infections must be properly treated, as they may affect fertility in the future and increase the risk of ectopic pregnancy. The Mirena system should be removed in cases of recurrent endometritis or pelvic inflammatory disease, especially if acute and severe symptoms occur or if symptoms do not resolve after several 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.
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 not in the correct position, it may not function as intended, thereby increasing the risk of pregnancy. Expulsion of the Mirena system results in loss of contraceptive protection.
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.
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 placement of the Mirena system”. If symptoms indicating expulsion occur or if the threads cannot be felt near the cervical os, 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. The Mirena system, if displaced outside the uterine cavity, will not prevent pregnancy and should be removed as soon as possible. Surgical intervention may be required to remove the Mirena system. The risk of perforation is higher in women who are breastfeeding and within 36 weeks after childbirth; the risk may also be increased in women with a persistently retroverted uterus (uterine retroversion). 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 system threads (see section 3 “How to use Mirena – Self-checking the correct placement of the Mirena system”)

Ectopic pregnancy
Pregnancy while using 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 using Mirena correctly 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 follicular rupture occurs. Occasionally, the unruptured follicle does not regress for some time and may enlarge. In most cases, these enlarged 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 depressed mood. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact your doctor as soon as possible for further medical advice.

Mirena and other medicines
Since the mechanism of action of the Mirena system is primarily local, taking other medicines should not increase the risk of pregnancy during use of this system.
However, you should inform your doctor about all medicines you are currently taking, including those obtained without a prescription.

Pregnancy, breastfeeding and effects on fertility

Pregnancy
Mirena must not be used during pregnancy or if pregnancy is suspected.
Very rarely, a woman may become pregnant while the Mirena system is correctly positioned. However, if the system becomes displaced, contraceptive protection is reduced, and alternative contraceptive methods should be used until you see your doctor.
During use of the Mirena system, 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), you should see a doctor for examination and perform a pregnancy test.
If you become 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 your 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 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. Contraceptive products containing only progestogens have not been shown to affect the quantity or quality of breast milk.
Hormonal contraception is not recommended as the first-choice method during breastfeeding; non-hormonal contraceptive methods are recommended. Methods using progestogen-only contraceptives, such as the Mirena system, are considered second-line options. The daily dose and blood concentration of levonorgestrel are lower than with other hormonal contraceptive methods.

Fertility
Removal of the Mirena system restores normal fertility.

If you are pregnant or breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines
No effects of the Mirena system on the ability to drive or operate machinery have been observed.

Important information about some components of the Mirena system
The T-shaped frame of the Mirena system contains barium sulfate, which allows the system to be visible on X-ray imaging.

3. How to use Mirena

Effectiveness of Mirena
The contraceptive effectiveness of Mirena is comparable to that of the most effective copper intrauterine devices. In clinical studies, approximately 2 pregnancies per 1000 women using Mirena were observed during the first year of use.
In the treatment of idiopathic heavy menstrual bleeding, reduction in bleeding intensity is observed as early as 3 months after starting Mirena. In some women, menstruation may even cease completely.

Insertion of Mirena
Mirena should be inserted within 7 days from the onset of menstruation. It may also be inserted immediately after a first-trimester abortion, provided there is no genital tract infection. Mirena may only be inserted after the uterus has returned to its normal size following childbirth and not earlier than 6 weeks postpartum (see section 2 – "Important information before using Mirena", subsection "Uterine perforation"). Mirena may be replaced with a new device at any time during the cycle.

Mirena must be inserted only by a physician or healthcare provider experienced in intrauterine device insertion.

Procedure for inserting Mirena
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 anaesthesia 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 the supine position, this may indicate incorrect placement of the device. A medical examination should be performed and, if necessary, the device should be removed.

After insertion, the patient should receive from the physician a patient reminder card, on which follow-up examination dates are recorded. This card should be brought to every scheduled visit.

When to contact a doctor
The physician should check the presence of Mirena 4 to 12 weeks after insertion, and subsequently monitor its presence 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 doctor if:

the threads are not palpable in the vagina
the lower part of the device is felt
pregnancy is suspected
persistent abdominal pain, fever, or abnormal 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 scanty or absent, followed by persistent bleeding or pain, or heavy bleeding begins)
other health problems arise, such as migraine headaches or severe recurrent headaches, sudden vision problems, jaundice, or elevated blood pressure
any of the conditions listed in section 2 "Important information before using Mirena" occur.

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

Duration of use of Mirena
Mirena provides contraception (exhibits contraceptive action) for 8 years after insertion. If the patient uses Mirena for this purpose, the device should be removed or replaced no later than after 8 years.

Mirena is effective for 5 years after insertion in the treatment of heavy menstrual bleeding (idiopathic). If the patient uses Mirena for this indication, the device should be removed or replaced when heavy menstrual bleeding recurs, or no later than after 8 years. If desired, a new device may be inserted immediately after removal of the previous one.

If Mirena is to be removed to achieve pregnancy or for another reason
A physician may easily remove Mirena at any time, after which pregnancy becomes possible. Removal is usually painless. Fertility returns after removal of Mirena.
If pregnancy is not planned, Mirena should not be removed after day 7 of the menstrual cycle unless another contraceptive method (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 device may be inserted immediately after removal of the previous one, in which case additional contraception is not required.

Can pregnancy occur after stopping use of Mirena?
Yes. Removal of Mirena does not impair fertility. Pregnancy may occur during the first menstrual cycle after removal of Mirena.

Does Mirena affect menstrual bleeding?
Mirena does not affect the menstrual cycle. However, it may cause various changes in menstrual bleeding, such as spotting (light blood loss), shorter or longer bleeding periods, light or heavy bleeding, or absence of bleeding.

During the first 3 to 6 months after insertion of Mirena, many women experience frequent spotting or light bleeding between periods. In some women, menstrual bleeding may become heavier or last longer than usual. In such cases, consult a physician, especially if symptoms do not resolve.

Generally, a gradual reduction in the number of bleeding days and the amount of blood lost each month may occur.

In some women, menstruation may eventually cease completely. Since Mirena typically reduces menstrual blood loss, many women experience an increase in hemoglobin concentration in the blood.

After removal of Mirena, menstruation returns to its previous pattern.

Is absence of bleeding normal?
Yes, when using Mirena. Absence of menstruation is a result of the hormonal effect on the endometrium. Monthly changes in the endometrial lining do not occur, so there is no tissue to be shed during menstruation. 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
Pregnancy during Mirena use 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 required unless other symptoms of pregnancy are present, such as nausea, fatigue, or breast tenderness.

Can Mirena cause pain or discomfort?
Some women experience pain (similar to menstrual cramps) during the first few weeks after insertion. Seek medical advice if severe pain occurs or if pain persists for more than 3 weeks after insertion.

Effect of Mirena on sexual intercourse
Neither the woman nor her partner should feel Mirena during sexual intercourse. If either does feel it, sexual intercourse should be avoided until a physician checks whether the device is still in the correct position.

How soon after insertion can sexual intercourse occur?
To allow the body to rest, it is advisable to wait approximately 24 hours after insertion before engaging in sexual intercourse. However, Mirena provides immediate protection against pregnancy from the moment of insertion.

Use of tampons or menstrual cups
Sanitary pads are recommended. If tampons or menstrual cups are used, they should be changed carefully to avoid pulling on the Mirena threads. If the patient suspects that Mirena has been displaced (see section "When to contact a doctor" for possible symptoms), sexual intercourse should be avoided or mechanical contraception (such as condoms) used, and the patient should contact her physician.

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

Self-checking for correct placement of Mirena
A woman may check herself whether the Mirena threads are in place. To do this, insert a finger gently into the vagina and feel for the threads near the cervix.
Do not pull on the threads, as this may inadvertently remove the device. If the threads cannot be felt, this may indicate expulsion of Mirena from the uterus or uterine perforation. In such cases, mechanical contraception (e.g. condoms) should be used and a physician contacted immediately.

4. Possible side effects

Like all medicines, Mirena may cause side effects, although not everybody gets them.

In addition to the possible side effects listed in other sections (e.g. section 2. Important information before use of Mirena), the side effects listed below are grouped according to the parts of the body affected and their frequency of occurrence.

Very common: may affect up to 1 in 10 patients
Reproductive system and breast disorders

Uterine or vaginal bleeding, including spotting, infrequent menstruation or absence of menstruation
Benign ovarian cysts (see section 2. "enlarged ovarian follicles")

Common: may affect up to 1 in 100 patients
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
Dysmenorrhoea (painful menstruation)
Vaginal discharge
Vulvovaginitis (inflammation of the vulva or vagina)
Breast tenderness
Breast pain
Expulsion of the intrauterine system

Investigations

Weight increase

Uncommon: may affect up to 1 in 1,000 patients
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)
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 (oedema)

Rare: may affect up to 1 in 10,000 patients
Skin and subcutaneous tissue disorders

Rash
Urticaria (hives)

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

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects helps 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.
No special storage conditions are required. Store in the original packaging.
Do not insert Mirena after the expiry date stated on the package. The expiry date refers to the last day of the month indicated.
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 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 – contains anhydrous colloidal silica (30-40%), T-body composition: polyethylene containing 20-24% barium sulfate, threads composition: polyethylene, 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 further information, consult your doctor, the marketing authorization holder, or the parallel importer.
Marketing Authorization 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:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorization Number in Romania, country of export: 7842/2015/01
Parallel Import License Number: 379/22