Mirena

Patient Information Leaflet

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. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Mirena is and what it is used for
2. Important information before using Mirena
3. How to use Mirena
4. Possible side effects
5. How to store Mirena
6. Contents of the pack and other information

1. What Mirena is and what it is used for

Mirena is a T-shaped intrauterine system which, after insertion, releases the hormone levonorgestrel into the uterine cavity. The T-shape ensures that the system fits properly within the uterine cavity. The white vertical part of the system contains a reservoir holding 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. Information before using Mirena

General information
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 methods may be ineffective because Mirena affects
monthly body temperature changes and cervical mucus patterns.
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Like other hormonal contraceptive products, Mirena does not protect against HIV (AIDS)
or against other sexually transmitted infections.
Do not use Mirena if any of the following conditions apply:

• allergy 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 tumour.

Warnings and precautions
Consult your doctor before starting to use the Mirena system.
Contact your doctor to 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)
• significant increase in blood pressure
• severe arterial disease, such as stroke or myocardial infarction
• acute venous thromboembolic disease.

Use Mirena with caution in women with congenital heart defects or valvular heart disease that increase the risk of endocarditis.
In diabetic women using the Mirena system, blood glucose levels should be monitored.
Irregular bleeding may mask symptoms and signs of endometrial polyps or cancer, and diagnostic evaluation 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 cavity size.
The Mirena system is not an appropriate contraceptive method for emergency contraception (post-coital contraception).
Infections
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The insertion tube helps protect the Mirena system from microbial contamination during insertion. The Mirena applicator 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 sexual contact with multiple partners. Pelvic infections must be properly treated, as they may affect fertility in the future and increase the risk of ectopic pregnancy. The Mirena system should be removed in cases of recurrent endometritis or pelvic inflammatory disease if there are acute and severe inflammatory conditions or if they do not resolve after several days of treatment.
In extremely rare cases, immediately after insertion of the 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 signs 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 of the system.
It is recommended to check by finger (e.g. during bathing) whether the threads are in the correct position.
See also section 3 “How to use Mirena – Self-checking the correct position of the Mirena system”. If symptoms indicating expulsion occur or if the threads cannot be felt at the cervical opening, use other 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 ineffective in preventing pregnancy and should be removed as soon as possible. Surgical intervention may be required to remove the Mirena system. The risk of perforation is higher in 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 a Mirena system inserted, especially if it is not the doctor who inserted it.
Possible signs and symptoms of perforation may include:

• severe pain (like menstrual cramps) or pain 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”).

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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 used Mirena experienced 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 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 for a while after insertion of Mirena.
Enlarged ovarian follicles surrounding the maturing egg
The contraceptive effect of the Mirena system is primarily local; therefore, in women of reproductive age, menstrual cycles are usually ovulatory and follicular rupture occurs. Occasionally, an unruptured follicle does not regress and may enlarge over time. In most cases, these enlarged follicles cause no symptoms, although they may cause pelvic pain or pain during intercourse. Such enlarged ovarian follicles usually regress spontaneously but may sometimes require medical intervention.
Psychiatric disorders
Some women using hormonal contraceptives, including the Mirena system, 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 other contraceptive methods should be used until you see your doctor.
During use of the Mirena system, menstrual bleeding may cease in some women after some time. Absence of menstrual bleeding does not always indicate pregnancy.
If menstrual bleeding stops and other signs of pregnancy occur (e.g. nausea, fatigue, breast tenderness), you should see your doctor for examination and take a pregnancy test.
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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 premature delivery. If the Mirena system cannot be removed, discuss the benefits and risks of continuing the pregnancy with your doctor. If the pregnancy continues, it should be closely monitored by a doctor, and you should immediately inform your doctor 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 girls 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 dose of levonorgestrel 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 a first-choice method during breastfeeding; non-hormonal contraceptive methods are recommended as first-line options. Second-line options include progestogen-only contraceptive methods 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 or operate machinery has been observed.
Important information about certain ingredients of the Mirena system
The T-shaped frame of the Mirena system contains barium sulfate, which allows the system to be visible during X-ray 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-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 idiopathic excessive menstrual bleeding, the intensity of bleeding 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 onset of menstrual bleeding. If inserted during this period, the system will act immediately and prevent pregnancy.

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• If the Mirena system cannot be inserted within 7 days from the start of menstrual bleeding, or if menstruation occurs unpredictably, 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 reliably prevent pregnancy immediately. Therefore, a barrier method of contraception (e.g., condoms) should be used, or sexual intercourse should be avoided during the first 7 days after insertion of the Mirena system.
• The Mirena system is not suitable for use as emergency contraception (post-coital contraception).

Starting use of the Mirena system after childbirth

• The Mirena system may be inserted after delivery once the uterus has returned to its normal size, but not earlier than 6 weeks after childbirth (see section 2: "Important information before using Mirena – Uterine perforation").
• See also "Starting use of the Mirena system" above for additional information regarding 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 act immediately.
Replacement of the Mirena system
The system may be replaced with a new one on any day of the menstrual cycle. Mirena will then act 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, sexual intercourse should be avoided or additional contraceptive protection used for the next 7 days.

Method of inserting the Mirena system
The Mirena system should only be inserted by a physician or other qualified healthcare professional experienced in intrauterine device 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 (applicator). If necessary, local anesthesia of the cervix may be administered prior to insertion.
Some individuals may experience pain and dizziness after insertion. If these symptoms do not resolve within half an hour in a patient lying down, this may indicate improper 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 from the physician a 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 doctor should check for the presence of the system 4 to 12 weeks after insertion and subsequently monitor its presence at least once a year. The doctor will determine individually how often and what follow-up examinations are needed. The patient reminder card provided by the doctor 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 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 light or absent, followed by persistent bleeding or pain, or heavy bleeding begins)
• Other health problems occur, such as migraine headaches or recurrent severe headaches, sudden vision problems, jaundice, or increased blood pressure
• Any of the conditions listed in section 2 "Important information before using Mirena" occur.

Remind your doctor that you have the Mirena system inserted, especially if it is not the doctor 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 the Mirena system for this purpose, it 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 idiopathic excessive menstrual bleeding. 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 immediately after removal of the previous one.

If you wish to remove the Mirena system to become pregnant or for another reason
A doctor 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 Mirena 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 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 additional protection is not required. If the patient does not wish to continue with the same method, she should consult her doctor about other reliable contraceptive methods.

Can you become pregnant after stopping use of the Mirena system?
Yes. Removal of the Mirena system does not impair fertility. Pregnancy can occur during the first menstrual cycle after removal of the Mirena system.

Does the Mirena system affect menstrual bleeding?
The Mirena system affects the menstrual cycle. It 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 slight bleeding may occur between periods. In some women, menstrual bleeding may increase in intensity or last longer than usual. In such cases, the doctor 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.
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In some women, menstruation may eventually cease completely. Since menstrual flow 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 uterine lining does not occur. Therefore, there is nothing to be shed through menstrual blood under normal circumstances. 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 bleedings.
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 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 doctor checks whether the system is still correctly positioned.

How long after insertion can sexual intercourse take place?
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 doctor" for possible symptoms), sexual intercourse should be avoided or mechanical contraception (such as condoms) used, and the patient should contact her doctor.

What happens if the Mirena system is spontaneously expelled?
Rarely, but possibly, the Mirena system may be expelled without the 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 her 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 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.
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Do not pull on the threads, as this may accidentally 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 immediately.

4. Possible adverse effects

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

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

Very common adverse effects: may affect more than 1 in 10 people
Disorders of the reproductive system and breast

• Uterine or vaginal bleeding, including spotting, infrequent menstruation or absence of menstruation
• Benign ovarian cysts (see section 2. "Enlarged follicles in the ovary surrounding the maturing egg cell")

Common adverse effects: may affect less than 1 in 10 people
Psychiatric disorders

• Depressed mood or depression
• Nervousness
• Decreased libido

Nervous system disorders

• Headache

Vascular disorders

• Dizziness

Gastrointestinal disorders

• Abdominal pain
• Nausea

Skin and subcutaneous tissue disorders

• Acne

Musculoskeletal, 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 delivery system

Investigations

• Weight increase

Uncommon adverse effects: may affect less than 1 in 100 people
Nervous system disorders
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• 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 – normal Papanicolaou class II smear in cytological examination (inflammation of the cervix)

General disorders and administration site conditions

• Swelling

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

• Eruption
• 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 that may be fatal) have been reported following insertion of the intrauterine delivery system.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 4921301
Fax: +48 (22) 4921309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Mirena

Keep the medicine out of the sight and reach of children.
Store below 30°C. Protect from moisture.
Do not insert the Mirena system after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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Medicines must 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.
• Other components of the medicine are: elastomeric polydimethylsiloxane, polydimethylsiloxane tubing. T-body composition: polyethylene (containing 20-24% barium sulfate). Threads composition: polyethylene, black iron oxide (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 consult your doctor, the marketing authorization holder, or the parallel importer.
Marketing Authorization Holder in Greece, country of export:
Bayer Hellas ABEE, Agisilaou 6-8, 151 23 Maroussi, Attica, Greece
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
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorization Number in Greece, country of export: 20731/1-4-2008
46275/25-6-2009
Parallel Import License Number: 831/15
If you have any further questions, please consult your doctor or pharmacist.
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