Label: information for the user

Mirena0.02 mg every 24 hours intrauterine delivery system

Levonorgestrel

1.What Mirena is and for what it is used

2.What you need to know before starting to use Mirena

3.How to use Mirena

4.Possible adverse effects

5.Storage of Mirena

6.Contents of the package and additional information

Mirena is an intrauterine system (IUS) in the shape of a T, which after insertion releases the hormone levonorgestrel into the uterus. The purpose of presenting a T-shaped body is for it to fit the shape of the uterus. The vertical arm of the white T-shaped body contains a medication reservoir containing levonorgestrel. At the lower end of the vertical arm, there is a handle to which two brown extraction threads are attached.

Mirena is used for pregnancy prevention (contraception) and excessive menstrual bleeding (idiopathic menorrhagia).

Girls and adolescents

Mirena is not indicated for use before the first menstruation (menarche).

Do not use Mirena if you have any of the following situations:

• Pregnancy or suspected pregnancy
• Tumors that depend on progestogenic hormones to develop, e.g. breast cancer
• Current or recurrent pelvic inflammatory disease (infection of the female reproductive organs)
• Cervical infection
• Lower genital tract infection
• Uterine infection after delivery
• Uterine infection after abortion in the last 3 months
• Situations associated with a higher risk of infection
• Cervical cell anomalies
• Uterine or cervical cancer, or suspected cancer
• Abnormal uterine bleeding due to an unknown cause
• Uterine or cervical anomalies, including fibroids if they deform the uterine cavity
• Acute liver disease or liver tumor
• Allergy to levonorgestrel or any of the other components of this medication (including in section 6)

Warnings and Precautions

Consult your doctor before starting to use Mirena.

If you have any of the situations listed below or if any of them appear for the first time while using Mirena, consult a specialist to decide whether you should continue using Mirena or remove the system:

• Migraine, asymmetric vision loss, or other symptoms that may indicate transient cerebral ischemia (temporary obstruction of blood flow to the brain)
• Exceptionally intense headache
• Icterus (yellowing of the skin, white of the eyes, and/or nails)
• Marked increase in blood pressure
• Severe arterial diseases such as stroke or heart attack
• Acute blood clots in the veins.

Mirena should be used with caution in women with congenital heart disease or valvular heart disease with a risk of infectious myocarditis.

In diabetic users, blood glucose concentration should be controlled.

Irregular bleeding may mask some symptoms and signs of endometrial polyps or cancer, and in these cases, diagnostic tests should be considered.

Medical Examination/Consultation

The pre-insertion examination may include a cervical cytology (Papanicolau smear), breast examination, and other tests, for example, for infections, including sexually transmitted diseases, pregnancy test if necessary. A gynecological examination should be performed to determine the position and size of the uterus.

Mirena should not be used as an emergency contraceptive (postcoital contraceptive).

Infections

The insertion tube helps to prevent Mirena contamination by microorganisms during insertion, and the Mirena inserter has been designed to minimize the risk of infection. Despite this, in users of copper intrauterine devices (IUDs), there is a higher risk of pelvic infection immediately after insertion and during the month following it. Pelvic infections in Mirena users are often related to sexually transmitted diseases. The risk of infection increases if the woman or her partner have multiple sexual partners. Pelvic infections should be treated promptly. A pelvic infection can harm fertility and increase the risk of a future ectopic pregnancy (pregnancy outside the uterus).

In extremely rare cases, a severe infection or septicemia (very severe infection that can be fatal) may occur shortly after insertion.

Mirena should be removed if recurrent pelvic infections, uterine lining infections, or if an acute infection is severe or does not respond to treatment within a few days.

Consult your doctor immediately if you experience persistent pain in the lower abdomen, fever, pain during sex, or abnormal bleeding.

Expulsion

Uterine contractions during menstruation may sometimes push the IUD out of its place or expel it. This is more likely to happen if you are overweight at the time of IUD insertion or if you have a history of heavy menstrual bleeding. If the IUD is expelled, it may not function properly, and the risk of pregnancy increases. If the IUD is expelled, you are no longer protected against pregnancy.

The possible symptoms of expulsion are pain and abnormal bleeding, but Mirena can also be expelled without being noticed. Since Mirena reduces menstrual flow, an increase in it may indicate expulsion.

It is recommended that you check the strings with your finger, for example, while showering.See also section 3 “How to use Mirena - How can I know if Mirena is properly placed?”.If you experience symptoms indicating expulsion or are unable to feel the strings, you should use an additional contraceptive method (such as condoms) and consult your healthcare professional.

Perforation

Perforation or penetration of the uterine wall may occur more frequently during insertion, although it may be detected later. A Mirena that has been lodged outside the uterine cavity is not effective in preventing pregnancy and should be removed as soon as possible. It may be necessary to perform surgical intervention to remove Mirena. The risk of perforation increases in women in the postpartum period and in women who have given birth up to 36 weeks before insertion, and may increase in women with a fixed and inverted uterus. If you suspect that you may have had a perforation, consult your doctor without delay and remind them that you have Mirena inserted, especially if it was not the person who inserted it.

The possible signs and symptoms of perforation may include:

• Severe pain (similar to menstrual cramps) or more intense pain than usual
• Abundant bleeding (after insertion)
• Persistent pain or bleeding for more than a few weeks
• Change in menstrual cycles
• Pain during sex
• You can no longer locate the Mirena strings (see section 3 “How to use Mirena - How can I know if Mirena is properly placed?”)

Ectopic Pregnancy

It is very unlikely to become pregnant while using Mirena. However, if you become pregnant while using Mirena, the risk of the fetus developing outside the uterus (ectopic pregnancy) is relatively increased. Approximately 1 in 1,000 women per year who use Mirena correctly have an ectopic pregnancy. This is lower than women who do not use any contraceptive method (approximately 3 to 5 in 1,000 women per year). A woman who has already had an ectopic pregnancy, tubal surgery to the uterus, or pelvic infection has a higher risk. An ectopic pregnancy is a serious condition that requires immediate medical attention. The following symptoms may indicate that you have an ectopic pregnancy, and you should see your doctor immediately:

• If you have stopped menstruating but then start experiencing persistent bleeding or pain
• If you experience diffuse or severe pain in the lower abdomen
• If you experience normal pregnancy symptoms, but still bleed and feel dizzy.

Dizziness

Some women feel dizzy after Mirena insertion. This is a normal physical response. Your doctor will tell you to rest for a while after Mirena insertion.

Increased Follicles (cells surrounding a mature ovum in the ovary)

Since Mirena's contraceptive effect is primarily local, it is common for women of childbearing age to have ovulatory cycles with follicular rupture. In some cases, follicular degeneration is delayed, and development may continue. Most of these follicles do not cause symptoms, but some may be accompanied by pelvic pain or pain during sex. These increased follicles may require medical attention, although they usually resolve on their own.

Psychiatric Disorders

Some women who use hormonal contraceptives like Mirena have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Other Medications and Mirena

Mirena's mechanism of action is primarily local, and it is not expected that taking other medications will increase the risk of pregnancy during Mirena use. However, consult your doctor if you are taking or have recently taken any other medication, including over-the-counter medications.

Pregnancy, Lactation, and Fertility

Pregnancy

Mirena should not be used during pregnancy or suspected pregnancy.

It is very rare for a woman to become pregnant with a Mirena inserted. However, if Mirena is expelled, you will no longer be protected, and you should use another contraceptive method until you see your doctor.

In some women, menstruation may stop while using Mirena. Not having a period is not necessarily a sign of pregnancy. If you do not have a period and also experience other pregnancy symptoms (e.g. nausea, fatigue, breast tenderness), visit your doctor for an examination and pregnancy test.

If you become pregnant with Mirena in place, you should see your healthcare provider immediately to remove Mirena. Removal may cause a miscarriage. However, if Mirena is left in place during pregnancy, the risk of spontaneous abortion increases, as well as the risk of premature birth. If Mirena cannot be removed, consult your healthcare provider about the benefits and risks of continuing the pregnancy. If the pregnancy continues, you will be closely monitored during it and should contact your doctor immediately if you experience stomach cramps, abdominal pain, or fever.

Mirena contains a hormone called levonorgestrel, and there have been isolated cases of effects on the genitals of female babies if they are exposed to levonorgestrel-containing IUDs while in the uterus.

Lactation

Mirena can be used during lactation. Levonorgestrel has been detected in small amounts in the milk of lactating women (0.1% of the dose is transferred to the baby). When Mirena is used, starting six weeks after delivery, it appears to have no negative effects on the baby's growth or development. Progestin-only contraceptives seem to have no effect on either the quantity or quality of breast milk.

Hormonal contraceptives are not recommended as a first-line contraceptive method during lactation; only non-hormonal methods are considered, followed by progestin-only contraceptives like Mirena. The daily dose and blood concentrations of levonorgestrel are lower than with any other hormonal contraceptive method.

Fertility

After removing Mirena, women regain their normal fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machines

No effects have been observed.

Mirena contains barium sulfate

The T-shaped structure of Mirena contains barium sulfate, making it visible in an X-ray examination.

What is the effectiveness of Mirena?

Mirena is as effective as the most modern and effective copper IUDs in contraception. Studies (clinical trials) showed that there were approximately two pregnancies per 1,000 women using Mirena in the first year.

In the treatment of idiopathic menorrhagia, Mirena produces a marked decrease in menstrual bleeding after three months of use. Some users may experience complete disappearance of their period.

When should Mirena be inserted?

Starting to use Mirena

• Before inserting Mirena, ensure you are not pregnant.
• Mirena should be inserted within 7 days of the start of menstruation. When inserted during those days, Mirena will work from the time of insertion and prevent pregnancy.
• If Mirena cannot be inserted within 7 days of the start of menstruation or if your menstruation is irregular, then Mirena can be inserted on any other day. In this case, you should not have had sexual intercourse without contraception since your last menstrual period, and you should have a negative pregnancy test before insertion. Additionally, Mirena may not reliably prevent pregnancy from the time of insertion. Therefore, you should use a barrier method of contraception (such as a condom) or abstain from vaginal intercourse for the next 7 days after Mirena insertion.
• Mirena is not indicated for use as emergency contraception (postcoital contraception).

Starting to use Mirenaafter giving birth

• Mirena can be inserted after giving birthafter the uterus has recovered to its normal size and not before 6 weeks after the birth (see section 2 “What you need to know before starting to use Mirena – Insertion”).
• See also “Starting to use Mirena” above to know what else you need to know for the time of insertion.

Starting to use Mirena after an abortion

Mirena can be inserted immediately after an abortion if the pregnancy lasted less than 3 months, as long as there are no genital infections. Mirena will work from the time of insertion.

Replacement of Mirena

Mirena can be replaced at any time during your menstrual cycle with a new Mirena. Mirena will work from the time of insertion.

Change from another method of contraception (such as combined hormonal contraceptives, implants)

• Mirena can be inserted immediately if you can ensure you are not pregnant.
• If more than 7 days have passed since the start of menstrual bleeding, you should abstain from vaginal intercourse or use additional barrier contraception for the next 7 days.

How is Mirena inserted?

Mirena should be inserted by a healthcare professional with experience in inserting Mirena.

After a gynecological examination, a device called a speculum is inserted into the vagina, and the cervix is cleaned with an antiseptic solution. The IUD is inserted into the uterus through a flexible and thin plastic tube (insertor). Before insertion, local anesthesia may be applied to the cervix if necessary.

Some women may experience pain and dizziness after insertion. If these do not subside within 30 minutes of rest, it may be due to the IUD not being correctly placed. An examination and removal of the IUD should be performed if necessary.

After Mirena placement, your doctor should provide you with a reminder card for follow-up visits. Bring this card to each visit.

When should I see my doctor?

You should review your IUD at 4-12 weeks after insertion, and then regularly, at least once a year. Your doctor will determine the frequency and type of follow-up visits that are suitable for your individual case. Bring the reminder card provided by your doctor to each visit.

You should also consult your doctor if any of the following situations occur:

• If you no longer feel the strings of extraction in your vagina
• If you can feel the lower part of the system
• If you think you are pregnant
• If you experience prolonged abdominal pain, fever, or abnormal vaginal discharge
• If you or your partner experience pain or discomfort during sexual intercourse
• If there are sudden changes in your menstrual bleeding (for example: if you experience light or no bleeding and suddenly start bleeding continuously, or if you experience pain, or if you start bleeding heavily)
• If you experience other medical problems such as migraines or intense headaches that recur, sudden vision problems, jaundice, or high blood pressure
• If you experience any of the conditions mentioned in section 2 “What you need to know before starting to use Mirena”.

Remember to inform your doctor that you have Mirena inserted, especially if it was not the person who inserted it.

For how long can Mirena be used?

Mirena is effective for 8 years when used for contraception. Are you using Mirena for this reason? If so, your Mirena should be removed or replaced after 8 years at the latest.

Mirena is effective for 5 years for heavy menstrual bleeding (idiopathic menorrhagia). Are you using Mirena for this reason? If so, your Mirena should be removed or replaced when heavy menstrual bleeding reappears or after 8 years at the latest.

If you wish, a new Mirena can be inserted when the old one is removed.

What happens if I want to get pregnant or remove Mirena for any other reason?

The IUD can be easily removed by your doctor at any time, after which pregnancy will be possible. Removal is usually a painless procedure. After Mirena removal, fertility returns to normal.

Continuation of contraception after removal

If you do not want to get pregnant, Mirena should not be removed after the seventh day of the menstrual cycle (menstrual period), unless you can ensure contraception with other methods (such as condoms) for at least 7 days before removal. If you have irregular periods (menstrual periods) or do not have periods, you should use barrier methods of contraception from 7 days before removal until your menstruation reappears.You can also insert a new Mirena immediately after removal; in this case, additional protection is not necessary.If you do not want to continue with the same method of contraception, consult your doctor about other reliable methods of contraception.

Can I get pregnant after stopping using Mirena?

Yes. After Mirena is removed, it will not interfere with your normal fertility. You may become pregnant during the first menstrual cycle after Mirena removal.

Can Mirena affect my menstrual periods?

Mirena affects your menstrual cycle. You may experience changes in your periods, such as spotting (small amount of bleeding), shorter or longer periods, light or heavy bleeding, or absence of bleeding.

During the first 3-6 months after Mirena insertion, many women experience frequent spotting or light bleeding in addition to their periods. Some women may experience heavy or prolonged bleeding during this time. Please inform your doctor if this situation persists.

Generally, you will likely experience a gradual reduction in the number of days of bleeding and the amount of blood lost each month. Some women may eventually observe that their period disappears completely. As the amount of menstrual bleeding decreases with Mirena use, most women experience an increase in their hemoglobin levels in the blood.

When the system is removed, your period will return to normal.

Is it an anomaly not to have a period?

No, when using Mirena. If you observe that you do not have a period while using Mirena, it is due to the effect of the hormone on the uterine lining. There is no engorgement of the lining, so nothing can come out in the form of a period. This does not necessarily mean you have reached menopause or are pregnant. Your own hormone levels remain normal.

Actually, not having a period can be a great advantage for women's health.

How can I know if I am pregnant?

Pregnancy is unlikely in women using Mirena, even if they do not have a period.

If, after six weeks, you have not had a period and are concerned, consider taking a pregnancy test. If it is negative, there is no need to take another test unless you experience other signs of pregnancy, such as nausea, fatigue, or breast tenderness.

Can Mirena cause pain or discomfort?

Some women may experience pain (such as menstrual cramps) during the first weeks after insertion. You should return to your doctor or clinic if you experience intense pain or if the pain persists for more than three weeks after Mirena insertion.

Can Mirena interfere with sexual intercourse?

You and your partner should not feel the IUD during sexual intercourse. If you do, you should avoid sexual contact until your doctor checks that the IUD is in the correct position.

How long should I wait after Mirena insertion to have sexual intercourse?

To give your body time to rest, it is best to wait 24 hours after Mirena insertion before having sexual intercourse. Depending on the time of your menstrual cycle when Mirena is inserted, you may need to use a barrier method of contraception (such as a condom) or abstain from vaginal intercourse for the first 7 days after insertion (see section 3 “How to use Mirena - When should Mirena be inserted?”).

Can I use tampons or menstrual cups?

It is recommended to use sanitary pads. If you use tampons or menstrual cups, you should change them carefully to avoid pulling on the extraction strings of Mirena. If you think you may have moved Mirena from its position (see “When should I see my doctor?” for possible signs), avoid sexual intercourse or use a barrier method of contraception (such as condoms), and contact your doctor.

What happens if Mirena comes out?

It is rare but possible for Mirena to come out during your menstruation without you noticing. An unusual increase in bleeding during your period may indicate that Mirena has come out completely through your vagina. It is also possible that a part of Mirena has come out of the uterus (you and your partner may notice this during sexual intercourse). If Mirena comes out completely or partially, you will not be protected against pregnancy.

How can I know if Mirena is properly placed?

You can check if the extraction strings are in place. Gently insert your finger into your vagina and feel the extraction strings at the end of your vagina, near the cervix.

Do not pull on the extraction stringsas you may accidentally remove Mirena. If you cannot locate the extraction strings, this may indicate that Mirena has been expelled or perforated. In this case, you should use a barrier method of contraception (such as condoms) and consult your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

In addition to the possible side effects described in other sections (e.g., section 2 “What you need to know before starting to use Mirena”), the following possible side effects are listed according to the parts of the body they affect and their frequency:

Very common side effects:can affect more than 1 in 10 people:

Reproductive system and breast disorders

• Uterine or vaginal bleeding, including spotting, infrequent periods (oligomenorrhea) and absence of bleeding (amenorrhea)
• Benign ovarian cysts (see section 2 “Increased ovarian follicles”)

Common side effects:can affect up to 1 in 10 people:

Mental health disorders

• Depressive mood or depression
• Nervousness
• Decreased libido

Nervous system disorders

• Headache

Vascular disorders

• Dizziness

Gastrointestinal disorders

• Abdominal pain
• Nausea (feeling dizzy)

Skin and subcutaneous tissue disorders

• Acne

Musculoskeletal, connective tissue and bone disorders

• Back pain

Reproductive system and breast disorders

• Pelvic pain

• Dysmenorrhea (painful menstruation)
• Vaginal discharge
• Vulvovaginitis (inflammation of the external genital organs or vagina)
• Breast tension
• Breast pain
• Expulsion of the intrauterine device

Diagnostic procedures

• Weight gain

Uncommon side effects:can affect up to 1 in 100 people:

Nervous system disorders

• Migraine

Gastrointestinal disorders

• Abdominal distension

Skin and subcutaneous tissue disorders

• Hirsutism (excessive hair growth on the body)
• Alopecia (hair loss)
• Pruritus (intense itching)
• Eczema (inflammation of the skin)
• Cloasma (brownish-yellow skin patches) or hyperpigmentation of the skin

Reproductive system and breast disorders

• Uterine perforation
• Pelvic inflammatory disease (infection of the upper female genital tract, female structures above the cervix)
• Endometritis
• Cervicitis/Papanicolau smear normal, class II (inflammation of the cervix)

General disorders and administration site conditions

• Edema (swelling)

Rare side effects:can affect up to 1 in 1,000 people:

Skin and subcutaneous tissue disorders

• Urticaria (hives)

If you become pregnant while using Mirena, there is a possibility that the pregnancy may develop outside the uterus (see section 2 “Ectopic pregnancy”).

Cases of septicemia (severe systemic infection that can be fatal) have been reported after the insertion of the IUD.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Mirena

• The active ingredient is levonorgestrel. The intrauterine system contains 52 mg of levonorgestrel.
• The other components are polydimethylsiloxane elastomer, anhydrous colloidal silica, polyethylene, barium sulfate, and iron oxide.

Appearance of the product and contents of the package

Contents of the package: a sterile intrauterine system for intrauterine use.

Marketing authorization holder

Bayer Hispania, S.L.

Av. Baix Llobregat 3-5

08970 Sant Joan Despí (Barcelona)

Spain

Responsible for manufacturing

Bayer Oy

Pansiontie 47

20210 Turku

Finland

For any information about this medicine, please contact the marketing authorization holder:

Bayer Hispania, S.L.

Av. Baix Llobregat 3-5

08970 Sant Joan Despí (Barcelona)

Spain

IF YOU HAVE ANY FURTHER QUESTIONS, PLEASE CONSULT YOUR DOCTOR OR PHARMACIST.

Last review date of this leaflet:May 2024

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).Other sources of information

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet, packaging, and patient reminder card with your smartphone. You can also access the same information on the following internet address:https://cima.aemps.es/info/63158

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The following information is intended only for healthcare professionals:

INSERTION INSTRUCTIONS

Mirena 0.02 mg per 24 hours intrauterine system

It must be inserted by a healthcare professional using an aseptic technique.

Mirena is supplied inside an inserter, in a sterile package that should not be opened until it is necessary to use it. Do not re-sterilize. As supplied, Mirena is for single use only. Do not use if the inner package is damaged or open. Do not insert after the expiration date (month and year) on the label.

To choose the time of insertion, consult the Mirena technical file.

Mirena includes a patient reminder card in the package. Complete the patient reminder card and give it to the patient after insertion.

Preparation for insertion

• Examine the patient to rule out contraindications for Mirena insertion and to exclude pregnancy (see Technical File, section 4.3 and section 4.4 under Medical examination/consultation).

• Insert a speculum, visualize the cervix, and then thoroughly clean the cervix and vagina with an appropriate antiseptic solution.

• Have an assistant if necessary.

• Hold the anterior lip of the cervix with a tenaculum or other holding forceps to stabilize the uterus. If the uterus is retroverted, it may be more appropriate to hold the posterior lip of the cervix. A gentle traction can be applied with the forceps to straighten the cervical canal. The forceps should be kept in place and a gentle traction should be maintained on the cervix throughout the insertion process.

• Insert a uterine sound through the cervical canal to the bottom to measure the depth and confirm the direction of the uterine cavity and to rule out any possibility of intrauterine anomaly (e.g., septum, submucosal fibroids) or the presence of a previously inserted intrauterine device that has not been removed.

Insertion

IMPORTANT!

If it is suspected that the system is not in the correct position, check its location (e.g., by ultrasound). Remove the system if it is not properly placed in the uterine cavity. Do not reinsert a removed system.

Removal/reinsertion

For removal/substitution, consult the Mirena technical file.