Intrauterine contraception immediately became popular among women, because it gives a high result and is very convenient to use. One of these contraceptives is the Mirena spiral, which is effective for, but before using it, you need to familiarize yourself with the reviews and consequences. It also does not hurt to find out the features of the remedy and its effect on the body.

Use in menopause

Mirena with menopause, or rather in its initial stages, helps a woman prevent unwanted pregnancy and normalize the hormonal balance of the body. In the initial stages of the process of ovarian failure, the likelihood of conception remains. But it can be very difficult, because the symptoms are very similar to the manifestation of menopause. Yes, and the absence of menstruation may be associated with the approach of menopause.

In addition, you can not be one hundred percent sure of the result of a pregnancy test. The fact is that the level of hCG during menopause is increased, and its indicators correspond to those of the first weeks after conception. It turns out that the test may be negative, but in fact there is a pregnancy.

Therefore, women decide to use Mirena to continue an active sex life without the threat of conception. At the same time, the spiral does not affect the quality of sexual relations. It is installed for a long period of time with minimal control requirements.

It is worth noting that this spiral differs from the usual options, because its composition includes progesterone of synthetic origin. Due to this, the hormonal balance is stabilized, which leads to the elimination of unpleasant symptoms of menopause.

Spiral features

The hormonal contraceptive comes in the form of a T-shaped device with two special antennae. Thanks to this shape, the spiral can be securely fixed in the uterus. In addition, a loop of threads is provided, with the help of which the system is removed.

In the body of the device itself, a cavity is provided in which the hormonal component, represented by levonorgestrel (52 milligrams), is located. The product itself is stored inside a special tube protected by a vacuum package consisting of plastic and paper. It must be stored at 15-30 degrees for no more than three years from the date of manufacture.

How it works

The active substance of the spiral belongs to the gestagens. Hormone:

• blocks the growth of the endometrium;
• prevents cancer cells from multiplying;
• normalizes the balance between estrogen and progesterone;
• does not affect the normal functioning of the ovaries;
• blocks the appearance of pathologies of the pelvic organs;
• reduces the symptoms of menopause;
• protects against unwanted conception;
• acts as an excellent means of preventing endometriosis.

After the system is installed, the woman's body receives a certain dose of levonorgestrel (20 mcg) every day. By the end of the five-year period of use, this figure drops to 10 mcg per day. It is important to note that almost the entire dose of the hormone is concentrated in the endometrium, and the hormone content in the blood does not exceed the microdose.

The active substance does not begin to flow into the blood immediately. This happens after about an hour, and after 14 days the blood contains the highest concentration of levonorgestrel, but this figure depends on the weight of the woman. If a woman weighs no more than 54 kilograms, then this figure will be 1.5 times more.

According to reviews, after installing the system, unstable discharge of a smearing nature may be noted, but only during the first few months. This is due to the restructuring of the endometrium, after which the duration and volume of bleeding are significantly reduced. And sometimes they stop altogether.

Hormonal spiral against menopausal diseases

Symptoms of menopausal syndrome are caused by destabilization of the hormonal background. But not always this problem can be solved by taking hormonal drugs with estrogen. The fact is that many diseases in the female body provoke the predominance of estrogen over progesterone. Here, the use of estrogen-containing drugs only exacerbates the problem, increasing the speed and neglect of the disease.

Levonorgestrel, which is contained in the Mirena spiral, can help in the fight against the following problems:

endometrial hyperplasia

Estrogen provokes excessive division of tissue cells, which can cause cancer. In addition, hormone surges can increase the symptoms of hyperplasia. In this case, the spiral reduces the effect of estrogen on the endometrium, but at the same time does not prevent the hormone from having a positive effect on the work of the heart, blood vessels, urinary system, bone tissue, etc.

endometriosis

This disease is a direct consequence of a lack of progesterone against the background of an excess of estrogen. Mirena blocks the development of endometriosis, and also contributes to the subsidence of the disease. Levonorgestrel has a beneficial effect on the uterine mucosa, blocking the further spread of endometriosis foci and the risk of developing cancer. It can be noted a huge number of positive reviews about the Mirena spiral for endometriosis in premenopause without negative consequences for women's health.

Myoma

We note right away that with such a disease it is not always possible to use a spiral. Everything will depend on the characteristics of the tumor (location and size). Here, the agent significantly reduces the supply of nutrition to the tumor.

Bleeding

Mirena contains an analogue of progesterone, which can reduce the activity of bleeding and their volume. But its use is allowed only if the bleeding is not associated with cancer.

A change in the hormonal background always leads to a decrease in the body's defenses, which is why these diseases often occur precisely with the approach of menopause. Mirena and premenopause are connected in such a way that the spiral itself significantly reduces the risk of various pathologies due to the support of the vaginal microflora and the stabilization of hormonal balance.

The main indications and contraindications for use

Unfortunately, not every woman can use the tool. To begin with, it is worth noting that a prerequisite is the examination of the whole organism.

In this case, contraindications are:

• malignant tumors;
• breast oncology;
• bleeding associated with serious illness;
• individual intolerance to gestagens;
• vein thrombosis;
• inflammation of the pelvic organs;
• infection in the urinary system;
• endometritis;
• liver problems (hepatitis, cirrhosis);
• heart and kidney disease;
• recent abortion (three months ago).

Important! Any inflammatory pathology of the pelvic organs are indications for the removal of the spiral. In addition, intrauterine contraceptives are contraindicated at a high risk of infectious diseases (problems with immunity, lack of a permanent partner).

Despite the minimal effect of levonorgestrel on the functioning of the body, it is contraindicated in all cancers. Relatively contraindicated diseases include migraines, arterial hypertension, thrombophlebitis and diabetes mellitus. In these cases, the possibility of using an intrauterine hormonal contraceptive is determined by the doctor, but only after a comprehensive laboratory diagnosis.

Main indications for use:

1. Contraception. The main purpose of the installation of the IUD remains the prevention of unwanted conception.
2. Idiopathic menorrhagia. The IUD is used as an element of therapy only in the absence of hyperplastic processes in the uterine mucosa, as well as extragenital pathologies.
3. Prevention of endometrial hyperplasia. It is used when prescribing estrogen replacement therapy when it is necessary to balance estrogens and progestins in the body.
4. Profuse bleeding with no clear cause. After installing the spiral, or rather after 4 months, the amount of discharge should return to normal.

Side effects of the Mirena coil

It is worth noting that often side effects appear only in the first few months after the doctor has installed the system. Here you need to pay attention to the strength of their manifestation. If the side effects are minor, then the woman can continue to use the remedy, but this issue is resolved with the attending physician.

Among the side effects it is worth highlighting:

• migraine;
• headache;
• ectopic pregnancy;
• jumps in blood pressure;
• nausea;
• vomit;
• the appearance of excess weight;
• dizziness;
• allergic rashes;
• breast pain;
• unstable emotional state;
• irritability;
• insomnia.

These side effects most often appear only at the very beginning of using the remedy. Judging by the reviews, most women who have undergone a preliminary examination and installed a spiral with an experienced specialist do not suffer from side effects. , hot flashes and irritability disappear almost immediately.

Very rarely, the use of a spiral can cause:

• tumor development;
• stroke
• myocardial infarction;
• formation of cysts in the ovaries;
• jaundice.

Abundant discharge after the installation of the spiral

A certain number of women's reviews contain information about spotting after the installation of Mirena. During premenopause, the coil can cause spotting and spotting, but this is normal only in the first four months after the procedure.

Similarly, the female body adapts to changes and normalization of hormonal balance. In addition, in the first few months after the installation of the spiral, there is a significant risk of inflammatory processes. Therefore, with any complaints, you should consult a doctor to eliminate other causes of bleeding, even if there are no other painful symptoms.

As for the duration of bleeding, it is within five or seven days. But soon Mirena should reduce the abundance of secretions, gradually bringing them closer to normal.

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Possible side effects of Mirena

According to reviews and studies, the following consequences, although they appear very rarely, still take place:

• ectopic pregnancy. At risk are women who suffered from protracted infectious diseases and inflammatory processes. In this case, immediate surgical intervention is required. Symptoms of complications include dizziness, nausea, pain in the lower abdomen, delayed menstruation, pallor of the skin and general weakness.
• Penetration. Ingrown means in the walls of the uterus occurs very rarely. This is possible against the background of lactation, the recent birth of a child, or a non-standard location of the uterus.
• The fall of the Navy. Spiral fallout is quite common. The likelihood of this undesirable process increases during menstruation, and it can go unnoticed. Women are advised to immediately consult a doctor to remove the product and install a new system.
• Inflammatory processes and infectious diseases. High probability of development in the first month after the installation of the system. A woman needs to see a doctor who will prescribe treatment and decide whether the coil needs to be removed.
• Amenorrhea. Possible six months after using the IUD. The first thing to do here is to rule out pregnancy. Note that after removing the remedy, the cycle becomes normal if the cessation of menstruation is not caused by other reasons.
• . Occur in only 12% of patients (approximately). It is also worth noting that enlarged follicles independently acquire normal sizes after a few months.

Nothing more can be said about the consequences. This is due to the individuality of each case and the impossibility of collecting information about every woman who used Mirena. Note that this IUD with levonorgestrel is relatively safe, like all drugs containing hormones. In most cases, patients successfully endure all five years with this system, but subject to a responsible attitude to their health and passing the necessary examination.

Installation, removal and features of the spiral

It is worth noting that not all doctors have sufficient experience in installing the Mirena coil. A woman needs to find a specialist who has already worked with this type of IUD and knows the features of this procedure.

The product is available in sterile packaging that cannot be opened at home. This is done by a specialist immediately before installation. If the integrity of the package has been violated, then the installation of the spiral is not allowed. It is destroyed as medical waste. The same applies to the removal procedure, because the used spiral still contains hormones.

Examination before the installation of Mirena

Before buying a Mirena spiral, you should check your health in advance. First you need to visit the attending doctor, who will advise:

• examine the vagina;
• visit a mammologist;
• examine the microflora of the vagina;
• do an ultrasound of the genitals.

In addition, it is worth taking tests for hormones in order to accurately determine the state of the hormonal background of the body.

Features of using the tool for various purposes

There is a list of prescriptions for the date of installation of the IUD:

• For contraception. The procedure should be carried out in the first week of the cycle. But the replacement of the IUD is performed on any day of the menstrual cycle.
• After childbirth. Here you should wait for the complete involution of the uterus, but even with this factor, Mirena is contraindicated during the first six weeks after the birth of the child. In addition, if severe pain occurs, the pelvic organs should be examined to exclude perforations.
• To protect the endometrium. Can be used in conjunction with HRT. The procedure is carried out in the last days of the cycle. With amenorrhea, the coil can be installed at any time.

How often to visit the doctor after the installation of the spiral

Without fail, a woman must appear at a gynecologist's appointment no later than 3 months after the installation of Mirena. Then you can visit the doctor once a year, and if you have complaints, you should immediately go to the hospital.

If the doctor has allowed the installation of the spiral to a woman suffering from diabetes, then she needs to closely monitor the level of glucose in the blood. The fact is that levonorgestrel still negatively affects glucose tolerance. Any ailments should not be ignored.

Spiral Removal

The system is removed by gently pulling on specially designed threads using sterile forceps. Sometimes it is impossible to see the threads, then the doctor resorts to using a traction hook for safe extraction. In addition, in some cases, the specialist expands the cervical canal.

Important! The system is removed after five years of use when the patient feels normal. For any serious complaints, the IUD should be removed from the body immediately.

As for the re-installation of a new tool, the procedure can be carried out almost immediately. Here everything will depend on the monthly. When saving menstrual flow, the installation of a new system is carried out on the days of menstruation in order to eliminate the risk of fertilization of the egg.

The doctor should warn the patient that the insertion or removal of an intrauterine hormonal contraceptive may cause certain pain and bleeding. Particular caution should be shown to women with epilepsy and cervical stenosis. Syncope, bradycardia or convulsive seizures are possible here.

After Mirena is removed, the system is checked for integrity in order to exclude slippage of the hormonal cavity of the spiral. Once the physician confirms the integrity of the remedy, no further action is required.

What the reviews say

Mirena solves several women's problems at once. Premenopause brings some discomfort, which is associated not only with unpleasant symptoms, but also with the need to select the optimal contraceptive. Most women note the practicality of this tool.

Often, patients wonder if they will be able to become pregnant after removing the system. So, 80% of women were able to conceive a child (planned) in the first year after the removal of the IUD. In other cases, diseases interfered or pregnancy occurred a little later.

Of course, with the approach of menopause, many women no longer plan to have a child. It is important to carry out the installation of the spiral at the right time.

In fact, the reviews are contradictory. The main group of women is not satisfied with the unstable emotional background in the first month of using the IUD. But here you need to take into account the restructuring of the body, which is trying to get used to the changes and the influence of the hormone.

In addition, women note that the Mirena spiral is much more convenient than oral ones, which require a strict regimen. If we take the price of the system, then it ranges from 9-13 thousand rubles. With the expectation of a five-year period, you can save a good amount in contrast to spending on contraceptives.

The Mirena intrauterine hormonal contraceptive is a real find during premenopause, when the likelihood of conception remains, and the hormonal balance needs to be normalized. In addition, Mirena shows itself well together with estrogen-based HRT. It remains only to follow the recommendations and monitor your health in order to avoid possible consequences.

The active components of the Mirena spiral are the hormones gestagen and levonorgestrel. The spiral is inserted directly into the uterine cavity. For the purposes of contraception, the IUD is installed in women of childbearing age within 7 days. from start . After an abortion in the 1st trimester of pregnancy, Mirena should be installed immediately. After childbirth, the spiral is used when the uterus is restored, but not earlier than after 6 weeks.

In order to protect the endometrium during estrogen replacement therapy in women with amenorrhea, Mirena can be used at any time; in women with saved, the procedure is performed, according to the cycle schedule, on the last days of menstruation or immediately after the end of bleeding. Before installing the spiral, it is necessary to undergo examinations of both the mammary glands and the pelvic organs, to pass an analysis of a smear from the cervix. It is also necessary to exclude pregnancy and - without fail - the presence of sexually transmitted diseases. Existing genital infections should be treated.

How to install the intrauterine device "Mirena"

"Mirena" is sold in a sterile package, which must be opened directly at the moment before installing the spiral. When handling an opened system, asepsis must be observed. If the sterility of the packaging is violated, the IUD is destroyed as medical waste. Mirena should be installed by a doctor who already has sufficient experience with this IUD. Before the procedure, the doctor determines the position of the uterus and the size of its cavity. Important is the correct location of the IUD in the fundus of the uterus, which creates the necessary conditions for maximum efficiency. Mirena is installed using sterile instruments - mirrors and forceps.

After 4-12 weeks, it is necessary to undergo an examination, then it is carried out once a year or more often if indicated. In case of difficulty in installing Mirena, in case of severe pain or in case of bleeding during the procedure or after it, ultrasound is performed immediately to exclude perforation (perforation) of the uterus. The spiral is removed after 5 years, it can be replaced with a new one any day.

Side effects of Mirena

Mirena may have the following side effects: nausea, discomfort and bloating, headache, nervousness, mood depression, decreased libido, breast engorgement, urticaria, menstrual dysfunction, acne, itching, eczema, back pain and pain in the small area. pelvis, dysmenorrhea, vaginal discharge and bleeding, spotting, endometritis, cervicitis, inflammatory diseases, benign ovarian cysts.

Indications for use
- Contraception
- Idiopathic menorrhagia
- Prevention of endometrial hyperplasia during HRT

INFORMATION IS PROVIDED STRICTLY
FOR HEALTHCARE PROFESSIONALS

Mirena - official instructions for use

Registration number:

P N014834/01 - 130617

Trade name of the drug:

International non-proprietary name:

Levonorgestrel

Dosage form:

Intrauterine Therapy System

Compound:

Active substance: levonorgestrel micronized 52 mg
Excipients:
polydimethylsiloxane elastomer core, polydimethylsiloxane elastomer membrane containing colloidal anhydrous silicon dioxide 30-40% wt.
Other components: T-shaped polyethylene body containing barium sulfate 20-24 wt. %, thin thread of brown polyethylene, dyed with iron oxide black< 1,0 % масс.
Delivery device: conductor - 1 pc. The composition is given for one intrauterine therapeutic system with a conductor.

Description:

The Mirena® Intrauterine Therapy System (IUD) is a T-shaped levonorgestrel-releasing construct placed in a guidewire tube. The guidewire components are an insertion tube, a piston, an index ring, a handle, and a slider. The IUD consists of a white or almost white hormonal elastomeric core placed on a T-shaped body and covered with an opaque membrane that regulates the release of levonorgestrel. The T-shaped body is equipped with a loop at one end and two arms at the other. Threads are attached to the loop to remove the system. The IUD is free from visible impurities.

Pharmacotherapeutic group:

Gestagen

ATX code:

G02BA03

Pharmacological properties

Pharmacodynamics

Mirena® is an intrauterine therapeutic system (IUD) that releases levonorgestrel and has mainly a local gestagenic effect. The progestogen (levonorgestrel) is released directly into the uterine cavity, which allows it to be used at an extremely low daily dose. High concentrations of levonorgestrel in the endometrium contribute to a decrease in the sensitivity of its estrogen and progesterone receptors, making the endometrium immune to estradiol and exerting a strong antiproliferative effect. When using Mirena®, morphological changes in the endometrium and a weak local reaction to the presence of a foreign body in the uterus are observed. An increase in the viscosity of the secretion of the cervix prevents the penetration of sperm into the uterine cavity, due to a decrease in sperm motility and changes in the endometrium, the likelihood of fertilization of the egg decreases. Some women experience inhibition of ovulation. Previous use of the drug Mirena® does not affect reproductive function. Approximately 80% of women who want to have a baby become pregnant within 12 months after the IUD is removed.
In the first months of using Mirena®, due to the process of inhibition of endometrial proliferation, an initial increase in “spotting” bloody discharge from the vagina may be observed. Following this, a pronounced suppression of endometrial proliferation leads to a decrease in the duration and volume of menstrual bleeding in women using Mirena®. Scanty bleeding often transforms into oligo- or amenorrhea. At the same time, ovarian function and the concentration of estradiol in the blood plasma remain normal.
Mirena® can be used to treat idiopathic menorrhagia, i.e. menorrhagia in the absence of hyperplastic processes in the endometrium (endometrial cancer, metastatic lesions of the uterus, submucosal or large interstitial myomatous node, leading to deformation of the uterine cavity, adenomyosis), endometritis, extragenital diseases and conditions accompanied by severe hypocoagulation (for example, von Willebrand disease, severe thrombocytopenia) symptoms of which is menorrhagia. After 3 months of using Mirena®, menstrual blood loss in women with menorrhagia is reduced by 62-94% and by 71-95% after 6 months of use. When using Mirena® for two years, the effectiveness of the drug (reducing menstrual blood loss) is comparable to surgical methods of treatment (ablation or resection of the endometrium). A less favorable response to treatment is possible with menorrhagia due to submucosal uterine myoma. Reducing menstrual blood loss reduces the risk of iron deficiency anemia. The drug Mirena® reduces the severity of symptoms of dysmenorrhea.
The efficacy of Mirena® in preventing endometrial hyperplasia during chronic estrogen therapy was equally high with both oral and transdermal estrogen.

Pharmacokinetics
Absorption
After the introduction of the drug Mirena®, levonorgestrel begins to be immediately released into the uterine cavity, as evidenced by the measurement data of its concentration in the blood plasma. The high local exposure of the drug in the uterine cavity, which is necessary for the local effect of Mirena® on the endometrium, provides a high concentration gradient in the direction from the endometrium to the myometrium (the concentration of levonorgestrel in the endometrium exceeds its concentration in the myometrium by more than 100 times) and low plasma concentrations of levonorgestrel blood (the concentration of levonorgestrel in the endometrium exceeds its concentration in blood plasma by more than 1000 times). Rate of release of levonorgestrel into the uterine cavity in vivo Initially, it is approximately 20 micrograms per day, and after 5 years it decreases to 10 micrograms per day.
Distribution
Levonorgestrel binds nonspecifically to plasma albumin and specifically to sex hormone-binding globulin (GSP1). About 1-2% of circulating levonorgestrel is present as the free steroid, while 42-62% is specifically bound to SHBG. During the use of the drug Mirena®, the concentration of SHBG decreases. Accordingly, the fraction associated with SHBG decreases during the period of use of Mirena®, and the free fraction increases. The mean apparent volume of distribution of levonorgestrel is about 106 liters. After the introduction of Mirena®, levonorgestrel is detected in the blood plasma after an hour. The maximum concentration is reached 2 weeks after the administration of Mirena®. In accordance with the decreasing release rate, the median plasma concentration of levonorgestrel in women of reproductive age with a body weight above 55 kg decreases from 206 pg / ml (25th - 75th percentiles: 151 pg / ml - 264 pg / ml), determined after 6 months, up to 194 pg / ml (146 pg / ml - 266 pg / ml) after 12 months and up to 131 pg / ml (113 pg / ml - 161 pg / ml) after 60 months. It has been shown that body weight and plasma SHBG concentration affect the systemic concentration of levonorgestrel, i.e. with low body weight and / or high concentration of SHBG, the concentration of levonorgestrel is higher. In women of reproductive age with low body weight (37-55 kg), the median plasma concentration of levonorgestrel is approximately 1.5 times higher.
In postmenopausal women who use Mirena® simultaneously with the use of intravaginal or transdermal estrogens, the median plasma concentration of levonorgestrel decreases from 257 pg / ml (25th - 75th percentiles: 186 pg / ml - 326 pg / ml), determined after 12 months, up to 149 pg / ml (122 pg / ml - 180 pg / ml) after 60 months. When Mirena® is used simultaneously with oral estrogen, the concentration of levonorgestrel in blood plasma, determined after 12 months, increases to approximately 478 pg / ml (25th - 75th percentiles: 341 pg / ml -655 pg / ml), which due to the induction of SHBG synthesis.
Biotransformation
Levonorgestrel is largely metabolized. The main metabolites in plasma are unconjugated and conjugated forms of 3a, 50-tetrahydrolevonorgestrel. Based on the results of in vitro and in vivo studies, the main isoenzyme involved in the metabolism of levonorgestrel is CYP3A4. The isoenzymes CYP2E1, CYP2C19 and CYP2C9 may also be involved in the metabolism of levonorgestrel, but to a lesser extent.
Elimination
The total clearance of levonorgestrel from blood plasma is approximately 1.0 ml / min / kg. In unchanged form, levonorgestrel is excreted only in trace amounts. Metabolites are excreted through the intestines and kidneys with an excretion rate of approximately 1.77. The half-life in the terminal phase, represented mainly by metabolites, is about a day.
Linearity/Nonlinearity
The pharmacokinetics of levonorgestrel depends on the concentration of SHBG, which, in turn, is influenced by estrogens and androgens. When using the drug Mirena®, a decrease in the average concentration of SHBG by approximately 30% was observed, which was accompanied by a decrease in the concentration of levonorgestrel in the blood plasma. This indicates the non-linearity of the pharmacokinetics of levonorgestrel over time. Given the predominantly local action of Mirena®, the effect of changes in systemic concentrations of levonorgestrel on the effectiveness of Mirena® is unlikely.

Indications for use

• Contraception.
• Idiopathic menorrhagia.
• Prevention of endometrial hyperplasia during estrogen replacement therapy.

Contraindications

• Pregnancy or suspicion of it.
• Acute or recurrent inflammatory diseases of the pelvic organs. Infections of the external genital organs. Postpartum endometritis.
• Septic abortion within the last three months.
• Cervicitis.
• Diseases accompanied by increased susceptibility to infections.
• Dysplasia of the cervix.
• Diagnosed or suspected malignant neoplasms of the uterus or cervix.
• Progestogen-dependent tumors, including breast cancer.
• Uterine bleeding of unknown etiology.
• Congenital or acquired anomalies of the uterus, including fibroids, leading to deformation of the uterine cavity.
• Acute diseases or tumors of the liver.
• Hypersensitivity to the components of the drug.
• Mirena® has not been studied in women over 65 years of age, therefore the use of Mirena® is not recommended for this category of patients.

Carefully

Under the following conditions, Mirena® should be used with caution after consulting a specialist:

• congenital heart disease or valvular heart disease (because of the risk of developing septic endocarditis);
• diabetes.

Consideration should be given to removing the system if any of the following conditions are present or first occur:

• migraine, focal migraine with asymmetric loss of vision or other symptoms indicating transient cerebral ischemia;
• unusually severe headache;
• jaundice;
• severe arterial hypertension;
• severe circulatory disorders, including stroke and myocardial infarction.

Use during pregnancy and during breastfeeding

Pregnancy

The use of the drug Mirena® is contraindicated in pregnancy or suspicion of it.
Pregnancy in women who have Mirena® installed is extremely rare. But if the IUD falls out of the uterus, the woman is no longer protected from pregnancy and must use other methods of contraception before consulting a doctor.
During the use of the drug Mirena®, some women do not have menstrual bleeding. The absence of menstruation is not necessarily a sign of pregnancy. If a woman does not have periods, and at the same time there are other signs of pregnancy (nausea, fatigue, soreness of the mammary glands), then it is necessary to consult a doctor for examination and a pregnancy test. If a woman becomes pregnant while using Mirena®, it is recommended to remove the IUD, as any intrauterine device left in situ increases the risk of spontaneous abortion, infection, or preterm birth. Removal of Mirena® or probing of the uterus may lead to spontaneous abortion. If careful removal of the intrauterine contraceptive is not possible, medical abortion should be discussed. If a woman wants to keep the pregnancy and the IUD cannot be removed, the patient should be informed about the risks, in particular, the possible risk of septic abortion in the second trimester of pregnancy, postpartum purulent-septic diseases, which can be complicated by sepsis, septic shock and death, as well as the possible consequences premature birth for a baby.
In such cases, the course of pregnancy should be carefully monitored. An ectopic pregnancy must be ruled out. A woman should be explained that she should inform the doctor about all symptoms suggesting complications of pregnancy, in particular, the appearance of spastic pain in the lower abdomen, bleeding or bloody discharge from the vagina, and fever.
The hormone contained in Mirena® is released into the uterine cavity. This means that the fetus is exposed to a relatively high local concentration of the hormone, although the hormone enters it in small quantities through the blood and placenta. Due to the intrauterine use and local action of the hormone, the possibility of a virilizing effect on the fetus must be taken into account. Due to the high contraceptive efficacy of Mirena®, clinical experience related to pregnancy outcomes with its use is limited. However, the woman should be informed that at this point in time there is no evidence of birth defects caused by the use of Mirena® in cases of continuation of pregnancy until delivery without removal of the IUD.

breastfeeding period

Breastfeeding of a child while using Mirena® is not contraindicated. About 0.1% of a dose of levonorgestrel can enter the child's body during breastfeeding. However, it is unlikely that it poses a risk to the child at doses released into the uterine cavity after the installation of Mirena®.
It is believed that the use of the drug Mirena® six weeks after birth does not adversely affect the growth and development of the child. Monotherapy with gestagens does not affect the quantity and quality of breast milk. Rare cases of uterine bleeding have been reported in women using Mirena® during breastfeeding.

Dosage and administration

Mirena® is injected into the uterine cavity and remains effective for five years.
The in vivo release rate of levonorgestrel is initially about 20 µg per day and decreases after five years to about 10 µg per day. The average rate of release of levonorgestrel is approximately 14 micrograms per day for up to five years. Mirena® IUD can be used in women receiving oral or transdermal estrogen-only hormone replacement therapy (HRT).
With the correct installation of the drug Mirena®, carried out in accordance with the instructions for medical use, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is approximately 0.2%. The cumulative rate, reflecting the number of pregnancies in 100 women using a contraceptive for 5 years, is 0.7%.
Instructions for use IUD Mirena®

Mirena® is supplied in a sterile package, which is opened only immediately before the installation of the intrauterine system. Asepsis must be observed when handling an opened system. If the sterility of the packaging appears to be compromised, the IUD should be disposed of as medical waste. The same should be done with the IUD removed from the uterus, since it contains hormone residues.
Installation, removal and replacement of the intrauterine system
It is recommended that Mirena® be installed only by a doctor who is experienced with this IUD or well trained in this procedure.
Before installation Mirena®, a woman should be informed about the effectiveness, risks and side effects of this IUD. It is necessary to conduct a general and gynecological examination, including an examination of the pelvic organs and mammary glands, as well as a smear from the cervix. Pregnancy and sexually transmitted diseases should be excluded, and inflammatory diseases of the genital organs should be completely cured. Determine the position of the uterus and the size of its cavity. If it is necessary to visualize the uterus before the introduction of the Mirena® IUD, an ultrasound examination (ultrasound) of the pelvic organs should be performed. After a gynecological examination, a special instrument, the so-called vaginal mirror, is inserted into the vagina, and the cervix is ​​​​treated with an antiseptic solution. Mirena® is then injected into the uterus through a thin, flexible plastic tube. The correct location of the Mirena® preparation in the bottom of the uterus is especially important, which ensures a uniform effect of the progestogen on the endometrium, prevents the expulsion of the IUD and creates conditions for its maximum effectiveness.
Therefore, you should carefully follow the instructions for installing Mirena®. Since the technique of insertion in the uterus of different IUDs is different, special attention should be paid to working out the correct technique for inserting a particular system.
The woman may feel the insertion of the system, but it should not cause her much pain. Before the introduction, if necessary, you can apply local anesthesia of the cervix.
In some cases, patients may have cervical stenosis. Do not use excessive force when administering Mirena® to such patients. Sometimes after the introduction of the IUD, pain, dizziness, sweating and pallor of the skin are observed. Women are advised to rest for some time after the administration of Mirena®. If after a half-hour stay in a calm position, these phenomena do not disappear, it is possible that the intrauterine system is not positioned correctly. A gynecological examination should be performed; if necessary, the system is removed. In some women, the use of Mirena® causes allergic skin reactions.
The woman should be re-examined 4-12 weeks after insertion, and then once a year or more often if clinically indicated.
In women of reproductive age, Mirena® should be placed in the uterine cavity within seven days from the onset of menstruation. Mirena® can be replaced with a new IUD on any day of the menstrual cycle. An IUD can also be inserted immediately after an abortion in the first trimester of pregnancy, provided there is no inflammatory disease of the genital organs.
The use of the IUD is recommended for women with a history of at least 1 birth.
The installation of the Mirena® IUD in the postpartum period should be carried out only after the complete involution of the uterus, but not earlier than 6 weeks after childbirth. With prolonged subinvolution, it is necessary to exclude postpartum endometritis and postpone the decision to administer Mirena® until the involution is completed. In the event of difficulty inserting an IUD and/or severe pain or bleeding during or after the procedure, a pelvic exam and ultrasound should be performed immediately to rule out perforation.
For the prevention of endometrial hyperplasia during HRT with estrogen-only drugs, in women with amenorrhea, Mirena® can be installed at any time; in women with preserved menstruation, the installation is performed in the last days of menstrual bleeding or bleeding of "cancellation".
Delete Mirena® preparation by gently pulling on the threads captured by the forceps. If the threads are not visible and the system is in the uterine cavity, it can be removed using a traction hook to remove the IUD. This may require the expansion of the cervical canal.
The system should be removed five years after installation. If a woman wants to continue using the same method, a new system can be installed immediately after the previous one is removed.
If further contraception is required in women of reproductive age, removal of the IUD should be performed during menstruation, provided that the menstrual cycle is maintained. If a system is removed in the middle of a cycle and a woman has had sexual intercourse within the previous week, she is at risk of becoming pregnant, unless the new system was installed immediately after the old one was removed.
The insertion and removal of an IUD can be accompanied by some pain and bleeding. The procedure may cause vasovagal syncope, bradycardia or seizures in patients with epilepsy, especially if there is a predisposition to these conditions or in case of cervical stenosis.
After removing Mirena®, the system should be checked for integrity. In case of difficulties with the removal of the IUD, isolated cases of slipping of the hormonal-elastomer core on the horizontal arms of the T-shaped body were noted, as a result of which they were hidden inside the core. Once the integrity of the IUD is confirmed, this situation does not require additional intervention.
Limiters on the horizontal arms usually prevent the core from completely separating from the T-body.
Additional information for some groups of patients
Children and teenagers
Mirena® is indicated only after the onset of menarche (establishment of the menstrual cycle).
Elderly patients
Mirena® has not been studied in women over 65 years of age, so the use of the drug
Mirena® is not recommended for this category of patients.
Mirena® is not a first-choice drug for postmenopausal women up to 65 years of age with severe uterine atrophy.
Patients with liver disorders
Mirena® is contraindicated in women with acute liver disease or tumors (see also section "Contraindications").
Patients with kidney disorders
Mirena® has not been studied in patients with renal impairment.

Side effect

In most women, after the installation of the drug Mirena®, a change in the nature of cyclic bleeding occurs. During the first 90 days of using Mirena®, an increase in the duration of bleeding is noted by 22% of women, and irregular bleeding occurs in 67% of women, the frequency of these phenomena decreases to 3% and 19%, respectively, by the end of the first year of its use. At the same time, amenorrhea develops in 0%, and rare bleeding in 11% of patients during the first 90 days of use. By the end of the first year of use, the frequency of these phenomena increases to 16% and 57%, respectively.
When Mirena® is used in combination with long-term estrogen replacement therapy, in most women, cyclic bleeding gradually stops during the first year of use.
The table shows data on the incidence of adverse drug reactions reported with the use of Mirena®. According to the frequency of occurrence, adverse reactions (AR) are divided into very frequent (> 1/10), frequent (from> 1/100 to<1/10), нечастые (от >1/1000 to<1/100), редкие (от >1/10 000 up to<1/1000) и с неизвестной частотой. В таблице НР представлены по классам системы органов согласно MedDRA. Данные по частоте отражают приблизительную частоту возникновения НР, зарегистрированных в ходе клинических исследований препарата Мирена® по показаниям «контрацепция» и «идиопатическая меноррагия» с участием 5091 женщин. НР, о которых сообщалось в ходе клинических исследований препарата Мирена® по показанию «профилактика гиперплазии эндометрия при проведении заместительной терапии эстрогенами» (с участием 514 женщин), наблюдались с той же частотой, за исключением случаев, обозначенных сносками (*, **).

System organ class	Often	Often	Infrequently	Rarely	Frequency unknown
Immune System Disorders					Hypersensitivity to the drug or a component of the drug, including rash, urticaria and angioedema
Mental disorders		Depressed mood, depression
Nervous System Disorders	Headache	Migraine
Gastrointestinal disorders	Abdominal pain/pelvic pain	Nausea
Skin and subcutaneous tissue disorders		acne hirsutism	Alopecia Itching Eczema Skin hyperpigmentation
Musculoskeletal and connective tissue disorders		Backache**
Genital and breast disorders	Changes in the volume of blood loss, including an increase and decrease in the intensity of bleeding, "spotting" spotting, oligomenorrhea and amenorrhea Vulvovaginitis* Discharge from the genital tract*	Pelvic infections ovarian cysts Dysmenorrhea Pain in the mammary glands* * Breast engorgement Expulsion Navy (full or partial)		Uterine perforation (including penetration)***
Laboratory and instrumental data					High blood pressure

* "Often" for the indication "prevention of endometrial hyperplasia during estrogen replacement therapy."
** "Very common" for the indication "prevention of endometrial hyperplasia during estrogen replacement therapy".
*** This frequency is based on data from clinical studies that did not include women who were breastfeeding. In a large prospective comparative non-interventional cohort study involving women using IUDs, uterine perforations in women during breastfeeding or in whom IUD insertion was carried out up to 36 weeks after birth were noted with a frequency of "infrequently" (see section "Special Instructions") .

MedDRA terminology is used in most cases to describe certain reactions, their synonyms, and related conditions.

Additional Information
If a woman with an established Mirena® drug becomes pregnant, the relative risk of ectopic pregnancy increases. The partner can feel the threads during intercourse.
The risk of breast cancer when Mirena® is used for the indication "prevention of endometrial hyperplasia during estrogen replacement therapy" is unknown. Cases of breast cancer have been reported (frequency unknown, see section "With caution" and "Special instructions").
The following adverse events have been reported in connection with the insertion or removal of Mirena®: pain during the procedure, bleeding during the procedure, insertion-related vasovagal reaction accompanied by dizziness or fainting. The procedure can provoke a seizure in patients with epilepsy.
infection
After the installation of the IUD, cases of sepsis (including group A streptococcal sepsis) have been reported (see section "Special Instructions").

Overdose

Not applicable.

Interaction with other drugs

Metabolism of progestogens may be increased by concomitant use of substances that are enzyme inducers, especially cytochrome P450 isoenzymes involved in the metabolism of drugs, such as anticonvulsants (eg, phenobarbital, phenytoin, carbamazepine) and agents for the treatment of infections (eg, rifampicin, rifabutin, nevirapine , efavirenz). The effect of these drugs on the effectiveness of Mirena® is not known, but it is believed that it is not significant, since Mirena® has a mainly local effect.

special instructions

Before installing Mirena®, pathological processes in the endometrium should be excluded, since irregular bleeding / “spotting” spotting is often noted in the first months of its use. Pathological processes in the endometrium should also be excluded if bleeding occurs after the start of estrogen replacement therapy in a woman who continues to use Mirena®, previously established for contraception. Appropriate diagnostic measures should also be taken when irregular bleeding develops during long-term treatment.
Mirena® is not used for postcoital contraception.
Mirena® should be used with caution in women with congenital or acquired valvular heart disease, bearing in mind the risk of septic endocarditis. When inserting or removing an IUD, these patients should be given antibiotics for prophylaxis.
Levonorgestrel in low doses can affect glucose tolerance, and therefore its plasma concentration should be regularly monitored in women with diabetes mellitus using Mirena®. As a rule, dose adjustment of hypoglycemic drugs is not required.
Some manifestations of polyposis or endometrial cancer may be masked by irregular bleeding. In such cases, additional examination is necessary to clarify the diagnosis.
The use of intrauterine contraception is preferred in women who have given birth. IUD Mirena® should not be considered the method of choice in young nulliparous women and should only be used if other effective methods of contraception cannot be used. IUD Mirena® should not be considered as the method of first choice in postmenopausal women with severe uterine atrophy.
Available data indicate that the use of Mirena® does not increase the risk of developing breast cancer in postmenopausal women under the age of 50 years. Due to the limited data obtained during the study of the drug Mirena® for the indication "prevention of endometrial hyperplasia during estrogen replacement therapy", the risk of breast cancer when Mirena® is used for this indication cannot be confirmed or refuted.

Oligo- and amenorrhea

Oligo- and amenorrhea in women of childbearing age develops gradually, in approximately 57% and 16% of cases by the end of the first year of using Mirena®, respectively. If menstruation is absent within six weeks after the start of the last menstruation, pregnancy should be excluded. Repeat pregnancy tests for amenorrhea are not necessary unless there are other signs of pregnancy. When Mirena® is used in combination with continuous estrogen replacement therapy, most women gradually develop amenorrhea during the first year.

Pelvic inflammatory disease (PID)

The guidewire helps protect Mirena® from infection during insertion, and the Mirena® injection device is specifically designed to minimize the risk of infection. PID in women using intrauterine contraception is often caused by sexually transmitted infections. It has been established that the presence of several sexual partners in a woman or several sexual partners in a woman's partner is a risk factor for PID. PID can have serious consequences: they can interfere with reproductive function and increase the risk of ectopic pregnancy. As with other gynecological or surgical procedures, severe infection or sepsis (including group A streptococcal sepsis) can develop after IUD insertion, although this is extremely rare.
With recurrent endometritis or PID, as well as with severe or acute infections that are resistant to treatment for several days, Mirena® should be removed. If a woman has persistent pain in the lower abdomen, chills, fever, pain associated with sexual intercourse (dyspareunia), prolonged or heavy spotting/bleeding from the vagina, a change in the nature of the discharge from the vagina, you should immediately consult a doctor. Severe pain or fever that occurs shortly after IUD insertion may indicate a severe infection that needs to be treated promptly. Even in cases where only a few symptoms indicate the possibility of infection, bacteriological examination and monitoring are indicated.

Expulsion

Possible signs of partial or complete expulsion of any IUD are bleeding and pain. Contractions of the muscles of the uterus during menstruation sometimes lead to displacement of the IUD or even to pushing it out of the uterus, which leads to the termination of the contraceptive effect. Partial expulsion may reduce the effectiveness of Mirena®. Since Mirena® reduces menstrual blood loss, its increase may indicate the expulsion of the IUD. A woman is advised to check the threads with her fingers, for example, while taking a shower. If a woman finds signs of displacement or prolapse of the IUD or does not feel the threads, sexual intercourse or other methods of contraception should be avoided, and a doctor should be consulted as soon as possible. If the position in the uterine cavity is incorrect, the IUD must be removed. At the same time, a new system can be installed.
It is necessary to explain to the woman how to check the threads of Mirena®.

Perforation and penetration

Perforation or penetration of the body or cervix of the IUD can occur mainly during insertion, which may reduce the effectiveness of Mirena®. In these cases, the system should be removed. With a delay in diagnosing perforation and migration of the IUD, complications may occur, such as adhesions, peritonitis, intestinal obstruction, intestinal perforation, abscesses or erosion of adjacent internal organs.
In a large prospective comparative non-interventional cohort study in IUD users (N=61448 women), the incidence of perforations was 1.3 (95% CI: 1.1-1.6) per 1000 insertions in the entire study cohort; 1.4 (95% CI: 1.1-1.8) per 1000 injections in the Mirena® cohort and 1.1 (95% CI: 0.7-1.6) per 1000 injections in the Mirena® cohort copper containing IUDs. The study demonstrated that both breastfeeding at the time of insertion and insertion up to 36 weeks postpartum were associated with an increased risk of perforation (see Table 1). These risk factors were independent of the type of IUD used.

Table 1. Perforation rate per 1000 insertions and hazard ratio stratified by breastfeeding and time postpartum at insertion (parous women, entire study cohort).

An increased risk of perforation with IUD insertion exists in women with fixed malposition of the uterus (retroversion and retroflexion).

Ectopic pregnancy

Women with a history of ectopic (ectopic) pregnancy, tubal surgery, or pelvic infection are at higher risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain, especially if it is combined with the cessation of menstruation, or when a woman with amenorrhea begins to bleed.
The frequency of ectopic pregnancy in clinical studies with the use of Mirena® was approximately 0.1% per year. In a large prospective comparative non-interventional cohort study with a follow-up period of 1 year, the incidence of ectopic pregnancy with Mirena® was 0.02%. The absolute risk of ectopic pregnancy in women using Mirena® is low. However, if a woman with an established Mirena® drug becomes pregnant, the relative likelihood of an ectopic pregnancy is higher.

Loss of threads

If, during a gynecological examination, the threads for removing the IUD cannot be found in the cervical region, pregnancy must be excluded. The threads can be drawn into the uterine cavity or cervical canal and become visible again after the next menstruation. If pregnancy is excluded, the location of the threads can usually be determined using careful probing with an appropriate instrument. If the threads cannot be detected, perforation of the uterine wall or expulsion of the IUD from the uterine cavity is possible. Ultrasound can be used to determine the correct location of the system. If it is unavailable or unsuccessful, an X-ray examination is used to determine the localization of the Mirena® drug.

ovarian cysts

Since the contraceptive effect of Mirena® is mainly due to its local action, women of childbearing age usually experience ovulatory cycles with rupture of the follicles. Sometimes the atresia of the follicles is delayed, and their development can continue. These enlarged follicles are clinically indistinguishable from ovarian cysts. Ovarian cysts have been reported as an adverse reaction in approximately 7% of women using Mirena®. In most cases, these follicles do not cause any symptoms, although sometimes they are accompanied by pain in the lower abdomen or pain during intercourse.
As a rule, ovarian cysts disappear on their own within two to three months of observation. If this does not happen, it is recommended to continue monitoring with ultrasound, as well as carrying out therapeutic and diagnostic measures. In rare cases, it is necessary to resort to surgical intervention.

The use of Mirena® in combination with estrogen replacement therapy

When using the drug Mirena® in combination with estrogens, it is necessary to additionally take into account the information specified in the instructions for use of the corresponding estrogen.

Fertility

After removal of the drug Mirena® in women, fertility is restored.

Excipients contained in Mirena®
The T-shaped base of Mirena® contains barium sulfate, which becomes visible on x-ray.
It must be borne in mind that Mirena® does not protect against HIV infection and other sexually transmitted diseases!

Additional information for patients
Regular checkups
The doctor should examine you 4-12 weeks after the insertion of the IUD, and then regular medical examinations are required at least once a year.
Consult your doctor as soon as possible if:

• You no longer feel the threads in the vagina.
• You can feel the bottom end of the system.
• You assume you are pregnant.
• You experience persistent abdominal pain, fever, or a change in your normal vaginal discharge.
• You or your partner experience pain during intercourse.
• You have noticed sudden changes in your menstrual cycle (for example, if you had few or no periods and then had persistent bleeding or pain, or if your periods became excessively heavy).
• You have other medical problems, such as migraine headache or severe recurring headache, sudden visual disturbances, jaundice, high blood pressure, or any of the other diseases and conditions listed in the sections "Contraindications" and "Use with caution".

What to do if you want to get pregnant or remove Mirena for other reasons

Your doctor can easily remove the IUD at any time, after which pregnancy becomes possible. Usually, the removal is painless. After removal of the drug Mirena®, reproductive function is restored.
When pregnancy is not desired, Mirena should be removed no later than the seventh day of the menstrual cycle. If Mirena® is removed later than the seventh day of the cycle, barrier methods of contraception (eg, a condom) should be used for at least seven days before it is removed. If there is no menstruation when using Mirena®, seven days before the removal of the IUD, you should start using barrier methods of contraception and continue their use until menstruation resumes. You can also install a new IUD immediately after removing the previous one; in this case, no additional measures of protection against pregnancy are required.

How long can Mirena® be used
Mirena® provides protection against pregnancy for five years, after which it should be removed. If you wish, you can install a new IUD after removing the old one.

Restoration of the ability to conceive (Is it possible to become pregnant after stopping the use of Mirena®)
Yes, you can. Once Mirena® is removed, it will no longer interfere with your normal reproductive function. Pregnancy may occur during the first menstrual cycle after Mirena® is removed.

Effects on the menstrual cycle (Can Mirena® affect your menstrual cycle)
The drug Mirena® affects the menstrual cycle. Under its influence, menstruation can change and acquire the character of "smearing" discharge, become longer or shorter, flow with more abundant or less than usual bleeding, or stop altogether.
In the first 3-6 months after the installation of Mirena®, many women experience, in addition to their normal menstruation, frequent spotting or light bleeding. In some cases, very heavy or prolonged bleeding is noted during this period. If you experience any of these symptoms, especially if they persist, tell your doctor.
It is most likely that with the use of Mirena®, the number of days of bleeding and the amount of blood lost will gradually decrease every month.
Some women eventually find that their periods have completely stopped. Since the amount of blood lost during menstruation with the use of Mirena® usually decreases, most women experience an increase in hemoglobin in the blood.
After removing the system, the menstrual cycle is normalized.

Lack of menstruation (Is it normal not to have periods)
Yes, if you are using Mirena®. If, after installing Mirena®, you noted the disappearance of menstruation, this is due to the effect of the hormone on the uterine mucosa. There is no monthly thickening of the mucous membrane, therefore, it is not rejected during menstruation. This does not necessarily mean that you have reached menopause or that you are pregnant. The plasma concentration of your own hormones remains normal.
In fact, the absence of menstruation can be a big advantage for a woman's comfort.

How can you know you are pregnant
Pregnancy in women using Mirena®, even if they do not have menstruation, is unlikely.
If you haven't had a period in six weeks and you're concerned about it, take a pregnancy test. If the result is negative, no further tests are needed unless you have other signs of pregnancy such as nausea, fatigue, or breast tenderness.
Can Mirena cause pain or discomfort?
Some women experience pain (similar to menstrual cramps) for the first two to three weeks after having an IUD inserted. If you feel severe pain, or if the pain continues for more than three weeks after the system was installed, contact your doctor or the hospital where you had Mirena® installed.
Does Mirena® affect sexual intercourse?
Neither you nor your partner should feel an IUD during intercourse. Otherwise, sexual intercourse should be avoided until your doctor is satisfied that the system is in the correct position.
How much time should elapse between the installation of Mirena® and sexual intercourse
The best way to give your body a rest is to refrain from sexual intercourse for 24 hours after Mirena® is inserted into the uterus. However, Mirena® has a contraceptive effect from the moment of installation.
Can tampons be used
The use of sanitary pads is recommended. If you use tampons, you should change them very carefully so as not to pull out the threads of Mirena®.
What happens if Mirena® spontaneously leaves the uterine cavity
Very rarely, during menstruation, IUD expulsion from the uterine cavity can occur. An unusual increase in blood loss during menstrual bleeding may mean that Mirena® has fallen out through the vagina. Partial expulsion of the IUD from the uterine cavity into the vagina is also possible (you and your partner may notice this during intercourse). With the complete or partial exit of the drug Mirena® from the uterus, its contraceptive effect immediately stops.
What signs can be used to judge that Mirena® is in place
You can check for yourself if the threads of Mirena® are still in place after your period has ended. After the end of menstruation, carefully insert your finger into the vagina and feel for the threads at the end of it, near the entrance to the uterus (cervix).
Shouldn't be pulled threads, as you may accidentally pull Mirena® out of the uterus. If you can't feel the threads, see your doctor.

Influence on the ability to drive vehicles and mechanisms

Not observed.

Release form

Intrauterine therapeutic system, 20 mcg/24 hours.
1 intrauterine therapy system with a guidewire is placed in a sterile blister of polyethylene film coated with a white non-woven fabric with an adhesive coating and polyester (PETG - polyethylene terephthalate glycol or APET - amorphous polyethylene terephthalate). The blister, along with instructions for use, is placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 30°C.
Keep out of the reach of children.

Expiration date (before administration)

3 years.
Enter no later than the expiration date indicated on the package.

Holiday conditions

On prescription.

Manufacturer

Bayer Oy, Finland
Guesthouse 47, 20210 Turku, Finland
Bayer Oy Finland
Pansiontie 47, 20210 Turku, Finland

Additional information can be obtained at:
107113 Moscow, 3rd Rybinskaya st., 18, building 2.

Application

Instructions for administration

It is installed only by a doctor using sterile instruments.
Mirena® is supplied with a guidewire in a sterile package that must not be opened before installation.
Do not re-sterilize. For single use only. Do not use Mirena® if the inner packaging is damaged or open. Do not install the drug Mirena® after the expiration of the month and year indicated on the package.
Before installation, please read the information on the use of Mirena®.

Preparation for the introduction

• Perform a gynecological examination to determine the size and position of the uterus and to exclude any signs of acute inflammatory diseases of the genital organs, pregnancy or other gynecological contraindications for the installation of Mirena®.
• Visualize the cervix with speculums and completely clean the cervix and vagina with an antiseptic solution.
• Get help from an assistant if necessary.
• Grab the anterior lip of the cervix with forceps. Straighten the cervical canal by gentle traction with forceps. The forceps should be in this position during the entire time of insertion of the Mirena® preparation to ensure gentle traction of the cervix towards the inserted instrument.
• Carefully moving the uterine probe through the cavity to the bottom of the uterus, determine the direction of the cervical canal and the depth of the uterine cavity (distance from the external os to the bottom of the uterus), exclude septa in the uterine cavity, synechia and submucosal fibroma. If the cervical canal is too narrow, widening the canal and possibly using pain medication/paracervical blockade is recommended.

Introduction

1. Open the sterile package (Figure 1). After that, all manipulations should be carried out using sterile instruments and sterile gloves.
Picture 1

2. Move the slider forward in the direction of the arrow to the farthest position to draw the IUD into the guide tube (Figure 2).
Figure 2

Important information!
Do not move the slider downwards as this may cause premature release of Mirena®. If this happens, the system will not be able to be placed inside the conductor again.

3. While holding the slider in the farthest position, set the top edge of the index ring according to the measured distance from the external os to the fundus of the uterus by the probe (Figure 3).

Figure 3

4. While continuing to hold the slider in its furthest position, advance the guidewire gently through the cervical canal and into the uterus until the index ring is about 1.5 to 2 cm from the cervix (Figure 4).

Figure 4

Important information!
Do not force the guidewire. If necessary, expand the cervical canal.

5. Keeping the guidewire motionless, move the slider to the mark to open the horizontal shoulders of Mirena® (Figure 5). Wait 5-10 seconds for the horizontal hangers to fully open.

Figure 5

6. Gently push the guidewire inward until the index ring contacts the cervix. Mirena should now be in the fundal position (Figure 6).

Figure 6

7. Holding the conductor in the same position, release Mirena® by moving the slider as far down as possible (Figure 7). While holding the slider in the same position, carefully remove the conductor by pulling on it. Cut the threads so that their length is 2-3 cm from the external os of the uterus.

Figure 7

Important information!
If you have any doubts that the system is installed correctly, check the position of the Mirena® preparation, for example, using an ultrasound scan or, if necessary, remove the system and insert a new, sterile system. Remove the system if it is not completely in the uterine cavity. The remote system must not be reused.

Mirena Removal/Replacement
Before removing/replacing Mirena®, please read the instructions for use of Mirena®.
The Mirena® preparation is removed by gently pulling on the threads grasped by the forceps. (Figure 8).

Figure 8

You can install VMS immediately after uninstalling the old one.

Thanks to modern methods of contraception, a woman can not only protect herself from unwanted pregnancy, but also get rid of certain diseases. One of the popular protection options that can give such a result is the hormonal spiral. This method of contraception has many positive aspects. The Mirena intrauterine device is the latest development in this field of gynecology. Let us consider this device in more detail, and also pay attention to its advantages, disadvantages and patient reviews.

What is

One of the most effective methods of birth control - an intrauterine device - is a device that is inserted into the uterine cavity and makes it difficult for male gametes to pass to the egg, preventing their fusion and attachment of the fetal egg (embryo).

Installing an intrauterine system reduces the chance of getting pregnant by up to a tenth of a percent. This is especially true now, when women are increasingly postponing the birth of a child. The device most often has a T-shape and is installed on the 3rd-5th day of the new menstrual cycle. Whether such a method of protection is suitable can only be said by the attending gynecologist after a medical examination of the woman.

How does the spiral work?

The main task of the intrauterine device is to prevent the fertilization of the egg and the further attachment of the fetal egg to the walls of the uterus. If the fusion of two germ cells nevertheless occurred, the system begins to have an abortive effect. In this case, the hormonal spiral causes an increased contraction of the fallopian tubes, which leads to the rapid entry of the fetal egg into the uterine cavity and its further death. After that, the uterus recognizes the "object" as a foreign one and turns on the process of rejection - the walls of the uterus begin to contract.

Types of intrauterine devices

In gynecological practice, a variety of spirals are used, which differ primarily in shape. The intrauterine system can be loop- and ring-shaped, in the form of a spiral or an umbrella, in the form of the letter F. But still, devices in the form of the letter T are more popular.

The materials from which they are made also differ: copper, silver, gold, plastic. The size of the contraceptive is selected individually for each woman and depends on the anatomical features of the patient.

The intrauterine device can be hormonal and non-hormonal. In the first case, the contraceptive effect is provided by the hormone contained in the leg of the device, which is released in small quantities. But even a low dose of the hormone causes a thickening of the mucous layer of the uterine cavity and prevents the penetration of male germ cells. Spirals made of copper and silver are of the second, non-hormonal type and have an inhibitory effect on spermatozoa. The attending gynecologist will help to find out whether the spiral is hormonal (one or another model).

Mirena - a modern method of protection

The intrauterine system "Mirena" is the latest achievement of science in the field of gynecology. It has a T-shape and can be installed in the uterine cavity for a long time (up to 5 years). The Mirena hormonal coil (the price of a contraceptive is about 12 thousand rubles) contains the hormone levonorgestrel, which has a progestogenic effect at the local level with a gradual release.

The amount of active substance is 52 mg. The hormone begins to be released immediately after the spiral is placed in the uterine cavity. At first, levonorgestrel is released at a rate of 20 micrograms per day. This figure is reduced by half by the end of the fifth year after the installation of the intrauterine system. The hormone is practically not absorbed into the general bloodstream, which makes this method of protection safe for health.

Features of the Mirena spiral

The hormonal intrauterine device "Mirena" already in the first month of installation somewhat changes the nature of menstruation. In the first months, bleeding may increase, but over time (usually by the end of the first year), the discharge becomes scarce. Some patients note the onset of amenorrhea - the complete absence of menstruation.

Due to this therapeutic effect, the spiral is often prescribed to women for therapeutic purposes. The attending gynecologist should check the condition of the contraceptive every 6 months.

How is the installation process going?

The hormonal spiral can only be installed by the attending physician. Previously, the patient must pass tests (cytology, a smear for the flora and sexually transmitted infections, a general blood and urine test). You will also need to do an ultrasound.

A hormonal spiral is established during the first 7 days of a new menstrual cycle (usually 3-5 days). In some cases, a later introduction is also possible. it is allowed to install at least 4-5 weeks later, when the uterus is finally restored. If you experience discomfort, bleeding or other pathological symptoms after the introduction of the spiral, you should immediately consult a doctor.

Indications for use

It should be understood that the installation of a hormonal coil is indicated in specific cases and is not a remedy for every woman. A specialist can also recommend such a method of contraception to the patient for certain diseases. The main indications for use are:

• endometriosis - pathological growth of the mucous membrane of the uterine cavity - endometrium;
• idiopathic menorrhagia - heavy menstrual flow;
• uterine fibroids - a benign tumor that occurs in the muscle tissue of this organ (the spiral can be used as a prophylaxis).

Who is not suitable for the hormonal intrauterine system?

Having decided to install intrauterine contraception, a woman must undergo a medical examination, which will help to exclude conditions in which this procedure is unacceptable. It is contraindicated to install a spiral in the following cases:

• pregnancy;
• dysplasia;
• cervical erosion;
• cervicitis;
• anomalies (acquired or congenital);
• infectious or inflammatory processes of the genitourinary system;
• postpartum endometritis;
• acquired immunodeficiency syndrome;
• postpartum period (first 4 weeks);
• liver pathology;
• deep vein thrombosis;
• intolerance to the components of the spiral.

Hormonal spiral "Mirena": reviews

Women who have chosen Finnish-made spirals for protection against spirals leave mostly positive reviews. The main advantage is a high degree of contraception. The hormone released during the operation of the device prevents pregnancy in the same way throughout the entire time. In addition, the active substance also has a therapeutic effect. Therefore, in some cases, doctors strongly recommend that the Mirena hormonal coil be installed.

The price of such a device is really high, even compared to most analogues. And if there are side effects, the spiral will have to be removed. The money will be wasted. However, judging by the reviews, side effects are extremely rare, and the cost of the intrauterine system pays off for the entire process of use. One has only to compare it with the amount that should be spent within 5 years on hormonal pills or other means of protection.

Women should not worry about the fact that after some time after the installation of the spiral, menstrual bleeding has stopped. This is a completely normal reaction of the body. The monthly cycle will be restored in the first months after the removal of the device from the uterine cavity.

Popular intrauterine systems

Depending on the preferences of the woman herself and the recommendations of the doctor, the most suitable hormonal coil can be selected. The price in this matter also plays a major role. Several types of IUDs have earned popularity, which are much more affordable than the Mirena device in pricing policy.

Yunona stamps are presented in the form of the letter T and rings of various diameters. The cost of systems - from 300 to 1000 rubles. T-shaped spirals can be made of plastic, contain silver, copper. Before installation, allergies to the selected material should be excluded. "Junona Bio-T super" is made of plastic and has a copper winding. In addition, the surface of the device is treated with a special antiseptic solution, which contains propolis.

The Nova-T spiral is another popular analogue of Mirena. You can also install the system for up to 5 years. The material from which the spiral is made is absolutely safe for health. The base is made of plastic, the winding is made of copper. The price of the spiral is 2300-2600 rubles.

Levonova is a popular hormonal spiral. Reviews of experts indicate that this is a complete analogue of Mirena. The main active ingredient is the hormone levonorgestrel.

Before purchasing an intrauterine hormonal device, you should consult a specialist who will help you choose the best remedy.

Methods of contraception are different. Some women use oral contraceptives to prevent unwanted pregnancies. Others use a condom, while others resort to injectable protection methods. There are also special patches and rings that prevent the fertilization process. And far from the last place in this list is the spiral. The Mirena system has been especially popular lately. Side effects from its use are not felt by all women. Some simply do not notice the spiral and consider it an excellent contraceptive.

Composition and description

The Mirena intrauterine device not only protects against unwanted pregnancy, but also heals. It contains the hormonal substance levonorgestrel in the amount of 52 ml. The secondary component in the composition of the spiral is polydimethylsiloxane elastomer.

The appearance of the intrauterine therapeutic system resembles the letter "T" placed in a special conductor tube, which has a white core and has an elastomeric-hormonal filling. The body of the spiral is equipped on one side with a loop, on the other - with two shoulders. Threads are attached to the loop, with the help of which the spiral is removed from the vagina.

Pharmacological properties

The Mirena therapeutic intrauterine device (side effects from using the product are described in detail in the instructions for use, and they should be studied before using the system) has a local gestagenic effect by releasing levonorgestrel into the cavity of the uterine environment. This makes it possible to use the hormonal substance in the minimum daily dosage.

Over time, levonorgestrel accumulates in the endometrium, and its high content reduces the sensitivity of progesterone and estrogen receptors. As a result, the endometrium does not perceive estradiol and has an antiproliferative effect.

IUD "Mirena" (side effects and contraindications before using the therapeutic system must be taken into account) when used, it affects morphological changes in the endometrium. It causes a rather weak reaction of the body to the presence of a foreign body. Affects the thickening of the lining of the cervical canal, which prevents sperm from entering the uterus. The spiral prevents the process of fertilization, inhibits the activity of spermatozoa, their motor functions. There are women in whom the product inhibits ovulation.

The use of "Mirena" does not have a negative impact on the reproductive apparatus of a woman. As a rule, after the removal of the spiral, a woman becomes pregnant within a year.

At first, using a therapeutic intrauterine system may be disturbed by spotting. Over time, the inhibition of the endometrium leads to a decrease in the duration of menstruation and a decrease in their abundance. The effect of the spiral on the woman's body does not affect the functioning of the ovaries and the amount of estradiol in plasma.

It is allowed to use a spiral in the treatment of idiopathic menorrhagia, but on condition that the woman does not have gynecological and extragenital diseases, as well as ailments with severe hypocoagulation.

After 90 days after the insertion of the spiral into the uterus, the volume of menstrual flow decreases by 88%. If there is menorrhagia, which was caused by fibroids, then the result of treatment with a therapeutic system is not pronounced. Reducing the duration of menstruation reduces the likelihood of iron deficiency anemia. Reduces negative symptoms in dysmenorrhea.

Indications and contraindications

What other reviews can you hear about Mirena? Side effects are very rare. According to women, the spiral can cause negative symptoms not only because of its incorrect use, but also because of the individual intolerance of the body. In this case, doctors advise to remove the therapeutic system and select other methods of contraception.

The main indications for the use of the Mirena therapeutic system (side effects after using this spiral are observed in many women, only in some women they disappear over time, while in others the negative symptoms worsen, which forces the woman to abandon this medical product) are protection from unwanted pregnancy and idiopathic menorrhagia. The intrauterine device is recommended to prevent endometrial hyperplasia, which can occur with estrogen replacement treatment.

The use of "Mirena" should be abandoned during pregnancy and if there is even the slightest suspicion of it. Do not use a spiral for gynecological inflammatory diseases. The intrauterine system should be abandoned if there are diseases of the genitourinary system, postpartum endometritis, cervical dysplasia, as well as malignant and benign formations in the body are observed.

Do not use a spiral after a septic abortion, with cervicitis, bleeding of various origins, abnormalities of the uterine organ, liver diseases and hypersensitivity to the components that are part of the therapeutic system.

"Mirena" should be used only after consulting a specialist if the patient suffers from migraine, severe headaches and if there is arterial hypertension. With extreme caution, a spiral is used for jaundice, circulatory disorders and after a stroke, myocardial infarction.

It is believed that in small doses levonorgestrel is able to penetrate into the milk of a nursing mother, but if the child is six weeks old, he is not able to harm the baby. Therefore, for the use of the spiral during breastfeeding, additional specialist advice is required.

"Mirena". Instructions for use, dosage

The spiral is inserted into the uterine cavity. Its term of operation is five years. At the very beginning of the use of the spiral, the daily release rate of levonorgesgrel is 20 mcg. Over time, this figure decreases. Five years later, it is 11 mcg per day. The approximate average daily rate of release of a hormonal substance is 14 mcg.

The therapeutic uterine system can be used in women who have used hormone replacement therapy in their treatment. The most important thing is that the drugs used in the treatment contain estrogen, and not a progestogen. If the Mirena spiral is installed properly, then it is 0.1%.

The Mirena product is sold in sterile packaging. If at the time of purchase the product did not have sterile packaging, then it should not be used. It is also not necessary to store spirals removed from the cervix, as they still have remnants of the hormonal substance.

The sterile packaging of the spiral is opened only before the introduction of the product into the body of a lady. Only an experienced doctor with relevant experience in this field should install Mirena. Before introducing a therapeutic system, the doctor must familiarize the lady with contraindications and possible negative phenomena. Conduct a gynecological examination. Take a gynecological smear. Send the lady for a blood test. The doctor examines the mammary glands before installing the Mirena product. Side effects (the instruction warns of all the negative consequences that often occur after the introduction of the spiral) will be minimized if the patient is examined and the therapeutic system is installed correctly.

During the examination of the patient, it is necessary to exclude pregnancy, as well as ailments of an infectious and inflammatory nature. All detected diseases must be eliminated before the introduction of the spiral into the body of a woman.

Before inserting the spiral, the uterus and the parameters of its cavity are studied. It is considered correct to find "Mirena" at the bottom of the uterine organ. In this case, a uniform effect of the active substance of the product on the uterine environment is ensured.

The first time a lady after installing a spiral is examined after 3 months, then once a year. If necessary, the patient is examined more often.

If a woman is of childbearing age, then the spiral is established within seven days from the beginning of critical days. Mirena can be replaced with another intrauterine device at any convenient time. It is allowed to install an IUD immediately after an abortion, which was made in the first trimester.

After delivery, the spiral is allowed to be inserted six months after the involution of the uterus. If the involution occurs with a delay, then you should wait for its completion. If the insertion of an IUD occurs with complications, severe pain, or is accompanied by bleeding, an ultrasound should be performed as soon as possible to rule out the possibility of perforation.

With estrogen replacement therapy, to maintain the functions of the endometrium, women with a diagnosis of amenorrhea have the Mirena coil installed at any time. In patients with prolonged menstruation, the therapeutic system is administered in the last days of menstruation. The spiral is not used for postcoital contraception.

The Mirena therapeutic system is removed carefully by pulling the threads with forceps. If the threads could not be found, then a traction hook is used to extract the spiral. Sometimes the cervix needs to be dilated to remove the IUD.

The system, if there are no side effects, is removed after five years. If the lady wants to continue to use this method of contraception, then a new spiral is introduced immediately after the removal of the previous system.

Hormonal spiral "Mirena". Side effects

Negative symptoms in patients may appear in the first days after the introduction of the therapeutic system into the uterus. So the body gets used to the foreign element. As a rule, if the spiral is used for a long time, then the side effects soon disappear.

Quite often, side effects after installing Mirena are the following symptoms:

• bleeding, both vaginal and uterine;
• discharge of a smearing bloody character;
• ovarian cysts;
• oligo- and amenoria;
• bad mood and nervousness;
• decrease in sexual desire;
• migraine;
• pain in the lower abdomen and in the back;
• nausea;
• acne rashes;
• tension and soreness in the region of the mammary glands;
• weight gain;
• hair loss;
• swelling.

If negative phenomena appear, you should consult a gynecologist. When using the Mirena therapeutic system, many side effects appear almost immediately, but gradually the body gets used to the foreign element.

special instructions

Women during treatment with the Mirena therapeutic system should pay attention to the appearance of signs of venous thrombosis. When they appear, it is recommended to consult a doctor and take all measures to treat this disease.

Many women have experienced side effects when using the therapeutic system. Reviews of the Mirena IUD note that when using this method of contraception in women, weight increased and acne appeared on the skin. If negative symptoms appear, the contraceptive should be removed from the body and replaced with another.

With caution, the spiral should be used by women with problems with the valves of the heart organ. In this case, there is a risk of septic endocarditis. Such patients, on the days of the manipulations associated with the installation and removal of the spiral, are prescribed a course of antibiotics to prevent the onset of this disease.

Small doses of levonorgestrel can affect glucose tolerance, so women with diabetes should have regular blood sugar tests when using the spiral.

In 20% of cases, Mirena can cause oligo- and amenorrhea. If menstruation does not appear in a lady for more than six months, then pregnancy must be completely excluded. Amenorrhea in women can be observed throughout the year if the spiral is used along with other hormonal agents in estrogen replacement therapy.

VCM "Mirena" is removed for infectious and bacterial diseases of the vagina, endometritis, pain and bleeding. The therapy system should be removed from the uterus if it is placed incorrectly.

About how to check the threads of the product, the doctor notifies the woman immediately after he has installed the Mirena spiral. According to reviews, the side effects after the introduction of the IUD should alert the lady. When they appear, you should immediately visit a doctor to exclude possible complications and pathologies. Many patients are satisfied with the contraceptive, as it affects the absence of heavy periods and reliable contraception for five years of operation.

The cost of an intrauterine device

The Mirena spiral not only protects against unwanted pregnancy, but also heals. This explains the increased interest of women in this product. You can buy it at a pharmacy. The cost of a therapeutic vaginal system ranges from 9-12 thousand rubles.