Midiana, 3 mg+30 mcg, film-coated tablets, 63 pcs.

Pharmacotherapeutic group and properties

This drug belongs to the group of combined estrogen-progestogen contraceptives. Also, the drug has antimineralocorticoid and antiandrogenic properties. The contraceptive properties of the drug are due to the inhibition of the process of egg maturation, as well as the effect on the mucous membrane of the uterine cavity.

In addition to contraceptive activity, the combined oral contraceptive Midiana normalizes the menstrual cycle, makes it regular, reduces the manifestations of premenstrual syndrome and reduces the volume of menstrual flow. Indirectly, this drug helps to avoid the development of iron deficiency anemia, which occurs with heavy menstruation. Drospirenone, which is part of the drug, has antiandrogenic properties, which helps eliminate seborrhea of ​​the scalp and acne. The progestogen component prevents the appearance of edema associated with excess estrogen in the body.

General information about the drug Midiana

Midiana is a modern hormonal drug, a monophasic oral contraceptive. It consists of 2 main parts:

• progestin part in the form of drospirenone;
• estrogen part in the form of ethinyl estradiol.

The main purpose of using this drug is its contraceptive effect. Thanks to the creation of an artificial hormonal background in response to the introduction into the body of exogenously tableted forms of estrogens and gestagens, a balance of hormones is created that prevents the occurrence of ovulation in a woman’s ovaries and prevents the endometrial transformations necessary for implantation of the embryo into the inner mucous membrane of the uterus.

An interesting feature of this drug is the content of the gestagenic component drospirenone. It has a pronounced antiandrogenic effect. The drug is effective for symptoms of hyperandrogenism in women - hirsutism in the form of male-type hair growth on the face, chin, deepening of the voice. When using Midiana, the symptoms of an increased amount of male sex hormones are leveled, the woman blossoms and becomes self-confident.

The main focus of Midiana's use is control of reproductive function and prevention of unwanted pregnancy.

To achieve the desired effect, you must follow the rules for using the drug, its dosage regimen, and also take into account the contraindications specified in the instructions. A history of various types of thrombosis and smoking are contraindications to taking combined oral contraceptives.

Pros and cons of OK Midiana

Before starting to take the oral combination drug Midiana, it is important to compare the advantages and disadvantages of this drug.

Reliably protects against unplanned pregnancy

Normalizes menstrual function

Improves skin and hair condition

May cause side effects, has contraindications

Requires adherence to a strict dosing schedule

Does not protect against sexually transmitted infections

For personal safety reasons, it is not recommended to select an oral contraceptive on your own. The issue of selecting contraceptive pills should be decided together with the attending gynecologist.

About contraception

Contraceptives, that is, contraceptives, are necessary to prevent the development of unwanted pregnancy, and in some cases, protect against sexually transmitted diseases.

There are methods of protection based on purely physiological processes of the body, that is, natural methods. This should include interrupted sexual intercourse, calendar and temperature methods, and the period of breastfeeding.

The second group includes barrier techniques (condoms, uterine caps) and hormonal drugs (injections, oral contraceptives, etc.).

The third group includes products that are used immediately before or during sexual intercourse. These are various gels, ointments, suppositories, foams.

There are agents injected directly into the uterine cavity. These are the so-called intrauterine devices.

The most rare and extremely radical method of contraception is sterilization. It can be performed on both women (tubal ligation) and men (vasectomy).

The effectiveness and reliability of the contraception technique is determined by the Pearl index. What is this criterion based on? This is the ratio of the number of pregnancies occurring when using a particular contraceptive method per 100 women. Simply put, the Pearl index shows how reliable the chosen method of protection is. Consequently, the higher the indicators, the less effective the contraception method is.

The table shows some types of contraception and their Pearl Index score.

As can be seen from the table, the effectiveness indicators of COCs are much better than those of the same condoms. How is this explained?

The fact is that COCs, including Midiana, act simultaneously in three “directions”.

1. First, they turn off ovulation. If the egg does not mature and is released, the sperm will not be able to fertilize it.
2. Secondly, cervical mucus thickens (located in the cervical canal). A thick viscous substance simply will not allow sperm to penetrate into the uterine cavity and continue on their way.
3. Thirdly, the mucous uterine layer changes. It becomes thin, which will not allow a fertilized egg to attach.

A condom is also considered a fairly reliable means, and it also protects against sexually transmitted infections. Why is the efficiency index lower? Unlike oral contraceptives, a condom only works in one direction. It creates an artificial barrier to the advancement of sperm. Accordingly, if the rubber of the product turns out to be weak, then the likelihood of pregnancy greatly increases, since there are no additional barriers.

Indications and contraindications for use

The main indication for the use of a combined tablet drug is protection against unplanned pregnancy. In the process of using Midiana hormonal tablets, a woman’s menstrual cycle normalizes and the manifestations of premenstrual syndrome decrease. Additionally, the drug improves skin condition and helps fight acne and seborrhea of ​​the scalp.

Contraindications for using the medication include:

• individual intolerance to one of the components of the drug;
• individual predisposition to thrombosis;
• previously diagnosed angina or transient ischemic attack;
• pathologies of the heart valves;
• hypertonic disease;
• functional failure of the liver or kidneys;
• previous surgical intervention, followed by a long period of rehabilitation;
• inflammation of the pancreas with severe hypertriglyceridemia;
• hormone-dependent tumors.

Instructions for use of Midiana hormonal tablets

In order to maintain the pharmacological effect of the hormonal drug Midiana, it must be taken strictly according to the regimen indicated in the official instructions for the medication. The dosage of the contraceptive is 1 tablet once a day, at regular intervals. It is necessary to take the drug for 21 days, after which there is a pause of 7 days .

The next day after completing the break, you need to switch to the product from the new package. If a woman is just starting to take this drug, then she should take the first tablet on the first day of menstruation. It is allowed to start taking Midiana between the 2nd and 5th day of the cycle, but in this case, in the next 7 days it is necessary to use barrier contraception. When Midiana is prescribed after 40 years of age, a woman must regularly visit a gynecologist.

What to do if the regime is violated?

If a woman misses another tablet of Midiana, the tactics depend on the length of the time interval from the moment of the miss. If the time period is less than 12 hours, then the missed unit must be taken immediately, while the contraceptive properties of the drug remain the same. If the time period is more than 12 hours, then, by analogy with the previous situation, the pill should be taken immediately and in the next 7 days resort to the use of barrier contraception.

When can you not use protection when taking Median?

The drug begins to have a contraceptive effect from the first dose, but maximum protection is achieved only after 7 days of continuous medication use. To be on the safe side, it is recommended to use barrier contraception during this time.

How long can you take Median?

If you follow all the recommendations, you can take the Midiana contraceptive until the woman plans to become pregnant. During the entire period of taking an oral hormonal contraceptive, it is recommended to regularly visit your gynecologist, undergo a comprehensive examination, and, if one or more side effects occur, immediately consult a gynecologist for advice.

When switching from others OK

If a woman previously used a combined hormonal contraceptive, the package of which contained 28 tablets, then it is necessary to switch to the median the very next day after taking the last tablet of the previous medication. If the package of the previous contraceptive contained 21 tablets, then you need to start taking Midiana hormonal tablets the next day the day after the end of the seven-day break.

If the transition is made from progestin drugs, then you can take the first Midiana tablet the very next day after finishing taking the mini-pill. If you have previously used implants or intrauterine contraception, you can start taking Midiana on the day the implant or intrauterine device is removed. In the case of hormonal injections, it is permissible to switch to Midiana on the day of the intended injection.

After an abortion

If the pregnancy was terminated within the 1st trimester, then it is permissible to start taking oral contraception on the same day after the abortion. In this case, there is no need to use barrier contraceptives. If the pregnancy was terminated spontaneously or artificially in the 2nd trimester, then the actions are similar, and you can take the first Midiana tablet on the same day after the termination of pregnancy. If the first pill was taken later, then barrier contraceptives should be used over the next 7 days.

Midiana®

If any of the conditions, diseases or risk factors listed below currently exist, the potential risks and expected benefits of using COCs, including the combination of drospirenone + ethinyl estradiol, should be carefully weighed in each individual case and discussed with the woman before starting to take the drug. If any of these conditions, diseases or risk factors worsen, intensify or appear for the first time, a woman should consult her doctor to decide whether to stop taking the drug.

Risk of developing VTE and ATE

The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as DVT, PE, myocardial infarction, cerebrovascular disorders). These diseases are rarely reported.

The increased risk of developing VTE associated with the use of COCs is due to the presence of estrogen in its composition.

Drugs containing levonorgestrel, norgestimate, or norethisterone as a progestogen component are associated with the lowest risk of VTE.

When using other COCs, such as the combination of drospirenone + ethinyl estradiol, the risk of developing VTE is twice as high. The choice of a COC with a higher risk of VTE should only be made after consultation with the woman to ensure that she fully understands the risk of VTE associated with the contraceptive, the effect of the drug on her existing risk factors and that the risk of developing VTE maximum in the first year of taking such drugs. An increased risk is also observed when COC use is resumed (after a break between doses of the drug of 4 weeks or more). The increased risk of developing VTE is present primarily during the first 3 months.

VTE can be life-threatening or lead to death (in 1-2% of cases). VTE, manifested as DVT and/or PE, can occur with all COCs.

It is extremely rare when using COCs that thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.

Symptoms of DVT:

unilateral swelling of the lower limb or along the vein, pain or discomfort only in an upright position or when walking, local increase in temperature, redness or discoloration of the skin in the affected lower limb.

Symptoms of pulmonary embolism:

difficulty or rapid breathing; sudden cough, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less severe conditions (eg, respiratory tract infection).

ATE can lead to stroke, vascular occlusion, or myocardial infarction.

Symptoms of a stroke:

sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, severe or prolonged headache for no apparent reason, unilateral or bilateral loss of vision; problems with speech and understanding; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden loss of consciousness or fainting with or without a seizure.

Other signs of vascular occlusion:

sudden pain, swelling and slight cyanosis of the extremities, “acute” abdomen.

Symptoms of myocardial infarction:

pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. ATE can be life-threatening and lead to death.

In women with a combination of several risk factors or high severity of one of the factors, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. In this case, the combination of drospirenone + ethinyl estradiol is contraindicated.

The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders increases:

-with age;

- in women who smoke (with an increase in the number of cigarettes or an increase in age, the risk increases, especially over the age of 35);

- if there is a family history (for example, VTE or ATE in close relatives or parents aged less than 50 years). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking COCs;

- for obesity (with a BMI more than 30 kg/m2);

- with dyslipoproteinemia;

- for arterial hypertension;

- for migraine;

- for diseases of the heart valves;

- with atrial fibrillation;

- in case of prolonged immobilization, serious surgery, any operation on the lower extremities, in the pelvic area or extensive trauma. In these cases, the use of COCs should be stopped (in the case of planned surgery, at least four weeks before it) and not resumed for two weeks after the woman has fully regained mobility.

Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially in the presence of other risk factors.

The possible role of varicose veins and thrombophlebitis of superficial veins in the development of VTE remains controversial.

The increased risk of thromboembolism in the postpartum period should be taken into account.

Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraine (which may precede cerebrovascular events) during the use of COCs is grounds for immediate discontinuation of these drugs.

Biochemical indicators indicating a hereditary or acquired predisposition to the development of venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteipemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition/disease may reduce the associated risk of thrombosis.

Tumors

The most significant risk factor for the development of cervical cancer (CC) is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing CC with long-term use of COCs. However, the connection with taking COCs has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior patterns (less use of barrier methods of contraception, greater number of sexual partners).

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women who are currently taking COCs or have recently taken it is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increase in risk may also be a consequence of earlier diagnosis of breast cancer in women using COCs (they are diagnosed with earlier clinical forms of breast cancer than women not taking COCs), the biological effects of COCs, or a combination of both of these factors.

In rare cases, during the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors, which in some cases led to life-threatening intra-abdominal bleeding, was observed. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.

Other states

Depressed mood and depression are known adverse reactions when using hormonal contraceptives. Depression can be a serious disorder and is a known risk factor for suicidal behavior and suicide. Women should be advised to contact their doctor if mood changes or depressive symptoms occur, including soon after starting treatment.

Drospirenone is an aldosterone antagonist with potassium-sparing properties. In most cases, there should be no increase in plasma potassium concentration. In clinical studies in some patients with mild to moderate renal impairment and concomitant use of potassium-sparing drugs, plasma potassium concentrations were slightly increased while taking drospirenone. Therefore, it is necessary to monitor the concentration of potassium in the blood plasma during the first cycle of taking the drug in patients with renal failure and when the initial potassium concentration is at the upper limit of normal, especially when taking potassium-sparing drugs concomitantly.

In women with hypertriglyceridemia (or a family history of this condition), the risk of developing pancreatitis may increase while taking COCs. Although slight increases in blood pressure (BP) have been described in many women taking COCs, clinically significant increases have rarely been reported. However, if a persistent clinically significant increase in blood pressure develops while using a COC, the COC should be discontinued and treatment of arterial hypertension should be initiated. COC use can be continued if normal blood pressure values ​​are achieved with antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven: cholestatic jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of COCs.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.

Acute or chronic liver dysfunction may require discontinuation of COCs until liver function tests return to normal. Recurrence of cholestatic jaundice, which developed for the first time during a previous pregnancy or previous use of sex hormones, requires discontinuation of COC use.

Although COCs may have an effect on insulin resistance and glucose tolerance, in patients with diabetes mellitus using low-dose COCs, as a rule, no dose adjustment of hypoglycemic drugs is required. However, women with diabetes mellitus should be carefully monitored while taking COCs.

Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs.

Effect on liver function tests

In clinical studies involving patients receiving hepatitis C viral therapy (a combination of drugs containing ombitasvir, paritaprevir, ritonavir, dasabuvir, with or without ribavirin), increases in ALT activity more than 5 times the upper limit of normal were recorded more often in patients using ethynyl-containing COCs.

If a course of therapy with this combination of drugs is necessary, a patient using the combination of drospirenone + ethinyl estradiol should be switched to alternative methods of contraception (non-hormonal or progestogen-only contraceptives) before starting treatment. You can resume taking the combination of drospirenone + ethinyl estradiol no earlier than 2 weeks after the end of the course of therapy with antiviral drugs.

Laboratory tests

The use of drugs such as drospirenone + ethinyl estradiol may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, kidney and adrenal function, the concentration of transport proteins in the blood plasma (for example, transcortin, lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis). These changes usually remain within normal physiological values.

Drospirenone increases plasma renin activity and aldosterone concentrations, which is associated with its antimineralocorticoid effect.

Reduced efficiency

The effectiveness of COCs may be reduced in the following cases: in case of missed pills, gastrointestinal disorders or as a result of drug interactions.

Effect on bleeding pattern

While taking COCs, irregular bleeding may occur (“spotting” and/or “breakthrough” bleeding), especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately three drug cycles.

If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.

Some women may not develop withdrawal bleeding during a break from taking the pills; pregnancy should be ruled out before continuing to take it.

Medical examinations

Before starting or resuming taking the drug drospirenone + ethinyl estradiol, it is necessary to familiarize yourself with the woman’s life history and family history, conduct a thorough general medical examination (including measuring blood pressure, determining BMI) and gynecological examination (with mandatory examination of the mammary glands and cytological examination of the cervical epithelium), and exclude pregnancy. The scope of additional studies and the frequency of follow-up examinations are determined individually. Typically, follow-up examinations should be carried out at least once every 6 months.

It must be remembered that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases!

You should stop taking the tablets and consult your doctor immediately if there are possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe pain in the lower limb or sudden swelling of any of the lower limbs.

Side effects

No matter how high-quality the drug is, the likelihood of negative reactions from the body always remains. The most likely side effects of Midiana hormonal tablets include:

• increase or decrease in libido;
• allergic reactions, including skin rash like urticaria;
• headache;
• arterial and venous thrombosis;
• migraine;
• erythema multiforme or nodosum;
• hardening and tenderness of the mammary glands, the appearance of clear discharge from the nipples;
• psychoemotional lability, depressive disorders;
• peripheral edema;
• increase or decrease in body weight;
• vulvovaginal candidiasis;
• increase in blood pressure;
• hearing loss.

If one or more side effects occur, it is recommended not to delay a visit to your gynecologist, who will decide whether to discontinue or replace the drug.

Menstruation after Midiana withdrawal may be irregular in the next few cycles. This indicates a change in hormonal levels.

Prices and storage conditions

It is necessary to store the medicine at a temperature no higher than +25 degrees, with a relative air humidity in the room of no more than 70%, in a place protected from direct sunlight. Subject to storage rules, the maximum shelf life of Midiana is 3 years. The cost of the drug may vary depending on the region and the individual pricing policies of pharmacy chains.

On average, a package of contraceptives costs 650-670 rubles.

Analogues of Midiana in composition

Drugs containing a similar combination of drospirenone ethinyl estradiol include:

• Model Pro;
• Yarina Plus;
• Simicia;
• Jess Plus;
• Jess;
• Vidor;
• Zentiva;
• Model Trend.

Despite the similar composition, each drug has distinctive features, so it is not recommended to independently select a replacement for Midiana. It is not recommended to use cheap analogues of the drug Midiana, since their quality does not always guarantee safety.

Which is better Jess or Midian?

If you are making a comparative description of two oral contraceptives, then you should take into account such main criteria as effectiveness, safety, ease of use, frequency and severity of adverse reactions and the number of contraindications. In terms of effectiveness and safety, Midiana and Jess are on the same level. The drugs Jess and Median also do not compete in the number of contraindications. Midiana, unlike Jess, more often provokes negative reactions from the body, but both drugs are not addictive, and after their discontinuation, pregnancy can occur in the next cycle.

Scanty and spotting discharge against the background of Midiana

Scanty, spotting discharge when taking Midiana can appear both on the days of taking this hormonal drug and during its seven-day period; “menstruation on Midiana” is not uncommon for a gynecologist.

Scanty brown discharge can bother a woman in the first three months in any phase of the cycle. This period is characterized by the adaptation of the female body with a specific hormonal background to the use of contraceptives. This is not a reason to change the contraceptive or stop taking it altogether. Basically, by the time you start taking the second pack of tablets, such discharge disappears.

Midiana: periods take a long time

What should you do if you start drinking Midiana, but your period doesn’t end? It happens that withdrawal bleeding at the time of a seven-day break in taking COCs does not end on time. In some cases, an increase in the duration of these discharges is accompanied by an increase in their intensity. Such phenomena most likely have the character of breakthrough bleeding.

The reason for this is that the woman’s body gets used to the dosages of hormonal drugs. A feature of modern low-dose drugs is the rather meager content of the estrogen component, which is responsible for the rapid regeneration of the endometrium, and therefore stopping bleeding. If, when taking Midiana, periods are frequent (for example, every 22 days) and are long-lasting, then you should think about changing the combined oral contraceptive to a drug with a different dosage of estrogen.

In Midian, your period came earlier: what to do?

The arrival of menstruation earlier than the scheduled time, that is, before taking 21 tablets, may indicate both the adaptive aspects of the body in response to the introduction of contraceptives, and the low content of the gestagen component, due to which earlier reflection of the inner layer of the endometrium occurs. If this phenomenon fits within the three-month limit, then this is a variant of the norm. If your period comes earlier than expected after taking Midiana for 3 months, you need to consult a doctor about changing the drug to a higher dose.

Midiana: menstruation does not start

The absence of menstruation when taking Miliana after 21 tablets can have different reasons:

• disruption of a woman’s hormonal levels;
• pregnancy - can happen if the drug dosage regimen is violated, as well as if one or more tablets are missed, or if you do not start taking COCs correctly;
• continuous use of COCs.

Usually, menstruation when taking Midiana occurs after the withdrawal of estrogen-progestin components (after taking 21 tablets). Next, the so-called withdrawal bleeding occurs, when the level of estrogens and gestagens in the body decreases. If this does not happen, then there is some kind of imbalance in the woman’s hormonal sphere.

How to delay your period with Midiana?

If you need to delay menstrual bleeding, then taking contraceptives can be a lifesaver. More information about COCs for delaying menstruation.

After completing 21 tablets, the next day you need to start taking the next pack without taking a break, starting with the first tablet. Thus, menstruation will not come when taking Midiana, because... the level of hormones will not fall, which means that the functional layer of the endometrium will not be rejected.

Irina Drozdova, obstetrician-gynecologist, especially for Mirmam.pro

Reviews

The drug Midiana is prescribed to women for the purpose of contraception no more often than other types of COCs. If a woman can be prescribed both Midiana and Jess, then gynecologists opt for the second name OK. Reviews from women (,) who have taken or are taking this remedy are also ambiguous.

The number of positive reviews is about 60%. The remaining 40% of patients, as a rule, experienced side effects.

Many women have a negative opinion about Midiana tablets due to a violation of the dosage regimen and medication regimen.