Mersilon - instructions for use, analogs, reviews and release forms (birth control pills) of a drug for contraception in women, including during pregnancy and lactation. Composition and side effects of admission

In this article, you can read the instructions for using the drug Mersilon. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of medical specialists on the use of Mersilon in their practice. A big request is to actively add their comments about the drug: the contraceptive medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Mersilon in the presence of existing structural analogs.Use for contraception in women, including during pregnancy and lactation. Composition of the preparation.

Mersilon - a combined contraceptive containing estrogen and progestogen. The contraceptive effect of Mersilon, as well as of other combined oral contraceptives (CPC), is based, first of all, on the ability to suppress ovulation and increase the secretion of cervical mucus.

The gestagenic preparation (desogestrel) inhibits the synthesis of LH and FSH by the pituitary gland and, thus, prevents the maturation of the follicle (blocks ovulation).

Ethinyl estradiol - a synthetic analogue of the follicular hormone estradiol, together with the hormone of the yellow body regulates the menstrual cycle.

Along with these central and peripheral mechanisms preventing the maturation of an ovum capable of fertilization, the contraceptive effect is due to an increase in the viscosity of mucus located in the cervix, which makes it relatively impenetrable for spermatozoa.

In addition to contraceptive properties, Mersilon has a number of effects that can be taken into account when choosing a method of contraception.Menstrualnopodobnye reactions become more regular, flow less painful and are accompanied by less pronounced bleeding. The latter circumstance leads to a decrease in the frequency of concomitant iron deficiency anemia. When using CPC, a reduction in the risk of ovarian cancer and endometrium was shown.

Composition

Ethinyl estradiol + Desogestrel + auxiliary substances.

Pharmacokinetics

Desogestrel

Orally administered desogestrel is rapidly and completely absorbed and converted into etonogestrel. Bioavailability is 62-81%. Etonogestrel binds to serum albumin and to sex hormone binding globulin (SHBG). Only 2-4% of the total drug concentration in the serum is present as a free steroid, and 40-70% is specifically associated with SHBG. Etonogestrel is completely metabolized by the known pathways of steroid metabolism. The level of serotonin in the serum is reduced in two phases. The distribution in the final phase is characterized by a half-life of about 30 hours. The pharmacokinetics of etonogestrel is affected by the level of SHBG, which increases three-fold under the action of ethinyl estradiol.After daily intake, the serum level of the drug increases approximately 2-3 times, reaching a state of equilibrium in the second half of the course of treatment.

Ethinylestradiol

When administered orally, ethinyl estradiol is rapidly and completely absorbed. Absolute bioavailability as a result of presystemic conjugation and the first stage of metabolism is approximately 60%. Ethinyl estradiol is strongly, but not specifically associated with serum albumin (approximately 98.5%) and causes an increase in serum concentration of SHBG. Ethiylestradiol is an object of presystemic conjugation both in the small intestine mucosa and in the liver. Ethinylestradiol is first metabolized by aromatic hydroxylation, but a wide variety of hydroxylated and methylated metabolites is formed, and they are present as free metabolites and as conjugates with glucuronides and sulfates. The level of ethinyl estradiol in the serum is reduced in two phases, the distribution in the final phase is characterized by a half-life period of about 24 hours. The unchanged drug is not excreted, the metabolites of ethinyl estradiol are excreted in the urine and bile in a ratio of 4: 6.The half-life of the metabolite is about 1 day.

Pre-clinical safety data

To assess the risk for human toxicity studies have been conducted in animals to both components - ethinyl estradiol and desogestrel - and combinations thereof. In a systematic study of tolerability with repeated administration of drugs, no effects were found that could indicate an unexpected risk to a person. In studies of long-term toxicity with repeated doses, no oncogenic potential was detected. However, it should be borne in mind that sex steroids can accelerate the growth of certain hormone-dependent tissues and tumors.

Embryotoxicity and teratogenicity studies and assessment of the impact of both components in the fertility of animals manufacturers, fetal development, lactation and the ability to reproduce in the offspring did not give indications of possible risk of adverse effects in humans following use of recommended doses of drugs.

In studies, no indication was given of a mutagenic potential.

Indications

contraception.

Forms of release

Tablets 20 mcg + 150 mcg.

Instructions for use and reception scheme

Tablets should be taken orally in the order given on the package, every day at approximately the same time, with a small amount of water, if necessary.

Take 1 tablet a day for 21 days. Receiving tablets from the next package should start 7 days after the end of the previous one. During these 7 days menstrual bleeding occurs. Usually, it begins on day 2-3 after the last pill and may not stop before the next package is taken.

How to start taking the drug Mersilon

If hormonal contraceptives are not used within the last month, then the drug should be taken on the first day of the menstrual cycle. You can start taking the drug 2-5 days after the start of the menstrual cycle, but in this case it is recommended to use an additional (non-hormonal) method of contraception during the first 7 days of taking the tablets in the first cycle.

Transition from combined hormonal contraceptives (PDA, vaginal ring or transdermal patch): it is advisable to begin taking the drug Mersilon the day after taking the last active tablet of the previously used drug (the last tablet containing the active substances), but not later,the day after the end of the usual break in taking the pills or the day after taking the last tablet that does not contain hormones. In the case of using the vaginal ring or transdermal patch, it is advisable to start taking the drug Mersilon on the day they are removed, but not later than the day the new ring was to be inserted or the next patch application was made.

If a woman used the previous method of contraception consistently and correctly and if it is reliably known that a woman is not pregnant, in this case a woman can switch to taking the drug Mersilon on any day of the cycle. It should be borne in mind that the usual interval in the application of the previous method of contraception should not exceed its recommended duration.

Transition from preparations containing only progestogen ("minipili", injections, implant) or with progestagen-releasing intrauterine system (IUD). A woman who takes "mini-drank" can switch to taking the drug Mersilon any day; using an implant or IUD - on the day of their removal; using the drug in the form of injections - the day that the next injection should be,In all cases, additional methods of contraception are recommended during the first 7 days of taking Mersilon.

After an abortion made in the first trimester: a woman can start taking the drug immediately. No need to use any additional methods of contraception.

After childbirth or abortion, made in the 2nd trimester, it is recommended to start taking the drug no earlier than 21-28 days after the birth or abortion made in the 2nd trimester of pregnancy. At the beginning of taking the drug at a later date, it is recommended that barrier methods of contraception be used during the first 7 days of taking Mersilon. In any case, if a woman has had sexual intercourse after giving birth or having an abortion prior to taking Mersilon, pregnancy should be excluded before the drug is taken or wait until the first menstrual period.

In case of missed regular intake of the drug

If the next pill is delayed for less than 12 hours, the reliability of contraception does not decrease. A woman should take a pill as soon as she remembers it, and follow-up tablets take at the usual time.

If the next pill is delayed more than 12 hours, the reliability of contraception can be reduced. In this case, the following rules should be followed:

taking pills should never be interrupted for more than 7 days;
for adequate suppression of the hypothalamic-pituitary-ovarian system, it is necessary to take the pill 7 days in a row.

Cyclical administration of the drug implies 3 weeks of use. Therefore, the following recommendations can be made.

Week 1. A woman should take a missed pill as soon as she remembers it, even if it means taking 2 tablets at a time. Then you should continue the reception in the usual way. Additionally, the barrier contraceptive method should be used for the next 7 days. If a woman has had sexual intercourse within the previous 7 days, the possibility of pregnancy should be considered. The more pills are missed, and the closer the break in taking the drug at the time of sexual intercourse, the higher the risk of pregnancy.

Week 2. A woman should take a missed pill as soon as she remembers it, even if it means taking two pills at the same time.Then you should continue the reception in the usual way. Provided that the woman took the pill on time for 7 days preceding the first missed dose, there is no need to use additional (non-hormonal) methods of contraception. Otherwise, or if a woman misses more than 1 tablet, it is recommended to use additional methods of contraception within the next 7 days.

Week 3. The reliability of contraception can be reduced, due to a subsequent break in taking the drug. This can be avoided by adapting the drug regimen. If you use either of the following two schemes, you do not need to use additional contraceptive measures, provided that the woman took the pills on time for 7 days preceding the first missed dose. Otherwise, it is recommended to use one of the two following schemes and also use additional contraceptive measures during the next 7 days.

1. A woman should take the missed pill as soon as she remembers it, even if it means taking 2 tablets at a time. Then you should continue the reception in the usual way.New packaging should be started as soon as the current packaging is finished, i.e. do not take a break between the packages. The probability of bleeding cancellation before the end of the second package is small, but some may have smearing or copious bleeding even while taking the drug.

2. You can recommend stopping the drug from the current package. A woman should take a break from taking the Mersilon drug for no longer than 7 days, including the days when she forgot to take the pills, and then start a new package.

If you miss a drug and the subsequent absence of bleeding cancellation at the nearest pause in taking pills, you should consider the possibility of pregnancy.

Recommendations in case of occurrence of gastrointestinal disorders

In severe gastrointestinal disorders, absorption may be incomplete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after taking the drug, you should use the recommendations for missing the next dose of the drug.If a woman does not want to change her usual intake schedule, she needs to take an additional tablet (s) from another package (the number of additional tablets is determined when you visit an obstetrician-gynecologist.

How to change the period of menstruation

In order to delay menstruation, you should continue taking the pills from the other package of the Mersilon drug without the usual interruption in admission. Delay menstruation can be for any period until the end of the tablet from the second package. During this period, a woman may have smearing or copious spotting. Admission of the drug according to the usual schedule should be resumed after a 7-day interval in admission.

In order to shift menstruation on a day of the week, which is different from what is expected if the usual intake scheme is followed, you can reduce the usual break in admission for as many days as necessary. The shorter the break, the higher the risk of a lack of menstruation during the break and the occurrence of copious or spotting spotting while taking the drug from the second package.

Side effect

thrombosis or thromboembolism ((including myocardial infarction, stroke, deep vein thrombosis,thromboembolism of the pulmonary artery) thromboembolism of the hepatic, mesenteric, renal arteries and veins, arteries of the retina);
increased blood pressure;
liver tumors;
mammary cancer;
Chloasma (especially if there is a history of chloasma in pregnancy);
acyclic spotting more often in the first months of admission;
allergic reactions;
increase in body weight;
fluid retention;
decrease in body weight;
depression;
change of mood;
headache;
migraine;
decreased libido;
increased libido;
intolerance to contact lenses;
nausea, vomiting;
abdominal pain;
skin rash;
hives;
erythema nodosum;
erythema multiforme;
tenderness of the mammary glands;
increased mammary glands;
vaginal discharge;
discharge from the mammary glands.

Contraindications

presence at the time or in an anamnesis of venous thrombosis (including deep vein thrombosis of the lower leg, pulmonary embolism);
the presence at the moment or in an anamnesis of arterial thrombosis (including myocardial infarction, stroke) or precursors of thrombosis (including the transient attack of coronary artery disease, angina pectoris).
the revealed predisposition to venous or arterial thrombosis,including resistance to activated protein C, hyperhomocysteinemia, antithrombin deficiency 3, protein C deficiency, protein deficiency S, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);
migraine with focal neurological symptoms in history;
diabetes mellitus with vascular lesions;
presence of severe or multiple risk factors for venous or arterial thrombosis (including arterial hypertension with blood pressure 160/100 mm Hg and above);
pancreatitis (including in the anamnesis), accompanied by severe hypertriglyceridemia;
severe liver disease (before the normalization of liver function), incl. in the anamnesis;
liver tumors (benign and malignant), incl. in the anamnesis;
hormone-dependent malignant neoplasms of genital organs or mammary glands (including suspected);
bleeding from the vagina of an unclear etiology;
Smoking over the age of 35 (more than 15 cigarettes a day);
pregnancy (including alleged);
lactation period;
lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
hypersensitivity to the components of the drug.

Carefully

If any of the conditions / risk factors indicated below are currently available, the potential risk and the expected benefit of using the Mersilon drug should be carefully weighed in each individual case:

age over 35 years;
smoking;
presence of thromboembolic diseases in a family history (venous or arterial thrombosis / thromboembolism in brothers, sisters or parents at a relatively early age);
obesity (body mass index> 30 kg / m2);
dyslipoproteinemia;
arterial hypertension;
migraine;
valvular heart disease;
atrial fibrillation;
prolonged immobilization, extensive surgical intervention, surgical intervention on the lower extremities, severe trauma (with prolonged immobilization and the above surgical interventions, it is recommended to stop the use of the drug, with planned surgical interventions no later than 4 weeks before surgery, and not resume reception within 2 weeks after complete re-mobilization);
varicose veins, superficial thrombophlebitis (at the moment there is no unequivocal opinion on the possible role of these conditions in the etiology of venous thromboembolism);
the postpartum period;
changes in biochemical parameters that may be markers of congenital or acquired predisposition to venous or arterial thrombosis (including resistance to activated protein C, hyperhomocysteinemia, antithrombin deficiency 3, protein C deficiency, protein S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin , lupus anticoagulant);
diabetes;
systemic lupus erythematosus;
hemolytic-uremic syndrome;
chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
sickle-cell anemia;
hypertriglyceridemia (including in family history);
acute and chronic liver disease, incl. congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome).

Application in pregnancy and lactation

The use of the drug Mersilon during pregnancy is contraindicated. In the case of pregnancy on the background of the use of Mersilon should stop taking the drug. It should be noted that extensive epidemiological studies have not revealed an increased risk of the birth of children with congenital defects in women taking COC prior to pregnancy,or teratogenic effects when unintentionally taking COCs at the start of pregnancy

Mersilon can affect lactation, because PDA reduce the amount and change the composition of breast milk. Therefore, Mersilon is not recommended until the breast feeding mother completely stops breastfeeding. A small number of contraceptive steroids and / or their metabolic products can be excreted in breast milk.

special instructions

If any of the following conditions or risk factors are present, you should carefully weigh the benefits and potential risk of taking Mersilon. This issue should be discussed with the patient even before taking the drug. In case of aggravation of the disease, worsening of the condition or appearance of the first symptoms of these conditions or risk factors, the patient should immediately consult a doctor. The doctor decides whether to cancel the drug individually.

Vascular diseases

In epidemiological studies, it was found that there may be a link between the use of the drug Mersilon and an increased risk of arterial and venous thrombotic and thromboembolic diseases such as myocardial infarction, stroke,deep vein thrombosis and thromboembolism of the pulmonary artery. These diseases are extremely rare.

The use of any PDA is associated with an increased risk of venous thromboembolism (VTE), manifested as deep vein thrombosis and / or pulmonary embolism, sometimes with fatal consequences. The risk is higher in the first year of admission than in women who take CPC for more than 1 year.

Some epidemiological studies show that women who took low-dose PDCs containing progestogenes of the third generation, including desogestrel, have an increased risk of VTE compared to those who took low-dose PDA with progestagen levonorgestrel.

Very rarely thrombosis occurs in other blood vessels (for example, in veins and arteries of the liver, mesentery, kidneys, brain or retina). There is no single point of view as to whether this thrombosis is a consequence of the use of the CCP.

Increasing the frequency and intensity of migraines when taking Mersilon (which may be a sign of cerebrovascular disorders) may be the reason for immediate withdrawal of the drug.

Tumors

The most important risk factor for developing cervical cancer is the persistence of the human papillomavirus (HPV infection). Some epidemiological studies have noted an increase in the risk of cervical cancer in women receiving long-term CPC, but there are still contradictions as to the extent to which these factors affect the mixing of various factors such as cervical screening and sexual behavior, including the use of barrier methods of contraception, or their interrelations.

There is evidence that there is a slight increase in the relative risk (1.24) of breast cancer in women using CPC. The increased risk gradually decreases within 10 years after the cancellation of COC. Because Breast cancer in women under 40 years is rare, the increase in the likelihood of developing breast cancer in women who are currently receiving CCPs or who have recently abandoned them is small relative to the initial likelihood of developing cancer. These studies do not provide data on the etiology of cancer. The increase in the risk of breast cancer can be explained by the fact that in women receiving CPC,the diagnosis of breast cancer is established at an earlier time, and the biological effects of CPC, or a combination of both of these factors.

There is a tendency according to which women who have ever received the CCP have breast cancer less clinically than women who have never taken a CCP.

It is extremely rare when using the drug Mersilon, there have been cases of development of benign, and even more rarely - malignant liver tumors. In some cases, these tumors resulted in life-threatening intra-abdominal bleeding. The physician should consider the possibility of having a liver tumor in the differential diagnosis of the disease in a woman receiving Mersilon if the symptoms include acute pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding.

Other diseases

If a woman or her family has hypertriglyceridemia diagnosed, there may be an increased risk of pancreatitis when taking Mersilon.

If a woman receiving Mersilon develops persistent clinically invasive hypertension, the doctor should cancel Mersilon and prescribe treatment for hypertension. In those cases, when using

antihypertensive therapy can achieve normal values of blood pressure, the doctor may consider it possible for the patient to resume taking the drug.

There are reports that jaundice and / or itching caused by cholestasis; the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (small chorea), herpes of pregnant women, hearing loss due to otosclerosis, (hereditary) angioedema, edema develop or worsen

Both with pregnancy and with the drug Mersilon, but the evidence for taking the drug Mersilon, are unconvincing.

Acute or chronic liver dysfunction can be the basis for the withdrawal of the drug Mersilon, until the liver function indicators are normalized. The recurrence of cholestatic jaundice, observed earlier in pregnancy or with the use of drugs of sex steroids, requires the abolition of the drug Mersilon.

Although Mersilon can affect the tolerance of peripheral tissues to insulin and glucose, there is no evidence that a patient with diabetes should change the therapeutic regimen for taking low-dose PDCs (containing less than 50 μg ethinyl estradiol).In any case, during the reception of the drug Mersilon diabetic patients need careful medical control.

There is evidence of a link between the administration of CPC and Crohn's disease and ulcerative colitis.

Sometimes when taking the drug Mersilon can be observed pigmentation of the face (chloasma), especially if it was previously in pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and UV irradiation from other sources when taking the drug Mersilon.

Medical examinations / consultations

Before starting or resuming the use of Mersilon, the physician should collect a detailed medical history (including a family history) and conduct a thorough examination. It is necessary to measure blood pressure and in case of detection of clinically significant signs it is necessary to conduct a physical examination, guided by contraindications and cautions. A woman should be instructed to carefully read the instructions for use and follow the recommendations. Frequency and list of examinations should be based on common practice and selected individually for each woman (but at least 1 time in 6 months).

A woman should be informed that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted infections.

Decreased efficiency

The effectiveness of the drug Mersilon may decrease in the case of skipping the drug, gastrointestinal disorders or with the concomitant use of certain medications.

Irregular spotting

When taking the drug Mersilon, especially in the first months of use, there may be irregular smearing or copious spotting. Therefore, an assessment of irregular bleeding should be made only after the end of the adaptation period, lasting 3 months.

If irregular bleeding persists or appears after previous regular cycles, you should consider possible non-hormonal causes of the disorder and conduct appropriate studies to exclude malignant neoplasms or pregnancy. These measures may include diagnostic scraping.

Some women may not have menstrual bleeding during a break between taking the drug.If the drug Mersilon was administered according to the above recommendations, the probability of pregnancy is low. Otherwise, or if bleeding is absent 2 times in a row, the possibility of pregnancy should be excluded.

Laboratory research

Oral contraceptives may influence the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney functions, the content of transport proteins in plasma, for example, corticosteroid-binding globulin and lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis parameters. Usually, these changes are within the normal values of laboratory indicators.

Lactose

Each Mersilon tablet contains less than 80 mg of lactose. Women with rare hereditary disorders, such as lactose intolerance, lactose deficiency, glucose-galactose malabsorption, which comply with the lactose-free diet, should take into account the lactose content of the drug Mersilon.

Impact on the ability to drive vehicles and manage mechanisms

The effect of the drug Mersilon on the ability to drive vehicles and work with mechanisms is not noted.

Drug Interactions

The interaction between oral contraceptives and other drugs can lead to acyclic bleeding and / or a decrease in the effectiveness of contraceptives. The following interaction is described in the literature.

Hepatic metabolism: interaction can occur with inducers of microsomal liver enzymes, which can lead to increased clearance of sex hormones (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, Griseofulvin and drugs, containing St. John's wort pitted). The maximum induction of enzymes is not observed in the first 2-3 weeks of taking the drug Mersilon, but may appear at the end of 4 weeks after a usual break in taking the drug.

There was also reported a contraception of the contraceptive effect when taking Mersilon with antibiotics such as ampicillin and tetracyclines. The mechanism of this influence is not clear.

Women who take any of the above drugs should temporarily use the barrier barrier method or choose another method of contraception. With the simultaneous use of inducers of microsomal enzymes, the barrier method of contraception should be applied throughout the course of treatment and within 28 days after discontinuation of treatment. In the case of prolonged treatment with the use of inducers of microsomal enzymes, another method of contraception should be used. During the administration of antibiotics (with the exception of rifampicin and griseofulvin, which are inducers of microsomal enzymes) it is necessary to use barrier method of contraception throughout the course of treatment and within 7 days after the end of therapy. If the period during which the barrier method of contraception is used continues after the end of the tablets in the CCP package, then the next package of the drug should be started without the usual interval in admission.

Oral contraceptives can affect the metabolism of other drugs and accordingly change their concentrations in plasma and in tissues: increase (eg, cyclosporine) or reduce (lamotrigine).

With the concomitant use of other drugs to determine the possible interaction should use the instruction for the medical use of these drugs.

Analogues of the drug Mersilon

Structural analogs for the active substance:

Marvelon;
Three Mercy.

Analogues for the pharmacological group (contraceptives):

Antotevin;
Benatex;
Gynecotheque;
Demulen;
Jess;
Jess Plus;
Evra;
Wife;
Genetten;
Clira;
Loveston;
Logest;
Microinon;
Microlus;
Miniziston;
Novinet;
Non Ovlon;
Norkolut;
Norplant;
Ovidon;
Silestus;
Synphase;
Sterilin;
Trikwilar;
Pharmatex;
Chloe;
Egestenol;
Exluent;
Yarina;
Yarina Plus.

If there are no analogues of the medication for the active substance, you can go to the links below for diseases, from which the corresponding drug helps, and to look at the available analogs for therapeutic effects.

Used for the treatment of diseases: contraceptive, contraception