The best analogue of Marvelon. Reviews about the analogues of "Marvelon"

After four months of taking Mercilon (he was prescribed to me by a doctor after passing all the tests for contraception), I decided to find a cheap replacement for him. The composition of Novinet is as similar as possible to Mercilon (ethinylestradiol 20mcg, desogestrel 150mcg), and the price is almost two times cheaper. I will compare these two drugs point by point:

1. As already noted, Novinet is much cheaper than Mercilon. For comparison: a package of Mercilon cost me 555 rubles (21 tablets), a package of Novinet - 268 rubles (21 tablets), that is, 48% cheaper. There is also an advantage - Novinet can be bought in a package of three blisters at once for three cycles (price 780 rubles).

2. Both drugs can be bought at any pharmacy, sold without a prescription.

3. The regimen is the same: 21 tablets every day at the same time, then a break for 7 days, during which withdrawal bleeding (menstruation) occurs.

I took Novinet for only one cycle, during which a lot of side effects came out, namely:

Approximately on the 8-9th tablet on the face appeared small pimples, which I easily hid with foundation, then after a couple of days, painful subcutaneous acne, from which the head just cracked and the whole face hurt. Novinet provoked an exacerbation of the herpes virus. The whole cycle of taking Acyclovir tablets and Acyclovir ointment was saved.
In comparison Mercilon did not give such side effects, but on the contrary, from the first days of taking all the rashes on my face disappeared and did not appear at all.

Appeared small rash in the decollete area. In comparison Mercilon didn't give that kind of benefit.

Hair began to get dirty faster, in this cycle it became sharply noticeable. With Novinet I wash my hair every other day, with Mercilon- every three days.

Hair growth on the body accelerated and returned to the state that it was before taking the COC. With Mercilon the growth of hair on the body, on the contrary, slowed down.

Decreased sexual desire, it became noticeable at 15-18 tablets. And during intercourse, the amount of lubrication decreased compared to what it was before taking COCs. Mercilon did not suppress desire, but did not increase it either, but the amount of lubrication increased compared to the period before taking COCs.

At the end of the cycle, the chest began to hurt, swollen. Little pleasant.

The whole cycle of taking Novinet was marked by depression, irritability, it's just constant PMS!

From the pluses I will note:
+ no increase in appetite
+ 100% pregnancy protection

And to be honest, I see no reason to recommend this COC. Anyway, it didn't work for me. Although someone can say that the period of adaptation to the drug has not yet passed, which should be at least three months, I can no longer put up with painful bumps on my face and constant depression. After seven day break I will start taking Mercilon again.

Since medicine and science do not stand still, every year there are more and more options for contraception that do not cause discomfort, do not negative influence on the woman's body and have an effective effect.

We are talking about contraceptive pills Mercilon, which are now taken by most women. But before starting the course, it is important to read the instructions and indications for use.

pharmachologic effect

the main task hormonal pills Mercilon is provision of contraception, protecting the body during sexual intercourse.

Mechanism of action of hormonal contraceptives

This happens due to the influence on the hormonal background, through a combination of hormones and the effect on the hypothalamus, pituitary gland, and through them - on the ovaries.

The egg in the body of a woman does not mature to the end, because it is worse fixed on the myometrium, from which it is impossible to carry out fertilization.

And also the drug Mercilon has additional effects which consist in the treatment of acne and seborrhea, restoration menstrual cycle, reducing the risk of breast cancer and tumors in the uterus.

Composition and form of release

The main active ingredients in Mercilon tablets are ethinyl ethsradiol and desogestrel in the amount of 20 and 150 mcg per tablet.

In addition, the preparation contains additional components which speed up the assimilation in the form of:

  1. starch;
  2. Povidone;
  3. acids;
  4. lactose.

Pills are classified as contraceptive, oral, hormonal and monophasic drugs.

Mercilon tablets are produced in the form of white tablets, which in a pack can be: 21 pieces and 63. Mercilon is produced in Switzerland and the Netherlands.

Indications for use

Hormonal contraception

Before starting a course of Mercilon tablets, you need to consider indications for use, which are:

  • Providing oral contraception;
  • Restoration of the menstrual cycle;
  • Prevention of oncology of the breast and genital organs;
  • Treatment of acne, seborrhea.

IN rare cases, Mercilon can be used to restore hormonal background, treatment PMS syndrome.

Contraindications

Remember that before starting a course of Mercilon tablets, you need to inform the doctor about the presence of contraindications, otherwise the patient may experience side effects, worsening the situation.

Usually we are talking about these contraindications:

  • Pregnancy and lactation;
  • Intolerance to some components of Mercilon tablets;
  • Liver and kidney failure;
  • rotor syndrome;
  • anemia;
  • Strokes;
  • diabetes mellitus;
  • Disorders in the process of metabolism.

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There are other pathologies that the doctor must inform about before prescribing a course of taking Mercilon.

Side effects

All side effects can be divided into rare, frequent, single, very rare and permanent

Each patient may experience a number of side effects that occur in the first days of treatment with Mercilon tablets.

This is about:

  • Headache;
  • Vomiting and nausea;
  • Decreased hearing and vision;
  • edema;
  • breast augmentation;
  • Pain when touching the chest;
  • Spotting discharge when taking Mercilon;
  • Weight gain.

So bleeding, pain during intercourse and migraines are rare, but they pass in a few days.

If the manifestations remain for five to seven days, then you need to urgently consult a doctor, interrupt the course of taking Mercilon tablets.

drug interaction

Exists whole line drugs with which you should not combine Mercilon tablets, otherwise adverse reactions, complications may occur, and efficiency decreases.

Therefore, first consult a doctor, indicate before operations and visiting a therapist what you use:

  • Rifampicin;
  • Ampicillin;
  • Tetraksilin;
  • Birbiturates;
  • Neomycin;
  • adsorbents;
  • Topiramate.

Photo gallery:

Rifampicin Ampicillin Tetraksilin Topiramate Neomycin

The same applies to anticoagulants, alkalodies, the effect of which may be reduced due to Mercilon tablets.

Similar reactions can persist for a month or three after the end of the course of treatment with the drug.

Dosage and overdose

It is necessary to take Mercilon according to the course, indications and instructions inside the tablets. But in the treatment of non-standard problems, the dosage may differ.

At the end of the package, Mercilon should be taken after seven days, which refer to the time of the menstrual cycle.

In most cases, bleeding begins a couple of days after taking Mercilon tablets from the first pack and lasts until the start of the next pack.

Regarding overdose, such situations have not yet been observed, although in rare cases a number of side or allergic reactions in the form of nausea, vomiting, headache, bleeding or chest pain.

This should also be reported to the doctor and the course of treatment with Mercilon should be interrupted.

Instructions for use

You need to drink Mercilon tablets according to the problem, individual course and doctor's recommendations. So as contraceptives you need start the course on day 2-3 of the cycle with a duration of 21 days and break for a week.

In the period after childbirth, you can start taking the drug Mercilon on the first day of menstruation or on the 28th day after childbirth. The duration of the course is the same as in the first case.

In case of abortion, the treatment of Mercilon tablets begins on the first day, if you skip the day of admission, you need to drink the dragee immediately.

In this case, you can double the dosage.

If it is necessary to delay menstruation, then you need to take pills without a break for seven days. One tablet should be taken daily with plenty of water.

Shelf life and storage of the drug

It is recommended to store the drug Mercilon in a dark, dry place, which is protected from direct contact with sun rays.

The temperature must be at 10-20 degrees Celsius.

Do not let the product get into the hands of children or mentally unhealthy people, do not allow Mercilon to come into contact with liquids, other medicines.

The shelf life is about three years, after which it is forbidden to take the tablets, otherwise it may occur adverse reaction, allergy.

special instructions

If patients have certain diseases, then this should be reported to the doctor in advance before taking Mercilon tablets, these are:

  • Vascular diseases;
  • hypertension;
  • Dysfunction of the liver and kidneys;
  • Colitis;
  • Discharge of blood and mucus;
  • Lactose.

Useful video:

It is also important that patients during the period of taking Mercilon come for scheduled examinations, take tests to monitor the situation.

In this article, you can read the instructions for using the drug Mercilon. Reviews of site visitors - consumers are presented this medicine, as well as the opinions of medical specialists on the use of Mercilon in their practice. A big request to actively add your reviews about the drug: helped or did not help contraceptive medicine get rid of the disease, what complications and side effects were observed, possibly not declared by the manufacturer in the annotation. Mercilon analogues, if available structural analogues. Use for contraception in women, including during pregnancy and lactation. The composition of the drug.

Mercilon- combined contraceptive drug containing estrogen and progestogen. The contraceptive effect of Mercilon, like other combined oral contraceptives (CPC), is based primarily on the ability to suppress ovulation and increase the secretion of cervical mucus.

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

Ethinylestradiol is a synthetic analogue of the follicular hormone estradiol, together with the hormone corpus luteum regulates the menstrual cycle.

Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to an increase in the viscosity of the mucus in the cervix, which makes it relatively impassable for spermatozoa.

In addition to contraceptive properties, Mercilon has a number of effects that can be taken into account when choosing a contraceptive method. Menstrual-like reactions become more regular, less painful and are accompanied by less severe bleeding. The latter circumstance leads to a decrease in the frequency of concomitant iron deficiency anemia. The use of COCs has been shown to reduce the risk of developing ovarian and endometrial cancer.

Compound

Ethinylestradiol + Desogestrel + excipients.

Pharmacokinetics

Desogestrel

Orally administered desogestrel is rapidly and completely absorbed and converted to etonogestrel. Bioavailability is 62-81%. Etonogestrel binds to serum albumin and sex hormone-binding globulin (SHBG). Only 2-4% off total concentration the drug is present in serum as a free steroid, and 40-70% is specifically bound to SHBG. Etonogestrel is completely metabolized by known pathways of steroid metabolism. Serum levels of zonogestrel decrease in two phases. 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 influence of ethinyl estradiol. After daily intake the serum drug level rises by about 2-3 times, reaching a state of equilibrium in the second half of the course of treatment.

Ethinylestradiol

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

Preclinical safety data

To assess the risk to humans, animal toxicity studies have been conducted for both components of the drug - ethinylestradiol and desogestrel - and for their combination. In a systematic study of tolerability with reintroduction drugs, no effects were found that could indicate an unexpected risk to humans. In studies of long-term toxicity with repeated doses, no oncogenic potential has been identified. 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 effect of both components on the fertility of breeding animals, fetal development, lactation and reproductive ability in offspring did not give indications of the possibility of risk unwanted effects in humans after using the recommended doses of drugs.

Studies did not provide indications of mutagenic potential.

Indications

  • contraception.

Release form

Tablets 20 mcg + 150 mcg.

Instructions for use and regimen

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

Take 1 tablet per day for 21 days. Taking tablets from the next package should be started 7 days after the end of the previous one. During these 7 days, menstrual bleeding occurs. It usually starts 2-3 days after ingestion. last pill and may not stop before the start of the next package.

How to start taking Mercilon

If hormonal contraceptives have not been used for last month, then the drug should be started on the 1st 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.

Switching from combined hormonal contraceptives (CHCs, vaginal ring or transdermal patch): it is advisable to start taking Mercilon the next day after taking the last active tablet of the previously used drug (the last tablet containing active substances), but no later than the next day after the end of the usual break in taking the pills or the next day after taking the last pill that does not contain hormones. In the case of using a vaginal ring or transdermal patch, it is advisable to start taking Mercilon on the day of their removal, but no later than the day when a 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 the woman is not pregnant, in this case the woman can switch to Mercilon on any day of the cycle. It should be borne in mind that the usual interval in the use of the previous method of contraception should not exceed its recommended duration.

Switching from progestogen-only preparations (mini-pills, injections, implant) or progestogen-releasing drugs intrauterine system(Navy). A woman taking "mini-pill" can switch to Mercilon on any day; using an implant or IUD - on the day of their removal; using the drug in the form of injections - on the day when the next injection should be, in all cases, during the first 7 days of taking Mercilon, it is recommended to use additional methods contraception.

After an abortion in the 1st trimester: a woman can start taking the drug immediately. There is no need to use any additional methods of contraception.

After childbirth or an 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. When you start taking the drug in more than late dates it is recommended to use barrier methods of contraception during the first 7 days of taking Mercilon. In any case, if a woman has already had sexual contacts after childbirth or abortion before taking Mercilon, pregnancy should be excluded before starting the drug or wait until the first menstruation.

In case of missing the next dose of the drug

If taking the next pill is delayed by less than 12 hours, the reliability of contraception does not decrease. The woman should take the pill as soon as she remembers, and take subsequent pills at the usual time.

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

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

The cycle of taking the drug implies 3 weeks of use. Therefore, the following recommendations can be made.

Week 1. A woman should take the missed pill as soon as she remembers it, even if it means taking 2 pills at the same time. Then you should continue taking the usual scheme. Additionally, you should use the method barrier contraception over the next 7 days. If a woman has had sexual intercourse within the previous 7 days, the possibility of pregnancy should be considered. How more pills missed, and the closer the break in taking the drug to the time of sexual intercourse, the higher the risk of pregnancy.

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

Week 3. The reliability of contraception may be reduced due to a subsequent interruption in taking the drug. This can be avoided by adapting the dosage regimen. If you use any of the two below the following schemes, there is no need to use additional contraceptive measures, provided that the woman took the pills on time during the 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 for the next 7 days.

1. A woman should take the missed pill as soon as she remembers it, even if it means taking 2 pills at the same time. Then you should continue taking the usual scheme. new packaging should be started as soon as the current package ends, i.e. do not take a break between packs. There is little chance of withdrawal bleeding before the end of the second pack, but some may experience spotting or heavy bleeding. bloody issues even while taking the drug.

2. It may be recommended to stop taking the drug from the current package. A woman should take a break from taking Mercilon for no more than 7 days, including days when she forgot to take the pills, and then start a new package.

If you skip taking the drug and the subsequent absence of withdrawal bleeding in the next break in taking the tablets, the possibility of pregnancy should be considered.

With severe gastrointestinal disorders ax 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 regarding skipping the next dose of the drug. If a woman does not want to change her usual dosage regimen, she needs to take an additional tablet(s) from another package (amount extra pills determined when visiting an obstetrician-gynecologist.

How to change the timing of your period

In order to delay menstruation, you should continue taking tablets from another package of Mercilon without the usual break in taking. You can delay menstruation for any period until the end of the pill from the second package. During this period, a woman may experience spotting or profuse spotting. Taking the drug according to the usual scheme should be resumed after a 7-day interval in taking.

In order to shift the menstruation to a day of the week other than what is expected while observing conventional scheme reception, you can reduce the usual break in reception for as many days as necessary. The shorter the break, the higher the risk of missing periods during the break and the occurrence of heavy or spotting bleeding while taking the drug from the second package.

Side effect

  • thrombosis or thromboembolism ((including myocardial infarction, stroke, deep vein thrombosis, thromboembolism pulmonary artery) thromboembolism of the hepatic, mesenteric, renal arteries and veins, arteries of the retina);
  • increase in blood pressure;
  • liver tumors;
  • mammary cancer;
  • chloasma (especially if there is a history of chloasma during pregnancy);
  • acyclic spotting more often in the first months of admission;
  • allergic reactions;
  • weight gain;
  • fluid retention;
  • weight loss;
  • 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;
  • soreness of the mammary glands;
  • breast enlargement;
  • vaginal discharge;
  • secretions from the mammary glands.

Contraindications

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

Carefully

If any of the conditions / risk factors listed below are currently present, then the potential risk and the expected benefit of using Mercilon should be carefully weighed in each individual case:

  • age over 35;
  • smoking;
  • the 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 defects hearts;
  • atrial fibrillation;
  • prolonged immobilization, extensive surgery, surgical intervention on lower limbs, severe injury (with prolonged immobilization and the above surgical interventions it is recommended to stop using the drug for planned surgical interventions no later than 4 weeks before surgery, and not resume taking it within 2 weeks after complete remobilization);
  • varicose veins veins, superficial thrombophlebitis (at the moment there is no unambiguous opinion about the possible role of these conditions in the etiology of the development of venous thromboembolism);
  • 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 3 deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin , lupus anticoagulant);
  • diabetes;
  • systemic lupus erythematosus;
  • hemolytic-uremic syndrome;
  • chronic inflammatory diseases bowel (Crohn's disease or ulcerative colitis);
  • sickle cell anemia;
  • hypertriglyceridemia (including family history);
  • sharp and chronic diseases liver, incl. congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndrome).

Use during pregnancy and lactation

The use of Mercilon during pregnancy is contraindicated. If pregnancy occurs during the use of Mercilon, the drug should be discontinued. It should be noted that extensive epidemiological studies have not revealed an increased risk of having children with birth defects in women who took COCs before pregnancy, or teratogenic effects in case of inadvertent use of COCs at the beginning of pregnancy

Mercilon can affect lactation, because. PDAs reduce the amount and change the composition breast milk. Therefore, Mercilon is not recommended for use until the nursing mother completely stops breast-feeding. A small amount 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, the benefits should be carefully weighed against possible risk taking Mercilon. This issue should be discussed with the patient before starting the drug. In case of exacerbation of diseases, worsening of the condition or the appearance of the first symptoms of these conditions or risk factors, the patient should immediately consult a doctor. The question of drug withdrawal is decided by the doctor individually.

Vascular diseases

In the course of epidemiological studies, it was found that there may be an association between the use of Mercilon and an increased risk of arterial and venous thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These diseases are extremely rare.

The use of any COC 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 use than in women taking COCs for more than 1 year.

Some epidemiological studies show that women who have taken low-dose 3rd-generation progestogen-containing COCs, including desogestrel, have an increased risk of VTE compared to women who have taken low-dose levonorgestrel-containing COCs.

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

An increase in the frequency and intensity of migraines when taking Mercilon (which may be a sign of cerebrovascular disorders) may serve as a basis for immediate discontinuation of the drug.

Tumors

Most an important factor The risk of 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 taking COCs for a long time, but so far there is controversy regarding the extent to which these data are affected by confounding. various factors such as cervical screening and sexual behavior, including the use of barrier methods of contraception, or their relationship.

There is evidence that there is a slight increase in the relative risk (1.24) of developing breast cancer in women using COCs. Increased Risk gradually decreases within 10 years after the abolition of COCs. Because breast cancer in women under 40 years of age is quite rare, the increase in the likelihood of developing breast cancer in women receiving COCs currently or who have recently stopped using them is small relative to the initial probability of developing cancer. These studies do not provide data on the etiology of cancer. The increased risk of breast cancer can be explained both by the earlier diagnosis of breast cancer in women taking COCs, and by the biological effects of COCs, or a combination of both.

There is a trend that women who have ever taken COCs have less clinically advanced breast cancer than women who have never taken COCs.

Extremely rarely, when using Mercilon, cases of benign development were observed, and even more rarely - malignant tumors liver. In some cases, these tumors have led to life-threatening intra-abdominal bleeding. The physician should consider the possibility of a liver tumor with differential diagnosis disease in a woman receiving Mercilon if symptoms include sharp pain in the upper abdomen, liver enlargement or signs of intra-abdominal bleeding.

Other diseases

If hypertriglyceridemia is diagnosed in a woman or her family members, then an increased risk of pancreatitis may be increased when taking Mercilon.

If a woman receiving Mercilon develops persistent clinically significant hypertension, the physician should discontinue Mercilon and prescribe treatment. arterial hypertension. In cases where with

antihypertensive therapy can be achieved normal values BP, 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; formation of stones in gallbladder, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema develop or worsen

both during pregnancy and when taking Mercilon, however, the evidence for taking Mercilon is inconclusive.

Acute or chronic disorders liver function may be the basis for discontinuation of the drug Mercilon as long as the liver function indicators are not normal. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex steroid preparations, requires discontinuation of Mercilon.

Although Mercilon may affect peripheral tissue tolerance to insulin and glucose, there is no evidence that patients diabetes it is necessary to change the therapeutic regimen for taking low-dose COCs (containing less than 50 micrograms of ethinyl estradiol). In any case, while taking the drug Mercilon, patients with diabetes need careful medical monitoring.

There is evidence of an association between COC use and Crohn's disease and ulcerative colitis.

Sometimes when taking the drug Mercilon, pigmentation of the skin of the face (chloasma) can be observed, especially if it was earlier during pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and UV radiation from other sources while taking Mercilon.

Medical examinations/consultations

Before starting or resuming the use of the drug Mercilon, the doctor should take a detailed medical history (including family history) and conduct thorough examination. It is necessary to measure blood pressure and, if clinically detected, significant features it is necessary to conduct a physical examination, guided by contraindications and warnings. The woman should be instructed to read carefully this manual on the use of the drug and follow the recommendations. The frequency and list of examinations should be based on generally accepted practice and selected individually for each woman (but not less than 1 time in 6 months).

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

Reduced efficiency

The effectiveness of the drug Mercilon may decrease in case of skipping the dose of the drug, gastrointestinal disorders or concomitant use of certain medicines.

Irregular spotting

When taking the drug Mercilon, especially in the first months of use, irregular spotting or profuse spotting may occur. Therefore, an assessment of irregular bleeding should be carried out only after the end of the adaptation period, lasting 3 months.

If irregular bleeding persists or occurs after previous regular cycles, it is necessary to take into account possible non-hormonal causes cycle disorders and conduct appropriate studies to exclude malignant neoplasms or pregnancy. These measures may include diagnostic curettage.

Some women may not experience menstrual bleeding between doses. If Mercilon was taken according to the above recommendations, the likelihood of pregnancy is low. Otherwise, or if there is no bleeding 2 times in a row, the possibility of pregnancy should be excluded.

Laboratory research

Oral contraceptives may affect the results of some laboratory research, including biochemical indicators liver function, thyroid gland, adrenal glands and kidneys, content transport proteins in plasma, for example, corticosteroid-binding globulin and lipid/lipoprotein fractions, carbohydrate metabolism parameters, coagulation and fibrinolysis parameters. Usually these changes are within the normal range of laboratory parameters.

Lactose

Each Mercilon tablet contains less than 80 mg of lactose. women with rare hereditary disorders, such as lactose intolerance, lactase deficiency, glucose-galactose malabsorption, who follow a lactose-free diet, should take into account the lactose content in Mercilon.

Influence on the ability to drive vehicles and control mechanisms

The effect of Mercilon on the ability to drive vehicles and work with mechanisms was not noted.

drug interaction

Interactions between oral contraceptives and other medicinal products may lead to acyclic bleeding and/or decreased effectiveness of contraceptives. The following interaction is described in the literature.

Hepatic metabolism: Interactions may occur with inducers of microsomal liver enzymes, which may 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). The maximum induction of enzymes is not observed in the first 2-3 weeks of taking Mercilon, but may occur at the end of 4 weeks after the usual break in taking the drug.

It has also been reported that there has been a breach contraceptive effect when taking Mercilon with antibiotics such as ampicillin and tetracyclines. The mechanism of this influence is not clear.

Women who are taking any of the above drugs should temporarily use an additional method of barrier contraception or choose another method of contraception. At simultaneous application Inducers of microsomal enzymes barrier method of contraception should be used throughout the course of treatment and for 28 days after stopping treatment. When long-term treatment with the use of inducers of microsomal enzymes, it is necessary to use another method of contraception. While taking antibiotics (with the exception of rifampicin and griseofulvin, which are inducers of microsomal enzymes), it is necessary to use a barrier method of contraception throughout the course of treatment and for 7 days after the end of therapy. If the period during which a barrier method of contraception is used continues after the end of the pills in the PDA package, then next package the drug must be started without the usual interval in admission.

Oral contraceptives may affect the metabolism of others medicines and, accordingly, change their concentration in plasma and in tissues: increase (for example, cyclosporine) or decrease (lamotrigine).

With the concomitant use of other drugs to determine possible interaction you must use the instructions for medical use these medicinal products.

Mercilon's analogues

Structural analogues for the active substance:

  • Marvelon;
  • Three Mercy.

Analogues by pharmacological group (contraceptives):

  • Anteovin;
  • Benatex;
  • Gynecoteks;
  • Desmoulins;
  • Jess;
  • Jess Plus;
  • Evra;
  • Genale;
  • Genetten;
  • Qlaira;
  • Loveston;
  • Logest;
  • Microgynon;
  • Microlute;
  • minisiston;
  • Novinet;
  • Non Ovlon;
  • Norkolut;
  • Norplant;
  • Ovidon;
  • Silest;
  • Common mode;
  • Sterile;
  • Triquilar;
  • Pharmatex;
  • Chloe;
  • Egestrenol;
  • Exluton;
  • Yarina;
  • Yarina Plus.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.


Mercilon analogues are presented, in accordance with medical terminology, called "synonyms" - drugs that are interchangeable in terms of effects on the body, containing one or more of the same active ingredients. When choosing synonyms, consider not only their cost, but also the country of origin and the reputation of the manufacturer.

Description of the drug

Mercilon - Contraceptive action COC is based on the interaction of various factors, the most important of which seem to be the inhibition of ovulation and changes in cervical secretion. In addition to protecting against pregnancy, COC also has a number of positive properties, as opposed to negative properties which may be helpful when choosing a birth control method. The cycle becomes more regular, periods are often less painful, and bleeding decreases. The latter may reduce the incidence of iron deficiency anemia. There is evidence that at high doses COC (50 mcg ethinyl estradiol) reduces the risk of fibrocystic tumors of the breast, ovarian cysts, pelvic inflammatory disease, ectopic pregnancy and endometrial and ovarian cancer. Whether this applies to low-dose COCs needs to be clarified.

List of analogues

Note! The list contains synonyms for Mercilon that have similar composition, so you can choose a replacement yourself, taking into account the form and dose of the medicine prescribed by the doctor. Give preference to manufacturers from the USA, Japan, Western Europe, as well as well-known companies from of Eastern Europe: Krka, Gedeon Richter, Actavis, Egis, Lek, Geksal, Teva, Zentiva.


Release form(by popularity)price, rub.
Tablets 21 pcs.1577
Tab 3x21 (N.V. Organon (Netherlands)4140.10
Tablets, 21 pcs. (Shering - Plow, USA)790

Reviews

Below are the results of surveys of visitors to the site about the drug Mercilon. They reflect the personal feelings of the respondents and cannot be used as official recommendation during treatment with this drug. We strongly recommend contacting a qualified medical specialist for a personalized treatment plan.

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1 per day1 100.0%

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Official instructions for use

There are contraindications! Before use, read the instructions

MERSILON ®

Registration number:

P N011971/01

Tradename: Mercilon

international generic name or group name:
desogestrel + ethinylestradiol

Dosage form:

pills CLOSE [X] Learn more about Leia

The composition of the drug:
1 tablet contains
Active substances: desogestrel 0.150 mg, ethinylestradiol 0.020 mg.
Excipients: potato starch 8.0 mg, povidone 2.4 mg, stearic acid 0.8 mg, colloidal silicon dioxide 0.8 mg, alpha-tocopherol 0.08 mg, lactose monohydrate up to 80 mg.

Description
Round biconvex tablets white color engraved with "TR" above the "4" on one side of the tablet and "ORGANON" with a five-pointed star on the other side of the tablet.

Pharmacotherapeutic group:

contraceptive combined (estrogen + gestagen)

ATC code: G03AA09

Pharmacological properties

Pharmacodynamics
The contraceptive effect of Mercilon ® , as well as other combined oral contraceptives (COCs), is based on the interaction of various factors, the most important of which are the suppression of ovulation and changes in cervical secretion.
The progestogen drug (desogestrel) reduces the secretion of gonadotropic hormones, to a greater extent luteinizing hormone (LH), and thus prevents the maturation of the follicle (blocks ovulation). Ethinyl estradiol, a synthetic analogue of the natural hormone estradiol, reduces the likelihood of acyclic bleeding with COCs.
Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to an increase in the viscosity of the mucus in the cervix, which makes it relatively impassable for spermatozoa.
In addition to contraceptive properties, Mercilon ® has a number of effects that can be taken into account when choosing a contraceptive method. Menstrual-like reactions become more regular, less painful and are accompanied by less severe bleeding. The latter circumstance leads to a decrease in the frequency of concomitant iron deficiency anemia. The use of COCs has been shown to reduce the risk of developing ovarian and endometrial cancer.

Pharmacokinetics

Desogestrel
Suction
Orally administered desogestrel is rapidly and completely absorbed and then converted to etonogestrel. Its maximum concentration in blood serum is reached in 1.5 hours. Bioavailability is 62-81%.
Distribution
Etonogestrel binds to serum albumin and to sex hormone-binding globulin (SHBG). Only 2-4% of the total serum etonogestrel concentration is present as a free steroid, 40-70% specifically binds to SHBG. An increase in the concentration of SHBG caused by ethinyl estradiol affects the distribution between blood proteins, leading to an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction. The apparent volume of distribution of desogestrel is 1.5 l/kg.
Metabolism
Etonogestrel is completely metabolized by known metabolic pathways. steroid hormones; the rate of metabolic excretion from blood serum is 2 ml / min / kg. There was no interaction of etonogestrel with concomitantly taken ethinyl estradiol.
breeding
The concentration of etonogestrel in the blood serum decreases in 2 stages. The final stage is characterized by a half-life (T1 / 2) of about 30 hours. Desogestrel and its metabolites are excreted by the kidneys and through the intestines in a ratio of approximately 6:4.

The pharmacokinetics of etonogestrel is influenced by SHBG, the concentration of which increases under the influence of ethinyl estradiol by 3 times. With daily intake, the concentration of etonogestrel in the blood serum increases by 2-3 times, reaching a constant value in the second half of the cycle.
Ethinylestradiol
Suction
Ethinylestradiol after oral intake rapidly and completely absorbed. Its maximum plasma concentration is reached within 1-2 hours after ingestion. Absolute bioavailability (result of first pass metabolism) is about 60%.
Distribution
Ethinylestradiol non-specifically binds to serum albumin almost completely (98.5%), increases the concentration of SHBG. The apparent volume of distribution of ethinylestradiol is 5 l/kg.
Metabolism
Ethinylestradiol undergoes first pass metabolism, both in the mucous membrane of the small intestine and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation to form a variety of hydroxylated and methylated metabolites, which are present both in the free state and as conjugates with glucuronides and sulfates. The rate of metabolic excretion of ethinylestradiol from blood plasma is about 5 ml / min / kg.
breeding
Serum ethinylestradiol concentration decreases in 2 stages. The final stage is characterized by T1 / 2 about 24 hours. The drug is not excreted unchanged, ethinylestradiol metabolites are excreted by the kidneys and through the intestines in a ratio of 4:6. T1 / 2 metabolites is about a day.
Conditions equilibrium state
The equilibrium concentration is reached after 3-4 days of administration, when the serum concentration is 30-40% higher than the concentration after taking a single dose.

Indications for use

Contraception.

Contraindications

Mercilon ® , as well as other combined oral contraceptives, should not be taken in the presence of any of the diseases (conditions) listed below. If any of them occurs while taking the drug, you should immediately stop taking it.
  • Hypersensitivity to active substances or to any excipient drug Mercilon ® .
  • The presence or history of venous thrombosis (including deep vein thrombosis of the lower leg, pulmonary embolism).
  • The presence or history of arterial thrombosis (including myocardial infarction, stroke) or precursors of thrombosis (including transient ischemic attack, angina pectoris).
  • Identified predisposition to venous or arterial thrombosis, including resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant).
  • Migraine with focal neurological symptoms in history.
  • Diabetes mellitus with vascular damage.
  • The presence of severe or multiple risk factors for venous or arterial thrombosis (including arterial hypertension with blood pressure of 160/100 mm Hg and above).
  • Pancreatitis (including history), accompanied by severe hypertriglyceridemia
  • Severe liver disease (before normalization of liver function indicators), incl. in history.
  • Liver tumors (benign and malignant), incl. in history.
  • Hormone-dependent malignant neoplasms of the genital organs or mammary glands (including suspected ones).
  • Bleeding from the vagina of unknown etiology.
  • Smoking over the age of 35 (more than 15 cigarettes per day).
  • Pregnancy (including intended).
  • lactation period.
  • Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

    Carefully
    If any of the conditions / risk factors listed below are currently present, then the potential risk and the expected benefit of using Mercilon ® should be carefully weighed in each individual case:

  • age over 35;
  • smoking;
  • the 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/m);
  • dyslipoproteinemia;
  • arterial hypertension;
  • migraine;
  • valvular heart disease;
  • atrial fibrillation;
  • prolonged immobilization, extensive surgery, surgery on the lower extremities, severe trauma (with prolonged immobilization and the above surgical interventions, it is recommended to stop using the drug, for planned surgical interventions no later than 4 weeks before surgery, and not resume taking within 2 weeks after complete remobilization).
  • varicose veins, superficial thrombophlebitis (at the moment there is no unambiguous opinion about the possible role of these conditions in the etiology of venous thromboembolism);
  • 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 III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (cardiolipin antibodies, lupus anticoagulant);
  • diabetes;
  • systemic lupus erythematosus;
  • hemolytic-uremic syndrome;
  • chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
  • sickle cell anemia;
  • hypertriglyceridemia (including family history);
  • acute and chronic liver diseases, incl. congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndrome).

    Pregnancy and lactation

    The use of Mercilon ® during pregnancy is contraindicated. If pregnancy occurs while using the drug Mercilon ®, you should stop taking the drug. It should be noted that extensive epidemiological studies have not found an increased risk of giving birth to children with birth defects in women who took COCs before pregnancy, or a teratogenic effect when inadvertently taking COCs at the beginning of pregnancy.
    Mercilon ® may affect lactation, as COCs reduce the amount and change the composition of breast milk. Therefore, the use of the drug Mercilon ® is not recommended until the nursing mother completely stops breastfeeding.
    Small amounts of contraceptive steroids and/or their metabolic products may be excreted in milk.

    Dosage and administration

    The tablets should be taken orally in the order indicated on the package, every day at approximately the same time, with a small amount of water if necessary. Take 1 tablet daily for 21 days. Taking tablets from the next package should be started 7 days after the end of the previous one. During these 7 days, menstrual bleeding occurs. It usually starts 2-3 days after taking the last pill and may not stop until the next pack is taken.
    How to start taking Mercilon ®
    - If hormonal contraceptives have not been used within the last month
    Tablets should begin on day 1 of the menstrual cycle (i.e. on the first day menstrual bleeding). You can start taking the drug on days 2-5 of the 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.
    - Switching from combined hormonal contraceptives (combined oral contraceptive, vaginal ring or transdermal patch)
    It is advisable to start taking Mercilon ® the next day after taking the last active tablet of the previously used drug (the last tablet containing active substances), but no later than the next day after the end of the usual break in taking the tablets or the next day after taking the last tablet, not containing hormones. In the case of using a vaginal ring or transdermal patch, it is advisable to start taking Mercilon ® on the day of their removal, but no later than the day when a 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 the woman is not pregnant, then the woman can switch to Mercilon ® on any day of the cycle.
    It should be borne in mind that the usual interval in the use of the previous method of contraception should not exceed its recommended duration.
    - Switching from progestogen-only preparations (mini-pills, injections, implant) or from a progestogen-releasing intrauterine system (IUD)
    A woman taking "mini-pill" can switch to Mercilon ® any day; using an implant or IUD - on the day of their removal; using the drug in the form of injections - on the day when the next injection is due, in all cases, during the first 7 days of taking the drug Mercilon ®, it is recommended to use additional methods of contraception.
    - After an abortion in the first trimester
    A woman can start taking the drug immediately. There is no need to use any additional methods of contraception.
    - After childbirth or an abortion in the second trimester
    For lactating mothers, see section "Use during pregnancy and during breastfeeding".
    It is recommended to start taking the drug no earlier than 21-28 days after childbirth or an abortion made in the second trimester of pregnancy. If you start taking the drug at a later date, it is recommended to use barrier methods of contraception during the first 7 days of taking Mercilon®. In any case, if a woman has already had sexual intercourse after childbirth or abortion before taking Mercilon ®, pregnancy should be excluded before taking the drug or wait until the first menstruation.
    What to do if you miss the next dose of the drug
    If the next pill is delayed by less than 12 hours, the reliability of contraception does not decrease. The woman should take the pill as soon as she remembers, and take subsequent pills at the usual time.
    If the next tablet is delayed by more than 12 hours, the reliability of contraception may be reduced. In this case, the following two rules should be followed:
    1. Tablets should never be interrupted for more than 7 days.
    2. For adequate suppression of the hypothalamic-pituitary-ovarian system, it is necessary to take pills for 7 days in a row.
    The cycle of taking the drug implies 3 weeks of use. Accordingly, the following recommendations can be made:
  • Week 1
    A woman should take the missed pill as soon as she remembers it, even if it means taking two pills at the same time. Then you should continue taking the usual scheme. In addition, you should use a barrier method of contraception 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 tablets missed, and the closer the break in taking the drug to the time of sexual intercourse, the higher the risk of pregnancy.
  • Week 2
    A woman should take the missed pill as soon as she remembers it, even if it means taking two pills at the same time. Then you should continue taking the usual scheme. Provided that the woman has taken the pills on time in the 7 days preceding the first missed dose, there is no need to use additional (non-hormonal) methods of contraception. Otherwise, or if the woman missed more than 1 tablet, it is recommended to use additional methods of contraception for the next 7 days.
  • Week 3
    The reliability of contraception may be reduced due to a subsequent interruption in taking the drug. This can be avoided by adapting the dosage regimen. If either of the following two regimens is used, there is no need to use additional contraceptive measures, provided that the woman has taken the pills on time in the 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 for the next 7 days.
    1. A woman should take the missed pill as soon as she remembers it, even if it means taking two pills at the same time. Then you should continue taking the usual scheme. A new pack should be started as soon as the current pack ends, i.e. there should be no break between packs. The likelihood of "withdrawal bleeding" before the end of the second pack is small, but some may experience spotting or profuse bleeding while still taking the drug.
    2. The woman may be advised to stop taking the drug from the current package. A woman should take a break from taking Mercilon ® for no more than 7 days, including days when she forgot to take the pills, and then start a new package.
    If you skip taking the drug and the subsequent absence of “withdrawal bleeding” in the next break in taking the pills, the possibility of pregnancy should be considered.
    Recommendations in case of gastrointestinal disorders
    In the presence of 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 regarding skipping the next dose of the drug. If a woman does not want to change her usual dosage regimen, she needs to take an additional tablet(s) from a different package (the number of additional tablets is determined by an obstetrician-gynecologist specialist at face-to-face consultation).
    How to change the timing of menstrual bleeding
    In order to delay menstrual-like bleeding, you should continue taking tablets from another package of Mercilon ® without the usual break in taking. You can delay menstrual-like bleeding for any period until the end of the pills from the second package. During this period, a woman may experience spotting or profuse spotting. Taking the drug according to the usual scheme should be resumed after a 7-day interval in taking.
    In order to shift the day of the onset of menstrual bleeding to another day, you can shorten the usual break in taking the pills by as many days as necessary. The shorter the break, the higher the risk of the absence of menstrual-like bleeding during the break and the occurrence of heavy or spotting bleeding while taking the pills from the second package.

    Side effects

  • Thrombosis or thromboembolism (including myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism), thromboembolism of the hepatic, mesenteric, renal arteries and veins, retinal arteries.
  • Increase in blood pressure.
  • Hormone dependent tumors (liver tumors, breast cancer).
  • Chloasma (especially if there is a history of chloasma during pregnancy).
  • Acyclic spotting is more common in the first months of admission.
  • Allergic reactions.
    Possible side effects that were noted when taking the drug Mercilon ® or other COCs are shown in the table below.
    System organ class Often (≥1/100) Uncommon (≥1/1000 - Rarely (
    Immune System Disorders Hypersensitivity
    Metabolic and nutritional disordersWeight gainFluid retentionWeight loss
    Psychiatric disordersDepression, mood swingsDecreased libidoIncreased libido
    Nervous System DisordersHeadacheMigraine
    Violations of the organ of vision contact lens intolerance
    Gastrointestinal disordersNausea, abdominal painVomiting, abdominal pain
    Skin and subcutaneous tissue disorders Skin rash, urticariaErythema nodosum, erythema multiforme
    Violations by reproductive system and mammary glandsSoreness of the mammary glands, enlargement of the mammary glandsbreast hypertrophyVaginal discharge, breast discharge

    Overdose

    Any serious complications in case of an overdose of the drug Mercilon ® were not observed. Symptoms that may occur with an overdose: nausea, vomiting, in young girls - bloody discharge from the vagina. There are no antidotes and further treatment should be symptomatic.

    Interaction with other drugs

    Interactions between oral contraceptives and other medicinal products may lead to acyclic bleeding and/or decreased effectiveness of contraceptives. The following interactions are described in the literature.
    Hepatic metabolism: interactions may occur with drugs that induce microsomal enzymes, which may lead to increased clearance of sex hormones (eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin; and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, and preparations containing Hypericum perforatum). The maximum induction of enzymes is not observed in the first 2-3 weeks of taking the drug Mercilon ® , but may occur at the end of 4 weeks after the usual break in taking the drug.
    Also, a violation of the contraceptive effect was reported when taking Mercilon ® with antibiotics such as ampicillin and tetracyclines. The mechanism of this influence is not clear.
    Women who are taking any of the above drugs should temporarily use an additional method of barrier contraception or choose another method of contraception. With the simultaneous use of microsomal enzyme inducers, the barrier method of contraception should be used throughout the course of treatment and for 28 days after stopping treatment. In the case of long-term treatment with the use of microsomal enzyme inducers, another method of contraception should be used. Women using antibiotics (with the exception of rifampicin and griseofulvin, which have the properties of inducers of microsomal enzymes) should use a barrier method of contraception throughout the course of treatment and within 7 days after the end of therapy. If the period during which a barrier method of contraception is used continues after the end of the tablets in the COC package, then the next package of the drug must be started without the usual interval in taking.
    Oral contraceptives may interfere with the metabolism of other drugs.
    Accordingly, their concentrations in plasma and tissues can change: increase (for example, cyclosporine) or decrease (lamotrigine).
    When treating with other drugs, to determine possible interactions, it is necessary to read the instructions for medical use of these drugs.

    special instructions

    If any of the following conditions or risk factors are present, the benefits should be carefully weighed against possible harm taking the drug Mercilon ® . This issue should be discussed with the patient before starting the drug. In the event of an exacerbation of diseases, worsening of the condition or the appearance of the first symptoms of the above conditions or risk factors, the patient should immediately consult a doctor. The doctor should decide whether to stop the drug.
    Vascular diseases
  • In the course of epidemiological studies, it was found that there may be an association between the use of COCs and an increased risk of arterial and venous thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These diseases are extremely rare.
  • The use of any COC is associated with an increased risk of venous thromboembolism (VTE), manifested as deep vein thrombosis and/or pulmonary embolism. The risk is higher in the first year of use than in women taking COCs for more than 1 year.
  • Some epidemiological studies show that women who have taken low-dose COCs containing third-generation progestogens, including desogestrel, have an increased risk of VTE compared with those women who have taken low-dose COCs containing the progestogen levonorgestrel.
  • Very rarely, thrombosis occurs in other blood vessels (for example, in the veins and arteries of the liver, mesentery, kidneys, brain, or retina). There is no single point of view whether this thrombosis is a consequence of the use of COCs.
  • An increase in the frequency and intensity of migraines while taking the drug Mercilon ® (which may be a sign of cerebrovascular disorders) may serve as a basis for immediate discontinuation of the drug. Tumors
  • The most important risk factor for developing cervical cancer is the persistence of human papillomavirus (HPV) infection. Epidemiological studies have shown an increased risk of cervical cancer in women who use COCs for a long time, however, there is still uncertainty about the degree to which these data are influenced by the confounding of various factors, such as an increase in cervical screening examinations and differences in sexual behavior, including the use of barrier methods. contraception, or their relationship.
  • There is evidence that there is a slight increase in the relative risk (1.24) of developing breast cancer in women using COCs. The increased risk gradually decreases within 10 years after the withdrawal of COCs. Since breast cancer is rare in women under 40 years of age, the increase in the likelihood of developing breast cancer in women who currently use COCs or have recently stopped using them is small relative to the baseline likelihood of developing cancer. These studies do not provide data on the etiology of cancer. The increased risk of breast cancer can be explained both by the fact that in women taking COCs, the diagnosis of breast cancer is established earlier, and by the biological effects of COCs, or a combination of both of these factors. There is a trend that women who have ever taken COCs have less clinically advanced breast cancer than women who have never taken COCs.
  • Very rarely, when using the drug Mercilon ®, cases of the development of benign, and even more rarely, malignant tumors of the liver were observed.
    In some cases, these tumors have led to life-threatening intra-abdominal bleeding. The physician should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking Mercilon ® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.
    Other diseases
  • If hypertriglyceridemia is diagnosed in a woman or her family members, then the risk of pancreatitis may increase when taking the drug Mercilon ® .
  • If a woman using Mercilon ® develops persistent clinically significant arterial hypertension, the physician should discontinue Mercilon ® and prescribe treatment for hypertension. In cases where antihypertensive therapy can achieve normal blood pressure values, 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; gallbladder stones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema develop or worsen both during pregnancy and when taking Mercilon ® , however, the evidence for this in terms of taking Mercilon ® is inconclusive.
  • Acute or chronic disorders of liver function may serve as a basis for discontinuation of the drug Mercilon ® until the indicators of liver function are normal. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex steroid preparations, requires discontinuation of Mercilon®.
  • Although the drug Mercilon ® may affect the tolerance of peripheral tissues to insulin and glucose, there is no evidence that patients with diabetes need to change the therapeutic regimen for taking low-dose COCs (containing less than 0.05 mg of ethinyl estradiol). In any case, women with diabetes mellitus should be carefully monitored by a doctor while taking the drug Mercilon ® .
  • There is evidence that there is an association between COC use and Crohn's disease and ulcerative colitis.
  • Sometimes when taking the drug Mercilon ®, pigmentation of the skin of the face (chloasma) can be observed, especially if it was earlier during pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and ultraviolet irradiation from other sources while taking Mercilon ® .
    Medical examinations/consultations
    Before starting or resuming the use of the drug Mercilon ® in a woman, it is necessary to collect a detailed medical history (including family history) and conduct a thorough examination. Need to be measured arterial pressure and if clinically significant signs are identified, a physical examination should be performed, guided by contraindications and warnings. The woman should be instructed to carefully read these instructions for use and follow the recommendations. The frequency and list of examinations should be based on generally accepted practice and selected individually for each woman (but not less than 1 time in 6 months).
    Women should be advised that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted infections.
    Reduced efficiency
    The effectiveness of the drug Mercilon ® may decrease in case of skipping the dose of the drug, gastrointestinal disorders or concomitant use of certain drugs (see section "Interaction with other drugs").
    Irregular spotting
    When taking the drug Mercilon ® , especially in the first months of use, irregular spotting or profuse spotting may occur. Therefore, an assessment of irregular bleeding should be carried out only after the end of the adaptation period, lasting three months.
    If irregular bleeding persists or appears after previous regular cycles, possible non-hormonal causes of cycle disturbance should be considered and appropriate studies should be carried out to rule out malignant neoplasms or pregnancy. These measures may include diagnostic curettage.
    Some women may not experience menstrual bleeding between doses. If the drug Mercilon ® was taken according to the recommendations above, the likelihood that a woman is pregnant is low. Otherwise, or if there is no bleeding twice in a row, you should exclude the possibility of pregnancy and consult a doctor.
    Laboratory research
    Oral contraceptives may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma transport proteins, for example, corticosteroid-binding globulin and lipid / lipoprotein fractions, parameters of carbohydrate metabolism, parameters of coagulation and fibrinolysis. Usually these changes are within the normal range of laboratory parameters.
    Lactose
    Each tablet of Mercilon ® contains less than 80 mg of lactose. Women with rare hereditary disorders, such as lactose intolerance, lactase deficiency, glucose-galactose malabsorption, who follow a lactose-free diet, should take into account the lactose content of Mercilon®.

    Influence on the ability to drive a car and other mechanisms
    The influence of the drug Mercilon ® on the ability to drive a car and work with mechanisms was not noted.

    Release form

    Tablets 150 mcg + 20 mcg. 21 tablets in a PVC/Al blister. Each blister is packed in a hermetically sealed sachet made of laminated aluminum foil. 1, 3 or 6 sachets, together with instructions for use, are placed in a cardboard box.

    Storage conditions

    Store at a temperature of 2 to 30 ° C in a dry, dark place.
    Keep out of the reach of children.

    Best before date

    3 years
    Do not use after the expiration date.

    Holiday conditions

    On prescription.

    RU owner

    Manufacturer

    Manufactured/Released Quality Control:
    N.V. Organon, Oss, Netherlands
    N.V. Organon, Kloosterstraat 6.5349 AB Oss, the Netherlands

    Consumer complaints should be directed to
    OOO MSD Pharmaceuticals
    st. Pavlovskaya, d. 7, building 1
    Moscow, Russia, 115093

    The information on the page was verified by the therapist Vasilyeva E.I.

  • pharmachologic effect

    Combined contraceptive drug containing estrogen and progestin. The contraceptive effect of Marvelon, like other combined oral contraceptives (CPC), is based primarily on the ability to suppress ovulation and increase the secretion of cervical mucus.

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

    Ethinylestradiol is a synthetic analogue of the follicular hormone estradiol, together with the corpus luteum hormone, regulates the menstrual cycle.

    Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to an increase in the viscosity of the mucus in the cervix, which makes it relatively impassable for spermatozoa.

    In addition to contraceptive properties, Mercilon ® has a number of effects that can be taken into account when choosing a contraceptive method. Menstrual-like reactions become more regular, less painful and are accompanied by less severe bleeding. The latter circumstance leads to a decrease in the frequency of concomitant iron deficiency anemia. The use of COCs has been shown to reduce the risk of developing ovarian and endometrial cancer.

    Pharmacokinetics

    Desogestrel

    Suction

    Orally administered desogestrel is rapidly and completely absorbed and converted to etonogestrel. The peak serum concentration is approximately 2 mg / ml and is reached approximately 1.5 hours after a single dose. Bioavailability is 62-81%.

    Distribution

    Etonogestrel binds to serum albumin and sex hormone-binding globulin (SHBG). Only 2-4% of the total drug serum concentration is present as the free steroid, and 40-70% is specifically bound to SHBG. The increase in SHBG induced by this nilestradiol affects the distribution between serum proteins, causing an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction. The estimated volume of distribution of desogestrel is 1.5 L/kg.

    Metabolism

    Etonogestrel is completely metabolized by known pathways of steroid metabolism. The rate of metabolic clearance from serum is about 2 ml/min/kg. No interaction was found with ethinyl estradiol administered simultaneously. breeding

    Serum levels of zonogestrel decrease in two phases. Distribution in the final phase is characterized by a half-life of about 30 hours. Desogestrel and its metabolites are excreted in the urine and bile in a ratio of approximately 6:4.

    Balance state

    The pharmacokinetics of etonogestrel is affected by the level of SHBG, which increases three-fold under the influence of ethinyl estradiol. After daily administration, 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

    Suction

    When administered orally, ethinylestradiol is rapidly and completely absorbed. The peak serum concentration of about 80 pg / ml is reached within 1-2 hours. Absolute bioavailability as a result of presystemic conjugation and the first stage of metabolism is approximately 60%.

    Distribution

    Ethinylestradiol is strongly but not specifically bound to serum albumin (approximately 98.5%) and causes an increase in serum SHBG concentration. It is determined that the apparent volume of distribution is about 5 l/kg.

    Metabolism

    Ethiiylestradiol is subject to presystemic conjugation both in the small intestine mucosa and in the liver. Ethinylestradiol is first metabolized by aromatic hydroxylation, but this produces a wide variety of hydroxylated and methylated metabolites, and they are present as free metabolites and as conjugates with glucuronides and sulfates. The rate of metabolic clearance is about 5 ml/min/kg.

    breeding

    The serum level of ethinylestradiol decreases in two phases, the distribution in the final phase is characterized by an elimination half-life of about 24 hours. The unchanged drug is not excreted, ethinylestradiol metabolites are excreted in the urine and bile in a ratio of 4:6. The half-life of the metabolite is about 1 day.

    Balance state

    Steady-state concentrations are reached after 3-4 days, when the serum level of the drug is 30-40% higher compared to a single dose.

    Preclinical safety data

    To assess the risk to humans, animal toxicity studies have been conducted for both components of the drug - ethinylestradiol and desogestrel - and for their combination. In a systematic study of tolerability with repeated administration of drugs, no effects were found that could indicate an unexpected risk to humans. In studies of long-term toxicity with repeated doses, no oncogenic potential has been identified. 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 the evaluation of the effect of both components on the fertility of breeding animals, fetal development, lactation and the ability to reproduce in offspring did not indicate the possibility of a risk of adverse effects in humans after using the recommended doses of drugs.

    No indications of mutagenic potential have been obtained from in vitro and in vivo studies.

    Indications

    - contraception.

    Dosing regimen

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

    Take 1 tablet / day for 21 days. Taking tablets from the next package should be started 7 days after the end of the previous one. During these 7 days, menstrual bleeding occurs. It usually starts 2-3 days after taking the last pill and may not stop until the next pack is taken.

    How to start taking Mercilon ®

    If hormonal contraceptives have not been used within the last month, then the drug should be started on the 1st 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.

    Switching from combined hormonal contraceptives (CHC, vaginal ring, or transdermal patch): it is advisable to start taking Mercilon ® the next day after taking the last active tablet of the previously used drug (the last tablet containing active substances), but no later than the next day after the end of the usual break in taking the tablets or the next day after taking the last tablet that do not contain hormones. In the case of using a vaginal ring or transdermal patch, it is advisable to start taking Mercilon ® on the day of their removal, but no later than the day when a 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 the woman is not pregnant, then the woman can switch to Mercilon ® on any day of the cycle. It should be borne in mind that the usual interval in the use of the previous method of contraception should not exceed its recommended duration.

    Switching from drugs containing only progestogen("mini-pill", injection, implant) or with a progestogen-releasing intrauterine system (IUD). A woman taking mini-drinks can switch to Marvelon any day; using an implant or IUD - on the day of their removal; using the drug in the form of injections - on the day when the next injection is due, in all cases, during the first 7 days of taking the drug Mercilon ®, it is recommended to use additional methods of contraception.

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

    After childbirth or an abortion in the second trimester, it is recommended to start taking the drug no earlier than 21-28 days after childbirth or an abortion made in the second trimester of pregnancy. If you start taking the drug at a later date, it is recommended to use barrier methods of contraception during the first 7 days of taking Mercilon®. In any case, if a woman after childbirth or abortion before taking Mercilon ® has already had sexual contacts, pregnancy should be excluded before starting the drug or wait until the first menstruation.

    In case of missing the next dose of the drug

    less than 12 hours the reliability of contraception is not reduced. The woman should take the pill as soon as she remembers, and take subsequent pills at the usual time.

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

    1. pills should never be interrupted for more than 7 days;

    2. For adequate suppression of the hypothalamic-pituitary-ovarian system, it is necessary to take pills for 7 days in a row.

    The cycle of taking the drug implies 3 weeks of use. Therefore, the following recommendations can be made.

    Week 1. A woman should take the missed pill as soon as she remembers it, even if it means taking 2 pills at the same time. Then you should continue taking the usual scheme. In addition, you should use a barrier method of contraception 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 tablets missed, and the closer the break in taking the drug to the time of sexual intercourse, the higher the risk of pregnancy.

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

    Week 3. The reliability of contraception may be reduced due to a subsequent interruption in taking the drug. This can be avoided by adapting the dosage regimen. If either of the following two regimens is used, there is no need to use additional contraceptive measures, provided that the woman has taken the pills on time in the 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 for the next 7 days.

    1. A woman should take the missed pill as soon as she remembers it, even if it means taking 2 pills at the same time. Then you should continue taking the usual scheme. A new pack should be started as soon as the current pack ends, i.e. do not take a break between packs. There is little chance of withdrawal bleeding before the end of the second pack, but some people may experience spotting or heavy bleeding even while taking the drug.

    2. It may be recommended to stop taking the drug from the current package. A woman should take a break from taking Mercilon ® for no more than 7 days, including days when she forgot to take the pills, and then start a new package.

    If you skip taking the drug and the subsequent absence of withdrawal bleeding in the next break in taking the tablets, the possibility of pregnancy should be considered.

    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 regarding skipping the next dose of the drug. If a woman does not want to change her usual dosage regimen, she needs to take an additional tablet(s) from a different package (the number of additional tablets is determined at a visit to the ob-gyn.

    How to change the timing of your period

    In order to delay menstruation, you should continue taking tablets from another package of Mercilon ® without the usual break in taking. You can delay menstruation for any period until the end of the tab. from the second package. During this period, a woman may experience spotting or profuse spotting. Taking the drug according to the usual scheme should be resumed after a 7-day interval in taking.

    In order to shift your period to a day of the week other than what you would expect from your normal dosing schedule, you can shorten your usual dosing break by as many days as needed. The shorter the break, the higher the risk of missing periods during the break and the occurrence of heavy or spotting bleeding while taking the drug from the second package.

    Side effect

    From the side of cardio-vascular system: thrombosis or thromboembolism (including myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism) thromboembolism of the hepatic, mesenteric, renal arteries and veins, retinal arteries); increase in blood pressure.

    Hormone dependent tumors: liver tumors, breast cancer.

    From the side skin: chloasma (especially if there is a history of chloasma during pregnancy).

    From the reproductive system: acyclic spotting more often in the first months of admission.

    Others: allergic reactions.

    Side effects that were observed when taking the drug Mercilon ® , but the relationship of which with the drug has not been proven

    Often
    (≥ 1/100)
    Infrequently
    (≥1/1000-<1/100)
    Rarely (< 1/1000)
    From the side of the immune system
    hypersensitivity
    From the side of metabolism and nutrition
    weight gainfluid retentionweight loss
    From the side of the nervous system
    depression
    change of mood
    headache
    migraine
    decreased libido
    increased libido
    From the organ of vision
    contact lens intolerance
    From the digestive system
    nausea
    abdominal pain
    vomit
    From the skin and subcutaneous tissues
    skin rash, hiveserythema nodosum
    erythema multiforme
    From the reproductive system
    soreness of the mammary glands
    breast enlargementvaginal discharge
    secretions from the mammary glands

    Contraindications for use

    - the presence at the moment or in the anamnesis of venous thrombosis (including deep vein thrombosis of the lower leg, pulmonary embolism);

    - the presence or history of arterial thrombosis (including myocardial infarction, stroke) or precursors of thrombosis (including a transient attack of coronary artery disease, angina pectoris) at the moment or in history.

    - Identified predisposition to venous or arterial thrombosis, including resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anti-cardiolipin antibodies, lupus anticoagulant);

    - migraine with focal neurological symptoms in history;

    - diabetes mellitus with vascular damage;

    - the presence of severe or multiple risk factors for venous or arterial thrombosis (including arterial hypertension with blood pressure of 160/100 mm Hg and above);

    - pancreatitis (including history), accompanied by severe hypertriglyceridemia;

    - severe liver disease (before normalization of liver function indicators), incl. in history;

    - liver tumors (benign and malignant), incl. in history;

    - hormone-dependent malignant neoplasms of the genital organs or mammary glands (including suspected ones);

    - bleeding from the vagina of unknown etiology;

    - smoking over the age of 35 (more than 15 cigarettes per day);

    - pregnancy (including intended);

    - lactation period;

    - lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

    - Hypersensitivity to the components of the drug.

    If any of the diseases (conditions) listed above occur during the use of the drug Mercilon ® (as well as other COCs), you should immediately stop taking the drug.

    Carefully

    If any of the conditions / risk factors listed below are currently present, then the potential risk and the expected benefit of using Mercilon ® should be carefully weighed in each individual case:

    - age over 35 years;

    - smoking;

    - the 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 / m 2);

    - dyslipoproteinemia;

    - arterial hypertension;

    - migraine;

    - valvular heart disease;

    - atrial fibrillation;

    - prolonged immobilization, extensive surgery, surgery on the lower extremities, severe trauma (with prolonged immobilization and the above surgical interventions, it is recommended to stop using the drug, for planned surgical interventions no later than 4 weeks before surgery, and not resume taking within 2 weeks after complete remobilization);

    - varicose veins, superficial thrombophlebitis (at the moment there is no unambiguous opinion about the possible role of these conditions in the etiology of venous thromboembolism);

    - 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 III deficiency, 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 family history);

    - acute and chronic liver diseases, incl. congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndrome).

    Use during pregnancy and lactation

    The use of Mercilon ® during pregnancy is contraindicated. If pregnancy occurs during the use of Mercilon, the drug should be discontinued. It should be noted that extensive epidemiological studies have not found an increased risk of having children with birth defects in women who took COCs before pregnancy, or a teratogenic effect with inadvertent use of COCs at the beginning of pregnancy.

    Mercilon ® may affect lactation, because. PDAs reduce the amount and change the composition of breast milk. Therefore, Mercilon ® is not recommended for use until the nursing mother completely stops breastfeeding. A small amount of contraceptive steroids and / or their metabolic products can be excreted in breast milk.

    Overdose

    Symptoms: possible nausea, vomiting, in young girls - bloody discharge from the vagina. There were no serious complications with an overdose of Mercilon ®.

    Treatment: conducting symptomatic therapy. There are no antidotes.

    drug interaction

    Interactions between oral contraceptives and other medicinal products may lead to acyclic bleeding and/or decreased effectiveness of contraceptives. The following interaction is described in the literature.

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

    Also, a violation of the contraceptive effect was reported when taking Mercilon ® with antibiotics such as ampicillin and tetracyclines. The mechanism of this influence is not clear.

    Women who are taking any of the above drugs should temporarily use an additional method of barrier contraception or choose another method of contraception. With the simultaneous use of microsomal enzyme inducers, the barrier method of contraception should be used throughout the course of treatment and for 28 days after stopping treatment. In the case of long-term treatment with the use of microsomal enzyme inducers, another method of contraception should be used. While taking antibiotics (with the exception of rifampicin and griseofulvin, which are inducers of microsomal enzymes), it is necessary to use a barrier method of contraception throughout the course of treatment and for 7 days after the end of therapy. If the period during which a barrier method of contraception is used continues after the end of the tablets in the PDA pack, then the next pack of the drug should be started without the usual interval in taking.

    Oral contraceptives can affect the metabolism of other drugs and, accordingly, change their plasma and tissue concentrations: increase (for example, cyclosporine) or decrease (lamotrigine).

    With the concomitant use of other drugs to determine the possible interaction, it is necessary to use the instructions for the medical use of these drugs.

    Terms of dispensing from pharmacies

    The drug is dispensed by prescription.

    Terms and conditions of storage

    The drug should be stored out of the reach of children, dry, dark place at a temperature of 2° to 30°C. Shelf life - 3 years.

    Application for violations of liver function

    The drug is contraindicated in serious illnesses liver, with liver tumors (benign and malignant), incl. in history.

    With caution: acute and chronic liver diseases, incl. congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndrome).

    Use in elderly patients

    Not applicable.

    special instructions

    If you have any of the conditions or risk factors listed below, you should carefully weigh the benefits and the possible risk of taking the drug Mercilon ®. This issue should be discussed with the patient before starting the drug. In case of exacerbation of diseases, worsening of the condition or the appearance of the first symptoms of these conditions or risk factors, the patient should immediately consult a doctor. The question of drug withdrawal is decided by the doctor individually.

    Vascular diseases

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

    The use of any COC 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 use than in women taking COCs for more than 1 year.

    Some epidemiological studies show that women who take low-dose COCs containing progestogens III generation, including desogestrel, have an increased risk of VTE compared with those women who took low-dose COCs containing the progestogen levonorgestrel.

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

    An increase in the frequency and intensity of migraines while taking the drug Mercilon ® (which may be a sign of cerebrovascular disorders) may serve as a basis for immediate discontinuation of the drug.

    Tumors

    The most important risk factor for developing cervical cancer is the persistence of human papillomavirus (HPV) infection. Some epidemiological studies have noted an increased risk of cervical cancer in women taking long-term COCs, but so far there is controversy regarding the degree to which these data are confounded by various factors, such as cervical screening and sexual behavior, including the use of barrier methods of contraception, or their relationships.

    There is evidence that there is a slight increase in the relative risk (1.24) of developing breast cancer in women using COCs. The increased risk gradually decreases within 10 years after the withdrawal of COCs. Because breast cancer in women under 40 years of age is quite rare, the increase in the likelihood of developing breast cancer in women receiving COCs currently or who have recently stopped using them is small relative to the initial probability of developing cancer. These studies do not provide data on the etiology of cancer. The increased risk of breast cancer can be explained both by the earlier diagnosis of breast cancer in women taking COCs, and by the biological effects of COCs, or a combination of both.
    There is a trend that women who have ever taken COCs have less clinically advanced breast cancer than women who have never taken COCs.

    Very rarely, when using the drug Mercilon ®, cases of the development of benign, and even more rarely, malignant tumors of the liver were observed. In some cases, these tumors have led to life-threatening intra-abdominal bleeding. The physician should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman receiving Mercilon ® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

    Other diseases

    If hypertriglyceridemia is diagnosed in a woman or her family members, then the risk of pancreatitis may increase when taking the drug Mercilon ® .

    If a woman receiving Mercilon ® develops persistent clinically significant hypertension, the doctor should stop Mercilon ® and prescribe treatment for hypertension. In cases where with
    antihypertensive therapy achieves normal blood pressure values, 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; gallbladder stones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema develop or worsen
    both during pregnancy and when taking the drug Mercilon ® , however, the evidence regarding the use of the drug Mercilon ® is inconclusive.

    Acute or chronic disorders of liver function may serve as a basis for discontinuation of the drug Mercilon ® until the indicators of liver function are normal. Recurrence of cholestatic jaundice, observed earlier during pregnancy or when using sex steroid preparations, requires discontinuation of Mercilon®.

    Although Mercilon ® may affect the tolerance of peripheral tissues to insulin and glucose, there is no evidence that patients with diabetes need to change the therapeutic regimen for taking low-dose COCs.
    (containing less than 50 micrograms of ethinyl estradiol). In any case, while taking the drug Mercilon ® patients with diabetes mellitus need careful medical monitoring.

    There is evidence of an association between COC use and Crohn's disease and ulcerative colitis.

    Sometimes when taking the drug Mercilon ®, pigmentation of the skin of the face (chloasma) can be observed, especially if it was earlier during pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and
    UV exposure from other sources while taking the drug Mercilon ® .

    Medical examinations/consultations

    Before starting or resuming the use of the drug Mercilon ®, the doctor should take a detailed medical history (including family history) and conduct a thorough examination. It is necessary to measure blood pressure and, if clinically significant signs are detected, a physical examination should be performed, guided by contraindications and warnings. The woman should be instructed to carefully read these instructions for use of the drug and follow the recommendations. The frequency and list of examinations should be based on generally accepted practice and selected individually for each woman (but not less than 1 time in 6 months).

    Women should be advised that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted infections.

    Reduced efficiency

    The effectiveness of the drug Mercilon ® may decrease in case of skipping the dose of the drug, gastrointestinal disorders or concomitant use of certain drugs.

    Irregular spotting

    When taking the drug Mercilon ® , especially in the first months of use, irregular spotting or profuse spotting may occur. Therefore, an assessment of irregular bleeding should be carried out only after the end of the adaptation period, lasting 3 months.

    If irregular bleeding persists or appears after previous regular cycles, possible non-hormonal causes of cycle disturbance should be considered and appropriate studies should be carried out to rule out malignant neoplasms or pregnancy. These measures may include diagnostic curettage.

    Some women may not experience menstrual bleeding between doses. If the drug Mercilon ® was taken according to the above recommendations, the likelihood of pregnancy is low. Otherwise, or if there is no bleeding 2 times in a row, the possibility of pregnancy should be excluded.

    Laboratory research

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

    Lactose

    Each tablet of Mercilon ® contains less than 80 mg of lactose. Women with rare hereditary disorders, such as lactose intolerance, lactase deficiency, glucose-galactose malabsorption, who follow a lactose-free diet, should take into account the lactose content of Mercilon®.

    Influence on the ability to drive vehicles and control mechanisms

    The effect of the drug Mercilon ® on the ability to drive vehicles and work with mechanisms was not noted.

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