Mersilon

Mersilon – the monophase COC (the combined oral contraceptive) suppressing an ovulation and increasing secretion of cervical slime.

Form of release and structure

Dosage form of Mersilon – a tablet: biconvex, round, white color, on one of the parties an engraving of "TR" over figure "4", on other party – the image of a five-pointed star and a text of "ORGANON" (on 21 pieces in the blister from PVC/aluminium, each blister is hermetically soldered in a sachet from the aluminum laminated foil; 1, 3 or 6 sachets (respectively 21, 63 or 126 tablets) in a cardboard pack).

Contain in 1 tablet:

• Active ingredients: dezogestret – 0,15 mg, ethinylestradiol – 0,02 mg;
• Auxiliary components: povidone, potato starch, stearic acid, α-tocopherol, silicon dioxide colloid, lactoses monohydrate.

Indications to use

Mersilon accept for contraception (for the purpose of protection from undesirable pregnancy).

Contraindications

Absolute:

• Venous thrombosis, including the thromboembolism of a pulmonary artery and a deep vein thrombosis of a shin (diagnosed at present or existence of data in the anamnesis);
• Arterial thrombosis (including a stroke, a myocardial infarction) or thrombosis harbingers (stenocardia, the tranzitorny ischemic attack) (diagnosed at present or existence of data in the anamnesis);
• Predisposition to arterial or venous thrombosis: a gipergomotsisteinemiya, resistance to the activated protein With, deficit of a protein With, deficit of antithrombin III, deficit of a protein of S, anti-phospholipidic antibodies (lupoid anticoagulant, antibodies to cardiolipin);
• Migraine (in the presence of data on focal neurologic symptomatology in the anamnesis);
• Diabetes mellitus with a mikroangiopatiya (defeat of vessels);
• Multiple or heavy risk factors of arterial or venous thrombosis, including arterial hypertension with the arterial pressure (AP) of 160/100 mm of mercury. and more;
• The pancreatitis which is followed by the expressed GTG (gipertriglitseridemiy) including data in the anamnesis;
• Damages of a liver of heavy degree, including data in the anamnesis (before normalization and recovery of functions of a liver);
• Liver tumors (malignant and high-quality), including data in the anamnesis;
• Malignant hormonedependent tumors of mammary glands or generative organs (including suspects);
• Lactose intolerance, lactose intolerance, glyukozo-galaktozny malabsorption;
• Vulval bleedings of the obscure etiology;
• Smoking after 35 years in number of 15 cigarettes a day and more;
• The pregnancy period (including assumed);
• Lactation (breastfeeding period);
• Hypersensitivity to active ingredients or to any auxiliary component of the CPC.

In case of any of diseases/states against the background of therapy by Mersilon it is required to stop its use immediately.

Relative (at any following states / diseases Mersilon's reception is allowed with care, after careful assessment of a ratio of potential risk and the expected advantage):

• Hypertension;
• Lipidemia;
• Anemia is drepanocytic;
• Migraine;
• The valve (acquired) heart diseases;
• Ciliary arrhythmia;
• Diabetes mellitus;
• SLE (system lupus erythematosus);
• Gasser's disease (gemolitiko-uraemic syndrome);
• Superficial thrombophlebitis, varicosity;
• Data on thromboembolic diseases in the family anamnesis (arterial or venous thrombosis / thromboembolism at parents, sisters, brothers at rather early age);
• Changes of biochemical indicators, such as resistance to the activated protein With, the deficit of antithrombin III, a gipergomotsisteinemiya, deficit of proteins of C and S, anti-phospholipidic antibodies (lupoid anticoagulant, antibodies to cardiolipin) indicating the inborn or acquired predisposition to arterial or venous thrombosis;
• Chronic inflammatory diseases of intestines (disease Krone and nonspecific ulcer colitis);
• Gipertriglitseridemiya (including data in the family anamnesis);
• Chronic diseases of a liver, including inborn hyperbilirubinemias – syndromes the Cudgel Johnson, Gilbert, the Rotor;
• Obesity (index ^{of body weight more than 30 kg/sq.m});
• Smoking;
• Puerperal period;
• The age is more senior than 35 years.

At a long immobilization, extensive surgical interventions (especially on the lower extremities), severe injuries it is recommended to stop Mersilon's use, in case of the planned operations not later than in 4 weeks and not to resume reception for 2 weeks after a remobilization.

Route of administration and dosage

Pill is taken inside, observing the order specified on packaging every day approximately in at one time, in case of need washing down with water in a small amount.

Dosing mode: 1 tablet a day for 3 weeks.

Pill from the following packaging begins to be taken 1 week of a break in which there passes the menstrualnopodobny bleeding beginning usually in 1-2 days after reception of the last tablet later; bleeding can proceed prior to reception of the following packaging.

The beginning of administration of drug Mersilon, depending on the previous ways of contraception or a condition of the woman:

• Hormonal contraceptives were not applied for the last month and more: a pill begins to be taken in 1 day of a menstrual cycle; reception of the first tablet for 2-5 day from the beginning of a menstrual cycle is allowed, but at the same time within the first week of reception of tablets in the first cycle in addition it is necessary to use a non-hormonal method of protection;
• CHC (the combined hormonal contraceptives): peroral dosage forms – Mersilon's use after reception of the last active tablet of the previous drug is desirable to begin next day, but no later than next day after the termination of a usual break in reception of tablets (next day after reception of the last tablet which is not containing hormones); a transdermalny plaster or a vaginal ring – it is desirable to begin to take a pill in day of removal of a plaster or ring, but not later than day when the next application of a plaster has to be made or the new ring is entered;
• The monodrugs containing only a gestagenny component – "mini-drank", injections, an implant, the progestagen-releasing intrauterine system (Naval Forces): with "mini-drank" on Mersilon it is possible to pass in any day; from an implant or Naval Forces – in day of their removal; from injections – in day of the next injection. In all cases for the first week of reception it is necessary to apply additional ways of protection;
• The abortion made in the I trimester: it is recommended to begin reception of the CPC at once, it is not necessary to use additional methods of contraception;
• The abortion made in the II trimester or childbirth: it is necessary to begin administration of drug on 3-4 week after abortion or childbirth; in case of the beginning of inclusion in later terms, for the first week it is necessary to apply in addition barrier ways of contraception; if before Mersilon's use for the woman after abortion or childbirth there were already sexual contacts, it is required to exclude existence of pregnancy prior to reception, or to wait the first menstrual bleeding.

Reliability of contraception does not decrease in case of a delay of reception of the next tablet less than for 12 hours. In such situation the woman needs to accept drug as soon as there is an opportunity, and to take the subsequent pill in usual time. If reception is detained more than for 12 hours, decrease in reliability of contraception is possible.

It is impossible to interrupt reception of tablets longer, than for 1 week. Adequate suppression гипоталамо - pituitary and ovarian system happens after reception of tablets for 1 week without breaks.

The cycle includes 3 weeks of use, for every week there are special recommendations in case of the admission of the next tablet of Mersilon.

I week. The passed pill needs to be taken as soon as the woman remembered the admission even if it will be necessary to take at the same time 2 medicines. Further reception continues according to the standard scheme. For the next week in addition it is required to use a method of barrier contraception, and in the presence of sexual contacts in the previous week it is necessary to consider a possibility of pregnancy. The risk of pregnancy of subjects is higher, than closer having rummaged in administration of drug by the time of the sexual intercourses and what more tablets are passed by.

II week. The passed pill needs to be taken as soon as the woman remembered the admission even if it will be necessary to take at the same time 2 medicines. Further reception continues according to the standard scheme. If within the week preceding the first passed dose, a pill was taken in time, there is no need to use in addition non-hormonal ways contraception. At the previous irregular reception or the admission more than 1 tablet within the next week is applied by additional measures of protection from pregnancy.

III week. Due to the subsequent break in administration of drug reliability of contraception can be reduced. If a pill was taken for the week preceding the first passed dose in time of need to use in addition non-hormonal ways there is no contraception. Otherwise it is necessary to apply one of two following schemes, and within a week to use additional measures of contraception:

1. The passed pill needs to be taken as soon as the woman remembered the admission even if it will be necessary to take at the same time 2 medicines. Further reception continues according to the standard scheme. New packaging needs to be begun at once upon termination of current, without doing between them a break. The chance of emergence of bleeding of cancellation before the end of the second packaging is small, but some women even at reception of tablets can have smearing or plentiful bloody allocations;
2. Administration of drug from the current packaging it is necessary to stop and take a break no more than 1 week, including days when the woman forgot to take a pill then to begin new packaging.

If at administration of drug there was an admission, and in the next break in reception of tablets there was no cancellation bleeding, it is necessary to consider probability of approach of pregnancy.

In case of heavy gastrointestinal frustration Mersilon's absorption can be incomplete therefore it is necessary to undertake additional measures of contraception. When developing vomiting within 3-4 hours after administration of drug, it is necessary to use recommendations about the admission of the next reception of tablets. If the woman does not want to change the usual scheme of reception, then from other packaging it is necessary to accept an additional tablet (i) in quantity which is defined by the obstetrician-gynecologist.

To delay approach of periods it is necessary to continue reception of tablets from other packaging without standard break. Duration of a delay can be any, up to the termination of tablets from the second packaging, at this time there can be smearing bloody allocations or plentiful bleedings. After a week break administration of drug should be resumed according to the usual scheme.

To shift periods the next day of week, other than the reception expected at observance of the standard scheme, it is recommended to reduce a break in reception by the number of days, necessary for shift. It is necessary to consider that than the break, that an absence high probability during this period of periods and emergence of the smearing or plentiful bloody allocations at reception of tablets from the second packaging is shorter.

Side effects

• Cardiovascular system: thrombosis or a thrombembolia (including a stroke, a myocardial infarction, a thrombembolia of a pulmonary artery, a deep vein thrombosis) a thromboembolism of arteries of a retina, mesenteric, hepatic, renal veins and arteries, increase in the ABP;
• Hormonedependent tumors: breast cancer, liver tumors;
• Integuments: a hloazma (especially in the presence in the anamnesis of a hloazma at pregnancy);
• Reproductive system: acyclic bloody allocations preferential in initial months of reception;
• Another: allergic reactions.

The side effects observed at Mersilon's reception which communication with administration of drug was not proved:

• Immune system: seldom – hypersensitivity;
• Metabolism and food: often – increase in weight; infrequently – a liquid delay; seldom – reduction of weight;
• Nervous system: often – change of mood, a depression, a headache; infrequently – decrease in a libido, migraine; seldom – increase in a libido;
• Organ of sight: seldom – intolerance of contact lenses;
• Alimentary system: often – an abdominal pain, nausea; infrequently – vomiting;
• Skin and hypodermic fabrics: infrequently – urticaria, skin rash; seldom – a mnogoformny erythema, a knotty erythema;
• Reproductive system: often – morbidity of a breast; infrequently – increase in a breast; seldom – allocations from a breast and from a vagina.

Special instructions

Existence of any of following states / factors demands careful assessment of advantages and possible risks of reception of Mersilon. It should be discussed with the doctor prior to course reception of a contraceptive. At an exacerbation of diseases, an aggravation of symptoms or in case of their first symptoms it is required to see a doctor who will resolve an issue of expediency of further use of drug immediately.

Vascular diseases
At epidemiological researches the possibility of communication between Mersilon's use and increase in risk of trombotichesky, thromboembolic arterial and venous diseases, such as a stroke, a myocardial infarction, a thrombembolia of a pulmonary artery and a deep vein thrombosis was established; these diseases extremely seldom are observed.

Use of any PDA increases risk of a venous thromboembolism (VTE) which is shown as a thromboembolism of a pulmonary artery and/or a deep vein thrombosis (in certain cases with fatal effects). The probability of diseases is higher in the first year of reception than in case drug is used more than 1 year.

As a result of some epidemiological researches it was revealed that at reception of the low-dosed PDA with the content of progestogens III of generation, including a dezogestrela, the risk of VTE is increased in comparison with reception of the low-dosed PDA with the content of progestogen of levonorgestrel.

In other blood vessels (arteries and veins of a mesentery, a liver, kidneys, a retina or a brain) of fibrinferments arises extremely seldom, and there is no consensus whether use of the CPC is the reason of its education.

In case of increase in intensity and frequency of migraines during administration of drug, Mersilon as such state can be a sign of cerebrovascular disturbances is recommended to cancel immediately.

New growths (tumor)
The most significant risk factor of formation of cancer of neck of uterus is the persistent human papillomavirus infection. In results of some epidemiological researches it was noted that the women receiving the CPC have long time, the risk of cancer of neck of uterus increases. However there are no reliable data concerning in what degree these indicators were influenced by mixing of various factors (such as sexual behavior of the woman (including use of barrier ways of contraception) and screenings of a neck of uterus) or their interrelations.

At use of the CPC slightly (to 1,24) the SHOUTING – relative risk of development of a breast cancer increases, and after cancellation the COOK it for 10 years gradually decreases. As the breast cancer, a gain of probability of its development against the background of reception of the CPC, current or recently stopped quite seldom occurs at women up to 40 years, rather basic probability of development of cancer it is insignificant. Data on cancer etiology are not provided in materials of these researches. Growth of risk of a breast cancer owing to reception of the CPC can be explained that breast cancer is diagnosed on earlier terms, and biological by influence of the CPC, or a combination of these factors.

The breast cancer at the women ever using the CPC is clinically less started, than at women, never their accepting.

Development of high-quality new growths of a liver when using drug Mersilon was observed extremely seldom, malignant tumors were even less often diagnosed, but as a result of it the intra belly bleedings posing a threat for life were in some cases noted. When carrying out differential diagnosis of diseases at the women receiving the CPC it is required to consider a possibility of existence of new growths of a liver which symptoms can be its increase, an acute pain in an upper part of a stomach or symptoms of intra belly bleeding.

Other diseases
At development of persistent, clinically significant arterial hypertension (AH) against the background of Mersilon's reception it it is necessary to cancel and begin therapy of AG. After by means of anti-hypertensive drugs it is possible to reduce pressure to normal, resuming of administration of drug is possible.

There is a probability of increase in risk of pancreatitis owing to Mersilon's reception if the gipertriglitseridemiya is diagnosed for the woman or for members of her family.

There are messages that cholelithiasis, the porphyria, Gasser's disease, a system lupus erythematosus, Sydenham's chorea, herpes of pregnant women, a hearing loss as a result of an otosclerosis, hereditary ангиоотек (NAO), an itch and/or jaundice, caused by a cholestasia, can develop or be aggravated both at pregnancy, and at Mersilon's reception, but proofs of communication of these effects using drug are unconvincing.

At acute or chronic abnormal liver functions drug withdrawal before normalization of indicators of function of a liver is required. Observed earlier (at use of sexual steroids or pregnancy) the recurrence of cholestatic jaundice is the basis for the termination of reception of Mersilon.

In spite of the fact that Mersilon is capable to influence peripheral tolerance to glucose and insulin, is not proved that at a diabetes mellitus change of the therapeutic scheme of reception low-dosed (with contents less than 50 mkg of ethinylestradiol) is required to the CPC, but such patients should be under careful medical observation.

There are data on communication of reception of the CPC with ulcer colitis and a disease Krone.

Owing to Mersilon's use the hloazma, in particular in the presence of a xanthopathy of the person can sometimes be observed earlier at pregnancy. At predisposition to a hloazma it is recommended to avoid UF-radiation and direct sunshine.

Before or resuming of reception of Mersilon the doctor should collect the full medical anamnesis, including family and to conduct careful medical examination of the patient. It is required to measure the ABP and at identification of clinically significant symptoms of hypertensia to perform physical inspection taking into account contraindications and cautions. The woman should read attentively the application instruction of Mersilon and to observe all recommendations. The list of necessary inspections and frequency of their carrying out have to be based on the standard practice, be selected individually and be carried out at least 1 time to half a year.

Oral contraceptives do not protect from a human immunodeficiency virus (VICh-SPID) and other infections, sexually transmitted.

Efficiency of contraception can decrease at the admission of administration of drug, in case of gastrointestinal frustration, or at a concomitant use of the CPC with some medicines.

Assessment of irregular bleeding should be carried out upon termination of the adaptation period which lasts 3 months as in the first months of use of Mersilon the probability of the plentiful bloody or irregular smearing allocations is high.

When irregular bleedings proceed or develop after the previous established cycles, it is necessary to consider a possibility of non-hormonal causes of infringement of a cycle and for the purpose of an exception of pregnancy or malignant new growths to conduct adequate researches (including a diagnostic scraping).

In the absence of menstrualnopodobny bleeding in a break between reception of tablets if all provided recommendations were observed, the probability of pregnancy is insignificant. If bleeding is absent the second time in a row, or recommendations about administration of drug were violated, it is required to exclude a possibility of pregnancy.

PDA exert impact on results of the next laboratory researches: content in plasma of transport proteins (for example, fractions of lipids/lipoproteins and kortikosteroidsvyazyvayushchy globulin), parameters of coagulation, fibrinolysis and carbohydrate metabolism, biochemical indicators of function of a thyroid gland, kidneys, adrenal glands and liver. Usually sizes of changes do not go beyond normal laboratory indicators.

Contains in one tablet of Mersilon less than 80 mg of lactose, but in case of rare inherited disorders, such as a lactose intolerance, a lactose intolerance, glyukozo-galaktozny malabsorption, availability of lactose in drug it is necessary to consider.

Medicinal interaction

For the accounting of possible interaction of Mersilon with other medicinal substances / means, in case of need their combined use, it is necessary to see consultation the attending physician.

Terms and storage conditions

To store in the dry, dark place, at a temperature not above 2-30 °C. To protect from children.

Period of validity – 3 years.