Marvelon

Marvelon – the combined monophase contraceptive drug.

Form of release and structure

Dosage form – tablets: a round biconvex form, white color, with an engraving on both parties: on one party a text of "ORGANON" with the image of a five-pointed star, on another – "TR" over figure "5" (on 21 pieces in blisters, in a sachet from aluminum foil 1, 3 or 6 of blisters, in a cardboard pack of 1 sachet).

Content of active agents is to 1 tablet of Marvelon:

• Dezogestrel – 0,15 mg;
• Ethinylestradiol – 0,03 mg.

Auxiliary components: lactoses monohydrate, stearic acid, povidone, silicon dioxide colloid, alpha tocopherol, potato starch.

Indications to use

Marvelon's use is shown to women of childbearing age for peroral contraception.

Contraindications

• Stenocardia, tranzitorny attack of coronary heart disease and other harbingers of thrombosis;
• Arterial or venous thrombosis and/or thromboembolism, including a pulmonary embolism, a deep vein thrombosis, a stroke, a myocardial infarction (including in the anamnesis);
• Migraine with focal neurologic symptomatology in the anamnesis;
• Heavy or multiple factors of risk of arterial or venous thrombosis, including arterial hypertension with the arterial pressure (AP) of 160/100 mm of a mercury column above;
• The expressed liver diseases, including the anamnesis (until a complete recovery of functional indicators of a liver);
• The pancreatitis proceeding with the expressed gipertriglitseridemiya (including the anamnesis);
• Benign and malignant tumors of a liver, including the anamnesis;
• The diabetes mellitus complicated by defeat of vessels;
• Vaginal bleeding of an unspecified etiology;
• Hormonedependent malignant new growths of mammary glands and generative organs, or suspicion on them;
• Glyukozo-galaktozny malabsorption, lactose intolerance, deficit of lactase;
• Breastfeeding period;
• Pregnancy or suspicion on it;
• Smoking more than 15 cigarettes in day is aged more senior than 35 years;
• Hypersensitivity to drug components.

If the specified pathologies for the first time arose during Marvelon's use – it is necessary to cancel administration of drug immediately.

With care, having weighed the expected individual effect and potential risk of use of peroral contraception, it is necessary to accept drug to women aged 35 years are more senior; during the smoking, existence of thromboembolic diseases in the family anamnesis in rather early age (at parents, brothers or sisters), dislipoproteinemiya, obesity (an index ^{of body weight more than 30 kg/sq.m}); arterial hypertension, valve heart diseases, migraine, fibrillation of auricles, a varicosity, superficial thrombophlebitis, a long immobilization after extensive surgical intervention, the lower extremity operation or a severe injury (it is necessary to stop use of drug in 4 weeks prior to planned operation, and to resume reception after a full remobilization within 2 weeks), a diabetes mellitus, a gemolitiko-uraemic syndrome, a system lupus erythematosus, a sickemia, acute and chronic diseases of a liver (including inborn hyperbilirubinemias, such as Gilbert's syndrome, the Rotor, Dabin-Johnson), gipertriglitseridemiya (including the family anamnesis), chronic inflammatory pathologies of intestines (ulcer colitis or a disease Krone), change of biochemical indicators (including a gipergomotsisteinemiya, resistance to the activated protein of C, deficit of antithrombin III, deficit of a protein of C, deficit of a protein of S, anti-phospholipidic antibodies (including antibodies to cardiolipin), lupoid anticoagulant); in a puerperal period.

Route of administration and dosage

Pill is taken inside, washing down with enough water.

The mode of dosing provides reception of 1 tablet of 1 times a day always in at one time within 21 days, strictly following the specified priority order on the blister. Then there comes the seven-day break in reception of tablets for which 2-3 day at the woman menstrualnopodobny bleeding begins. Reception of tablets from the following blister is begun in 7 days after previous at the scheduled time even if the periods did not stop.

In the absence of peroral contraception last month it is necessary to begin administration of drug in 1 day of a menstrual cycle. In case of the beginning of reception of tablets from 2 to 5 day of a menstrual cycle it is necessary to use in addition the first 7 days of the first cycle barrier methods of contraception.

Upon transition from other combined hormonal contraceptive Marvelon's reception needs to be begun next day after the last active tablet of the previous drug, but no later than the last tablet which is not containing hormones or the provided seven-day break.

Upon transition from a transdermalny plaster or a vaginal ring administration of drug should be begun in day of their removal, but no later than alleged following application or introduction of a new ring.

Upon transition from drugs mini-drank tablets it is possible to begin to accept in any day of a menstrual cycle, from the progestagen-releasing intrauterine system or an implant – in day of their removal, from injection contraception – in day of another procedure. Each of the specified transitions has to be followed by use of an additional barrier method of contraception during the first 7 days.

After abortion in the I trimester reception of tablets should be begun in day of operation without use of additional contraception.

After abortion in the II trimester or childbirth use of drug is recommended to be begun not earlier than in 21-28 days. If reception is begun during later period, the first 7 days it is necessary to use not oral contraceptives in addition. If during the period after abortion or childbirth the woman had sexual contacts, prior to Marvelon's use it is necessary to be convinced of lack of pregnancy or to postpone use until the first periods.

The reception delay at the scheduled time can reduce efficiency of contraception.

If accidental delay of reception of the next tablet makes less than 12 hours and the woman took a pill in this interval of time – contraception is not broken, reception should be continued in the usual mode.

If delay in reception of the next tablet exceeds 12 hours, it is necessary to be guided by the following rules:

• Adequate suppression гипоталамо - pituitary and ovarian system is reached by continuous reception of tablets within 7 days;
• Administration of drug cannot be interrupted for more than 7 days.

Considering the recurrence of reception of tablets calculated on 3 weeks, further actions of the woman depend on at what moment of a cycle there was a reception delay more than for 12 hours.

If delay happened on the first week of administration of drug it is necessary to take the passed pill at once as soon as remembered even if it will mean a concomitant use of 2 tablets and to continue reception in the set mode. Continuation of reception provides additional barrier contraception during the next 7 days.

Existence of sexual contacts during the previous 7 days does not exclude pregnancy existence.

If delay (more than 12 hours) happened on the 2nd week of therapy, the woman has to take the passed pill at once as soon as she remembered even if it will mean a concomitant use of 2 tablets and to continue reception according to the scheme. At timely reception of the previous 7 tablets, before delay, additional measures of contraception are not required. At the admission more than 1 tablet in the next 7 days it is necessary to apply additional non-hormonal methods of protection.

If delay happened on the 3rd week of a course, reliability of contraception can lower the forthcoming seven-day break in administration of drug. On condition of timely reception of all previous tablets of the blister, the woman, having taken the passed pill, continues therapy without use of additional contraception. Otherwise it is necessary to adhere to one of the following recommendations with simultaneous use of additional barrier methods of contraception. In the first case the woman has to take a pill at once as soon as she remembered and to continue reception according to the scheme. In the first day of an estimated break it is necessary to begin reception of tablets with the following blister at the scheduled time. Lack of a seven-day break can cause the smearing or plentiful bleedings even before the end of the second packaging.

At delay more than for 12 hours on the third week of therapy it is possible to stop reception of tablets from the current blister and to take a break which duration should not exceed 7 days (including days of the admission) then it is necessary to begin new packaging. Absence of bleeding of cancellation in the period of a seven-day break after the termination of tablets from the second blister can be connected with pregnancy existence.

At emergence of the heavy gastrointestinal frustration which are followed by vomiting, process of absorption of drug can be incomplete and cause decrease in reliability of contraception. If the woman pulled out within the first 3-4 hours after reception of the next tablet, and she does not wish to change the usual scheme of therapy, it is possible to use similar tablets from the new blister (their quantity should be defined at visit of the obstetrician-gynecologist).

To delay periods for the desirable period it is necessary to continue reception of tablets from the following blister without usual seven-day break. This period can last up to the termination of all tablets of the following blister. Then it is necessary to continue contraception according to the usual scheme. During reception of tablets from the second blister emergence of the smearing allocations or breakthrough bleedings is possible.

To displace the beginning of periods for desirable day it is necessary to reduce a break in reception by a certain number of days. At the same time it is necessary to consider that the break is less, the lack of periods in a break of reception and development of bleedings (plentiful or smearing) during use of tablets from the following blister is more probable.

Side effects

• Cardiovascular system: a thrombembolia or thrombosis (including a myocardial infarction, a deep vein thrombosis, a stroke, a thrombembolia of arteries of a retina, pulmonary artery, mesenteric, hepatic, renal arteries and veins), increase in the ABP;
• Alimentary system: ulcer colitis, a disease Krone, a cholelithiasis, an aggravation or emergence of jaundice and/or the skin itch caused by a cholestasia;
• Integument: a hloazma, especially at women with hloazmy in the anamnesis at pregnancy;
• Reproductive system: acyclicity of bloody allocations (is more often in the first months of reception);
• Others: a system lupus erythematosus, a porphyria, a gemolitiko-uraemic syndrome, herpes of pregnant women, a hysterical chorea, allergic reactions, a hearing loss against the background of an otosclerosis.

The side effects noted during Marvelon's use (communication between their emergence and administration of drug is not proved):

• Nervous system: often – migraine, a headache, a depression, decrease in a libido, change of mood; seldom – increase in a libido;
• Alimentary system: often – an abdominal pain, nausea, vomiting, diarrhea;
• Metabolism and food: often – a liquid delay, increase in body weight; seldom – a body degrowth;
• Immune system: seldom – hypersensitivity;
• Skin and hypodermic fabrics: often – skin rash, a small tortoiseshell; seldom – a mnogoformny erythema, a knotty erythema;
• Organ of sight: seldom – intolerance of contact lenses;
• Reproductive system: often – morbidity and/or increase in mammary glands, a stethalgia; seldom – allocations from mammary glands, allocations from a vagina.

Special instructions

Use of drug should be begun only after consultation of the gynecologist during which it is necessary to weigh carefully desirable effect and possible risk of alleged therapy.

The doctor has to make purpose of drug on the basis of the detailed medical anamnesis and carrying out the careful inspection based on the standard practice, and including measurement of the ABP, a research of abdominal organs, mammary glands and a small pelvis (including a cytologic research of a neck of uterus). Besides, considering individual risk factors, additional inspections can be offered the woman. During peroral contraception similar examinations have to be conducted at least 1 time in 6 months.

The patient needs to be informed on need of the immediate address to the doctor in case of an aggravation of symptoms, an exacerbation of the available pathologies or at emergence of signs of risk factors.

The woman has to know that Marvelon's use can increase risk of development of venous and arterial trombotichesky and thromboembolic pathologies, such as a deep vein thrombosis, a myocardial infarction, a thrombembolia of a pulmonary artery, a stroke, sometimes with a fatal outcome. These diseases arise extremely seldom and more often in the first year of reception of the combined contraceptives. Sometimes development of thrombosis is possible in arteries and veins of a liver, kidneys, mesenteries, a retina or a brain.

The intensive and often developing migraine demanding immediate drug withdrawal can become a symptom of cerebrovascular disturbances.

It is necessary to consider possible influence of prolonged use of drug on increase in risk of development of cancer of neck of uterus and a mammary gland.

Very seldom at the women accepting Marvelon development of high-quality is observed and is even more rare – malignant new growths of a liver which can become the reason of intra belly bleedings, life-threatening patients. At diagnostic inspection of the woman accepting drug, the doctor has to consider a possibility of presence of a tumor at increase in a liver, complaints to an acute pain in an upper part of a stomach and at symptoms of intra belly bleeding.

At a gipertriglitseridemiya, including in the anamnesis of a family, there is a big risk of development of pancreatitis.

At development of persistent clinically significant arterial hypertension against the background of hormonal contraception, administration of drug it is necessary to cancel and appoint therapy of arterial hypertension. Resuming of peroral contraception is possible only after achievement of the normal steady ABP.

In case of a recurrence of cholestatic jaundice, acute or chronic functional frustration drug should be cancelled before normalization of indicators of function of a liver.

Women with a diabetes mellitus need to conduct medical examinations regularly.

The patients predisposed to a hloazma should avoid ultra-violet radiation and direct sunshine.

The contraceptive effect of drug can be broken at the admission of reception of tablets, gastrointestinal frustration or a concomitant use of some medicines.

Exact assessment of emergence of the irregular smearing or plentiful bloody allocations, especially during the first months of use, it is necessary to carry out after three months of adaptation of an organism to drug.

The reason of the proceeding irregular bleedings pregnancy or a tumor can become possible; to be convinced of their absence, it is necessary to conduct the corresponding researches which can include a diagnostic scraping.

In the absence of menstrualnopodobny bleeding more than two a time in a row, it is necessary to see a doctor for a pregnancy exception.

Marvelon does not protect from infections, sexually transmitted (including HIV (AIDS)).

Hormonal contraceptives can exert impact on results of laboratory researches (changes, usually, are in limits of normal values).

Insignificant content of lactose in 1 tablet poses an improbable threat of development of complications in women with a lactose intolerance.

Use of drug does not exert impact on ability of the patient to control of vehicles and mechanisms.

Medicinal interaction

To avoid decrease in contraceptive efficiency of Marvelon and development of undesirable side effects, in need of simultaneous use of other medicines it is necessary to get advice of the doctor previously.

Terms and storage conditions

To protect from children.

To store in the protected from light, dry place at a temperature of 2-30 °C.

Period of validity – 3 years.