Marvelon: Instructions for use: Description of the drug: Price on EUROLAB

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Manufacturers: Organon Inc.

Active ingredients

Desogestrel
Ethinyl estradiol

Disease class

Monitoring contraceptive use

Clinical and pharmacological group

Not indicated. See instructions

Pharmacological action

Contraceptive
Estrogen-progestogen

Pharmacological group

Estrogens, gestagens; their homologs and antagonists in combinations

Marvelon oral tablets

Instructions for medical use of the drug

Description of pharmacological action

Contraceptive drug. Inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect is due to the effect on the hypothalamic-pituitary-ovarian system. Ethinyl estradiol is a synthetic analogue of the follicular hormone estradiol, which participates together with the corpus luteum hormone in the menstrual cycle. A progestin drug (desogestrel) inhibits the synthesis of LH and FSH by the pituitary gland (preventing follicle maturation), etc. blocks ovulation. Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus located in the cervix, which makes it relatively impenetrable for sperm. It has a beneficial effect on lipid metabolism: it increases the concentration of HDL in plasma without affecting the content of LDL. During treatment, there is a significant decrease in the amount of blood lost (with initial menorrhagia). It has a beneficial effect on the skin, especially improving its condition in cases of acne vulgaris; when taken regularly, it also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Indications for use

Contraception.

Release form

Tablets 1 tablet. desogestrel 0.15 mg ethinyl estradiol 0.03 mg excipients: potato starch; povidone; stearic acid; colloidal anhydrous silicon oxide; α-tocopherol; lactose monohydrate in a blister of 21 pcs.; There are 1, 3 or 6 blisters in a box.

Pharmacodynamics

Pharmacokinetics

Desogestrel: quickly and completely absorbed from the gastrointestinal tract when taken orally and converted to etonogestrel. Bioavailability - 62–81%. TC max - 1.5 hours, Cmax - 2 ng/ml. When taking desogestrel daily, serum concentrations of etonogestrel increase 2-3 times, reaching Css in the 2nd half of the tablet cycle. Etonorgestrel is 40–70% bound to sex hormone binding globulin (SHBG) and albumin, 2–4% is present in free form. Ethinyl estradiol, increasing the concentration of SHBG by 3 times, increases the fraction of etonogestrel associated with SHBG and reduces the fraction associated with albumin. Volume of distribution - 1.5 l/kg. Completely metabolized by endogenous steroid metabolism pathways. Clearance - 2 ml/min/kg. The final T1/2 is 30 hours. Desogestrel and its metabolites are excreted in the urine in a ratio of 6:4. Ethinyl estradiol: quickly and completely absorbed from the gastrointestinal tract when taken orally; bioavailability - 60% due to presystemic conjugation in the mucous membrane of the small intestine and liver. TCmax - 1–2 hours, Cmax - 80 pg/ml. TCss - 3–4 days. Connection with proteins (albumin) - 98.5%, increases the serum concentration of SHBG. Volume of distribution - 5 l/kg. The main mechanism of metabolism is aromatic hydroxylation; Numerous hydroxylated and methylated metabolites were found, incl. in the form of conjugates with glucuronides and sulfates. Clearance - 5 ml/min/kg. The final T1/2 is 24 hours. It is excreted in the form of metabolites in urine and bile in a ratio of 4:6.

Other special occasions at reception

Conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, family history, obesity (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, valvular heart disease, atrial fibrillation, prolonged immobilization, major surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period, changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant). Diabetes mellitus, SLE, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia; hypertriglyceridemia (including family history), acute and chronic liver diseases, incl. congenital hyperbilirubinemia (Gilbert, Dubin-Johnson, Rotor syndrome) until biochemical parameters are restored.

Contraindications for use

Hypersensitivity, venous or arterial thrombosis/thromboembolism (including deep vein thrombosis of the leg, pulmonary embolism, myocardial infarction, stroke), incl. history, precursors of thrombosis (including transient ischemic attack, angina), incl. history, 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 severe arterial hypertension with blood pressure 160/100 mmHg or more), pancreatitis (including a history), accompanied by severe hypertriglyceridemia, severe liver disease (until normalization of liver functional parameters), incl. history of liver tumors, incl. history, hormone-dependent malignant neoplasms of the genital organs and mammary glands (including suspected ones), vaginal bleeding of unknown etiology, smoking women over 35 years of age (more than 15 cigarettes per day), pregnancy (including suspected), lactation period .

Side effects

Thrombosis or thromboembolism (including myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism). Chloasma (especially if there is a history of chloasma during pregnancy), Crohn's disease, ulcerative colitis, intermenstrual bleeding (spotting or heavy) in the first months of taking the drug, allergic reactions. The connection with the drug has not been established: thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins; headache, migraine, changes in libido, emotional lability, depression; dysfunction of the gastrointestinal tract, incl. nausea, vomiting; soreness, enlargement and engorgement of the mammary glands, galactorrhea; increased body weight, fluid retention in the body, increased blood pressure; skin rash, erythema nodosum or exudative, intolerance to contact lenses, changes in vaginal secretion; the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis, porphyria, SLE, hemolytic-uremic syndrome, minor chorea, gestational herpes, hearing loss due to otosclerosis.

Directions for use and doses

Orally, in the order indicated on the package, every day at approximately the same time, if necessary, with a small amount of water. Take 1 tablet. per day for 21 days. Taking tablets from the next package should begin 7 days after the end of the previous one. During these 7 days, menstrual-like bleeding occurs. It usually starts 2–3 days after taking the last tablet and may not stop until you start taking the next tablet from the pack. How to start taking Marvelon® if hormonal contraceptives have not been used during the last month. Taking pills should start 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 pills in the initial cycle. Switching from other combined oral contraceptives It is advisable to start taking Marvelon® the next day after taking the last tablet of a previously used drug containing hormones, or, as a last resort, immediately after a break in taking tablets or after taking a tablet that does not contain hormones. Switching from drugs containing only progestogen ("mini-pills", injections, implants) A woman taking a "mini-pill" can switch to taking Marvelon® on any day: using an implant - on the day of its removal; using the drug in the form of injections - on the day of the next injection. In all cases, during the first 7 days of taking Marvelon®, 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 abortion in the second trimester It is recommended to start taking the drug on the 21st or 28th day after childbirth or an abortion performed in the second trimester of pregnancy. When starting to take the drug at a later date, it is recommended to use barrier methods of contraception during the first 7 days of taking Marvelon®. In any case, if a woman has already had sexual intercourse after childbirth or abortion before starting to take Marvelon®, pregnancy should be excluded before starting to take the drug or wait until her first menstruation. The use of the drug is contraindicated during lactation. If you miss 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. A woman should take the tablet as soon as she remembers and take subsequent tablets at the usual time. If taking the next pill is delayed for more than 12 hours, the reliability of contraception may be reduced. In this case, the following rules should be followed: 1 week A woman should take the missed pill as soon as she remembers, even if this means taking 2 tablets. simultaneously. Then you should continue taking it as usual. Additionally, you should use a barrier contraception method for the next 7 days. If a woman has had sexual intercourse within the previous 7 days, the possibility of pregnancy should be considered. The more pills are missed, and the closer the break in taking the drug is 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, even if this means taking 2 pills. simultaneously. Then you should continue taking it as usual. Provided that a woman has taken her pills on time during 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 has 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 drug dosage regimen. If you use either of the following two regimens, there is no need for additional contraceptive measures, provided that the woman has taken the pills on time for 7 days preceding the first missed dose. Otherwise, it is recommended to use one of the two following regimens and additional contraceptive measures for the next 7 days. A woman should take the missed tablet as soon as she remembers, even if this means taking 2 tablets. simultaneously. Then you should continue taking it as usual. New packaging should be started as soon as the current one ends, i.e. there should be no break. The likelihood of withdrawal bleeding before the end of the second package is small, but some may experience spotting or heavy bleeding while taking the drug. It may be recommended to stop taking the drug from the current package. A woman should take a break from taking Marvelon® for up to 7 days, including days when she forgot to take the pills, and then start a new pack. If you miss taking the drug and there is no subsequent bleeding in the next break in taking, you should consider the possibility of pregnancy. Recommendations in case of vomiting If vomiting occurs within 3-4 hours after taking the drug, absorption may be incomplete. In this case, you should use the recommendations regarding skipping the next dose of the drug. If a woman does not want to change her usual dosing schedule, she will need to take additional tablet(s) from a different package. How to change the onset of menstruation In order to delay menstruation, you should continue taking tablets from another package of Marvelon® without the usual break in taking it. You can delay menstruation for any period until the end of the pills from the second package. During this period, a woman may experience spotting or heavy bleeding. Taking the drug according to the usual regimen should be resumed after a 7-day dosing interval. In order to shift your menstruation to a different day of the week from the one expected if you follow your usual dosage regimen, you can shorten the usual break in dosage by as many days as necessary. The shorter the break, the higher the risk of absence of menstruation during the break and the occurrence of heavy or spotting bloody discharge while taking the drug from the second package.

Overdose

Symptoms: nausea, vomiting, and in girls, bleeding from the vagina. Treatment: symptomatic.

Interactions with other drugs

Drugs that induce liver enzymes, such as hydantoin, barbiturates, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, drugs containing St. John's wort reduce the effectiveness of oral contraceptives and increase the risk of breakthrough bleeding. The maximum level of induction is usually achieved no earlier than 2–3 weeks, but can last up to 4 weeks after discontinuation of the drug. Ampicillin, tetracycline - reduce effectiveness (the mechanism of interaction has not been established). If co-administration is necessary, it is recommended to use an additional barrier method of contraception throughout the course of treatment and for 7 days (for rifampicin - within 28 days) after discontinuation of the drug.

Special instructions for use

Before starting and every 6 months of using the drug, a general medical and gynecological examination is recommended (including gynecological control, examination of the mammary glands, liver function, monitoring of blood pressure and cholesterol concentrations in the blood, urine analysis). It is a reliable contraceptive drug: Pearl index (the number of pregnancies that occurred during the use of a contraceptive method in 100 women over 1 year) - 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, in the first 2 weeks of treatment it is recommended to additionally use non-hormonal methods of contraception. After acute viral hepatitis, it should be taken after normalization of liver function (no earlier than 6 months). In case of diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception). Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35 years of age) and on the number of cigarettes smoked. During lactation, milk secretion may decrease; small amounts are excreted in breast milk. Estrogen-containing drugs increase the risk of thrombosis in women who have undergone surgery or prolonged immobilization. Women who have chloasma should avoid sun exposure.

Storage conditions

In a dry place, protected from light, at a temperature of 2–30 °C.

Best before date

36 months

ATX classification:

G Genitourinary system and sex hormones

G03 Sex hormones and modulators of the reproductive system

G03A Systemic hormonal contraceptives

G03AA Progestogens and estrogens (fixed combinations)

G03AA09 Desogestrel and estrogen

Instructions for use MARVELON® (MARVELON)

If you have any of the following conditions or risk factors, you should carefully weigh the benefits and possible risks of taking Marvelon. The patient should be warned about the need to immediately consult a doctor if any adverse reactions occur while taking the drug.

When assessing the positive and negative effects of combined hormonal contraceptives, it should be borne in mind that with adequate treatment of these diseases and conditions, the risk of thrombosis can be significantly reduced, and that the risk of thrombosis during pregnancy against the background of these diseases is significantly higher than when taking combined oral contraceptives.

Before starting to use the drug, it is necessary to conduct a general medical examination (detailed family and personal history, blood pressure measurement, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). Such a study should be carried out regularly during the period of taking the drug.

The effectiveness of Marvelon is reduced if tablets are missed, with vomiting and diarrhea, as well as when taken simultaneously with other medications.

When taking combined oral contraceptives, venous thromboembolism (VTE) may develop, manifested as deep coronary thrombosis and/or pulmonary embolism. The estimated incidence of this complication when taking combined oral contraceptives with low estrogen content (less than 50 mcg) is 4 cases per 10,000 patients (compared to 0.5-3 cases per 10,000 patients in women not taking these drugs). It is believed that the incidence of VTE in women taking these drugs is significantly lower than in women during pregnancy (6 cases per 10,000 women).

Possible symptoms of venous or arterial thrombosis:

pain and/or swelling of the lower extremity, unexpected sharp chest pain radiating to the left arm, unexpected feeling of shortness of breath, unexpected coughing fit, any unusual, acute, prolonged headache, unexpected total or partial loss of vision, diplopia, slurred speech or impairment speech, dizziness, collapse, accompanied or not accompanied by local convulsions, weakness or a pronounced feeling of numbness in one side or part of the body, impaired motor function, symptom complex “acute abdomen”.

Risk factors for arterial or venous thromboembolic diseases:

age, smoking, family history of thromboembolic diseases, obesity (body mass index above 30 kg/m2), dyslipoproteinemia, arterial hypertension, heart valve disease, atrial fibrillation, diabetes mellitus, prolonged immobilization (after major surgery, after surgery on lower extremities, after severe trauma).

There is no consensus on the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism.

It should be taken into account that the risk of thromboembolism increases in the postpartum period; for diseases that can cause disturbances in the circulatory system, incl. for diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, inflammatory bowel diseases (Crohn's disease, ulcerative colitis) and sickle cell anemia.

An increase in the frequency and intensity of migraine attacks while taking combined hormonal contraceptives may be a sign of cerebrovascular disorders and may serve as a basis for immediate discontinuation of the drug.

A meta-analysis of 54 large-scale studies found that there is a small increase in the relative risk (1.24) of developing breast cancer in women taking combined hormonal contraceptives. The increased risk gradually decreases over 10 years after stopping these drugs. Because Breast cancer in women under 40 years of age is quite rare; the increase in the risk of developing breast cancer in women currently taking combined hormonal contraceptives or who have recently stopped using them is small relative to the initial risk of developing cancer. These studies do not provide data on the etiology of cancer. The increased risk of breast cancer may be explained both by the earlier diagnosis of breast cancer in women taking these drugs and by the biological effects of hormonal contraceptives. There is a trend that women who have ever taken combined hormonal contraceptives have less clinically advanced breast cancer than women who have never taken these drugs.

The possibility of a liver tumor should be considered in the differential diagnosis of diseases in a woman taking combined hormonal contraceptives if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intraperitoneal bleeding.

If there is a family history of hypertriglyceridemia, there may be an increased risk of developing pancreatitis when taking combined hormonal contraceptives.

There is no established connection between the use of combined hormonal contraceptives and clinically significant arterial hypertension. In any case, if a clinically significant increase in blood pressure is observed when taking combined hormonal contraceptives for a long time, hormonal contraceptives should be discontinued and antihypertensive therapy should be prescribed. In cases where, with the help of antihypertensive therapy, it is possible to achieve normal blood pressure values, the doctor may decide to resume taking combined oral contraceptives.

Acute or chronic liver dysfunction may warrant discontinuation of combined oral contraceptives until liver function tests return to normal. Recurrence of cholestatic jaundice, previously observed during pregnancy or while taking sex steroids, requires discontinuation of combined oral contraceptives.

Combined oral contraceptives should be prescribed with caution to patients with diabetes mellitus.

Women predisposed to skin pigmentation should avoid direct sunlight and ultraviolet radiation from other sources while taking combined oral contraceptives.

The patient should be informed that Marvelon does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

While taking Marvelon, irregular bleeding may occur (minor discharge or sudden bleeding that does not coincide with menstruation). Any bleeding can be regarded as clinically significant only after an adaptation period lasting three menstrual cycles.

Some women do not experience bleeding during a break in taking Marvelon. If the Marvelon dosage regimen is followed, then pregnancy is unlikely. If the recommended dosage regimen is violated and there is no bleeding from discontinuation of the drug, or if there is no bleeding 2 times in a row, pregnancy should be excluded before resuming taking Marvelon.

When taking medications with which Marvelon interacts with drugs for a short period, you should temporarily use a barrier contraception method in addition to hormonal contraception throughout the entire treatment period and for 7 days after discontinuation of the drug. When taking rifampicin, a barrier contraception method should be used in addition to taking Marvelon throughout the entire course of treatment and for 28 days after discontinuation of rifampicin.

If the course of treatment with these drugs ends later than the current package of Marvelon, then you should start taking the drug from the next package without the usual break in taking it.

In case of long-term use of drugs that cause the induction of microsomal liver enzymes, it is recommended to increase the dose of oral contraceptive. If increasing the contraceptive dose is not desirable, or if they do not achieve satisfactory and reliable results, for example in the case of irregular bleeding, other methods of contraception should be used.

It is recommended to stop taking Marvelon for elective surgery at least 4 weeks before surgery and not to start taking it until 2 weeks after full functional recovery.

Impact on the ability to drive vehicles and operate machinery

There was no effect of the drug Marvelon on the ability to drive vehicles or operate machinery.

Similar drugs:

Regulon Oral tablets
Mercilon Oral tablets
Cilest Tablets
Novynette Oral tablets
Egestrenol (Egoestrenolum) Oral tablets

** The Drug Directory is intended for informational purposes only. For more complete information, please refer to the manufacturer's instructions. Do not self-medicate; Before starting to use the drug Marvelon, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of information posted on the portal. Any information on the site does not replace medical advice and cannot serve as a guarantee of the positive effect of the drug.

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** Attention! The information presented in this medication guide is intended for medical professionals and should not be used as a basis for self-medication. The description of the drug Marvelon is provided for informational purposes and is not intended for prescribing treatment without the participation of a doctor. Patients need to consult a specialist!

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Marvelon®

If any of the following conditions/diseases/risk factors are present, a careful assessment of the benefit-risk ratio of the use of COCs should be carried out. This issue should be discussed with the woman before starting the drug. In case of exacerbation of diseases, deterioration of condition, or the appearance of the first symptoms of conditions/diseases or risk factors, a woman should immediately consult a doctor to decide whether to stop taking the drug. In this section, the term CHC is used when data are available for both oral and non-oral contraceptives; the term COC is used when data is available only for oral contraceptives.

Risk of developing VTE and ATE

- Epidemiological studies have established an association between the use of CHCs and an increased risk of arterial and venous thrombosis and thromboembolism, such as myocardial infarction, stroke, DVT and PE. These diseases are extremely rare.

- The use of any CHC is associated with an increased risk of developing VTE, manifested as DVT and/or PE. The greatest risk of developing VTE is observed in the first year of CHC use. An increased risk of developing this complication is also observed when the use of CHCs is resumed after a break of 4 weeks or more.

- The use of drugs containing levonorgestrel, norgestimate or norethisterone as a progestogen is associated with the lowest risk of developing VTE. The use of low-dose COCs containing third-generation progestogens, including desogestrel, may double the risk of developing VTE. The incidence of VTE within 1 year in women taking COCs containing desogestrel ranges from 9 to 12 cases; those containing levonorgestrel - 6-7 cases per 10,000 women. In women who do not use COCs, the incidence of VTE is 2 cases per 10,000 women. The incidence of VTE with the use of COCs is lower than the incidence of this complication during pregnancy and the postpartum period. VTE can be fatal in 1-2% of cases.

- It is extremely rare that when taking COCs, thrombosis occurs in other blood vessels (for example, in the veins and arteries of the liver, mesentery, kidneys, brain or retina).

— Symptoms of VTE, ATE or acute cerebrovascular accident may include the following conditions: sudden pain and/or swelling of the lower extremity; sudden intense chest pain, with or without radiation to the left arm; sudden shortness of breath; sudden cough; unusual severe or prolonged headache; sudden partial or complete loss of vision; diplopia; speech impairment or aphasia; dizziness; collapse with or without convulsive attack; weakness or severe numbness that suddenly appears on one side of the body; movement disorders; "acute belly"

— The risk of developing VTE increases with the presence of the following risk factors:

age;
obesity (BMI >30 kg/m2);
a family history of venous or arterial thrombosis, or thromboembolism in brothers, sisters or parents under the age of 50 years (if a hereditary predisposition is suspected, you should consult a specialist before starting to take CHC);
prolonged immobilization, major surgery, any surgery on the lower extremities, pelvis or neurosurgery, or major trauma. In these cases, you should stop taking the COC (at least 4 weeks before planned surgery) and resume it only 2 weeks after the woman has fully recovered her mobility (see also section “Contraindications”);
temporary immobilization, including air travel lasting more than 4 hours, is also a risk factor for the development of VTE, especially in women with other risk factors;
the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.

— The risk of developing ATE increases in the presence of the following risk factors:

age;
smoking (the risk increases even more with heavy smoking, especially in women over 35 years of age);
dyslipoproteinemia;
obesity (BMI >30 kg/m2);
arterial hypertension;
migraine;
heart valve disease;
atrial fibrillation;
a family history of venous or arterial thrombosis, or thromboembolism in brothers, sisters or parents under the age of 50 years (if a hereditary predisposition is suspected, you should consult a specialist before starting to take CHC).

— It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

— Other conditions/diseases that cause poor circulation include: diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (eg, Crohn's disease or ulcerative colitis), and sickle cell disease.

— An increase in the frequency or intensity of migraine (which may be a prodromal symptom of cerebrovascular accidents) while taking a COC is grounds for immediate discontinuation of its use.

- Biochemical factors that may indicate hereditary or acquired predisposition to VTE or ATE include activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

— When assessing the benefit/risk ratio, it should be taken into account that therapy for these conditions/diseases can reduce the associated risk of thrombosis.

Tumors

— The most important risk factor for the development of cervical cancer (CC) is persistent human papillomavirus infection (HPV). Epidemiological studies show an increased risk of developing cervical cancer in women infected with HPV and long-term users of COCs (>5 years), however, there is still controversy regarding the degree to which these data are influenced by various factors, in particular, cervical screening examinations or characteristics of a woman’s sexual behavior ( number of sexual partners and the use of barrier methods of contraception), as well as the cause-and-effect relationship of these factors.

— According to a meta-analysis of the results of 54 epidemiological studies, a slight increase (1.24) in the risk of developing breast cancer (BC) in women using COCs was identified. The increased risk gradually disappears within 10 years after discontinuation of COCs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women who are currently or recently taking COCs is small relative to the overall risk of developing this disease.

— The connection between breast cancer and COC use has not been proven. The observed increased risk may be a consequence of earlier diagnosis of breast cancer in women taking COCs (they are diagnosed with earlier clinical forms of breast cancer than women not taking COCs), the biological effects of COCs, or a combination of both.

- Very rarely, when using COCs, cases of the development of benign, and even more rarely, malignant liver tumors were observed. In some cases, these tumors have led to life-threatening intra-abdominal bleeding. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.

Hepatitis C

In clinical studies of patients receiving hepatitis C virus therapy with drugs containing ombitasvir/paritaprevir/ritonavir and dasabuvir, with or without ribavirin, increases in ALT levels greater than 5 times the upper limit of normal were observed significantly more often in women using ethinyl estradiol-containing drugs. drugs such as CHCs. Marvelon® should be discontinued before starting antiviral therapy and may be resumed 2 weeks after completion of therapy with these antiviral drugs.

Other states

- Women with hypertriglyceridemia or a corresponding family history have an increased risk of developing pancreatitis when taking COCs.

- Many women taking COCs experienced a slight increase in blood pressure (BP), but clinically significant increases in BP were rare. The connection between taking COCs and arterial hypertension has not been established. However, if persistent arterial hypertension develops while taking COCs, then it is advisable to stop taking COCs and prescribe antihypertensive therapy. With adequate blood pressure control using antihypertensive drugs, it is possible to resume taking COCs.

— During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been definitively established: jaundice and/or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (minor chorea), gestational herpes, hearing loss due to otosclerosis, hereditary angioedema.

— Acute or chronic liver dysfunction may warrant discontinuation of COCs until liver function tests return to normal. Recurrence of cholestatic jaundice, previously observed during pregnancy or when using sex hormones, requires discontinuation of COCs.

— Despite the fact that COCs can have an effect on insulin resistance and glucose tolerance, there is usually no need to adjust the dose of hypoglycemic drugs in patients with diabetes mellitus taking COCs. However, patients with diabetes mellitus should be under close medical supervision while taking COCs.

— There is evidence that there is a connection between taking COCs and Crohn's disease and ulcerative colitis.

- Sometimes, when taking COCs, pigmentation of the facial skin (chloasma) may occur, especially if it occurred earlier during pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and ultraviolet radiation from other sources when taking COCs.

— 1 tablet of Marvelon® contains less than 80 mg of lactose. The drug is contraindicated for women with rare hereditary diseases associated with lactase deficiency, lactose intolerance, glucose-galactose malabsorption, and those on a lactose-free diet.

All of the above information should be taken into account when choosing a contraceptive method.

Medical examinations/consultations

Before prescribing or resuming the use of the drug Marvelon®, you should carefully familiarize yourself with the woman’s life history (including family history), conduct a thorough general medical examination (including measuring blood pressure and determining body mass index) and gynecological examination (with mandatory examination of the mammary glands and cytological examination of a vaginal smear and cervix), exclude pregnancy. The volume of additional studies and the frequency of control examinations are determined individually; control examinations should be carried out at least once every 6 months. It is important to draw a woman's attention to the risk of developing venous and arterial thrombosis, including the risk of using Marvelon® compared to other CHCs, symptoms and known risk factors for the development of VTE and ATE, and what to do if thrombosis is suspected.

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

Reduced efficiency

The effectiveness of Marvelon® may be reduced if you miss pills, have gastrointestinal disorders, or take concomitant medications that reduce the concentration of the active metabolite of desogestrel (etonogestrel) in the blood plasma. Herbal preparations containing St. John's wort ( Hypericum perforatum

), should not be used simultaneously with Marvelon® due to the risk of reducing the concentration of etonogestrel and the contraceptive effectiveness of the drug (see sections “Method of administration and dosage” and “Interaction with other drugs”).

Insufficient cycle control

When taking COCs, especially in the first months of use, irregular spotting or heavy bleeding may occur, so assessment of irregular bleeding should be carried out only after the end of the adaptation period of three months.

If irregular bleeding persists or appears after previous regular cycles, possible non-hormonal causes of cycle disruption should be taken into account and appropriate studies should be carried out to exclude malignant neoplasms or pregnancy. Diagnostic curettage of the cavity and cervical canal of the uterus may be required.

Some women may not experience menstrual bleeding during the interval between taking the drug. If the COC was taken as recommended above, there is little chance that the woman is pregnant. Otherwise, or if there is no bleeding twice in a row, the possibility of pregnancy should be excluded before continuing to use the COC.

Laboratory research

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