Instructions for use MARVELON® (MARVELON)

Marvelon

Contraceptive pills based on ethinyl estradiol and desogestrel. It acts to suppress ovulation, change the structure of the endometrium and increase the viscosity of cervical mucus. It is difficult for sperm to pass through the cervix, and the fertilized cell cannot attach to the endometrium.

In addition to the contraceptive effect, Marvelon has a beneficial effect on menorrhagia (painful, excessively heavy menstruation), affects the condition of the skin and reduces the appearance of acne vulgaris, when taken regularly, it normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including cancer.

Contraindications to taking Marvelon are:

• liver failure;
• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes);
• liver tumors, liver diseases;
• thromboembolism;
• cerebrovascular accidents, including stroke;
• cardiac ischemia;
• high blood pressure;
• atherosclerosis;
• decompensated heart defects, myocarditis;
• diabetes;
• retinopathy, angiopathy, sickle cell anemia;
• breast and endometrial cancer;
• endometrial hyperplasia, endometriosis;
• breast fibroadenoma,
• disorders of fat metabolism;
• jaundice or itching during a former pregnancy;
• otosclerosis worsening during pregnancy.

Marvelon should not be taken during pregnancy. It is not recommended for women over 35 who smoke.

Although the drug belongs to a new generation of contraceptives and has minimal side effects, they are nevertheless present and can manifest themselves, especially in the first months of use. Side effects may include:

• headache, nausea, vomiting;
• soreness and engorgement of the mammary glands;
• weight gain;
• fluid retention in the body, swelling;
• change in libido;
• mood swings, irritability, depression;
• skin rash;
• conjunctivitis, discomfort when wearing contact lenses;
• visual or hearing impairment;
• thrombophlebitis, thromboembolism;
• cholestatic jaundice;
• increased blood pressure;
• intermenstrual bleeding;
• changes in vaginal secretion, up to the development of vaginal candidiasis.

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Reception scheme

Marvelon is taken one tablet per day, preferably at the same time. The first day of admission is the first day of the menstrual cycle. The duration of administration is 21 days, until the tablets in the package run out. Next, a break is taken for seven days, during which menstrual-like bleeding occurs. After the break, you begin taking pills from the next package. This means that the first tablet from each package is taken on the same day of the week.

It is allowed to start taking it on the second to fourth day of the menstrual cycle, but no later than the fifth day. In this case, you need to additionally use barrier methods of contraception for two weeks.

If more than 5 days have passed since the start of menstruation, then taking the pills should be postponed and wait until the next menstruation.

After a natural birth or cesarean section, you must wait until your first spontaneous menstruation. After a miscarriage or induced abortion, Marvelon should be taken immediately or wait until the first menstruation.

If you forget to take your pill

It must be remembered that the continuous maximum contraceptive effect of Marvelon is maintained only if the tablets are taken systematically. The delay in taking the drug should not exceed 12 hours. If for some reason you did not take the pill on time and the duration of the delay exceeds 13 hours, then the next day at the usual time you should take 2 tablets of the drug, and at the same time use additional barrier contraceptives for the next 14 days or until the next day. menses.

It is important to know!

Before starting to take Marvelon and then every six months, it is recommended to undergo a general medical and gynecological examination, which includes:

• gynecological examination,
• examination of the condition of the mammary glands,
• liver function test,
• control of blood pressure and cholesterol concentration in the blood,
• Analysis of urine.

Due to the fact that the contraceptive effect of the drug does not fully manifest itself immediately, but only by the 14th day from the start of administration, it is recommended to additionally use barrier methods of contraception during these 14 days.

If you have suffered acute viral hepatitis, then you need to wait until your liver function normalizes (usually this happens no earlier than six months later).

In case of intestinal disorders and vomiting, the contraceptive effect may be reduced, so additional barrier methods of protection must be used.

Marvelon is not recommended for smoking women over 35 years of age.

Women who have chloasma should avoid exposure to the sun while taking Marvelon.

If you take a number of medications, the contraceptive effect of Marvelon may be reduced. Be sure to notify your doctor about the contraceptive you are taking if he has prescribed you: rifampicin, isoniazid, ampicillin, neomycin, penicillins, tetracycline, chloramphenicol, griseofulvin, barbiturates, carbamazepine, activated charcoal and laxatives.

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.

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.