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Instructions / Instruction for use: Gestodene + Ethinylestradiol (Gestodenum+ Aethinyloestradiolum)

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Pharmacological group

Estrogens, gestagens; Their homologues and antagonists in combinations

Nosological classification (ICD-10)

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

Z30 Monitoring contraceptive use

Local Contraception, Contraception oral, Local contraception, Episodic prevention of pregnancy, Hormonal Contraception, Contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Contraceptive intrauterine, Contraception in women with androgenization phenomena, Installation and removal of the intrauterine device, Prevention of pregnancy (contraception)

Characteristics of substances Gestodene + Ethinylestradiol

Combination gestagen + estrogen.

Pharmacology

The pharmacological action is estrogen-gestagenic, contraceptive.

Pharmacodynamics

Combination Gestodene + ethinylestradiol - low-dose monophasic COC.

The combination of gestodene + ethinylestradiol inhibits the secretion of gonadotropic hormones; Inhibits maturation of follicles; Hinders the process of ovulation; Reduces the susceptibility of the endometrium to the blastocyst and increases the viscosity of the secretion of the cervix, making it difficult to penetrate the spermatozoon into the uterine cavity.

In women taking COC, the cycle becomes more regular, the pain and intensity of menstrual bleeding decreases, which decreases one of the risk factors for the development of iron deficiency anemia. Taking COC with a high content of ethinylestradiol (50 μg) reduces the risk of developing ovarian and endometrial cancer. There are no data confirming this pharmacological effect for COC preparations with a lower ethinylestradiol content.

When used correctly, Perl's index (an indicator that reflects the frequency of pregnancy in 100 women during the year of use of the contraceptive) is <1. If the combination is missed or the application is incorrect, the Pearl index may increase.

Pharmacokinetics

Gestoden

Suction. After oral administration, Gestodene is rapidly and completely absorbed. Cmax in blood plasma is about 4 ng / ml and is reached after about 1 hour. Bioavailability is approximately 99%.

Distribution. Gestodene binds to plasma albumin and GSHG (globulin binding sex hormones). In a free form, only 1-2% of the total concentration in the blood plasma is found, about 50-70% - is specifically associated with SHBG. Induction with ethinylestradiol synthesis of SHBG affects the binding of Gestodene to plasma proteins. The average apparent Vd (distribution volume) of Gestodene is 0.7 l / kg.

Metabolism. Gestodene is almost completely metabolized. The clearance from the blood plasma is approximately 0.8 ml / min / kg.

Excretion. There is a two-phase decrease in the concentration of Gestodene in the blood plasma, T1 / 2 in the terminal phase is 12-15 hours. Unmodified Gestodene is not excreted. It is excreted as metabolites by the kidneys and through the intestine in a ratio of approximately 6: 4 with T1 / 2 approximately 24 hours.

Css. The pharmacokinetics of Gestodene is influenced by the concentration of SHBG in the blood plasma. As a result of the daily administration of the combination, the concentration of the substance in the blood plasma increases 4-fold during the second half of the contraceptive cycle.

Ethinylestradiol

Suction. After ingestion, ethinylestradiol is rapidly and completely absorbed from the digestive tract (gastrointestinal tract). Cmax in blood plasma, approximately 82 pg / ml, is achieved in 1.4 hours. Absolute bioavailability averages 45% due to the effect of the first passage through the liver.

Distribution. Ethinyl estradiol is non-specifically, but firmly binds to plasma albumin (about 98%) and induces an increase in the concentration of SHBG in the blood plasma. The apparent Vd is about 5 l / kg.

Metabolism. Ethinyl estradiol undergoes presystemic conjugation in both the mucosa of the small intestine and the liver. The main pathway of metabolism is aromatic hydroxylation. The clearance from the blood plasma is about 5 ml / min / kg.

Excretion. There is a two-phase decrease in the concentration in the blood plasma: the first phase is characterized by T1 / 2 about 1 hour, the second - 10-20 hours. Unchanged from the body is not excreted. It is excreted as metabolites by the kidneys and through the intestine in a ratio of 4: 6 with T1 / 2 for about 24 hours.

Css (equilibrium concentration). It is reached approximately in 1 week of reception of a combination.

Application of Gestodene + Ethinylestradiol

Oral contraception.

Contraindications

The combination Gestodene + ethinyl estradiol, like other COCs, is contraindicated in the presence of any of the diseases / conditions / risk factors listed below. If any of them occurs against the background of the combination, its administration should be stopped immediately: thromboses (venous and arterial); Thromboembolism now or in anamnesis (including deep vein thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction); Cerebrovascular disorders (hemorrhagic and ischemic); Conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in the anamnesis; The presence of a high risk of venous or arterial thrombosis (see "Precautions"); A predisposed predisposition to venous or arterial thrombosis, including resistance to activated protein C; Hyperhomocysteinemia; Deficiency of antithrombin III; Protein C deficiency; Deficiency of protein S; Antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant); Uncontrolled arterial hypertension; Severe dyslipoproteinemia; Migraine with focal neurologic symptoms at present or in the anamnesis; Diabetes mellitus with vascular complications; Pancreatitis with severe hypertriglyceridemia at present or in the anamnesis; liver failure; Acute or chronic liver disease of a serious degree (before the normalization of the parameters of functional liver samples); Liver tumors (benign or malignant) at present or in the anamnesis; Identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspected of them; Bleeding from the vagina of unknown origin; Hypersensitivity to any of the combination components; Pregnancy or suspicion of it; The period of breastfeeding.

Restrictions for use

The potential risk and the expected benefit of using COCs in each individual case should be carefully weighed in the presence of the following diseases / conditions or risk factors: risk factors for thrombosis and thromboembolism - thrombosis, myocardial infarction or cerebral circulation impairment at a young age in any of the next of kin; Overweight (BMI more than 25 and less than 30 kg / m2); Dyslipoproteinemia; Controlled arterial hypertension; Migraine (without focal neurological symptoms); Uncomplicated diseases of the heart valves; Heart rhythm disturbances; smoking; Other diseases in which peripheral circulation disorders may be noted - cancer, diabetes mellitus without vascular complications, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins; Therapy with anticoagulants; Hypertriglyceridemia; Liver disease of mild and moderate severity in history with normal indicators of functional liver samples; Diseases that first appeared or worsened during pregnancy or against the background of previous administration of sex hormones (eg jaundice and / or itching associated with cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham's chorea); depression; epilepsy; Impaired renal function; Postpartum period; In women with hereditary angioedema, exogenous estrogens can cause or exacerbate symptoms of angioedema.

pregnancy and lactation

The action category for fetus by FDA is X.

The use of combination gestoden + ethinyl estradiol is contraindicated during pregnancy and breastfeeding. In case of pregnancy during the application of the combination, further reception should be stopped immediately. However, numerous epidemiological studies have not revealed any increased risk of congenital malformations in children born to mothers who received COC prior to pregnancy, or teratogenic effects when KOC was given randomly during early pregnancy.

The combination of Gestodene + ethinyl estradiol, like other COCs, can reduce the amount of breast milk and change its composition, so the combination during breastfeeding is contraindicated. A small amount of sex hormones and / or their metabolites can be excreted in breast milk.

Side effects

To determine the incidence of side effects, combinations are classified as follows: very often (≥1 / 10); Often (≥1 / 100, <1/10); Infrequently (≥1 / 1000, <1/100); Rarely (≥1 / 10000, <1/1000); Very rarely (≥1 / 10,000).

From the immune system: rarely - hypersensitivity, allergic reactions.

From the side of metabolism and nutrition: infrequently - fluid retention.

From the side of the psyche: often - a decrease in mood, mood swings; Infrequently - decreased libido; Rarely - increased libido.

From the nervous system: often - headache; Infrequently - a migraine.

From the side of the vessels: rarely - venous and arterial thromboembolic complications1.

From the side of the organ of vision: rarely - intolerance to contact lenses (discomfort when wearing them), impaired vision.

From the digestive tract (gastrointestinal tract): often - nausea, pain in the abdomen; Infrequently - vomiting, diarrhea.

From the genitals and the breast2: often - soreness of the mammary glands, engorgement of the mammary glands, acyclic spotting spotting, metrorrhagia; Infrequently, mammary gland hypertrophy; Rarely - discharge from the genital tract, discharge from the mammary glands.

From the skin and subcutaneous tissues: infrequently - rash, hives; Rarely erythema nodosum, erythema multiforme.

Common disorders: often - weight gain; Infrequently - swelling; Rarely - weight loss.

1Counting frequency according to epidemiological studies covering a group of women who received COCs.

Venous and arterial thromboembolic events following combined nosological entities: occlusion of peripheral deep venous thrombosis and for thrombosis / pulmonary vascular occlusion, thrombosis, embolism and infarction / myocardial infarction / cerebral infarction and stroke, as hemorrhagic unclassified.

2B during post-marketing studies have reported the following adverse events, which was not possible to estimate the frequency: menstrualnopodobnoe absence of bleeding, reduction in volume menstrualnopodobnoe bleeding, amenorrhea after discontinuation of combined drugs.

The following undesirable phenomena with very low frequency or delayed development of symptoms, which are supposedly associated with the administration of COCs (see "Contraindications", "Precautions") are listed below.

Tumors

- In women using COC (combined oral contraceptives), the incidence of breast cancer detection is very slightly increased. Because breast cancer is rare in women younger than 40, the increase in the incidence of cancer in women using COC is insignificant in relation to the overall risk of breast cancer. A causal relationship with the use of COCs has not been identified;

- Liver tumors (benign and malignant).

Other states

- hypertriglyceridemia (an increased risk of developing pancreatitis with COCs);

- Increased blood pressure;

- the onset and deterioration of conditions in which communication with the use of COCs is not undeniable: jaundice and / or pruritus associated with cholestasis; Formation of gallstones; Porphyria; Systemic lupus erythematosus; Hemolytic-uremic syndrome; chorea; Herpes during pregnancy; Hearing loss associated with otosclerosis;

- in women with hereditary angioedema, exogenous estrogens can cause or exacerbate symptoms of angioedema;

- violations of the liver function;

- impaired glucose tolerance or influence on peripheral insulin resistance;

- Crohn's disease, ulcerative colitis;

- Chloasma.

Interaction

Due to the interaction of other drugs (drug) (inducers of microsomal liver enzymes) breakthrough bleeding may occur with oral contraception and / or reducing the contraceptive effect (see. "Interaction").

Interaction

The effect of other drugs on the combination Gestodene + ethinylestradiol

Possible interactions with drugs that induce microsomal enzyme system of liver cytochrome P450, which can result in increased clearance of sex hormones, which in turn may lead to an acyclic breakthrough uterine bleeding and / or reducing the contraceptive effect.

Drugs that increase clearance combination gestodene + ethinylestradiol (attenuating efficiency by induction of microsomal liver enzymes): barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin; AIDS drugs - ritonavir, nevirapine, efavirenz, and possibly oxcarbazepine, topiramate, felbamate, griseofulvin and drugs containing St. John's wort.

If the Gestodene + Ethinyl estradiol combination is finished, it is recommended that a new combination of Gestodene + Ethinylestradiol without a normal interruption be started before the end of the inductor application.

If inductive agents of microsomal liver enzymes are applied in a short course

Women who receive treatment with inductive agents of microsomal enzymes in addition to the combination Gestodene + ethinyl estradiol, it is recommended to temporarily use the barrier method of contraception or choose a different non-hormonal method of contraception. The barrier method of contraception (intrauterine devices or condoms) should be used during the entire period of taking the concomitant funds and for another 28 days after their withdrawal.

If the means-inducers of microsomal liver enzymes are used for a long time

Women who receive long-term treatment with inductive agents of microsomal enzymes are advised to consider the use of nonhormonal methods to provide a more reliable contraceptive effect.

LS with different effect on the clearance of the combination Gestodene + ethinyl estradiol

When coupled with a combination of Gestodene Ethinylestradiol + many HIV protease inhibitors (human immunodeficiency virus) or hepatitis C virus and NNRTIs can both increase and decrease the concentration of estrogen or progestogen in blood plasma. In some cases, such an effect may be clinically significant. Therefore, before using these drugs, you should first study the nature of their possible interaction with the combination Gestodene + ethinyl estradiol and, in case of any doubt, recommend that a woman additionally use barrier contraceptives.

When the joint application combination with ethinylestradiol gestodene + perampanelom, vemurafenib, dabrafenibom, modafinil or rufinamidom should reduce the likelihood of contraceptive effectiveness due to the acceleration of metabolism of sex hormones. It is recommended to use additional methods of contraception (intrauterine devices or condom) throughout the course of co-administration of the remedy and for 2-6 months after its termination.

Drugs that reduce the clearance of the combination Gestodene + ethinyl estradiol (inhibitors of microsomal liver enzymes)

Strong or mild inhibitors isoenzyme CYP3A4, such as azole antifungal agent (e.g. itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g. clarithromycin, erythromycin), diltiazem and grapefruit juice may increase the plasma concentrations of estrogen or progestogen or both.

The use of etorikoksib in doses of 60 and 120 mg / day when taken together with COC containing 0.035 mg of ethinylestradiol raises the concentration of ethinyl estradiol in blood plasma by 1.4 and 1.6 times, respectively. This increase in the concentration of ethinyl estradiol should be taken into account when selecting the appropriate COC for co-administration with etorikoksibom. Such interaction can lead to an increase in the frequency of thromboembolism due to an increase in the exposure of ethinylestradiol.

Reduction of ethinyl estradiol concentration in the blood plasma is observed while the application of certain antibiotics (e.g. penicillins and tetracyclines) due to changes in the microflora in the intestines, so during antibiotic therapy, except rifampicin and griseofulvin and barrier method should additionally be used within 7 days after their withdrawal Contraception.

NSAIDs (non-steroidal anti-inflammatory drugs) reduce the effectiveness of the combination Gestodene + ethinyl estradiol.

Effect of combination Gestodene + ethinyl estradiol on other drugs

The combination of gestodene + ethinyl estradiol can affect the metabolism of other drugs, causing a change in plasma and tissue concentrations, for example, to increase (cyclosporine) or reduce (lamotrigine).

Interaction with the preparations - substrates of the isoenzyme CYP1A2

Since ethinylestradiol is an inhibitor of isozyme CYP1A2 (cytochrome P450), then the combined use of a combination of gestodene + ethinylestradiol with PM - substrates isoenzyme CYP1A2 (for example clozapine, mirtazapine, olanzapine, theophylline, zolmitriptan, melatonin, tizanidine) may increase their concentration in blood plasma , Which may increase the risk of adverse reactions.

When the combination of Gestodene + ethinylestradiol and HIV and hepatitis C protease inhibitors is combined, an increase in the incidence of hepatotoxicity (an increase in hepatic transaminase activity) is possible.

Overdose

Symptoms: nausea, vomiting, irregular spotting, absence of menstrual bleeding.

Treatment: symptomatic. There is no specific antidote.

Routes of administration

Inside.

Precautions

If any of the conditions, diseases and risk factors outlined below are present, the potential risk and expected benefits of using COCs in each individual case should be carefully weighed and discussed with the woman before she decides to start taking the combination. With aggravation, intensification, or the first manifestation of risk factors, the combination may need to be canceled.

CCC diseases (cardiovascular system)

There is evidence of increasing incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) in the COC. These diseases are rare.

Before starting the combination Gestodene + ethinyl estradiol should discuss with a woman a higher (almost 2 times) risk of VTE development than when taking other COCs containing levonorgestrel, norgestimate or norethisterone. This risk is highest in the first year of taking the combination or resuming its use after a break for 4 weeks or more.

Data from a large prospective study with 3 groups of women show that this increased risk is present mainly during the first 3 months.

The overall risk of VTE (venous thromboembolism) in women taking low-dose COCs (<50 μg ethinylestradiol) is 2-3 times higher than in women who do not take COC and are not pregnant, and it remains lower in comparison with the risk of VTE in pregnancy And childbirth; In 1-2% of cases VTE leads to a lethal outcome.

VTE, manifested as deep vein thrombosis and / or PE, can occur with any COCs.

Very rarely, with the use of COCs, thrombosis occurs in other blood vessels, for example, liver, mesenteric, renal, cerebral veins and arteries or retinal vessels.

Symptoms of deep vein thrombosis: edema of the lower limb or along the vein on the lower limb, pain or discomfort in the lower extremity only in the vertical position or walking, sensation of heat in the lower extremity, reddening or discoloration of the skin of the lower limb.

Symptoms of PE: difficulty or rapid breathing; Sudden cough, incl. With hemoptysis; Acute pain in the chest, which can increase with a deep breath; sense of anxiety; Severe dizziness; Rapid or irregular heartbeat.

Arterial thromboembolism can lead to stroke, vascular occlusion or myocardial infarction. Symptoms of a stroke: sudden weakness or loss of sensitivity of the face, limbs, especially on the one hand; Sudden confusion; Disorientation and dysarthria; Sudden full or partial loss of vision; Sudden gait disturbance; dizziness; Loss of coordination of movements; Sudden severe or prolonged headache for no apparent reason; Loss of consciousness or fainting, accompanied by a seizure or without seizures. Other signs of vascular occlusion: sudden pain, puffiness and weak blueing of the extremities, sharp abdomen.

Symptoms of myocardial infarction: pain, discomfort, pressure, feeling of heaviness, compression or raspiraniya in the chest, arm or behind the breastbone; Discomfort with irradiation in the back, cheekbone, larynx, hand, stomach; cold sweat; nausea, vomiting; dizziness; Strong weakness; sense of anxiety; dyspnea; Rapid or irregular heartbeat.

Arterial thromboembolism can be life threatening or fatal.

In women with a combination of several risk factors or high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of risk increase may be higher than with a simple summation of factors.

In this case, the combination of gestodene + ethinylestradiol is contraindicated (see "Contraindications").

The risk of developing thrombosis (venous and / or arterial) and thromboembolism increases:

- with age;

- for smokers (with an increase in the number of cigarettes or an increase in age, the risk further increases, especially in women over 35 years of age);

- if there is a family history (ie venous or arterial thromboembolism in relatives or parents at a relatively young age) - in the case of hereditary predisposition woman should be assessed and the appropriate specialist to solve the problem of the possibility of COC;

- with obesity (BMI more than 30 kg / m2);

- in case of prolonged immobilization, serious surgical interventions, any operation on the lower limbs or extensive trauma. In these situations, the combination should be discontinued (in the case of a planned operation at least 4 weeks before it) and do not resume reception for 2 weeks after the end of immobilization. The temporary immobilization (e.g. flight lasting more than 4 hours) may also be a risk factor for venous thromboembolism (venous thromboembolism), in particular in the presence of other risk factors;

- with dyslipoproteinemia;

- with arterial hypertension;

- with migraine;

- with diseases of the heart valves;

- with atrial fibrillation.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.

An increased risk of thromboembolism in the postpartum period should be considered.

Peripheral circulatory disorders as may occur in diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraine during the use of COCs (which may precede cerebrovascular disorders) may be the reason for the immediate discontinuation of these funds.

By biochemical parameters indicating the inherited or acquired predisposition to venous or arterial thrombosis include resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein deficit S, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).

In assessing the relationship between risk and benefit, it should be borne in mind that adequate treatment of the relevant condition can reduce the risk of thrombosis associated with it.

Tumors

There has been a reported increase in the risk of cervical cancer with prolonged use of COCs. However, the connection with the use of COCs has not been proven. Controversy remains as to the extent to which these data are associated with cervical pathology or features of sexual behavior (a more rare use of barrier methods of contraception). The most significant risk factor for developing cervical cancer is persistent papillomavirus infection.

A meta-analysis of 54 epidemiological studies has shown that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COC (relative risk 1.24). Increased risk gradually disappears within 10 years after discontinuation of these funds. Due to the fact that breast cancer is rarely seen in women under 40 years of age, an increase in the number of diagnoses of breast cancer in women who are currently taking COCs or who have recently taken COC is insignificant in relation to the overall risk of this disease. The relationship between the development of breast cancer and the administration of COC has not been proven. The observed increase in risk may be due not only to an earlier diagnosis of breast cancer in women using COCs, but the biological effects of sex hormones, or a combination of these two factors. Women who have ever used COC have earlier stages of breast cancer than women who have never used them.

In rare cases on the background of the development of benign COCs were observed, and in rare - malignant tumors of the liver, which in some cases lead to life-threatening intraabdominal bleeding. This should be taken into account when making a differential diagnosis in the event of severe pain in the abdomen, increased liver, or signs of intra-abdominal bleeding.

Other states

In women with hypertriglyceridemia (or in the presence of this condition in a family history), an increased risk of developing pancreatitis during COC administration is possible.

Despite the fact that a small increase in blood pressure was described in many women taking COC, a clinically significant increase in blood pressure was noted rarely. Nevertheless, if a persistent, clinically significant increase in blood pressure develops during the administration of COC, these remedies should be abolished and the treatment of arterial hypertension should begin. Reception of COCs can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy. Women with a history of arterial hypertension or diseases that are associated with hypertension (including renal dysfunction) should use other methods of contraception. If women with hypertension make a choice in taking COC, then they need careful medical supervision. In the case of a significant increase in blood pressure, the COC should be stopped.

The following conditions have been reported to develop or worsen, both during pregnancy and when taking COC, but their relationship with COCs has not been proven: jaundice and / or pruritus associated with cholestasis; Formation of stones in the gallbladder; Porphyria; Systemic lupus erythematosus; Hemolytic-uremic syndrome; chorea; Herpes during pregnancy; Hearing loss associated with otosclerosis. Also, cases of Crohn's disease and ulcerative colitis are described in the background of the use of COCs.

In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.

When using the combination, it is possible to develop chloasma, especially in women with a history of pregnant chloasma. Women with a tendency to chloasma while taking COC should avoid prolonged exposure to sunlight and exposure to UV radiation.

In acute or chronic violations of liver function, it may be necessary to cancel the remedy until the liver function indicators return to normal. The recurrence of cholestatic jaundice, which developed for the first time in pregnancy or previous reception of sex hormones, requires discontinuation of COCs.

Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose COCs (<50 μg ethinylestradiol). Nevertheless, women with diabetes require careful monitoring of blood glucose concentrations during the application of the drug.

With the combination of gestodene + ethinyl estradiol, worsening of the course of endogenous depression and epilepsy can be noted.

Medical check-ups

Before starting or resuming the use of the Gestodene + Ethinylestradiol combination, it is necessary to familiarize yourself with the history of life, the family history of the woman, to conduct a thorough general medical (including measurement of blood pressure, heart rate, BMI definition) and gynecological examination, including breast examination and cytology of cervical scraping Pap test), to exclude pregnancy. In addition, violations of the blood coagulation system should be avoided. The volume of additional studies and the frequency of follow-up visits are determined individually. Usually, follow-up examinations should be conducted at least once every 6 months.

A woman should be informed that the combination Gestodene + ethinyl estradiol does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Decrease in efficiency

The effectiveness of the combination of egestodene + ethinyl estradiol may decrease if the combination is missed, gastrointestinal disorders or as a result of interaction (see "Interaction").

Effect on the nature of bleeding

With the use of COC, irregular (acyclic) bleeding (spotting and / or breakthrough bleeding) can occur, especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to exclude malignant neoplasms or pregnancy.

Some women may not develop withdrawal bleeding during a break in the combination. If the COC was administered in accordance with the directions, pregnancy is unlikely. Nevertheless, if before the reception of COC was performed irregularly or there are no consecutive two bleeding cancellations, then before continuing with the combination, pregnancy should be excluded.

Impact on laboratory test scores

Acceptance of COC can influence the results of some laboratory tests, including indicators of liver, kidney, thyroid, adrenal gland function, concentration of transport proteins in blood plasma, lipid fraction, parameters of carbohydrate metabolism, parameters of coagulation and fibrinolysis. Changes usually remain within normal physiological values.

Influence on the ability to drive vehicles and mechanisms. The effect of the combination Gestodene + ethinyl estradiol on the ability to drive vehicles and mechanisms is not revealed.