Lindinet 30 should not be taken over 35. Geotar medicinal reference book. Video: How to choose birth control pills

INN: Gestodene, Ethinylestradiol

Manufacturer: Gedeon Richter OJSC

Anatomical-therapeutic-chemical classification: Gestodene and estrogen

Registration number in the Republic of Kazakhstan: No. RK-LS-5No. 014071

Registration period: 03.06.2014 - 03.06.2019

Instructions

Tradename

Lindinet 30

International nonproprietary name

Dosage form

Film-coated tablets

Compound

One tablet contains

active substances: ethinyl estradiol 0.03 mg,

gestodene 0.075 mg,

Excipients: sodium calcium edetate, magnesium stearate, colloidal silicon dioxide anhydrous, povidone, corn starch, lactose monohydrate,

shell composition: quinoline yellow (E 104), povidone, titanium dioxide (E 171), macrogol 6000, talc, calcium carbonate, sucrose

Description

Round, biconvex, film-coated tablets yellow color(for Lindinet 30).

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system. Hormonal contraceptives for systemic use. Progestogens and estrogens (fixed combinations). Gestodene and estrogens

ATX code G03AA10

Pharmacological properties

Pharmacokinetics

Gestoden

Suction

After oral administration, gestodene is rapidly and completely absorbed. Peak plasma concentrations after a single dose are reached after approximately 1 hour and are approximately 2-4 ng/ml. Bioavailability is about 99%.

Distribution

Gestodene binds to serum albumin and sex hormone binding globulin (SHBG). Only 1-2% of the total concentration of the substance in the blood serum is in the form of a free steroid, and 50-75% is specifically associated with SHBG. Ethinyl estradiol-induced increases in SHBG levels affect the amount of gestodene bound to serum protein, causing an increase in the fraction of gestodene bound to SHBG and a decrease in the fraction bound to albumin. The apparent volume of distribution of gestodene is 0.7-1.4 l/kg.

Metabolism

Gestodene is completely metabolized through known pathways of steroid hormone metabolism.

The average rate of metabolic clearance from blood plasma is 0.8-1.0 ml/min/kg.

Removal

Serum gestodene levels undergo a biphasic decrease. The half-life in the terminal phase is 12-20 hours. Gestodene is excreted in urine and bile only in the form of metabolites in a ratio of 6:4. The half-life of metabolites is approximately 1 day.

Equilibrium concentration

The pharmacokinetics of gestodene is affected by the level of SHBG, which increases approximately threefold with concomitant administration of ethinyl estradiol. After daily administration, the level of gestodene in the blood serum increases approximately three to four times, reaching an equilibrium concentration in the second half of the drug course.

Ethinyl estradiol

Suction

After oral administration, ethinyl estradiol is rapidly and completely absorbed. Peak plasma concentrations are reached after approximately 1-2 hours and are approximately 30-80 pg/ml. Absolute bioavailability as a result of presystemic conjugation and the first-pass effect through the liver is approximately 60%.

Distribution

Ethinyl estradiol binds strongly but nonspecifically to serum albumin (approximately 98.5%), resulting in increasing serum SHBG concentrations. The apparent volume of distribution of gestodene is 5-18 l/kg.

Metabolism

Ethinyl estradiol is metabolized primarily by aromatic hydroxylation, however, it forms a large number of hydroxylated and methylated metabolites, including both free metabolites and conjugates with glucuronides and sulfates. The rate of metabolic clearance is approximately 5-13 ml/min/kg.

Removal

Serum ethinyl estradiol levels undergo a biphasic decline, with a terminal half-life of approximately 16-24 hours. It is excreted only in the form of metabolites, the ratio between urine and bile is 2:3. The half-life of metabolites is approximately 1 day.

Equilibrium concentration

Steady-state concentrations are reached after 3-4 days, during which time serum ethinyl estradiol levels increase by 20% compared to the level after a single dose.

Pharmacodynamics

The effect of combined oral contraceptives (COCs) is due to the suppression of the production of gonadotropic hormones. Although the primary mechanism of action is the suppression of ovulation, other mechanisms of action, including changes in the cervical mucus (which makes it difficult for sperm to enter the uterus) and the endometrium (which reduces the likelihood of implantation), also have a contraceptive effect.

In addition to the contraceptive effect, they have a number of other positive effects.

Effect on the menstrual cycle:

Regulate the menstrual cycle, reduce blood and iron loss during menstruation, and reduce the incidence of dysmenorrhea.

Actions, associated with inhibition of ovulation:

Reduces the incidence of functional ovarian cysts and ectopic pregnancy.

Other actions

They reduce the incidence of fibroadenomas and fibrous cysts of the mammary glands, infections of the pelvic organs, endometrial cancer, and improve the condition of the skin with acne.

Indications for use

Oral contraception

Directions for use and doses

Take one tablet daily (preferably at the same time of day) for 21 days. Taking tablets from the next package should begin after a 7-day break, during which withdrawal bleeding should begin. Bleeding usually starts 2 or 3 days after taking the last tablet and may not stop until you start taking the next pack of tablets.

Taking Lindinet 30 for the first time

The first Lindinet 30 tablet should be taken on the first day of the menstrual cycle.

You can also start taking the pills on days 2 to 5 of your period, but in this case you must use additional non-hormonal contraceptive measures for the first seven days of taking the pills during your first cycle.

Switching from taking another combined oral contraceptive

The first Lindinet 30 tablet should be taken the day after taking the last active (hormone-containing) tablet from the previous package of oral contraceptives, but no later than the next day after taking regular tablets (or taking placebo tablets) from the previous package of oral contraceptives.

Transition from progestogen-containing drugs (mini-pill, injections, implant, IUD)

The transition from taking the “mini-pill” to taking Lindinet 30 can be done on any day of the menstrual cycle (from the implant and intrauterine device - on the day of their removal, from injections - on the day when the next injection is necessary). In these cases, additional contraceptive measures must be used during the first 7 days of taking the pills.

After an abortion in the 1st trimester

Oral contraceptives can be started immediately after a first trimester abortion. Additional measures contraception is not required.

After childbirth or abortion in the 2nd trimester

Women who are not breastfeeding can start taking oral contraceptives 21 to 28 days after vaginal birth or after a 2nd trimester abortion. If you start taking oral contraceptives later, barrier methods of contraception must be used as additional measures during the first 7 days.

If sexual intercourse has already taken place, pregnancy should be excluded before starting to take the pills, or the drug should be postponed until the first menstrual bleeding begins.

Missed pills

If the tablet is not taken on time, it should be taken as quickly as possible. If the missed pill has been taken within 12 hours After the usual time of taking it, the contraceptive effect of the drug does not decrease, and additional contraceptive measures are not required. Subsequent tablets should be taken at the usual time.

If there is a delay in taking the pill exceeds 12 hours, the contraceptive effect may decrease. A woman should take the missed pill as soon as she remembers, even if she has to take 2 pills at the same time. From now on, the woman should take the pills at the usual time. Additional contraceptive measures are required during the next 7 days of taking the pills. If there are less than 7 tablets left in the current pack, the woman should start taking tablets from the next pack immediately after taking the last tablet from the current pack: this means that there will be no break between taking tablets from two packs. In this case, you should not expect withdrawal bleeding until the second pack of tablets runs out, but spotting or breakthrough bleeding may develop.

If, after finishing taking the tablets from the second package, withdrawal bleeding does not develop, then before starting to take the tablets from the next package, it is necessary to exclude the presence of pregnancy.

Measures to be taken in case of vomiting

If vomiting occurs within 3-4 hours after taking the tablet, absorption of the tablet may not be complete. In such cases, it is necessary to take the precautions described above regarding missed tablets. If a woman does not want to change her usual pill regimen, she should take the necessary additional pills from a different pack.

Acceleration of the onset of menstruation or delay of menstruation

To ensure that menstrual bleeding begins earlier than usual when taking the pill, it is recommended to shorten the interval between pills by the desired number of days. The shorter the break, the higher the risk of breakthrough bleeding or spotting when taking tablets from the second package (as in the case of delayed menstrual bleeding).

To delay the onset of menstrual bleeding, you should start taking tablets from new packaging immediately after the tablets from the current package run out, without leaving a break between them. Menstruation can be delayed as long as required until all the pills in the second pack are gone. When taking tablets from the second package, breakthrough bleeding or spotting may occur. Regular use of Lindinet 30 can be resumed after the usual 7-day break.

Side effects

Very often (≥/10)

Breakthrough bleeding, spotting between periods

Often (≥1/100 to<1/10)

Headache, dizziness, migraine

Mood changes, depression, nervousness, irritability, decreased or increased libido

Fluid retention

Vulvaginal candidiasis

Nausea, vomiting, abdominal pain

Soreness and engorgement of the mammary glands

Decrease/increase in body weight

Uncommon (≥1/1000 to<1/100)

Decreased/increased appetite

Mammary cancer

Arterial hypertension

Chloasma, melasma

Rarely (≥1/10000 to<1/1000)

Anaphylactic reactions

Impaired glucose tolerance, hyperlipidemia, hypertriglyceridemia

Contact lens intolerance

Otosclerosis

Thrombosis, embolism

Very pcaustically<1/1000 0 )

Gallbladder diseases, cholelithiasis, pancreatitis, hepatocellular carcinoma, liver adenoma

Exacerbations of systemic lupus erythematosus

Exacerbation of chorea, optic neuritis

Stroke, myocardial infarction

Retinal artery thrombosis

Hemolytic-uremic syndrome

The use of oral contraceptives is associated with an increased risk of developing the following conditions:

Arterial and venous thrombotic and thromboembolic complications, including myocardial infarction, stroke, venous thrombosis and pulmonary embolism.

Cervical intraepithelial neoplasia and cervical cancer

Mammary cancer

Optic neuritis can lead to partial or complete loss of vision. The use of COCs can aggravate the course of existing gallbladder disease and accelerate the development of the disease in women who previously had no symptoms of the disease.

Contraindications

- hypersensitivity to the components of the drug

Pregnancy or suspicion of it

Vaginal bleeding of unknown etiology

Current or history of arterial or venous thrombosis

Presence of serious risk factors for thrombosis or embolism (blood clotting disorders, valvular heart disease, and atrial fibrillation)

History of prodromal symptoms of thrombosis (eg, transient cerebral ischemic attack, angina)

Cardiovascular disorders (pathology of the heart valve(s), arrhythmias)

Severe hypertension

History of liver tumors (benign or malignant)

Serious liver diseases, until liver function test parameters are normalized

Diagnosed or suspected malignant tumors of the mammary glands

Diagnosed or suspected malignant endometrial tumors or other estrogen-dependent neoplasms

Vascular ophthalmopathy

History of pregnancy herpes

Sickle cell anemia

Hyperlipidemia

Diabetes complicated by angiopathy

Migraine with focal neurological symptoms

Children and teenagers up to 18 years of age

Hereditary fructose intolerance, Lapp-lactase enzyme deficiency, glucose-galactose malabsorption

Drug interactions

Interactions between ethinyl estradiol and concomitantly administered drugs may result in increased or decreased plasma ethinyl estradiol levels.

A decrease in the level of ethinyl estradiol in plasma can lead to an increase in the number of breakthrough bleeding and menstrual irregularities, and sometimes a decrease in the contraceptive effect of Lindinet 30 is also observed. Therefore, in the case of simultaneous use of ethinyl estradiol and drugs that reduce the level of ethinyl estradiol in plasma, in addition to taking Lindinet 30, it is recommended to use non-hormonal methods of contraception (for example, condoms, spermicides). If long-term use of drugs containing such active substances is necessary, the possibility of abandoning the use of hormonal contraceptives as the main method of contraception should be considered.

After discontinuation of medications that reduce the concentration of ethinyl estradiol in the blood, it is recommended to use additional non-hormonal methods of contraception for at least 7 days. After discontinuation of medications that can cause the induction of microsomal liver enzymes and lead to a decrease in the concentration of ethinyl estradiol in the blood serum, it is recommended to use additional non-hormonal methods of contraception for a longer period. Sometimes, depending on the dose, duration of treatment, and the rate of elimination of the enzyme-inducing drug, weeks may pass before liver enzyme induction completely stops.

Active substances that may reduce the serum concentration of ethinyl estradiol:

Any active substance that reduces gastrointestinal transit time and therefore reduces absorption;

Substances that induce liver microsomal enzymes, for example, rifampicin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, griseofulvin, topiramate, some protease inhibitors and modafinil;

Hypericum perforatum (St. John's wort) and ritonavir (due to the ability to induce microsomal liver enzymes);

Some antibiotics (eg, ampicillin and other penicillins, tetracyclines), as they reduce the enterohepatic recirculation of estrogens.

Active substances that may increase serum concentrations of ethinyl estradiol:

Atorvastatin;

Drugs that also undergo sulfation in the wall of the gastrointestinal tract, for example, ascorbic acid (vitamin C) and paracetamol;

Substances that inhibit cytochrome P 450 3A4 isoenzymes, for example, indinavir, fluconazole, troleandomycin.

Troleandomycin, when used in combination with oral contraceptives, may increase the risk of intrahepatic cholestasis.

Ethinyl estradiol may affect the metabolism of other drugs by inhibiting liver microsomal enzymes or causing drug conjugation in the liver, in particular glucuronidation. Therefore, plasma and tissue concentrations of other drugs may be increased (eg, cyclosporine, theophylline, corticosteroids) or decreased. When prescribing any drugs, you should take into account information about their combined use in order to establish possible interaction reactions.

Changes in laboratory results

The use of oral contraceptives may affect the results of some laboratory tests, including tests of liver, thyroid, adrenal, kidney function, lipoprotein and carrier protein levels, as well as parameters of carbohydrate metabolism, coagulation and fibrinolysis.

Usually the changes do not go beyond the reference values ​​and remain within normal limits.

special instructions

Circulatory disorders

Contraceptive use is associated with an increased risk of myocardial infarction. The risk is higher in women who smoke and have additional risk factors for coronary artery disease, such as hypertension, high cholesterol, morbid obesity and diabetes.

Smoking increases the risk of serious cardiovascular complications associated with oral contraceptives. The risk increases with age, and also in the case of smoking a large number of cigarettes, this risk is quite significant in women over 35 years of age. Women taking oral contraceptives should be advised to quit smoking.

Women with risk factors for developing cardiovascular disease should be prescribed oral contraceptives with caution.

It has been proven that taking oral contraceptives increases the risk of developing cerebrovascular diseases (ischemic and hemorrhagic stroke).

Increased blood pressure (BP) has also been reported in women taking oral contraceptives. Increased blood pressure is usually observed in older women and in those who take oral contraceptives for a long time.

The data obtained show that the incidence of arterial hypertension increases depending on the amount of estrogen.

Women who have previously suffered from hypertension or diseases associated with hypertension or impaired renal function should be advised to use another method of contraception. These women should be closely monitored if they decide to take oral contraceptives. If there is a significant increase in blood pressure, you should stop taking oral contraceptives.

In most women, elevated blood pressure normalizes after discontinuation of oral contraceptives; there are no differences in the incidence of arterial hypertension between women who previously used and did not use oral contraceptives.

Venous and arterial thrombosis and thromboembolism

The use of combined oral contraceptives is associated with an increased risk of venous and arterial thrombotic and thromboembolic complications. For each specific estrogen/progestogen combination, a dosing regimen should be prescribed that contains the minimum amount of estrogen and progestogen while maintaining a low failure rate and meeting the patient's needs.

Venous thrombosis and thromboembolism

The use of any combined oral contraceptives carries an increased risk of venous thromboembolism (VTE) compared with that without the use of COCs. The additional risk of venous thromboembolism is greatest during the very first year of combined oral contraceptive use. This risk is less than the risk of pregnancy-associated VTE, which is 60 per 100,000 pregnancies; VTE is fatal in 1-2% of cases.

The incidence of VTE for combined oral contraceptives containing levonorgestrel and less than 50 mcg ethinyl estradiol is approximately 20 cases per 100,000 women per year of use. The incidence of VTE for combined oral contraceptives containing gestodene is approximately 30-40 cases per 100,000 women per year of use. The effect of the relative risk on the number of additional cases is greater in women during the very first year of combined oral contraceptive use.

Epidemiological studies have not confirmed that women taking combined oral contraceptives containing desogestrel or gestodene and 0.02 mg ethinyl estradiol have a lower risk of developing VTE than women taking combined oral contraceptives containing desogestrel or gestodene and 0.03 mg ethinyl estradiol.

Risk factors for arterial and/or venous thromboembolism

Age

Smoking (for heavy smokers, the risk increases with age, especially in women over 35 years of age)

Hereditary predisposition (for example, arterial or venous thromboembolism in siblings or parents at a relatively young age). If there is a hereditary predisposition, the woman should be referred to a specialist before deciding to take oral contraceptives

Obesity (body mass index more than 30 kg/m2)

Dyslipoproteinemia

Arterial hypertension

Heart valve disease

Atrial fibrillation

Prolonged immobilization (since the risk of thromboembolism is increased in the postoperative period, it is recommended to stop taking oral contraceptives at least four weeks before planned surgery and return to taking them no earlier than two weeks after returning to normal physical activity).

Since the period immediately after childbirth is associated with an increased risk of thromboembolism, Lindinet 30 should be started no earlier than 28 days after childbirth or abortion in the second trimester of pregnancy.

Arterial thrombosis and thromboembolism

Lindinet 30 increases the risk of developing arterial thrombotic and thromboembolic complications. Described complications include myocardial infarction and cerebrovascular disorders (ischemic and hemorrhagic stroke, transient ischemic attack). The risk of developing arterial thrombotic and thromboembolic complications is higher in women with additional risk factors.

Lindinet should be prescribed with caution to women who have risk factors for the development of thrombotic and thromboembolic complications.

Examples of risk factors contributing to the development of thrombotic and thromboembolic complications:

Smoking

Certain hereditary and acquired thrombophilias

Arterial hypertension

Hyperlipidemia

Obesity

Age

Women who suffer from migraines and take COCs have an increased risk of stroke.

The drug should be stopped immediately if symptoms indicating the development of thrombosis appear: severe chest pain that may radiate to the left arm, unusual pain in the leg, swelling of the leg, sharp pain when breathing or coughing, the appearance of bloody sputum.

Biochemical parameters indicating the presence of hereditary or acquired predisposition to venous or arterial thrombosis include the following: activated protein C resistance (APC), hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Tumors

Some studies have reported an increased risk of cervical cancer in women taking combined oral contraceptives for a long time, but this information is controversial. Sexual behavior and other risk factors, such as human papillomavirus (HPV), may also influence the development of cervical cancer.

A meta-analysis of 54 pharmacoepidemiological studies showed that the relative risk of developing breast cancer is slightly higher in women taking combined oral contraceptives (RR = 1.24). This increased risk gradually decreases over 10 years after stopping combined oral contraceptives. However, these studies did not confirm the presence of a cause-and-effect relationship between the disease and taking the drug.

Women who take oral contraceptives are diagnosed with breast cancer at an earlier stage than those who do not use them.

A connection has been established between the formation of benign liver tumors and the use of oral contraceptives, although such benign tumors are rare. When these tumors rupture, intraperitoneal bleeding occurs, which can be fatal.

In rare cases, the development of malignant liver tumors has been reported in women taking oral contraceptives for a long time.

In patients with a history of cholestatic jaundice or itching during pregnancy, as well as in patients who have previously taken combined oral contraceptives, the risk of developing the diseases described above is higher. If such patients take Lindinet 30, careful monitoring of their condition is necessary, and if the pathological condition returns, the use of the drug must be discontinued.

Other states

In rare cases, retinal thrombosis has been reported when taking oral contraceptives. In case of unexplained partial or complete loss of vision, the appearance of exophthalmos or diplopia, papilledema or damage to the retinal vessels, it is necessary to stop taking oral contraceptives and undergo additional medical examination.

Previous studies have suggested an increased lifetime relative risk of gallbladder disease in women taking oral contraceptives and estrogen-containing medications. However, recent studies have shown that the relative risk of developing gallbladder disease may be minimal in women taking low-dose oral contraceptives.

The appearance of migraine, or worsening migraine attacks, as well as the appearance of a new type of headache, recurrent, constant or very severe, requires discontinuation of oral contraceptives.

You should immediately stop taking Lindinet 30 if you experience itching all over your body or epileptic seizures.

Effect on carbohydrate and lipid metabolism

There are reports of impaired glucose tolerance in women taking oral contraceptives. Therefore, the condition of women with diabetes and using oral contraceptives should be carefully monitored.

A small number of women experience persistent hypertriglyceridemia while taking oral contraceptives. Decreases in high-density lipoprotein (HDL) levels have been reported with the use of some progestogen-containing drugs. Because estrogen increases HDL cholesterol, the cumulative effect of oral contraceptives on lipid metabolism depends on the ratio between estrogen and progestogen doses, the type of progestogen, and the absolute amount of progestogen used in the oral contraceptive.

Women with hyperlipidemia should be closely monitored if they decide to take oral contraceptives.

There are reports that women with hereditary hyperlipidemia who take oral contraceptives containing estrogen experience a significant increase in plasma triglyceride levels, which can lead to pancreatitis.

Menstrual irregularities

When taking the pills, especially during the first three months, irregular menstruation (spotting or breakthrough bleeding) may occur.

If irregular menstruation persists for a long time or develops after a regular cycle has been established, it should be taken into account that this phenomenon may have a non-hormonal cause. In this case, to exclude the possibility of developing a malignant neoplasm or pregnancy, it is necessary to conduct a gynecological examination. If a pathological condition is excluded, the use of another type of oral contraceptives may be recommended.

In some cases, a 7-day break in contraception is not accompanied by bleeding. In cases where the contraceptive was not taken as prescribed, or when there is no bleeding after taking all the tablets from the current package, pregnancy should be excluded before continuing to take the contraceptive from the next package.

Precautionary measures

Medical examination and follow-up

Before starting the use of oral contraceptives, the patient's family and personal history should be collected, a general medical and gynecological examination should be performed, including blood pressure measurement, laboratory tests, examination of the mammary glands and pelvic organs, and a vaginal smear for cytology; in the future, these procedures should be repeated periodically.

Patients should be advised that this drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Liver function

In case of acute or chronic liver dysfunction, the drug should be discontinued until liver function tests return to normal. In patients with impaired liver function, the metabolism of steroid hormones may be insufficient.

Affective disorders

Women who develop severe depression while using oral contraceptives should stop taking the pill. These women should be advised to use an alternative method of contraception, and an attempt should be made to determine whether these symptoms are due to the use of oral contraceptives. Women who have previously suffered from depression should be closely monitored; If attacks of depression recur, you should stop taking the oral contraceptive drug.

Folate levels

Serum folate levels may decrease due to the use of oral contraceptives. This may be clinically significant if a woman becomes pregnant soon after stopping oral contraceptives.

Chloasma

The appearance of chloasma is especially common in women with a history of chloasma during pregnancy. Women predisposed to chloasma should avoid exposure to the sun and ultraviolet radiation while taking COCs.

Other

In addition to the conditions listed above, increased precautions should be taken in the case of otosclerosis, multiple sclerosis, epilepsy, chorea, intermittent porphyria, seizures, renal dysfunction, obesity, systemic lupus erythematosus and uterine fibroids.

Patients with rare hereditary pathologies such as fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency should not use this drug.

Pregnancy and lactation

Before starting Lindinet 30, pregnancy should be excluded. If pregnancy occurs while using the drug, you must immediately stop taking oral contraceptives.

Extensive epidemiological studies have found neither an increased risk of congenital malformations in newborns born to women who took oral contraceptives before pregnancy, nor teratogenic effects (particularly heart defects and limb abnormalities) in cases where oral contraceptives were inadvertently taken early in pregnancy pregnancy.

A small amount of the active substance is excreted in breast milk, which can cause side effects in newborns such as jaundice and breast enlargement. During breastfeeding, it is not recommended to take oral contraceptives, as this can lead to a reduction in the amount of breast milk and a change in its composition.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Considering the possibility of developing side effects such as dizziness and blurred vision, care must be taken when driving a vehicle and working with driving mechanisms.

Overdose

Symptoms: nausea, vomiting, slight vaginal bleeding in young girls.

Description of the dosage form

Release form, composition and packaging

Film-coated tablets light yellow, round, biconvex, both sides without inscriptions; on the fracture it is white or almost white with a light yellow edging.

Excipients: sodium calcium edetate, magnesium stearate, colloidal silicon dioxide, povidone, corn starch, lactose monohydrate.

Shell composition: quinoline yellow dye (D+S yellow No. 10) (E104), povidone, titanium dioxide, macrogol 6000, talc, calcium carbonate, sucrose.

21 pcs. - blisters (1) - cardboard packs.
21 pcs. - blisters (3) - cardboard packs.

Clinical and pharmacological group

Monophasic oral contraceptive

pharmachologic effect

Monophasic oral contraceptive. Inhibits the secretion of gonadotropic hormones of the pituitary gland. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is ethinyl estradiol, a synthetic analogue of the follicular hormone estradiol, which participates together with the corpus luteum hormone in the regulation of the menstrual cycle. The gestagenic component is gestodene, a derivative of 19-nortestosterone, which is superior in strength and selectivity to not only the natural corpus luteum hormone progesterone, but also other synthetic gestagens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has virtually no effect on lipid and carbohydrate metabolism.

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. In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Gestoden

Suction

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. After a single dose, Cmax is observed after 1 hour and is 2-4 ng/ml. Bioavailability is about 99%.

Distribution

Gestodene binds to albumin and sex hormone binding globulin (SHBG). 1-2% is found in plasma in free form, 50-75% specifically binds to SHBG. An increase in the level of SHBG in the blood caused by ethinyl estradiol affects the level of gestodene: the fraction associated with SHBG increases and the fraction associated with albumin decreases. Average V d - 0.7-1.4 l/kg. The pharmacokinetics of gestodene depends on the level of SHBG. The concentration of SHBG in blood plasma under the influence of estradiol increases 3 times. When taken daily, the concentration of gestodene in the blood plasma increases 3-4 times and in the second half of the cycle reaches a state of saturation.

Metabolism and excretion

Gestodene is biotransformed in the liver. The average plasma clearance is 0.8-1 ml/min/kg. The level of gestodene in the blood serum decreases in two phases. T1/2 in the β-phase is 12-20 hours. Gestodene is excreted only in the form of metabolites, 60% in urine, 40% in feces. T 1/2 metabolites - about 1 day.

Ethinyl estradiol

Suction

After oral administration, ethinyl estradiol is absorbed quickly and almost completely. The average Cmax in blood serum is reached 1-2 hours after administration and is 30-80 pg/ml. Absolute bioavailability due to presystemic conjugation and primary metabolism is about 60%.

Distribution

Completely (about 98.5%), but nonspecifically binds to albumin and induces an increase in the level of SHBG in the blood serum. Average Vd - 5-18 l/kg.

C ss is established by the 3-4th day of taking the drug, and it is 20% higher than after a single dose.

Metabolism

It undergoes aromatic hydroxylation to form hydroxylated and methylated metabolites, which are present in the form of free metabolites or in the form of conjugates (glucuronides and sulfates). Metabolic clearance from blood plasma is about 5-13 ml.

Removal

Serum concentration decreases in two phases. T1/2 in the β-phase is about 16-24 hours. Ethinyl estradiol is excreted only in the form of metabolites, in a 2:3 ratio with urine and bile. T 1/2 metabolites - about 1 day.

Indications for use of the drug

- contraception.

Dosage regimen

Prescribe 1 tablet/day for 21 days, if possible at the same time of day. After taking the last tablet from the package, take a 7-day break, during which withdrawal bleeding occurs. The next day after a 7-day break (i.e., 4 weeks after taking the first tablet, on the same day of the week), the drug is resumed.

The first tablet of Lindinet 20 should be taken from the 1st to the 5th day of the menstrual cycle.

At switching to taking Lindinet 20 from another combined oral contraceptive The first Lindinet 20 tablet should be taken after taking the last tablet from the package of another oral hormonal contraceptive, on the first day of withdrawal bleeding.

At switching to taking Lindinet 20 from drugs containing only progestogen (“mini-pill”, injections, implant), When taking the “mini-pill”, taking Lindinet 20 can be started on any day of the cycle; you can switch from using the implant to taking Lindinet 20 the next day after removal of the implant; when using injections, on the eve of the last injection. In these cases, additional methods of contraception should be used in the first 7 days.

After an abortion in the first trimester of pregnancy You can start taking Lindinet 20 immediately after surgery. In this case, there is no need to use additional methods of contraception.

After childbirth or after an abortion in the second trimester of pregnancy Taking the drug can be started on days 21-28. In these cases, additional methods of contraception must be used in the first 7 days. If you start taking the drug later, an additional barrier method of contraception should be used in the first 7 days. If sexual contact took place before starting contraception, pregnancy should be ruled out before starting the drug or the start of use should be delayed until the first menstruation.

At pass taking a pill, the missed pill should be taken as quickly as possible. If the interval in taking pills was less than 12 hours, then the contraceptive effect of the drug is not reduced, and in this case there is no need to use an additional method of contraception. The remaining tablets should be taken at the usual time. If the interval was more than 12 hours, then the contraceptive effect of the drug may be reduced. In such cases, you should not make up for the missed dose, continue taking the drug as usual, but in the next 7 days you must use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, taking the drug from the next package should be started without interruption. In this case, withdrawal bleeding does not occur until the end of taking the drug from the second package, but spotting or breakthrough bleeding may occur.

If withdrawal bleeding does not occur after completing the drug from the second package, then pregnancy should be excluded before continuing to take the drug.

If within 3-4 hours after taking the drug begins vomiting and/or diarrhea, a decrease in the contraceptive effect is possible. In such cases, you should follow the instructions for skipping pills. If the patient does not want to deviate from her usual contraceptive regimen, the missed pills should be taken from another package.

For accelerating the onset of menstruation the break in taking the drug should be reduced. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking tablets from the next package (similar to cases with delayed menstruation).

For delayed onset of menstruation The drug should be continued from the new package without a 7-day break. Menstruation can be delayed as long as necessary until the end of taking the last tablet from the second pack. When menstruation is delayed, breakthrough or spotting bleeding may occur. Regular use of Lindinet 20 can be resumed after the usual 7-day break.

Side effect

Side effects requiring discontinuation of the drug

From the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss due to otosclerosis.

Others: hemolytic-uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects are more common but less severe. The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

From the reproductive system: acyclic bleeding/spotty discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes in the vagina, candidiasis, tension, pain, enlarged mammary glands, galactorrhea.

From the digestive system: epigastric pain, nausea, vomiting, Crohn's disease, ulcerative colitis, the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis, hepatitis, liver adenoma.

Dermatological reactions: Erythema nodosum, exudative erythema, rash, chloasma, increased hair loss.

From the side of the central nervous system: headache, migraine, mood lability, depression.

From the senses: decreased hearing, increased sensitivity of the cornea (when wearing contact lenses).

From the side of metabolism: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates, hyperglycemia, increased TG levels.

Others: allergic reactions.

Contraindications to the use of the drug

- the presence of severe and/or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebral or coronary artery disease, severe or moderate arterial hypertension with blood pressure ≥ 160/100 mm Hg);

- presence or indication in history of precursors of thrombosis (including transient ischemic attack, angina pectoris);

- migraine with focal neurological symptoms, incl. in the anamnesis;

- venous or arterial thrombosis/thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;

- history of venous thromboembolism;

- surgery with long-term immobilization;

— diabetes mellitus (with angiopathy);

- pancreatitis (including a history), accompanied by severe hypertriglyceridemia;

- dyslipidemia;

- severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization);

- jaundice when taking GCS;

- gallstone disease currently or in history;

- Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;

- liver tumors (including in history);

- severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;

— hormone-dependent malignant neoplasms of the genital organs and mammary glands (including if they are suspected);

- vaginal bleeding of unknown etiology;

- smoking over the age of 35 (more than 15 cigarettes per day);

— pregnancy or suspicion of it;

- lactation period;

- hypersensitivity to the components of the drug.

WITH caution the drug should be prescribed for conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family), hemolytic uremic syndrome, hereditary angioedema, liver diseases, diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including porphyria, herpes of pregnant women, minor chorea / Sydenham disease /, Sydenham chorea, chloasma), obesity (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, major surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis , postpartum period (non-lactating women /21 days after childbirth/; lactating women after the end of the lactation period), the presence of severe depression (including a history), changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, incl. . antibodies to cardiolipin, lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic liver diseases.

Use of the drug during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

The components of the drug are excreted in breast milk in small quantities.

When used during lactation, milk production may decrease.

Use for liver dysfunction

Contraindicated in case of liver dysfunction.

Use for renal impairment

special instructions

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 examinations during the period of taking the drug are carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women over 1 year) when used correctly is about 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 taking the drug, it is recommended to additionally use non-hormonal methods of contraception.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception.

The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

— diseases of the hemostasis system;

— conditions/diseases predisposing to the development of cardiovascular and renal failure;

- epilepsy;

- migraine;

- the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;

- diabetes mellitus, not complicated by vascular disorders;

- severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B 6 can be used for correction);

- sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;

- the appearance of abnormalities in laboratory tests assessing liver function.

Thromboembolic diseases

Epidemiological studies have shown that there is a connection between taking oral hormonal contraceptives and an increased risk of developing arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). An increased risk of venous thromboembolic diseases has been proven, but it is significantly less than during pregnancy (60 cases per 100 thousand pregnancies). When using oral contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of arterial or venous thromboembolic disease increases:

- with age;

- when smoking (heavy smoking and age over 35 years are risk factors);

- if there is a family history of thromboembolic diseases (for example, in parents, brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;

- for obesity (body mass index more than 30 kg/m2);

- for dislipoproteinemia;

- for arterial hypertension;

— for diseases of the heart valves complicated by hemodynamic disorders;

- with atrial fibrillation;

- with diabetes mellitus complicated by vascular lesions;

- with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed to temporarily stop using the drug (no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

It should be taken into account that diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia increase the risk of developing venous thromboembolic diseases.

It should be taken into account that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.

When assessing the benefit/risk ratio of taking the drug, it should be taken into account that targeted treatment of this condition reduces the risk of thromboembolism. Symptoms of thromboembolism are:

- sudden chest pain that radiates to the left arm;

- sudden shortness of breath;

- any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, acute abdomen.

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies found that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection rate of breast cancer may have been associated with more regular medical screening. Breast cancer is rare among women under 40, whether they take hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, the woman should be made aware of the possible risk of developing breast cancer based on an assessment of the benefit-risk ratio (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be kept in mind when differentially assessing abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chloasma

Chloasma can develop in women with a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or ultraviolet radiation while taking Lindinet 20.

Efficiency

The effectiveness of the drug may be reduced in the following cases: missed pills, vomiting and diarrhea, simultaneous use of other drugs that reduce the effectiveness of birth control pills.

If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they run out in the next package. If at the end of the second cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, stop taking the pills and resume it only after pregnancy has been ruled out.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

After acute viral hepatitis, the drug should be taken after normalization of liver function (no earlier than 6 months).

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take 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.

The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted to study the effect of Lindinet 20 on the abilities necessary to drive a car and operate machinery.

Overdose

No severe symptoms have been described after taking the drug in high doses.

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

Treatment: symptomatic therapy is prescribed; there is no specific antidote.

Drug interactions

The contraceptive activity of Lindinet 20 is reduced when taken simultaneously with ampicillin, tetracycline, rifampicin, barbiturates, primidone, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine. The contraceptive effect of oral contraceptives is reduced when these combinations are used, breakthrough bleeding and menstrual irregularities become more frequent. While taking Lindinet 20 with the above drugs, as well as for 7 days after completing the course of taking them, it is necessary to use additional non-hormonal (condom, spermicidal gels) methods of contraception. When using rifampicin, additional methods of contraception should be used for 4 weeks after completion of the course of taking it.

When used simultaneously with Lindinet 20, any drugs that increase gastrointestinal motility reduce the absorption of active substances and their level in the blood plasma.

Sulfation of ethinyl estradiol occurs in the intestinal wall. Drugs that are also subject to sulfation in the intestinal wall (including ascorbic acid) competitively inhibit the sulfation of ethinyl estradiol and thereby increase the bioavailability of ethinyl estradiol.

Inducers of microsomal liver enzymes reduce the level of ethinyl estradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oscarbazepine).

Liver enzyme inhibitors (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma.

Some antibiotics (ampicillin, tetracycline), by interfering with the intrahepatic circulation of estrogens, reduce the level of ethinyl estradiol in plasma.

Ethinyl estradiol, by inhibiting liver enzymes or accelerating conjugation (primarily glucuronidation), can affect the metabolism of other drugs (including cyclosporine, theophylline); The concentration of these drugs in the blood plasma may increase or decrease.

When Lindinet 20 is used simultaneously with St. John's wort preparations (including infusion), the concentration of active substances in the blood decreases, which can lead to breakthrough bleeding and pregnancy. The reason for this is the inducing effect of St. John's wort on liver enzymes, which continues for another 2 weeks after completing the course of taking St. John's wort. It is not recommended to prescribe this combination of drugs.

Ritonavir reduces the AUC of ethinyl estradiol by 41%. In this regard, during the use of ritonavir, a hormonal contraceptive with a higher ethinyl estradiol content should be used or additional non-hormonal methods of contraception should be used.

It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraceptives may decrease carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life - 3 years.

"

Compound Lindinet 20(1 tablet):

• – 0.02 mg;
• – 0.075 mg;
• Magnesium stearate – 0.2 mg;
• povidone – 1.7 mg;
• corn starch – 15.5 mg;

Compound Lindinet 30(1 tablet):

• ethinyl estradiol – 0.03 mg;
• gestodene – 0.075 mg;
• sodium calcium edetate – 0.065 mg;
• Magnesium stearate – 0.2 mg;
• colloidal silicon dioxide – 0.275 mg;
• povidone – 1.7 mg;
• corn starch – 15.5 mg;
• lactose monohydrate – 37.165 mg.

Both pharmaceutical forms are supplied in the form of tablets, the shell of which has the following components:

• sucrose – 19.66 mg;
• – 8.231 mg;
• macrogol 6000 – 2.23 mg;
• titanium dioxide – 0.46465 mg;
• povidone – 0.171 mg;
• yellow quinoline dye (D+S yellow No. 10 – E 104) – 0.00135 mg.

Release form

In pharmacy kiosks, the drug is presented in the form of round, biconvex tablets, which are coated with a light yellow coating on both sides. There are no inscriptions or designations. At the break, the tablet is white or close to white in color with a light yellow edging of the shell.

pharmachologic effect

Lindinet belongs to the group of monophasic combined oral medications based on sex hormones , accordingly, is used primarily for the purpose of contraception. The main therapeutic effect of the drug is associated with several mechanisms of action, including a decrease in the secretion of gonadotropic hormones , actively preventing ovulatory processes and inhibiting the maturation of follicles in the ovaries.

First of all, it should be noted that ethinylestradiol , one of the biologically active components, is a synthetic analogue of follicular hormone , which, together with the hormones of the corpus luteum, is involved in the regulation of a woman’s menstrual cycle, significantly inhibiting it at certain stages.

Another active ingredient is gestodene is a progestogen 19-nortestosterone derivative and is a stronger and more selective version of natural secreted by the corpus luteum. This component is used in ultra-low quantities, due to which it does not realize its androgenic potential (the chemical basis for gestodene is a variation of the male sex hormone) and has the weakest effect on the carbohydrate and lipid metabolism of the body.

In addition to the central mechanisms of action directly on sex hormones, the drug exerts contraceptive properties indirectly through peripheral components. Under the influence of a pharmaceutical drug, susceptibility decreases to the blastocyst, which makes the process of implantation of the initial forms of the fetus almost impossible. The density and viscosity of the mucus localized in the cervix also increases, which becomes largely impenetrable for sperm making active movements towards the female egg.

Lindinet not only has contraceptive effects, the pharmaceutical drug promotes active prevention some gynecological diseases and more. In particular, the possibility of the appearance of functional ovarian cysts And . Reduces the risk of occurrence in the mammary glands, congestive inflammatory processes practically disappear. The beneficial properties of the drug also apply to skin , since their general condition improves and the degree of manifestation decreases (with regular use, dermatological defects disappear completely).

Pharmacodynamics and pharmacokinetics

Pharmacokinetic abilities of gestodene

After oral administration, the active component is absorbed quite quickly and almost completely from the gastrointestinal tract, because its bioavailability is about 99%, and the maximum concentration of 2-4 ng/ml is observed after 1 hour.

In the bloodstream gestodene contacts And specific globulin SHBG , only 1-2% of the amount of the active ingredient remains in free form. The pharmacokinetics of gestodene largely depends on the level of SHBG and the concentration of estradiol, because the amount of the selective transporter increases 3 times under the influence of the sex hormone. Constant use of oral contraceptives also contributes to the active saturation of gestodene; with daily use, the concentration increases by 3-4 times.

The active component undergoes the main stages of biochemical transformation in the liver, after which only in the form of metabolites is excreted in the urine (60%) and feces (40%). The half-life of the active component is biphasic and takes about 1 day, since the average plasma clearance ranges from 0.8 to 1 ml/million/kg.

Pharmacokinetic properties of ethinyl estradiol

The second active component has slightly lower absorption rates - due to presystemic conjugation and primary metabolism, the absolute bioavailability of the pharmacological component from the digestive tube is only 60%, and the maximum concentration of 30-80 pg/ml is achieved after 1-2 hours.

On the distribution side, ethinyl estradiol, on the contrary, outperforms gestodene, because 98.5% of the active substance binds to nonspecific albumin. Also, the active component induces an increase in SHBG levels, which has a beneficial effect on the overall effectiveness of the oral contraceptive. A constant average level of ethinyl estradiol is established by 3-4 days after the start of the therapeutic course, and it is 20% higher than after a single dose of Lindinet tablet.

Biotransformation of the active substance occurs in the liver and is aromatic hydroxylation with the formation of methylated and hydroxylated metabolic products in free form or in the form of conjugates with sulfates or glucuronides. Metabolic clearance from blood plasma ranges from 5-13 ml.

Ethinyl estradiol is excreted only in the form of metabolic products with urine and bile in a ratio of 2:3. The half-life, like that of gestodene, is biphasic and is about 1 day.

Indications for use

• contraception;
• functional disorders of the menstrual cycle.

Contraindications

• individual hypersensitivity to the pharmaceutical drug or its components;
• risk factors for arterial or venous thrombosis;
• moderate to severe;
• or as a harbinger of thrombosis;
• surgery with prolonged immobilization;
• with a pronounced increase in blood triglycerides;
• dyslipidemia ;
• severe liver disease ( hepatitis , cholestatic jaundice and etc);
• , Dubin-Johnson, Rotor;
• neoplasm localized in the liver;
• otosclerosis or a history of it in a previous pregnancy or after taking glucocorticosteroids;
• smoking over the age of 35;
• hormone-dependent malignant tumors genitals and mammary glands;
• vaginal bleeding of unknown origin;
• period of lactation and childbearing.

Side effects

Adverse effects of treatment requiring immediate cancellation pharmaceutical therapy:

• From the outside of cardio-vascular system: arterial hypertension, , , deep vein thrombosis of the lower extremities, , venous or arterial thromboembolism hepatic, mesenteric, retinal or renal vessels.
• From the outside sense organs: hearing loss caused by otosclerosis .
• Others: porphyria , hemolytic-uremic syndrome, exacerbation of reactive , Sydenham's chorea .

Side effects, after the appearance of which the advisability of further use of the drug is decided in individual order:

• From the outside reproductive system: acyclic bleeding from the vagina of unknown etiology, , colpocytological changes in vaginal mucus, inflammatory diseases, , pain, breast enlargement, galactorrhea .
• From the outside central nervous system: hearing loss, , , mood lability.
• Dermatological reactions: or exudative erythema , unclear rash, chloasma, increased .
• From the outside digestive system: epigastric pain, nausea and vomiting, Crohn's disease , nonspecific ulcerative , jaundice and the itching that is caused by it, cholelithiasis , liver adenoma, hepatitis.
• From the outside metabolic processes: fluid retention in the body, decreased tolerance to carbohydrates, increased levels of triglycerides or blood glucose, weight gain.
• Other allergic reactions.

Instructions for use of Lindinet (Method and dosage)

Lindinet 20, instructions for use

Birth control pills are used orally once a day, without chewing and with a sufficient amount of water, regardless of meals. If possible, you should take the pills at the same time of day for 21 days, then take a break for 7 days, and then resume using contraceptives. That is, the next tablet should be used 4 weeks from the start of the course on the same day of the week. During the break, uterine bleeding will be observed, which corresponds to menstruation in a normal cycle.

A course of conservative contraception should be started from the 1st to the 5th day of the menstrual cycle, if other oral contraceptives have not been used before. Otherwise, the 1st tablet must be taken after taking the last dose of the previous pharmaceutical preparation containing hormones, on the 1st day of bleeding after discontinuation.

Transition from progestogen-containing products Lindinet requires the use of an additional method of contraception in the first week. The date of first use of a new contraceptive should be consistent with the pharmaceutical form of the previous drug:

• in the form of mini-tablets - on any day of the menstrual cycle;
• in case of injections - on the eve of the last injection;
• implant - the day after its removal.

Lindinet 30, instructions for use

Since this pharmaceutical form is an enhanced version of Lindinet 20 with a higher concentration of ethinyl estradiol, it is recommended to be prescribed after abortion , so that the restoration of physiological hormonal levels occurs much faster and less painfully.

If the abortion was performed in 1st trimester of pregnancy , then there is nothing to worry about. Taking oral contraceptives can be started immediately after gynecological manipulation and there is no need to use additional methods of contraception.

If the abortion or childbirth occurred during 2nd trimester of pregnancy , then taking the pharmaceutical drug can be started only on the 21-28th day after the obstetric surgery. If the course of conservative protection is started later, a barrier method of contraception should be used in the first week. If full sexual intercourse took place before starting to take the drug, then before taking birth control you need to make sure that there is no new pregnancy.

Missing an oral contraceptive pill

If the next dose of the tablet was missed, then the missing amount of the pharmaceutical drug in the bloodstream must be replenished as quickly as possible. With a delay that duration does not exceed 12 hours , the clinical effects of the contraceptive are not reduced and the need for additional protection by other methods of contraception automatically disappears. Subsequent tablets are taken according to the usual regimen.

If a woman misses a pill and did not make up for her loss within 12 hours , then the pharmacological effectiveness of the drug is reduced, which requires special measures and precautions. First of all, you should resume taking the drug as soon as possible and continue to take it as usual. It is recommended to use any other methods of contraception for a week after the missed period.

This situation may become more complicated if There are less than 7 tablets left in the package . How to take it in this case - start the next pack without observing the required one-week break, which is carried out only after the end of the 2nd pack of contraceptives. It should be noted that while using the 2nd pack, spotting or even breakthrough bleeding may be observed, which can indirectly indicate the presence of pregnancy. If hemorrhages have not stopped after the end of the 2nd pack, then before continuing to take birth control you should consult a doctor and rule out the presence of a developing fetus in the womb.

Overdose

Taking an excess amount of contraceptive is accompanied by the following symptoms:

• nausea;
• vomit;
• vaginal bleeding in small quantities.

There is no specific pharmaceutical antidote for the drug, therefore symptomatic therapy of individual clinical manifestations of intoxication is used.

Interaction

The contraceptive properties of a pharmaceutical drug are reduced when used with drugs such as , , , barbiturates, Primidon , , Phenylbutazone , Phenytoin , , Oxcarbazepine .

Therefore, if it is necessary to use these drugs together with Lindinet, it is necessary to use additional non-hormonal contraceptives for 7 days (it is recommended to visit an additional consultation with your doctor and clarify the period for certain). You may also experience spotting or breakthrough bleeding, menstrual irregularities, or some other side effects.

In conditions increased peristalsis or diarrhea the residence time of the contraceptive drug in the lumen of the gastrointestinal tract is reduced, which significantly reduces the absorption properties of the hormonal contraceptive. Any drug that shortens the stay of Lindinet in the digestive tube leads to a decrease in the concentration of active components in the blood, and accordingly to a decrease in their beneficial effect.

Drug interactions at the suction stage are modeled on the combined use of a contraceptive with, since biologically active substances are equally subject to sulfation in the intestinal wall, which inhibits metabolic chains and increases the bioavailability of ethinyl estradiol.

Terms of sale

The purchase of medicines is permitted only using a prescription form.

Storage conditions

The pharmaceutical product must be stored in a dry place, protected from direct sunlight, inaccessible to young children at a temperature not exceeding 25 degrees Celsius.

Best before date

special instructions

Pregnancy after using hormonal contraceptives

Oral hormonal contraceptives are a group of pharmaceuticals based on synthetic analogs of female sex hormones (estrogen and progesterone) that prevent the onset of ovulation, preventing the very possibility of fertilization. Of course, a large audience of women is convinced that using them for contraception is harmful, since a normal, physiological pregnancy will most likely not occur after drug changes in hormonal levels. However, this is one of the myths about this group of drugs.

After stopping taking hormonal contraceptives and completing a course of conservative contraception, the effects of the drugs gradually disappear. The only peculiarity is that when planning pregnancy You should find out the exact timing of the optimal moment for fertilization in the antenatal clinic or from your personal gynecologist. After all, every time a woman takes a pill for a headache, she does not worry about the health of her unconceived child; in this case, the situation is almost identical.

When can you not use barrier methods of contraception?

Lindinet is a reliable hormonal contraceptive drug, which can be determined from a special indicator of the number of pregnancies that occurred during a course of oral contraception in 100 women for 1 year. For this pharmaceutical product, it is only 0.05, if you use the contraceptive correctly and only according to the application plan. However, the pharmacological effects of Lindinet do not fully develop immediately, but only by the 14th day from the start of taking the tablets, because in the first 2 weeks It is recommended to use barrier methods of contraception.

Lindinet 20 and Lindinet 30 - what's the difference?

A large number of visitors to pharmaceutical forums for women ask the following series of questions: “Lindynet 20 and 30 - what is the difference?”, as well as whether the drugs are interchangeable and, finally, which is better of the two forms of the contraceptive drug. The difference in forms of the same contraceptive lies in concentrations one of the active components is ethinyl estradiol. In oral tablets, the level can be 0.02 mg and 0.03 mg, respectively, which in biochemical terms does place them in different categories.

Lindinet 20 has a milder pharmacological effect and contributes to a lesser extent to increasing the selective SHBG transporter, which makes it possible to use it for contraception, however for therapeutic needs , as a rule, a stronger form of the drug is required, which is why Lindinet 30 is used. How the more concentrated form of the drug differs from weaker tablets is not advertised, since sometimes for individual indications it is necessary to use Lindinet 30 even as a contraceptive, which may be perceived by the woman as an unfair burden with a hormonal drug.

It is strictly contraindicated to replace pharmaceutical forms of a drug on your own, because a qualified specialist who prescribes contraceptives or therapeutic agents relies on the results of clinical studies, their interpretation and many years of experience in his field, and not on an approximate idea of ​​the biomechanism of the female body. If any side effects or other adverse effects occur, you should seek advice and resolve the issue on an individual basis.

Since Lindinet is produced in Hungary, its cost in pharmacy kiosks is much lower than that of the drug produced jointly by French and German pharmacists, but this in no way indicates the effectiveness of the former, therefore the choice of a contraceptive should be entrusted to a qualified specialist, because he is based on individual indicators of hormonal balance and some other medical aspects.

Which is better: Novinet or Lindinet 20?

Novinet – monophasic oral contraceptive, which in addition to ethinyl estradiol contains a synthetic progestogen , which somewhat changes the mechanism of action of the contraceptive drug. Like all artificial pharmaceutical components of this nature, desogestrel has a high affinity for progesterone receptors located in the hypothalamic-pituitary region, on which its effects are based. In sufficiently small quantities, it is able to “turn on” the negative feedback mechanism, which results in a sharp inhibition of the release and production of gonadotropins and a complete blocking of ovulation.

Since Novinet includes such a potent pharmaceutical component as one of the active ingredients, its price is accordingly almost twice as high as that of Lindinet. However, with certain individual indications or contraindications, a woman does not have the opportunity to use a cheaper contraceptive, which makes it possible to include Novinet in a conservative course of contraception.

Alcohol and Lindinet

Biochemical studies have proven that small amounts of alcohol do not affect the effectiveness of oral contraception. Moderate dosages of alcoholic beverages are considered to be up to 3 glasses of wine or 50 grams of cognac, but no more, since an increase in the amount of alcohol in the blood increases the risk of possible pregnancy.

Last update of the description by the manufacturer 07/13/2015

Filterable list

Active substance:

ATX

Pharmacological group

Nosological classification (ICD-10)

3D images

Compound

Film-coated tablets	1 table
active substances:
ethinylestradiol	0.03 mg
gestodene	0.075 mg
Excipients
core: sodium calcium edetate - 0.065 mg; magnesium stearate - 0.2 mg; colloidal silicon dioxide - 0.275 mg; povidone - 1.7 mg; corn starch - 15.5 mg; lactose monohydrate - 37.155 mg
shell: quinoline yellow dye (D+S yellow No. 10 - E104) - 0.018 mg; povidone - 0.171 mg; titanium dioxide - 0.448 mg; macrogol 6000 - 2.23 mg; talc - 4.242 mg; calcium carbonate - 8.231 mg; sucrose - 19.66 mg

pharmachologic effect

pharmachologic effect- estrogen-gestagenic, contraceptive.

Directions for use and doses

Inside, without chewing, drinking plenty of water, regardless of meals.

Take 1 tablet. per day (at the same time of day if possible) for 21 days. Then, after taking a 7-day break from taking the tablets, resume oral contraception (i.e. 4 weeks after taking the 1st tablet, on the same day of the week). During the 7-day break, uterine bleeding occurs as a result of hormone withdrawal.

First dose of the drug: Taking Lindinet 30 should start from the 1st to the 5th day of the menstrual cycle.

Switching from a combined oral contraceptive to taking Lindinet 30. 1st table Lindinet 30 is recommended to be taken after taking the last hormone-containing tablet of the previous drug, on the 1st day of withdrawal bleeding.

Transition from progestogen-containing drugs (mini-tablets, injections, implant) to taking Lindinet 30. The transition from mini-pills can be started on any day of the menstrual cycle; in the case of an implant - the day after its removal; in case of injections - on the eve of the last injection.

In this case, in the first 7 days of taking Lindinet 30, it is necessary to use an additional method of contraception.

Taking Lindinet 30 after an abortion in the first trimester of pregnancy. You can start taking contraceptives immediately after an abortion, and there is no need to use an additional method of contraception.

Taking Lindinet 30 after childbirth or after an abortion in the second trimester of pregnancy. You can start taking the contraceptive on days 21-28 after childbirth or abortion in the second trimester of pregnancy. If you start taking a contraceptive later, in the first 7 days, it is necessary to use an additional, barrier method of contraception. In the case where sexual intercourse took place before the start of contraception, before starting to take the drug, you should exclude the presence of a new pregnancy or wait until the next menstruation.

Missed pills. If the next scheduled dose is missed, then you should make up for the missed dose as soon as possible. If the delay does not exceed 12 hours, the contraceptive effect of the drug is not reduced, and there is no need to use an additional method of contraception. The remaining tablets are taken as usual.

If there is a delay of more than 12 hours, the contraceptive effect may be reduced. In such cases, you should not make up for the missed dose, continue taking the drug as usual, but in the next 7 days you must use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, then take the tablets from the next package without taking a break. In such cases, uterine withdrawal bleeding occurs only after the completion of the 2nd pack; While taking tablets from the 2nd package, spotting or breakthrough bleeding is possible.

If, upon completion of taking the tablets from the 2nd package, withdrawal bleeding does not occur, then pregnancy should be excluded before continuing to take the contraceptive.

Measures to be taken in case of vomiting and diarrhea. If vomiting occurs in the first 3-4 hours after taking another tablet, the tablet is not completely absorbed. In such cases, you should act in accordance with the instructions described in paragraph Missed pills.

If the patient does not want to deviate from her usual contraceptive regimen, the missed pills should be taken from another package.

Delay of menstruation and acceleration of the onset of menstruation. In order to delay menstruation, take pills from a new package without taking a break. Menstruation can be delayed at will until all the tablets from the 2nd package are gone. If menstruation is delayed, breakthrough or spotting uterine bleeding is possible. You can return to your usual pill intake after a 7-day break.

INSTRUCTIONS

on medical use of drugs

Lindinet 20 and Lindinet 30

(LINDYNETTE 20, LINDYNETTE30)

General characteristics:

international and chemical names: gestodene, ethinyl estradiol;

basic physical and chemical properties: Lindinet 20 - round, biconvex, sugar-coated tablets, pale yellow, unlabeled, approximately 5.6 mm in diameter;

Lindinet 30- round, biconvex, sugar-coated tablets, yellow, unlabeled, approximately 5.6 mm in diameter;

1 tablet of Lindinet 20 contains 0.075 mg of gestodene and 0.02 mggetinylest radiolu;

1 tablet Lindinet 30contains 0.075 mg gestodene and 0.03 mggetinylest radiolu;

Excipients: sodium calcium edetate, magnesium stearate silicon colloidal anhydrous povidone; corn starch; lactose; quinoline yellow (E 104); titanium dioxide (E 171); macrogol 6000, talc; calcium carbonate; sucrose.

Release form. Film-coated tablets.

Pharmacotherapeutic group. Hormonal contraceptives for systemic use. Gestodene and estrogen. ATC code G03A A10.

Pharmacological properties. Combined oral contraceptives block dijugonadotropins. The primary effect of these drugs is aimed at inhibiting ovulation. The drug leads to changes in cervical mucus, which makes it difficult for sperm to pass into the uterine cavity and affects the endometrium, thereby reducing the possibility of implantation. All this leads to the prevention of pregnancy.

Oral contraceptives, in addition to preventing pregnancy, may have a number of positive effects.

• Impact on the monthly cycle.
• The monthly cycle becomes regular.
• The amount of blood loss during menstruation is reduced and iron loss is reduced.
• The frequency of dysmenorrhea decreases.
• Actions associated with inhibition of ovulation.
• The incidence of functional ovarian cysts is reduced.
• The incidence of ectopic pregnancy is reduced.
• Other actions.
• The incidence of fibroadenomas and fibrocysts in the mammary glands is reduced.
• The incidence of inflammatory processes in the pelvic organs is reduced.
• The incidence of endometrial cancer is reduced.
• The condition of the skin with acne improves.

Pharmacokinetics

Gestoden.

Absorption of oral gestodene is rapidly absorbed and almost completely. After a single dose, the maximum concentration is observed an hour after administration and is 2-4 ng in 1 ml of blood plasma. The bioavailability of gestodene is approximately 99%.

Distribution in the body: gestodene binds to albumin and sex hormone-binding globulin. 1-2% is in the form of a free steroid, 50-75% binds specifically to sex hormone-binding globulin. An increase in globulin levels caused by ethinyl estradiol affects the level of gestodene; an increase in the globulin fraction leads to a decrease in the fraction associated with albumin. The average volume of distribution of gestodene is 0.7-1.4 l/kg.

Metabolism: Gestodene is broken down by known steroid metabolism. Average clearance values: 0.8-1.0 ml/min/kg (0.8-1.0 ml per person 1 kg of body weight).

Highlight: the level of gestodene in the blood serum is biphasic. In the last phase, the half-life is 12-20 hours.

Gestodene is excreted only in the form of metabolites, 60% in urine, 40% in feces. The half-life of metabolites is approximately 1 day.

Saturation stage: The pharmacokinetics of gestodene depends on the level of sex hormone binding globulin. The concentration in the blood of globulin, which binds sex hormones, increases threefold under the influence of ethinylest radiolu. Due to daily administration, the level of gestodene in the blood plasma increases three to four times and balances out in the second half of the cycle.

Ethinyl estradiol.

Absorption of oral ethinyl estradiol is absorbed by Shvydka almost completely. The average maximum concentration in blood serum is 30-80 pg/ml 1-2 hours after taking the drug. The bioavailability of ethinylest radiol through pre-systemic conjugation and primary metabolism is approximately 60%.

Distribution in the body: Ethinyl estradiol binds completely, but nonspecifically, to albumin (about 98.5%) and causes an increase in the level of sex hormone-binding globulin in the blood serum. The average volume of rozpodiluetinylest radiolu is 5-18 l/kg.

Metabolism: Ethinyl estradiol mainly undergoes aromatic hydroxylation, which results in the formation of large quantities of hydroxyl vanites and ethylated metabolites present in the form of free metabolites or in formic conjugates (glucuronides and sulfates).

Metabolic clearance of ethinylest radiol from blood plasma is about 5-13 ml/min per 1 kg of body weight.

Excretion from the body: The concentration of ethinylest radiolu in blood serum is biphasic. The half-life of the second phase is almost 16-24 hours. Ethinyl estradiol is excreted only in the form of metabolites, with urine and bile in a ratio of 2:3. The half-life of metabolites is approximately 1 day.

Saturation stage: a stable concentration is established for 3-4 days, when the level of ethinylest radiolu in the serum is 20% higher than after a single dose.

INDICATIONS

Contraception.

Directions for use and doses

The drug should be taken for 21 days, 1 tablet per day (if possible at the same time). Then take a 7-day break. The next 21 tablets should be taken the next day after a 7-day break (four weeks later, on the same day of the week on which the course of taking the drug was started). During the 7-day break, menstrual-like bleeding appears due to drug withdrawal.

First dose of the drug

Taking Lindinet 20 or Lindinet 30 should be started on the first day of the menstrual cycle.

Switching to taking Lindinet 20 or Lindinet 30 from another oral contraceptive.

The first tablet of Lindinet 20 or Lindinet 30 should be taken after taking the last tablet from the previous package of another oral hormonal contraceptive drug, on the first day of menstrual bleeding.

Switching to taking Lindinet 20 or Lindinet 30 from drugs containing only progestogen (mini-pills, injections, implants).

From the “mini-pill” you can switch to taking Lindinet 20 or Lindinet 30 on any day of the cycle. You can switch from the implant to taking Lindinet 20 or Lindinet 30 the next day after removal of the implant; from solution for injection - the day before the injection.

In these cases, additional methods of contraception must be used in the first 7 days.

Taking Lindinet 20 or Lindinet 30 after an abortion in the first trimester of pregnancy

After an abortion, you can start taking the drug immediately; in this case, there is no need to use an additional method of contraception.

Taking Lindinet 20 or Lindinet 30 after childbirth or after an abortion in the second trimester of pregnancy

You can take the drug 28 days after childbirth or abortion in the second trimester of pregnancy. In such cases, additional methods of contraception must be used in the first 7 days.

If sexual intercourse has already taken place after childbirth or abortion, pregnancy should be excluded before taking the drug or you must wait until your first menstruation.

Missed pills.

If a pill was missed, the missed pill should be taken as quickly as possible. If the interval is less than 12 hours, the effectiveness of the drug will not decrease, and in this case there is no need to use an additional method of contraception. Take the remaining tablets at the usual time.

If the interval is more than 12 hours, the effectiveness of the drug may decrease. In this case, the woman should not take the missed tablet(s), but should take the next tablet(s) as normal. In this case, additional methods of contraception must be used in the next 7 days. If there are less than 7 tablets left in the package, taking the drug from the next package begins without interruption. In this case, there is no menstrual-like bleeding due to discontinuation of the drug before completion of the drug from the second package, but occasional breakthrough bleeding may occur.

If menstrual-like bleeding does not occur due to discontinuation of the drug after completing the drug from the second package, then pregnancy should be excluded before continuing to take the contraceptive

Measures taken in case of vomiting

If vomiting begins within 3-4 hours after taking the drug, then the active substance from the tablet is not completely absorbed. In this case, you must act according to the paragraph “Missed pills”. If the patient does not want to deviate from the dosage regimen, the missed tablets must be taken from an additional package.

Acceleration or delay of the menstrual cycle

It is possible to speed up the menstrual cycle, with a shorter break in taking the drug. The shorter the break in taking the drug, the more likely it is that menstrual-like bleeding will not occur, and breakthrough or spotting bleeding will appear while taking the drug from the next package.

To delay menstruation, the drug must be continued from the new package without interrupting the drug. Menstruation can be delayed as long as necessary by the end of taking the last tablet from the second package. When menstruation is delayed, breakthrough or spotting bleeding may occur. Regular use of Lindinet 20 or Lindinet 30 can be resumed after the usual 7-day break.

Side effects. During the first period of taking the drug, 10-30% of women may experience the following side effects: tension in the mammary glands, deterioration in health, spotting bleeding. These side effects, as a rule, are mild and disappear after 2-4 cycles.

Other possible side effects

Among women taking Lindinet 20 or Lindinet 30, the following side effects may occur: nausea, vomiting, headache, breast tension, changes in weight and libido, depressed mood, chloasma, bleeding disorders, complaints when wearing contact lenses.

Rarely, increased levels of triglycerides and blood sugar, decreased glucose tolerance, increased blood pressure, thromboembolism, hepatitis, liver adenoma, gallbladder disease, jaundice, skin rashes, hair loss, changes in the consistency of vaginal discharge, fungal infection of the vagina, unusual fatigue, diarrhea.

Contraindications. Lindinet 20 or Lindinet 30 should not be taken in the following cases:

during pregnancy or if you suspect it;

with active or history of arterial or venous thromboembolic diseases (for example: deep vein thrombophlebitis, pulmonary embolism, cerebrovascular disorders, myocardial infarction);

if there is a risk of arterial or venous thromboembolism (diseases of the hemostatic system, heart disease, atrial fibrillation);

in the presence of a benign or malignant tumor or severe liver disease,

if there is a history of malignant tumors of the uterus or mammary glands;

with bleeding from the vagina of unknown etiology;

if there is a history of cholestatic jaundice of pregnancy or pruritus of pregnancy;

with a history of herpes during pregnancy;

with progression of otosclerosis during a previous pregnancy;

with sickle cell anemia;

with hyperlipidemia;

with severe hypertension;

diabetic angiopathy;

in case of hypersensitivity to the constituent components of the drug.

Overdose

After taking large doses of Lindinet 20 or Lindinet 30, severe symptoms are not known. Signs of overdose: nausea, vomiting, in young girls, slight vaginal bleeding. The drug does not have a specific antidote; treatment is symptomatic.

Features of application.

Diseases of the circulatory system.

Oral contraceptives increase the risk of myocardial infarction. The risk of myocardial infarction is higher in smokers and have other risk factors, such as hypertension, hypercholesterolemia, obesity and diabetes.

Lindinet 20 or Lindinet 30 should be administered with caution to women at risk of cardiovascular disease.

The use of Lindinet 20 or Lindinet 30 increases the risk of developing cerebrovascular diseases and venous thromboembolic disorders.

The risk of developing venous thromboembolic disease (VTD) increases in the first year of drug use among women who have not yet taken such drugs. This risk is much lower than the risk of VTD in pregnant women. Out of 100,000 pregnant women, approximately 60 have VTZ and 1-2% of all cases of VTZ result in death.

The incidence of VTD among women taking 50 mcg or less of ethinylest radiolu in combination with levonorgestrel is approximately 20 cases out of 100,000 women per year. The incidence of VTD among women taking gestodene in combination is approximately 30-40 cases per 100,000 women per year. Women with a history of high blood pressure or conditions associated with high blood pressure, or kidney disease are not recommended to use Lindinet 20 or Lindinet 30. If, despite this, a woman with hypertension wishes to take oral contraceptives , it is necessary to keep it under strict control and if there is a significant increase in blood pressure, the drug should be discontinued.

In most women, blood pressure returns to normal when the drug is stopped, and there is no subsequent increased risk of hypertension.

An increase in blood pressure was more often observed in older women, as well as with long-term use.

Smoking significantly increases the risk of cardiovascular complications, which may occur when using Lindinet 20 or Lindinet 30. This risk increases with age, so women over 35 years of age and those who smoke heavily have a significantly increased risk of cardiovascular complications. Women who take oral contraceptives are advised to stop smoking.

The risk of arterial venous or thromboembolic disease increases:

with age;

when smoking (severe burning sensation and age, especially over 35 years, is an additional risk factor);

with a positive family history (for example: diseases of the father, brother, sister at a young age). If there is a congenital tendency to thromboembolic diseases, you should consult a specialist before using the drug;

for obesity (body mass index above 30 kg/m2);

in case of fat metabolism disorders (dyslipoproteinemia);

for hypertension;

for diseases of the heart valves;

atrial fibrillation

with prolonged immobilization, severe operations, operations on the lower extremities, severe injuries. Due to the fact that the risk of thromboembolic diseases increases in the postoperative period, it is proposed to stop taking the drug 4 weeks before the planned operation and start taking it 2 weeks later, after the patient’s remobilization.

Taking Lindinet 20 or Lindinet 30 should be stopped immediately if the following signs of thromboembolism appear: pain in the chest, radiating to the left arm, unusually severe pain in the legs, swelling of the legs, stabbing pain when inhaling or when coughing, bloody discharge from the bronchi.

Biochemical indicators indicating a tendency to thromboembolic diseases: resistance to activated protein C (APC), hyperhomocysteinemia, deficiency of antithrombin III, protein C and protein S, the presence of antiphospholipid antibodies (anticardiolipin, lupus anticoagulant).

Tumors.

Some studies have reported an increased incidence of cervical cancer among women taking oral contraceptives for a long time, but the results are mixed. The likelihood of developing cervical cancer depends on sexual behavior and other factors (for example: human papillomavirus).

Identified cases of breast cancer in women taking oral contraceptives were clinically at an earlier stage than in women not taking these drugs.

There are isolated reports of the development of benign liver tumors in women who have been taking hormonal contraceptives for a long time.

Among women taking oral contraceptives for a long time, the development of a malignant liver tumor has rarely been observed.

Other pathological conditions.

When using oral contraceptives, retinal thrombosis can sometimes occur. The drug should be discontinued in case of loss of vision (complete or partial), exophthalmos, diplopia, or swelling of the optic nerve nipple or disorders in the retinal vessels.

With the appearance or intensification of migraine attacks, with the appearance of persistent or repeated unusually severe headaches, the drug should be discontinued.

Taking Lindinet 20 or Lindinet 30 should be stopped immediately if itching occurs or an epileptic attack occurs.

Studies have shown that the relative risk of developing gallstones increases with age among women taking oral contraceptives or medications containing estrogens. Recent studies have shown that the risk of cholelithiasis is low when using drugs with a low dose of hormones.

Effect on carbohydrate and lipid metabolism

Among women taking Lindinet 20 or Lindinet 30, a decrease in carbohydrate tolerance may be observed. In this regard, women with diabetes mellitus taking Lindinet 20 or Lindinet 30 should be monitored more closely.

Increased levels of triglycerides in the blood have been found in some women using oral contraceptives. A number of progestogens reduce the level of HDL cholesterol in the blood plasma. Due to the fact that estrogen increases the level of HDL cholesterol in the blood plasma, the effect of Lindinet 20 or Lindinet 30 on lipid metabolism depends on the ratio of estrogen and progestogen and on the dose and form of the progestogen.

Women who have hyperlipidemia and who nevertheless decide to take contraceptives should be closely monitored.

Among those women who have hereditary hyperlipidemia and took the drug with estrogen, a sharp increase in plasma triglycerides was found, which could lead to the development of pancreatitis.

Bleeding.

When using Lindinet 20 or Lindinet 30, irregular (breakthrough) bleeding may occur, especially in the first three months. If such bleeding is present for quite a long time or appears after regular cycles have formed, their cause is usually non-hormonal and an appropriate gynecological examination should be performed to exclude pregnancy or malignant formations. If a non-hormonal cause can be excluded, you need to switch to taking another drug.

In some cases, menstrual-like bleeding does not appear after discontinuation of the drug during a 7-day break. If before the absence of bleeding the regimen of taking the drug was violated or if there is no bleeding after taking the second package, then to continue the course of taking the drug it is necessary to exclude pregnancy.

Conditions requiring special care

Before starting to use the drug Lindinet 20 or Lindinet 30, it is necessary to collect a detailed family history and conduct a general medical and gynecological examination. These studies must be repeated regularly. During a physical examination, it is necessary to measure blood pressure, examine the mammary glands, palpate the abdomen, conduct a gynecological examination with a cytological smear, as well as laboratory tests.

The woman should be warned that the drug does not protect her from sexually transmitted infections, in particular from AIDS.

In case of acute or chronic impairment of liver function, the drug should be discontinued until liver enzymes normalize. If the function of liver enzymes is impaired, the metabolism of steroid hormones may be disrupted.

For those women who experience depression while taking contraceptives, it is advisable to discontinue the drug and temporarily switch to another method of contraception to determine the cause of the depressive state. Women with a history of depression should be closely monitored and the oral contraceptive should be discontinued if depression returns.

When using oral contraceptives, the level of folic acid in the blood may decrease. This is only clinically significant if conception occurs shortly after completion of a course of oral contraceptives.

In addition to the conditions listed above, you need to pay special attention to stanzhinki in the presence of the following diseases: otosclerosis, multiple sclerosis, epilepsy, chorea minor, intermittent porphyria, tetanic conditions, renal failure, obesity, systemic lupus erythematosus, uterine fibroids.

Pregnancy, breastfeeding.

Use of the drug immediately before pregnancy or in the early stages of pregnancy does not affect the development of the fetus.

The use of hormonal contraceptives during breastfeeding is not recommended, since these drugs reduce milk production, change its composition, and also penetrate into milk in small quantities.

Interaction with other drugs.

With the simultaneous use of rifampicin and Lindinet 20 or Lindinet 30, the effect of the hormonal drug is reduced. The incidence of breakthrough bleeding and bleeding disorders increases. There is a similar interaction between the drug Lindinet 20 or Lindinet 30 and barbiturates, phenylbutazone, phenytoin, griseofulvin, ampicillin, tetracycline. Those women who receive such drugs simultaneously with an oral contraceptive are advised to use additional non-hormonal (condom, spermicidal gels) methods of contraception. These methods of contraception should be used when using the above drugs and for 7 days after completion of the course. When using rifampicin, additional methods of contraception should be used for 4 weeks after completing the course of taking it.

Interactions associated with drug absorption. With diarrhea, intestinal motility increases and hormone absorption decreases. Any drug, by its action, shortens the time of presence of a hormonal drug in the large intestine, reduces the level of the hormone in the blood.

Interactions associated with drug metabolism.

Intestinal wall: Sulfation of ethinylest radiolu occurs in the intestinal wall. Drugs (for example: ascorbic acid), which are also susceptible to sulfation in the intestinal wall, inhibit this process and increase the bioavailability of ethinylest radiolu.

Metabolism in the liver: drugs that activate microsomal liver enzymes, and thereby reduce the level of ethinylest radiolu in the blood plasma (for example: rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate). Inhibitors of liver enzymes (itraconazole, fluconazole) and thus increase the level of ethinylest radiol in the blood plasma.

Effect on the intrahepatic circulation: some antibiotics (ampicillin, tetracycline) inhibit the intrahepatic circulation of estrogens, thereby reducing rivenetinylest radiolu in the blood plasma.

Effect on the metabolism of other drugs: Ethinyl estradiol may affect the metabolism of other drugs by blocking liver enzymes or accelerating conjugation (primarily glucuronidation). Therefore, the level of other drugs in the blood may increase or decrease (for example: cyclosporine, theophylline).

The use of other drugs or St. John's wort tea (Hypericumperforatum) simultaneously with Lindinet 20 or Lindinet 30 tablets is contraindicated, as this can reduce the level of the active substance of Lindinet 20 or Lindinet 30 tablets in the blood and lead to breakthrough bleeding and pregnancy. The reason for this is the inducing effect of St. John's wort on liver enzymes, the effect of which continues for another 2 weeks after the end of taking St. John's wort.

When using Riton Vera and an oral contraceptive simultaneously, you should use the drug with a higher dose of ethinylest radiolu or use non-hormonal methods of contraception.

Under the influence of oral contraceptives, the level of some laboratory parameters (indicators of liver function, kidney function, adrenal glands, thyroid gland, blood coagulation system and fibrinolytic factors, lipoproteins and transport proteins) may change. Despite this, the indicators remain within normal limits.

Storage conditions. Store at a temperature of 15 - 300C.

Best before date- 3 years.