How to take Lindinet 20 for the first time. Birth control pills Lindinet

Release form

Pills

Compound

Active ingredient: ethinylestradiol 30 mcg. gestodene 75 mcg. Excipients: sodium calcium edetate, magnesium stearate, anhydrous colloidal silicon, povidone, corn starch, lactose monohydrate. Base volume: Tablet Active ingredient concentration (mcg): 105 mcg.

Pharmacological effect

Combined oral contraceptives such as Lindinet 20 film-coated tablets contain hormones similar to those your body produces (estrogen and progestogen). They help prevent pregnancy in the same way that your natural hormones would prevent you from fertilizing an egg again if you were already pregnant. Combined oral contraceptives protect you from pregnancy in three ways: 1. The egg will not be released from the ovary and the sperm will not be able to fertilize it. 2. The mucus in the cervix will become more sperm towards the egg. 3. The lining of the uterus becomes thinner, making the egg not fertilized.

Pharmacokinetics

Gestodene Absorption After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. Source - portal about medicine After a single dose, Cmax is noted after 1 hour and is 2-4 ng / ml. Source - medicine portal Bioavailability - about 99%. Source - medicine portal Distribution Gestodene binds to albumin and to sex hormone-binding globulin (SHBG). Source - portal about medicine 1-2% is in plasma in free form, 50-75% specifically binds to SHBG. Source - portal about medicine. 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. Source - medicine portal Average Vd - 0. Source - medicine portal 7-1. Source - portal about medicine 4 l / kg. Source - portal about medicine. The pharmacokinetics of gestodene depends on the level of SHBG. Source - a portal about medicine. The concentration of SHBG in the blood plasma under the influence of estradiol increases 3 times. Source - portal about medicine With daily intake, the concentration of gestodene in the blood plasma increases by 3-4 times and in the second half of the cycle reaches a state of saturation. Source - medicine portal Metabolism and excretion Gestodene is biotransformed in the liver. Source - portal about medicine The average plasma clearance is 0. Source - portal about medicine 8-1 ml / min / kg. Source - a portal about medicine The level of gestodene in the blood serum decreases in two phases. Source - portal about medicine in the β-phase - 12-20 hours Source - portal about medicine Gestodene is excreted only in the form of metabolites, 60% - with urine, 40% - with feces. Source - portal about metabolite medicine - about 1 day. Source - medicine portalEthinylestradiol Absorption After oral administration, ethinylestradiol is absorbed rapidly and almost completely. Source - a portal about medicine. The average Cmax in blood serum is reached 1-2 hours after ingestion and is 30-80 pg / ml. Source - portal about medicineAbsolute bioavailability due to presystemic conjugation and primary metabolism - about 60%. Source - Medicine Portal Distribution Fully (about 98. Source - Medicine Portal 5%), but non-specifically binds to albumin and induces an increase in serum SHBG levels. Source - portal about medicine Average Vd - 5-18 l / kg. Source - portal about medicineCss is established by 3-4 days of taking the drug, and it is 20% higher than after a single dose. Source - portal about medicine Metabolism Undergoes aromatic hydroxylation with the formation of hydroxylated and methylated metabolites, which are present in the form of free metabolites or in the form of conjugates (glucuronides and sulfates). Source - portal about medicine Metabolic clearance from blood plasma is about 5-13 ml. Source - a portal about medicineRemoval The concentration in blood serum decreases in two phases. Source - portal about medicine in β-phase - about 16-24 hours. Source - portal about medicineEthinylestradiol is excreted only in the form of metabolites, in a ratio of 2: 3 with urine and bile. Source - portal about metabolite medicine - about 1 day.

Indications

Contraception.

Contraindications

Individual hypersensitivity to the drug or its components. The presence of severe or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, cerebrovascular or coronary artery disease). Uncontrolled arterial hypertension of moderate or severe degree with a blood pressure of 160100 mm Hg. Art. And more). Harbingers of thrombosis (including transient ischemic attack, angina pectoris), including history. Migraine with focal neurological symptoms, including history. Venous or arterial thrombosis thromboembolism (including deep vein thrombosis of the leg, pulmonary embolism, myocardial infarction, stroke) at present or history. The presence of venous thromboembolism in relatives. Major surgery with prolonged immobilization. Diabetes mellitus (with the presence of angiopathy). Pancreatitis (including history), accompanied by severe hypertriglyceridemia. Dyslipidemia. Severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, including history (before the normalization of functional and laboratory parameters and within 3 months after the return of these indicators to normal). Jaundice due to the use of drugs containing steroids. Gallstone disease at present or history. Syndrome of Gilbert, club-Johnson, rotor. Tumors of the liver (including history). Severe itching, otosclerosis, or progression of otosclerosis during a previous pregnancy or when taking corticosteroids. Hormone-dependent malignant neoplasms of the genital organs and mammary glands (including suspected ones). Vaginal bleeding of unknown etiology. Smoking over the age of 35 (more than 15 cigarettes per day). Pregnancy or suspicion of it. Lactation.

Precautionary measures

Diseases of the circulatory system. Oral contraceptives increase the risk of myocardial infarction. The risk of myocardial infarction and thromboembolic complications of various localization increases in women who smoke and have other risk factors (for example: arterial hypertension, hypercholesterolemia, obesity, diabetes mellitus, family history of VTS, age over 35–40 years). This should be taken into account for women over 35 years of age and heavy smokers. In older women and taking the drug for a long time, an increase in blood pressure was noted. An increase in blood pressure is more often observed with the use of drugs with large doses of hormones. It is necessary to consult a specialist before using the drug if a woman has: a congenital predisposition to thromboembolic diseases, obesity (body mass index above 30 kg / m2), a violation of fat metabolism (dyslipoproteinemia), arterial hypertension, heart valve disease, atrial fibrillation, in cases prolonged immobilization, major surgery, surgery on the legs, severe trauma (due to the fact that the risk of thromboembolic diseases increases in the postoperative period, it is necessary to stop taking the drug 4 weeks before the planned operation and resume taking it 2 weeks after the patient is activated). The drug should be stopped immediately if symptoms of thromboembolism appear: chest pain that may radiate to the left arm, unusually severe pain in the legs, swelling of the legs, sharp stabbing pain when inhaling or coughing, hemoptysis. Tumors. Some studies have noted an increase in cervical cancer among women who have taken oral contraceptives for a long time (however, a causal relationship with taking the drug has not been proven). The likelihood of developing cervical cancer depends on sexual behavior and other factors (human papillomavirus). Studies have not proven a causal relationship between breast cancer and drug use: in women taking oral contraceptives, the disease was detected at an earlier stage than in women who did not take these drugs. There have been isolated reports of the development of a benign liver tumor in women taking hormonal contraceptives for a long time, with the development of intra-abdominal bleeding. Other pathological conditions. The drug should be discontinued if there is a loss of vision (complete or partial), exophthalmos, diplopia, or if edema of the papilla of the optic nerve or vascular disorders of the retina are detected. Studies show that the relative risk of developing gallstones increases with age among women who take oral contraceptives or drugs containing estrogen. Recent studies have shown that the risk of developing gallstone disease is less with the use of drugs with a low dose of hormones. If a migraine occurs, worsens the course of a migraine, or if a persistent or recurring unusually severe headache occurs, the drug should be discontinued. Lindinet should be discontinued immediately if generalized itching occurs or if an epileptic seizure occurs. The effect of the drug on the metabolism of carbohydrates and lipids. In women taking oral contraceptives, there may be a decrease in carbohydrate tolerance. Some women have been found to have elevated blood triglyceride levels when using oral contraceptives. In women with hereditary hyperlipidemia, taking the drug with estrogen, a sharp increase in plasma triglycerides was found, which could lead to the development of pancreatitis. When using oral contraceptives, especially in the first 3 months, irregular (spotting or breakthrough) bleeding may occur. If bleeding occurs for a long time or occurs after regular cycles have formed, the cause is usually non-hormonal, and an appropriate pelvic examination should be performed to rule out pregnancy or malignancy. If a non-hormonal cause can be excluded and intermenstrual bleeding continues for more than 4 months, you should switch to another drug. In some cases, menstrual-like bleeding due to discontinuation of the drug during the 7-day interval does not occur. If the regimen of taking the drug was violated before the absence of bleeding or if there is no bleeding after taking the second package, pregnancy must be excluded before continuing the course of taking the drug. Before starting the use of birth control pills, a detailed family and personal history should be taken and a general medical and gynecological examination should be performed. These studies are repeated every 6 months. During a physical examination, blood pressure is measured, breast examinations are performed, abdominal palpation, a gynecological examination is performed with a cytological examination of a smear, as well as laboratory studies according to indications (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, indicators of blood coagulation and fibrinolytic factors, levels of lipoproteins and transport proteins). A woman must 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 hepatic function, the drug should be discontinued until the values ​​of liver enzymes are restored. With impaired liver function, the metabolism of steroid hormones may be impaired. For those women who develop depression while taking contraceptives, it is advisable to stop the drug and temporarily switch to another method of contraception, to clarify the relationship between the development of depression and taking the drug. Careful monitoring should be carried out if there is a history of depression, and if depression recurs, the oral contraceptive course should be completed. When using oral contraceptives, the concentration of folic acid in the blood may decrease. This is of clinical significance only if pregnancy occurs within a short period of time after completion of the oral contraceptive course. With diarrhea, intestinal motility increases and absorption of the drug decreases.

Use during pregnancy and lactation

If you think you are pregnant, stop taking this drug immediately and call your doctor. Use another method of contraception, such as a condom or a cap plus spermicide, until you have consulted with your doctor. Consult your doctor or pharmacist before taking any medicine. Since the active substance contained in oral contraceptives can penetrate into breast milk and reduce the amount of breast milk, the use of Lindinet during breastfeeding is not recommended.

Dosage and administration

Inside, without chewing, drinking plenty of water, regardless of the meal. Take 1 table. per day (if possible at the same time of day) for 21 days. Then, after taking a 7-day break in taking the pills, 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. The first dose of the drug: taking the drug Lindinet 30 should be started from the 1st to the 5th day of the menstrual cycle. The transition from a combined oral contraceptive to taking the drug 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. Switching from progestogen-containing drugs (mini-tablets, injections, implant) to taking Lindinet 30. You can start switching from mini-tablets 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 the drug Lindinet 30, it is necessary to use an additional method of contraception. Taking the drug Lindinet 30 after an abortion in the first trimester of pregnancy. You can start taking a contraceptive immediately after an abortion, and there is no need to use an additional method of contraception. Taking the drug Lindinet 30 after childbirth or after an abortion in the second trimester of pregnancy. You can start taking a contraceptive on the 21st-28th day after childbirth or abortion in the second trimester of pregnancy. With a later start of taking a contraceptive, in the first 7 days, it is necessary to use an additional, barrier method of contraception. In the case when sexual contact took place before the start of contraception, before you start taking the drug, you should exclude the presence of a new pregnancy or wait for the next menstruation. Missed pills. If the next scheduled pill was missed, then the missed dose should be replenished as soon as possible. With a delay not exceeding 12 hours, the contraceptive effect of the drug does not decrease, and there is no need to use an additional method of contraception. The remaining tablets are taken as usual. With more than a 12-hour delay, the contraceptive effect may decrease. 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 need to use an additional method of contraception. If at the same time less than 7 tablets remained in the package. , then they start taking the tablets from the next package without observing a break. In such cases, uterine withdrawal bleeding occurs only after the completion of the 2nd pack. while taking the tablets from the 2nd package, spotting or breakthrough bleeding is possible. If there is no withdrawal bleeding at the end of taking the pills from the 2nd pack, then pregnancy should be ruled out before continuing to take the contraceptive. Measures to be taken in case of vomiting and diarrhoea. If vomiting occurs in the first 3-4 hours after taking the next tablet, the tablet is not completely absorbed. In such cases, you should act in accordance with the instructions described in Missed Pills. If the patient does not want to deviate from the 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, they start taking pills from a new package without observing a break. Menstruation can be delayed at will until all the pills from the 2nd package run out. With a delay in menstruation, breakthrough or spotting uterine bleeding is possible. You can return to the usual intake of tablets after observing a 7-day break. In order to earlier the onset of menstrual bleeding, you can shorten the 7-day break by the desired number of days. The shorter the break, the more likely is the occurrence of breakthrough or spotting bleeding while taking the pills from the next pack (similar to cases with delayed menstruation).

Side effects

Side effects that require immediate discontinuation of the drug: arterial hypertension, hemolytic-uremic syndrome, porphyria, hearing loss due to otosclerosis. Rarely occurring, arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). exacerbation of reactive SLE. Very rare, arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins. Sydenham's chorea (passing after discontinuation of the drug). Other Side effects, less severe, but more common, the advisability of continuing the use of the drug is decided individually after consultation with the doctor, based on the benefit-to-risk ratio. On the part of the reproductive system: acyclic bleeding, spotting from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, the development of inflammatory processes in the vagina (for example, candidiasis), changes in libido. From the mammary glands: tension, pain, enlargement of the mammary glands, galactorrhea. From the gastrointestinal tract and hepatobiliary system: nausea, vomiting, diarrhea, epigastric pain, Crohn's disease, ulcerative colitis, hepatitis, liver adenoma, occurrence or exacerbation of jaundice or itching associated with cholestasis, cholelithiasis. From the skin: nodular exudative erythema, rash, chloasma, increased hair loss. From the side of the central nervous system: headache, migraine, mood changes, depressive states. Metabolic disorders: fluid retention in the body, a change (increase) in body weight, an increase in the amount of triglycerides and sugar in the blood, a decrease in carbohydrate tolerance. From the sensory organs: hearing loss, increased sensitivity of the cornea of ​​the eye when wearing contact lenses. Other: allergic reactions.

Overdose

No serious side effects have been reported after taking a significant dose of oral contraceptives. Symptoms such as nausea, vomiting and, in young girls, slight vaginal bleeding may occur. However, if you have taken more Lindinet 20 tablets than you should, tell your doctor or pharmacist immediately.

Interaction with other drugs

Rifampicin (increases clearance), as well as barbiturates, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine can lead to breakthrough uterine bleeding or reduce the contraceptive effect. Contraceptive reliability is reduced when taking ampicillin, tetracycline (the mechanism of this action has not been elucidated). During concomitant use with the above drugs, as well as within 7 days after the completion of their course, it is necessary to use other non-hormonal (condom, spermicidal gels) methods of contraception. When using rifampicin, additional methods of contraception should be used within 4 weeks after completion of the course of its administration. Any drug that increases gastrointestinal motility reduces the level of the drug in the blood. Drugs (for example, ascorbic acid), which undergo sulfation in the intestinal wall, competitively inhibit the sulfation of ethinyl estradiol and enhance its bioavailability. Inhibitors of liver enzymes (eg itraconazole, fluconazole), increase the concentration of ethinyl estradiol in blood plasma. Ethinylestradiol, by inhibiting liver enzymes or accelerating conjugation (primarily glucuronidation), can affect the metabolism of other drugs, increasing or decreasing their concentration in the blood (for example, cyclosporine, theophylline). The use of St. John's wort (including tea) reduces the concentration of the drug in the blood, which can lead to breakthrough bleeding, pregnancy (the reason is the inducing effect of St. John's wort on liver enzymes, which continues for another 2 weeks after completion of the course of St. John's wort). Ritonavir reduces the AUC of ethinylestradiol by 41%. In this regard, during the use of ritonavir, you should use a drug with a higher dose of ethinyl estradiol (Lindinet 30) or use non-hormonal methods of contraception.

special instructions

Influence of the drug on the ability to drive a car and work with mechanisms No studies have been conducted to study the possible effect of the drug on the ability to drive a car and work with mechanisms. Important information about some of the ingredients that make up Lindinet film-coated tablets. The preparation contains milk sugar (lactose) and sucrose. If your doctor has told you that you have an intolerance to some sugars, talk with your doctor before taking this drug. Laboratory tests: If you need to have a blood test, tell your doctor or lab technician that you are taking oral contraceptives, as they may change the results of some tests.

Lindinet 20 is a drug belonging to the group of combined oral contraceptives. The tool is used to prevent the onset of unwanted pregnancy and the correction of hormonal levels in women. The drug has a complex effect, therefore, a doctor who has studied the characteristics of the hormonal background should prescribe it to a woman. Rough use will not lead to the expected results.

Dosage form

The drug is available in the form of film-coated tablets intended for oral administration.

Description and composition

The contraceptive drug Lindinet 20 consists of estradiol and gestodene. This composition inhibits the production of gonadotropic hormones by the pituitary gland, which contributes to the inhibition of the process of maturation of the follicles. The estrogen component of the contraceptive is represented by ethinyl estradiol, which is part of the synthetic analogues of estradiol produced in the human body, which takes an active part in the process of ensuring the flow of the menstrual cycle in a woman's body.

The activity of the contraceptive is associated with the functioning of central and peripheral mechanisms that inhibit the process of maturation of the follicles, reducing the susceptibility of the endometrial uterine layer. The viscosity of cervical mucus secretions increases, the likelihood of conception decreases.

The data of statistical tests confirm the fact that the constant use of Lindinet can significantly reduce the likelihood of developing dangerous gynecological diseases, including oncological ones.

The drug has a special composition.

The active components are:

• ethinylestradiol;
• gestodene.

List of auxiliary components:

• calcium edetate sodium;
• magnesium stearate;
• colloidal silicon dioxide;
• povidone;
• corn starch;
• lactose monohydrate.

The shell contains the following components:

• yellow quinoline;
• povidone;
• titanium dioxide;
• macrogol;
• talc;
• calcium carbonate;
• sucrose.

Taking such a remedy is prohibited for women who have allergic reactions to any of the components of the remedy.

Pharmacological group

Oral contraceptive action, which is due to the effectiveness of its constituent components. Such components reduce the pituitary secretion of gonadotropic hormones. The effect that provides the prevention of unwanted pregnancy is associated with the presence and provision of several mechanisms. Ethinylestradiol, which is a synthetic analogue of estradiol, is present as an estrogen component in the composition of the drug. The progestogen component in this case is a nortestosterone derivative. Such an element is superior in selectivity and strength to the female hormone of the corpus luteum.

Women should take into account the fact that the effectiveness of the remedy can be traced only if used regularly. The gynecologist will determine the exact number of required courses of exposure when taking the remedy in order to prevent the occurrence of dangerous gynecological diseases. In most cases, it is enough to take the remedy for 3-4 cycles to restore the hormonal background.

Indications for use

The drug is prescribed to women of childbearing and menopausal age in order to restore normal hormonal levels. Lindinet 20 prevents pregnancy, therefore it can be used for contraceptive purposes.

for adults

The only indication for the use of the drug, according to manufacturers, is contraception. The ability of such a composition to regulate the hormonal background with regular use is confirmed by clinical trials.

for kids

The drug is not used in pediatric practice because the main purpose of the application is to prevent unwanted pregnancy. In extremely rare cases, on the recommendation of a gynecologist, the composition can be prescribed to girls during puberty. Dosages and frequency of administration will be determined individually.

During pregnancy, Lindinet 20 is not prescribed. Such a remedy can cause a significant change in the hormonal background of the mother. Such actions can provoke irreversible consequences.

Contraindications

The list of contraindications to the use of the drug is as follows:

• increased risk of venous or arterial thrombosis;
• damage to the valvular apparatus of the heart;
• pathology of cerebral vessels;
• hypertension with aggravated course;
• the presence of precursors of thrombosis in history;
• migraine focal lesions;
• surgical interventions;
• pancreatitis;
• dyslipidemia;
• severe liver damage;
• allergic reactions when taking oral contraceptives;
• the presence of hormone-dependent tumors in the body.
• bleeding of unknown etiology;
• smoking over the age of 35;
• pregnancy and lactation.

With increased caution, the drug is taken in the following cases:

• the presence of a genetic predisposition to thrombosis in a patient;
• acute disorders of cerebral circulation;
• liver damage;
• herpetic rash;
• valvular heart disease;
• migraine;
• arterial hypertension;
• thrombophlebitis;
• postpartum period;
• ulcerative colitis;
• Crohn's disease.

Applications and doses

The use of the hormonal agent Lindinet should be done daily, at the same time. This condition is optimal and allows you to get the best contraceptive effect. In case of accidental skipping of the composition, the tablet should be taken as soon as possible. The contraceptive effect is maintained if the pass was valid - no more than 12 hours. Do not take a double dose of the drug on the same day. Such actions can cause a serious imbalance of hormonal odds. The possibility of side effects cannot be ruled out.

for adults

If the COC is taken for the first time, then the tablet is taken from the 1st to the 5th day of the menstrual cycle, and it is mandatory to continue taking it for the next 21 days. After this time, a seven-day break is required. taking hormonal pills from the next pack begins on day 8, regardless of whether the bleeding has ended.

If you accidentally miss a tablet by less than 12 hours, you should take it as soon as possible. In the case when the pass is more than 12 hours, the drug is taken the next day. It is important to remember that in this case, you need to use additional contraceptives.

for kids

Lindinet 20 is not used in pediatric practice. If there are indications for use in the form of hormonal disorders, the drug can be prescribed to adolescents after the onset of menarche. The decision on the advisability of using a combined oral contraceptive is made by the doctor after establishing the true cause of the imbalance.

for pregnant women and during lactation

The drug is not prescribed during pregnancy and breastfeeding.

Side effects

The list of possible adverse reactions is presented as follows:

• hypertonic disease;
• porphyria;
• hearing loss;
• thrombotic damage to the veins;
• circulatory disorders in the brain;
• pathology of veins and arteries;
• damage to the retina;
• violations of the reproductive system;
• vaginal hemorrhages;
• lack of menstrual bleeding on the background of the withdrawal of the drug;
• change in the state of the mucous membranes;
• feeling of discomfort and burning;
• an increase in the size of the breast;
• digestive disorders;
• nausea;
• diarrhea;
• the appearance of pain in the epigastric region;
• granulomatous enteritis;
• hair loss;
• manifestation of pigmentation on the face;
• metabolic change;
• hearing loss;
• the appearance of discomfort in the eyes;
• other hypersensitivity reactions.

Patients should remember that the risk of adverse reactions increases several times with uncontrolled use of the drug. In some cases, such actions can cause infertility or prolonged absence of menstruation.

Interaction with other drugs

The drug has a composition similar to Lindinet. The pack contains 121 or 63 tablets, depending on the configuration. The advantage of this tool is the possibility of using it for the purpose of correcting the hormonal background and influencing the process of treating certain diseases. The drug has its drawbacks - there is a possibility of side effects. The composition has a rather high cost.

Mirelle is also a combined oral contraceptive. This composition is well tolerated and rarely provokes the manifestation of side effects. The drug has a fairly affordable cost among the list of drugs of this drug group.

Price

The cost of Lindinet 20 is an average of 687 rubles. Prices range from 335 to 1195 rubles.

"Lindinet 20" is a combination drug produced in the form of tablets. It has a contraceptive effect and is used for planned, regular contraception. The composition includes gestodene and ethinylestradiol, which in combination provide a reliable contraceptive effect. The drug inhibits the pituitary secretion of gonadotropins due to the action of estrogen-gestagens. The components of the drug prevent the maturation of the egg and do not allow it to be fertilized. What else is included in Lindinet 20? Feedback will be provided below.

Ethinylestradiol

Ethinylestradiol is a highly effective component belonging to the group of estrogens. It is produced by the adrenal glands and ovaries and has an estrogenic effect. In combination with progesterone, ethinyl estradiol regulates the menstrual cycle, provokes the reproduction and division of endometrial cells and has a stimulating effect on the development of secondary sexual characteristics and the uterus in case of their insufficiency. In addition, this type of hormone is able to mitigate or completely eliminate complications due to gonadal dysfunction and lower blood cholesterol levels. This confirms the instructions for use for Lindinet 20 and 30. Analogies are of interest to many.

Gestodene

The second active component of the drug is gestodene. It is a synthetic progestin, which is similar in structure to levonorgestrel, but surpasses it in selectivity and potency. It inhibits the synthesis of luteotropin and follitropin by the pituitary gland, while blocking ovulation.

In addition to such effects as blocking the fertilization of the egg, the contraceptive effect is due to a decrease in the sensitivity of the uterine endometrium to the blastocyst and an increase in the viscous properties of the mucus in the cervix, which creates an obstacle to the passage of spermatozoa through it. Regular intake of Lindinet 20 for a certain time, according to gynecologists, contributes to the regulation of the menstrual cycle, reduces the risk of pathologies of the woman's reproductive organs, including neoplasms.

The drug should be prescribed by a doctor based on the collected history and taking into account the individual characteristics of the patient.

Contraindications

The drug is contraindicated for use in patients with the following manifestations:

• Individual intolerance to the components of the drug or hormones in a certain combination.
• Tendency or presence of factors that can lead to venous thrombosis.
• Ischemia as a precursor of thrombosis.
• Irregular hypertension.
• Damage to arteries and veins by thrombosis and thromboembolism.
• Frequent migraines associated with disorders of a neurotic nature.
• The operation and, as a result, a prolonged lack of motor activity.
• Blockage of the veins of the next of kin (thromboembolism).
• dyslipidemic syndrome.
• Angiopathy of a diabetic nature (as a consequence of diabetes mellitus).
• Severe liver damage.
• cholelithiasis.
• Neoplasms in the liver.
• Pigmentary hepatosis (only some forms).
• Yellowness of the skin as a result of taking steroid drugs.
• Otospongiosis, severe itching.
• Vaginal bleeding.
• Pathological inflammatory processes in the pancreas with an increase in triglycerides in the blood.
• Smoking, especially over the age of 35.
• Tumors of the mammary glands and organs of the female reproductive system.
• Lactation.
• Pregnancy.

How to take "Lindinet 20"? Reviews confirm that this should be done only after consulting with a specialist.

Cautious reception

With caution, you should drink the drug in the following situations:

• Development of azotemia, thrombocytopenia and hemolytic anemia (hemolytic uremic syndrome).
• Diseases of the liver.
• Quincke's edema due to a genetic factor.
• Conditions that increase the risk of thromboembolic or thrombotic damage to the arteries and veins, such as age over 35, heredity, or smoking.
• Diseases manifested during pregnancy, as well as against the background of taking other hormonal drugs: chloasma, herpes, porphyria, rheumatic chorea.
• Obesity.
• Hypertension.
• Migraines of a regular nature.
• Dyslipoproteinemic syndrome.
• Seizures.
• Dysfunction of the heart valves.
• A state of prolonged immobility.
• Severe injuries.
• Extensive operations.
• Atrial fibrillation.

What other restrictions does the instructions for use indicate to Lindinet 20?

• Superficial thrombophlebitis of veins and varicose veins.
• postpartum period.
• Depression.
• Biochemical changes in blood composition.
• Systemic lupus erythematosus (Libman-Sachs disease).
• Diabetes mellitus that does not affect blood vessels.
• Granulomatous enteritis.
• Liver diseases in acute and chronic form.
• Anemia (sickle cell).
• Inflammatory processes in the large intestine on the background of an ulcer.
• Elevated levels of triglycerides (lipids based on glycerol) in the blood.

Side effects

Birth control pills "Lindinet 20", according to reviews, are usually well tolerated. But there are still side effects.

The drug is completely canceled with the following symptoms: porphyria, hypertension, hearing loss as a result of otospongiosis and hemolytic-uremic syndrome.

The following pathologies are rare: thromboembolism of the arteries and veins of the circulatory system, lower extremities, brain, lungs, as well as aggravation of lupus erythematosus (Libman-Sachs disease).

The most rare are thromboembolism of the arteries and veins of the liver, mesentery of the retina, kidneys and chorea. This is confirmed by the "Lindinet 20" instructions for use and reviews.

Frequent manifestations

Common side effects include:

• On the part of the reproductive system: the absence of menstrual bleeding after discontinuation of the drug, irregular vaginal hemorrhages and discharge, decreased libido, vaginal inflammation, changes in the state of mucus.
• Discomfort, enlargement, soreness and galactorrhea of ​​the mammary glands.
• On the part of the digestive system: diarrhea, vomiting, nausea, granulomatous enteritis, pain in the epigastric region, ulcerative inflammatory process in the colon, vdenomatous liver damage, hepatitis, liver dysfunction, bile stasis and cholelithiasis.
• Allergic reactions: rashes, erythema, alopecia, increased pigmentation.
• From the side of the central nervous system: migraines, depression, headaches and emotional lability.
• Weight gain and fluid retention, hyperglycemia, hypertriglyceridemia, decreased tolerance and absorption of carbohydrate compounds by the body as a result of changes in metabolism.
• Decreased hearing function, feeling of discomfort when wearing contact lenses.
• Hypersensitivity.

There are a lot of reviews of gynecologists about Lindinet 20.

special instructions

When deciding to take an oral contraceptive, you need to take into account the following features:

1. Lactation and pregnancy are absolute contraindications for taking.

2. Before prescribing a medication, the doctor needs to collect comprehensive information about the health of the patient and immediate family. Twice a year, you need to undergo a gynecological and medical examination to eliminate the risk of contraindications and complications.

3. Studies have accurately proven the high contraceptive effectiveness of Lindinet 20, since during the year of use, pregnancy out of 100 women occurred in 0.05 percent of cases.

4. The maximum contraceptive effect is achieved two weeks after the start of taking the pills, so during this period there is a need to use additional non-hormonal contraceptives.

5. The drug is prescribed taking into account the individual characteristics of the patient's body. The specialist evaluates the feasibility and necessity of prescribing Lindinet 20, informing the patient about possible side effects. While taking hormonal drugs, regular gynecological control is necessary. This describes the instructions for Lindinet 20. Reviews of gynecologists are given below.

6. There are situations when it is necessary to completely abandon the use of hormonal contraceptives and switch to other contraceptives. These complications include: convulsions, impaired hemostasis and, as a result, the development of problems in the circulatory system and kidneys, migraines, diabetes mellitus, depression, a poor blood test for biochemistry, anemia and a high risk of neoplasms due to hormone intake.

7. A scientifically proven fact is the relationship between taking hormonal drugs and the development of blood clots and thromboembolism in different systems and organs.

8. The risk of thrombosis and thromboembolism is especially high with the following factors: the patient's age is over 35 years old, genetic predisposition, smoking, obesity, atrial fibrillation, hypertension, heart valve pathology, etc.

9. In the postpartum period, the risk of thromboembolism is significantly increased.

10. Deviations of biochemical parameters of blood from the norm increase the risk of developing thromboembolism of veins and arteries. Bringing the indicators back to normal reduces the likelihood of the disease. The most common symptoms of thromboembolism are: shortness of breath, pain in the retrosternal region, radiating to the left arm, headaches that provoke visual impairment, dizziness, speech disorder, epilepsy, heart failure, numbness and weakness of the body, acute abdomen, pain in the calf muscle.

11. Studies have shown that taking hormonal contraceptives increases the risk of developing cervical cancer. The same applies to the development of breast cancer.

12. Oral hormonal contraceptives do not protect against contracting sexually transmitted infections.

13. The appearance of pain in the abdomen against the background of long-term use of Lindinet 20 may indicate the development of a neoplasm (benign or malignant), which may be a sign of hepatomegaly or bleeding into the abdominal cavity.

14. The effect of taking the drug may decrease against the background of a missed pill, diarrhea, vomiting, improper combination with other drugs.

15. While taking a contraceptive with drugs that reduce the contraceptive effect, it is necessary to use additional methods of contraception. There are reviews of gynecologists about this. Lindinet 20 may not be up to the task.

16. A common complication during pregnancy is chloasma. It can also occur while taking oral contraceptives. If such a probability is not excluded, it is necessary to exclude exposure to ultraviolet and sunlight during the reception.

17. Estrogens can affect the kidneys, liver, thyroid and adrenal glands, making changes in test results.

18. After therapy of a liver affected by a virus, Lindinet 20 can be taken only after six months.

19. The effect of the contraceptive may decrease as a result of severe intestinal disorders and vomiting.

20. Smoking at the same time as taking the drug can cause problems with blood vessels, especially after 35 years.

Method of application and dosage of "Lindinet 20"

How to take Lindinet 20 (LS)? Reviews confirm that there is nothing complicated in this.

The drug is taken 1 tablet once a day, it is undesirable to change the time of admission. After three weeks of admission, a week-long break is made, after which a new package begins on the eighth day. During the break between doses of the drug, bleeding begins.

The first tablet should be taken from the first to the fifth day of menstruation. If you switch to Lindinet 20 from another hormonal contraceptive, then the first tablet is taken the next day after the end of the previous drug. When switching from progestin drugs, you can start taking it on any day of the cycle. After removal of the implant, you can start taking the drug the next day, after the injection before the last injection.

During the first week of admission, you will need to use additional methods of contraception to avoid unwanted pregnancy.

The contraceptive effect is maintained even if you miss one pill. This is confirmed by reviews of gynecologists about Lindinet 20.

INN: Ethinylestradiol

Manufacturer: Gedeon Richter JSC

Anatomical-therapeutic-chemical classification: Gestodene and estrogen

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 014072

Registration period: 03.06.2014 - 03.06.2019

Instruction

Tradename

Lindinet 20

International non-proprietary name

Dosage form

Coated tablets

Compound

One tablet contains

active substances: ethinylestradiol 0.02 mg,

gestodene 0.075 mg,

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

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

Description

Tablets of a round form, with a biconvex surface, covered with a cover of light yellow color (for Lindinet 20).

Pharmacotherapeutic group

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

ATX code G03AA10

Pharmacological properties

Pharmacokinetics

Gestodene

Suction

After oral administration, gestodene is rapidly and completely absorbed. Peak plasma concentration after a single dose is reached after approximately 1 hour and is 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. The ethinylestradiol-induced increase in SHBG levels affects the amount of gestodene associated with serum protein, which causes an increase in the fraction of gestodene associated with SHBG and a decrease in the fraction associated with 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.

breeding

Serum gestodene levels undergo a biphasic decrease. The half-life in the terminal phase is 12-20 hours. Gestodene is excreted in the 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 three times while taking 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 course of taking the drug.

Ethinylestradiol

Suction

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

Distribution

Ethinylestradiol binds strongly but non-specifically to serum albumin (approximately 98.5%) resulting in increase in serum SHBG concentration. The apparent volume of distribution of gestodene is 5-18 l/kg.

Metabolism

Ethinylestradiol is metabolized mainly by aromatic hydroxylation, however, a large number of hydroxylated and methylated metabolites are formed, including both free metabolites and conjugates with glucuronides and sulfates. The metabolic clearance rate is approximately 5-13 ml/min/kg.

breeding

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

The equilibrium concentration is reached after 3-4 days, during which time the level of ethinylestradiol in serum increases by 20% compared with the level after taking a single dose.

Pharmacodynamics

The action of combined oral contraceptives (COCs) is due to the suppression of the production of gonadotropic hormones. Although the main mechanism of action is the suppression of ovulation, other mechanisms of action, including changes in the condition of 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 the loss of blood and iron during menstruation, reduce the incidence of dysmenorrhea.

Actions, associated with inhibition of ovulation:

Reduce the incidence of functional ovarian cysts and ectopic pregnancy.

Other actions

They reduce the frequency of development 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

Dosage and administration

One tablet should be taken daily (preferably at the same time of day) for 21 days. Taking the tablets from the next pack should be started after a 7-day break, during which withdrawal bleeding should begin. Bleeding usually starts on the 2nd or 3rd day after the last pill and may not end before the next pack starts.

Taking Lindinet 20 for the first time

The first tablet of Lindinet 20 should be taken on the first day of the menstrual cycle.

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

Switching from another combined oral contraceptive

The first Lindinet 20 tablet should be taken the next day after taking the last active (hormone-containing) tablet from the previous pack of oral contraceptives, but no later than the next day after taking regular pills (or taking placebo pills) from the previous pack of oral contraceptives.

Switching from progestogen-containing drugs (“mini-pill”, injections, implant, IUD)

The transition from taking the "mini-pill" to taking Lindinet 20 can be made 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 to be made). In these cases, additional contraceptive measures must be used during the first 7 days of taking the tablets.

After an abortion in the 1st trimester

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

After childbirth or abortion in the 2nd trimester

Women who are not breastfeeding may start taking oral contraceptives 21-28 days after vaginal delivery or after a 2nd trimester abortion. With a later start of taking oral contraceptives during the first 7 days, barrier methods of contraception should be used as additional measures.

If sexual intercourse has already taken place, the presence of pregnancy should be excluded before taking the tablets, or the drug should be postponed until the start of the first menstrual bleeding.

Missed pills

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

If after the end of taking the tablets from the second package, withdrawal bleeding does not develop, then pregnancy must be excluded before starting the tablets from the next package.

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, the precautions described above for missed tablets should be taken. If a woman does not want to change her usual pill regimen, she should take the necessary additional pills from another package.

Accelerating the onset of menstruation or delaying menstruation

In order for menstrual bleeding to start earlier than usual when taking the pills, it is recommended to shorten the interval between taking the pills by the desired number of days. The shorter the break, the higher the risk of breakthrough bleeding or spotting when taking pills from the second pack (as in the case of delayed menstrual bleeding).

To delay the onset of menstrual bleeding, you should start taking the tablets from the new package 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 from the second package run out. When taking the tablets from the second pack, breakthrough bleeding or spotting may occur. Regular intake of Lindinet 20 can be resumed after the usual 7-day break.

Side effects

Very common (≥/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

Weight loss/increase

Uncommon (≥1/1000 to<1/100)

Decreased/increased appetite

Mammary cancer

Arterial hypertension

Chloasma, melasma

Rare (≥1/10000 to<1/1000)

Anaphylactic reactions

Impaired glucose tolerance, hyperlipidemia, hypertriglyceridemia

contact lens intolerance

Otosclerosis

thrombosis, embolism

Very pcaustically<1/1000 0 )

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

Exacerbations of systemic lupus erythematosus

Exacerbation of chorea, optic neuritis

Stroke, myocardial infarction

Thrombosis of the retinal artery

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 may aggravate existing gallbladder disease and accelerate disease progression in previously asymptomatic women.

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

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 pectoris)

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

Severe arterial hypertension

History of liver tumors (benign or malignant)

Serious liver disease, before normalization of parameters of liver function tests

Diagnosed or suspected breast cancer

Diagnosed or suspected endometrial malignancies or other estrogen-dependent neoplasms

Vascular ophthalmopathy

History of herpes in pregnancy

sickle cell anemia

Hyperlipidemia

Diabetes complicated by angiopathy

Migraine with focal neurological symptoms

Children and adolescents up to 18 years of age

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

Drug Interactions

Interaction between ethinylestradiol and concomitantly used drugs can lead to an increase or decrease in plasma levels of ethinylestradiol.

A decrease in the level of ethinylestradiol in plasma can lead to an increase in the number of breakthrough bleeding and menstrual irregularities, sometimes there is also a decrease in the contraceptive effect of Lindinet 20. Therefore, in the case of simultaneous use of ethinylestradiol and drugs that reduce the level of ethinylestradiol in plasma, in addition to taking Lindinet 20, it is recommended to use non-hormonal methods of contraception (eg, condoms, spermicides). If long-term use of preparations containing such active substances is necessary, consideration should be given to abandoning the use of hormonal contraceptives as the main method of contraception.

After stopping the use of drugs that reduce the concentration of ethinylestradiol in the blood, it is recommended to use additional non-hormonal methods of contraception for at least 7 days. After stopping the use of drugs that can cause the induction of microsomal liver enzymes and lead to a decrease in the concentration of ethinylestradiol 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, it may take weeks before the induction of liver enzymes stops completely.

Active substances that can reduce the concentration of ethinylestradiol in the blood serum:

Any active substance that reduces transit time through the gastrointestinal tract, and therefore reduces absorption;

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

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

Some antibiotics (eg, ampicillin and other penicillins, tetracyclines) because they reduce hepatic estrogen recirculation.

Active substances that can increase the concentration of ethinylestradiol in the blood serum:

Atorvastatin;

Drugs that also undergo sulfation in the gastrointestinal wall, such as ascorbic acid (vitamin C) and paracetamol;

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

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

Ethinylestradiol may interfere with the metabolism of other drugs by inhibiting hepatic microsomal enzymes or by causing hepatic drug conjugation, in particular glucuronidation. Thus, plasma and tissue concentrations of other drugs may increase (eg, ciclosporin, theophylline, corticosteroids) or decrease. When prescribing any drugs, information on their combined use should be taken into account 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, levels of lipoproteins and carrier proteins, as well as parameters of carbohydrate metabolism, coagulation and fibrinolysis.

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

special instructions

Circulatory disorders

The use of contraceptives 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 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 stop smoking.

Women with risk factors for the development of cardiovascular disease should be given oral contraceptives with caution.

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

An increase in blood pressure (BP) has also been reported in women taking oral contraceptives. An increase in 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 choose to take oral contraceptives. In the event of a significant increase in blood pressure, oral contraceptives should be discontinued.

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 have previously used and have not used 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 any given estrogen/progestogen combination, a dosing regimen should be prescribed that contains the minimum amount of estrogen and progestogen, while at the same time providing a low failure rate and meeting the needs of the patient.

Venous thrombosis and thromboembolism

The use of any combined oral contraceptives entails an increased risk of venous thromboembolism (VTE) compared to that without the use of COCs. The additional risk of venous thromboembolism is highest during the very first year of combined oral contraceptive use. This risk is less than the risk of pregnancy-related 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 micrograms of 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 relative risk on the number of additional cases is higher in women during the very first year of using combined oral contraceptives.

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

Risk factors for arterial and/or venous thromboembolism

Age

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

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

Obesity (body mass index over 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 a planned operation 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 20 should be started no earlier than 28 days after childbirth or abortion in the second trimester of pregnancy.

Arterial thrombosis and thromboembolism

Lindinet 20 increases the risk of developing arterial thrombotic and thromboembolic complications. The 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 20 should be used with caution in women with risk factors for 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 migraine and take COCs have an increased risk of stroke.

The drug should be stopped immediately if symptoms appear that indicate the development of thrombosis: severe chest pain, which may radiate to the left arm, unusual pain in the leg, swelling of the leg, acute pain during breathing or coughing, sputum with blood.

Biochemical parameters that indicate a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C (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 the 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 discontinuation of combined oral contraceptives. However, these studies did not confirm the presence of a causal relationship between the disease and the drug.

In women taking oral contraceptives, breast cancer is diagnosed at an earlier stage than in those who do not use them.

An association 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 who have been 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 20, careful monitoring of their condition is necessary, and if the pathological condition returns, the drug should be discontinued.

Other states

In rare cases, retinal thrombosis has been reported with oral contraceptives. In the event of unexplained partial or complete loss of vision, exophthalmos or diplopia, edema of the optic disc, or damage to the retinal vessels, it is necessary to stop taking oral contraceptives and undergo an additional medical examination.

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

The onset of a migraine, or an increase in migraine attacks, as well as the appearance of a new type of headache, recurring, persistent or very severe, requires discontinuation of oral contraceptives.

You should immediately stop taking Lindinet 20 in case of itching all over the body or epileptic seizures.

Effects on carbohydrate and lipid metabolism

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

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

Women suffering from hyperlipidemia should be carefully monitored if they decide to take oral contraceptives.

There are reports that in women with hereditary hyperlipidemia and taking oral contraceptives containing estrogen, there is a significant increase in plasma triglycerides, which can lead to pancreatitis.

Menstrual irregularities

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

If irregular periods persist for a long time or develop 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, in order 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 other types of oral contraceptives can 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 at the end of taking all the pills 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, you should collect the patient's family and personal history, conduct a general medical and gynecological examination, including measurement of blood pressure, laboratory tests, examination of the mammary glands and pelvic organs, and also take a smear from the vagina 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, it is necessary to stop taking the drug until the liver function tests are 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. Such women should be advised to use an alternative method of contraception, and an attempt should be made to determine whether these symptoms result from the use of oral contraceptive drugs. You should carefully monitor the condition of women who have suffered from depression before; in the event that attacks of depression resume, you should stop taking the drug for oral contraception.

Folate levels

Serum folate levels may decrease due to the use of oral contraceptives. This may be of clinical importance if a woman becomes pregnant shortly after stopping oral contraceptives.

Chloasma

The appearance of chloasma is especially often observed in women with a history of chloasma during pregnancy. Women who are prone to chloasma should avoid sun exposure and ultraviolet radiation while taking COCs.

Other

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

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

Pregnancy and lactation

Before you start taking Lindinet 20, pregnancy should be excluded. If pregnancy occurs during the period of use of 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 (in particular, 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 to a change in its composition.

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

Given the possibility of developing such side effects as dizziness, visual impairment, care must be taken when driving a vehicle and working with driving mechanisms.

Overdose

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

international and chemical names: gestodene, ethinyl estradiol;

Basic physical and chemical properties

Lindinet 20 - round, biconvex tablets, sugar-coated, pale yellow, without an inscription, with a diameter of approximately 5.6 mm;

1 tablet Lindinet 20 contains 0.075 mg gestodene and 0.02 mgetinilest radiol;

Excipients

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

Release form

Coated tablets.

Pharmacotherapeutic group

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

Pharmacological properties

Combined oral contraceptives block the action of gonadotropins. The primary action of these drugs is aimed at inhibiting ovulation. The drug leads to a change 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, have a number of positive effects.

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

Pharmacokinetics

Gestodene. Oral absorption Gestodene is rapidly and almost completely absorbed. After a single dose, the maximum concentration is observed one 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% specifically binds to sex hormone-binding globulin. Ethinyl estradiol-induced globulin elevation affects gestodene levels, while globulin fraction elevation leads to a decrease in albumin-bound fraction. The mean volume of distribution of gestodene is 0.7-1.4 l/kg.

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

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

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

Saturation stage: the pharmacokinetics of gestodene depends on the level of globulin that binds sex hormones. The concentration in the blood of globulin that binds sex hormones under the action of ethinylest radiol increases three times. In connection with the daily administration, the level of gestodene in the blood plasma increases by three to four times and is balanced in the second half of the cycle.

Ethinylestradiol. Absorption Oral administration of ethinyl estradiol is absorbed rapidly and 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: ethinylestradiol completely but non-specifically binds to albumin (about 98.5%) and causes an increase in the level of globulin that binds sex hormones in the blood serum. The mean volume of distribution of ethinylest radiol is 5-18 L/kg.

Metabolism: Ethinylestradiol mainly undergoes aromatic hydroxylation, and therefore hydroxylated and m-ethylated metabolites are formed in large quantities, present in the form of free metabolites or in the form of conjugates (glucuronides and sulfates).

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

Indications

Contraception.

Dosage and administration

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 (in four weeks, on the same day of the week on which the course of taking the drug was started). During a 7-day break, menstrual-like bleeding appears due to discontinuation of the drug.

First dose of the drug

Taking the drug Lindinet 20 should be started from the first day of the menstrual cycle.

Switching to Lindinet 20 from another oral contraceptive.

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

Switching to taking the drug Lindinet 20 from drugs containing only progestogen ("mini-pill", injections, implants).

With the "mini-pill" you can switch to Lindinet 20 on any day of the cycle. From the implant, you can switch to Lindinet 20 the day after the removal of the implant; from a 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 after an abortion in the first trimester of pregnancy

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

Taking Lindinet 20 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 should 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 it is necessary to wait for the first menstruation.

Missed pills.

If a pill was missed, the missed pill should be taken as soon as possible. If the interval was less than 12 hours, then the effectiveness of the drug will not decrease, 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 is more than 12 hours, then the effectiveness of the drug may decrease. In this case, the woman should not take the missed pill(s), but should take the next pill(s) as normal. In this case, additional methods of contraception must be used for the next 7 days. If there are less than 7 tablets left in the package, the drug from the next package is started without interruption. In this case, there is no menstrual-like bleeding due to discontinuation of the drug before the end of taking the drug from the second package, but spotting or breakthrough bleeding may occur.

If menstrual-like bleeding does not occur due to discontinuation of the drug after the completion of taking 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, it is necessary to act according to the item "Missed pills". If the patient does not want to deviate from the regimen, the missed tablets should be taken from an additional package.

Acceleration or delay of the menstrual cycle

There is an opportunity to accelerate the menstrual cycle, with a shortening of the 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 occur while taking the drug from the next package.

To delay menstruation, the drug should be continued from a new package without interruption in taking the drug. Menstruation can be delayed for as long as necessary at the end of the last pill from the second package. With a delay in menstruation, breakthrough or spotting bleeding may occur. Regular intake of Lindinet 20 can be restored after the usual 7-day break.

Side effect

In the first period of taking the drug, 10-30% of women may experience such side effects: tension of the mammary glands, deterioration of health, spotting bleeding. These side effects are usually mild and disappear after 2-4 cycles.

Other possible side effects

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

Rarely, increases in the level 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 should not be taken in the following cases:

during pregnancy or if it is suspected;

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

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

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

in the presence of a history of malignant tumors of the uterus or mammary glands;

with bleeding from the vagina of unclear etiology;

in the presence of a history of cholestatic jaundice of pregnancy or itching of pregnant women;

with a history of herpes in pregnant women;

with the progress of otosclerosis bath during a previous pregnancy;

with sickle cell anemia;

with hyperlipidemia;

with severe hypertension;

diabetic angiopathy;

with hypersensitivity to the constituent components of the drug.

Overdose

After taking large doses of Lindinet 20, severe symptoms are unknown. Signs of overdose: nausea, vomiting, in young girls, slight vaginal bleeding. The drug has no specific antidote, treatment is symptomatic.

Application features

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 mellitus.

Lindinet 20 should be used with caution in women at risk for cardiovascular disease.

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

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

The incidence of VTS among women taking 50 micrograms or less of ethinylest radiol in combination with levonorgestrel is approximately 20 cases out of 100,000 women per year. The incidence of VTS among women taking gestodene in combination is approximately 30-40 cases per 100,000 women per year. For those women who have previously observed high blood pressure or conditions associated with high blood pressure, or had kidney disease, it is not recommended to use Lindinet 20. If, despite this, a woman with hypertension wants to take oral contraceptives, it is necessary to keep it is 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 with discontinuation of the drug, and in the future, an increased risk of hypertension is uncharacteristic.

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

Smoking significantly increases the risk of cardiovascular complications that may occur with the use of the drug Lindinet 20. This risk increases with age, so in women over 35 years of age and those who smoke a lot, the risk of cardiovascular complications increases significantly. Women who are taking oral contraceptives are advised to stop smoking.

The risk of arterial venous or thromboembolic diseases increases:

with age;

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

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

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

in violation of fat metabolism (dyslipoproteinemia);

with hypertension;

with 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 after the patient is remobilized.

Taking the drug Lindinet 20 should be stopped immediately if such 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 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 increase in cervical cancer among women who have taken 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 who did not take these drugs.

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

Among women who take oral contraceptives for a long time, the development of a malignant tumor of the liver has occasionally been observed.

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

With the appearance or intensification of migraine attacks, with the appearance of a constant or repeated unusually severe headache, the drug should be discontinued.

The use of Lindinet 20 should be stopped immediately if itching occurs, or if an epileptic seizure occurs.

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

Influence on the metabolism of carbohydrates and lipids. Among women taking Lindinet 20, there may be a decrease in carbohydrate tolerance. In this regard, women with diabetes mellitus taking Lindinet 20 should be closely monitored.

In some women, when using oral contraceptives, an increase in the level of three glycerides in the blood was found. A number of progestogens reduce the level of cholesterol HDL) HDL in blood plasma. Due to the fact that estrogen increases the level of cholesterol HDL) HDL in blood plasma, the effect of Lindinet 20 on lipid metabolism depends on the ratio of estrogens and progestogen and on the dose and form of progestogen.

Careful monitoring of women who have hyperlipidemia and who, despite this, decide to take contraceptives should be carried out carefully.

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

Bleeding. When using the drug Lindinet 20, especially in the first three months, irregular (breakthrough) bleeding may occur. 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 rule out pregnancy or malignancy. If a non-hormonal cause can be ruled out, it is necessary to switch to another drug.

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

Conditions requiring special care. Before starting the use of the drug Lindinet 20, it is necessary to collect a detailed family history, conduct a general medical and gynecological examination. These studies should be repeated regularly. At physical examination, blood pressure should be measured, breast examination, abdominal palpation, gynecological examination with a cytological smear, and laboratory tests.

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

In acute or chronic hepatic impairment, the drug should be discontinued until normalization of liver enzymes. In violation of the function of liver enzymes, the metabolism of steroid hormones may be disturbed.

For those women who develop depression while taking contraceptives, it is advisable to stop 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 oral contraceptives should be discontinued if depression returns.

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

In addition to the conditions listed above, special attention should be paid to the condition of a woman 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. The 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, as these drugs reduce the secretion of milk, change its composition, and also penetrate into milk in a small amount.

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

Interactions associated with the absorption of the drug. With diarrhea, intestinal motility increases and the absorption of hormones decreases. Any drug, by its action, reduces the time of the 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: ethinylest radiol sulfation occurs in the intestinal wall. Drugs (for example: ascorbic acid), which are also amenable to sulfation in the intestinal wall, inhibit this process, enhance the bioavailability of ethinylest radiol.

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

Effects on intrahepatic circulation: Some antibiotics (ampicillin, tetracycline) inhibit intrahepatic circulation of estrogen, thereby reducing plasma levels of ethinylest radiol.

Influence on the metabolism of other drugs: ethinylestradiol can 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. 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 completion of St. John's wort.

With the simultaneous use of riton ver and an oral contraceptive, a drug with a higher dose of ethinilest radiol should be used or non-hormonal methods of contraception should be used.

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