Lindinet 20, 63 pcs., 20 mcg+75 mcg, film-coated tablets

Compound

Composition of Lindinet 20 (1 tablet):

• ethinyl estradiol – 0.02 mg;
• gestodene – 0.075 mg;
• sodium calcium edetate – 0.065 mg;
• Magnesium stearate – 0.2 mg;
• colloidal silicon dioxide – 0.275 mg;
• povidone – 1.7 mg;
• corn starch – 15.5 mg;
• lactose monohydrate – 37.165 mg.

Composition of Lindinet 30 (1 tablet):

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

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

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

pharmachologic effect

Lindinet belongs to the group of monophasic combined oral contraceptive drugs based on sex hormones , and accordingly is used primarily for the purpose of contraception. The main therapeutic effect of the drug is associated with several mechanisms of action, including a decrease in the secretion of pituitary , active inhibition of ovulatory processes and inhibition of follicle maturation in the ovaries.

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

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

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

Lindinet not only has contraceptive effects, the pharmaceutical drug promotes the active prevention of certain gynecological diseases and more. In particular, the possibility of functional ovarian cysts and ectopic pregnancies . The risk of fibroadenomas in the mammary glands is reduced, and congestive inflammatory processes practically disappear. The beneficial properties of the drug also apply to the skin , as their general condition improves and the severity of acne (with regular use, dermatological defects disappear completely).

Pharmacodynamics and pharmacokinetics

Pharmacokinetic abilities of gestodene

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

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

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

Pharmacokinetic properties of ethinyl estradiol

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

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

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

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

Lindinet 20 No. 21 tab.

LINDYNETTE 20

ATX code: G03AA10 (Gestodene and estrogen)

Active substances

ethinylestradiol (ethinylestradiol) Rec.INN registered by WHO gestodene (gestodene) Rec.INN registered by WHO

Dosage form

The drug is dispensed with a prescription LINDINET 20 tablets, coated. coated, 20 mcg+75 mcg: 21 or 63 pcs. reg. No.: P N015122/01 dated 10.31.08 - Indefinitely

Release form, composition and packaging

Light yellow film-coated tablets, round, biconvex, unprinted on both sides; on the fracture it is white or almost white with a light yellow edging.

1 tab. ethinylestradiol 20 mcg gestodene 75 mcg

Excipients: sodium calcium edetate - 0.065 mg, magnesium stearate - 0.2 mg, colloidal silicon dioxide - 0.275 mg, povidone - 1.7 mg, corn starch - 15.5 mg, lactose monohydrate - 37.165 mg.

Shell composition: quinoline yellow dye (D+S yellow No. 10) (E104) - 0.00135 mg, povidone - 0.171 mg, titanium dioxide - 0.46465 mg, macrogol 6000 - 2.23 mg, talc - 4.242 mg, calcium carbonate - 8.231 mg, sucrose - 19.66 mg.

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

Clinical and pharmacological group: Monophasic oral contraceptive.

Pharmacotherapeutic group: Contraceptive (estrogen + progestogen).

pharmachologic effect

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

Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus located in the cervix, which makes it relatively impenetrable for sperm. In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Gestoden

Suction

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

Distribution

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

Metabolism and excretion

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

Ethinyl estradiol

Suction

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

Distribution

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

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

Metabolism

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

Removal

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

Indications for use

• contraception.

ICD-10 codes

Dosage regimen

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

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

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

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

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

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

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

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

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

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

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

Side effects

Side effects requiring discontinuation of the drug

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

From the senses: hearing loss caused by otosclerosis.

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

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

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

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

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

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

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

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

Other: allergic reactions.

Contraindications for use

• the presence of severe and/or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the heart valve apparatus, atrial fibrillation, diseases of the cerebral vessels or coronary arteries, severe or moderate arterial hypertension with blood pressure 160/100 mm Hg. Art.);
• presence or indication in history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
• migraine with focal neurological symptoms, incl. in the anamnesis;
• venous or arterial thrombosis/thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
• a history of venous thromboembolism in relatives;
• surgery with prolonged immobilization;
• diabetes mellitus (with angiopathy);
• pancreatitis (including a history), accompanied by severe hypertriglyceridemia;
• dyslipidemia;
• severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization);
• jaundice when taking GCS;
• gallstone disease currently or in history;
• Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;
• liver tumors (including history);
• severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
• hormone-dependent malignant neoplasms of the genital organs and mammary glands (including if they are suspected);
• vaginal bleeding of unknown etiology;
• smoking over the age of 35 (more than 15 cigarettes per day);
• pregnancy or suspicion of it;
• lactation period;
• hypersensitivity to the components of the drug.

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

Use during pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy and lactation. The components of the drug are excreted in breast milk in small quantities. When used during lactation, milk production may decrease.

Use for liver dysfunction

Contraindicated in case of liver dysfunction.

Use for renal impairment

The drug is not recommended for use in patients with kidney disease.

special instructions

Before starting to use the drug, it is necessary to conduct a general medical examination (detailed family and personal history, blood pressure measurement, laboratory tests) and gynecological examination (including examination of the mammary glands, pelvic organs, cytological analysis of a cervical smear). Such examinations during the period of taking the drug are carried out regularly, every 6 months.

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women over 1 year) when used correctly is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, it is recommended to additionally use non-hormonal methods of contraception in the first 2 weeks of taking the drug.

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

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

• diseases of the hemostatic system;
• conditions/diseases predisposing to the development of cardiovascular and renal failure;
• epilepsy;
• migraine;
• the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
• diabetes mellitus not complicated by vascular disorders;
• severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used for correction);
• sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;
• the appearance of abnormalities in laboratory tests assessing liver function.

Thromboembolic diseases

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

The risk of arterial or venous thromboembolic disease increases:

• with age;
• when smoking (heavy smoking and age over 35 years are risk factors);
• if there is a family history of thromboembolic diseases (for example, parents, brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;
• for obesity (BMI more than 30 kg/m2);
• with dislipoproteinemia;
• with arterial hypertension;
• for diseases of the heart valves complicated by hemodynamic disorders;
• with atrial fibrillation;
• with diabetes mellitus complicated by vascular lesions;
• with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed that the use of the drug should be temporarily discontinued (no later than 4 weeks before surgery, and resumed no earlier than 2 weeks after remobilization).

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

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

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

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

• sudden chest pain that radiates to the left arm;
• sudden shortness of breath;
• any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, symptom complex “acute abdomen”.

Tumor diseases

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

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

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

Chloasma

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

Efficiency

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

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

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

Changes in laboratory parameters

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

Additional Information

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

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take the drug, it is necessary to use additional non-hormonal methods of contraception.

Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35 years of age) and on the number of cigarettes smoked.

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

Impact on the ability to drive vehicles and operate machinery

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

Overdose

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

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

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

Drug interactions

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

When used simultaneously with Lindinet 20, any drug that increases gastrointestinal motility reduces the absorption of active substances and their level in the blood plasma.

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

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

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

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

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

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

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

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

Storage conditions

The drug should be stored in a dry place, protected from light, out of reach of children, at a temperature not exceeding 25°C. Shelf life: 3 years.

Shelf life

3 years. Do not use after expiration date.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Contraindications

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

Side effects

Adverse effects of treatment requiring immediate discontinuation of pharmaceutical therapy:

• From the cardiovascular system: arterial hypertension, myocardial infarction , stroke , deep vein thrombosis of the lower extremities, pulmonary embolism , venous or arterial thromboembolism of the hepatic, mesenteric, retinal or renal vessels.
• From the senses: hearing loss caused by otosclerosis .
• Other: porphyria , hemolytic-uremic syndrome, exacerbations of reactive systemic lupus erythematosus , Sydenham's chorea .

Side effects, after the appearance of which the advisability of further use of the drug is decided on an individual basis:

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

Side effects

While taking oral contraceptives Lindinet 20, side effects of the medication may develop.

They manifest themselves in the form of the following symptoms:

• porphyria;
• complete or partial deafness;
• arterial hypertension;
• thrombosis of the great vessels of the lower extremities;
• thromboembolism of the hepatic arteries;
• heart rhythm disturbance;
• ischemic cerebral stroke;
• muscle tension and pain;
• painful condition of the mammary glands;
• Strong headache;
• sudden changes in mood and depression;
• nausea and vomiting;
• bowel dysfunction accompanied by diarrhea;
• the occurrence of inflammatory processes inside the vagina;

• change in the consistency of mucus that is secreted from the internal genital organs;
• excess body weight gain;
• candidiasis of the vaginal mucosa;
• decreased sex drive;
• allergic reactions in the form of a red rash on the skin surface of the body, itching, swelling, and the appearance of bronchial spasms;
• the appearance of jaundice caused by a pathological condition of the liver and gall bladder.

The occurrence of the above side effects of Lindinet 20 requires discontinuation of further medication use. The appearance of these symptoms must be reported to a gynecologist.

Instructions for use of Lindinet (Method and dosage)

Lindinet 20, instructions for use

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

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

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

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

Lindinet 30, instructions for use

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

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

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

Missing an oral contraceptive pill

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

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

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

Indications for use

Lindinet 20 (reviews from women indicate the high effectiveness of the drug) is indicated for use in girls of childbearing age who are sexually active and do not want an unplanned pregnancy.

The medication can only be used as a contraceptive, non-barrier contraception.

Interaction

The contraceptive properties of the pharmaceutical drug are reduced when used with drugs such as Ampicillin , Tetracycline , Rifampicin , barbiturates, Primidone , Carbamazepine , Phenylbutazone , Phenytoin , Griseofulvin , Topiramate , Oxcarbazepine .

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

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

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

special instructions

Pregnancy after using hormonal contraceptives

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

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

When can you not use barrier methods of contraception?

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

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

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

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

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

Release forms and composition of the drug

Lindinet 20 is available in the form of round tablets, slightly convex at the edges, which are coated with a protective coating. The drug has a light yellow color. The tablets are packaged in blisters made of plastic and foil. Each cassette contains 21 tablets.

The main packaging of contraceptives is a cardboard box, inside of which there are 1 or 3 blisters with tablets. According to reviews from women who have used Lindinet 20, the formulation of the drug is convenient for daily use.

The table below details the constituent substances of the drug, and also describes their intended purpose in an oral contraceptive:

In combination, all of the above main and auxiliary substances of the drug Lindinet 20 provide a potent contraceptive effect. The components of the oral contraceptive do not have toxic or mutagenic properties.

Analogs

Level 4 ATC code matches:
Ovidon

Rigevidon

Non-Ovlon

Mercilon

Yarina Plus

Yarina

Miniziston 20 fem

Novinet

Microgynon

Janine

Cyclo-Proginova

Regulon

Logest

Midiana

Belara

Femoden

Jess Plus

Jess

Zoely

Among pharmaceutical drugs similar to Lindinet, several groups of contraceptives should be distinguished:

• Lindinet 20 analogues with identical ATX code and composition of active ingredients: Logest , Model Tin , Femoden ;
• analogues with the same level 4 ATX code: Angeleta , Vidora , Dayla , Naadin , Novinet .

Lindinet 20 or Logest - which is better?

Like Lindinet, Logest belongs to the group of combined oral hormonal contraceptives. The pharmaceutical preparation contains the same active ingredients in identical quantities, that is, 1 contraceptive tablet contains 0.02 mg ethinyl estradiol and 0.075 mg gestodene. The only significant difference between medicines is the country of production, and, accordingly, the price indicator.

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

Which is better: Novinet or Lindinet 20?

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

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

Reviews about Lindinet

Reviews about Lindinet 20 can be found in antenatal clinics, on pharmaceutical or other thematic forums, and almost everywhere hormonal contraceptive pills receive good responses, because oral contraceptives really effectively help solve this issue. Of course, some women complain that weight increases unreasonably when following the dosage regimen and correct dosages of the contraceptive, but side effects are not common, especially since hormonal levels are one of the most unstable balances in the body.

Birth control pills, in addition to their main purpose, are also used as a therapeutic agent for functional disorders of the menstrual cycle and some other gynecological pathologies, and even cope with this task perfectly. Reviews about Lindinet 30 on forums fully confirm the advisability of conservative treatment with this form of pharmaceutical drug, because the dosage of active components in it is slightly higher.

Reviews from doctors on Lindinet 20, as well as for the more concentrated form of the drug, have a positive advantage, because thanks to the carefully developed pharmaceutical formula and regimen for taking the oral contraceptive, you can easily achieve the desired effects for a long time. Of course, qualified specialists are overshadowed by the fact that women allow themselves to independently change the forms, and sometimes dosages, of the drug based on the fact that side effects are observed, but this does not always lead to catastrophic consequences.

However, experienced pharmacists and gynecologists recommend seeking additional advice in advance if side effects begin to bother you during a conservative course of taking Lindinet 20 or 30 or any other types of discomfort that arise during drug treatment.

Overdose

Lindinet 20 (reviews from women who took the drug are mostly positive) is an oral contraceptive, taking large doses of which did not cause the development of signs of severe intoxication or other pathological conditions of the body.

Despite this, doctors do not rule out the appearance of the following symptoms:

• nausea;
• severe vomiting;
• the opening of vaginal bleeding (this sign is most often found with an overdose in girls aged 18 to 23 years);
• headache;
• diarrhea;
• physical weakness;
• painful condition of the mammary glands.

In case of an overdose of Lindinet 20, a woman is prescribed symptomatic treatment depending on the current state of her health. A specific antidote for the active components of the contraceptive has not been created. In most cases, all therapeutic measures are aimed at neutralizing signs of intoxication of the body.

Lindineta price, where to buy

The price of Lindinet 20 in pharmacies in the Russian Federation averages 300-350 rubles. How much a stronger form of a pharmaceutical drug costs should be found out individually, since it is prescribed much less frequently.

The cost of Lindinet 20 in Ukrainian pharmacies ranges from 150 to 200 hryvnia, and the price of Lindinet 30 starts at 170 hryvnia.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Lindinet 20 tablets p.p.o.
  21 pcs. JSC Gedeon Richter 600 rub. order
• Lindinet 20 tablets p.p.o. 63 pcs. JSC Gedeon Richter

  RUB 1,392 order

• Lindinet 30 tablets p.p.o. 21 pcs. JSC Gedeon Richter

  606 rub. order

Pharmacy Dialogue

• Lindinet 30 (tab. No. 21)Gedeon-Richter

  RUB 593 order

• Lindinet 20 (tab. No. 21x3) Gedeon-Richter

  RUB 1,343 order

• Lindinet 20 (tab. No. 21) Gedeon-Richter

  RUR 585 order

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Pharmacy24

• Lindinet 20 mg No. 63 tablets VAT "Gedeon Richter", Ugorshchina
  452 UAH. order

PaniPharmacy

• Lindinet 20 tablets Lindinet 20 tablets. p/o No. 63 Hungary, Gedeon Richter

  540 UAH. order

• Lindinet 20 tablets Lindinet 20 tablets. p/o No. 21 Hungary, Gedeon Richter

  164 UAH order

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Pharmacological properties

Lindinet 20 (reviews from women about this drug are 95% positive) has the following main pharmacological properties:

• influence on the reproductive cycle of the female body;
• suppression of the ovulation phase;
• changes in the physiological balance of female sex hormones;
• providing a contraceptive effect;
• estrogen-gestogen effect on the female reproductive system.

The pharmacological properties of Lindinet 20 tablets are determined by the biochemical activity of its main components, which are sex hormones of synthetic origin.