Lindynette 30 Reviews from women, instructions for use, analogues

Release form, composition and packaging

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

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

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

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

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.

Analogs

In addition to Lindinet 30, you can buy many of its analogues for sale:

1. Rigevidon. A combined contraceptive, which is available in the form of white-coated tablets. It contains ethinyl estradiol and levonorgestrel as active ingredients. The drug is used not only to prevent unwanted pregnancy, but also to normalize the menstrual cycle and eliminate premenstrual tension. The medication is contraindicated for women over 40 years of age.
2. Microgynon. The drug is available in tablets; its active ingredients are ethinyl estradiol and levonorgestrel. It is used as a contraceptive.
3. Zoely. This is a combined contraceptive whose active ingredients are estradiol and nomegestrol. It is prescribed as a contraceptive.

Only a doctor should select an analogue of the drug Lindinet 30, since each of them has its own characteristics.

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 0.8-1.0 ml/min/kg. The level of gestodene in the blood serum decreases in two phases. T1/2 in the β-phase is 12-20 hours. Gestodene is excreted only in the form of metabolites, 60% in urine, 40% in feces. 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 β-phase is about 16-24 hours. Ethinyl estradiol is excreted only in the form of metabolites, in a 2:3 ratio with urine and bile. T1/2 of metabolites - about 1 day.

Kinetic ability

How does the absorption of a medication such as Lindinet 30 occur? The instructions indicate that after taking the medicine, its main substances are quickly absorbed from the gastrointestinal tract.

With a single dose of the drug, its peak concentration in the blood is reached after 1 hour. The bioavailability of this medicine is 98.9%.

Gestodene binds to globulin and albumin. It undergoes biotransformation in the liver and is excreted from the body only in the form of derivatives along with feces and urine.

As for ethinyl estradiol, it undergoes aromatic hydroxylation. In this case, hydroxylated and methylated metabolites are formed. Ethinyl estradiol is excreted only in the form of derivatives, along with bile and urine in a ratio of 3:2.

LINDYNET 30: DOSAGE

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 30 should be taken from the 1st to the 5th day of the menstrual cycle.

When switching to Lindinet 30 from another combined oral contraceptive, the first Lindinet 30 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 30 from drugs containing only progestogen (mini-pill, injections, implant), when taking a “mini-pill”, taking Lindinet 30 can be started on any day of the cycle, switching from using an implant to taking Lindinet 30 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 30 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 30 can be resumed after the usual 7-day break.

Indications for use

for adults

The medication is used for contraception.

for children

The drug is not recommended for persons under 18 years of age.

for pregnant women and during lactation

The drug is contraindicated during pregnancy and lactation. In small quantities, the active substances are excreted in breast milk; in addition, they can suppress lactation. If a woman is not breastfeeding, she can start taking Lindinet 30 3 weeks after giving birth.

Drug interactions

The contraceptive activity of Lindinet 30 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 30 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 30, 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 30 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.

Reviews from experts

Now you know why you need a product like Lindinet 30. The instructions and purpose of this medicine were presented above. What do gynecologists say about him? Most experts leave extremely positive reviews about this medication. They claim that such an oral contraceptive effectively helps resolve the issue of unwanted pregnancy. At the same time, doctors make a reservation that even when taking the correct dosages of the drug and following a strict regimen, the patients’ weight may unreasonably increase, which, of course, cannot but upset them.

Gynecologists also report that, in addition to their main purpose, the contraceptive pills in question are actively used as a therapeutic agent for gynecological pathologies, including functional disorders of the monthly cycle.

Thanks to a carefully developed formula, as well as a thoughtful regimen for taking the contraceptive, you can easily achieve the desired results for a long time. At the same time, gynecologists claim that Lindinet 30 tablets can cause adverse reactions. In this regard, before taking them, you should definitely seek additional advice from an experienced specialist.

LINDYNET 30: 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

• the presence of severe and/or multiple risk factors for venous or arterial thrombosis (incl.
• complicated lesions of the heart valve apparatus,
• atrial fibrillation,
• diseases of the cerebral vessels or coronary arteries,
• arterial hypertension severe or moderate with blood pressure ≥ 160/100 mmHg);
• presence or indication in history of precursors of thrombosis (incl.
• transient ischemic attack,
• angina);
• migraine with focal neurological symptoms,
• incl.
• in the anamnesis;
• venous or arterial thrombosis/thromboembolism (incl.
• myocardial infarction,
• stroke,
• deep vein thrombosis of the leg,
• pulmonary embolism) currently or in history;
• a history of venous thromboembolism;
• surgery with prolonged immobilization;
• diabetes mellitus (with angiopathy);
• pancreatitis (incl.
• in the anamnesis),
• accompanied by severe hypertriglyceridemia;
• dyslipidemia;
• severe liver diseases,
• cholestatic jaundice (incl.
• 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 (incl.
• in the anamnesis);
• severe itching
• otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
• hormone-dependent malignant neoplasms of the genital organs and mammary glands (incl.
• if you suspect them);
• 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 (body mass index more than 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, major surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period (non-lactating women /21 days after childbirth/; lactating women after the end of the lactation period), the presence of severe depression (including a history), changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, incl. . antibodies to cardiolipin, lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia (including family history), acute and chronic liver diseases.

special instructions

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

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

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

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

• diseases of the hemostatic system;
• conditions/diseases,
• predisposing to the development of cardiovascular disease,
• renal failure;
• epilepsy;
• migraine;
• the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
• diabetes,
• not complicated by vascular disorders;
• severe depression (if depression is associated with impaired tryptophan metabolism,
• then vitamin B6 can be used for correction purposes);
• sickle cell anemia,
• because
• in some cases (for example,
• infections,
• hypoxia) estrogen-containing drugs in 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,
• from parents,
• brother or sister).
• If a genetic predisposition is suspected,
• It is necessary to consult a specialist before using the drug;
• for obesity (body mass index more than 30 kg/m2);
• with dislipoproteinemia;
• with arterial hypertension;
• for diseases of the heart valves,
• complicated by hemodynamic disorders;
• with atrial fibrillation;
• for diabetes mellitus,
• complicated by vascular lesions;
• with prolonged immobilization,
• after major surgery,
• after surgery on the lower extremities,
• after a serious injury.

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
• which radiates to the left hand;
• sudden shortness of breath;
• any unusually severe headache,
• lasting for a long time or appearing 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,
• motor disorders,
• severe unilateral pain in the calf muscle,
• acute stomach.

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 30.

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

Studies have not been conducted to study the effect of the drug Lindinet 30 on the abilities necessary to drive a car and operate machinery.