Lindineth 20 and 30 - instructions for use, analogs, testimonials and formulations (tablets) of hormonal contraceptive for contraception in women, including during pregnancy and lactation. Side effects (bleeding, pain)

In this article, you can read the instructions for using the drug Lindinet 20 and 30. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Lindineth in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Lindineth in the presence of existing structural analogs. Use of hormonal contraceptive for contraception in women, including during pregnancy and lactation. Side effects (bleeding, pain).

Lyndynet - monophasic oral contraceptive. Oppresses the secretion of gonadotropic hormones in the pituitary gland. The contraceptive effect of the drug is associated with several mechanisms. The estrogen component of the drug is ethinyl estradiol, a synthetic analogue of the follicular hormone estradiol, which, together with the hormone of the yellow body, regulates the menstrual cycle. The gestagen component is Gestodene, a derivative of 19-nortestosterone, which is superior in strength and selectivity to the action of not only the natural hormone of the yellow body, progesterone, but also other synthetic gestagens (for example, levonorgestrel). Due to the high activity, Gestodene is used in low dosages in which it does not display androgenic properties and has almost no effect on lipid and carbohydrate metabolism.

Along with these central and peripheral mechanisms preventing the maturation of an ovum 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 spermatozoa.In addition to the contraceptive effect, the drug with regular reception has a therapeutic effect, normalizing the menstrual cycle and contributing to the prevention of the development of a number of gynecological diseases, incl. tumor nature.

The difference of the drug Lindineth 20 from Lindineth 30

The main difference between the two drugs lies in the different amounts of ethinylestradiol, which is part of the component, in one type of preparation it contains 30 μg, in the other 20 μg. Hence the various names of similar nevertheless preparations. Also, both preparations contain Gestodene in an amount of 75 μg.

Pharmacokinetics

Gestoden

After oral administration, it is quickly and completely absorbed from the digestive tract. Bioavailability is about 99%. Gestodene is biotransformed in the liver. It is excreted only in the form of metabolites, 60% - with urine, 40% - with feces.

Ethinylestradiol

After ingestion, ethinylestradiol is absorbed rapidly and almost completely. Ethinyl estradiol is excreted only in the form of metabolites, in a ratio of 2: 3 with urine and bile.

Indications

• contraception.

Forms of release

The tablets covered with a cover.

Instructions for use and reception scheme

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

The first pill of Lindineth should be taken from the 1st to the 5th day of the menstrual cycle.

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

In the transition to the reception Lindinet with formulations containing only a progestogen ( "mini-pill", injection, implant), when receiving the "mini-pill" reception Lindinet preparation can begin on any day of the cycle, go with the use of the implant at the reception Lindinet drug can be at the next day after removal of the implant, with the injection - on the eve of the last injection. In these cases, additional contraceptive methods should be used in the first 7 days.

After an abortion in the first trimester of pregnancy, you can start taking Lindineth immediately after the operation.In this case, there is no need for additional methods of contraception.

After childbirth or after an abortion in the 2nd trimester of pregnancy, the drug can be taken on 21-28 days. In these cases, in the first 7 days, additional contraceptive methods should be used. At a later start of the drug in the first 7 days, an additional, barrier method of contraception should be used. In the case of sexual contact before the start of contraception, before starting the drug should be excluded from pregnancy or postpone the start of admission before the first menstruation.

If you miss a pill, the missed pill should be taken as soon as possible. If the interval in taking the tablets was less than 12 hours, the contraceptive effect of the drug does not decrease, and in this case there is no need for 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, the missed dose should not be filled, the drug should be taken as usual, however, an additional contraceptive method should be used in the next 7 days.If at the same time there are less than 7 tablets left in the package, the preparation from the next package should be started without interruption. In this case, bleeding cancellation does not occur until the completion of the drug from the second package, but may appear bleeding or breakthrough bleeding.

If bleeding cancellation does not occur after the completion of taking the drug from the second package, then before continuing with the drug should be excluded from pregnancy.

If vomiting and / or diarrhea occurs within 3-4 hours after taking the drug, a reduction in the contraceptive effect is possible. In such cases, follow the instructions for skipping the reception of tablets. If the patient does not wish to deviate from the usual contraceptive regimen, the missed tablets should be taken from another package.

To accelerate the onset of menstruation, you should reduce the break in taking the drug. The shorter the break, the more likely the emergence of breakthrough or smearing bleeding during taking the tablets from the next package (similar to cases with a delay in menstruation).

To delay the onset of menstruation, the drug should be taken from the new package without a 7-day break.Menstruation can be delayed as long as necessary until the end of taking the last tablet from the second package. When menstruation is delayed, breakthrough or spotting bleeding may occur. Regular use of Lindineth can be restored after an ordinary 7-day break.

Side effect

Side effects that require drug withdrawal:

• arterial hypertension;
• arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, thromboembolism of the pulmonary artery);
• arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins;
• hearing loss due to otosclerosis;
• hemolytic-uremic syndrome;
• porphyria;
• exacerbation of reactive systemic lupus erythematosus;
• Sydenham's chorea (passing after withdrawal of the drug).

Other adverse events (less severe):

• acyclic bleeding / spotting from the vagina;
• amenorrhea after drug withdrawal;
• change in the state of vaginal mucus;
• development of inflammatory processes of the vagina;
• candidiasis;
• tension, pain, enlargement of the mammary glands;
• galactorrhea;
• pain in epigastrium;
• nausea, vomiting;
• Crohn's disease;
• ulcerative colitis;
• occurrence or exacerbation of jaundice and / or pruritus associated with cholestasis;
• adenoma of the liver;
• erythema nodosum;
• exudative erythema;
• rash;
• Chloasma;
• increased hair loss;
• headache;
• migraine;
• mood lability;
• depression;
• hearing loss;
• increased sensitivity of the cornea (when wearing contact lenses);
• fluid retention in the body;
• change (increase) in body weight;
• decreased tolerance to carbohydrates;
• hyperglycemia;
• allergic reactions.

Contraindications

• presence of severe and / or multiple risk factors for venous or arterial thrombosis (including complicated heart valve disease, atrial fibrillation, cerebrovascular or coronary artery disease, arterial hypertension of severe or moderate severity with BP ≥ 160/100 mm Hg .st.);
• presence or indication in the anamnesis of the precursors of thrombosis (including transient ischemic attack, angina pectoris);
• Migraine with focal neurologic symptoms, incl. in the anamnesis;
• venous or arterial thrombosis / thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower leg, pulmonary embolism) at present or in the anamnesis;
• presence of a venous thromboembolism in the anamnesis;
• surgical intervention with prolonged immobilization;
• diabetes mellitus (with angiopathy);
• pancreatitis (including in the anamnesis), accompanied by severe hypertriglyceridemia;
• dyslipidemia;
• severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. in the anamnesis (before normalization of functional and laboratory parameters and within 3 months after their normalization);
• jaundice when taking SCS;
• cholelithiasis at present or in the anamnesis;
• Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome;
• liver tumors (including in the anamnesis);
• severe itching, otosclerosis or its progression with a previous pregnancy or SCS;
• hormone-dependent malignant neoplasms of genital organs and mammary glands (including when suspected of them);
• vaginal bleeding of unclear etiology;
• Smoking over the age of 35 (more than 15 cigarettes a day);
• pregnancy or suspected of it;
• lactation period;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

The drug is contraindicated for use in pregnancy and lactation.

In small amounts, the components of the drug are excreted in breast milk.

When used during lactation, the release of milk may decrease.

special instructions

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

The drug is a reliable contraceptive: Perl index (the indicator of the number of pregnancies that occurred during the application of the method of contraception in 100 women for 1 year), with proper application is about 0.05. Due to the fact that the contraceptive effect of the drug from the onset of admission is fully manifested by day 14, in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal methods of contraception.

In each case, before the appointment of hormonal contraceptives individually evaluated the benefits or possible negative effects of their reception. This issue should be discussed with the patient,which after receiving the necessary information will make the final decision on the preferences of hormonal or some other method of contraception.

The state of women's health must be carefully monitored. If during the reception of the drug appears or worsens any of the below listed conditions / diseases, you must stop taking the drug and go to another, non-hormonal method of contraception:

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

Thromboembolic diseases

Epidemiological studies have shown that there is a link between the intake of oral hormonal contraceptives and an increased risk of arterial and venous thromboembolic diseases (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism). The increased risk of venous thromboembolic diseases has been proven, but it is significantly less than in pregnancy (60 cases per 100,000 pregnancies). When using oral contraceptives, arterial or venous thromboembolism of hepatic, mesenteric, renal vessels or retinal vessels is very rare.

The risk of arterial or venous thromboembolic disease increases:

• with age;
• when smoking (intensive smoking and age over 35 are among the risk factors);
• if there is a family history of thromboembolic diseases (for example, in parents, a brother or a sister). If you suspect a genetic predisposition, you must consult a specialist before using the drug;
• with obesity (body mass index more than 30 kg / m2);
• with dyslipoproteinemia;
• with arterial hypertension;
• with diseases of the heart valves complicated by hemodynamic disorders;
• with atrial fibrillation;
• with diabetes mellitus, complicated by vascular lesions;
• with prolonged immobilization, after a large surgical intervention, after surgery on the lower limbs, after severe trauma.

In these cases, a temporary discontinuation of the use of the drug is contemplated (no later than 4 weeks before surgery, and resumed no earlier than 2 weeks after remobilization).

In women after childbirth, the risk of venous thromboembolic disease increases.

It should be borne in mind that diabetes mellitus, systemic lupus erythematosus, haemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, increase the risk of venous thromboembolic disease.

It should be noted that resistance to activated protein C, hyperhomocysteinemia, deficiency of proteins C and S, deficiency of antithrombin 3, the presence of antiphospholipid antibodies, increase the risk of arterial or venous thromboembolic diseases.

When assessing the benefit / risk of taking the drug, it should be borne in mind that targeted treatment of this condition reduces the risk of thromboembolism. Symptoms of thromboembolism are:

• sudden pain in the chest, which radiates into the left arm;
• sudden shortness of breath;
• any unusually severe headache that lasts a long time or appears for the first time, especially when combined with sudden total or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of the body, motor impairment, severe unilateral pain in the gastrocnemius muscle, sharp abdomen.

Tumor diseases

Some studies have reported increased incidence of cervical cancer in those women who have long taken hormonal contraceptives, but the results of research are contradictory. In the development of cervical cancer, sexual behavior, infection with human papillomavirus and other factors play a significant role.

A meta-analysis of 54 epidemiological studies has shown that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives,however, a higher detection of breast cancer could be associated with a more regular medical examination. Breast cancer is rare among women younger than 40, regardless of whether they take hormonal contraceptives or not, and increases with age. The intake of tablets can be regarded as one of many risk factors. However, a woman should be advised of the possibility of a risk of developing breast cancer, based on an assessment of the benefit-risk ratio (protection against ovarian cancer and endometrium).

There are few reports of the development of a benign or malignant liver tumor in women who take long-term hormonal contraceptives. This should be borne in mind in the differential diagnosis of abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chlazmy

Chloasma can develop in women who have this disease in a history of pregnancy. For women who are at risk of developing chloasma, avoid contact with sunlight or ultraviolet light while taking Lindineth.

Efficiency

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

If the patient simultaneously takes another drug that may decrease the effectiveness of birth control pills, additional contraceptive methods should be used.

The effectiveness of the drug may decrease if after several months of their application irregular, spotting or breakthrough bleeding occurs, in such cases it is advisable to continue taking the tablets before their end in the next package. If at the end of the second cycle menstrual bleeding does not begin or acyclic spotting does not stop, stop taking the pills and resume it only after the pregnancy is excluded.

Changes in laboratory indicators

Under the influence of oral contraceptive pills - in connection with the estrogen component - the level of certain laboratory parameters (functional parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis, levels of lipoproteins and transport proteins) can vary.

Additional Information

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

With diarrhea or intestinal disorders, vomiting contraceptive effect may decrease. Do not stop taking the drug, you need to use additional non-hormonal methods of contraception.

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

A 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 manage mechanisms

Studies on the study of the effect of the drug Lindineth on the abilities necessary for driving and production mechanisms have not been carried out.

Drug Interactions

Contraceptive activity lindinet reduced while reception with ampicillin, tetracycline, rifampicin, barbiturates, primidone, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine.Contraceptive effect of oral contraceptives is reduced when these combinations are used, breakthrough bleeding and menstruation disorders are more frequent. During the reception of Lindineth with the above mentioned preparations, and also within 7 days after the completion of the course of their intake, it is necessary to use additionally 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.

With the simultaneous use with Lindineth any drug that increases the motility of the gastrointestinal tract, reduces the absorption of active substances and their level in the blood plasma.

Sulphation of ethinylestradiol occurs in the wall of the intestine. Preparations that are also subjected to sulfation in the wall of the intestine (including ascorbic acid), competitively inhibit sulfation of ethinyl estradiol and thereby enhance the bioavailability of ethinylestradiol.

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).Inhibitors of liver enzymes (itraconazole, fluconazole) increase the level of ethinyl estradiol in blood plasma.

Some antibiotics (ampicillin, tetracycline), preventing 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.

With the simultaneous use of Lindineth with preparations of St. John's wort (including infusion), the concentration of active substances in the blood decreases, which can lead to the emergence of breakthrough bleeding, pregnancy. The reason for this is the inducing effect of St. John's wort on liver enzymes, which continues for another 2 weeks after the completion of the course of St. John's wort. It is not recommended to prescribe this combination of drugs.

Ritonavir reduces the AUC of ethinylestradiol by 41%. Therefore, during the application of ritonavir, a hormonal contraceptive with a higher ethinylestradiol content (Lindineth 30) or supplementary non-hormonal contraceptive methods should be used.

It may be necessary to correct the dosage regimen when hypoglycemic agents are used, because oral contraceptives can reduce tolerance to carbohydrates, increase the need for insulin or oral antidiabetics.

Analogues of the drug Lindineth

Structural analogs for the active substance:

• Logest;
• Mirell;
• Femoden.

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