Lindynette 30
If any of the conditions, diseases or risk factors listed below currently exist, the potential risks and expected benefits of using COCs, including the combination of gestodene + ethinyl estradiol, should be carefully weighed in each individual case and discussed with the woman before starting to take the drug. If any of these conditions, diseases or risk factors worsen, intensify or appear for the first time, a woman should consult her doctor to decide whether to stop taking the drug.
Risk of developing venous and arterial thromboembolism (VTE and ATE)
The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as DVT, PE, myocardial infarction, cerebrovascular disorders). These diseases are rare.
The increased risk of developing VTE associated with the use of COCs is due to the presence of estrogen in its composition. COCs containing levonorgestrel, norgestimate or norethisterone as a progestogen component are associated with the lowest risk of VTE. When using other COCs, such as the combination of gestodene + ethinyl estradiol, the risk of developing VTE is twice as high.
The choice of a COC with a higher risk of VTE should only be made after consultation with the woman to ensure that she fully understands the risk of VTE associated with the contraceptive, the effect of the drug on her existing risk factors and that the risk of developing VTE maximum in the first year of taking such drugs. An increased risk is also observed when COC use is resumed (after a break between doses of the drug of 4 weeks or more). The increased risk of developing VTE is present primarily during the first 3 months.
VTE can be life-threatening or lead to death (in 1-2% of cases). VTE, manifested as DVT and/or PE, can occur with all COCs.
It is extremely rare when using COCs that thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels.
Symptoms of DVT:
unilateral swelling of the lower limb or along the vein, pain or discomfort only in an upright position or when walking, local increase in temperature, redness or discoloration of the skin in the affected lower limb.
Symptoms of pulmonary embolism:
difficulty or rapid breathing; sudden cough, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less severe conditions (eg, respiratory tract infection).
ATE can lead to stroke, vascular occlusion, or myocardial infarction.
Symptoms of a stroke
: sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, severe or prolonged headache for no apparent reason, one- or two-sided loss of vision; problems with speech and understanding; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden loss of consciousness or fainting with or without a seizure.
Other signs of vascular occlusion
: sudden pain, swelling and slight cyanosis of the extremities, “acute” abdomen.
Symptoms of myocardial infarction
: pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat. ATE can be life-threatening and lead to death.
In women with a combination of several risk factors or high severity of one of the factors, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. In this case, taking the combination of gestodene + ethinyl estradiol is contraindicated.
The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders increases:
-with age;
- in women who smoke (with an increase in the number of cigarettes or an increase in age, the risk increases, especially over the age of 35);
- if there is a family history (for example, VTE or ATE in close relatives or parents aged less than 50 years). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of taking COCs;
- for obesity (with a BMI more than 30 kg/m2);
- with dyslipoproteinemia;
- for arterial hypertension;
- for migraine;
- for diseases of the heart valves;
- with atrial fibrillation;
- in case of prolonged immobilization, serious surgery, any operation on the lower extremities, in the pelvic area or extensive trauma.
In these cases, the use of COCs should be stopped (in the case of planned surgery, at least four weeks before it) and not resumed for two weeks after the woman has fully regained mobility.
Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially in the presence of other risk factors.
The possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.
The increased risk of thromboembolism in the postpartum period should be taken into account. Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
An increase in the frequency and severity of migraine (which may precede cerebrovascular events) during the use of COCs is grounds for immediate discontinuation of these drugs.
Biochemical indicators indicating a hereditary or acquired predisposition to the development of venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition/disease may reduce the associated risk of thrombosis.
Tumors
The most significant risk factor for the development of cervical cancer (CC) is persistent human papillomavirus infection. There are reports of a slight increase in the risk of developing CC with long-term use of COCs. However, the connection with taking COCs has not been proven. Controversy remains regarding the extent to which these findings are related to screening for cervical pathology or to sexual behavior patterns (less use of barrier methods of contraception, greater number of sexual partners).
A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years of stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the incidence of breast cancer in women who are currently taking COCs or have recently taken it is insignificant in relation to the overall risk of this disease. Its connection with COC use has not been proven. The observed increase in risk may also be a consequence of earlier diagnosis of breast cancer in women using COCs (they are diagnosed with earlier clinical forms of breast cancer than women not taking COCs), the biological effects of COCs, or a combination of both of these factors.
In rare cases, during the use of COCs, the development of benign, and in extremely rare cases, malignant liver tumors, which in some cases led to life-threatening intra-abdominal bleeding, was observed. In case of severe abdominal pain, liver enlargement or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis.
Other states
Depressed mood and depression are known adverse reactions when using hormonal contraceptives. Depression can be a serious disorder and is a known risk factor for suicidal behavior and suicide. Women should be advised to contact their doctor if mood changes or depressive symptoms occur, including soon after starting treatment.
In women with hypertriglyceridemia (or a family history of this condition), the risk of developing pancreatitis may increase while taking COCs.
Although slight increases in blood pressure have been described in many women taking COCs, clinically significant increases have rarely been reported. However, if a persistent clinically significant increase in blood pressure develops during the use of COCs, the COC should be discontinued and treatment of arterial hypertension should be initiated. COC use can be continued if normal blood pressure values are achieved with antihypertensive therapy.
The following conditions have been reported to develop or worsen both during pregnancy and while taking COCs, but their relationship with COC use has not been proven: cholestatic jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of COCs.
In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.
Acute or chronic liver dysfunction may require discontinuation of COCs until liver function tests return to normal. Recurrence of cholestatic jaundice, which developed for the first time during a previous pregnancy or previous use of sex hormones, requires discontinuation of COC use.
Although COCs may have an effect on insulin resistance and glucose tolerance, in patients with diabetes mellitus using low-dose COCs, as a rule, no dose adjustment of hypoglycemic drugs is required. However, women with diabetes mellitus should be carefully monitored while taking COCs.
Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking COCs.
Effect on liver function tests
In clinical studies involving patients receiving hepatitis C viral therapy (a combination of drugs containing ombitasvir, paritaprevir, ritonavir, dasabuvir, with or without ribavirin), increases in ALT activity more than 5 times the upper limit of normal were recorded more often in patients using ethynyl-containing COCs.
If a course of therapy with this combination of drugs is necessary, a patient using the contraceptive drug gestodene + ethinyl estradiol should be switched to alternative methods of contraception (non-hormonal or contraceptives containing only gestagen) before starting the course of treatment. You can resume taking the combination of gestodene + ethinyl estradiol no earlier than 2 weeks after the end of the course of therapy with antiviral drugs.
Laboratory tests
The use of drugs such as gestodene + ethinyl estradiol may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, kidney and adrenal function, the concentration of transport proteins in plasma (for example, transcortin, lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis). These changes usually remain within normal physiological values.
Reduced efficiency
The effectiveness of COCs may be reduced in the following cases: in case of missed pills, gastrointestinal disorders or as a result of drug interactions.
Effect on bleeding pattern
While taking COCs, irregular bleeding may occur (“spotting” and/or “breakthrough” bleeding), especially during the first months of use. Therefore, any irregular bleeding should be assessed only after an adaptation period of approximately 3 cycles of dosing.
If irregular bleeding recurs or develops after previous regular cycles, careful evaluation should be performed to rule out malignancy or pregnancy.
Some women may not develop bleeding during a break in taking pills. “ooContraindications” and “With caution.”
-Local compaction in the mammary gland.
-Concomitant use of other medications.
-If prolonged immobilization is expected (for example, a cast is applied to the lower extremity), hospitalization or surgery is planned (at least four weeks before the proposed operation).
-Unusually heavy bleeding from the vagina.
-Missed a pill in the first week of taking the drug and had sexual intercourse seven days or less before.
- Absence of regular menstrual-like bleeding two times in a row or suspicion of pregnancy (you should not start taking pills from the next package before consulting your doctor).
You should stop taking the tablets and consult your doctor immediately if there are possible signs of thrombosis, myocardial infarction or stroke: unusual cough; unusually severe pain behind the sternum, radiating to the left arm; unexpected shortness of breath, unusual, severe and prolonged headache or migraine attack; partial or complete loss of vision or double vision; slurred speech; sudden changes in hearing, smell, or taste; dizziness or fainting; weakness or loss of sensation in any part of the body; severe abdominal pain; severe pain in the lower limb or sudden swelling of any of the lower limbs.
This medicine contains lactose (in the form of lactose monohydrate) and sucrose. Patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome, as well as rare congenital forms of fructose intolerance or sucrase-isomaltase deficiency should not take this drug.
Lindinet 30 film-coated tablets 75mcg+30mcg No. 21
pharmachologic effect
Lindinet is a combination drug, the effect of which is determined by the effects of the components included in its composition.
Inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is the highly effective oral drug ethinyl estradiol (a synthetic analogue of estradiol, which participates together with the corpus luteum hormone in the regulation of the menstrual cycle). The gestagenic component is the 19-nortestosterone derivative gestodene, which is superior in strength and selectivity to not only the natural corpus luteum hormone progesterone, but also modern synthetic gestagens (levonorgestrel). Due to its high activity, gestodene is used in very 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. When taken orally, it is quickly and completely absorbed. After taking one dose, Cmax in plasma is measured after an hour and is 24 ng/ml. Bioavailability is about 99%.
Distribution. It binds with albumin and sex hormone binding globulin (SHBG). 12% are in a free state, 5075% are specifically associated with SHBG. The increase in SHBG levels caused by ethinyl estradiol affects the level of gestodene, leading to an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction. Vd of gestodene 0.71.4 l/kg.
Metabolism. Corresponds to steroid metabolism. Average plasma clearance is 0.81 ml/min/kg.
Excretion. Blood levels decrease in two stages. The half-life in the final phase is 1220 hours. It is excreted exclusively in the form of metabolites: 60% in urine, 40% in feces. T1/2 of metabolites is approximately 1 day.
Stable concentration. The pharmacokinetics of gestodene largely depends on the level of SHBG. Under the influence of ethinyl estradiol, the concentration of SHBG in the blood increases 3 times; with daily administration of the drug, the level of gestodene in plasma increases 34 times and reaches a saturation state in the second half of the cycle.
Ethinyl estradiol
Suction. When taken orally, it is absorbed quickly and almost completely. Cmax in the blood is measured after 12 hours and is 3080 pg/ml. Absolute bioavailability 60% (due to presystemic conjugation and primary metabolism in the liver).
Distribution. Easily enters into a nonspecific relationship with blood albumin (about 98.5%) and causes an increase in SHBG levels. Average Vd 518 l/kg.
Metabolism. It is carried out mainly due to aromatic hydroxylation with the formation of large quantities of hydroxylated and methylated metabolites, partly in free, partly in conjugated form (glucuronides and sulfates). Plasma clearance 513 ml/min/kg.
Excretion. Serum concentration decreases in 2 stages. T1/2 in the second phase is 1624 hours. It is excreted exclusively in the form of metabolites in a ratio of 2:3 with urine and bile. T1/2 of metabolites 1 day.
Stable concentration. It is established by the 34th day, while the level of ethinyl estradiol is 20% higher than after taking a single dose.
Indications
Contraception.
Contraindications
- individual hypersensitivity to the drug or its components,
- the presence of severe or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebrovascular disease or coronary artery disease),
- uncontrolled moderate or severe arterial hypertension with blood pressure 160/100 mm Hg. Art. and more),
- precursors of thrombosis (including transient ischemic attack, angina), incl. in the anamnesis,
- migraine with focal neurological symptoms, incl. in the anamnesis,
- venous or arterial thrombosis/thromboembolism (including deep vein thrombosis of the leg, pulmonary embolism, myocardial infarction, stroke) currently or in history,
- presence of venous thromboembolism in relatives,
- major surgery with prolonged immobilization,
- diabetes mellitus (with the presence of 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 these parameters return to normal),
- jaundice due to taking drugs containing steroids,
- gallstone disease currently or in history,
- Gilbert, Dubin-Johnson, Rotor syndrome,
- liver tumors (including history),
- severe itching, otosclerosis or progression of otosclerosis during a previous pregnancy or while taking corticosteroids,
- hormone-dependent malignant neoplasms of the genital organs and mammary glands (including suspicion of them),
- vaginal bleeding of unknown etiology,
- smoking over the age of 35 (more than 15 cigarettes per day),
- pregnancy or suspicion of it,
- lactation.
With caution: 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's disease, Sydenham's chorea, chloasma), obesity (body mass index more than 30), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, extensive surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period (non-lactating women 21 the day after childbirth, nursing women after completion of the lactation period), the presence of severe depression, incl. 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, systemic red lupus (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. If it is necessary to prescribe the drug during lactation, the issue of stopping breastfeeding should be decided. The active substances of the drug are excreted in small quantities into breast milk, affecting the quantity and quality of milk.
special instructions
Before starting to use the drug, it is recommended to collect a detailed family and personal history and subsequently undergo a general medical and gynecological examination every 6 months (examination by a gynecologist, examination of a cytological smear, examination of the mammary glands and liver function, monitoring of blood pressure, cholesterol concentrations in the blood, urine analysis). These studies must be repeated periodically due to the need for timely identification of risk factors or contraindications that have arisen.
The drug is a reliable contraceptive drug; 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, 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 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 an association between taking 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). 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 you suspect a genetic predisposition, you should consult a specialist before using the drug.
- for obesity (body mass index above 30),
- with dislipoproteinemia,
- for arterial hypertension,
- for diseases of the heart valves complicated by hemodynamic disorders,
- with atrial fibrillation,
- with diabetes mellitus complicated by vascular lesions,
- with prolonged immobilization, after major surgery, surgery on the lower extremities, severe trauma.
In these cases, temporary cessation of use of the drug is assumed. It is advisable to stop no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization.
The risk of venous thromboembolic diseases increases in women after childbirth.
Diseases such as diabetes mellitus, SLE, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, and sickle cell anemia increase the risk of developing venous thromboembolic diseases.
Biochemical abnormalities such as resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of arterial or venous thromboembolic diseases.
When assessing the benefit/risk ratio of taking the drug, it must be borne in mind that targeted treatment of this condition reduces the risk of thromboembolism.
Signs of thromboembolism are:
- sudden chest pain that radiates to the left arm,
- sudden shortness of breath,
- any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, acute abdomen.
Tumor diseases
Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer.
A meta-analysis of 54 epidemiological studies found that there was 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 are taking hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, women should be made aware of the possible risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian, endometrial and colon 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 diagnosing abdominal pain, which may be associated with an increase in liver size or intra-abdominal bleeding.
The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
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 2nd cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, you should stop taking the pills and resume it only after pregnancy has been ruled out.
Chloasma
Chloasma can occasionally occur in women who have a history of it during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or UV rays while taking the pills.
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.
After acute viral hepatitis, it should be taken after normalization of liver function (no earlier than 6 months). In case of diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease (without stopping 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 the number of cigarettes smoked. During lactation, milk secretion may decrease; in small quantities, the components of the drug are excreted in breast milk.
The effect of the drug on the ability to drive a car and operate machinery. Studies have not been conducted to study the possible effect of Lindinet 30 on the ability to drive a car or other machines.
Compound
1 tablet contains: active substances: ethinyl estradiol 30 mcg, gestodene 75 mcg, excipients: sodium calcium edetate, magnesium stearate, colloidal anhydrous silicon, povidone, corn starch, lactose monohydrate, shell composition: D+S yellow N 10 C.I. 47005, E104, povidone, titanium oxide CI 7791, E171, macrogol 6000, talc, calcium carbonate, sucrose.
Directions for use and doses
Orally, without chewing, with a sufficient amount of water, regardless of meals.
Take 1 tablet. per day (at the same time of day if possible) for 21 days. Then, after taking a 7-day break from taking the tablets, resume oral contraception (i.e. 4 weeks after taking the 1st tablet, on the same day of the week). During the 7-day break, uterine bleeding occurs as a result of hormone withdrawal.
First dose of the drug: Lindinet 30 should be taken from the 1st to the 5th day of the menstrual cycle.
Transition from a combined oral contraceptive to taking Lindinet 30. Table 1. Lindinet 30 is recommended to be taken after taking the last hormone-containing tablet of the previous drug, on the 1st day of withdrawal bleeding.
Transition from progestagen-containing drugs (mini-tablets, injections, implant) to taking Lindinet 30. The transition from mini-tablets can be started on any day of the menstrual cycle, in the case of an implant the day after its removal, in the case of injections on the eve of the last injection.
In this case, in the first 7 days of taking Lindinet 30, it is necessary to use an additional method of contraception.
Taking Lindinet 30 after an abortion in the first trimester of pregnancy. You can start taking contraceptives immediately after an abortion, and there is no need to use an additional method of contraception.
Taking Lindinet 30 after childbirth or after an abortion in the second trimester of pregnancy. You can start taking the contraceptive on the 2128th day after childbirth or abortion in the second trimester of pregnancy. If you start taking a contraceptive later, in the first 7 days, it is necessary to use an additional, barrier method of contraception. In the case where sexual intercourse took place before the start of contraception, before starting to take the drug, you should exclude the presence of a new pregnancy or wait until the next menstruation.
Missed pills. If the next scheduled dose of the tablet was missed, then you should make up for the missed dose as soon as possible. If the delay does not exceed 12 hours, the contraceptive effect of the drug is not reduced, and there is no need to use an additional method of contraception. The remaining tablets are taken as usual.
If there is a delay of more than 12 hours, the contraceptive effect may be reduced. In such cases, you should not make up for the missed dose, continue taking the drug as usual, but in the next 7 days you must use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, then take the tablets from the next package without taking a break. In such cases, uterine withdrawal bleeding occurs only after the completion of the 2nd package; spotting or breakthrough bleeding is possible while taking tablets from the 2nd package.
If, upon completion of taking the tablets from the 2nd package, withdrawal bleeding does not occur, then pregnancy should be excluded before continuing to take the contraceptive.
Measures to be taken in case of vomiting and diarrhea. If vomiting occurs in the first 34 hours after taking another tablet, the tablet is not completely absorbed. In such cases, you should act in accordance with the instructions described in the section Missed tablets.
If the patient does not want to deviate from her usual contraceptive regimen, the missed pills should be taken from another package.
Delay of menstruation and acceleration of the onset of menstruation. In order to delay menstruation, take pills from a new package without taking a break. Menstruation can be delayed at will until all the tablets from the 2nd package are gone. If menstruation is delayed, breakthrough or spotting uterine bleeding is possible. You can return to your usual pill intake after a 7-day break.
In order to achieve an earlier onset of menstrual bleeding, you can shorten the 7-day break by the desired number of days. 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).
Side effects
Side effects that require immediate discontinuation of the drug:
- arterial hypertension,
- hemolytic-uremic syndrome,
- porphyria,
- hearing loss caused by otosclerosis.
Rarely occurring arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism), exacerbation of reactive SLE.
Very rare arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins, Sydenham's chorea (passing after discontinuation of the drug).
Other side effects, less severe, but more common, the advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.
From the reproductive system: acyclic bleeding/spotting from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes in the vagina (for example, candidiasis), changes in libido.
From the mammary glands: tension, pain, enlargement of the mammary glands, galactorrhea.
From the gastrointestinal tract and hepatobiliary system: nausea, vomiting, diarrhea, epigastric pain, Crohn's disease, ulcerative colitis, hepatitis, liver adenoma, the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis.
Skin: erythema nodosum/exudative, rash, chloasma, increased hair loss.
From the central nervous system: headache, migraine, mood changes, depressive states.
Metabolic disorders: fluid retention in the body, change (increase) in body weight, increased triglycerides and blood sugar, decreased tolerance to carbohydrates.
From the senses: hearing loss, increased sensitivity of the cornea when wearing contact lenses.
Other: allergic reactions.
Drug interactions
The contraceptive effect of oral contraceptives is reduced with simultaneous use of rifampicin, breakthrough bleeding and menstrual irregularities become more frequent. Similar, but less studied, interactions exist between contraceptives and carbamazepine, primidone, barbiturates, phenylbutazone, phenytoin and presumably griseofulvin, ampicillin and tetracyclines. During treatment with the above drugs, simultaneously with oral contraception, it is recommended to use an additional method of contraception (condom, spermicidal gel). After completing the course of treatment, the use of an additional method of contraception should be continued for 7 days, in the case of treatment with rifampicin for 4 weeks.
Interactions associated with drug absorption
During diarrhea, the absorption of hormones decreases (due to increased intestinal motility). Any drug that shortens the time a hormonal agent remains in the large intestine leads to low concentrations of the hormone in the blood.
Interactions related to drug metabolism
Intestinal wall. Drugs that undergo sulfation in the intestinal wall like ethinyl estradiol (for example, ascorbic acid) inhibit metabolism and increase the bioavailability of ethinyl estradiol.
Metabolism in the liver. Inducers of microsomal liver enzymes reduce the level of ethinyl estradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oxcarbazepine). Liver enzyme blockers (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma.
Effect on intrahepatic circulation. Some antibiotics (for example, ampicillin, tetracycline), by interfering with the intrahepatic circulation of estrogens, reduce the level of ethinyl estradiol in plasma.
Effect on the metabolism of other drugs
By blocking liver enzymes or accelerating conjugation in the liver, mainly increasing glucuronidation, ethinyl estradiol affects the metabolism of other drugs (for example, cyclosporine, theophylline), leading to an increase or decrease in their plasma concentrations.
The simultaneous use of St. John's wort (Hypericum perforatum) with Lindinet 20 tablets is not recommended (due to a possible decrease in the contraceptive effect of the active substances of the contraceptive, which may be accompanied by breakthrough bleeding and unwanted pregnancy). St. John's wort activates liver enzymes; after stopping the use of St. John's wort, the effect of enzyme induction can persist for the next 2 weeks.
Concomitant use of ritonavir and a combined contraceptive was associated with a 41% decrease in the mean AUC of ethinyl estradiol. During treatment with ritonavir, it is recommended to use a drug with a higher ethinyl estradiol content or a non-hormonal method of contraception. 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.
Check the interaction of other drugs with Lindinet 30 Add
The drugs you have chosen
Clear all Check interactions &lsaquo, Return to drug selection Do not stop taking the drug without consulting your doctor! We under no circumstances encourage you to self-medicate or diagnose yourself or your loved ones based on the data in our directory. All information is presented for informational purposes only, to make it easier for you to understand what exactly is bothering you and which specialist doctor you should contact.
Overdose
Taking large doses of the contraceptive was not accompanied by the development of severe symptoms.
Symptoms: nausea, vomiting, in young girls, slight vaginal bleeding.
Treatment: symptomatic, there is no specific antidote.
Storage conditions
Store at a temperature not exceeding 25C, out of the reach of children.
Best before date
3 years.
