Lindinet 30

General characteristics. Structure:

Active agents: ethinylestradiol - 0,03 mg and гестоден - 0,075 mg

Excipients:

- in a kernel: Calcium sodium эдетат; magnesium stearate; silicon dioxide colloid; povidone; starch corn; lactoses monohydrate;
- in a cover: Dye quinolinic yellow E 104 (Д + About Yellow No. 10 E 104); povidone; titanium dioxide; macrogoal 6000; talc; calcium carbonate; sucrose.

Pharmacological properties:

Pharmacodynamics. The combined means which action is caused by effects of the components which are its part. Oppresses pituitary secretion of gonadotropic hormones. The contraceptive effect of drug is connected with several mechanisms. An oestrogenic component of drug is highly effective peroral the HP - ethinylestradiol (a synthetic analog of the oestradiol participating together with hormone of a yellow body in regulation of a menstrual cycle). The Gestagenny component is derivative the 19-nortestosterona - гестоден, the progesterone, but also modern synthetic gestagena surpassing in force and selectivity of action not only natural hormone of a yellow body (levonorgestrel, etc.). Thanks to high activity гестоден use in very low dosages in which he does not show androgenic properties and practically does not exert impact on lipidic and carbohydrate exchanges.
Along with the specified central and peripheral mechanisms interfering maturing of an ovum, capable to fertilization, the contraceptive effect is caused by decrease in a susceptibility of an endometria to a blastocyste, and also increase in viscosity of the slime which is in a neck of uterus that does it rather impassable for spermatozoa. In addition to contraceptive effect drug at regular reception has also medical effect, normalizing a menstrual cycle and promoting the prevention of development of a number of gynecologic diseases, including the tumoral nature.

Pharmacokinetics. Gestoden:
Absorption: at intake it is quickly and completely soaked up. After reception of one dose the maximum concentration is measured in plasma in an hour and makes 2-4 ng/ml. Biological availability about 99%. Distribution: takes up with albumine and the globulin, connecting sex hormones (G,CSH). 1-2% are in a stand-at-ease, 50-75% are specifically connected with GSPG. The increase in the GSPG level caused by ethinylestradiol influences the level of a gestoden, leading to increase in the fraction connected with GSPG, and decrease in the fraction connected with albumine. Volume of distribution of a gestoden of 0,7-1,4 l/kg.
Metabolism: corresponds to a way of metabolism of steroids. Average plasma clearance: 0,8-1,0 ml/min.
Removal: level in blood decreases in two stages. Half-decay time in a final phase 12-20 hour. It is removed only in the form of metabolites: 60% with urine, 40% - with a fecal masses. Time of semi-removal of metabolites about 1 days.
Stable concentration: the pharmacokinetics of a gestoden substantially depends on the GSPG level. Under the influence of ethinylestradiol concentration of GSPG in blood increases three times; at daily administration of drug the level of a gestoden in plasma increases by three-four times and in the second half of a cycle reaches a condition of saturation.
Ethinylestradiol:
Absorption: at intake it is soaked up quickly and almost completely. The maximum concentration is measured in blood in 1-2 hours and makes 30-80 pg/ml. Absolute biological availability ≅ 60% because of presystem conjugation and primary metabolism in a liver.
Distribution: easily enters nonspecific communication with blood albumine (about 98,5%) and causes increase in the GSPG level. The average volume of distribution is 5-18 l/kg. Metabolism: it is carried out mainly at the expense of an aromatic hydroxylation with formation of large numbers of the hydroxylated and metilirovanny metabolites which are partially in free, partially in the conjugated form (glucuronides and sulfates). Plasma clearance ≅ 5-13 ml/min.
Removal: Concentration in serum decreases in two stages. Semi-removal time in the second phase ≅ 16-24 hour. It is removed only in the form of metabolites in the ratio 2:3 with urine and bile. Time of semi-removal of metabolites ≅ 1 days.
Stable concentration: Stable concentration is established by 3-4 day, at the same time the level of ethinylestradiol is 20% higher, than after reception of one dose.

Indications to use:

Contraception.

Route of administration and doses:

To accept on 1 tablet a day within 21 days, whenever possible at the same time days. Then, having taken a 7-day break in reception of tablets, to resume peroral contraception (i.e. in 4 weeks after reception of the first tablet, on the same day weeks). During a 7-day break there is uterine bleeding as a result of hormone cancellation. First tablet: Administration of drug of Lindinet 30 should be begun from the first to the fifth day of a menstrual cycle.
Transition from the combined oral contraceptive to administration of drug of Lindinet 30: The first pill of drug of Lindinet 30 is recommended to be taken after reception of the last gormonsoderzhashchy tablet of the previous drug, in the first day of bleeding of cancellation.
Transition from the progestagen-containing drugs ("pass" tablets, injections, an implant) to administration of drug of Lindinet 30: Transition from "pass" tablets it is possible to begin in any day of a menstrual cycle; in case of an implant - next day after its removal; in case of injections - on the eve of the last injection.
At the same time in the first 7 days of administration of drug of Lindinet 30 it is necessary to apply an additional method of contraception.

Administration of drug of Lindinet 30 after abortion on the first trimester of pregnancy: Reception of a contraceptive can be begun at once after abortion, at the same time there is no need for use of an additional method of contraception.

Administration of drug of Lindinet 30 after the delivery or after abortion on the second trimester of pregnancy: Reception of a contraceptive can be begun for 21-28 days after the delivery or abortion on the second trimester of pregnancy. At later beginning of reception of a contraceptive, in the first 7 days, it is necessary to apply an additional, barrier method of contraception. In case the sexual contact took place prior to contraception before starting administration of drug, it is necessary to exclude existence of new pregnancy or to wait for the following periods.

The passed tablets. If the reception of a tablet, next on the schedule, was missed, then it is necessary to fill the passed dose as soon as possible. At the delay which is not exceeding 12 hours, contraceptive effect of drug does not decrease, and there is no need for use of an additional method of contraception. Other pill is taken in the usual mode.
At more, than a 12-hour delay the contraceptive effect can decrease. In such cases it is not necessary to fill the passed dose, administration of drug is continued in the usual mode, however in the next 7 days use of an additional method of contraception is necessary. If at the same time in packaging there were less than 7 tablets, then reception of tablets from the following packaging is started without observance of a break. In such cases uterine bleeding of cancellation arises only upon completion of the second packaging; during reception of tablets from the second packaging the smearing or breakthrough bleedings are possible.
If upon completion of reception of tablets does not come from the second packaging of bleeding of cancellation, then, before continuing reception of a contraceptive, it is necessary to exclude pregnancy existence.
The measures taken in case of vomiting and diarrhea:
If in the first 3-4 hours after reception of the next tablet there is vomiting, the tablet is soaked up by incompleteness. In such cases it is necessary to arrive according to the instructions described in The Passed Tablets point.
If the patient does not wish to deviate the usual mode of contraception, the passed pill should be taken from other packaging.

Delay of periods and acceleration of terms of approach of periods:
For the purpose of a periods delay from new packaging start reception of tablets without observance of a break. Periods it is possible to detain at will until all tablets from the second packaging come to an end. At a delay of periods the breakthrough or smearing uterine bleedings are possible. It is possible to return to standard practice of tablets after observance of a 7-day break.
For the purpose of earlier approach of menstrual bleeding it is possible to reduce a 7-day break by desirable number of days. Than the break is shorter, especially emergence of the breakthrough or smearing bleeding during reception tablets from the following packaging is probable (like cases with a periods delay).

Features of use:

Before use of drug it is recommended to collect the detailed family and personal anamnesis and each 6 months to undergo all-medical and gynecologic examination in the subsequent (survey by the gynecologist, a research of a cytologic smear, a research of mammary glands and function of a liver, control of the arterial pressure (AP), concentration of cholesterol in blood, the analysis of urine). These researches need to be repeated periodically, due to the need of early detection of risk factors or the arisen contraindications.
Drug is well-tried contraceptive medicine: Perl's index (an indicator of number of the pregnancies which occurred during use of a method of contraception for 100 women during 1 year) at the correct use makes about 0:05. Because contraceptive effect of drug from the beginning of reception is fully shown by 14th day, in the first 2 weeks of administration of drug, contraception is recommended to apply in addition non-hormonal methods.
In each case before purpose of hormonal contraceptives advantages or possible negative effects of their reception are individually estimated. This question needs to be discussed with the patient who after obtaining the necessary information will make the final decision on preference of hormonal or any other method of contraception. The state of health of the woman needs to be controlled carefully. If during administration of drug any of below the listed states/diseases appears or worsens, it is necessary to stop administration of drug and to pass to other, non-hormonal method of contraception:

- diseases of system of a hemostasis.
- the states / diseases contributing to development of a cardiovascular, renal failure.
- epilepsy
- migraine
- the risk of development is oestrogenic - a dependent tumor or is oestrogenic - dependent gynecologic diseases;
- the diabetes mellitus which is not complicated by vascular disorders;
- a heavy depression (if the depression is connected with tryptophane exchange disturbance, then for the purpose of correction it is possible to apply B6 vitamin);
- drepanocytic anemia as in some cases (for example, infections, a hypoxia) it is oestrogenic - the containing drugs at this pathology can provoke the thromboembolism phenomena.
- emergence of deviations in laboratory tests of assessment of function of a liver.

Thromboembolic diseases.
Epidemiological researches proved that there is a communication between reception of peroral hormonal contraceptives and increase in risk of arterial and venous thromboembolic diseases (including a myocardial infarction, a stroke, a deep vein thrombosis of the lower extremities, a thromboembolism of a pulmonary artery). The increased risk of venous thromboembolic diseases is proved, but it is much less, than at pregnancy (60 cases on 100 thousand pregnancies). At use of peroral contraceptive drugs the arterial or venous thromboembolism of hepatic, mezenterialny, renal vessels or vessels of a retina is very seldom observed.
The risk of emergence of arterial or venous thromboembolic diseases increases:
with age;
- when smoking (intensive smoking and age are more senior than 35 years treat risk factors);
- in the presence in the family anamnesis of thromboembolic diseases (for example, at parents, the brother or the sister). At suspicion on genetic predisposition, it is necessary to consult before use of drug with the specialist.
- at obesity (the index of body weight is higher than 30 kg/sq.m);
- at dislipoproteinemiya;
- at arterial hypertension;
- at diseases of the valves of heart complicated by hemodynamic disturbances
- at fibrillation of auricles;
- at the diabetes mellitus complicated by vascular defeats;
- at a long immobilization, after a big operative measure, after an operative measure on the lowest extremities, after a severe injury.
In these cases temporary phase-out of drug is supposed: it is desirable to stop not later, than in 4 weeks prior to an operative measure, and to renew - not early, than in 2 weeks after a remobilization.
The risk of developing of venous thromboembolic diseases at women after the delivery increases.

Such diseases as diabetes mellitus, system lupus erythematosus, gemolitiko-uraemic syndrome, disease the Krone, nonspecific ulcer colitis, drepanocytic anemia, increase risk of development of venous thromboembolic diseases.
Such biochemical aberrations as resistance to the activated protein With, the giperkhromotsisteinemiya, deficit of proteins of C, S, deficit of antithrombin III, existence of anti-phospholipidic antibodies, increase risk of formation of arterial or venous thromboembolic diseases.
At ratio assessment the advantage/risk of administration of drug should be meant that purposeful treatment of this state reduces risk of formation of a thromboembolism.
Signs of developing of a thrombembolia are:
- a sudden stethalgia which irradiates in the left hand,
- sudden asthma,
- any unusually severe headache proceeding long time or developing for the first time, especially at a combination to sudden total or partial loss of sight or a diplopia, aphasia, dizziness, a collapse, focal epilepsy), weakness or the expressed numbness of a half of a body, motive disturbances, severe unilateral pain in a gastrocnemius muscle, an acute abdomen).

Tumoral diseases.
In some researches reported about increase of developing of cancer of neck of uterus at those women who long time accepted hormonal contraceptives, but results of researches are contradictory. In development of cancer of neck of uterus the sexual behavior, infection with a virus of papilloma of the person and other factors play a significant role. The metaanalysis of 54 epidemiological researches showed that there is a relative increase in danger of cancer of mammary glands among the women accepting peroral hormonal contraceptives, however higher detectability of cancer of mammary glands could be connected with more regular medical examination. Cancer of mammary glands occurs seldom among women more young than 40 years irrespective of, they accept hormonal contraceptives or not, and increases with age. Reception of tablets can be regarded as one of many risk factors. Nevertheless, the woman has to be informed of a possibility of risk of development of cancer of mammary glands, proceeding from assessment of a ratio of advantage and risk (protection against cancer of an ovary, an endometria and a large intestine).
There are not numerous messages on development of a benign or malignant tumor of a liver in women, is long accepting hormonal contraceptives. It should be meant at differential and diagnostic assessment of abdominal pains which can be connected with increase in the size of a liver or intra belly bleeding.
It is necessary to warn the woman that drug does not protect from HIV infection (AIDS) and other diseases, sexually transmitted.
Efficiency of drug can decrease at the following cases: the passed tablets, vomiting and diarrhea, simultaneous use of other drugs reducing efficiency of contraceptive tablets.
If the patient at the same time accepts other drug which can reduce efficiency of contraceptive tablets, it is necessary to apply additional methods of contraception.
Efficiency of drug can decrease if after several months of their use there are irregular, smearing or breakthrough bleedings, in such cases it is reasonable to continue reception of tablets before their termination in the following packaging. If at the end of the second cycle menstrualnopodobny bleeding does not begin or acyclic bloody allocations do not stop, to stop reception of tablets and to renew only it after a pregnancy exception.
Hloazma
Hloazma from time to time can occur at those women at whom she took place in the anamnesis during pregnancy. Those women who have a risk of emergence хлоазм should avoid contact with sunshine or ultraviolet during reception of tablets. Changes of laboratory indicators
Under the influence of peroral contraceptive tablets - in connection with an oestrogenic component - the level of some laboratory parameters (functional indicators of a liver, kidneys, adrenal glands, a thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) can change.
After an acute viral hepatitis it is necessary to accept after normalization of function of a liver (not earlier than in 6 months). At diarrhea or intestinal frustration, vomiting the contraceptive effect can decrease (without stopping administration of drug, it is necessary to use additional non-hormonal methods of contraception). The smoking women have the increased risk of development of vascular diseases with serious effects (a myocardial infarction, a stroke). The risk depends on age (especially at women 35 years are more senior) and on quantity of the smoked cigarettes. In the period of a lactation release of milk can decrease, in insignificant quantities components drug is emitted with breast milk.

Influence of drug on ability to drive the car and other machines
Researches on studying of possible influence of drug of Lindinet 30 on ability to drive the car or other machines were not conducted.

Side effects:

Side effects at which emergence the immediate termination of administration of drug is necessary:

- arterial hypertension;
- gemolitiko-uraemic syndrome;
- porphyria;
- the hearing loss caused by an otosclerosis.
Seldom meeting: arterial and venous thromboembolisms (в.т.ч. myocardial infarction, stroke, deep vein thrombosis of the lower extremities, thromboembolism of a pulmonary artery); aggravation of a reactive system lupus erythematosus.
Very seldom meeting: arterial or venous thromboembolism of hepatic, mezenterialny, renal, retinal arteries and veins; the chorea of Sidenkhem (passing after drug withdrawal).
Other side effects, less heavy, but more often meeting. Expediency of continuation of use of drug is solved individually after consultation with the doctor, proceeding from a ratio advantage/risk.
- Reproductive system: acyclic bleedings / bloody allocations from a vagina, an amenorrhea after drug withdrawal, change of a condition of vulval slime, development of inflammatory processes of a vagina (e.g.: candidiasis), change of a libido.
- Mammary glands: tension, pain, increase in mammary glands, galactorrhoea.
- Digestive tract and gepato-biliary system: nausea, vomiting, diarrhea, pains in epigastriums, a disease Krone, ulcer colitis, hepatitis, liver adenoma, emergence or an exacerbation of jaundice and/or the itch connected with a cholestasia, a cholelithiasis.
- Skin: nodal/exudative erythema, rash, hloazma, strengthening of a hair loss.
- Central nervous system: headache, migraine, changes of mood, depressions.
- Metabolic disturbances: a liquid delay in an organism, change (increase) of body weight, increase in level of triglycerides and sugar of blood, decrease in tolerance to carbohydrates.
- Sense bodys: decrease in hearing, increase in sensitivity of a cornea of an eye when carrying contact lenses.
- Other: allergic reactions.

Interaction with other medicines:

Contraceptive action of oral contraceptives decreases at simultaneous use of rifampicin, breakthrough bleedings and disturbances of periods become frequent. Similar, however, less studied interaction exists between contraceptive means and carbamazepine, Primidonum, barbiturates, phenylbutazone, Phenytoinum and, presumably, griseofulvin, ampicillin and tetracyclines. During treatment above the listed drugs along with peroral contraception recommend to apply an additional method of contraception (a condom, spermicidal gel). After end of a course of treatment use of an additional method of contraception should be continued within 7 days, in case of treatment by rifampicin - within 4 weeks.
The interactions connected with drug absorption: During diarrhea absorption of hormones because of the increased motility of intestines decreases. Any drug shortening the time spent of hormonal means in a large intestine results in low concentration of hormone in blood.

The interactions connected with drug metabolism:
Intestines wall: The drugs which are exposed to sulphation in a wall of intestines it is similar to ethinylestradiol (e.g. ascorbic acid), in the kompetitivny way slow down metabolism and increase bioavailability of ethinylestradiol.
Metabolism in a liver: Inductors of microsomal enzymes of a liver reduce ethinylestradiol level in a blood plasma (rifampicin, barbiturates, phenylbutazone, Phenytoinum, griseofulvin, топирамат, hydantoin, фелбамат, рифабутин, оскарбазепин). Blockers of enzymes of a liver (итраконазол, флуконазол) increase ethinylestradiol level in a blood plasma.
Influence on intra hepatic circulation: Some antibiotics (e.g., ampicillin, tetracycline), interfering with intra hepatic circulation of estrogen, reduce ethinylestradiol level in plasma.
Influence on exchange of other medicines: Blocking enzymes of a liver or accelerating conjugation in a liver, mainly strengthening a glyukuronirovaniye, ethinylestradiol influences metabolism of other drugs (e.g., cyclosporine, theophylline), leading to increase or decrease in their concentration in plasma.
Simultaneous use of drugs from a St. John's Wort (Hypericum perforatum) with Lindinet's tablets 30 because of possible decrease in contraceptive effect of active agent of a contraceptive is not recommended that can be followed by emergence of breakthrough bleedings and undesirable pregnancy. The St. John's Wort activates liver enzymes; after the termination of administration of drugs of a St. John's Wort the effect of induction of enzymes can remain within the next 2 weeks.

Simultaneous use of a ritonavir and the combined contraceptive is followed by decrease in the average size AUC of ethinylestradiol by 41%. During treatment ritonaviry it is recommended to use drug with high content of ethinylestradiol or to apply a non-hormonal method of contraception. Correction of the mode of dosing at use of hypoglycemic means since peroral contraceptives can reduce tolerance to carbohydrates, increase the need for insulin or peroral antidiabetic means can be required.

Contraindications:

- pregnancy or suspicion on it;
- lactation;
- existence of heavy or multiple factors of risk of venous or arterial thrombosis, including the complicated defeats of the valve device of heart, fibrillation of auricles, diseases of vessels of a brain or coronary arteries; uncontrollable arterial - hypertensia of average or heavy degree with the ABP 160/100 мм.рт.ст and more);
- thrombosis harbingers (including the tranzitorny ischemic attack, stenocardia), including in the anamnesis;
- migraine with focal neurologic symptomatology, including in the anamnesis;
- venous or arterial thrombosis / thromboembolism (including a shin deep vein thrombosis, an embolism of a pulmonary artery, a myocardial infarction, a stroke) now or the anamnesis, existence of a venous thromboembolism at relatives;
- serious surgical intervention with a long immobilization;
- a diabetes mellitus (with existence of an angiopatiya);
- the pancreatitis (including in the anamnesis) which is followed by the expressed gipertriglitseridemiya;
- dislipidemiya;
- a serious illness of a liver, cholestatic jaundice (including during pregnancy), hepatitis, including in the anamnesis (before normalization of functional and laboratory parameters and within three months after return of these indicators to norm);
- jaundice owing to reception of the HP containing steroids;
- zhelchekamenny disease now or anamnesis;
- Gilbert's syndrome, Cudgel Johnson, Rotor;
- liver tumors (including in the anamnesis);
- a severe itch, an otosclerosis or progressing of an otosclerosis during the previous pregnancy or at reception of glucocorticosteroids;
- hormonedependent malignant new growths sexual, bodies and mammary glands (including suspicion on them);
- vaginal bleeding of not clear etiology;
- smoking is aged more senior than 35 years (more than 15 cigarettes a day);
- individual hypersensitivity to drug or its components.

With care.

The states increasing Risk of development of venous or arterial thrombosis / thromboembolism: the age is more senior than 35 years, smoking, genetic predisposition to thrombosis (fibrinferments, иифаркт a myocardium or disturbance of cerebral circulation at young age at any of the immediate family); hemolitic uraemic syndrome, hereditary Quincke's disease, liver diseases; the diseases which for the first time arose or aggravated during pregnancy or against the background of the previous reception of sex hormones (including a porphyria, herpes of pregnant women, a hysterical chorea (Sydenham's disease), Sydenham's chorea, a hloazm); obesity (an index of body weight more than 30 kg / кв.м), a dislipoproteinemiya, arterial hypertension, migraine, epilepsy, valve heart diseases, fibrillation of an auricle, a long immobilization, extensive surgical intervention, surgical intervention on the lower extremities, the severe injury, a varicosity and superficial thrombophlebitis, the puerperal period (which are not feeding the woman 21 days after the delivery; the feeding women after end of the period of a lactation), existence of a heavy depression, including in the anamnesis, changes of biochemical indicators (resistance of the activated protein With, a gipergomotsisteinemiya, deficit of antithrombin III, deficit of a protein of C or S, anti-phospholipidic antibodies, including antibodies to cardiolipin, lupoid anticoagulant).
The diabetes mellitus which is not complicated by vascular disorders, the system lupus erythematosus (SLE), a disease Krone, ulcer colitis, a sickemia; a gipertriglitseridemiya (including in the family anamnesis), acute and chronic diseases of a liver.

Pregnancy and period of a lactation.
Use of drug during pregnancy and during feeding by a breast contraindicated.

Overdose:

Reception of high doses of contraceptive was not followed by development of heavy symptoms. Overdose signs: nausea, vomiting, young girls have a small vulval bleeding. There is no specific antidote, a symptomatic treatment.

Storage conditions:

To store at a temperature not above 30 °C. To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Tablets are coated.
21 tablets in the blister from a film of PVH/PVDH and aluminum foil. 1 or 3 blisters in a cardboard pack with the application instruction.