Lindinet 20

Lindinet 20 – monophase peroral contraceptive means.

Form of release and structure

Dosage form – tablets, coated: a round biconvex form, light yellow color, under a cover structure of almost white or white color (on 21 pieces in blisters, in a cardboard pack 1 or 3 blisters).

Content of active ingredients of Lindinet 20 in 1 tablet:

• Ethinylestradiol – 0,02 mg;
• Gestoden – 0,075 mg.

Auxiliary components: starch corn, magnesium stearate, calcium sodium эдетат, silicon dioxide colloid, lactoses monohydrate, povidone.

Structure of a cover: povidone, titanium dioxide, a macrogoal 6000, calcium a carbonate, dye quinolinic yellow (Д + About yellow No. 10) (E104), sucrose, talc.

Indications to use

Lindinet's use 20 is shown for peroral contraception.

Contraindications

• Multiple and/or heavy risk factors of arterial or venous thrombosis (including fibrillation of auricles, the complicated defeats of the valve device of heart, average or heavy degree of arterial hypertension (the arterial pressure (AP) of 160/100 mm of a mercury column and more), diseases of coronary arteries or vessels of a brain);
• Stenocardia, the tranzitorny ischemic attack and other harbingers of thrombosis, including the anamnesis;
• Venous thromboembolism in the anamnesis;
• Long immobilization after surgical intervention;
• Migraine with focal neurologic symptomatology, including the anamnesis;
• Arterial or venous thromboembolism or thrombosis (shin deep vein thrombosis, myocardial infarction, embolism of a pulmonary artery, stroke), including the anamnesis;
• Pancreatitis (including the anamnesis) against the background of the expressed gipertriglitseridemiya;
• Liver tumors, including the anamnesis;
• Lipidemia;
• Jaundice at use of glucocorticoids (GKS);
• The expressed liver diseases, cholestatic jaundice (including during pregnancy), hepatitis (including the anamnesis) – until recovery of laboratory and functional indicators and after their normalization within 3 months;
• The diabetes mellitus complicated by an angiopatiya;
• Cholelithiasis, including the anamnesis;
• Rotor syndrome, Dabin-Johnson's syndrome, Gilbert's syndrome;
• Severe itch;
• Otosclerosis and its progressing against the background of reception of GKS or during the previous pregnancy;
• Vaginal bleedings of unspecified genesis;
• Hormonedependent malignant new growths of generative organs and mammary glands, or at suspicion on them;
• Smoking is aged more senior than 35 years (over 15 cigarettes a day);
• Breastfeeding period;
• Pregnancy or suspicion on it;
• Hypersensitivity to drug components.

It is necessary to be careful at Lindinet's appointment to 20 women with the risk factors increasing probability of development of arterial or venous thrombosis or thromboembolism: the age is more senior than 35 years, genetic predisposition to thrombosis (a myocardial infarction, thromboses or disturbance of cerebral circulation at the immediate family at young age), smoking, a gemolitiko-uraemic syndrome, the liver diseases, a hereditary Quincke's disease, a hloazma, herpes of pregnant women, a porphyria, a chorea of Sidenkhem, a hysterical chorea and other diseases which arose or aggravated during the previous use of sex hormones or at pregnancy, obesity with an index of body weight more than 30 kg on ^sq.m, valve heart diseases arterial hypertension, fibrillation of an auricle, a dislipoproteinemiya, migraine, epilepsy, a severe injury, a long immobilization, extensive operation, surgical intervention on the lower extremities, a sickemia, superficial thrombophlebitis and a varicosity, a diabetes mellitus (without complications vascular disorders), a puerperal period, ulcer colitis, heavy depression (including the anamnesis), a disease Krone, chronic and acute diseases of a liver, a system lupus erythematosus, a gipertriglitseridemiya (including the family anamnesis), deviations of biochemical indicators (lupoid anticoagulant, a gipergomotsisteinemiya, resistance of the activated protein of C, deficit of antithrombin III, a protein of S or C, anti-phospholipidic antibodies, including antibodies to cardiolipin).

Route of administration and dosage

Pill is taken inside, irrespective of meal, always in at one time days.

The first pill from the blister needs to be taken from 1st to the 5th day of menstrual bleeding. Lindinet's use 20 provides reception of 1 tablet in days within 21 days, then the seven-day break during which there comes cancellation bleeding follows. Reception of tablets from the following blister is begun in the first day after 7 days of a break at the same time, as in the previous cycle.

For transition from other oral combined contraceptive the first pill of drug is taken next day after the end of the previous packaging, in the first day of bleeding of cancellation.

At reception mini-drank transition to Lindinet's reception 20 it is possible to begin in any day of a cycle, at the previous use of an implant – next day after its removal, at use of injections – on the eve of the following injection. Transition from monodrugs needs to be accompanied with use of additional barrier methods of contraception during the first 7 days.

When performing abortion in the I trimester of pregnancy reception of tablets should be begun right after operation without use of additional measures of contraception.

After abortion in the II trimester of pregnancy or after the delivery use of drug is begun 21-28 days later without use of additional methods of contraception. If administration of drug is begun later, then during the first 7 days it is necessary to apply an additional method of contraception.

If prior to contraception the woman had a sexual contact, use of drug should be begun after an exception of pregnancy or with approach of menstrual bleeding.

At the admission of reception of the next dose of drug at the scheduled time if delay made less than 12 hours (contraceptive effect of drug was not broken) the pill should be taken at once as remembered, and the following tablets – in usual time. If delay exceeds 12 hours, then it is not necessary to take the passed pill, and to continue administration of drug according to the scheme, using additional methods of contraception during the next 7 days. If the admission of reception happened less than 7 days prior to the end of packaging, reception of tablets from the following blister needs to be begun without interruption. Cancellation bleeding in this case will come after end of the second blister, but emergence of the smearing or breakthrough bleedings before a break is possible. In the absence of menstrual bleeding after reception of all tablets from the second blister, continuation of peroral contraception is possible only after a pregnancy exception.

If at the woman within the first 3-4 hours after reception of the next tablet vomiting and/or diarrhea which broke process of absorption and reduced clinical effect of drug began, then in this case there are two options of further therapy. One of them consists in reception of the following tablet according to the scheme at the scheduled time and further taking measures according to the recommendations connected with the admission of administration of drug. The second option – the woman can take a similar pill from other blister, without deviating the usual mode of contraception.

If it is necessary to accelerate the beginning of periods it is recommended to reduce a break in reception of tablets. It is necessary to consider that the break is less, the risk of developing of the smearing or breakthrough bleedings during reception of tablets from the following blister is more (similar to periods delay cases).

In case of need delays of the next periods for later period reception of tablets should be continued from new packaging without seven-day break. It is possible to detain the beginning of periods for the desirable period, up to the termination of tablets from the second packaging. In the period of the planned delay of menstrual bleeding emergence of the breakthrough or smearing bleedings is possible. After a seven-day break it is necessary to continue regular administration of drug.

Side effects

Use of drug should be cancelled at development of the following side effects:

• Sense bodys: the hearing loss caused by an otosclerosis;
• Cardiovascular system: arterial hypertension; seldom – a myocardial infarction, a deep vein thrombosis of the lower extremities, a stroke, a thrombembolia of a pulmonary artery both other venous and arterial thromboembolisms; very seldom – a venous or arterial thromboembolism of renal, hepatic, retinal, mezenterialny arteries and veins;
• Others: porphyria, gemolitiko-uraemic syndrome; seldom – an aggravation of a reactive system lupus erythematosus; very seldom – a chorea of Sidenkhem (passes after the termination of administration of drug).

Besides, Lindinet's action 20 can exponentiate development of other less heavy by-effects, but is more often than arising:

• Reproductive system: bloody allocations or acyclic vulval bleedings, candidiasis, an amenorrhea (after cancellation), change of a condition of vulval slime, development of inflammatory processes in a vagina, a galactorrhoea, increase in mammary glands, their tension and pain;
• Nervous system: headache, lability of mood, migraine, depression;
• Metabolism: a hyperglycemia, increase in body weight, a liquid delay in an organism, decrease in tolerance to carbohydrates, increase in level of concentration of thyreoglobulin;
• Alimentary system: nausea, pains in epigastriums, vomiting, ulcer colitis, a disease Krone, hepatitis, a cholelithiasis, liver adenoma, an aggravation or emergence of the itch connected with a cholestasia and/or jaundices;
• Sense bodys: women with contact lenses have an increase in sensitivity of a cornea, decrease in hearing;
• Dermatological reactions: rash, knotty erythema, strengthening of a hair loss, exudative erythema, hloazma;
• Others: development of allergic reactions.

The decision on expediency of further administration of drug is made after consultation with the doctor individually, by a ratio of advantage and risk of contraception.

Special instructions

Lindinet's use 20 needs to be begun after consultation of the doctor and carrying out the all-medical and gynecologic examination including inspection of bodies of a small pelvis, mammary glands, the cytologic analysis of a cervical smear. Inspection is recommended to spend each 6 months during reception of tablets.

Considering a clinical condition of the woman and risk factors of development of side effects, advantage or a lack of peroral contraception is estimated and the decision concerning its use is made. The doctor has to inform on possible usugubleniye of the available pathologies, undesirable effects of drug and need of the request for consultation at deterioration in health.

It is necessary to cancel hormonal contraception at emergence or deterioration in any of the following diseases or states: the diseases contributing development of a cardiovascular and renal failure and states, epilepsy, pathologies of system of a hemostasis, risk of development of estrogenzavisimy gynecologic diseases or an estrogenzavisimy tumor, migraine, a diabetes mellitus without vascular disorders, a heavy depression, a sickemia, deviations in laboratory tests of functional assessment of a liver.

Drug has reliable contraceptive effect in 2 weeks of reception therefore within the first 2 weeks it is recommended to apply in addition barrier methods of contraception to an exception of possible pregnancy.

Against the background of use of peroral hormonal contraceptives the probability of venous and arterial thromboembolic diseases increases, it is necessary to consider possible (very rare) development of an arterial or venous thromboembolism of hepatic, renal, mezenterialny vessels or vessels of a retina.

To the factors promoting increase in risk of development of arterial or venous thromboembolic diseases genetic predisposition, intensive smoking, obesity, and also existence of a dislipoproteinemiya, arterial hypertension, diseases of valves of heart treats with hemodynamic disturbances, fibrillations of auricles, a diabetes mellitus with vascular defeats. The risk increases women, at the long immobilization caused by extensive surgical intervention including on the lower extremities or after a severe injury with age. At planned operations drug should be cancelled in 4 weeks prior to operation and to resume reception in 2 weeks after a remobilization.

Regular observation of the doctor is demanded by use of drug at a diabetes mellitus, a system lupus erythematosus, a gemolitiko-uraemic syndrome, a disease Krone, nonspecific ulcer colitis, a sickemia and from women after the delivery.

The risk of development of arterial or venous thromboembolic diseases is increased by a gipergomotsisteinemiya, resistance to the activated protein of C, deficit of proteins of C and S, existence of anti-phospholipidic antibodies, deficit of antithrombin III.

Lindinet's reception 20 can be regarded as one of many factors influencing development of cancer of neck of uterus or a breast cancer. The increased data recording of pathologies at the women accepting hormonal contraceptives can be connected with regular observation of the doctor and performing medical examinations.

After long peroral hormonal contraception it is necessary to consider possible development of a benign or malignant tumor of a liver at differential and diagnostic assessment of an abdominal pain which can be connected with intraperitoneal bleeding or increase in the size of a liver.

The women predisposed to a hloazma are recommended to avoid stay under direct sunshine or ultraviolet radiation.

Contraceptive effect of drug decreases in case of the admission of reception of the next dose, at vomiting or diarrhea, a concomitant use of the medicines influencing its efficiency. To avoid conception the woman has to apply additional barrier contraceptives according to recommendations.

Emergence of the irregular smearing or breakthrough bleedings and absence of menstrual bleeding in the period of a seven-day break can turn out to be consequence of pregnancy. Therefore before reception of tablets from the following blister it is necessary to consult with the doctor and to resume therapy after a pregnancy exception.

The oestrogenic component of drug can influence laboratory parameters of level of transport proteins and lipoproteins, functional indicators of kidneys, a liver, a thyroid gland, adrenal glands, hemostasis indicators.

Use of drug after an acute viral hepatitis is shown not earlier than in 6 months on condition of normalization of function of a liver.

The smoking women, especially after 35 years are subject to the increased risk of development of vascular diseases (the risk degree depends on age and quantity of the smoked cigarettes in day).

Lindinet 20 does not protect from infection with sexually transmitted infections, including HIV infection (AIDS).

Influence of drug on ability of the patient to control of vehicles and mechanisms is not established.

Medicinal interaction

• Inductors of microsomal enzymes of a liver (rifampicin, phenylbutazone, barbiturates, griseofulvin, Phenytoinum, hydantoin, топирамат, рифабутин, фелбамат, окскарбазепин), antibiotics (ampicillin, tetracycline): promote decrease in content of ethinylestradiol in a blood plasma;
• Inhibitors of enzymes of a liver (флуконазол, итраконазол): increase the level of concentration of ethinylestradiol in a blood plasma;
• The means increasing motility of digestive tract: reduce absorption of active ingredients and their concentration in a blood plasma at a combination to Lindinet 20;
• The ascorbic acid and other means which are exposed to sulphation in an intestines wall: competitively slow down sulphation of ethinylestradiol and increase its biological availability.

Leads a concomitant use of a ritonavir, tetracycline, ampicillin, rifampicin, Primidonum, barbiturates, phenylbutazone, carbamazepine, Phenytoinum, a topiramat, griseofulvin, an okskarbazepin, a felbamat to decrease in contraceptive efficiency of drug. Therefore during reception and within 7 days (at a combination to rifampicin – 4 weeks) after therapy by the specified medicines the woman has to apply additional barrier methods of contraception.

Drug influences metabolism of cyclosporine and theophylline.

Co-administration of drugs of a St. John's Wort as the risk of breakthrough bleedings increases is not recommended.

Patients with a diabetes mellitus can have a need for dose adjustment of hypoglycemic means.

Terms and storage conditions

To protect from children.

To store at a temperature up to 25 °C in the protected from light, dry place.

Period of validity – 3 years.