Lactinet, 28 pcs., 75 mcg, film-coated tablets

Compound

One tablet of Lactinet contains 0.075 mcg of desogestrel and a number of auxiliary components:

• colloidal silicon dioxide (Silicii dioxydum colloidale);
• D,L-α-tocopherol (dl-alfa-Tocopherol);
• stearic acid (Acidum stearicum);
• magnesium stearate (Magnesium stearate);
• povidone K30 (Povidonum K30);
• potato starch (Amylum solani);
• lactose monohydrate.

The film shell with which the tablets are coated contains:

• talc (Talcum);
• macrogol 3000 (Macrogolum 3000);
• titanium dioxide CI 77891 (Titanium Dioxide);
• Opadry II White;
• polyvinyl alcohol (Spiritus polyvinylicus).

Pharmacodynamics and pharmacokinetics

Film-coated contraceptive pills Lactinet are a contraceptive based on the third generation progestogen desogestrel .

The high degree of affinity of the substance for progesterone ensures reliable contraception even when used in low doses. Its main advantage is that it has virtually no effect on the lipid spectrum of the blood . carbohydrate metabolism and hemostasis .

These beneficial qualities of desogestrel are the key to the safety (taking into account contraindications to their use) of modern low-dose oral contraceptives , which include Lactinet.

Since no other hormonal components are used as an active substance except progestogen , Lactinet tablets are safe for women who are breastfeeding , as well as for women who have contraindications or do not want to take estrogen-containing drugs.

The mechanism of action of desogestrel is determined by inhibition of ovulation , which is confirmed by the absence of a follicle ultrasound diagnostic procedure , as well as by indicators of low levels of luteotropic (lactogenic) hormone .

The effectiveness of desogestrel is also confirmed by the low concentration of progesterone in the middle of the menstrual cycle .

Another equally important property of the substance is the ability to increase the density and viscosity of cervical mucus, which is produced by the glands of the cervix . This in turn creates a barrier to the passage of sperm and prevents fertilization of the egg .

The Pearl index for the drug is 0.4. This indicator reflects the number of pregnancies in a group of thousand women during the year without using contraceptives , as well as the level of reliability of the contraceptive . The lower it is, the more effective the contraceptive .

With regard to Lactinet, the Pearl index is similar to the indicator established for combined type contraceptives .

Data from a comparative study showed that when taking missed pills a maximum of three hours after the proper time, in the group of women taking the drug, the Pearl index remained unchanged - 0.4. The Pearl index for levonorgestrel increased to 1.6.

desogestrel tablet per os, it is quickly absorbed from the stomach and intestines . The average maximum concentration of the substance in the circulating blood is observed after 1.8 to 2 hours. The bioavailability rate is within 70%.

Under the influence of enzymes, desogestrel undergoes hydroxylation and dehydrogenation , as a result of which it is biotransformed to etonogestrel , which is its main metabolite . Further metabolization of etonogestrel is completed by the formation of glucuronide and sulfate conjugates .

Etonogestrel , which is the most active metabolite of desogestrel , has the ability to bind to plasma proteins by 95.5-99%. This applies to a greater extent to albumins , and to a somewhat lesser extent to globular proteins ( globulins ), which are responsible for the binding of sex hormones .

The average half-life of desogestrel metabolites is approximately 30 hours. Moreover, its duration does not change depending on whether the drug was taken once or in a course (multiple doses).

Equilibrium concentration is observed 4-5 days after starting to take the tablets.

Excretion of metabolites in the form of conjugates and free steroid hormones is carried out mainly by the kidneys with urine. To a much lesser extent, they are excreted in the intestinal .

In breastfeeding women, etonogestrel passes into the milk. The milk/blood plasma ratio is 0.37/0.55. This, and also the fact that on average a child receives about 150 ml of breast milk per kilogram of his weight during the day, he can also receive from 0.01 to 0.05 mcg of etonogestrel .

Lactinet tablet. p/o 0.075 mg per bl. in pack No. 28x1

Name

Description

Round, biconvex, film-coated tablets, white or off-white, approximately 5.5 mm in diameter, marked “D” on one side and “75” on the other side. Pharmacotherapeutic group: Hormonal contraceptives for systemic use. Progestogens. ATX code: G03AC09.

Main active ingredient

Release form

Dosage

special instructions

pharmachologic effect

Lactinet®-Richter is a progestogen-containing contraceptive (contains only progestogen - desogestrel). Like other contraceptives containing only progestogen, Lactinet®-Richter is suitable for nursing mothers, as well as women who cannot or do not want to take estrogens. Unlike conventional progestogen-only contraceptives, the drug acts primarily by suppressing ovulation. Other effects include increasing the viscosity of cervical mucus. Clinical study data on efficacy and safety In a study conducted over 2 cycles, in which confirmation of ovulation was considered a progesterone level above 16 nmol/L for 5 consecutive days, ovulation occurred in only 1% (1/103) of women; while the 95% CI in the ITT subgroup was 0.02%-5.29% (failure due to method ineffectiveness or inappropriate use of the drug). Suppression of ovulation was achieved from the first cycle of drug use. Ovulation was observed on average 17 days (7-30 days) after discontinuation of desogestrel used for 2 cycles (56 consecutive days). According to a comparative study of effectiveness (with a maximum delay of 3 hours in taking a tablet), the Pearl index value for desogestrel in the ITT subgroup was 0.4 (95% CI 0.09 - 1.20), compared with 1.6 for 30 mcg levonorgestrel (95% CI 0.42 – 3.96). Thus, the Pearl index value for desogestrel is comparable to that for combined oral contraceptives (COCs) in the general population taking COCs. The use of desogestrel leads to a decrease in estradiol levels to values ​​​​corresponding to the early follicular phase. No clinically significant effects on carbohydrate metabolism, lipid metabolism and hemostasis were detected. Children and adolescents under 18 years of age There are no data from clinical studies of efficacy and safety in this age group.

Pharmacodynamics

Pharmacokinetics

Absorption After oral administration, desogestrel is rapidly absorbed and metabolized to etonogestrel. At steady state, the maximum plasma concentration is achieved 1.8 hours after administration; The absolute bioavailability of etonogestrel is approximately 70%. Distribution and binding to plasma proteins Etonogestrel is 95.5-99.0% bound to plasma proteins, mainly albumin and, to a lesser extent, sex hormone binding globulin (SHBG). Biotransformation Desogestrel is metabolized by hydroxylation and dehydrogenation to the active metabolite, etonogestrel. Etonogestrel is metabolized by the formation of sulfate and glucuronide conjugates. Elimination: With single and multiple doses, the average half-life of etonogestrel is approximately 30 hours. Equilibrium concentration in blood plasma is achieved after 4-5 days. The serum clearance of etonogestrel when administered intravenously is approximately 10 L/hour. Etonogestrel and its metabolites are excreted in the form of free steroids or conjugates in urine and feces (in a ratio of 1.5:1). In nursing women, etonogestrel is excreted into breast milk in a ratio of 0.37-0.55 (milk/blood plasma). Taking into account these data, as well as the fact that the child consumes 150 ml of milk per kg of body weight per day, he can receive approximately 0.01-0.05 mcg of etonogestrel per day in breast milk. Pharmacokinetics in certain groups of patients Impaired renal function Studies of the pharmacokinetics of desogestrel in patients with kidney disease have not been conducted. Impaired liver function Studies of the pharmacokinetics of desogestrel in patients with liver disease have not been conducted. However, it should be taken into account that if liver function is impaired, the metabolism of steroid hormones is disrupted. Ethnic groups Comparisons of the pharmacokinetics of desogestrel in different ethnic groups have not been conducted.

Indications for use

Contraception

Directions for use and doses

Dosage To achieve a contraceptive effect, you must follow the rules for taking the drug (see paragraphs “Rules for taking the drug Lactinet®-Richter” and “How to start taking the drug Lactinet®-Richter”). Special groups of patients Impaired renal function No clinical studies have been conducted in patients with impaired renal function. Impaired liver function Clinical studies have not been conducted in patients with impaired liver function. In case of severe liver dysfunction, the metabolism of steroid hormones may be disrupted, therefore, in such cases, the drug Lactinet-Richter is prescribed only after normalization of liver function tests (see section “Contraindications”). Children and adolescents under 18 years of age The safety and effectiveness of Lactinet®-Richter in children and adolescents under 18 years of age have not been established. There are no data on the use of the drug in this age group. Method of administration Inside Rules for taking the drug Lactinet®-Richter Tablets are taken daily, at approximately the same time, so that the interval between taking two tablets is always 24 hours. The first tablet is taken on the first day of menstrual bleeding. Then continue to take one tablet per day, including when a menstrual-like reaction occurs. A new blister pack is started the next day after the tablets from the previous pack run out. How to start taking Lactinet®-Richter Patients who have not previously used hormonal contraceptives (in the previous month) Taking pills should start on the first day of a woman’s natural menstrual cycle (i.e. on the first day of menstrual bleeding). It is allowed to start taking the drug on days 2-5 of the first menstrual cycle, but in this case, during the first seven days of taking the pills, it is recommended to use a barrier method of contraception. Termination of pregnancy in the first trimester You can start taking the drug immediately after termination of pregnancy, then no additional methods of contraception are required. Childbirth or termination of pregnancy in the second trimester It is advisable to start taking the drug on days 21-28 after childbirth or termination of pregnancy in the second trimester. Women who start taking pills later should additionally use barrier contraceptives in the first seven days of taking the drug. If you had unprotected sexual intercourse before taking the drug, you must rule out pregnancy or wait until your first menstrual bleeding before taking the first tablet of Laktinet®-Richter. For additional information on the use of the drug during breastfeeding, see the section “Use during pregnancy and breastfeeding.” How to start taking Lactinet®-Richter after using other methods of contraception Switching to taking Lactinet®-Richter from a combined oral contraceptive (COC), vaginal ring or transdermal patch It is preferable to start taking the drug the day after taking the last active tablet of the previous COC (t i.e. tablet containing active substances) or on the day of removal of the vaginal ring or transdermal patch. In such cases, additional contraceptive measures are not required. A woman can also start taking Lactinet®-Richter no later than the day after the usual pill-taking interval, patch- or ring-taking interval, or placebo-tablet-taking interval of the previous combined hormonal contraceptive. In this case, additional (barrier) methods of contraception should be used in the first seven days of taking the drug. Switching to taking the drug Lactinet®-Richter from drugs containing only progestogen (mini-pills, injections, implants) or from a progestogen-releasing intrauterine system (IUD) A woman can switch from taking “mini-pills” to taking the drug Lactinet ®-Richter any day. Switching to taking Laktinet®-Richter is possible on the day of removal of the implant/IUD or on the day of the next scheduled injection of injectable forms of contraceptives. Taking missed pills If more than 36 hours pass between taking two pills, the contraceptive effect may be reduced. If the delay in taking the pill is less than 12 hours, the woman takes the missed pill as soon as she remembers, and the next pill at the usual time. If the delay in taking the pill is more than 12 hours, an additional method of contraception should be used for the next seven days of taking the drug. If a woman misses one or more tablets during the first week and has had sexual intercourse the week before, there is a risk of pregnancy. Recommendations for taking the drug for gastrointestinal disorders In severe gastrointestinal disorders, absorption of the active substance may be incomplete, so additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after taking the tablet, absorption of the drug may be reduced. Since this situation is similar to skipping a dose, in such situations follow the instructions for taking missed pills (see section “Taking missed pills”). Monitoring the woman's health while taking the drug Before prescribing Lactinet®-Richter, it is necessary to collect a detailed medical history and conduct a thorough gynecological examination to exclude pregnancy. In case of menstrual irregularities (oligo- or amenorrhea), an appropriate examination should be carried out before starting to take the drug. While taking the drug Lactinet®-Richter, regular medical examinations are carried out, the frequency of which is determined individually. If there is a risk of exacerbation of a latent or manifest disease (see section “Precautions”), control examinations are carried out at appropriate intervals. While taking the drug Lactinet®-Richter, bleeding from the vagina may occur, including in patients who do not miss taking pills. If bleeding is frequent or irregular, alternative methods of contraception should be considered. If symptoms persist, organic pathology must be excluded. The scope and nature of the examination for amenorrhea (while taking the drug) depend on whether the patient followed the instructions for taking the drug; Among the first tests for such patients is a pregnancy test. If pregnancy is confirmed, the drug is stopped. The woman should be warned that Lactinet®-Richter does not protect her from HIV infection (AIDS) and other sexually transmitted diseases.

Use during pregnancy and lactation

Pregnancy Lactinet®-Richter is not indicated during pregnancy. If pregnancy occurs, stop taking the drug. Animal studies have shown that very high doses of progestogens can lead to masculinization of female fetuses. Extensive epidemiological studies have not found an increased risk of congenital malformations in children born to women who took COCs before pregnancy, or teratogenicity in the case of unintentional use of COCs in early pregnancy. Pharmacovigilance data for various desogestrel-containing COCs also do not indicate an increased risk of developmental defects. Breastfeeding Desogestrel does not affect the production or quality (concentration of protein, lactose or fat) of breast milk. However, small amounts of etonogestrel (a metabolite of desogestrel) are excreted in breast milk: the baby may receive 0.01-0.05 mcg etonogestrel per kg body weight per day (based on an approximate milk intake of 150 ml/kg/day). There is limited data from long-term studies among children whose mothers started taking Lactinet®-Richter between 4 and 8 weeks after birth. Children were breastfed until 7 months. They were followed up to 1.5 years (n=32) and up to 2.5 years (n=14). When assessing growth, physical and psychomotor development, no differences were found in comparison with infants whose mothers used a copper intrauterine device (IUD) during breastfeeding. Considering the available data, the drug Lactinet®-Richter can be used during breastfeeding. However, it is necessary to carefully monitor the growth and development of a child whose mother is using Lactinet®-Richter. Fertility The drug Laktinet®-Richter is intended to prevent pregnancy. For information on restoring fertility (ovulation), see the Pharmacodynamics section.

Precautionary measures

If any of the following diseases/risk factors are present, it is necessary to conduct an individual assessment of the balance between the benefits of using the drug Lactinet®-Richter and possible risks and discuss the results with the woman before she decides to start taking the drug. If these conditions appear, intensify or worsen, the woman should consult a doctor who will decide whether to discontinue the drug. In general, your risk of developing breast cancer increases with age. Women taking combined oral contraceptives have a slightly increased risk of developing breast cancer. Within 10 years after stopping COCs, the risk of breast cancer gradually decreases. This risk is not related to the duration of COC use, but to the age of the woman taking the COC. The table below shows the estimated incidence of cancer among 10,000 women using COCs (up to 10 years after stopping COCs) compared with those who did not use COCs during the same period of time. Data are calculated and presented by age groups. Age group Expected number of cancer diagnoses among women using COCs Expected number of cancer diagnoses among women not using COCs 16-19 years 4.5 4 20-24 years 17.5 16 25-29 years 48.7 44 30-34 years 110 100 35-39 years 260 230 The incidence of breast cancer while taking progestogen-only contraceptives (such as Lactinet®-Richter) is most likely similar to that in women taking COCs. However, the evidence for minipills is less clear. The increased risk of breast cancer associated with COC use is lower than the lifetime risk of developing breast cancer. Women who use COCs are usually diagnosed with cancer at an earlier stage than those who do not use COCs. The increased risk in women taking COCs may be explained by earlier diagnosis, the biological effect of the pills, or a combination of both factors. Since a negative effect of progestogen on the dynamics of liver malignancies cannot be excluded, in the presence of such lesions the benefit/risk ratio for the drug should be assessed individually ok. In case of acute or chronic liver dysfunction, a woman should be referred for examination and consultation with a specialist. According to epidemiological studies, the use of COCs is associated with an increased incidence of venous thromboembolism (VTE, deep vein thrombosis and pulmonary thromboembolism). Although the clinical significance of this information in relation to desogestrel used in contraceptives without an estrogen component is unknown, if thrombosis develops, Lactinet®-Richter should be discontinued. Consideration should be given to discontinuing the use of Lactinet®-Richter in case of prolonged immobilization due to surgery or illness. If there is a history of thromboembolic complications, the woman should be warned about possible relapses of the disease while taking the drug. Although progestogens may alter insulin resistance and glucose tolerance, there is currently no evidence to support changes in diabetes mellitus or minipill therapy. However, during the first month of using the drug Lactinet®-Richter, careful monitoring of blood sugar levels is indicated. If stable or refractory arterial hypertension develops while taking Lactinet®-Richter, the drug is discontinued. Taking the drug Lactinet®-Richter leads to a decrease in the concentration of estradiol in the blood serum to a level corresponding to the early follicular phase. It is still unknown whether this has a clinically significant effect on bone mineral density. Progestogen-only contraceptives protect against ectopic pregnancy less effectively than combined oral contraceptives. This is explained by the fact that when using contraceptives containing only progestogen, ovulation occurs quite often. Despite the fact that the drug Lactinet®-Richter effectively suppresses ovulation, when carrying out the differential diagnosis of amenorrhea or abdominal pain, the possibility of an ectopic pregnancy should be taken into account. In rare cases, chloasma may occur, especially if this condition has occurred previously (during pregnancy). Women predisposed to chloasma should avoid exposure to the sun and exposure to ultraviolet radiation while taking Lactinet®-Richter. During pregnancy or the use of sex hormones, the following diseases have been reported, the connection of which with the use of progestogens has not been established: jaundice and/or itching due to cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus, hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis; angioedema, including hereditary The drug Lactinet®-Richter, film-coated tablets, contains 52.34 mg of lactose in the form of lactose monohydrate. Patients with rare hereditary disorders such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome should not take this drug. Effect on the ability to drive vehicles: Desogestrel does not have or has an insignificant effect on the ability to drive vehicles and operate machinery.

Interaction with other drugs

Interactions between hormonal contraceptives and other drugs may result in breakthrough bleeding and/or contraceptive failure. Interactions with the following drugs have been reported in the literature (this mainly applies to combined contraceptives, but may also apply to contraceptives containing only progestogen). Interactions at the stage of metabolism in the liver: interactions may develop with drugs that induce microsomal liver enzymes, which, in turn, can lead to an increase in the clearance of sex hormones (drugs such as hydantoins (for example, phenytoin), barbiturates (for example, phenobarbital), primidone, carbamazepine, rifampicin, and possibly oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and preparations containing St. John's wort (Hypericum perforatum). Maximum induction of liver enzymes is observed no earlier than after 2-3 weeks, but may persist for at least 4 weeks after cessation of therapy. Women taking Lactinet®-Richter and one of the above medications are recommended to temporarily use additional barrier methods of contraception. When using the drug Lactinet®-Richter together with other enzyme-inducing drugs, it is recommended to use a barrier method of contraception during the entire course of therapy and up to 28 days after stopping treatment. In women receiving long-term treatment with liver enzyme inducers, the use of a non-hormonal method of contraception should be considered. When taking activated carbon, the absorption of steroids, and, consequently, the effectiveness of contraception will decrease. Since this situation is similar to skipping a drug dose, in such situations follow the instructions for taking missed pills (see section "Dosage and Administration"). Hormonal contraceptives may affect the metabolism of other drugs. Accordingly, their concentration in blood plasma and tissues may increase (for example, cyclosporine) or decrease. Note: To identify possible interactions with other medications, you should read the instructions for use. Laboratory tests: It has been shown that during the use of COCs, the results of some laboratory parameters may change, including biochemical indicators of liver, thyroid, adrenal and kidney function; concentrations of transport proteins in the blood serum (for example, sex hormone binding globulin (SHBG)), lipid/lipoprotein fractions, indicators of carbohydrate metabolism, as well as indicators of blood coagulation and fibrinolysis. As a rule, these indicators do not go beyond normal values. Accurate data for “mini-pills” have not been obtained.

Contraindications

– Hypersensitivity to the active substance or any component of the drug (see section “Composition”). – Venous thromboembolism at the time of starting the drug. – Previous or existing severe liver diseases (the drug is not used until liver tests are normalized). – Diagnosed or suspected malignant hormone-dependent tumors. – Bleeding from the vagina of unknown etiology.

Compound

Each tablet contains: Active ingredients: desogestrel - 75 mcg. Excipients: tablet core: lactose monohydrate, potato starch, povidone K-30, colloidal anhydrous silicon dioxide, stearic acid 50, complete racemate-α-tocopherol tablet shell: OPADRAY II. 85F28751 white (polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc).

Overdose

Side effect

The most commonly reported adverse reaction (ADR) in clinical trials was irregular vaginal bleeding. Irregular bleeding was observed in 50% of women using desogestrel. Since desogestrel (unlike other progestogen-only contraceptives) suppresses ovulation in almost 100% of cases, irregular bleeding occurs more often when taking it than when taking other progestogen-only contraceptives. In 20-30% of women, bleeding becomes more frequent, while in another 20%, bleeding becomes less frequent or stops. In addition, longer bleeding may occur. After two months of taking the drug, menstrual bleeding becomes less frequent. A woman who has received the necessary information, including during a consultation with a doctor, and keeps a diary of menstruation, will better adapt to the new cycle. According to clinical studies of desogestrel, the most commonly reported (>2.5% of cases) adverse reactions were acne, mood changes, breast pain, nausea and weight gain. Undesirable side effects are listed in the table below. Adverse reactions are classified by frequency and organ system class. Determination of the frequency of adverse reactions: often (from ≥1/100 to

Storage conditions

The medicine does not require special temperature storage conditions. Store in original packaging to protect from light and moisture. Keep out of the reach of children.

Buy Lactinet tablet. p/o 0.075 mg per bl. in pack No. 28x1 in the pharmacy

Price for Lactinet tablet. p/o 0.075 mg per bl. in pack No. 28x1

Instructions for use for Lactinet tablet. p/o 0.075 mg per bl. in pack No. 28x1

Contraindications

Contraindications to the use of the drug are:

• thromboembolism (history or current);
• severe liver pathologies (contraindication remains until liver function tests return to normal);
• dysfunction, as well as liver failure ;
• the presence or suspicion of the presence of a hormone-dependent malignant neoplasm ;
• vaginal discharge of unknown origin;
• pregnancy or suspicion of it;
• lactose intolerance;
• lactase deficiency;
• glucose-galactose malabsorption;
• forced immobilization for a long period of time;
• hypersensitivity to the active substance or any of the auxiliary components.

Side effects

Studies of the drug Lactinet and its active substance have shown that the most common adverse reaction to taking the drug is disruption of the regularity of the menstrual cycle .

Approximately half of women taking the drug experience non-cyclical bloody vaginal discharge . In every third to fifth woman, while taking the pills, menstruation becomes less frequent (even to the point that it completely disappears over time) or, on the contrary, becomes more frequent.

In some cases, an increase in the duration of menstrual bleeding . However, as a rule, after two months of use, menstruation becomes less frequent.

To increase the degree of safety and reduce the risk of side effects, a woman taking Lactinet is recommended to regularly visit her gynecologist, inform him of all changes in her condition, and also keep a diary of menstrual flow.

The category of effects most often occurring while taking gestagen-containing oral contraceptives includes:

• attacks of nausea;
• the appearance of acne ;
• mood lability;
• decreased sex drive;
• soreness in the mammary glands ;
• weight gain;
• headache.

Slightly less common:

• increased fatigue;
• vomit;
• hair loss ( alopecia );
• increased level of intracranial pressure ;
• inflammatory processes of the vaginal mucosa ;
• cystic formations in the ovaries;
• infectious diseases of the vagina;
• increased severity of pain in the lower abdomen during menstrual bleeding .

Quite rarely, phenomena such as skin rashes, erythema nodosum , redness of the skin, and urticaria . Some women may experience breast discharge . In rare cases, ectopic pregnancy .

Taking Lactinet can become a provoking factor for the development or increase in the severity of angioedema , as well as for its exacerbation, if the latter is congenital.

There are cases where women who took oral contraceptives experienced more serious consequences. These include the formation of hormone-dependent cancer tumors and the development of thromboembolism (venous or arterial) .

Instructions for use of Lactinet: method of administration and dosage of the drug

If a woman has not taken any oral contraceptives , the pills should be taken from the first day of the cycle. The daily dose of the drug is 1 tablet.

At the same time, it is recommended to take it exactly at the same time, maintaining an interval of 24 hours and following the instructions indicated on the package. When taking Lactinet, there is no need to take intervals between each two courses.

If a woman has not previously used hormonal contraception (at least in the previous month), pills should be taken on the first day after the end of menstrual bleeding . Auxiliary barrier contraceptives are not needed.

If the drug is started between 2 and 5 days after the end of menstrual bleeding , in this case birth control pills are supplemented with barrier contraceptives .

If it is necessary to replace another combined contraceptive with Lactinet, it is recommended to do this the very next day after stopping the previously used drug. There is no need to use additional protective equipment.

If it is necessary to replace another monocomponent drug containing a progestogen with Lactinet, taking tablets is also started immediately after discontinuation of the previously used drug, be it mini-pills , progestogen-containing injections , intrauterine contraceptives or implants .

In each case, during the first week, for greater reliability of contraception barrier contraceptives along with pills .

After an abortion , as well as after a spontaneous abortion in the first three months of pregnancy , it is recommended to start taking the drug immediately after termination of pregnancy . need for additional methods of contraception .

After termination of pregnancy between 13 and 24 weeks, as well as after childbirth , Lactinet is prescribed no earlier than 21-28 days later. If you plan to start the course later, then in the first seven days the tablets are combined with the use of barrier contraceptives .

In situations where unprotected sexual relations took place before starting the course of taking the drug, the woman is advised to exclude the possibility of pregnancy or is advised to shift the first day of starting to use the pills to the first day of the next menstrual cycle .

If the previous dose of the pill was missed, but less than twelve hours have passed, the contraceptive effect of the drug remains unchanged, further administration is continued in accordance with the usual regimen, without using additional methods of protection against unwanted pregnancy .

If from twelve hours to three days have passed, then the reliability of contraception decreases significantly. The drug continues to be taken according to the usual regimen, however, it is supplemented with the use of other methods of contraception .

vomiting begins a few hours after taking the tablet , this is evidence that complete absorption of the active substance of the drug has not occurred. In this case, the instructions for Lactinet recommend resorting to countermeasures similar to those used if the next dose was missed. To replenish the missing tablet, it is taken from the next package of the drug.

menstrual irregularities while taking the pills (for example, excessively frequent, prolonged, painful or irregular bleeding), you should consider changing the drug. If the symptoms do not disappear even after this, a thorough examination is necessary to determine the exact cause of its occurrence.

In some cases, amenorrhea and other cycle disorders may occur as a result of improper use of the drug.

If pregnancy occurs , Lactinet should be stopped immediately.

Lactinette®

In the absence of previous use of hormonal contraceptives (within the last month), taking tablets begins on the 1st day of the menstrual cycle, 1 tablet per day, if possible at the same time of day, following the direction indicated on the package, so that there is a break between doses two tablets was 24 hours, if necessary with a small amount of liquid. This drug does not require a break in use. Each subsequent package should begin immediately after the end of the previous one.

First dose of the drug

Women who did not take oral contraceptives in the previous month

The first tablet should be taken on the 1st day of the menstrual cycle (menstruation). In this case, the use of additional methods of contraception is not required.

You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle, you must use additional methods of contraception in the first 7 days of taking the pills.

Women who switch from another combined oral contraceptive (COC) to Lactinet®

If possible, the day after taking the last tablet of the previous COC. In this case, the use of additional methods of contraception is not required.

Women who are switching from progestogen-only medications (mini-pills, injections, implants, or progestogen-releasing intrauterine devices)

When switching from a mini-pill, you can start taking the drug on any day, in the case of injections - on the day when the next injection should have been given, in the case of an implant - on the day after its removal.

In all of these cases, it is recommended to use barrier methods of contraception during the first 7 days.

Taking the drug after an abortion in the first trimester of pregnancy

After an abortion in the first trimester of pregnancy, it is recommended to start taking the drug immediately after the abortion, and in this case there is no need to use additional methods of contraception.

Taking the drug after childbirth or after termination of pregnancy in the second trimester

The drug should be taken no earlier than 21-28 days after termination of pregnancy in the second trimester or after childbirth. If you plan to start taking the drug later, then you must use a barrier method of contraception for the first 7 days. In addition, if unprotected sexual intercourse occurred before starting to use the drug, it is necessary to exclude pregnancy or postpone the start of taking the drug to the first day of the next menstruation (when the menstrual cycle is restored).

Missed (forgotten) pills

The effectiveness of the contraceptive decreases if more than 36 hours have passed between taking two tablets. If the break does not exceed 12 hours

, the contraceptive effect is not reduced, and the use of an additional contraceptive method is not required. The remaining tablets are continued as usual.

In case of a break of more than 12 hours

the contraceptive effect may be reduced.
To achieve effective blocking of the hypothalamic-pituitary-ovarian system, it is necessary to take the drug daily for 7 days. Thus, after a break of more than 12 hours,
the drug is continued as usual, however, in the next 7 days it is necessary to use additional (barrier) methods of contraception. If taking the pill was missed in the first week of using the drug and unprotected sexual intercourse took place in the previous 7 days, then the possibility of pregnancy cannot be excluded.

Measures to be taken in case of vomiting

If vomiting develops within 3-4 hours after taking the tablet, the tablet is not completely absorbed. In this case, you should proceed in the same way as in the case of missed pills. The required tablet(s) must be replenished from another package.

Observation

Despite taking the pills regularly, menstrual irregularities may occur. If menstruation occurs very frequently and irregularly, you should consider using another method of contraception. If disorders persist, an organic cause must be excluded.

Tactics for amenorrhea that occurs during use of the drug depend on whether the tablets were taken in accordance with the instructions or not; a pregnancy test may be required.

If pregnancy occurs, the drug must be stopped.

It must be remembered that taking Lactinet® does not protect against infection with HIV and other sexually transmitted diseases.

Interaction

Concomitant use with drugs that induce microsomal liver enzymes may cause breakthrough bleeding and reduce the contraceptive effect of Lactinet.

Such drugs include hydantoin :

• phenytoin;
• carbamazepine;
• topiramate;
• griseofulfin;
• rifabutin;
• barbiturates;
• primidone oxcarbazepine.

If it is necessary to undergo treatment with these drugs, a woman is recommended to supplement her intake of birth control pills with the use of additional contraceptives throughout the course of treatment and for another seven days after its completion. After stopping rifampicin, to use barrier contraceptives for another 28 days.

The contraceptive effect of Lactinet is reduced by the simultaneous use of antibiotics , as well as during treatment activated carbon and drugs similar in action to it.

After taking activated carbon or its analogue, you should follow the recommendations regarding the dosage of the drug if you skip a pill.

Lactinet, 28 pcs., 75 mcg, film-coated tablets

Inside.

In the absence of previous use of hormonal contraceptives (during the last month), taking tablets begins on the first day of the menstrual cycle, 1 tablet. per day, if possible at the same time of day, following the direction indicated on the package, so that there is a break between taking 2 tablets. was 24 hours, if necessary with a small amount of liquid. This drug does not require a break in use. Each subsequent package should begin immediately after the end of the previous one.

How to take the drug

Women who did not take oral contraceptives in the previous month.

Reception of the 1st table. should start on the first day of the menstrual cycle (menstruation). In this case, the use of additional methods of contraception is not required.

You can start taking pills from the 2nd–5th day of menstruation, but in this case, in the first cycle, you must use additional methods of contraception in the first 7 days of taking the pills.

Women who switch from another combined oral contraceptive (COC) to Lactinet®.

If possible, the day after taking the last tablet of the previous PDA. In this case, the use of additional methods of contraception is not required.

Women who are switching from progestogen-only medications (mini-pills, injections, implants, or progestogen-releasing intrauterine devices).

When switching from a mini-pill, you can start taking the drug on any day; in the case of injections - on the day when the next injection should be given; in the case of an implant - the day after its removal.

In all of these cases, it is recommended to use barrier methods of contraception during the first 7 days.

Taking the drug after an abortion in the first trimester of pregnancy.

After an abortion in the first trimester of pregnancy, it is recommended to start taking the drug immediately after the abortion, and in this case there is no need to use additional methods of contraception.

Taking the drug after childbirth or after termination of pregnancy in the second trimester.

The drug should be taken no earlier than 21–28 days after termination of pregnancy in the second trimester or after childbirth. If you plan to start taking the drug later, then you must use a barrier method of contraception for the first 7 days. In addition, if unprotected sexual intercourse occurred before starting to use the drug, it is necessary to exclude pregnancy or postpone the start of taking the drug to the 1st day of the next menstruation (when the menstrual cycle is restored).

Missed (forgotten) pills.

The effectiveness of the contraceptive decreases if 2 tablets are taken between doses. more than 36 hours have passed. If the break does not exceed 12 hours, the contraceptive effect is not reduced, and the use of an additional contraceptive method is not required. The remaining tablets are continued as usual.

If there is a break of more than 12 hours, the contraceptive effect may decrease. To achieve effective blocking of the hypothalamic-pituitary-ovarian system, it is necessary to take the drug daily for 7 days. Thus, if there is a break of more than 12 hours, the drug is continued as usual, but in the next 7 days it is necessary to use additional (barrier) methods of contraception. If taking the pill was missed in the 1st week of using the drug and unprotected sexual intercourse took place in the previous 7 days, then the possibility of pregnancy cannot be excluded.

Measures to be taken in case of vomiting.

If vomiting develops within 3-4 hours after taking the tablet, the tablet is not completely absorbed. In this case, you should proceed in the same way as in the case of missed tablets. The required tablet(s) must be replenished from another package.

Observation.

Despite taking the pills regularly, menstrual irregularities may occur. If your periods are very frequent and irregular, you should consider using another method of contraception. If disorders persist, an organic cause must be excluded.

Tactics for amenorrhea that occurs during use of the drug depends on whether the tablets were taken in accordance with the instructions or not; A pregnancy test may be required.

If pregnancy occurs, the drug must be stopped.

It must be remembered that taking Lactinet® does not protect against infection with HIV (AIDS) and other sexually transmitted diseases.

Analogs

Level 4 ATX code matches:
Eskinor-F

Microlute

Exluton

Postinor

Escapelle

Implanon NKST

Charosetta

Analogues of Lactinet are the drugs Charozetta and Desogestrel .

Use of Lactinet during breastfeeding and pregnancy

The use of Lactinet by pregnant women is prohibited. This is due to the results of preclinical studies showing that high doses of progestogens (one of which is the active substance of the drug) contribute to excessive masculinization of female fetuses.

As for epidemiological studies , they did not reveal an increased risk of congenital deformities in the child and any disorders of embryogenesis in newborn infants whose mothers took contraceptives before pregnancy or, unintentionally, in the first weeks after its onset.

Lactinet taken during breastfeeding does not affect the quantity of breast milk in a woman and its quality indicators. However, desogestrel has the ability to pass into milk in small quantities.

Observations of nursing women using Lactinet to prevent pregnancy while breastfeeding have confirmed that desogestrel does not provoke any disturbances in growth and development (both physical and mental).

However, for safety reasons, close monitoring of the child by a qualified pediatrician is recommended.

Lactinet tablets No. 28

Directions for use and doses

In the absence of previous use of hormonal contraceptives (within the last month), taking tablets begins on the first day of the menstrual cycle, one tablet per day, if possible at the same time of day, following the direction indicated on the package, so that the interval between taking two tablets is 24 hours, if necessary with a small amount of liquid.
This drug does not require a break in use. Each subsequent package should begin immediately after the end of the previous one. First dose of the drug Women who did NOT take oral contraceptives in the previous month: Taking the first tablet should begin on the first day of the menstrual cycle (menstruation). In this case, the use of additional methods of contraception is not required. You can start taking pills from the 2-5th day of menstruation, but in this case, in the first cycle, you must use additional methods of contraception in the first 7 days of taking the pills. Women who switch from another combined oral contraceptive (COC) to Lactinet® If possible, the day after taking the last tablet of the previous COC. In this case, the use of additional methods of contraception is not required.

Women who are switching from single-component drugs containing only progestogen (mini-pills, injections, implants or progestogen-releasing intrauterine devices) When switching from a mini-pill, the drug can be started on any day; in the case of injections - on the day when the next injection should be given; in the case of an implant - on the day after its removal. In all of these cases, it is recommended to use barrier methods of contraception during the first 7 days.

Taking the drug after an abortion in the first trimester of pregnancy After an abortion in the first trimester of pregnancy, it is recommended to start taking the drug immediately after the abortion, and in this case there is no need to use additional methods of contraception. Taking the drug after childbirth, or after termination of pregnancy in the second trimester. The drug should be taken no earlier than 21-28 days after termination of pregnancy in the second trimester or after childbirth. If you plan to start taking the drug later, you must use a barrier method of contraception for the first 7 days. In addition, if unprotected sexual intercourse occurred before starting to use the drug, it is necessary to exclude pregnancy or postpone the start of taking the drug to the first day of the next menstruation (when the menstrual cycle is restored).

Missed (forgotten) pills The effectiveness of the contraceptive decreases if more than 36 hours pass between taking two pills. If the break does not exceed 12 hours , the contraceptive effect is not reduced, and the use of an additional contraceptive method is not required. The remaining tablets are continued to be taken as usual. In case of a break of more than 12 hours , the contraceptive effect may decrease. To achieve effective blocking of the hypothalamic-pituitary-ovarian system, it is necessary to take the drug daily for 7 days. Thus, if there is a break of more than 12 hours , the drug is continued as usual, however, in the next 7 days it is necessary to use additional (barrier) methods of contraception. If taking the pill was missed in the first week of using the drug and unprotected sexual intercourse took place in the previous 7 days, then the possibility of pregnancy cannot be excluded.

Measures taken in case of vomiting If vomiting develops within 3-4 hours after taking the tablet, the tablet is not completely absorbed. In this case, you should proceed in the same way as in the case of missed pills. The required tablet(s) must be replenished from another package.

Observation Despite regular use of tablets, menstrual irregularities may occur. If your periods are very frequent and irregular, you should consider using another method of contraception. If disorders persist, an organic cause must be excluded. Tactics for amenorrhea that occurs during use of the drug depends on whether the tablets were taken in accordance with the instructions or not; A pregnancy test may be required. If pregnancy occurs, the drug must be stopped. It must be remembered that taking Lactinet® does not protect against infection with HIV (AIDS) and other sexually transmitted diseases.

Reviews about Laktinet

Reviews from doctors about the drug are positive. Most experts note that if properly selected, taking into account all the recommendations and contraindications given in the instructions, it does not cause any serious side effects even with long-term use.

Another compelling argument in favor of the prescription is that Lactinet contraceptive pills are suitable for breastfeeding mothers, as well as for those who are contraindicated with combined oral contraceptives .

Reviews of Lactinet for breastfeeding indicate that the drug does not affect the taste or other qualities of milk and is considered safe for the health of the baby.

Reviews left by women who took this contraceptive are more contradictory. Many of them were satisfied with the tablets, emphasizing the ease of use and the absence of adverse reactions.

But along with this, there are also negative comments, which note that after taking the drug, the menstrual cycle ( bleeding became more frequent and heavy or disappeared altogether), hair began to fall out , and weight increased .

Some people also consider its relatively high cost to be a disadvantage of the drug.

On the pharmaceutical market of Russia and Ukraine, an analogue of Lactinet is the drug Charozetta , which is produced by ORGANON NV (Netherlands). When trying to decide which is better - Charozetta or Lactinet - you should take into account the fact that in terms of their properties, indications and composition they are almost identical, and the only significant difference is the price (Lactinet is somewhat cheaper than its analogue).

Lactinette®-Richter

If any of the diseases/conditions or risk factors listed below are present, the expected benefit should be assessed against the possible risk of using the drug. This issue should be discussed with the patient before starting to take Lactinet®-Richter. In case of exacerbation of diseases, deterioration of the condition or the appearance of the first symptoms of the above-mentioned conditions or risk factors, the patient should immediately consult a doctor. The doctor should decide whether it is necessary to discontinue the drug Lactinet®-Richter.

Mammary cancer

The risk of breast cancer (BC) increases with age. While using COCs, the risk that a woman will be diagnosed with breast cancer increases slightly. This increased risk decreases gradually over 10 years after stopping the use of oral contraceptives and is not related to the duration of use but depends on the woman's age at the time of COC use. The expected number of diagnosed cases of breast cancer among 10,000 women who used COCs (within 10 years after stopping their use), relative to women who never used them over the same period, calculated for the corresponding age groups, is presented in the table below.

The risk in women using progestogen-only oral contraceptives, for example, Lactinet®-Richter, may be similar to that when using COCs. However, the data for progestogen-only oral contraceptives are less clear. Compared with the lifetime risk of breast cancer, the increase in risk associated with COC use is small.

Women who take COCs are diagnosed with earlier clinical stages of breast cancer than women who have never used them. The increased risk of breast cancer in women using COCs may be due to earlier diagnosis, biological effects of the drug, or a combination of these two factors.

Since it is impossible to exclude the biological effect of gestagens on the development of liver cancer, an individual assessment of the benefit-risk ratio should be carried out when prescribing the drug to women with liver cancer.

In case of acute or chronic liver dysfunction

a woman should contact a specialist for examination and consultation.

In case of development of stable arterial hypertension

while taking the drug Lactinet®-Richter or if antihypertensive therapy is ineffective and there is a clinically significant increase in blood pressure, the possibility of discontinuing the use of the drug Lactinet®-Richter should be considered.

Thromboembolic disorders

Venous thromboembolism

Epidemiological studies have established an association between COC use and an increased incidence of VTE (DVT and PE). Although the clinical significance of these data for desogestrel, as a contraceptive that does not contain an estrogen component, is unknown, the drug should be discontinued if thrombosis develops.

Prolonged immobilization due to surgery or illness

Discontinuation of desogestrel should be considered in the event of prolonged immobilization due to surgery, injury or illness. If there is a history of thromboembolic complications, the woman should be warned about possible relapses of the disease while taking the drug.

Diabetes

Although gestagens can affect peripheral insulin resistance and glucose tolerance, adjustment of the dosage regimen of hypoglycemic drugs in patients with diabetes mellitus using gestagen-containing oral contraceptives, as a rule, is not required. However, such women should be under close medical supervision during the first months of taking Lactinet®-Richter.

Bone mineral density (BMD)

The use of desogestrel leads to a decrease in the concentration of estradiol in the blood plasma to a level corresponding to the early follicular phase. It is currently unknown whether this decrease has any clinically significant effect on BMD.

Prevention of ectopic pregnancy

Prevention of ectopic pregnancy with traditional gestagen-containing oral contraceptives (“mini-pills”) is not as effective as when taking COCs, since ovulation often occurs with their use.

Although desogestrel effectively suppresses ovulation, in the case of amenorrhea or abdominal pain, ectopic pregnancy should be excluded.

Chloasma, especially in women with a history of chloasma during a previous pregnancy

In rare cases, chloasma has developed, especially in women with a history of chloasma during pregnancy. Women with a predisposition to chloasma should avoid exposure to sunlight or ultraviolet radiation while taking desogestrel.

The following conditions have been observed during pregnancy and the use of sex hormones, although their relationship with the use of gestagens has not yet been established: jaundice and/or itching associated with cholestasis; cholelithiasis, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham's chorea, herpes of pregnancy, hearing loss associated with otosclerosis, hereditary angioedema.

Depressed mood and depression are a known adverse reaction when using hormonal contraceptives (see section "Side effects"). 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.

Medical examinations/consultations

Before prescribing the drug, a woman should carefully collect a general and gynecological history and conduct a clinical and laboratory examination to exclude pregnancy. If there is a history of menstrual irregularities, for example, oligomenorrhea and amenorrhea, the cause of their occurrence should be determined.

The interval between control medical examinations is determined by the doctor in each individual case (but not less than once a year).

If taking desogestrel may affect a latent or existing disease, an appropriate schedule of follow-up medical examinations should be established.

Despite regular use of the drug Lactinet®-Richter, irregular bleeding may sometimes occur. If bleeding is very frequent and irregular, you should consider using another method of contraception. If the above symptoms are persistent, then in this case it is necessary to exclude organic pathology.

Management of amenorrhea while using the drug depends on whether the tablets were taken as directed and may include a pregnancy test. In case of pregnancy, taking Lactinet®-Richter should be discontinued.

Women should be informed that Laktinet®-Richter does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of gestagen-containing oral contraceptives may be reduced in case of missed pills (see section "Dosage and Administration"), gastrointestinal disorder (see section "Dosage and Administration"), or in the case of concomitant therapy, which reduces the concentration of etonogestrel - the active metabolite of desogestrel - in the blood plasma (see section “Interaction with other drugs”).

Changes in the nature of menstruation

During the period of taking gestagen-containing contraceptives, in some women, bleeding from the genital tract may become more frequent or longer lasting, less frequent, or even stop altogether. These changes are often the reason that a woman refuses this method of contraception or ceases to strictly follow the doctor's instructions. In detailed consultation with women who decide to use desogestrel as a method of contraception, the doctor should discuss the possibility of such changes in the nature of the menstrual cycle. Evaluation of bleeding should be based on clinical findings and may include evaluation to rule out malignancy or pregnancy.

Follicle development

When taking all low-dose hormonal contraceptives, follicle development occurs; occasionally, the size of the follicle can reach sizes exceeding those in a normal cycle. This is often asymptomatic, and in some cases there may be mild pain in the lower abdomen. Typically, these enlarged follicles regress spontaneously. Surgery is rarely required.

Lab tests

The use of COCs may affect the results of some laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function, concentrations of (transport) proteins in the blood plasma, for example, sex hormone binding globulin (SHBG), lipid fractions/ lipoproteins, indicators of carbohydrate metabolism, blood clotting and fibrinolysis. Usually these changes remain within normal limits. It is unknown to what extent this also applies to progestogen-only contraceptives.

Excipients

Patients with lactose intolerance should keep in mind that one tablet of Lactinet®-Richter contains 55.095 mg of lactose monohydrate. Patients with rare hereditary diseases such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this drug.

Lactinet price, where to buy

The average market price of Lactinet in Russia is 750 rubles per pack of 28 tablets. In Ukrainian pharmacies it sells for an average of 135 hryvnia.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine
• Online pharmacies in KazakhstanKazakhstan

ZdravCity

• Lactinet tablets p.p.o.
  75mkg 28pcs JSC Gedeon Richter RUB 905 order

Pharmacy Dialogue

• Laktinet (No. 28 tablet p/o) Gedeon-Richter

  910 rub. order

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Pharmacy24

• Lactinet 0.075 mg N28 tablets VAT "Gedeon Richter", Ugorshchina
  294 UAH. order

PaniPharmacy

• Lactinet tablets Lactinet tablets. p/o No. 28 Hungary, Gedeon Richter

  298 UAH order

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