Contraceptive pills Lindinet. Lindinet contraceptives - an effective monophasic contraceptive Lindinet 20 for treatment

Which not only prevent unwanted pregnancy, but also have a pronounced medicinal property for gynecological diseases. One of these drugs is Lindinet 20 And 30 . In this article we will introduce you to the instructions, method of use and other important points regarding these birth control pills.

How to use Lindinet, a brief overview of the instructions

Taking pills 1 time per day for 21 days. You need to drink it at the same time of day daily.

For example, you took the first pill at 09:00, which means that all subsequent days you take the pills at 09:00.

When all the tablets (21 pieces) have been taken, a seven-day break is taken, during which bleeding should occur.

Then, on the same day of the month when the first tablet was taken (for example, the 18th of January), the use of the drug is resumed again (the 18th of February). And so on every month.

The first contraceptive pill must be taken from the 1st to the 5th day of menstruation.

In the case when there is a transition from one oral contraceptive (combined type) to Lindinet, the very first tablet is taken immediately on second day after stopping the previous contraceptive.

After an abortion, which took place in the 1st trimester of pregnancy, Lindenet should be started on the second day or on the day after surgery. There is no need to resort to auxiliary methods of protection.

But after an abortion in the 2nd trimester, as well as after childbirth, you can start taking pills no earlier than 21-28 days.

In this case, additional methods of contraception will be required in the first 7 days.

What is the difference between Lindinet 20 and Lindinet 30?

Only a doctor can prescribe which pills are right for you, based on tests.

Lindinet 20 is more designed for young nulliparous girls. The hormone content in it is less than in Lindinet 30 tablets.

If you do not take into account the characteristics of the body of each specific woman, then if you are 20 years old, most likely the doctor will prescribe Lindinet 20, and, accordingly, after 30 years old, he will prescribe Lindinet 30.

Features of taking Lindinet 20 and Lindinet 30 tablets

When taking Lindinet birth control pills form 20 or 30, it is necessary to take into account that if drugs such as ampicillin, tetracycline, felbamate, fluconazole are used, the activity of the contraceptive is reduced.

Therefore, if you take Lindinet along with these medications, take care of additional contraceptive measures, for example, based on spermicides, or any of the barrier methods.

Also, St. John's wort tea reduces the level of Lindenet in the blood and can cause pregnancy or intermediate bleeding.

Therefore, if you take Lindenet 20 or Lindenet 30 together with other medications, you should consult your doctor and make sure that they do not reduce the active substance of birth control pills.

It is worth noting that the drug should not be taken during pregnancy, diabetes, lactation, venous insufficiency, or any disorders associated with the kidneys and liver.

Side effects from taking Lindinet

The individual characteristics of each woman also have their own side effects from taking Lindinet. If one or more of the side effects listed below occur, you should stop taking the drug.

These side effects include:

1. Cardiovascular system disorders. It manifests itself in the form of arterial hypertension or thromboembolism.

2. Hearing loss.

3. Sindenham's chorea.

4. Candidiasis.

5. Bleeding.

6. Galactorrhea.

7. Nausea and vomiting.

8. Breast enlargement and pain in it.

9. Hepatitis.

10. Rash.

11. Erythema nodosum.

12. Headache.

13. Depression.

14. Weight gain.

15. And other allergic reactions.

If you experience any of the above after taking Lindinet birth control pills, tell your doctor immediately.

What to do if you missed a Lindinet dose?

If for some reason you missed a Lindinet 20 or 30 tablet, you should take it immediately if possible.

Less than 12 hours

If the interval between taking pills was no more than 12 hours, the contraceptive properties of the drug will not decrease. You do not need to resort to additional contraception.

Taking subsequent tablets should continue as usual.

More than 12 hours

When the interval between taking a contraceptive is more than 12 hours, the effectiveness of the drug may decrease.

There is no need to take the missed dose.

But within a week you will need to use additional contraceptives (condoms, suppositories) to avoid pregnancy.

Menstruation while taking Lindinet

Menstruation may occur while taking Lindinet if the cyclical use of the contraceptive drug has been disrupted. But in any case, whether there was a failure to take the pills or not, you need to contact a gynecologist.

The cause of bleeding while using Lindinet may be diseases of the genital tract. Therefore, you should immediately consult a doctor, who, after an examination, will be able to detect the real reason bleeding.

The contraceptive Lindinet 20 is a hormonal drug. When taken, changes occur in the body that prevent a woman from becoming pregnant. Only a doctor can prescribe this remedy - otherwise there is a high risk of side effects.

Lindinet 20 is a single-phase contraceptive. When taken, the active ingredients are ethinyl estradiol and gestodene. The contraceptive is available in two versions. How are they different? In birth control pills Lindinet 20 the estradiol content is less than in Lindinet 30.

Lindinet 20 or Lindinet 30, depends on the hormonal background of the woman. It usually changes with age. For example, after childbirth, the level of estrogen in the female body increases. Therefore, if a woman is 3-35 years old and has already given birth, most likely, a drug containing 20 mcg of estradiol will be better suited.

How does the drug work? Lindinet 20 changes the condition of the gynecological organs. These changes are of such a nature that fertilization becomes unlikely, and even practically impossible:

  • Typically, sperm enter the female reproductive system through the cervix. Excess estrogen acts in such a way that the mucous membrane of this area becomes excessively viscous. The man’s seed simply cannot overcome this barrier, and the sperm die in the vagina without continuing the journey;
  • The internal tissues of the uterus become immune to the fertilized egg (blastocyst). That is, even if conception has occurred, the female reproductive cell will not be able to receive nutrients and will die.

In addition, the relatively small dose of sex hormones in the drug has not only a contraceptive effect. If Lindinet 20 turned out to be the right choice and was taken correctly, according to the scheme, then it will have a beneficial effect on the female body:

  • The likelihood of developing cancer will decrease;
  • Gynecological organs will be less susceptible to inflammation;
  • Negative symptoms of menstruation will disappear;
  • The monthly cycle is normalized over time.

Lindinet 20 – hormonal pills. And you need to be very careful with any external hormones. When prescribing, the doctor takes into account whether the following problems are observed in the body:

  • Sugar metabolism disorders;
  • Vaginal and uterine bleeding;
  • Heart diseases;
  • Liver disorders;
  • Tendency to form blood clots;
  • Kidney failure;
  • High blood pressure;
  • Development of malignant and benign neoplasms;
  • Nicotine addiction;
  • High levels of estrogen in the body.

In addition, it is unacceptable to use Lindinet 20 tablets while a woman is carrying a child or breastfeeding it. After all, at this time the estrogen content in the female body is already very high. Additional doses can quickly lead to negative consequences. Not to mention how they will affect the baby's development.

During lactation, it is also important to remember the restrictions on hormonal contraceptives. After all, the active substances – artificial hormones – are also excreted through mother’s milk. Thus, they can affect the baby's growth in the first months of life. And the results of such an impact are difficult to predict.

You need to start drinking Lindinet 20 in the first five days of your period. However, they may suddenly stop. You should not be afraid of this - the pills begin to act. In the first 14 days, the contraceptive effect will develop. During this period, you need to use additional contraceptives - for example, condoms or interrupted intimate intercourse.

When taking it, you need to follow a time regime. Set yourself a time at which it is most convenient for you to drink Lindinet 20. And do not deviate from your regimen.

The pack contains 21 tablets. This will be enough for exactly a month. We take the pills daily and then take a week's break. During this period, vaginal bleeding is most likely to occur. It may seem to you that menstruation has arrived - in fact, this phenomenon only resembles them. There is no real menstruation when taking birth control pills with estrogen.

The contraceptive effect is stable. After your body has gotten used to Lindinet 20 in the first two weeks, you can forget about other contraceptive methods. Of course, if there is no need for protection from STDs, modern medicine has not come up with anything other than condoms.

Switching from other contraceptives

How to switch to these tablets? If you previously took contraceptives with 28 capsules in a pack, you need to start taking Lindinet 20 the next day after you finished the package of the previous drug. If the previous contraceptive prescribed a 21-day regimen, take the usual break. And then go to Lindinet 20.

Whether to use additional contraception for the first two weeks depends on the previous drug. If it contained artificial estrogen, Lindinet 20 will simply maintain the required level of hormones. If these were mini-pills and did not contain estrogen, you should be extra safe.

After pregnancy

During the first trimester of pregnancy, estrogen levels did not change much. If at this time the pregnancy stops for some reason, you can drink Lindinet 20 the next day. In such a situation, there is no need for additional protection.

If the pregnancy was terminated in the second or third semester, it is better to wait until the next menstruation begins. And in its first days, start using Lindinet 20 according to the usual regimen. After a normal pregnancy that ends in childbirth, you need to wait for your period. In their first days, we begin to take birth control pills, as indicated for general cases.

There is no need to worry if you remember the missed pill before 12 hours have passed. In this case, drink it immediately. The contraceptive effect will not weaken.

If a woman misses a pill and 12 hours have already passed, you need to act according to the recommendations:

  • 1st week. Over the next week, you should additionally use a condom;
  • 2nd week of the cycle. If the girl has not taken the drug at this time, her hormonal levels will allow her not to use additional contraception. Of course, if the girl has not already forgotten about the pills this month;
  • 3rd week. Additionally, you will not need to use contraceptives. But in this situation, a week-long pause will have to be abandoned.

When taking Lindinet 20, you can make sure that menstruation-like discharge this time bypasses the woman. To do this, you just need to not use the usual pause.

This may seem like a convenient option if you are planning important things or vacations. But be very careful. Doing this more than once in a row would be a bad idea. Indeed, in this case, a slow overdose of the drug occurs. And the side effects may get worse.

Memo for girls

Hormone therapy is not a toy. Hormones can significantly change both physiological and psychological condition person. Even an ideal doctor will not always be able to predict the side and simply additional effects of Lindinet 20.

Therefore, you need to be very careful when choosing birth control pills. If your friends or relatives recommended Lindinet 20 to you, do not rush to go to the pharmacy. Even if the pills were really good for them, this may not be the case in your case.

To find out if Lindinet 20 tablets are right for you, do not ask anyone other than your doctor. The gynecologist and endocrinologist have the greatest competence in this matter. They will conduct the necessary examinations and tests. They will understand if you have any contraindications. And most importantly, they will decide what dosages of hormones are suitable for your estrogen level. Perhaps hormonal therapy will be very useful, or perhaps strictly contraindicated.

The instructions clearly define the dosage regimen for a reason. It is designed to regulate and normalize your menstrual cycle. Therefore, it is better not to forget about the pills. Keep the pack of Lindinet 20 birth control pills where they will be visible to you and the time of taking them will not slip out of your mind.

Lindinet 20 (ethinyl estradiol + gestodene) is a monophasic tablet combined (estrogen + progestogen) contraceptive. Manufacturer - Hungarian pharmaceutical company « Gedeon Richter" Date of entry into the world market - 2004. The drug is valued for its ability to provide reliable contraception and effectively control the menstrual cycle. Lipndinet 20 is well tolerated and does not affect performance blood pressure and aldosterone concentration, which is especially important for women in the premenopausal and menopausal periods. Lindinet 20 is an excellent choice for women of average reproductive age (from 22 to 35 years old) who need long-term, reliable and safe contraception, as well as for girls just starting to use hormonal contraceptives. Despite the low quantitative content of active ingredients, the drug reliably controls the menstrual cycle and is guaranteed to eliminate characteristic pain in the lower abdomen. Lindinet 20 is the optimal choice in cases where a woman has developed undesirable effects caused by a high dose of the estrogen or progestin component. Lindinet 20 contains a minimal dose of ethinyl estradiol and a gestagen (gestodene), which ensures a rapid drop in the concentration of estrogen in plasma. Gestodene is included in the drug in a dose that does not have clinically significant glucocorticoid activity, which helps maintain stable body weight.

This is confirmed by studies of the drug, demonstrating the absence of a significant increase in a woman’s body weight. Gestodene is one of the most powerful and highly selective progestins present on the pharmaceutical market today. Due to its high activity, this substance is used in low concentrations, in which it does not affect the metabolism of fats and carbohydrates and does not exhibit androgenic properties. In addition to contraception, the drug also has therapeutic effect, preventing the development of a number of gynecological diseases, incl. tumor etiology.

Before starting to use Lindinet 20, a woman must undergo a medical examination, including the collection of family and personal anamnestic data, blood pressure measurement, laboratory tests, and a gynecological examination. In the future, such an examination, provided that the woman is taking oral contraceptives, should be carried out once every six months. Before starting contraceptive therapy using hormonal contraceptives, all possible benefits and potential risks are weighed for each woman, after which the doctor, together with the woman, makes a joint decision on choosing one or another method of contraception. If, after starting to take the drug, a woman develops or worsens circulatory system diseases, cardiovascular diseases, epilepsy, diabetes, depression, then contraceptive therapy should be discontinued.

Pharmacology

Monophasic oral contraceptive. Inhibits the secretion of gonadotropic hormones of the pituitary gland. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is ethinyl estradiol - a synthetic analogue of the follicular hormone estradiol, which participates together with the corpus luteum hormone in the regulation menstrual cycle. The gestagenic component is gestodene, a derivative of 19-nortestosterone, which is superior in strength and selectivity to not only the natural corpus luteum hormone progesterone, but also other synthetic gestagens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has virtually no effect on lipid and carbohydrate metabolism.

Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus located in the cervix, which makes it relatively impenetrable for sperm. In addition to the contraceptive effect, the drug, when taken regularly, also has therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Gestodene

Suction

After oral administration, it is quickly and completely absorbed from the gastrointestinal tract. After a single dose, Cmax is observed after 1 hour and is 2-4 ng/ml. Bioavailability - about 99%.

Distribution

Gestodene binds to albumin and sex hormone binding globulin (SHBG). 1-2% is found in plasma in free form, 50-75% specifically binds to SHBG. An increase in the level of SHBG in the blood caused by ethinyl estradiol affects the level of gestodene: the fraction associated with SHBG increases and the fraction associated with albumin decreases. Average V d - 0.7-1.4 l/kg. The pharmacokinetics of gestodene depends on the level of SHBG. The concentration of SHBG in blood plasma under the influence of estradiol increases 3 times. When taken daily, the concentration of gestodene in the blood plasma increases 3-4 times and in the second half of the cycle reaches a state of saturation.

Metabolism and excretion

Gestodene is biotransformed in the liver. The average plasma clearance is 0.8-1 ml/min/kg. The level of gestodene in the blood serum decreases in two phases. T1/2 in the β-phase is 12-20 hours. Gestodene is excreted only in the form of metabolites, 60% in urine, 40% in feces. T 1/2 metabolites - about 1 day.

Ethinyl estradiol

Suction

After oral administration, ethinyl estradiol is absorbed quickly and almost completely. The average Cmax in blood serum is reached 1-2 hours after administration and is 30-80 pg/ml. Absolute bioavailability due to presystemic conjugation and primary metabolism is about 60%.

Distribution

Completely (about 98.5%), but nonspecifically binds to albumin and induces an increase in the level of SHBG in the blood serum. Average Vd - 5-18 l/kg.

C ss is established by the 3-4th day of taking the drug, and it is 20% higher than after a single dose.

Metabolism

It undergoes aromatic hydroxylation to form hydroxylated and methylated metabolites, which are present in the form of free metabolites or in the form of conjugates (glucuronides and sulfates). Metabolic clearance from blood plasma is about 5-13 ml.

Removal

Serum concentration decreases in two phases. T1/2 in the β-phase is about 16-24 hours. Ethinyl estradiol is excreted only in the form of metabolites, in a 2:3 ratio with urine and bile. T 1/2 metabolites - about 1 day.

Release form

Light yellow film-coated tablets, round, biconvex, unprinted on both sides; on the fracture it is white or almost white with a light yellow edging.

Excipients: sodium calcium edetate - 0.065 mg, magnesium stearate - 0.2 mg, colloidal silicon dioxide - 0.275 mg, povidone - 1.7 mg, corn starch - 15.5 mg, lactose monohydrate - 37.165 mg.

Shell composition: quinoline yellow dye (D+S yellow No. 10) (E104) - 0.00135 mg, povidone - 0.171 mg, titanium dioxide - 0.46465 mg, macrogol 6000 - 2.23 mg, talc - 4.242 mg, calcium carbonate - 8.231 mg, sucrose - 19.66 mg.

21 pcs. - blisters (1) - cardboard packs.
21 pcs. - blisters (3) - cardboard packs.

Dosage

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

The first tablet of Lindinet 20 should be taken from the 1st to the 5th day of the menstrual cycle.

When switching to Lindinet 20 from another combined oral contraceptive, the first Lindinet 20 tablet should be taken after taking the last tablet from the package of another oral hormonal contraceptive, on the first day of withdrawal bleeding.

When switching to taking Lindinet 20 from drugs containing only gestagen ("mini-pill", injections, implant), when taking the "mini-pill", taking Lindinet 20 can be started on any day of the cycle, switching from using the implant to taking Lindinet 20 is possible the day after removal of the implant, when using injections - on the eve of the last injection. In these cases, in the first 7 days you should use additional methods contraception.

After an abortion in the first trimester of pregnancy, you can start taking Lindinet 20 immediately after surgery. In this case, there is no need to use additional methods of contraception.

After childbirth or after an abortion in the second trimester of pregnancy, taking the drug can be started on days 21-28. In these cases, additional methods of contraception must be used in the first 7 days. If you start taking the drug later, an additional barrier method of contraception should be used in the first 7 days. If sexual contact took place before starting contraception, pregnancy should be ruled out before starting the drug or the start of use should be delayed until the first menstruation.

If you miss a pill, take the missed pill as quickly as possible. If the interval in taking the pills is less than 12 hours, then the contraceptive effect of the drug is not reduced, and in this case there is no need to use an additional method of contraception. The remaining tablets should be taken at the usual time. If the interval is more than 12 hours, the contraceptive effect of the drug may be reduced. In such cases, you should not make up for the missed dose, continue taking the drug as usual, but in the next 7 days you must use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, taking the drug from the next package should be started without interruption. In this case, withdrawal bleeding does not occur until the end of taking the drug from the second package, but spotting or breakthrough bleeding may occur.

If withdrawal bleeding does not occur after completing the drug from the second package, then pregnancy should be excluded before continuing to take the drug.

If vomiting and/or diarrhea begins within 3-4 hours after taking the drug, the contraceptive effect may be reduced. In such cases, you should follow the instructions for skipping pills. If the patient does not want to deviate from her usual contraceptive regimen, the missed pills should be taken from another package.

To speed up the onset of menstruation, you should reduce the break in taking the drug. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking tablets from the next package (similar to cases with delayed menstruation).

To delay the onset of menstruation, the drug must be continued from a new package without a 7-day break. Menstruation can be delayed as long as necessary until the end of taking the last tablet from the second pack. When menstruation is delayed, breakthrough or spotting bleeding may occur. Regular use of Lindinet 20 can be resumed after the usual 7-day break.

Overdose

No severe symptoms have been described after taking the drug in high doses.

Symptoms: nausea, vomiting, in girls - bloody issues from the vagina.

Treatment: symptomatic therapy is prescribed; there is no specific antidote.

Interaction

The contraceptive activity of Lindinet 20 is reduced when taken simultaneously with ampicillin, tetracycline, rifampicin, barbiturates, primidone, carbamazepine, phenylbutazone, phenytoin, griseofulvin, topiramate, felbamate, oxcarbazepine. The contraceptive effect of oral contraceptives is reduced when these combinations are used, breakthrough bleeding and menstrual irregularities become more frequent. While taking Lindinet 20 with the above drugs, as well as for 7 days after completing the course of taking them, it is necessary to use additional non-hormonal (condom, spermicidal gels) methods of contraception. When using rifampicin, additional methods of contraception should be used for 4 weeks after completion of the course of taking it.

When used simultaneously with Lindinet 20, any drug that increases gastrointestinal motility reduces the absorption of active substances and their level in the blood plasma.

Sulfation of ethinyl estradiol occurs in the intestinal wall. Drugs that are also subject to sulfation in the intestinal wall (including ascorbic acid) competitively inhibit the sulfation of ethinyl estradiol and thereby increase the bioavailability of ethinyl estradiol.

Inducers of microsomal liver enzymes reduce the level of ethinyl estradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oscarbazepine).

Liver enzyme inhibitors (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma.

Some antibiotics (ampicillin, tetracycline), by interfering with the intrahepatic circulation of estrogens, reduce the level of ethinyl estradiol in plasma.

Ethinyl estradiol, by inhibiting liver enzymes or accelerating conjugation (primarily glucuronidation), can affect the metabolism of other drugs (including cyclosporine, theophylline); The concentration of these drugs in the blood plasma may increase or decrease.

When Lindinet 20 is used simultaneously with St. John's wort preparations (including infusion), the concentration of active substances in the blood decreases, which can lead to breakthrough bleeding and pregnancy. The reason for this is the inducing effect of St. John's wort on liver enzymes, which continues for another 2 weeks after completing the course of taking St. John's wort. It is not recommended to prescribe this combination of drugs.

Ritonavir reduces the AUC of ethinyl estradiol by 41%. In this regard, during the use of ritonavir, a hormonal contraceptive with a higher ethinyl estradiol content should be used or additional non-hormonal methods of contraception should be used.

It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraception may reduce carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.

Side effects

Side effects requiring discontinuation of the drug

From the cardiovascular system: arterial hypertension; rarely - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, thromboembolism pulmonary artery); very rarely - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins.

From the senses: hearing loss caused by otosclerosis.

Other: hemolytic-uremic syndrome, porphyria; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passing after discontinuation of the drug).

Other side effects are more common, but less severe. The advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

From the reproductive system: acyclic bleeding/bloody discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, the development of inflammatory processes in the vagina, candidiasis, tension, pain, enlarged mammary glands, galactorrhea.

From the digestive system: epigastric pain, nausea, vomiting, Crohn's disease, ulcerative colitis, the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis, hepatitis, liver adenoma.

Dermatological reactions: erythema nodosum, exudative erythema, rash, chloasma, increased hair loss.

From the central nervous system: headache, migraine, mood lability, depression.

From the senses: hearing loss, increased sensitivity of the cornea (when wearing contact lenses).

From the metabolic side: fluid retention in the body, change (increase) in body weight, decreased tolerance to carbohydrates, hyperglycemia, increased TG levels.

Other: allergic reactions.

Indications

Contraception.

Contraindications

  • the presence of severe and/or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the heart valve apparatus, atrial fibrillation, cerebral or coronary artery disease, severe or moderate arterial hypertension with blood pressure ≥ 160/100 mm Hg .st.);
  • presence or indication in history of precursors of thrombosis (including transient ischemic attack, angina pectoris);
  • migraine with focal neurological symptoms, incl. in the anamnesis;
  • venous or arterial thrombosis/thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the leg, pulmonary embolism) currently or in history;
  • a history of venous thromboembolism;
  • surgery with prolonged immobilization;
  • diabetes mellitus (with angiopathy);
  • pancreatitis (including a history), accompanied by severe hypertriglyceridemia;
  • dyslipidemia;
  • severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after their normalization);
  • jaundice when taking GCS;
  • gallstone disease currently or in history;
  • Gilbert's syndrome, Dubin-Johnson syndrome, Rotor syndrome;
  • liver tumors (including history);
  • severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
  • hormone dependent malignant neoplasms genitals and mammary glands (including if they are suspected);
  • vaginal bleeding of unknown etiology;
  • smoking over the age of 35 (more than 15 cigarettes per day);
  • pregnancy or suspicion of it;
  • lactation period;
  • hypersensitivity to the components of the drug.

The drug should be prescribed with caution in conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism: age over 35 years, smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or disorder cerebral circulation at a young age in one of the immediate relatives), hemolytic-uremic syndrome, hereditary angioedema, liver diseases, diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including porphyria, herpes of pregnant women, minor chorea / Sydenham disease /, Sydenham chorea, chloasma), obesity (BMI more than 30 kg/ m 2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, major surgery, surgery on the lower extremities, severe trauma, varicose veins veins and superficial thrombophlebitis, the postpartum period (non-lactating women /21 days after childbirth/; nursing women after completion of the lactation period), the presence of severe depression (including a history), changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia , antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant), diabetes mellitus not complicated by vascular disorders, SLE, Crohn's disease, ulcerative colitis, sickle cell anemia, hypertriglyceridemia ( including family history), acute and chronic liver diseases.

Features of application

Use during pregnancy and breastfeeding

The drug is contraindicated for use during pregnancy and lactation.

The components of the drug are excreted in breast milk in small quantities.

When used during lactation, milk production may decrease.

Use for liver dysfunction

Contraindicated in case of liver dysfunction.

Use for renal impairment

The drug is not recommended for use in patients with kidney disease.

special instructions

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

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women over 1 year) when used correctly is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, it is recommended to additionally use non-hormonal methods of contraception in the first 2 weeks of taking the drug.

In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception.

The woman's health condition must be carefully monitored. If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

  • diseases of the hemostatic system;
  • conditions/diseases predisposing to the development of cardiovascular and renal failure;
  • epilepsy;
  • migraine;
  • the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
  • diabetes mellitus not complicated by vascular disorders;
  • severe depression (if depression is associated with a violation of tryptophan metabolism, then vitamin B 6 can be used for correction);
  • sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;
  • appearance of deviations in laboratory tests assessment of liver function.

Thromboembolic diseases

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

The risk of arterial or venous thromboembolic disease increases:

  • with age;
  • when smoking (heavy smoking and age over 35 years are risk factors);
  • if there is a family history of thromboembolic diseases (for example, parents, brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;
  • for obesity (BMI more than 30 kg/m2);
  • with dislipoproteinemia;
  • with arterial hypertension;
  • for diseases of the heart valves complicated by hemodynamic disorders;
  • with atrial fibrillation;
  • with diabetes mellitus complicated by vascular lesions;
  • with prolonged immobilization, after major surgery, after surgery on the lower extremities, after severe trauma.

In these cases, it is assumed to temporarily stop using the drug (no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization).

Women after childbirth have an increased risk of venous thromboembolic disease.

It should be taken into account that diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia increase the risk of developing venous thromboembolic diseases.

It should be taken into account that resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of developing arterial or venous thromboembolic diseases.

When assessing the benefit/risk ratio of taking the drug, it should be taken into account that targeted treatment of this condition reduces the risk of thromboembolism. Symptoms of thromboembolism are:

  • sudden chest pain that radiates to the left arm;
  • sudden shortness of breath;
  • any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, symptom complex "acute abdomen".

Tumor diseases

Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer.

A meta-analysis of 54 epidemiological studies found that there was a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher incidence of breast cancer may have been associated with more regular use. medical examination. Breast cancer is rare among women under 40, whether they take hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, the woman should be made aware of the possible risk of developing breast cancer based on an assessment of the benefit-risk ratio (protection against ovarian and endometrial cancer).

There are few reports of the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be kept in mind when differentially assessing abdominal pain, which may be associated with an increase in liver size or intraperitoneal bleeding.

Chloasma can develop in women with a history of this disease during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sun rays or ultraviolet radiation while taking Lindinet 20.

Efficiency

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

If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they run out in the next package. If at the end of the second cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, stop taking the pills and resume it only after pregnancy has been ruled out.

Changes in laboratory parameters

Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

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

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may be reduced. While continuing to take the drug, it is necessary to use additional non-hormonal methods of contraception.

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

The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Impact on the ability to drive vehicles and operate machinery

No studies have been conducted to study the effect of Lindinet 20 on the abilities necessary to drive a car and operate machinery.

Compound Lindinet 20(1 tablet):

  • – 0.02 mg;
  • – 0.075 mg;
  • Magnesium stearate – 0.2 mg;
  • povidone – 1.7 mg;
  • corn starch – 15.5 mg;

Compound Lindinet 30(1 tablet):

  • ethinyl estradiol – 0.03 mg;
  • gestodene – 0.075 mg;
  • sodium calcium edetate – 0.065 mg;
  • Magnesium stearate – 0.2 mg;
  • colloidal silicon dioxide – 0.275 mg;
  • povidone – 1.7 mg;
  • corn starch – 15.5 mg;
  • lactose monohydrate – 37.165 mg.

Both pharmaceutical forms are supplied in the form of tablets, the shell of which has the following components:

  • sucrose – 19.66 mg;
  • – 8.231 mg;
  • macrogol 6000 – 2.23 mg;
  • titanium dioxide – 0.46465 mg;
  • povidone – 0.171 mg;
  • yellow quinoline dye (D+S yellow No. 10 – E 104) – 0.00135 mg.

Release form

In pharmacy kiosks, the drug is presented in the form of round, biconvex tablets, which are coated with a light yellow coating on both sides. There are no inscriptions or symbols. At the break, the tablet is white or close to white in color with a light yellow edging of the shell.

pharmachologic effect

Lindinet belongs to the group of monophasic combined oral medications based on sex hormones , accordingly, is used primarily for the purpose of contraception. The main therapeutic effect of the drug is associated with several mechanisms of action, including a decrease in the secretion of gonadotropic hormones , actively preventing ovulatory processes and inhibiting the maturation of follicles in the ovaries.

First of all, it should be noted that ethinylestradiol , one of the biologically active components, is a synthetic analogue of follicular hormone , which, together with the hormones of the corpus luteum, is involved in the regulation of a woman’s menstrual cycle, significantly inhibiting it at certain stages.

Another active ingredient is gestodene is a progestogen 19-nortestosterone derivative and is a stronger and more selective version of natural secreted by the corpus luteum. This component is used in ultra-low quantities, due to which it does not realize its androgenic potential (the chemical basis for gestodene is a variation of the male sex hormone) and has the weakest effect on the carbohydrate and lipid metabolism of the body.

In addition to the central mechanisms of action directly on sex hormones, the drug exerts contraceptive properties indirectly through peripheral components. Under the influence of a pharmaceutical drug, susceptibility decreases to the blastocyst, which makes the process of implantation of the initial forms of the fetus almost impossible. The density and viscosity of the mucus localized in the cervix also increases, which becomes largely impenetrable for sperm making active movements towards the female egg.

Lindinet not only has contraceptive effects, the pharmaceutical drug promotes active prevention some gynecological diseases and more. In particular, the possibility of the appearance of functional ovarian cysts And . Reduces the risk of occurrence in the mammary glands, congestive inflammatory processes practically disappear. The beneficial properties of the drug also apply to skin , since their general condition improves and the degree of manifestation decreases (with regular use, dermatological defects disappear completely).

Pharmacodynamics and pharmacokinetics

Pharmacokinetic properties of gestodene

After oral administration, the active component is absorbed quite quickly and almost completely from gastrointestinal tract, because its bioavailability is about 99%, and the maximum concentration of 2-4 ng/ml is observed after 1 hour.

In the bloodstream gestodene contacts And specific globulin SHBG , only 1-2% of the amount of the active ingredient remains in free form. The pharmacokinetics of gestodene largely depends on the level of SHBG and the concentration of estradiol, because the amount of the selective transporter increases 3 times under the influence of the sex hormone. Constant use of oral contraceptives also contributes to the active saturation of gestodene; with daily use, the concentration increases by 3-4 times.

The active component undergoes the main stages of biochemical transformation in the liver, after which only in the form of metabolites is excreted in the urine (60%) and feces (40%). The half-life of the active component is biphasic and takes about 1 day, since the average plasma clearance ranges from 0.8 to 1 ml/million/kg.

Pharmacokinetic properties of ethinyl estradiol

The second active component has slightly lower absorption rates - due to presystemic conjugation and primary metabolism, the absolute bioavailability of the pharmacological component from the digestive tube is only 60%, and the maximum concentration of 30-80 pg/ml is achieved after 1-2 hours.

On the distribution side, ethinyl estradiol, on the contrary, outperforms gestodene, because 98.5% of the active substance binds to nonspecific albumin. Also, the active component induces an increase in SHBG levels, which has a beneficial effect on the overall effectiveness of the oral contraceptive. A constant average level of ethinyl estradiol is established by 3-4 days after the start of the therapeutic course, and it is 20% higher than after a single dose of Lindinet tablet.

Biotransformation of the active substance occurs in the liver and is aromatic hydroxylation with the formation of methylated and hydroxylated metabolic products in free form or in the form of conjugates with sulfates or glucuronides. Metabolic clearance from blood plasma ranges from 5-13 ml.

Ethinyl estradiol is excreted only in the form of metabolic products with urine and bile in a ratio of 2:3. The half-life, like that of gestodene, is biphasic and is about 1 day.

Indications for use

  • contraception;
  • functional disorders of the menstrual cycle.

Contraindications

  • individual hypersensitivity to the pharmaceutical drug or its components;
  • risk factors for arterial or venous thrombosis;
  • moderate to severe;
  • transient ischemic attack or as a harbinger of thrombosis;
  • surgery with prolonged immobilization;
  • with a pronounced increase in blood triglycerides;
  • dyslipidemia ;
  • severe liver disease ( hepatitis , cholestatic jaundice and etc);
  • Gilbert, Dubin-Johnson, Rotor syndrome;
  • neoplasm localized in the liver;
  • otosclerosis or a history of it in a previous pregnancy or after taking glucocorticosteroids;
  • smoking over the age of 35;
  • hormone-dependent malignant tumors genitals and mammary glands;
  • vaginal bleeding of unknown origin;
  • period of lactation and childbearing.

Side effects

Adverse effects of treatment requiring immediate cancellation pharmaceutical therapy:

  • From the outside of cardio-vascular system: arterial hypertension, , , deep vein thrombosis of the lower extremities, , venous or arterial thromboembolism hepatic, mesenteric, retinal or renal vessels.
  • From the outside sense organs: hearing loss caused by otosclerosis .
  • Other: porphyria , hemolytic-uremic syndrome, exacerbation of reactive , Sydenham's chorea .

Side effects, after the appearance of which the advisability of further use of the drug is decided in individual order:

  • From the outside reproductive system: acyclic bleeding from the vagina of unknown etiology, , colpocytological change in vaginal mucus, inflammatory diseases, , pain, breast enlargement, galactorrhea .
  • From the outside central nervous system: hearing loss, , , mood lability.
  • Dermatological reactions: or exudative erythema , unclear rash, chloasma, increased .
  • From the outside digestive system: epigastric pain, nausea and vomiting, Crohn's disease , nonspecific ulcerative , jaundice and the itching that is caused by it, cholelithiasis , liver adenoma, hepatitis.
  • From the outside metabolic processes: fluid retention in the body, decreased tolerance to carbohydrates, increased levels of triglycerides or blood glucose, weight gain.
  • Other allergic reactions.

Instructions for use of Lindinet (Method and dosage)

Lindinet 20, instructions for use

Birth control pills are used orally once a day, without chewing and with a sufficient amount of water, regardless of meals. If possible, you should take the pills at the same time of day for 21 days, then take a break for 7 days, and then resume using contraceptives. That is, the next tablet should be used 4 weeks from the start of the course on the same day of the week. During the break, uterine bleeding will be observed, which corresponds to menstruation in a normal cycle.

A course of conservative contraception should be started from the 1st to the 5th day of the menstrual cycle, if other oral contraceptives have not been used before. Otherwise, the 1st tablet must be taken after taking the last dose of the previous pharmaceutical preparation containing hormones, on the 1st day of bleeding after discontinuation.

Transition from progestogen-containing agents Lindinet requires the use of an additional method of contraception in the first week. The date of first use of a new contraceptive should be consistent with the pharmaceutical form of the previous drug:

  • in the form of mini-tablets - on any day of the menstrual cycle;
  • in case of injections - on the eve of the last injection;
  • implant - the day after its removal.

Lindinet 30, instructions for use

Since this pharmaceutical form is an enhanced version of Lindinet 20 with a higher concentration of ethinyl estradiol, it is recommended to be prescribed after abortion , so that the restoration of physiological hormonal levels occurs much faster and less painfully.

If the abortion was performed in 1st trimester of pregnancy , then there is nothing to worry about. Taking oral contraceptives can be started immediately after gynecological manipulation and there is no need to use additional methods of contraception.

If the abortion or childbirth occurred during 2nd trimester of pregnancy , then taking the pharmaceutical drug can be started only on the 21-28th day after the obstetric surgery. If the course of conservative protection is started later, a barrier method of contraception should be used in the first week. If full sexual intercourse took place before starting to take the drug, then before taking birth control you need to make sure that there is no new pregnancy.

Skipping an oral contraceptive pill

If the next dose of the tablet was missed, then the missing amount of the pharmaceutical drug in the bloodstream must be replenished as quickly as possible. With a delay that duration does not exceed 12 hours , the clinical effects of the contraceptive are not reduced and the need for additional protection by other methods of contraception automatically disappears. Subsequent tablets are taken according to the usual regimen.

If a woman misses a pill and did not make up for her loss within 12 hours , then the pharmacological effectiveness of the drug is reduced, which requires special measures and precautions. First of all, you should resume taking the drug as soon as possible and continue to take it as usual. It is recommended to use any other methods of contraception for a week after the missed period.

This situation may become more complicated if There are less than 7 tablets left in the package . How to take it in this case - start the next pack without observing the required one-week break, which is carried out only after the end of the 2nd pack of contraceptives. It should be noted that while using the 2nd pack, spotting or even breakthrough bleeding may be observed, which can indirectly indicate the presence of pregnancy. If hemorrhages have not stopped after the end of the 2nd pack, then before continuing to take birth control you should consult a doctor and rule out the presence of a developing fetus in the womb.

Overdose

Taking an excess amount of contraceptive is accompanied by the following symptoms:

  • nausea;
  • vomit;
  • vaginal bleeding in small quantities.

There is no specific pharmaceutical antidote for the drug, therefore symptomatic therapy of individual clinical manifestations intoxication.

Interaction

The contraceptive properties of a pharmaceutical drug are reduced when used with drugs such as , , , barbiturates, Primidon , , Phenylbutazone , Phenytoin , , Oxcarbazepine .

Therefore, if it is necessary to use these drugs together with Lindinet, it is necessary to use additional non-hormonal contraceptives for 7 days (it is recommended to visit an additional consultation with your doctor and clarify the period for certain). You may also experience spotting or breakthrough bleeding, menstrual irregularities, or some other side effects.

In conditions increased peristalsis or diarrhea the residence time of the contraceptive drug in the lumen of the gastrointestinal tract is reduced, which significantly reduces the absorption properties of the hormonal contraceptive. Any drug that shortens the stay of Lindinet in the digestive tube leads to a decrease in the concentration of active components in the blood, and accordingly to a decrease in their beneficial effect.

Drug interactions at the suction stage are modeled on the combined use of a contraceptive with, since biologically active substances are equally subject to sulfation in the intestinal wall, which inhibits metabolic chains and increases the bioavailability of ethinyl estradiol.

Terms of sale

The purchase of medicines is permitted only using a prescription form.

Storage conditions

The pharmaceutical product must be stored in a dry place, protected from direct sunlight, inaccessible to young children at a temperature not exceeding 25 degrees Celsius.

Best before date

special instructions

Pregnancy after using hormonal contraceptives

Oral hormonal contraceptives are a group of pharmaceuticals based on synthetic analogs of female sex hormones (estrogen and progesterone) that prevent the onset of ovulation, preventing the very possibility of fertilization. Of course, a large audience of women is convinced that using them for contraception is harmful, since a normal, physiological pregnancy will most likely not occur after drug changes in hormonal levels. However, this is one of the myths about this group medicines.

After stopping taking hormonal contraceptives and completing a course of conservative contraception, the effects of the drugs gradually disappear. The only peculiarity is that when planning pregnancy You should find out the exact timing of the optimal moment for fertilization in the antenatal clinic or from your personal gynecologist. After all, every time a woman takes a pill for a headache, she does not worry about the health of her unconceived child; in this case, the situation is almost identical.

When can you not use barrier methods of contraception?

Lindinet is a reliable hormonal contraceptive drug, which can be determined from a special indicator of the number of pregnancies that occurred during a course of oral contraception in 100 women for 1 year. For this pharmaceutical product, it is only 0.05, if you use the contraceptive correctly and only according to the application plan. However, the pharmacological effects of Lindinet do not fully develop immediately, but only by the 14th day from the start of taking the tablets, because in the first 2 weeks It is recommended to use barrier methods of contraception.

Lindinet 20 and Lindinet 30 - what's the difference?

A large number of visitors to pharmaceutical forums for women ask the following series of questions: “Lindynet 20 and 30 - what is the difference?”, as well as whether the drugs are interchangeable and, finally, which is better of the two forms of the contraceptive drug. The difference in forms of the same contraceptive lies in concentrations one of the active components is ethinyl estradiol. In oral tablets, the level can be 0.02 mg and 0.03 mg, respectively, which in biochemical terms does place them in different categories.

Lindinet 20 has a milder pharmacological effect and contributes to a lesser extent to increasing the selective SHBG transporter, which makes it possible to use it for contraception, however for therapeutic needs , as a rule, a stronger form of the drug is required, which is why Lindinet 30 is used. How the more concentrated form of the drug differs from weaker tablets is not advertised, since sometimes for individual indications it is necessary to use Lindinet 30 even as a contraceptive, which may be perceived by the woman as an unfair burden with a hormonal drug.

It is strictly contraindicated to replace pharmaceutical forms of a drug on your own, because a qualified specialist who prescribes contraceptives or therapeutic agents relies on the results of clinical studies, their interpretation and many years of experience in his field, and not on an approximate understanding of the biomechanism female body. If any side effects or other adverse effects occur, you should seek advice and resolve the issue on an individual basis.

Since Lindinet is produced in Hungary, its cost in pharmacy kiosks is much lower than that of the drug produced jointly by French and German pharmacists, but this in no way indicates the effectiveness of the former, therefore the choice of a contraceptive should be entrusted to a qualified specialist, because he based on individual performance hormonal balance and some other medical aspects.

Which is better: Novinet or Lindinet 20?

Novinet – monophasic oral contraceptive, which, in addition to ethinyl estradiol, contains a synthetic progestogen , which somewhat changes the mechanism of action of the contraceptive drug. Like all artificial pharmaceutical components of this nature, desogestrel has a high affinity for progesterone receptors located in the hypothalamic-pituitary region, on which its effects are based. In sufficiently small quantities, it is able to “turn on” the negative feedback mechanism, which results in a sharp inhibition of the release and production of gonadotropins and a complete blocking of ovulation.

Since Novinet includes such a potent pharmaceutical component as one of the active ingredients, its price is accordingly almost twice as high as that of Lindinet. However, with certain individual indications or contraindications, a woman does not have the opportunity to use a cheaper contraceptive, which makes it possible to include Novinet in a conservative course of contraception.

Alcohol and Lindinet

Biochemical studies have proven that small amounts of alcohol do not affect the effectiveness of oral contraception. Moderate dosages of alcoholic beverages are considered to be up to 3 glasses of wine or 50 grams of cognac, but no more, since an increase in the amount of alcohol in the blood increases the risk of possible pregnancy.

  • Active substance

    Ethinyl estradiol and Gestodene Ethinyl estradiol and Gestodene

  • ATX Anatomical-therapeutic-chemical classification - international system classification of medicines. Abbreviations used: Latin ATC (Anatomical Therapeutic Chemical) or Russian: ATX

    G03AB06 Gestodene + ethinyl estradiol G03AA10 Gestodene + ethinyl estradiol

  • Pharmacological group

    Contraceptive agent (estrogen + progestogen) [Estrogen, gestagen; their homologues and antagonists in combinations] Contraceptive [Estrogen, gestagens; their homologues and antagonists in combinations]

  • Nosological classification (ICD-10)

    Z30 Monitoring contraceptive use
    Z30.0 General advice and advice on contraception

  • Compound
  • Description of the dosage form

    Tablets: round, biconvex, light yellow film-coated, both sides unlabeled.

    Tablets: round, biconvex, yellow film-coated, both sides unlabeled.

    On the break: white or almost white, with a light yellow edging.

  • Characteristic
  • pharmachologic effect

    Contraceptive, estrogen-gestagenic.

  • Pharmacodynamics

    Combined remedy, the action of which is due to the effects of the components included in its composition. Inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is a highly effective oral drug - ethinyl estradiol (a synthetic analogue of estradiol, which participates together with the corpus luteum hormone in the regulation of the menstrual cycle). The gestagenic component is a derivative of 19-nortestosterone - gestodene, which is superior in strength and selectivity to not only the natural hormone of the corpus luteum progesterone, but also modern synthetic gestagens (levonorgestrel). Due to its high activity, gestodene is used in very low dosages, in which it does not exhibit androgenic properties and has virtually no effect on lipid and carbohydrate metabolism.

    A combined agent, the effect of which is determined by the effects of the components included in its composition. Inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is a highly effective oral drug - ethinyl estradiol (a synthetic analogue of estradiol, which participates together with the corpus luteum hormone in the regulation of the menstrual cycle). The gestagenic component is a derivative of 19-nortestosterone - gestodene, which is superior in strength and selectivity to not only the natural hormone of the corpus luteum progesterone, but also modern synthetic gestagens (levonorgestrel). Due to its high activity, gestodene is used in very low dosages, in which it does not exhibit androgenic properties and has virtually no effect on lipid and carbohydrate metabolism.

    Along with the indicated central and peripheral mechanisms that prevent the maturation of an egg capable of fertilization, the contraceptive effect is due to a decrease in the susceptibility of the endometrium to the blastocyst, as well as an increase in the viscosity of the mucus located in the cervix, which makes it relatively impenetrable for sperm. In addition to the contraceptive effect, the drug, when taken regularly, also has a therapeutic effect, normalizing the menstrual cycle and helping to prevent the development of a number of gynecological diseases, incl. tumor nature.

  • Pharmacokinetics

    Gestodene

    Distribution. It binds with albumin and sex hormone binding globulin (SHBG). 1–2% are in a free state, 50–75% are specifically bound to SHBG. The increase in SHBG levels caused by ethinyl estradiol affects the level of gestodene, leading to an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction. Vd of gestodene - 0.7–1.4 l/kg.

    Ethinyl estradiol

    Stable concentration. It is established by the 3rd–4th day, while the level of ethinyl estradiol is 20% higher than after taking a single dose. Gestodene

    Suction. When taken orally, it is quickly and completely absorbed. After taking one dose, Cmax in plasma is measured after an hour and is 2-4 ng/ml. Bioavailability is about 99%.

    Distribution. Binds to albumin and sex hormone binding globulin (SHBG). 1–2% are in a free state, 50–75% are specifically bound to SHBG. The increase in SHBG levels caused by ethinyl estradiol affects the level of gestodene, leading to an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction. Vd of gestodene - 0.7–1.4 l/kg.

    Metabolism. Corresponds to steroid metabolism. Average plasma clearance is 0.8–1 ml/min/kg.

    Excretion. The blood level decreases in two stages. The half-life in the final phase is 12–20 hours. It is excreted exclusively in the form of metabolites - 60% in urine, 40% in feces. T1/2 of metabolites - approximately 1 day.

    Stable concentration. The pharmacokinetics of gestodene largely depends on the level of SHBG. Under the influence of ethinyl estradiol, the concentration of SHBG in the blood increases 3 times; with daily use of the drug, the level of gestodene in plasma increases 3–4 times and in the second half of the cycle reaches a state of saturation.

    Ethinyl estradiol

    Suction. When taken orally, it is absorbed quickly and almost completely. Cmax in the blood is measured after 1–2 hours and is 30–80 pg/ml. Absolute bioavailability »60% (due to presystemic conjugation and primary metabolism in the liver).

    Distribution. Easily enters into a nonspecific relationship with blood albumin (about 98.5%) and causes an increase in SHBG levels. Average Vd - 5–18 l/kg.

    Metabolism. It is carried out mainly due to aromatic hydroxylation with the formation of large quantities of hydroxylated and methylated metabolites, partly in free, partly in conjugated form (glucuronides and sulfates). Plasma clearance »5–13 ml/min/kg.

    Excretion. Serum concentration decreases in 2 stages. T1/2 in the second phase is 16–24 hours. It is excreted exclusively in the form of metabolites in a ratio of 2:3 with urine and bile. T1/2 of metabolites » 1 day.

    Stable concentration. It is established by the 3rd–4th day, while the level of ethinyl estradiol is 20% higher than after taking a single dose.

  • Indications

    Contraception Contraception

  • Contraindications

    Dyslipidemia;

    Lactation.

    individual hypersensitivity to the drug or its components;

    The presence of severe or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the heart valve apparatus, atrial fibrillation, diseases of the cerebral vessels or coronary arteries);

    Uncontrolled moderate or severe hypertension with blood pressure 160/100 mm Hg. Art. and more);

    Precursors of thrombosis (including transient ischemic attack, angina), incl. in the anamnesis;

    Migraine with focal neurological symptoms, incl. in the anamnesis;

    Venous or arterial thrombosis/thromboembolism (including deep vein thrombosis of the leg, pulmonary embolism, myocardial infarction, stroke) currently or in history;

    Presence of venous thromboembolism in relatives;

    Major surgery with prolonged immobilization;

    Diabetes mellitus (with the presence of angiopathy);

    Pancreatitis (including a history), accompanied by severe hypertriglyceridemia;

    Dyslipidemia;

    Severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis, incl. history (before normalization of functional and laboratory parameters and within 3 months after these parameters return to normal);

    Jaundice due to taking drugs containing steroids;

    Current or history of gallstone disease;

    Gilbert, Dubin-Johnson, Rotor syndrome;

    Liver tumors (including history);

    Severe itching, otosclerosis or progression of otosclerosis during a previous pregnancy or while taking corticosteroids;

    Hormone-dependent malignant neoplasms of the genital organs and mammary glands (including suspicion of them);

    Vaginal bleeding of unknown etiology;

    Smoking over 35 years of age (more than 15 cigarettes per day);

    Pregnancy or suspicion of it;

    Lactation.

    With caution: conditions that increase the risk of developing venous or arterial thrombosis/thromboembolism (age over 35 years, smoking, hereditary predisposition to thrombosis - thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the immediate family); hemolytic uremic syndrome; hereditary angioedema; liver diseases; diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones (including porphyria, herpes of pregnant women, minor chorea - Sydenham's disease, Sydenham's chorea, chloasma); obesity (body mass index more than 30); dyslipoproteinemia; arterial hypertension; migraine; epilepsy; valvular heart defects; atrial fibrillation; long-term immobilization; extensive surgery; surgery on the lower extremities; severe injury; varicose veins and superficial thrombophlebitis; postpartum period (non-lactating women - 21 days after birth; nursing women - after completion of the lactation period); presence of severe depression, incl. in the anamnesis; changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant); diabetes mellitus not complicated by vascular disorders; systemic lupus erythematosus (SLE); Crohn's disease; ulcerative colitis; sickle cell anemia; hypertriglyceridemia (including family history); acute and chronic liver diseases.

  • Use during pregnancy and breastfeeding

    The use of the drug during pregnancy and breastfeeding is contraindicated.

  • Side effects

    Arterial hypertension;

    Porphyria;

    From the reproductive system: acyclic bleeding/bloody discharge from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes of the vagina (for example, candidiasis), changes in libido.

    Side effects that require immediate discontinuation of the drug:

    Arterial hypertension;

    Hemolytic-uremic syndrome;

    Porphyria;

    Hearing loss caused by otosclerosis.

    Rarely encountered - arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); exacerbation of reactive SLE.

    Very rare - arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins; Sydenham's chorea (passing after discontinuation of the drug).

    Other side effects, less severe, but more common - the advisability of continuing to use the drug is decided individually after consultation with a doctor, based on the benefit/risk ratio.

    From the reproductive system: acyclic bleeding/spotting from the vagina, amenorrhea after discontinuation of the drug, changes in the state of vaginal mucus, development of inflammatory processes in the vagina (for example, candidiasis), changes in libido.

    From the mammary glands: tension, pain, enlargement of the mammary glands, galactorrhea.

    From the gastrointestinal tract and hepatobiliary system: nausea, vomiting, diarrhea, epigastric pain, Crohn's disease, ulcerative colitis, hepatitis, liver adenoma, the occurrence or exacerbation of jaundice and/or itching associated with cholestasis, cholelithiasis.

    Skin: erythema nodosum/exudative, rash, chloasma, increased hair loss.

    From the central nervous system: headache, migraine, mood changes, depressive states.

    Metabolic disorders: fluid retention in the body, change (increase) in body weight, increased triglycerides and blood sugar, decreased tolerance to carbohydrates.

    From the senses: hearing loss, increased sensitivity of the cornea when wearing contact lenses.

    Other: allergic reactions.

  • Interaction

    The simultaneous use of St. John's wort (Hypericum perforatum) with Lindinet 20 tablets is not recommended (due to a possible decrease in the contraceptive effect of the active substances of the contraceptive, which may be accompanied by breakthrough bleeding and unwanted pregnancy). St. John's wort activates liver enzymes; after stopping the use of St. John's wort, the effect of enzyme induction may persist for the next 2 weeks.

    Concomitant use of ritonavir and a combined contraceptive was associated with a 41% decrease in the mean AUC of ethinyl estradiol. During treatment with ritonavir, it is recommended to use a drug with a higher ethinyl estradiol content or a non-hormonal method of contraception. It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraceptives may decrease carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents. The contraceptive effect of oral contraceptives is reduced with simultaneous use of rifampicin, breakthrough bleeding and menstrual irregularities become more frequent. Similar, but less studied, interactions exist between contraceptives and carbamazepine, primidone, barbiturates, phenylbutazone, phenytoin and presumably griseofulvin, ampicillin and tetracyclines. During treatment with the above drugs, simultaneously with oral contraception, it is recommended to use an additional method of contraception (condom, spermicidal gel). After completing the course of treatment, the use of an additional method of contraception should be continued for 7 days, in the case of treatment with rifampicin - for 4 weeks.

    Interactions associated with drug absorption

    During diarrhea, the absorption of hormones decreases (due to increased intestinal motility). Any drug that shortens the time a hormonal agent remains in the large intestine leads to low concentrations of the hormone in the blood.

    Interactions related to drug metabolism

    Intestinal wall. Drugs that undergo sulfation in the intestinal wall like ethinyl estradiol (for example, ascorbic acid) inhibit metabolism and increase the bioavailability of ethinyl estradiol.

    Metabolism in the liver. Inducers of microsomal liver enzymes reduce the level of ethinyl estradiol in the blood plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oxcarbazepine). Liver enzyme blockers (itraconazole, fluconazole) increase the level of ethinyl estradiol in the blood plasma.

    Effect on intrahepatic circulation. Some antibiotics (for example, ampicillin, tetracycline), by interfering with the intrahepatic circulation of estrogens, reduce the level of ethinyl estradiol in plasma.

    Effect on the metabolism of other drugs

    By blocking liver enzymes or accelerating conjugation in the liver, mainly increasing glucuronidation, ethinyl estradiol affects the metabolism of other drugs (for example, cyclosporine, theophylline), leading to an increase or decrease in their plasma concentrations.

    The simultaneous use of St. John's wort (Hypericum perforatum) with Lindinet 30 tablets is not recommended (due to a possible decrease in the contraceptive effect of the active substances of the contraceptive, which may be accompanied by breakthrough bleeding and unwanted pregnancy). St. John's wort activates liver enzymes; after stopping the use of St. John's wort, the effect of enzyme induction may persist for the next 2 weeks.

    Concomitant use of ritonavir and a combined contraceptive is associated with a 41% decrease in the mean AUC of ethinyl estradiol. During treatment with ritonavir, it is recommended to use a drug with a high content of ethinyl estradiol or a non-hormonal method of contraception. It may be necessary to adjust the dosage regimen when using hypoglycemic agents, because oral contraceptives may decrease carbohydrate tolerance and increase the need for insulin or oral antidiabetic agents.

  • Directions for use and doses

    First dose of the drug: taking Lindinet 20 should start from the 1st to the 5th day of the menstrual cycle.

    Transition from a combined oral contraceptive to taking Lindinet 20. Table 1. Lindinet 20 is recommended to be taken after taking the last hormone-containing tablet of the previous drug, on the 1st day of withdrawal bleeding.

    Transition from progestogen-containing drugs (mini-tablets, injections, implant) to taking Lindinet 20. The transition from mini-tablets can be started on any day of the menstrual cycle; in the case of an implant - the day after its removal; in case of injections - on the eve of the last injection.

    In this case, in the first 7 days of taking Lindinet 20, it is necessary to use an additional method of contraception.

    Taking Lindinet 20 after an abortion in the first trimester of pregnancy. You can start taking contraceptives immediately after an abortion, and there is no need to use an additional method of contraception.

    Taking Lindinet 20 after childbirth or after an abortion in the second trimester of pregnancy. You can start taking the contraceptive on days 21–28 after childbirth or abortion in the second trimester of pregnancy. If you start taking a contraceptive later, in the first 7 days, it is necessary to use an additional, barrier method of contraception. In the case where sexual intercourse took place before the start of contraception, before starting to take the drug, you should exclude the presence of a new pregnancy or wait until the next menstruation.

    In order to achieve an earlier onset of menstrual bleeding, you can shorten the 7-day break by the desired number of days. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking tablets from the next package (similar to cases with delayed menstruation). Orally, without chewing, with a sufficient amount of water, regardless of meals.

    Take 1 tablet. per day (at the same time of day if possible) for 21 days. Then, after taking a 7-day break from taking the tablets, resume oral contraception (i.e. 4 weeks after taking the 1st tablet, on the same day of the week). During the 7-day break, uterine bleeding occurs as a result of hormone withdrawal.

    First dose of the drug: Lindinet 30 should be taken from the 1st to the 5th day of the menstrual cycle.

    Transition from a combined oral contraceptive to taking Lindinet 30. Table 1. Lindinet 30 is recommended to be taken after taking the last hormone-containing tablet of the previous drug, on the 1st day of withdrawal bleeding.

    Transition from progestogen-containing drugs (mini-tablets, injections, implant) to taking Lindinet 30. The transition from mini-tablets can be started on any day of the menstrual cycle; in the case of an implant - the day after its removal; in case of injections - on the eve of the last injection.

    In this case, in the first 7 days of taking Lindinet 30, it is necessary to use an additional method of contraception.

    Taking Lindinet 30 after an abortion in the first trimester of pregnancy. You can start taking contraceptives immediately after an abortion, and there is no need to use an additional method of contraception.

    Taking Lindinet 30 after childbirth or after an abortion in the second trimester of pregnancy. You can start taking the contraceptive on days 21–28 after childbirth or abortion in the second trimester of pregnancy. If you start taking a contraceptive later, in the first 7 days, it is necessary to use an additional, barrier method of contraception. In the case where sexual intercourse took place before the start of contraception, before starting to take the drug, you should exclude the presence of a new pregnancy or wait until the next menstruation.

    Missed pills. If the next scheduled dose of the tablet was missed, then you should make up for the missed dose as soon as possible. If the delay does not exceed 12 hours, the contraceptive effect of the drug is not reduced, and there is no need to use an additional method of contraception. The remaining tablets are taken as usual.

    If there is a delay of more than 12 hours, the contraceptive effect may be reduced. In such cases, you should not make up for the missed dose, continue taking the drug as usual, but in the next 7 days you must use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, then take the tablets from the next package without taking a break. In such cases, uterine withdrawal bleeding occurs only after the completion of the 2nd pack; While taking tablets from the 2nd package, spotting or breakthrough bleeding is possible.

    If, upon completion of taking the tablets from the 2nd package, withdrawal bleeding does not occur, then pregnancy should be excluded before continuing to take the contraceptive.

    Measures to be taken in case of vomiting and diarrhea. If vomiting occurs in the first 3-4 hours after taking another tablet, the tablet is not completely absorbed. In such cases, you should act in accordance with the instructions described in the section Missed tablets.

    If the patient does not want to deviate from her usual contraceptive regimen, the missed pills should be taken from another package.

    Delay of menstruation and acceleration of the onset of menstruation. In order to delay menstruation, take pills from a new package without taking a break. Menstruation can be delayed at will until all the tablets from the 2nd package are gone. If menstruation is delayed, breakthrough or spotting uterine bleeding is possible. You can return to your usual pill intake after a 7-day break.

    In order to achieve an earlier onset of menstrual bleeding, you can shorten the 7-day break by the desired number of days. The shorter the break, the more likely it is that breakthrough or spotting bleeding will occur while taking tablets from the next package (similar to cases with delayed menstruation).

  • Overdose

    Taking large doses of the contraceptive was not accompanied by the development of severe symptoms.

    Symptoms: nausea, vomiting, in young girls, slight vaginal bleeding.

    Treatment: symptomatic, there is no specific antidote.

  • special instructions

    Epilepsy;

    Migraine;

    With age;

    For dislipoproteinemia;

    Sudden shortness of breath;

    Tumor diseases

    The effect of the drug on the ability to drive a car and operate machinery. Research studies possible influence The drug Lindinet 20 has not been tested on the ability to drive a car or other machines. Before starting to use the drug, it is recommended to collect a detailed family and personal history and subsequently undergo a general medical and gynecological examination every 6 months (examination by a gynecologist, examination of a cytological smear, examination of the mammary glands and liver function, monitoring of blood pressure, cholesterol concentrations in the blood, urine analysis). These studies must be repeated periodically due to the need for timely identification of risk factors or contraindications that have arisen.

    The drug is a reliable contraceptive drug - the Pearl index (an indicator of the number of pregnancies occurring during the use of a contraceptive method in 100 women over 1 year) when used correctly is about 0.05. Due to the fact that the contraceptive effect of the drug from the start of administration is fully manifested by the 14th day, it is recommended to additionally use non-hormonal methods of contraception in the first 2 weeks of taking the drug.

    In each case, before prescribing hormonal contraceptives, the benefits or possible negative effects of their use are individually assessed. This issue must be discussed with the patient, who, after receiving the necessary information, will make the final decision on the preference for hormonal or any other method of contraception. The woman's health condition must be carefully monitored.

    If any of the following conditions/diseases appear or worsen while taking the drug, you must stop taking the drug and switch to another, non-hormonal method of contraception:

    Diseases of the hemostatic system;

    Conditions/diseases predisposing to the development of cardiovascular and renal failure;

    Epilepsy;

    Migraine;

    The risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;

    Diabetes mellitus not complicated by vascular disorders;

    Severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used for correction);

    Sickle cell anemia, because in some cases (for example, infections, hypoxia), estrogen-containing drugs for this pathology can provoke thromboembolism;

    The appearance of abnormalities in laboratory tests assessing liver function.

    Thromboembolic diseases

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

    The risk of arterial or venous thromboembolic disease increases:

    With age;

    When smoking (heavy smoking and age over 35 years are risk factors);

    If you have a family history of thromboembolic diseases (for example, parents, brother or sister). If you suspect a genetic predisposition, you should consult a specialist before using the drug;

    For obesity (body mass index above 30);

    For dislipoproteinemia;

    For arterial hypertension;

    For diseases of the heart valves complicated by hemodynamic disorders;

    With atrial fibrillation;

    For diabetes mellitus complicated by vascular lesions;

    With prolonged immobilization, after major surgery, surgery on the lower extremities, severe trauma.

    In these cases, temporary cessation of use of the drug is assumed. It is advisable to stop no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization.

    The risk of venous thromboembolic diseases increases in women after childbirth.

    Diseases such as diabetes mellitus, SLE, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, and sickle cell anemia increase the risk of developing venous thromboembolic diseases.

    Biochemical abnormalities such as resistance to activated protein C, hyperhomocysteinemia, protein C and S deficiency, antithrombin III deficiency, and the presence of antiphospholipid antibodies increase the risk of arterial or venous thromboembolic diseases.

    When assessing the benefit/risk ratio of taking the drug, it must be borne in mind that targeted treatment of this condition reduces the risk of thromboembolism.

    Signs of thromboembolism are:

    Sudden chest pain that radiates to the left arm;

    Sudden shortness of breath;

    Any unusually severe headache that continues for a long time or appears for the first time, especially when combined with sudden complete or partial loss of vision or diplopia, aphasia, dizziness, collapse, focal epilepsy, weakness or severe numbness of half the body, movement disorders, severe unilateral pain in the calf muscle, acute abdomen.

    Tumor diseases

    Some studies have reported an increased incidence of cervical cancer in women who took hormonal contraceptives for a long time, but the results of the studies are inconsistent. Sexual behavior, infection with the human papillomavirus and other factors play a significant role in the development of cervical cancer.

    A meta-analysis of 54 epidemiological studies found that there was a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection rate of breast cancer may have been associated with more regular medical screening. Breast cancer is rare among women under 40, whether they are taking hormonal birth control or not, and increases with age. Taking pills can be considered one of many risk factors. However, women should be made aware of the possible risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian, endometrial and colon cancer).

    There are few reports of the development of benign or malignant liver tumors in women taking hormonal contraceptives for a long time. This should be kept in mind when diagnosing abdominal pain, which may be associated with an increase in liver size or intra-abdominal bleeding.

    The woman should be warned that the drug does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

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

    If the patient is simultaneously taking another drug that may reduce the effectiveness of birth control pills, additional methods of contraception should be used.

    The effectiveness of the drug may decrease if, after several months of their use, irregular, spotting or breakthrough bleeding appears, in such cases it is advisable to continue taking the tablets until they run out in the next package. If at the end of the 2nd cycle menstrual-like bleeding does not begin or acyclic bleeding does not stop, you should stop taking the pills and resume it only after pregnancy has been ruled out.

    Chloasma can occasionally occur in women who have a history of it during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or UV rays while taking the pills.

    Changes in laboratory parameters

    Under the influence of oral contraceptive pills - due to the estrogen component - the level of some laboratory parameters (functional indicators of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

    After acute viral hepatitis, it should be taken after normalization of liver function (no earlier than 6 months). In case of diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease (without stopping the drug, it is necessary to use additional non-hormonal methods of contraception). Women who smoke have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk depends on age (especially in women over 35 years of age) and the number of cigarettes smoked. During lactation, milk secretion may decrease; in small quantities, the components of the drug are excreted in breast milk.

    The effect of the drug on the ability to drive a car and operate machinery. Studies have not been conducted to study the possible effect of Lindinet 30 on the ability to drive a car or other machines.

  • Release form