Tablets dtd 20 instructions for use. Birth control pills Lindinet. Memo for girls


The drug "Lindinet 20" is used for contraception. It is also prescribed for functional defects of the menstrual cycle. Feedback on Lindinet 20 from satisfied consumers will be presented in this article.

The drug is taken orally, regardless of food intake, always at the same time. The first tablet is taken from the first to the fifth day of menstruation. The use of this remedy involves the use of one tablet per day for 21 days, after which a week-long break is taken, that is, menstruation actually begins. Reviews of Lindinet 20 confirm that this is how most contraceptives work.

Tablets from another blister are taken on the first day after a seven-day break at the same time as in the previous cycle. To switch from another combination, you need to take the first tablet of the drug the next day after the previous package is finished, at the beginning of the menstrual cycle. What are the reviews about Lindinet 20 for women over 30?

They write in their comments that while using the mini-pill, you can start switching to Lindinet 20 on any day of your cycle. If an implant was used before, then the next day after it is removed. If injections were used, then before the next injection. To switch from single drugs, you need to accompany this stage with the use of barrier contraceptive methods as an adjunct during the first week. If an abortion was performed in the first trimester of pregnancy, then it is recommended to take pills immediately after the operation, without using additional methods of protection.

After the abortion

After an abortion in the second trimester or after childbirth, the use of the drug should be started after 21-28 days, also without using additional methods of contraception. If a woman had an intimate relationship before the start of protection, then the drug should be taken after pregnancy is excluded or with the onset of menstruation.

Reviews of Lindinet 20 birth control pills confirm this.

If the next dose was missed at the set time, then if the delay is less than twelve hours, the pill should be taken immediately, as soon as the missed pass was remembered (the contraceptive effect of the drug has not yet been broken), the next pills should be taken at the usual time. If you are late for more than twelve hours, you do not need to take the missed pill, but continue using the drug in accordance with the scheme and using additional contraceptive methods over the next week.

If the reception is missed less than seven days before the end of the pack, then you need to start using the drug from the next blister without a break. In this case, menstruation begins after the second blister is completed, oral contraception should be continued only after pregnancy has been ruled out.

Reviews of women about "Lindinet 20" indicate that taking pills is skipped quite often, but with the right further actions, unwanted pregnancy did not occur in anyone.

When is an additional tablet required?

If the patient develops diarrhea and / or vomiting within 3-4 hours after taking the pill, which disrupted the absorption process and reduced the clinical effect of the drug, then in this case there are two ways of further treatment. So, one of them is based on the fact that the next pill is taken at the set time according to the scheme, after which measures are taken that comply with the recommendations that are associated with skipping the drug. Another way is for a woman to take the same pill from another blister, while not deviating from her usual contraceptive regimen. If acceleration of the onset of menstruation is required, it is recommended to reduce the break in the use of Lindinet 20, according to doctors.

It should be borne in mind that the shorter the break, the higher the risk of breakthrough or spotting bleeding while taking pills from another blister (similar to situations with a delay in menstruation). If you want to delay menstruation at a later time, then you need to continue taking the pills from a new pack without a week break. The onset of menstruation can be delayed for the desired period, even until the end of the drug from the second package. During a planned delay in bleeding, spotting or bloody breakthrough discharge may occur. After a week break, you must continue to use Lindinet 20 regularly. There are reviews on this.

Contraindications

As contraindications are:

  • severe and / or multiple signs of the risk of thrombosis of the veins or arteries (including atrial fibrillation, which is complicated by disorders of the heart valve apparatus, severe or moderate arterial hypertension (blood pressure of 160/100 mm and above), diseases of the coronary vessels or arteries of the head brain);
  • ischemic transient attack, angina pectoris and other precursors of thrombosis;
  • venous thromboembolism;
  • long immobilization after the intervention of the surgeon;
  • migraine with neurological symptoms of focal type;
  • thromboembolism of the veins or arteries or thrombosis (deep vein thrombosis of the lower leg, pulmonary artery embolism, myocardial infarction, stroke);
  • liver tumors;
  • jaundice when using glucocorticoids;
  • pancreatitis;
  • hyperlipidemia;
  • liver pathology of a pronounced nature, cholestatic jaundice (the period of bearing a child is also considered), hepatitis (including history) - until the period when functional and laboratory parameters are not restored, after their normalization for three months;
  • cholelithiasis;
  • syndromes of Gilbert, Dabin-Johnson, Rotor;
  • severe itching;
  • diabetes mellitus, which is complicated by angiopathy;
  • vaginal bleeding of unknown origin;
  • otosclerosis with further progression during a previous pregnancy or with the use of corticosteroids;
  • malignant hormone-dependent neoplasms of the mammary glands and various organs of the reproductive system, or suspicion of them;
  • breastfeeding time;
  • smoking by people over the age of 35 (more than fifteen cigarettes per day);
  • hypersensitivity to the constituent components of the drug;
  • pregnancy or its assumption.

Carefully

Reviews of women about "Lindinet 20" confirm that you need to be extremely careful when using the drug for patients with risk factors that increase the likelihood of thrombosis of the veins or arteries, as well as thromboembolism. Risk factors:

  • genetic predisposition of the patient to thrombosis (thrombosis, circulatory defects of the brain and myocardial infarction in the youth of the next of kin);
  • age over 35 years;
  • smoking;
  • liver pathology;
  • angioedema hereditary edema;
  • herpes of pregnant women;
  • chloasma;
  • chorea of ​​Sydenham;
  • porphyria;
  • chorea and other diseases that appear or worsen during the previous use of sex hormones or during childbearing;
  • obesity with a weight index over 30 kg per m 2;
  • arterial hypertension;
  • hemolytic-uremic syndrome;
  • valve defects, dyslipoproteinemia, atrial fibrillation;
  • epilepsy, prolonged immobilization, migraine, severe trauma;
  • surgical intervention in the lower extremities, major surgery, superficial thrombophlebitis, sickle cell anemia, Crohn's disease, postpartum period, varicose veins, diabetes mellitus (not complicated by vascular disorders), ulcerative colitis, acute and chronic liver pathologies, systemic lupus erythematosus , abnormalities in biochemical tests, deficiency of antithrombin III and protein C or S, including antibodies to cardiolipin, severe depression, hyperhomocysteinemia, lupus anticoagulant, antiphospholipid antibodies, activated protein C resistance, hypertriglyceridermia.

Side effects

According to reviews, "Lindinet 20" can cause the following side effects:

  • sense organs: hearing loss due to otosclerosis;
  • system of vessels and heart: arterial hypertension;
  • in more rare cases - myocardial infarction, stroke, thromboembolism of the lung artery, deep vein thrombosis of the legs and other arterial and venous thromboembolism;
  • in very rare cases - thromboembolism of the hepatic, mesenteric, retinal, hepatic veins and arteries.

But most often the use of "Lindinet 20", according to reviews, does not provoke negative reactions of the body.

In addition, the tool can cause other side effects. Not as severe, but more common:

  • genital organs: vaginal acyclic bleeding and discharge, candidiasis, deformation of the state of the vaginal mucosa, after termination - amenorrhea, the development of vaginal inflammation processes, an increase in the size of the mammary glands, their pain and tension, galactorrhea;
  • from the nervous system: unstable mood, headache, depression, migraine;
  • metabolism: weight gain, hyperglycemia, fluid retention in the body, a decrease in carbohydrate tolerance, an increase in the degree of thyroglobulin concentration;
  • digestive system: epigastric pain, nausea, ulcerative colitis, vomiting, Crohn's disease, cholelithiasis, hepatitis, hepatic adenoma, itching or exacerbation due to cholestasis, jaundice;
  • dermatological reactions: erythema nodosum, rash, severe hair loss, chloasma, exudative erythema;
  • sensory organs: increased corneal sensitivity in patients with contact lenses, hearing loss;
  • others: the development of allergic reactions.

This information is available in the instructions and reviews for Lindinet 20. The decision on the possibility of further use of the drug should be made only after consulting with a specialist on an individual basis, analyzing the risks and benefits of this contraceptive method.

special instructions

"Lindinet 20" is required to be used after a medical consultation and a gynecological and general medical examination.

It is recommended to be examined every six months. Taking into account the clinical condition of the patient and risk factors for the occurrence of side effects, the disadvantages and advantages of oral protection are determined, and the question of the appropriateness of its use is decided.

Reviews of Lindinet 20 tablets are contradictory.

The specialist should inform the woman about the possible worsening of her existing diseases, the undesirable effects of the drug and the mandatory visit to the doctor if her health changes for the worse. Hormonal contraception is also canceled if any of the following conditions or diseases worsen or occur: epilepsy, pathology. They can cause the development of renal and cardiovascular insufficiency, diseases of the hemostasis system, migraine, the likelihood of developing gynecological estrogen-dependent diseases, diabetes mellitus without vascular defects, severe depression, deviations in the results of laboratory tests of the functional state of the liver, sickle cell anemia.

The drug is characterized by a good contraceptive effect two weeks after the start of administration, and therefore, to exclude pregnancy during this time, it is recommended to use additional contraceptive barrier methods. This is confirmed by the instructions and reviews for Lindinet 20.

Against the background of taking hormonal oral contraceptives, the likelihood of arterial and venous thromboembolic diseases increases. It is necessary to take into account the possible (but very rare) occurrence of venous or arterial thromboembolism of the mesenteric, renal, hepatic or retinal vessels.

Risk factors

Factors that increase the risk of developing venous or arterial thromboembolic pathologies are: hereditary predisposition, obesity, excessive smoking, the patient has arterial hypertension, dyslipoproteinemia, heart valve pathologies with hemodynamic defects, diabetes mellitus with vascular lesions, atrial fibrillation. Reviews of women about "Lindinet 20" for 20 years will be considered at the end of the article.

The risk also increases with the age of the patient, with prolonged immobilization due to extensive surgical intervention, including operations on the lower extremities, or after a serious injury. During elective operations, the drug is advised to cancel the drug four weeks before the event, and resume taking it fourteen days after remobilization. According to reviews and instructions for use, Lindinet 20 requires constant medical supervision for diagnosed Crohn's disease, systemic lupus erythematosus, diabetes mellitus, hemolytic uremic syndrome, ulcerative colitis of a nonspecific nature, sickle cell anemia, and also in the postpartum period. The likelihood of developing thromboembolic pathologies of veins or arteries increases resistance to protein activated C, lack of antithrombin III, proteins S and C, as well as the presence of antiphospholipid antibodies. Reception of the drug is regarded as one of the many factors that affect the development of cervical or breast cancer.

So with caution should be taken "Lindinet 20". Reviews about contraceptives on the network are plentiful, they will help you make the right decision.

An increase in the number of registration of such diseases in patients who take hormonal contraceptives may be due to irregular medical supervision and appropriate examinations. With prolonged hormonal oral protection, it is necessary to take into account the possible appearance of a liver tumor of a malignant or benign nature in the differential diagnostic study of abdominal pain associated with bleeding inside the peritoneum or an increase in liver volume.

This is confirmed by reviews of Lindinet 20. Women after 35 years of age who have a predisposition to chloasma, it is desirable to be less under the direct rays of the sun or ultraviolet radiation.

The tool reduces its contraceptive effect in the case when the next dose was missed, with diarrhea and vomiting, while the use of drugs that may affect its effectiveness. In order to avoid conception, the patient must use additional protective barriers in accordance with the recommendations. If irregular breakthrough or spotting bleeding occurs, and there is no menstruation during a week break, then this may indicate pregnancy. That is why, before using the tablets from the new blister, it is necessary to discuss all the nuances with the doctor, and start treatment again only after the pregnancy is excluded. The presence of an estrogen component in the preparation can affect the result of laboratory tests of the degree of lipoproteins and transport proteins, functional data of the kidneys, thyroid gland, liver, hemostasis, adrenal glands. This is confirmed by the instructions and reviews of doctors about "Lindinet 20".

You can use the drug after acute viral hepatitis no earlier than six months later, if the functioning of the liver has been normalized. Patients who smoke are more likely to develop vascular diseases, especially after the age of 35 (the level of risk is also determined by age parameters and the number of cigarettes smoked during the day). Means "Lindinet 20" is not able to protect against infection with various sexual infections, including HIV infection. The impact of the drug on the woman's ability to drive mechanisms and vehicles has not been identified.

Interaction with other drugs

Inducers of hepatic microsomal enzymes (barbiturates, Oxcarbazepine, Rifampicin, Hydantoin, Felbamate, Phenylbutazone, Rifabutin, Griseofulvin, Topiramate, Phenytoin), antibiotics (Tetracycline, "Ampicillin") help to reduce the degree of ethinyl estradiol in the blood plasma.

Hepatic enzyme inhibitors increase the level of ethinylestradiol in the blood plasma.

Drugs that increase gastrointestinal motility, reduce the absorption of active active ingredients and their concentration in the blood plasma when used with Lindinet 20.

Ascorbic acid and other agents that are susceptible to sulfation in the intestinal wall slow down the sulfation of ethinyl estradiol and increase its bioavailability. The simultaneous use of Tetracycline, Ritonavir, Rifampicin, Ampicillin, barbiturates, Primidone, Carbamazepine, Topiramate, Phenylbutazone, Phenytoin, Griseofulvin also leads to a decrease in the contraceptive effect of the drug , "Felbamata", "Oxcarbazepine".

That is why during the reception and for a week (with simultaneous use with "Rifampicin" - four weeks) after treatment with the listed drugs, the patient needs to use indirect barrier contraceptive methods.

It is undesirable to simultaneously prescribe drugs with St. John's wort, as the likelihood of breakthrough bleeding increases. Patients with a diagnosis such as diabetes mellitus may need to adjust the dosage of hypoglycemic drugs.

Lindinet 20 is a drug that is part of the group of monophasic contraceptives, indicated for use to prevent unwanted pregnancies.

What is the composition and form of the drug Lindinet 20?

Active components of Lindinet 20: gestodene - 75 micrograms and ethinylestradiol 20 micrograms. Pharmaceutical excipients: quinoline dye, calcium carbonate, talc, titanium dioxide, colloidal silicon dioxide, macrogol 6000, magnesium stearate, sodium calcium edetate, corn starch, lactose monohydrate, sucrose, povidone.

The drug Lindinet 20 is available in the form of white film-coated tablets. Supplied in packs of 21. Sold upon presentation of a prescription from a doctor.

What is the effect of Lindinet 20?

Monophasic contraceptive that inhibits the endocrine activity of the pituitary gland. The action is associated with several important mechanisms. The estrogen component is represented by ethinyl estradiol, the progestogen component is gestodene.

First of all, the drug inhibits the processes of egg maturation. Secondly, it changes the susceptibility of the endometrium to the blastocyst, which is a factor preventing the introduction of the embryo into the uterus. In addition, the contraceptive changes the properties of cervical mucus, complicating the penetration of spermatozoa into the uterine cavity.

In addition to the contraceptive effect, Lindinet 20 is able to improve the functional state of the endocrine glands, normalize the menstrual cycle, and help prevent the development of gynecological diseases, including cancer.

The oral contraceptive Lindinet 20, due to the low concentration of gestagens, has practically no effect on other parts of the endocrine system. Long-term use of the drug does not lead to the development of obesity, does not modify carbohydrate metabolism.

When taken orally, it is actively absorbed from the intestine. The therapeutic concentration of active ingredients in the blood is formed after an hour. The bioavailability coefficient is high, not less than 99 percent.

Gestodene and ethinyl estradiol are excreted in the urine and, to a lesser extent, in the stool. The half-life ranges from 16 to 24 hours. Biological transformation reactions take place in the liver, with the formation of several inactive components.

What are the indications for Lindinet 20?

Taking the drug Lindinet 20 is indicated for only one purpose - the prevention of unwanted pregnancies.

I remind you of the inadmissibility of unauthorized prescription of a contraceptive drug. Only after a comprehensive examination and exclusion of possible pathology, you can start taking this pharmaceutical.

What are the contraindications for Lindinet 20?

Taking the contraceptive Lindinet 20 instructions for use prohibits in the following cases:

Diseases of the vessels of the brain;

Atrial fibrillation;

Pregnancy and lactation;

Pathology of the coronary arteries;

Severe arterial hypertension;

Migraine with neurological symptoms;

History of venous thromboembolism;

Smoking over the age of 35;

Diabetes;

pancreatitis;

Blood lipid disorders;

Tumors of the liver;

Hormone-dependent tumors of the genital organs;

Individual intolerance.

Relative contraindications: liver disease, arterial hypertension, obesity, severe depression, ulcerative colitis, prolonged immobilization, in addition, the use of drugs containing sex hormones.

What are the uses and dosage of Lindinet 20 tablets?

Lindinet 20 should be taken from days 1 to 5 of the cycle, strictly 1 tablet every day, for 21 days. For maximum effectiveness, it is recommended to use the medicine at the same time of day. After taking the last pill, you need to take a 7-day break.

In case of accidental skipping, you need to continue taking the drug according to the standard scheme. If a significant interruption occurs, the contraceptive ability of the agent may decrease.

drug overdose

Symptoms: vomiting, bloody or mucous discharge from the vagina. Treatment: No specific antidote is known. Therapy is symptomatic.

What are the side effects of Lindinet 20?

From the organs of the reproductive system: vaginal discharge, acyclic bleeding, galactorrhea, breast enlargement, candidiasis, pain in the lower abdomen, inflammatory diseases of gynecological organs.

Other side effects: depression, headache, mood lability, decreased hearing and vision, allergic manifestations, hepatitis, dyspepsia, connective tissue diseases, coronary heart disease, myocardial infarction, deep vein thrombosis, hair loss, weight gain.

special instructions

The maximum contraceptive effect of the drug develops by the 14th day of taking the drug. Therefore, the first two weeks you need to use other non-hormonal contraceptive methods. And we are on www.!

How to replace Lindinet 20, what analogs to use?

Mirelle, Gestarella, Gestoden + Ethinylestradiol, Femoden, Logest, Lindinet 30, and Artisia.

Conclusion

The use of hormonal contraceptives is an effective means of preventing unwanted pregnancies. The Pearl Index of the drug is only 0.05. In addition, taking medication can have a positive effect on the functional state of the organs of the reproductive and endocrine systems, but only if there is control from the gynecologist.

The patient should independently study the instructions for the use of the prescribed drug. Be healthy!

In this article, you can read the instructions for using the drug Lindinet 20 and 30. Reviews of site visitors - consumers of this medicine, as well as opinions of specialist doctors on the use of Lindinet in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Lindinet analogs in the presence of existing structural analogs. Use of hormonal birth control for contraception in women, including during pregnancy and breastfeeding. Side effects (bleeding, pain).

Lindinet- monophasic oral contraceptive. It inhibits the secretion of gonadotropic hormones from the pituitary gland. The contraceptive effect of the drug is associated with several mechanisms. The estrogenic component of the drug is ethinylestradiol, a synthetic analogue of the follicular hormone estradiol, which, together with the corpus luteum hormone, participates in the regulation of the menstrual cycle. The progestogen component is gestodene, a derivative of 19-nortestosterone, which is superior in strength and selectivity of action not only to the natural hormone of the corpus luteum progesterone, but also to other synthetic progestogens (for example, levonorgestrel). Due to its high activity, gestodene is used in low dosages, in which it does not exhibit androgenic properties and has practically 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 in the cervix, which makes it relatively impassable for spermatozoa. 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.

The difference between Lindinet 20 and Lindinet 30

The main difference between both drugs lies in the different amounts of ethinylestradiol included in the component in one type of drug it contains 30 mcg, in the other 20 mcg. Hence the various names of similar nevertheless preparations. Also in the composition of both preparations there is gestodene in the amount of 75 mcg.

Pharmacokinetics

Gestodene

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. Bioavailability - about 99%. Gestodene is biotransformed in the liver. It is excreted only in the form of metabolites, 60% - with urine, 40% - with feces.

Ethinylestradiol

After oral administration, ethinylestradiol is absorbed rapidly and almost completely. Ethinylestradiol is excreted only in the form of metabolites, in a ratio of 2:3 with urine and bile.

Indications

  • contraception.

Release form

Coated tablets.

Instructions for use and regimen

Assign 1 tablet per day for 21 days, if possible at the same time of day. After taking the last tablet from the package, a 7-day break is taken, 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 should be taken from the 1st to the 5th day of the menstrual cycle.

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

When switching to taking Lindinet from drugs containing only progestogen ("mini-pili", injections, implant), when taking "mini-drink", you can start taking Lindinet on any day of the cycle, you can switch from using an implant to taking Lindinet on the next day after the removal of the implant, when using injections - on the eve of the last injection. In these cases, additional methods of contraception should be used in the first 7 days.

After an abortion in the 1st trimester of pregnancy, you can start taking Lindinet immediately after surgery. In this case, there is no need to use additional methods of contraception.

After childbirth or after an abortion in the 2nd trimester of pregnancy, the drug can be taken on the 21-28th day. In these cases, additional methods of contraception must be used in the first 7 days. With a later start of taking the drug in the first 7 days, an additional, barrier method of contraception should be used. In the case when sexual contact took place before the start of contraception, before starting the drug, pregnancy should be excluded or the start of the drug should be postponed until the first menstruation.

If you miss a pill, you should take the missed pill as soon as possible. If the interval in taking the tablets was less than 12 hours, then the contraceptive effect of the drug does not decrease, 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 was more than 12 hours, then the contraceptive effect of the drug may decrease. 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 need to use an additional method of contraception. If at the same time there are less than 7 tablets left in the package, the drug from the next package should be started without interruption. In this case, withdrawal bleeding does not occur until the completion of the second pack, but spotting or breakthrough bleeding may occur.

If withdrawal bleeding does not occur after the end of taking 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 decrease. In such cases, you should proceed in accordance with the instructions for skipping pills. If the patient does not want to deviate from the usual contraceptive regimen, the missed pills should be taken from another package.

To accelerate the onset of menstruation, you should reduce the break in taking the drug. The shorter the break, the more likely the occurrence of breakthrough or spotting bleeding while taking the pills from the next pack (similar to cases with delayed menstruation).

To delay the onset of menstruation, the drug should be continued from a new package without a 7-day break. Menstruation can be delayed as long as necessary until the end of the last pill from the second package. With a delay in menstruation, breakthrough or spotting bleeding may occur. Regular use of the drug Lindinet can be restored after the usual 7-day break.

Side effect

Side effects requiring discontinuation of the drug:

  • arterial hypertension;
  • arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism);
  • arterial or venous thromboembolism of the hepatic, mesenteric, renal, retinal arteries and veins;
  • hearing loss due to otosclerosis;
  • hemolytic-uremic syndrome;
  • porphyria;
  • exacerbation of reactive systemic lupus erythematosus;
  • Sydenham's chorea (passing after discontinuation of the drug).

Other side effects (less severe):

  • acyclic bleeding / bloody discharge from the vagina;
  • amenorrhea after discontinuation of the drug;
  • change in the state of vaginal mucus;
  • development of inflammatory processes of the vagina;
  • candidiasis;
  • tension, pain, breast enlargement;
  • galactorrhea;
  • pain in the epigastrium;
  • nausea, vomiting;
  • Crohn's disease;
  • ulcerative colitis;
  • the occurrence or exacerbation of jaundice and / or itching associated with cholestasis;
  • liver adenoma;
  • erythema nodosum;
  • exudative erythema;
  • rash;
  • chloasma;
  • increased hair loss;
  • headache;
  • migraine;
  • mood lability;
  • depression;
  • hearing loss;
  • increased sensitivity of the cornea (when wearing contact lenses);
  • fluid retention in the body;
  • change (increase) in body weight;
  • decreased tolerance to carbohydrates;
  • hyperglycemia;
  • allergic reactions.

Contraindications

  • the presence of severe and / or multiple risk factors for venous or arterial thrombosis (including complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries, severe or moderate arterial hypertension with blood pressure ≥ 160/100 mm Hg .st.);
  • the presence or indication in the anamnesis of the precursors of thrombosis (including transient ischemic attack, angina pectoris);
  • migraine with focal neurological symptoms, incl. in history;
  • venous or arterial thrombosis / thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower leg, pulmonary embolism) at present or in history;
  • the presence of venous thromboembolism in history;
  • surgery with prolonged immobilization;
  • diabetes mellitus (with angiopathy);
  • pancreatitis (including history), accompanied by severe hypertriglyceridemia;
  • dyslipidemia;
  • severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. in history (before the normalization of functional and laboratory parameters and within 3 months after their normalization);
  • jaundice when taking GCS;
  • cholelithiasis at present or in history;
  • Gilbert's syndrome, Dubin-Johnson syndrome, Rotor's syndrome;
  • liver tumors (including history);
  • severe itching, otosclerosis or its progression during a previous pregnancy or taking corticosteroids;
  • hormone-dependent malignant neoplasms of the genital organs 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.

Use during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

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

When used during lactation, milk production may decrease.

special instructions

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

The drug is a reliable contraceptive: the Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women for 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, in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal methods of contraception.

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 state of health of women 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 hemostasis system;
  • conditions/diseases predisposing to the development of cardiovascular, renal failure;
  • epilepsy;
  • migraine;
  • the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
  • diabetes mellitus, not complicated by vascular disorders;
  • severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used to correct it);
  • sickle cell anemia, tk. in some cases (for example, infections, hypoxia), estrogen-containing drugs in this pathology can provoke thromboembolism;
  • the appearance of abnormalities in laboratory tests for assessing 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 disease has been proven, but it is significantly less than during pregnancy (60 cases per 100,000 pregnancies). When using oral contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.

The risk of developing arterial or venous thromboembolic diseases increases:

  • with age;
  • when smoking (heavy smoking and age over 35 are risk factors);
  • if there is a family history of thromboembolic diseases (for example, in parents, a brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug;
  • with obesity (body mass index over 30 kg/m2);
  • with dyslipoproteinemia;
  • with arterial hypertension;
  • in 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 a severe injury.

In these cases, a temporary discontinuation of the drug is expected (no later than 4 weeks before surgery, and resumed no earlier than 2 weeks after remobilization).

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

It should be borne in mind 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 borne in mind that resistance to activated protein C, hyperhomocysteinemia, deficiency of proteins C and S, deficiency of antithrombin 3, 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. The symptoms of thromboembolism are:

  • sudden chest pain that radiates to the left arm;
  • sudden shortness of breath;
  • any unusually severe headache that lasts 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 one side of the body, movement disorders, severe unilateral pain in the calf muscle, sharp abdomen.

Tumor diseases

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

A meta-analysis of 54 epidemiological studies showed that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection of breast cancer could be associated with more regular medical examinations. 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 regarded as one of many risk factors. However, women should be advised of the potential risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian and endometrial cancer).

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

Chloasma

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

Efficiency

The effectiveness of the drug may decrease 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 can 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 are finished in the next package. If at the end of the second cycle, menstrual bleeding does not begin or acyclic spotting does not stop, stop taking the tablets 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 parameters of the liver, kidneys, adrenal glands, thyroid gland, hemostasis indicators, levels of lipoproteins and transport proteins) may change.

Additional Information

After suffering acute viral hepatitis, the drug should be taken after normalization of liver function (not earlier than after 6 months).

With diarrhea or intestinal disorders, vomiting, the contraceptive effect may decrease. Without stopping taking 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) and on the number of cigarettes smoked.

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

Influence on the ability to drive vehicles and control mechanisms

Studies on the effect of the drug Lindinet on the ability to drive a car and work machinery have not been conducted.

drug interaction

The contraceptive activity of Lindinet 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 with the use of these combinations, breakthrough bleeding and menstrual disorders become more frequent. While taking Lindinet with the above drugs, as well as within 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 within 4 weeks after completion of the course of its administration.

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

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

Inducers of microsomal liver enzymes reduce the level of ethinylestradiol in plasma (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oscarbazepine). Liver enzyme inhibitors (itraconazole, fluconazole) increase plasma levels of ethinylestradiol.

Some antibiotics (ampicillin, tetracycline), preventing the intrahepatic circulation of estrogens, reduce the level of ethinylestradiol in plasma.

Ethinylestradiol, 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.

With the simultaneous use of Lindinet with St. John's wort (including infusion), the concentration of active substances in the blood decreases, which can lead to breakthrough bleeding, pregnancy. The reason for this is the inducing effect of St. John's wort on liver enzymes, which continues for another 2 weeks after the completion of the course of taking St. John's wort. This combination of drugs is not recommended.

Ritonavir reduces the AUC of ethinylestradiol by 41%. In this regard, during the use of ritonavir, a hormonal contraceptive with a higher content of ethinyl estradiol (Lindinet 30) should be used or additional non-hormonal methods of contraception should be used.

It may be necessary to correct the dosing regimen when using hypoglycemic agents, tk. oral contraceptives may reduce carbohydrate tolerance, increase the need for insulin or oral antidiabetic agents.

Lindinet's analogues

Structural analogues for the active substance:

  • Logest;
  • Mirelle;
  • Femoden.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

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

How to use Lindinet, a brief overview of the instructions

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

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

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

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

The first birth control 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 drunk immediately on second day after the end of the previous contraceptive.

After the abortion, held in the 1st trimester of pregnancy, Lindenet should start drinking on the second day or the day after the operation. There is no need to resort to auxiliary methods of protection.

But after an abortion made in the 2nd trimester, as well as after childbirth, the use of tablets can be started no earlier than 21-28 days.

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

What is the difference between Lindinet 20 and Lindinet 30?

Which pills are right for you, only a doctor can prescribe, based on tests.

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

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

Features of taking Lindinet 20 and Lindinet 30 tablets

When taking contraceptive pills Lindinet form 20 or 30, it must be borne in mind that if drugs such as ampicillin, tetracycline, felbamate, fluconazole are used, then the activity of the contraceptive decreases.

Therefore, if you drink Lindinet along with these medicines, 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 intermittent bleeding.

Therefore, in the case of taking Lindenet 20 or Lindenet 30 together with other drugs, you need to consult a doctor and make sure that they do not affect the decrease in the active substance of contraceptive pills.

It should be noted that the drug should not be taken during pregnancy, diabetes mellitus, lactation, venous insufficiency, with any disorders associated with the kidneys and liver.

Side effects of taking Lindinet

The individual characteristics of each woman impose their own side effects from taking Lindinet. If one or more of the side effects listed below occur, the drug should be discontinued.

These side effects include:

1. Violation of the cardiovascular system. It manifests itself in the form of arterial hypertension or thromboembolism.

2. Hearing loss.

3. Chorea Sindenham.

4. Candidiasis.

5. Bleeding.

6. Galactorrhea.

7. Nausea and vomiting.

8. Breast enlargement and pain in it.

9. Hepatitis.

10. Rash.

11. Nodular erythema.

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 healthcare provider right away.

What should I do if I miss Lindinet's appointment?

If, for any reason, a Lindinet 20 or 30 tablet was missed, it is necessary to drink it as soon as possible.

Less than 12 hours

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

Reception of subsequent tablets should be continued in the standard mode.

More than 12 hours

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

There is no need to take the missed dose.

But during the week you will need to use additional contraceptives (condoms, candles) to avoid pregnancy.

Menstruation while taking Lindinet

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

The cause of bleeding during the use of Lindinet may be diseases of the genital tract. Therefore, you should immediately consult a doctor who, after examining, will be able to detect the true cause of bleeding.

P No. 015122/01

Trade name of the drug:

Lindinet 20

International non-proprietary name:

ethinylestradiol + gestodene

Dosage form:

coated tablets.

Compound:

active substance: ethinylestradiol - 0.02 mg and gestodene - 0.075 mg
Excipients: in the core: Sodium calcium edetate - 0.065 mg; magnesium stearate - 0.200 mg; colloidal silicon dioxide - 0.275 mg; povidone - 1,700 mg; corn starch - 15.500 mg; lactose monohydrate 37.165 mg;
in shell: Dye quinoline yellow E 104 (D + C Yellow No. 10 E 104) - 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.

Description:

Round, biconvex film-coated tablets, light yellow. On a break white or almost white with a light yellow edging, both sides without an inscription.

Pharmacotherapeutic group:

contraceptive (estrogen + progestogen)

ATX code:

G03AB06

Pharmacological properties

Pharmacodynamics
Combined remedy, the action of which is due to the effects of the components that make up its composition. Inhibits 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 progestogen component is a derivative of 19-nortestosterone - gestodene, which is superior in strength and selectivity of action not only to the natural hormone of the corpus luteum progesterone, but also to modern synthetic gestagens (levonorgestrel, etc.). Due to its high activity, gestodene is used in very low dosages, in which it does not exhibit androgenic properties and has practically 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 in the cervix, which makes it relatively impassable for spermatozoa.
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:
Suction: when taken orally, it is rapidly and completely absorbed. After taking a single dose, the maximum plasma concentration is measured after an hour and is 2-4 ng / ml. Bioavailability about 99%.
Distribution: binds to albumin and sex hormone-binding globulin (SHBG). 1-2% is in the free state, 50-75% is specifically bound to SHBG. The increase in SHBG levels caused by ethinyl estradiol affects the level of gestodene, leading to an increase in the fraction associated with SHBG and a decrease in the fraction associated with albumin. The volume of distribution of gestodene is 0.7-1.4 l/kg.
Metabolism: Corresponds to the pathway of steroid metabolism. Average plasma clearance: 0.81.0 ml / min / kg.
breeding: blood levels decrease in two stages. The half-life in the final phase is 1220 hours. It is excreted exclusively in the form of metabolites: 60% in the urine, 40% in the feces. The half-life of metabolites is approximately 1 day.
Stable concentration: The pharmacokinetics of gestodene is largely dependent on the level of SHBG. Under the influence of ethinylestradiol, the concentration of SHBG in the blood increases three times; with daily administration of the drug, the level of gestodene in plasma increases by three to four times and reaches a state of saturation in the second half of the cycle.
Ethinylestradiol:
Suction: when taken orally, it is absorbed quickly and almost completely. The maximum concentration in the blood is measured after 1-2 hours and is 30-80 pg / ml. Absolute bioavailability ≈60% due to pre-systemic conjugation and primary metabolism in the liver.
Distribution: easily enters into a non-specific relationship with blood albumin (about 98.5%) and causes an increase in the level of SHBG. The average volume of distribution is 5-18 l / kg.
Metabolism: carried out mainly due to aromatic hydroxylation with the formation of large amounts of hydroxylated and methylated metabolites, partly in free, partly in conjugated form (glucuronides and sulfates). Plasma clearance ≈5-13 ml / min / kg.
breeding: Serum concentration decreases in two steps. The half-life 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. The half-life of metabolites is ≈1 day.
Stable concentration: Stable concentration is established by 3-4 days, while the level of ethinylestradiol is 20% higher than after taking a single dose.

Indications for use

Contraception.

Contraindications

  • pregnancy or suspicion of it;
  • lactation;
  • the presence of severe or multiple risk factors for venous or arterial thrombosis, incl. complicated lesions of the valvular apparatus of the heart, atrial fibrillation, diseases of the cerebral vessels or coronary arteries; uncontrolled arterial hypertension of moderate or severe degree with blood pressure of 160/100 mm Hg or more);
  • precursors of thrombosis (including transient ischemic attack, angina pectoris), including history;
  • migraine with focal neurological symptoms, including a history;
  • venous or arterial thrombosis / thromboembolism (including deep vein thrombosis of the lower leg, pulmonary embolism, myocardial infarction, stroke) at the present time or history,
  • the presence of venous thromboembolism in relatives;
  • major surgery with prolonged immobilization;
  • diabetes mellitus (with the presence of angiopathy);
  • pancreatitis (including history), accompanied by severe hypertriglyceridemia;
  • dyslipidemia;
  • severe liver disease, cholestatic jaundice (including during pregnancy), hepatitis, incl. in history (before the normalization of functional and laboratory parameters and within three months after the return of these indicators to normal);
  • jaundice due to taking drugs containing steroids;
  • cholelithiasis at present or history;
  • syndrome of Gilbert, Dubin-Johnson, Rotor;
  • liver tumors (including history);
  • severe itching, otosclerosis, or progression of otosclerosis during a previous pregnancy or when taking glucocorticosteroids;
  • hormone-dependent malignant neoplasms of the genital organs and mammary glands (including suspicion of them);
  • vaginal bleeding of unknown etiology;
  • smoking over the age of 35 (more than 15 cigarettes per day);
  • individual hypersensitivity to the drug or its components.

Carefully
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 closest relatives); hemolytic uremic syndrome, hereditary angioedema, liver disease; diseases that first arose or worsened during pregnancy or against the background of a previous intake of sex hormones (including porphyria, herpes in pregnancy, chorea minor (Sydenham's disease), Sydenham's chorea, chloasma); obesity (body mass index over 30 kg/m2), dyslipoproteinemia, arterial hypertension, migraine, epilepsy, valvular heart disease, atrial fibrillation, prolonged immobilization, extensive surgery, surgery on the lower extremities, severe trauma, varicose veins and superficial thrombophlebitis, postpartum period (non-lactating women 21 days after birth; lactating women after the end of the lactation period), the presence of severe depression, incl. in history, changes in biochemical parameters (activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C or S deficiency, antiphospholipid antibodies, including antibodies to cardiolipin, lupus anticoagulant).
Diabetes mellitus, not complicated by vascular disorders, systemic lupus erythematosus (SLE), Crohn's disease, ulcerative colitis, sickle cell anemia; hypertriglyceridemia (including family history), acute and chronic liver disease.

Pregnancy and lactation

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

Dosage and administration

Take 1 tablet daily for 21 days, at the same time of day if possible. Then, after taking a 7-day break in taking the pills, resume oral contraception (i.e. 4 weeks after taking the first pill, on the same day of the week). During the 7-day break, uterine bleeding occurs as a result of hormone withdrawal.
First tablet : Lindinet 20 should be taken from the first to the fifth day of the menstrual cycle.
Switching from a combined oral contraceptive to taking Lindinet 20: The first tablet of Lindinet 20 is recommended to be taken after taking the last hormone-containing tablet of the previous drug, on the first day of withdrawal bleeding.
Switching from progestogen-containing drugs (“mini” pills, injections, implant) to taking Lindinet 20: The transition from "mini" pills can be started on any day of the menstrual cycle; in the case of an implant, the next 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 a contraceptive immediately after an abortion, and there is no need to use an additional method of contraception.
Taking the drug Lindinet 20 after childbirth or after an abortion in the second trimester of pregnancy: Taking a contraceptive can be started on the 21-28th day after childbirth or abortion in the second trimester of pregnancy. With a later start of taking the contraceptive, in the first 7 days, it is necessary to use an additional, barrier method of contraception. In the case when sexual contact took place before the start of contraception, before you start taking the drug, you should exclude the presence of a new pregnancy or wait for the next menstruation.
Missed pills
If the next scheduled pill was missed, then the missed dose should be replenished as soon as possible. With a delay not exceeding 12 hours, the contraceptive effect of the drug does not decrease, and there is no need to use an additional method of contraception. The remaining tablets are taken as usual.
With more than a 12-hour delay, the contraceptive effect may decrease. 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 need to use an additional method of contraception. If at the same time less than 7 tablets remained in the package, then they start taking the tablets from the next package without observing a break. In such cases, uterine withdrawal bleeding does not occur until after the completion of the second pack; while taking the tablets from the second package, spotting or breakthrough bleeding is possible.
If at the end of taking the pills from the second 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 the next tablet, the tablet is not completely absorbed. In such cases, you should act in accordance with the instructions described in the paragraph "Missed pills".
If the patient does not want to deviate from the 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, they start taking pills from a new package without observing a break. Menstruation can be delayed at will until all the pills from the second package run out. With a delay in menstruation, breakthrough or spotting uterine bleeding is possible. You can return to the usual intake of tablets after observing a 7-day break.
In order to earlier the onset of menstrual bleeding, you can shorten the 7-day break by the desired number of days. The shorter the break, the more likely is the occurrence of breakthrough or spotting bleeding while taking the pills from the next pack (similar to cases with delayed menstruation).

Side effect

Side effects that require immediate discontinuation of the drug:

  • arterial hypertension;
  • hemolytic-uremic syndrome;
  • porphyria;
  • hearing loss due to otosclerosis.

rare: arterial and venous thromboembolism (including myocardial infarction, stroke, deep vein thrombosis of the lower extremities, pulmonary embolism); exacerbation of reactive systemic lupus erythematosus.
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 are less severe but more common. The expediency of continuing the use of the drug is decided individually after consultation with a doctor, based on the benefit / risk ratio.

  • reproductive system: acyclic bleeding / spotting from the vagina, amenorrhea after discontinuation of the drug, changes in the state of the vaginal mucus, the development of inflammatory processes in the vagina (eg: candidiasis), changes in libido.
  • Mammary gland: tension, pain, breast enlargement, galactorrhea.
  • Gastrointestinal tract and hepato-biliary system: nausea, vomiting, diarrhea, epigastric pain, Crohn's disease, ulcerative colitis, hepatitis, liver adenoma, occurrence or exacerbation of jaundice and / or itching associated with cholestasis, cholelithiasis.
  • Leather: nodular / exudative erythema, rash, chloasma, increased hair loss.
  • central nervous system: headache, migraine, mood changes, depressive states.
  • Metabolic disorders: fluid retention in the body, a change (increase) in body weight, an increase in the level of triglycerides and blood sugar, a decrease in carbohydrate tolerance.
  • sense organs: hearing loss, increased sensitivity of the cornea of ​​​​the eye when wearing contact lenses.
  • Other: allergic reactions.

Overdose

Taking large doses of contraception was not accompanied by the development of severe symptoms. Signs of overdose: nausea, vomiting, in young girls, slight vaginal bleeding. There is no specific antidote, treatment is symptomatic.

Interaction with other drugs

The contraceptive effect of oral contraceptives is reduced with the simultaneous use of rifampicin, breakthrough bleeding and menstrual irregularities become more frequent.
A similar, but less studied, interaction exists between contraceptives and carbamazepine, primidone, barbiturates, phenylbutazone, phenytoin, and presumably griseofulvin, ampicillin, and tetracyclines. During treatment with the above drugs, it is recommended to use an additional method of contraception (condom, spermicidal gel) simultaneously with oral contraception. After completion of 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.
Absorption-related interactions: During diarrhea, the absorption of hormones is reduced due to increased intestinal motility. Any drug that shortens the time a hormone spends in the large intestine leads to low concentrations of the hormone in the blood.
Interactions related to drug metabolism:
intestinal wall: Drugs that undergo sulphation in the intestinal wall, like ethinylestradiol (eg ascorbic acid), inhibit metabolism in a competitive way and increase the bioavailability of ethinylestradiol.
Metabolism in the liver: Inducers of microsomal liver enzymes reduce plasma levels of ethinylestradiol (rifampicin, barbiturates, phenylbutazone, phenytoin, griseofulvin, topiramate, hydantoin, felbamate, rifabutin, oscarbazepine). Liver enzyme blockers (itraconazole, fluconazole) increase the level of ethinylestradiol in the blood plasma.
Influence on intrahepatic circulation: Some antibiotics (eg, ampicillin, tetracycline), by interfering with intrahepatic circulation of estrogens, reduce the level of ethinylestradiol in plasma.
Influence 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 (eg, cyclosporine, theophylline), leading to an increase or decrease in their plasma concentrations.
The simultaneous use of preparations from St. John's wort is not recommended ( Hypericum perforatum) with Lindinet 20 tablets due to a possible decrease in the contraceptive effect of the active substance of the contraceptive, which may be accompanied by the appearance of breakthrough bleeding and unwanted pregnancy. St. John's wort activates liver enzymes; after discontinuation of St. John's wort, the effect of enzyme induction may persist for the next 2 weeks.
The simultaneous use of ritonavir and a combined contraceptive is accompanied by a decrease in the average AUC of ethinylestradiol by 41%. During treatment with ritonavir, it is recommended to use a drug with a high content of ethinylestradiol or use a non-hormonal method of contraception. It may be necessary to correct the dosing regimen when using hypoglycemic agents, tk. oral contraceptives may reduce carbohydrate tolerance, increase the need for insulin or oral antidiabetic agents.

special instructions

Before starting the use of the drug, it is recommended to collect a detailed family and personal history and subsequently every 6 months. undergo a general medical and gynecological examination (examination by a gynecologist, examination of a cytological smear, examination of the mammary glands and liver function, control of blood pressure (BP), cholesterol concentration in the blood, urinalysis). These studies must be periodically repeated, due to the need for timely identification of risk factors or emerging contraindications.
The drug is a reliable contraceptive drug: the Pearl index (an indicator of the number of pregnancies that occurred during the use of a contraceptive method in 100 women for 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, in the first 2 weeks of taking the drug, it is recommended to additionally use non-hormonal methods of contraception.
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 state of health of women 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 hemostasis system.
  • conditions / diseases predisposing to the development of cardiovascular, renal failure.
  • epilepsy
  • migraine
  • the risk of developing an estrogen-dependent tumor or estrogen-dependent gynecological diseases;
  • diabetes mellitus, not complicated by vascular disorders;
  • severe depression (if depression is associated with impaired tryptophan metabolism, then vitamin B6 can be used to correct it);
  • sickle cell anemia, since in some cases (for example, infections, hypoxia), estrogen-containing drugs in this pathology can provoke thromboembolism.
  • the appearance of abnormalities in laboratory tests for assessing liver function.

Thromboembolic diseases
Epidemiological studies have shown that there is a link 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 disease has been proven, but it is significantly less than during pregnancy (60 cases per 100,000 pregnancies). When using oral contraceptives, arterial or venous thromboembolism of the hepatic, mesenteric, renal or retinal vessels is very rarely observed.
The risk of developing arterial or venous thromboembolic diseases increases:

  • with age;
  • when smoking (heavy smoking and age over 35 are risk factors);
  • if there is a family history of thromboembolic diseases (for example, in parents, a brother or sister). If a genetic predisposition is suspected, it is necessary to consult a specialist before using the drug.
  • with obesity (body mass index above 30 kg / m 2);
  • with dyslipoproteinemia;
  • with arterial hypertension;
  • in 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, a temporary discontinuation of the drug is expected: it is advisable to stop no later than 4 weeks before surgery, and resume no earlier than 2 weeks after remobilization.
There is an increased risk of venous thromboembolic disease in women after childbirth.
Diseases such as diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia increase the risk of venous thromboembolic disease.
Such biochemical abnormalities as resistance to activated protein C, hyperchromocysteinemia, deficiency of proteins C, S, deficiency of antithrombin III, the presence of antiphospholipid antibodies increase the risk of arterial or venous thromboembolic diseases.
When evaluating the benefit / risk ratio of taking the drug, it should 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 lasts 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 one side of the body, movement disorders, severe unilateral pain in calf muscle, acute abdomen).

Tumor diseases
Some studies have reported an increase in the occurrence of cervical cancer in women who have been taking hormonal contraceptives for a long time, but the results of the studies are conflicting. Sexual behavior, human papillomavirus infection and other factors play a significant role in the development of cervical cancer.
A meta-analysis of 54 epidemiological studies showed that there is a relative increase in the risk of breast cancer among women taking oral hormonal contraceptives, but the higher detection of breast cancer could be associated with more regular medical examinations. 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 regarded as one of many risk factors. However, women should be advised of the potential risk of developing breast cancer based on a benefit-risk assessment (protection against ovarian, endometrial, and colon cancers).
There are few reports of the development of benign or malignant liver tumors in women who take hormonal contraceptives for a long time. This should be kept in mind in the differential diagnostic evaluation of abdominal pain, which may be associated with an increase in the size of the liver or intra-abdominal bleeding.
A 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 decrease 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 can 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 are finished in the next package. If at the end of the second cycle, menstrual bleeding does not begin or acyclic spotting does not stop, stop taking the tablets and resume it only after pregnancy has been ruled out.
Chloasma
Chloasma can occasionally occur in those women who have had a history of them during pregnancy. Those women who are at risk of developing chloasma should avoid contact with sunlight or ultraviolet light 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 parameters 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 (not earlier than after 6 months). With 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) and on the number of cigarettes smoked. During lactation, the excretion of milk 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 work mechanisms

Studies to study the possible effect of the drug Lindinet 20 on the ability to drive a car or other machines have not been conducted.

Release form

Coated tablets.
21 tablets in a blister made of PVC/PVDC film and aluminum foil.
1 or 3 blisters in a cardboard box with instructions for use.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25°C.
Keep out of the reach of children!

Best before date

3 years.
Use the drug only taking into account the expiration date indicated on the package.

Terms of dispensing from pharmacies

Released by prescription.

Manufacturer

OJSC "Gedeon Richter", Hungary
1103 Budapest, st. Djemrei, 19-21, Hungary

Send consumer claims to the address of the Moscow Representative Office:
119049 Moscow, 4th Dobryninsky lane, building 8

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