Lindynette 20 tabs #63

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Instruction for Lindynette 20

You can buy Lindynette 20 on this page

Lindynette 20 is a monophasic oral contraceptive.

Release form and composition

Lindynette 20 dosage form - coated tablets: round, biconvex, light yellow, under the shell structure is almost white or white (21 pieces in blisters, in a carton pack 1 or 3 blisters).
The content of active ingredients in 1 tablet Lindynette 20:
    Ethinylestradiol - 0.02 mg;
    Gestodene - 0.075 mg.
Auxiliary components: corn starch, magnesium stearate, sodium calcium edetate, colloidal silicon dioxide, lactose monohydrate, povidone.
Shell composition: povidone, titanium dioxide, macrogol 6000, calcium carbonate, quinoline yellow dye (D + C yellow No. 10) (E104), sucrose, talc.

Pharmacodynamics

Lindynette 20 is a combined drug that inhibits the pituitary secretion of gonadotropic hormones.
Ethinylestradiol is the estrogenic component of Lindynette 20. It is a synthetic analogue of estradiol, which is involved in the regulation of the menstrual cycle together with the corpus luteum hormone.
Gestodene is the progestogen component of the drug. It is a derivative of 19-nortestosterone and is superior in selectivity and potency to progesterone (a natural hormone of the corpus luteum) and modern synthetic progestogens (eg, levonorgestrel). Due to its high activity, gestodene is used in low dosages, at which it practically does not affect carbohydrate and lipid metabolism and does not exhibit androgenic properties.
The contraceptive effect of Lindynette 20 is due to central and peripheral mechanisms that prevent the maturation of the egg, as well as a decrease in the susceptibility of the inner layer of the uterus to the blastocyst and an increase in the viscosity of the cervical fluid, making it practically impassable for spermatozoa.
In addition to the contraceptive action, Lindynette 20, with regular use, exhibits a therapeutic effect, normalizing the female menstrual cycle and preventing some gynecological diseases, including tumor origin.

Pharmacokinetics

Ethinylestradiol is almost completely and rapidly absorbed in the digestive tract. After 1–2 hours, its maximum plasma concentration is reached (30–80 pg/ml). Ethinylestradiol undergoes presystemic conjugation and primary metabolism in the liver, so its absolute bioavailability is only about 60%. Approximately 98.5% binds to plasma proteins (albumin). The mean volume of distribution is 5–18 L/kg.
Ethinylestradiol is metabolized mainly by aromatic hydroxylation. As a result of metabolism, methylated and hydroxylated metabolites are formed, which are partly in conjugated and partly in free form (sulfates and glucuronides). Clearance from plasma is 5–13 ml/min/kg. It is excreted in the urine and bile in two stages, exclusively in the form of metabolites with a half-life of 24 hours. A stable concentration of ethinyl estradiol is established for 3-4 days, while its level is 20% higher than the concentration after taking a single dose.
Gestodene is also rapidly absorbed from the gastrointestinal tract. The maximum plasma concentration (2-4 ng / ml) is reached after 1 hour. The bioavailability of gestodene is approximately 99%. 50-75% binds to SHBG (sex hormone-binding globulin) and albumin. Only 1–2% of gestodene is in the free state. The apparent volume of distribution is 0.7-1.4 l / kg.
The metabolism of gestodene corresponds to that of other steroids. Clearance from plasma is 0.8–1 ml/min/kg. The level of gestodene in the blood decreases gradually. In the second phase, the half-life is 12-20 hours. It is excreted only in the form of metabolites: 40% - with feces, 60% - with urine. The half-life of metabolites is about 24 hours. A stable concentration of gestodene is reached in the second half of the cycle.

Indications for use

The use of Lindynette 20 is indicated for oral contraception.

Contraindications

    Multiple and/or severe risk factors for arterial or venous thrombosis (including atrial fibrillation, complicated valvular heart disease, moderate or severe hypertension (blood pressure (BP) 160/100 mm Hg or more), coronary artery or cerebral vascular disease brain);
    Angina pectoris, transient ischemic attack and other precursors of thrombosis, including history;
    History of venous thromboembolism;
    Prolonged immobilization after surgery;
    Migraine with focal neurological symptoms, including history;
    Arterial or venous thromboembolism or thrombosis (deep vein thrombosis of the leg, myocardial infarction, pulmonary embolism, stroke), including history;
    Pancreatitis (including history) against the background of severe hypertriglyceridemia;
    Tumors of the liver, including history;
    Hyperlipidemia;
    Jaundice with the use of glucocorticoids (GCS);
    Severe liver diseases, cholestatic jaundice (including during pregnancy), hepatitis (including anamnesis) - until the restoration of laboratory and functional parameters and after their normalization within 3 months;
    Diabetes mellitus complicated by angiopathy;
    Gallstone disease, including history;
    Rotor syndrome, Dubin-Johnson syndrome, Gilbert's syndrome;
    severe itching;
    Otosclerosis and its progression while taking GCS or during a previous pregnancy;
    Vaginal bleeding of unknown origin;
    Hormone-dependent malignant neoplasms of the genital organs and mammary glands, or if they are suspected;
    Smoking over the age of 35 (over 15 cigarettes per day);
    The period of breastfeeding;
    Pregnancy or suspicion of it;
    Hypersensitivity to the components of the drug.
Caution should be exercised when prescribing Lindynette 20 to women with risk factors that increase the likelihood of developing arterial or venous thrombosis or thromboembolism: age over 35 years, hereditary predisposition to thrombosis (myocardial infarction, thrombosis or cerebrovascular accident in close relatives at a young age), smoking, hemolytic uremic syndrome, liver disease, hereditary angioedema, chloasma, herpes of pregnancy, porphyria, Sydenham's chorea, chorea minor and other diseases that have arisen or worsened during the period of previous use of sex hormones or during pregnancy, obesity with a body weight index of more than 30 kg per m2, valvular heart disease, arterial hypertension, atrial fibrillation, dyslipoproteinemia, migraine, epilepsy, severe trauma, prolonged immobilization, major surgery, surgery on the lower extremities, sickle cell anemia, superficial thrombophlebitis and varicose veins veins, diabetes mellitus (without complications of vascular disorders), postpartum period, ulcerative colitis, severe depression (including history), Crohn's disease, chronic and acute liver disease, systemic lupus erythematosus, hypertriglyceridemia (including family history), abnormal biochemical parameters (lupus anticoagulant , hyperhomocysteinemia, activated protein C resistance, deficiency of antithrombin III, protein S or C, antiphospholipid antibodies, including antibodies to cardiolipin).


Instructions for use Lindynette 20: method and dosage

Lindynette 20 tablets are taken orally, regardless of food intake, always at the same time of day.
The first tablet from the blister must be taken from the 1st to the 5th day of menstrual bleeding. The use of Lindynette 20 involves taking 1 tablet per day for 21 days, followed by a seven-day break, during which withdrawal bleeding occurs. Taking tablets from the next blister is started on the first day after a 7-day break at the same time as in the previous cycle.
To switch from another oral combined contraceptive, the first Lindynette 20 tablet is taken the next day after the end of the previous package, on the first day of withdrawal bleeding.
When taking a mini-pill, the transition to Lindynette 20 can be started on any day of the cycle, with the previous use of the implant - on the day after its removal, when using injections - on the eve of the next injection. The transition from single drugs must be accompanied by the use of additional barrier methods of contraception during the first 7 days.
When carrying out an abortion in the first trimester of pregnancy, taking the pills should be started immediately after the operation without the use of additional contraceptive measures.
After an abortion in the second trimester of pregnancy or after childbirth, the use of Lindynette 20 begins after 21-28 days without the use of additional methods of contraception. If the drug is started later, then during the first 7 days it is necessary to use an additional method of contraception.
If a woman had sexual intercourse before the start of contraception, the use of the drug should be started after the exclusion of pregnancy or with the onset of menstrual bleeding.
If you miss taking the next dose of Lindynette 20 at the scheduled time, if the delay was less than 12 hours (the contraceptive effect of the drug was not disturbed), the pill should be taken immediately, as remembered, and the next pills should be taken at the usual time. If the delay exceeds 12 hours, then you should not take the missed pill, but continue taking the drug according to the scheme, using additional methods of contraception for the next 7 days. If the missed dose occurred less than 7 days before the end of the package, taking the tablets from the next blister must be started without interruption. Withdrawal bleeding in this case will occur after the completion of the second blister, but spotting or breakthrough bleeding may occur before the break. In the absence of menstrual bleeding after taking all the pills from the second blister, the continuation of oral contraception is possible only after the exclusion of pregnancy.
If a woman has vomiting and / or diarrhea within the first 3-4 hours after taking the next pill, which disrupted the absorption process and reduced the clinical effect of Lindynette 20, then in this case there are two options for further therapy. One of them is to take the next tablet according to the schedule at the scheduled time and then follow up on the recommendations associated with skipping the drug. The second option is that a woman can take a similar pill from another blister without deviating from her usual contraceptive regimen.
If it is necessary to accelerate the onset of menstruation, it is recommended to shorten the break in taking Lindynette 20. It should be borne in mind that the shorter the break, the greater the risk of spotting or breakthrough bleeding during the period of taking the pills from the next blister (similar to cases of delayed menstruation).
If it is necessary to delay the next menstruation for a later period, the tablets should be continued from a new package without a seven-day break. You can delay the onset of menstruation for the desired period, until the end of the pills from the second package. During the period of the planned delay in menstrual bleeding, breakthrough or spotting bleeding may occur. After a seven-day break, regular use of Lindynette 20 should be continued.

Side effects

The use of Lindynette 20 should be canceled with the development of the following side effects:
    Sense organs: hearing loss caused by otosclerosis;
    Cardiovascular system: arterial hypertension; rarely - myocardial infarction, deep vein thrombosis of the lower extremities, stroke, pulmonary embolism and other venous and arterial thromboembolism; very rarely - venous or arterial thromboembolism of the renal, hepatic, retinal, mesenteric arteries and veins;
    Others: porphyria, hemolytic uremic syndrome; rarely - exacerbation of reactive systemic lupus erythematosus; very rarely - Sydenham's chorea (passes after discontinuation of the drug).
In addition, the action of Lindynette 20 can potentiate the development of other less severe side effects, but more often occurring:
    Reproductive system: spotting or acyclic vaginal bleeding, candidiasis, amenorrhea (after cancellation), changes in the state of vaginal mucus, development of inflammatory processes in the vagina, galactorrhea, enlargement of the mammary glands, their tension and pain;
    Nervous system: headache, mood lability, migraine, depression;
    Metabolism: hyperglycemia, weight gain, fluid retention in the body, decreased carbohydrate tolerance, increased thyroglobulin concentration;
    Digestive system: nausea, epigastric pain, vomiting, ulcerative colitis, Crohn's disease, hepatitis, cholelithiasis, liver adenoma, exacerbation or appearance of itching associated with cholestasis, and / or jaundice;
    Sense organs: in women with contact lenses - increased sensitivity of the cornea, hearing loss;
    Dermatological reactions: rash, erythema nodosum, increased hair loss, exudative erythema, chloasma;
    Other: development of allergic reactions.
The decision on the advisability of further taking the drug is made after consultation with the doctor individually, by comparing the benefits and risks of contraception.

Overdose

Taking large doses of Lindynette 20 does not lead to severe overdose symptoms. Nausea and vomiting are common, and in young girls, light vaginal bleeding.
There is no specific antidote. The appointment of symptomatic therapy is recommended.


Special instructions

The use of Lindynette 20 should be started after consulting a doctor and conducting a general medical and gynecological examination, including an examination of the pelvic organs, mammary glands, and a cytological analysis of a cervical smear. Examination is recommended every 6 months during the period of taking the tablets.
Taking into account the clinical condition of the woman and the risk factors for side effects, the advantage or disadvantage of oral contraception is assessed and a decision is made regarding its use. The doctor should inform about the possible aggravation of existing pathologies, undesirable actions of Lindynette 20 and the need to seek advice if you feel worse.
It is necessary to cancel hormonal contraception if any of the following diseases or conditions appear or worsen: diseases and conditions predisposing to the development of cardiovascular and renal failure, epilepsy, pathologies of the hemostatic system, the risk of developing estrogen-dependent gynecological diseases or an estrogen-dependent tumor, migraine, diabetes mellitus without vascular disorders, severe depression, sickle cell anemia, abnormal liver function tests.
Lindynette 20 has a reliable contraceptive effect after 2 weeks of use, therefore, to exclude a possible pregnancy during the first 2 weeks, it is recommended to use additional barrier methods of contraception.
Against the background of the use of oral hormonal contraceptives, the likelihood of venous and arterial thromboembolic diseases increases, the possible (very rare) development of arterial or venous thromboembolism of the hepatic, renal, mesenteric or retinal vessels should be taken into account.
Factors that increase the risk of developing arterial or venous thromboembolic diseases include genetic predisposition, heavy smoking, obesity, as well as the presence of dyslipoproteinemia, arterial hypertension, heart valve disease with hemodynamic disturbances, atrial fibrillation, diabetes mellitus with vascular lesions. The risk increases with a woman's age, with prolonged immobilization caused by extensive surgery, including on the lower extremities, or after a severe injury. With planned operations, Lindynette 20 should be canceled 4 weeks before the operation and resumed 2 weeks after remobilization.
Regular medical supervision requires the use of Lindynette 20 in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia and in women after childbirth.
The risk of developing arterial or venous thromboembolic diseases is increased by hyperhomocysteinemia, resistance to activated protein C, protein C and S deficiency, the presence of antiphospholipid antibodies, and antithrombin III deficiency.
Admission Lindynette 20 can be regarded as one of the many factors affecting the development of cervical cancer or breast cancer. The increased registration of these pathologies in women taking hormonal contraceptives may be associated with regular medical supervision and medical examinations.
After long-term oral hormonal contraception, the possible development of a benign or malignant liver tumor should be considered in the differential diagnostic evaluation of abdominal pain, which may be associated with intraperitoneal bleeding or an increase in liver size.
Women prone to chloasma are advised to avoid exposure to direct sunlight or ultraviolet radiation.
The contraceptive effect of Lindynette 20 is reduced if the next dose is missed, with vomiting or diarrhea, while taking medications that affect its effectiveness. To avoid conception, a woman should use additional barrier contraceptives as recommended.
The appearance of irregular spotting or breakthrough bleeding and the absence of menstrual bleeding during the seven-day break can be a consequence of pregnancy. Therefore, before starting taking the tablets from the next blister, it is necessary to consult a doctor and resume therapy after the exclusion of pregnancy.
The estrogenic component of the drug can affect the laboratory parameters of the level of transport proteins and lipoproteins, the functional parameters of the kidneys, liver, thyroid gland, adrenal glands, and hemostasis parameters.
The use of Lindynette 20 after acute viral hepatitis is indicated no earlier than after 6 months, subject to the normalization of liver function.
Women who smoke are at an increased risk of developing vascular disease, especially after the age of 35 (the degree of risk depends on age and the number of cigarettes smoked per day).
Lindynette 20 does not protect against infection with sexually transmitted infections, including HIV infection (AIDS).
The effect of the drug on the patient's ability to drive vehicles and mechanisms has not been established.

Use during pregnancy and lactation

Lindynette 20 is contraindicated in pregnant and lactating women.
The components of the drug are secreted in small amounts with breast milk.
Taking an oral contraceptive while breastfeeding may reduce milk production.

For impaired renal function

Lindynette 20 is not recommended for use in patients with kidney disease.

For impaired liver function

According to the instructions, Lindynette 20 is contraindicated in patients with impaired liver function.

Drug interaction

    Inducers of microsomal liver enzymes (rifampicin, phenylbutazone, barbiturates, griseofulvin, phenytoin, hydantoin, topiramate, rifabutin, felbamate, oxcarbazepine), antibiotics (ampicillin, tetracycline): help reduce the content of ethinyl estradiol in blood plasma;
    Liver enzyme inhibitors (fluconazole, itraconazole): increase the level of ethinylestradiol concentration in blood plasma;
    Means that increase the motility of the gastrointestinal tract: reduce the absorption of active substances and their concentration in blood plasma when combined with Lindynette 20;
    Ascorbic acid and other agents that undergo sulfation in the intestinal wall: competitively slow down the sulfation of ethinyl estradiol and enhance its bioavailability.
The simultaneous use of ritonavir, tetracycline, ampicillin, rifampicin, primidone, barbiturates, phenylbutazone, carbamazepine, phenytoin, topiramate, griseofulvin, oxcarbazepine, felbamate leads to a decrease in the contraceptive effectiveness of the drug. Therefore, during the period of admission and within 7 days (when combined with rifampicin - 4 weeks) after therapy with these drugs, a woman should use additional barrier methods of contraception.
The drug affects the metabolism of cyclosporine and theophylline.
The simultaneous administration of St. John's wort is not recommended, as the risk of breakthrough bleeding increases.
Patients with diabetes may need to adjust the dose of hypoglycemic agents.

Terms and conditions of storage

Keep away from children.
Store at temperatures up to 25 ° C, protected from light, dry place.
Shelf life - 3 years.

Reviews about Lindynette 20

According to reviews, Lindynette 20 does an excellent job with its main task - protection from unwanted pregnancy. Women note that the menstrual cycle becomes more regular, critical days pass easier, pain in the lower abdomen disappears. In some patients, the condition of the hair and skin improves, the mood improves. Another advantage of the drug is its relative cheapness (especially compared to some more expensive analogues). Also, the drug helps to restore hormonal levels after gynecological operations.
Despite the large share of positive reviews, Lindynette 20 also receives negative ratings, most often due to individual intolerance to the drug. Birth control pills are not suitable for all women and can cause side effects, sometimes very serious (weight gain, swelling, nausea, vomiting, pain in the stomach, decreased libido, etc.). Among the shortcomings of the drug, some women also mention the fact that the days of the week are not marked on the package.
Doctors categorically forbid patients to prescribe Lindynette 20 on their own, as well as change the dosage of the drug (for example, switch to Lindynette 30). If side effects appear or worsen, it is recommended to seek the advice of a specialist.

Terms of sell

You can buy Lindynette 20 without a prescription.