Trikvilar tablets p / o 0.075 + 0.04mg, No. 21

Oral contraception.

Functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia); premenstrual tension syndrome.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

The levonrgestrel / ethinyl estradiol combination is available in different fixed doses in various drugs. The preparations can also contain different types of tablets, with different fixed doses of the components. Therefore, a specific medicinal product containing this combination should be taken strictly in accordance with the instructions for use.

For oral administration.

ethinylestradiol - 40 mcg

levonorgestrel - 75 mcg

Excipients : lactose monohydrate - 33.035 mg, corn starch - 18 mg, povidone 25,000 - 2.1 mg, talc - 1.65 mg, magnesium stearate - 100 ?g.

Shell composition: sucrose - 19.66 mg, povidone 700,000 - 171 ?g, macrogol 6000 - 2.18 mg, calcium carbonate - 8.697 mg, talc - 4.242 mg, mountain glycolic wax - 50 ?g.

• Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);

• conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;

• multiple or severe risk factors for venous or arterial thrombosis;

• hereditary or acquired predisposition to venous or arterial thrombosis: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);

• migraine with focal neurological symptoms at present or in history;

• uncontrolled arterial hypertension;

• diabetes mellitus with diabetic angiopathy;

• pancreatitis with severe hypertriglyceridemia at present or in history;

• liver failure and severe liver disease (until the normalization of liver function tests);

• liver tumors (benign or malignant), current or history;

• severe dyslipoproteinemia; identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them;

• vaginal bleeding of unknown origin;

• pregnancy or suspicion of it;

• lactation period (breastfeeding);

• postmenopausal period;

• age under 18;

• simultaneous use with St. John's wort preparations;

• hypersensitivity to the components of the combination.

Carefully

The potential risk and expected benefit of the use of combined oral contraceptive drugs (COCs) in each individual case should be carefully weighed in the presence of the following diseases / conditions or risk factors:

• risk factors for the development of thrombosis and thromboembolism: smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), overweight (BMI <30 kg / m2), dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve disease;

• other diseases in which peripheral circulation disorders may occur: diabetes mellitus without diabetic angiopathy, SLE, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;

• hypertriglyceridemia;

• liver disease of mild to moderate severity with normal liver function tests;

• diseases that first appeared or worsened during a previous pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham's chorea);

• women with hereditary angioedema, chloasma, depression, epilepsy.

Clinical and pharmacological group: Three-phase oral contraceptive

Pharmaco-therapeutic group: Contraceptive (estrogen + progestogen)

pharmachologic effect

Combined hormonal contraceptive for oral administration.

The contraceptive effect is due to two mechanisms. Under the influence of levonorgestrel, there is a blockade of the release of releasing factors (LH and FSH) of the hypothalamus, inhibition of the secretion of gonadotropic hormones by the pituitary gland, which leads to inhibition of maturation and the release of an egg ready for fertilization (ovulation). Ethinylestradiol helps to maintain a high viscosity of cervical mucus, which makes it difficult for sperm to enter the uterine cavity.

Along with the contraceptive effect, with regular intake of drugs containing this combination, the menstrual cycle normalizes, due to the replenishment of the level of endogenous hormones with hormonal components.

Pharmacokinetics

When taken orally, the active substances are rapidly and completely absorbed from the gastrointestinal tract. The time to reach Cmax of levonorgestrel is 2 hours, ethinyl estradiol is 1.5 hours. Both components are excreted in breast milk. Active substances are metabolized in the liver. T1 / 2 - 2-7 hours. Excretion of levonorgestrel by the kidneys is 60%, 40% through the intestines; ethinylestradiol - 40% by the kidneys, 60% - through the intestines.

Indications

Oral contraception.

Functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia); premenstrual tension syndrome.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

The levonrgestrel / ethinyl estradiol combination is available in different fixed doses in various drugs. The preparations can also contain different types of tablets, with different fixed doses of the components. Therefore, a specific medicinal product containing this combination should be taken strictly in accordance with the instructions for use.

For oral administration.

Side effect

Determination of the frequency of side effects: very often (? 1/10), often (? 1/100, <1/10), sometimes (? 1/1000, <1/100), rarely (? 1/10 000, <1 / 1000), very rarely (<1/10 000), including isolated cases.

From the reproductive system: possibly - engorgement of the mammary glands, decreased libido, intermenstrual bleeding; rarely - increased vaginal discharge, vaginal candidiasis.

From the digestive system: possibly - nausea, vomiting; rarely - jaundice, hepatitis, liver adenoma, gallbladder disease (eg, cholelithiasis, cholecystitis), diarrhea.

From the nervous system: possibly - headache, depressed mood; with long-term use, it is very rare - an increase in the frequency of epileptic seizures.

From the senses: in some cases - eyelid edema, conjunctivitis, visual impairment, discomfort when wearing contact lenses (these phenomena are temporary and disappear after discontinuation without prescribing any therapy); with long-term use, very rarely - hearing loss.

From the side of metabolism: it is possible - an increase in body weight; rarely - an increase in the concentration of triglycerides, glucose in the blood, a decrease in glucose tolerance.

On the part of the skin and subcutaneous tissues: possibly - chloasma; rarely - skin rash, hair loss; very rarely with prolonged use - generalized itching.

Others: rarely - increased fatigue, increased blood pressure, thrombosis and venous thromboembolism; with prolonged use, very rarely - cramps of the calf muscles, coarsening of the voice.

Contraindications for use

• Thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disorders);

• conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;

• multiple or severe risk factors for venous or arterial thrombosis;

• hereditary or acquired predisposition to venous or arterial thrombosis: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);

• migraine with focal neurological symptoms at present or in history;

• uncontrolled arterial hypertension;

• diabetes mellitus with diabetic angiopathy;

• pancreatitis with severe hypertriglyceridemia at present or in history;

• liver failure and severe liver disease (until the normalization of liver function tests);

• liver tumors (benign or malignant), current or history;

• severe dyslipoproteinemia; identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspicion of them;

• vaginal bleeding of unknown origin;

• pregnancy or suspicion of it;

• lactation period (breastfeeding);

• postmenopausal period;

• age under 18;

• simultaneous use with St. John's wort preparations;

• hypersensitivity to the components of the combination.

Carefully

The potential risk and expected benefit of the use of combined oral contraceptive drugs (COCs) in each individual case should be carefully weighed in the presence of the following diseases / conditions or risk factors:

• risk factors for the development of thrombosis and thromboembolism: smoking, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or cerebrovascular accident at a young age in one of the closest relatives), overweight (BMI <30 kg / m2), dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve disease;

• other diseases in which peripheral circulation disorders may occur: diabetes mellitus without diabetic angiopathy, SLE, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;

• hypertriglyceridemia;

• liver disease of mild to moderate severity with normal liver function tests;

• diseases that first appeared or worsened during a previous pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham's chorea);

• women with hereditary angioedema, chloasma, depression, epilepsy.

Application during pregnancy and lactation

Use during pregnancy or suspicion of it is contraindicated; lactation period (breastfeeding).

Application for violations of liver function

Contraindicated in liver failure, liver tumors (hemangioma, liver cancer).

Caution: liver disease

Application for impaired renal function

With caution: kidney disease.

Application in children

The drug is contraindicated for use in children and adolescents under the age of 18 years.

Use in elderly patients

Contraindicated in postmenopausal women.

special instructions

Before starting the use of hormonal contraception and then every 6 months, a general medical and gynecological examination is recommended, including a cytological analysis of a smear from the cervix, an assessment of the state of the mammary glands, determination of blood glucose, cholesterol and other indicators of liver function, blood pressure control, urinalysis.

The use of oral contraception is allowed no earlier than 6 months after the transferred viral hepatitis, provided that the liver functions are normalized.

With the appearance of sharp pain in the upper abdomen, hepatomegaly and signs of intra-abdominal bleeding, a suspicion of a liver tumor may arise.

If liver function is impaired while taking drugs containing this combination, a therapist's consultation is necessary.

If acyclic (intermenstrual) bleeding occurs, this combination should be continued, because in most cases, these bleeding stops spontaneously. If acyclic (intermenstrual) bleeding does not disappear or recur, a medical examination should be carried out to exclude organic pathology of the reproductive system.

In case of vomiting or diarrhea, the drug should be continued using a different, non-hormonal method of contraception.

Women who smoke and take hormonal contraceptives have an increased risk of developing cardiovascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women over 35).

Taking drugs containing a combination of levonorgestrel / ethinyl estradiol should be discontinued in the following cases: when a migraine-like headache appears for the first time or worsens; when an unusually severe headache appears; when there are early signs of phlebitis or phlebothrombosis (unusual pain or swelling of the veins in the legs); if jaundice or hepatitis occurs without jaundice; with cerebrovascular disorders; with the appearance of stabbing pains of unclear etiology when breathing or coughing, pain and tightness in the chest; with an acute deterioration in visual acuity; if you suspect a thrombosis or heart attack; with a sharp increase in blood pressure; when generalized itching occurs; with an increase in epileptic seizures; 3 months before the planned pregnancy; approximately 6 weeks before the planned surgical intervention; with prolonged immobilization;with the onset of pregnancy.

Drug interactions

Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives can increase the metabolism of the steroid hormones that make up the drug.

A decrease in contraceptive efficacy can also be observed with simultaneous administration with some antimicrobial agents (including ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines), which is associated with a change in the intestinal microflora.

With simultaneous use with anticoagulants, coumarin or indandione derivatives , an additional determination of the prothrombin index and a change in the dose of the anticoagulant may be required.

When using tricyclic antidepressants, maprotiline, beta-blockers , their bioavailability and toxicity may increase.

When using oral hypoglycemic drugs and insulin, it may be necessary to change their dose.

When combined with bromocriptine, its effectiveness decreases.

When combined with drugs with a potential hepatotoxic effect, for example, with the drug dantrolene , an increase in hepatotoxicity is observed, especially in women over 35 years old.