Leia - Instructions For The Use Of Tablets, Reviews, Price, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Lei

Leia: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Leya

ATX code: G03AA12

Active ingredient: drospirenone (Drospirenone) + ethinylestradiol (Ethinylestradiol)

Manufacturer: Sindea Pharma S. L. (Cyndea Pharma SL) (Spain)

Description and photo updated: 2018-29-11

Prices in pharmacies: from 397 rubles.

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Leia is a hormonal contraceptive of a combined composition with antimineralocorticoid and antiandrogenic action.

Release form and composition

The drug is produced in the form of film-coated tablets: active - round, biconvex, pink; placebo - round, biconvex, white (in a blister there are 24 active tablets and 4 placebo tablets, in a cardboard box of 1, 2, 3 or 6 blisters and instructions for use of Leah).

Composition of 1 active tablet (pink):

• active ingredients: drospirenone - 3 mg, ethinylestradiol - 0.02 mg;
• auxiliary components: potassium polacrilin, magnesium stearate, povidone K30, lactose monohydrate;
• film shell: opadry II pink 85F34048 (polyvinyl alcohol, talc, titanium dioxide, macrogol 3350, dyes iron oxide yellow and iron oxide red).

Composition of 1 placebo tablet (white):

• auxiliary components: magnesium stearate, povidone K30, potassium polacrilin, colloidal silicon dioxide, lactose monohydrate;
• film casing: opadry II white 85F18422 (polyvinyl alcohol, talc, titanium dioxide, macrogol 3350).

Pharmacological properties

Pharmacodynamics

Leia is a monophasic combined oral contraceptive (COC) that contains estrogen (ethinyl estradiol) and progestogen (drospirenone).

The mechanism of action of the drug Leia is due to various factors. The most important is the ability of the drug to suppress ovulation and change the properties of the cervical canal, as a result of which it becomes impermeable to spermatozoa.

Drospirenone, when used in therapeutic doses, also has antiandrogenic and moderate antimineralocorticoid activity, due to which its pharmacological profile is comparable to that of natural progesterone. This drug is effective in severe premenstrual syndrome (PMS), manifested by engorgement of the mammary glands, severe psychoemotional disorders, weight gain, joint and muscle pain, headache and other symptoms. Drospirenone reduces the appearance of acne (acne), reduces oily skin and hair. Prevents an increase in body weight and the appearance of edema due to fluid retention caused by estrogen, thereby improving the tolerability of Leia.

In combination with ethinyl estradiol, drospirenone has a beneficial effect on the lipid profile, which is characterized by an increased content of high density lipoproteins in the blood plasma.

Thus, Leia not only prevents unwanted pregnancies, but also normalizes the menstrual cycle, reduces the pain of menstruation and the intensity of bleeding, thereby reducing the risk of anemia. In addition, according to epidemiological studies, the use of COCs reduces the risk of ovarian and endometrial cancer.

Pharmacokinetics

Drospirenone

Once in the gastrointestinal tract, the substance is absorbed quickly and almost completely. After a single oral administration, the maximum plasma concentration (C _max) is reached within 1–2 hours and is ~ 38 ng / ml. Bioavailability does not change with meals, depending on individual characteristics it ranges from 76% to 85%.

The decrease in the plasma concentration of drospirenone occurs in two phases, with a half-life (T _½) in the second - 31 hours. As a free steroid, ~ 3-5% of the total concentration of the substance in plasma circulates in the blood. Drospirenone binds to albumin. Does not bind to corticosteroid-binding globulin (CSG) and sex hormone-binding globulin (SHBG). The increase in SHBG induced by ethinyl estradiol does not affect the binding of drospirenone to blood plasma proteins. The average apparent volume of distribution (V _d) is 3.7 ± 1.2 l / kg.

With cyclic administration of Leia, the maximum equilibrium concentration (C _ss) of drospirenone in blood plasma is achieved within 8 days of regular administration and is approximately 70 ng / ml. An increase in the plasma concentration of the substance (due to cumulation) was noted by approximately 2–3 times, due to the ratio of T _1/2 in the terminal phase and the dosing interval. A further increase in the concentration of the substance in plasma was observed between 1 and 6 cycles of taking the drug, a further increase was not observed.

Drospirenone undergoes extensive biotransformation with the formation of metabolites, which are represented mainly by its acidic forms.

The metabolic clearance rate of drospirenone in blood plasma is 1.5 ± 0.2 ml / min / kg. The substance is excreted mainly in the form of metabolites by the kidneys and through the intestines in a ratio of 1.4: 1.2. It is displayed unchanged only in trace amounts. T _{½ of} metabolites is about 24 hours.

Pharmacokinetics in special cases:

• renal failure: with mild severity [creatinine clearance (CC) 50–80 ml / min) C _{ss is} comparable to that in women with normal renal function (CC> 80 ml / min). With moderate severity (CC 30-50 ml / min), plasma concentration increases by an average of 37%. In all groups of patients, drospirenone was well tolerated and did not have a significant effect on the level of potassium in the blood plasma. The pharmacokinetic parameters of drospirenone in women with severe renal insufficiency have not been studied;
• hepatic impairment: with mild to moderate severity (class B according to the Child - Pugh classification) drospirenone was well tolerated. Pharmacokinetic parameters of the substance in patients with severe hepatic impairment have not been studied.

Ethinylestradiol

Once in the gastrointestinal tract, the substance is absorbed quickly and almost completely. After a single oral administration, C _{max is} reached within 1–2 hours and amounts to ~ 33 ng / ml.

The absolute bioavailability due to presystemic conjugation and first-passage metabolism is about 60%. With the simultaneous intake of food, the bioavailability of ethinyl estradiol decreases in about 25% of women, in the rest of the patients changes are not observed.

The decrease in the plasma concentration of ethinyl estradiol occurs in two phases with a T _{1/2 of} approximately 24 hours.

Ethinylestradiol significantly (~ 98.5%) and not specifically binds to blood plasma albumin. Causes an increase in plasma concentrations of SHBG. The average apparent V _d is about 5 l / kg.

The drug undergoes presystemic conjugation in the mucous membrane of the small intestine and in the liver. Primarily metabolized by aromatic hydroxylation with the formation of various methylated and hydroxylated metabolites (free metabolites, as well as in the form of conjugates with sulfuric and glucuronic acids). The metabolic clearance rate is approximately 5 ml / min / kg.

Ethinyl estradiol is metabolized completely, therefore, it is almost not excreted unchanged. Metabolites are excreted by the kidneys and through the intestines in a ratio of 4: 6. T _½ is about 24 hours.

C _{ss is} reached during the second half of the cycle of taking the drug, while the plasma concentration of ethinyl estradiol increases by about 1.4–2.1 times.

According to preclinical data obtained in standard studies for the presence of genotoxicity, toxicity with repeated administration of the drug, carcinogenic potential, as well as toxicity to the reproductive system, the drug does not pose a particular risk to humans. However, it is worth remembering that sex hormones can enhance the growth of some hormone-dependent tumors and tissues.

Indications for use

• contraception;
• contraception and treatment of severe forms of PMS;
• contraception and therapy for moderate acne (acne vulgaris).

Contraindications

Absolute (the use of Leia is strictly contraindicated):

• bleeding from the vagina of unspecified etiology;
• diagnosed or suspected hormone-dependent malignant diseases (including genitals or mammary glands);
• lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
• the presence of a current or history of migraine with focal neurological symptoms;
• pancreatitis associated with the presence of severe triglyceridemia, present or history;
• adrenal insufficiency;
• severe liver disease (before normalization of liver function indicators);
• liver failure;
• liver tumors (both malignant and benign), including a history;
• acute or severe renal failure;
• conditions that can cause the development of thrombosis (for example, transient ischemic attacks or angina pectoris), currently or in history;
• hereditary or acquired predisposition to the development of venous / arterial thrombosis: antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant), protein S or protein C deficiency, hyperhomocysteinemia, antithrombin III deficiency, resistance to activated protein C;
• multiple or pronounced risk factors for venous / arterial thrombosis: atrial fibrillation, complicated lesions of the valvular apparatus of the heart, uncontrolled arterial hypertension, diseases of the coronary arteries or cerebral vessels, diabetes mellitus with vascular complications, severe dyslipoproteinemia, extensive trauma or serious surgical immobilization followed by, obesity with a BMI (body mass index) of more than 30 kg / m ², smoking over the age of 35;
• venous / arterial thrombosis and thromboembolism (myocardial infarction, pulmonary thromboembolism, deep vein thrombosis) or cerebrovascular disorders currently or in history;
• the period of pregnancy and breastfeeding;
• hypersensitivity to any component of the drug.

If any of the above diseases / conditions first occurs during the period of COC use, contraceptive therapy should be discontinued immediately.

Relative (the use of Leia is possible after a thorough assessment of the balance of benefits and risks, under the close supervision of a physician):

• postpartum period;
• hereditary angioedema;
• diseases that first appeared or worsened during a previous pregnancy or previous use of sex hormones (for example, herpes of pregnant women, otosclerosis with hearing impairment, Sydenham's chorea, porphyria, cholestasis, cholelithiasis, jaundice);
• liver disease;
• hypertriglyceridemia;
• the presence of risk factors for the development of thrombosis / thromboembolism: cerebrovascular accident or myocardial infarction at a young age in any close relative, thrombosis (including in history), controlled arterial hypertension, heart rhythm disturbances, heart valve disease without complications, migraine without focal neurological symptoms, dyslipoproteinemia, obesity with a BMI of less than 30 kg / m ², smoking;
• the presence of diseases that can cause disorders of peripheral circulation: ulcerative colitis, Crohn's disease, hemolytic uremic syndrome, systemic lupus erythematosus, diabetes mellitus, sickle cell anemia, phlebitis of superficial veins.

In case of aggravation or aggravation of any disease / condition / risk factor described above, it is necessary to consult a doctor, who will decide whether it is advisable to continue taking Leia or to stop taking it.

Leia, instructions for use: method and dosage

Leia's tablets should be taken orally, daily for 28 days, at about the same time of day, with plenty of water. Follow the order indicated on the blister pack. You do not need to take a break in taking this drug, that is, after the end of the current package, the next day you need to start taking the pills from the next one, adhering to the established schedule for using the drug.

Directions for taking Leia depend on the circumstances:

• in the previous month, no hormonal contraceptives were taken: the first pill should be taken on the first day of menstruation. You can start taking it in any of the first 5 days of the menstrual cycle, but during the first 7 days, you must additionally use a barrier method of contraception. Withdrawal bleeding usually occurs 2–3 days after the start of the placebo pill (white) and may continue at the start of the active pill (pink);
• switching from other COCs: the first dose of Leia tablets should be the next day after taking the last active tablet of the withdrawn COC. It is allowed to start taking it later, but not more than the next day after the usual 7-day break (with the previous intake of COCs with 21 active tablets in the package) or after taking the last placebo tablet (with the previous intake of COCs with 28 active tablets in the package);
• switching from a transdermal patch or vaginal ring: it is advisable to start taking Leia on the day the patch / ring is removed. You can start taking it later, but no more than the day when you need to stick a new patch or install a new ring;
• switching from contraceptives containing only progestogens (intrauterine contraceptive, implant, mini-pills, injectable contraceptives): intrauterine therapeutic system or implant - the first dose of Leia is recommended on the day of their removal; "Mini-drank" - any day, but without interruptions in the reception; injectable contraceptives - Leia's first pill should replace the next injection. In all cases described, women should use an additional reliable method of contraception for the first 7 days;
• abortion in the first trimester of pregnancy: it is advisable to start taking Leia from the first day of termination of pregnancy, additional precautions are not required in this case;
• abortion in the second trimester of pregnancy or childbirth: the first pill should be taken 21-28 days after the termination of pregnancy or childbirth (provided that the woman is not breastfeeding). It is possible to start taking Leia's drug later, but then during the first 7 days of its use, additional barrier protection is required; if you have had sexual intercourse before, pregnancy should be excluded.

Missed pills and gastrointestinal disturbances

If you miss a placebo pill, you do not need to take any action. However, the pills that have not been taken should be thrown away so as not to accidentally take them later, as this will prolong the placebo intake.

Recommendations apply only to skipping active pills. If the delay is less than 24 hours, you should take the missed pill as soon as the woman remembers, then adhere to the usual schedule. In this case, contraceptive protection is not reduced.

If the delay is more than 24 hours, the contraceptive effect of the drug may be reduced. The more pills are not taken, and the closer the period of taking the placebo pills, the higher the likelihood of pregnancy. In such cases, the following general and specific rules should be followed.

General instructions:

• never interrupt the appointment for more than 7 days;
• during the first 7 days of admission, use additional barrier protection - this is how much time is needed to adequately suppress the hypothalamic-pituitary-ovarian system.

Specific instructions for women in whom the gap in taking the active pill was more than 24 hours depends on the day of the menstrual cycle on which the delay occurred:

• days 1 to 7: take the pill as soon as the patient remembers it, even if you have to take 2 pills right away. In the future, adhere to the usual schedule for using the drug Leia, but use barrier contraception in the first 7 days. If on any of the previous 7 days there was sexual intercourse, the likelihood of pregnancy must be taken into account;
• days 8 to 14: take the pill as soon as the patient remembers it, even if you have to take 2 pills right away. In the future, adhere to the usual schedule for using Leia. If in the 7 days prior to missing one tablet, the woman strictly followed the recommendations for admission, barrier contraception will not be needed. If you missed taking two or more pills, or there were violations in the schedule of use, additional contraceptive protection must be used within 7 days;
• days 15 to 24: option 1 - take the pill as soon as the patient remembers it, even if you have to take 2 pills right away. In the future, adhere to the usual schedule for using the drug Leia until the end of the active pills, placebo pills should be thrown out and start taking active pills from a new package. Consideration should be given to the likelihood of spotting or breakthrough bleeding. Option 2 - stop taking active pills for 4 days (including skipping days) and start taking the drug from a new package. If withdrawal bleeding does not appear while taking the placebo pills from the new package, a pregnancy test should be done. In both cases, there is no need to use additional barrier protection if the woman took the contraceptive correctly during the 7 days preceding the pass. If not, additional contraception is required within 7 days.

In case of gastrointestinal disorders, the absorption of the drug may be impaired. If vomiting / diarrhea occurs after taking the active tablet within 4 hours, the recommendations for taking the missed tablets should be followed. In order not to change the usual dosage regimen and not to postpone the onset of menstruation to another day of the week, you can use a pill from a new package to replace the missed dose.

Change in day of onset of menstrual bleeding

• postponement of the day of the onset of menstruation: do not take placebo pills, but continue taking active pills from a new package for such a number of days to which you need to postpone the onset of withdrawal bleeding, if necessary, until the end of active pills from the second package However, it should be noted that the occurrence of spotting or breakthrough uterine bleeding is possible. After the end of taking the placebo pills from the second package, you need to resume the usual regimen of Leia's drug;
• shift of the day of the beginning of menstruation to another day of the week: reduce the intake of placebo tablets by the required number of days. The shorter this interval, the higher the likelihood of no withdrawal bleeding, and later (while taking the second pack) - the appearance of spotting and breakthrough bleeding.

Side effects

Classification of the frequency of adverse reactions: very often -> 10%, often - from ≥ 1% to <10%, infrequently - from ≥ 0.1% to <1%, rarely - from ≥ 0.01% to <0.1%, very rarely - <0.01%, unknown frequency - it is not possible to determine the frequency of development from the available data.

Adverse reactions from organs and systems according to clinical studies:

• from the genitals and mammary gland: often - absence of menstrual bleeding, metrorrhagia, pain and engorgement of the mammary glands; infrequently - hot flashes, dryness of the vaginal mucosa, leucorrhoea, galactorrhea, pain in the pelvic region, ovarian cyst, scanty menstrual bleeding, painful menstrual bleeding, enlarged mammary glands, breast neoplasms, decreased libido, change in Pap smear results; rarely - profuse menstrual bleeding, postcoital bleeding, dyspareunia, enlargement of the uterus, vaginitis, endometrial atrophy, cervical polyp, cervical neoplasia, fibrocystic mastopathy;
• from the immune system: infrequently - allergic reactions; rarely - bronchial asthma; unknown frequency - hypersensitivity reactions; in women with hereditary angioedema - manifestation of the disease or its exacerbation;
• from the nervous system: often - headache; infrequently - dizziness, paresthesia, migraine; rarely - tremor;
• on the part of the organ of hearing and vision: infrequently - dry eye syndrome, conjunctivitis, visual impairment; rarely - hearing loss;
• from the digestive system: often - nausea; infrequently - diarrhea, vomiting, gastroenteritis; rarely - abdominal pain or bloating, constipation;
• from the kidneys and urinary tract: infrequently - cystitis;
• from the liver and biliary tract: rarely - cholecystitis;
• on the part of the cardiovascular system: infrequently - pulmonary thromboembolism, tachycardia, increase / decrease in blood pressure (BP), extrasystoles, varicose veins; rarely - syncope, arterial / venous thromboembolism;
• on the part of the endocrine system: very rarely - a change in glucose tolerance or an effect on insulin resistance;
• from the respiratory system: pharyngitis;
• on the part of the blood and lymphatic system: rarely - thrombocytopenia, anemia;
• on the part of musculoskeletal and connective tissue: infrequently - muscle cramps, pain in the lumbar region, neck or limbs;
• on the part of the skin and subcutaneous tissues: infrequently - skin rashes, itching of the skin, acne, seborrhea; rarely - dry skin, acneform dermatosis, photodermatitis, eczema, erythema nodosum, hypertrichosis, alopecia, striae, erythema multiforme;
• mental disorders: often - emotional lability; infrequently - sleep disorders, nervousness, depression; rarely - anorgasmia;
• infectious and parasitic diseases: infrequently - herpes simplex, oral mucosa candidiasis, vaginal candidiasis;
• laboratory data: infrequently - hyponatremia, hyperkalemia;
• others: often - an increase in body weight; infrequently - asthenia, sweating, excessive thirst, edema, weight loss, anorexia, increased appetite.

In the course of post-marketing studies, cases of severe adverse reactions were identified (frequency unknown): increased blood pressure, arterial and venous thromboembolic complications, liver neoplasms. The relationship of their occurrence with taking Leia's drug has not been proven with the development or worsening of the following diseases in the patient: herpes of pregnant women, uterine fibroids, chloasma, Sydenham's chorea, porphyria, epilepsy, cholestatic jaundice, hemolytic uremic syndrome, ulcerative colitis, Crohn's disease, systemic lupus erythematosus …

In women taking COCs, the frequency of breast cancer diagnostics is slightly increased, however, a causal relationship with the use of hormonal contraceptives has not been established.

Overdose

To date, there have been no reports of an overdose of Leia.

Taking into account the clinical experience of using COCs, it is possible to assume the development of the following symptoms in case of an overdose: metrorrhagia or spotting spotting, nausea, vomiting. There is no antidote, symptomatic treatment.

special instructions

Before prescribing Leia and after resuming the intake in case of a break, the doctor should exclude pregnancy, as well as study the woman's personal and family history, conduct a thorough gynecological (including cytology of cervical mucus and examination of the mammary glands) and general medical examination (including determining the mass index body, measurement of blood pressure and heart rate). The nature and frequency of subsequent control studies are determined individually, but it is recommended to conduct them at least once every six months.

Every patient should be warned that Leia does not protect against any sexually transmitted diseases (including HIV).

The contraceptive effect of the drug may decrease in case of skipping active pills, vomiting and diarrhea, as well as the simultaneous use of certain drugs.

While taking COCs, irregular bleeding is possible (spotting, breakthrough bleeding), especially in the first months of taking the drug. In this regard, the assessment of irregular menstruation should be carried out only after the adaptation period, which is usually 3 cycles. If irregular bleeding recurs after 3 menstrual cycles or develops after previous regular cycles, careful medical examination is indicated to rule out pregnancy and the likely presence of malignant neoplasms.

Some women may not have withdrawal bleeding while taking the placebo pill (white). If Leia is used as directed by a doctor, pregnancy is unlikely. If there have been violations of the dosage regimen, as well as in cases where withdrawal bleeding does not occur two cycles in a row, pregnancy must be excluded.

COCs can affect the results of some laboratory tests, including indicators of carbohydrate metabolism, the level of transport proteins in plasma, parameters of fibrinolysis and coagulation, indicators of adrenal, kidney, liver and thyroid function. As a rule, these changes do not exceed the upper bounds of normal values.

Drospirenone has an anti-mineralocorticoid effect, therefore it is able to increase the activity of plasma renin and aldosterone.

Tumors

Persistent human papillomavirus infection is the most significant risk factor for cervical cancer. However, there are reports that long-term use of COCs slightly increases this risk, although the connection with the use of oral contraceptives has not been proven. Therefore, to date, there are controversies regarding the degree of connection of these data with the frequency of screening for possible pathologies of the cervix or with features of sexual behavior (more rare use of barrier contraception).

According to a meta-analysis of 54 epidemiological studies, women who are currently taking COCs are at a slightly increased relative risk of developing breast cancer (relative risk is 1.24). Within 10 years after stopping the use of COCs, the degree of risk gradually decreases and disappears.

Given the fact that breast cancer is rarely diagnosed in women under 40 years of age, the increase in the number of diagnoses in women who received oral contraceptives at the time of the study or before that is insignificant in relation to the overall risk of this pathology. The observed increase may be due to an earlier diagnosis of the disease, the biological effect of COCs, or a combination of both factors. Due to the need for frequent screening while taking oral contraceptives, women who take them, breast cancer is usually detected at earlier stages than women who have never taken COCs.

There are rare cases of development of benign liver tumors against the background of the use of COCs, extremely rare - malignant ones, sometimes leading to intra-abdominal bleeding, life-threatening (possibly fatal). In this regard, taking the drug Leia should be taken into account in the differential examination of a patient with complaints of severe pain in the abdomen, an enlarged liver, or signs of intra-abdominal bleeding.

Diseases of the cardiovascular system

Arterial / venous thrombosis and thromboembolism (cerebrovascular disorders, myocardial infarction, pulmonary embolism, deep vein thrombosis) occur rarely while taking COCs. However, according to epidemiological studies, oral contraceptives increase the incidence of these diseases.

The likelihood of developing venous thromboembolism (VTE) is highest in the first year of COC use. After the initial use of COCs or resumption of its use (the same drug or another) after a break of 4 weeks, an increased risk is noted during the first 3 months.

The overall risk of developing VTE in women receiving low-dose COCs (<50 mcg ethinyl estradiol) is 2-3 times higher than in patients not taking oral contraceptives. However, compared with the risk of VTE during pregnancy and childbirth, this risk is lower. Venous thromboembolism is a potentially life-threatening complication of the patient, which is fatal in 1–2% of cases.

Deep vein thrombosis and pulmonary embolism can develop with the use of any COC.

Thrombosis of other blood vessels, for example, renal, hepatic, mesenteric, cerebral arteries and veins, and retinal vessels, occurs extremely rarely against the background of hormonal contraceptive therapy.

Deep vein thrombosis (DVT) can manifest with the following symptoms: redness or discoloration of the skin on the leg, pain or discomfort only in an upright position or only when walking, unilateral edema of the lower limb or along a vein in the leg, local temperature increase.

Pulmonary embolism (PE) manifests itself with symptoms such as sudden cough (including hemoptysis), rapid or difficult breathing, acute chest pain (worse with deep breath), rapid or irregular heartbeat, severe dizziness, anxiety … Some signs are nonspecific (for example, cough and shortness of breath) and can therefore be misinterpreted and mistaken for symptoms of other conditions (for example, respiratory tract infection).

Arterial thromboembolism can lead to the development of vascular occlusion, stroke and myocardial infarction.

The main signs of a stroke are sudden weakness and / or confusion, sudden one- or two-way vision loss, problems with speech and understanding, loss of sensation in the face, leg, or arm (especially on one side of the body), dizziness, sudden gait disturbance, loss of coordination of movements or balance, prolonged or severe headache for no apparent reason, loss of consciousness or fainting, including with an epileptic seizure. Other signs of vascular occlusion: acute abdomen symptom complex, sudden pain, slight blue discoloration and swelling of the extremities.

The main signs of myocardial infarction: heaviness, pressure, discomfort, pain, a feeling of fullness or tightness in the chest or behind the sternum, a feeling of discomfort radiating to the jaw, back, epigastric region and / or left upper limb, rapid or irregular heartbeat, severe weakness, dizziness, cold sweat, anxiety, nausea, vomiting, shortness of breath. Arterial thromboembolism is life-threatening and can be fatal.

The risk of developing venous and / or arterial thrombosis and thromboembolism increases in the following cases:

• arterial hypertension;
• atrial fibrillation;
• heart valve disease;
• dyslipoproteinemia;
• migraine;
• obesity with a BMI over 30 kg / m ²;
• increasing age;
• smoking (the risk increases with the number of cigarettes smoked per day and with increasing age, especially in women over 35);
• an unfavorable family history (for example, the development of thromboembolism in one of the parents or close relatives at a relatively young age);
• prolonged immobilization, extensive trauma, neurosurgical operations, serious interventions, any surgical interventions on the lower limbs or pelvic area. In all these cases, Leia should be discontinued, in the case of a planned operation - at least 4 weeks in advance and resumed no earlier than 2 weeks after the end of immobilization. It should be borne in mind that the risk factor for VTE also includes temporary immobilization, for example, a long flight (more than 4 hours).

The risk of developing thrombosis and thromboembolism is mutually increased when several of the factors described are combined.

The risk of thromboembolism is increased in the postpartum period.

The question of the possible influence of varicose veins and superficial thrombophlebitis on the development of venous thromboembolism is still controversial.

Peripheral circulation disorders are also possible with the following diseases: diabetes mellitus, sickle cell anemia, hemolytic uremic syndrome, systemic lupus erythematosus, chronic inflammatory bowel disease (Crohn's disease, ulcerative colitis).

In case of an increase in the severity and frequency of migraine episodes against the background of contraceptive therapy, Leia should be discontinued immediately, since this condition may precede cerebrovascular disorders.

Biochemical indicators indicating a hereditary or acquired predisposition to the development of thrombosis: deficiency of antithrombin III, protein C or protein S, resistance to activated protein C, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant), hyperhomocysteinemia.

When assessing the benefits of taking Leia and the risk of complications during its use, it should be borne in mind that adequate treatment of the existing disease / condition can reduce the associated risk of thrombosis. It is also important to know that the risk of thrombosis and thromboembolism in pregnant women is higher than in patients taking low-dose oral contraceptives (<0.05 mg ethinyl estradiol).

There is some evidence that COCs with drospirenone in the formulation have a higher risk of thromboembolic complications than COCs containing norgestimate, norethindrone, or levonorgestrel.

Other conditions

If a woman has hypertriglyceridemia or has a family history, COCs may increase the risk of developing pancreatitis.

In patients with hereditary forms of angioedema, ethinyl estradiol may cause or worsen symptoms of the disease.

Many women have a slight increase in blood pressure, but clinically significant cases are rare. Nevertheless, with a persistent, clinically significant increase in blood pressure, you should stop taking Leia tablets and begin treatment of arterial hypertension. Taking COCs can be resumed only after reaching normal blood pressure with antihypertensive therapy.

The following conditions can develop or worsen not only during pregnancy, but also when taking COCs, however, their relationship with the use of oral contraceptives has not been proven: pruritus associated with cholestasis and / or jaundice, herpes of pregnant women, gallstones, hemolytic uremic syndrome, porphyria, Sydenham's chorea, systemic lupus erythematosus, hearing loss associated with otosclerosis. There are also known cases of ulcerative colitis and Crohn's disease.

Clinical studies have shown that drospirenone has no effect on the plasma potassium concentration in the presence of mild or moderate renal failure. The potential risk of developing hyperkalemia is in women with concomitant renal dysfunction with an initial potassium concentration at the upper limit of the norm, taking simultaneously drugs that cause potassium retention in the body. If there is a risk of hyperkalemia, it is recommended to monitor the plasma potassium level during the first cycle of taking Leia.

In acute and chronic disorders of hepatic function, it may be necessary to temporarily discontinue the drug Leia until the functional parameters of the liver return to normal.

It is necessary to cancel COCs in case of recurrence of cholestatic jaundice, which was first diagnosed with a previous intake of sex hormones or a previous pregnancy.

There are known cases of the development of chloasma while taking COCs, especially in women with chloasma during a previous pregnancy. Patients at risk are advised to avoid prolonged sun exposure and exposure to ultraviolet radiation.

COCs can affect glucose tolerance and insulin resistance, however, in women receiving low-dose drugs (including Leia's drug), as a rule, there is no need to adjust the dose of hypoglycemic drugs. Nevertheless, patients with diabetes mellitus are recommended to be closely monitored by an endocrinologist.

Cases of epilepsy and depression occurring while taking COCs have been described.

Influence on the ability to drive vehicles and complex mechanisms

The influence of the components of Leia tablets on the reaction rate and concentration of attention has not been established.

Application during pregnancy and lactation

Epidemiological studies have not identified the risk of congenital developmental defects in children whose mothers took COCs before pregnancy. Also, no teratogenic effect was found in children whose mothers took the drug in early pregnancy through negligence. However, the available data on the use of Leia during pregnancy is insufficient to fully assess the degree of its effect on the course of pregnancy, fetal and newborn health. In this regard, Leia is contraindicated in pregnant women. If pregnancy occurs while using COCs, it should be discontinued immediately.

COCs can alter the quality of breast milk and reduce the amount. Sex hormones and / or their metabolites can pass into the mother's milk in small amounts and possibly affect the infant. In this regard, Leia is contraindicated during lactation.

Pediatric use

Leia can only be used on girls after menarche. No dose adjustment is required.

With impaired renal function

In acute and severe renal failure, the drug is contraindicated.

For violations of liver function

In liver disease, Leia is prescribed with caution, after a careful assessment of the balance of benefits and risks, under the close supervision of a physician.

In severe liver diseases, the drug should not be taken until the functional parameters of the liver are normalized.

With liver failure, Leia is contraindicated.

Use in the elderly

Leia is intended for contraception and is therefore not used after menopause.

Drug interactions

The simultaneous use of certain drugs can reduce the contraceptive activity of the drug or cause the development of breakthrough bleeding. In this regard, taking any medications while using Leia tablets must be coordinated with your doctor.

An increase in the clearance of sex hormones can be caused by inducers of microsomal liver enzymes: rifampicin, carbamazepine, phenytoin, primidone, barbiturates, and also, presumably, griseofulvin, topiramate, oxcarbazepine, felbamate, St. John's wort.

Non-nucleoside reverse transcriptase inhibitors (for example, nevirapine), HIV protease (for example, ritonavir), and their combinations have the potential to influence hepatic metabolism of sex hormones.

Some antibiotics (for example, tetracycline and penicillins) can reduce intestinal-hepatic recirculation of estrogens and, as a result, reduce their concentration.

While taking antibiotics such as tetracyclines and ampicillins, and for 7 days after their cancellation, you must use an additional barrier method of contraception. If, in any of these 7 days, the active tablets (pink) run out in the packaging of Leia, you must discard the placebo tablets (white) and start taking the active tablets from the new packaging.

Drugs that affect microsomal enzymes reduce the contraceptive effect of Lei tablets, therefore, during their administration and within 28 days after withdrawal, additional barrier contraceptive protection is required.

Like other COCs, Leia can affect the metabolism of other drugs, which may cause changes in their concentration in plasma and tissues, for example, an increase in the concentration of cyclosporine, a decrease in lamotrigine.

Drospirenone is metabolized without the participation of isoenzymes of the cytochrome P _{450 system}, therefore, inhibitors of these isoenzymes can hardly affect the metabolism of the drug.

According to in vitro and in vivo interaction studies, the effect of drospirenone (when taken in a daily dose of 3 mg) on the metabolism of midazolam, simvastatin and omeprazole is unlikely.

Presumably, Leia can increase the plasma concentration of potassium while using the following drugs: potassium-sparing diuretics, ACE (angiotensin converting enzyme) inhibitors, angiotensin II receptor antagonists, aldosterone antagonists, some nonsteroidal anti-inflammatory drugs. However, in studies of the interaction of drospirenone with indomethacin and ACE inhibitors, there was no significant difference between the plasma potassium concentrations compared with the simultaneous use of placebo. Nevertheless, if it is necessary to simultaneously use drugs that can increase the plasma concentration of potassium, it is recommended to monitor this indicator during the first cycle of taking Leia.

Every woman is advised to study the instructions for use before taking any medication, since they usually indicate possible interactions with COCs.

Analogs

Leah's analogs are: Anabella, Belara, Dimia, Gestarella, Dailla, Jess, Evra, Genetten, Mikroginon, Zoely, Tri-Regol, Lindinet 20, Lindinet 30, Logest, Marvelon, Janine, Mersilon, Midiana, Miniziston 20 fem, Bonade, Novinet, Oralkon, Regulon, Rigevidon, Silest, Siluet, Tri-Mersey, Trigestrel, Trikvilar, Themiss Messi, Femoden, Yarina, etc.

Terms and conditions of storage

Store at temperatures up to 30 ° C in a place out of the reach of children, protected from moisture.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Leia

Reviews about Leia are somewhat controversial. Most patients point to the effectiveness of this contraceptive drug, noting the presence of a beneficial effect on acne and PMS, good tolerance, ease of administration (without interruptions), the presence of an envelope for storing a blister with pills, as well as low cost compared to many analogues, including the popular and common jess.

Rare negative reviews contain complaints of adverse reactions, including decreased libido, headache, nausea, spotting spotting during the entire period of taking active pills, uterine bleeding, fatigue, irritability. There are isolated reports of the onset of pregnancy while taking the drug. Some women consider it a disadvantage to label the tablets on the blister not by numbers, but by days of the week, moreover, from Monday, which creates inconvenience and confusion in counting receptions.

Leia price in pharmacies

Approximate prices for Leia: for a pack of 28 tablets - 432-599 rubles, for a pack of 84 tablets - 1298-1439 rubles.

Leia: prices in online pharmacies

Drug name Price Pharmacy

Leia 3 mg + 0.02 mg a set of tablets film-coated tablets 24 tablets. active + 4 tab. placebo 28 pcs. 397 r Buy

Leia pills p.o. 3mg + 0.02mg 28 pcs. 408 RUB Buy

Leia 3 mg + 0.02 mg a set of tablets film-coated tablets 24 tablets. active + 4 tab. placebo 84 pcs. 982 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!