Leya pills 3mg+0.02mg, 84pcs

Composition

Tablets covered with a film-coated pink color, round, biconvex. 1 tab.

Drospirenone 3 mg

ethinyl estradiol 0.02 mgm Auxiliary substances:

lactose monohydrate – 68.18 mg,

potassium polacrylin-4 mg,

povidone K 30-4 mg,

magnesium stearate-0.8 mg. Shell composition:

opadray II pink 85F34048 – 2 mg (macrogol 3350-0.404 mg, titanium dioxide-0.496 mg, polyvinyl alcohol-0.8 mg, talc-0.296 mg, iron oxide red dye-0.0036 mg, iron oxide yellow dye-0.0004 mg). Placebo tablets are white, round, and biconvex. Auxiliary substances:

lactose monohydrate – 73.4 mg,

potassium polacrylin-1.6 mg,

povidone K-30-4 mg,

colloidal silicon dioxide-0.2 mg,

magnesium stearate-0.8 mg. Shell composition:

opadray II white 85F18422 – 2 mg (macrogol-3350-0.8 mg, titanium dioxide-0.5 mg, polyvinyl alcohol-0.404 mg, talc-0.296 mg).

Pharmacological action

Monophasic oral contraceptive with antiandrogenic properties

Indications

-contraception

— – contraception and treatment of moderate acne (acne vulgaris);

— contraception and treatment of severe premenstrual syndrome (PMS).

Contraindications

Leia is contraindicated in the presence of any of the conditions listed below; if any of these conditions occur for the first time during COC treatment, they should be discontinued immediately.

— thrombosis (venous and arterial) and thromboembolism in the present or in history (including deep vein thrombosis, pulmonary embolism, myocardial infarction), cerebrovascular disorders (including in the anamnesis);

— status, previous thrombosis (including transient ischemic attack, angina) in the present or in the anamnesis;

— hereditary or acquired predisposition for venous or arterial thrombosis, such as resistance to activated protein C, antithrombin III deficiency, deficiency of protein C deficiency protein S, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);

— migraine with focal neurological symptoms in the present or in the anamnesis;

— multiple or severe risk factors for venous or arterial thrombosis, including the complicated lesions of valvular apparatus of the heart, atrial fibrillation; vascular diseases of the brain or coronary arteries; uncontrolled hypertension; severe dislipoproteinemia, diabetes mellitus with vascular complications, major surgery with prolonged immobilization; Smoking age 35 years; obesity with a BMI over 30 kg/m 2; extensive injury;

— liver failure, severe liver disease (up to normalization of liver function);

— liver tumors (benign or malignant), including in the anamnesis;

— severe renal insufficiency, acute renal failure;

— adrenal insufficiency;

— pancreatitis, including history, if associated with the presence of heavy triglyceridemia;

— identification of hormone-dependent cancers (including genitalia or mammary glands) or suspected them;

— vaginal bleeding of unknown etiology;

— pregnancy or suspicion of it;

— the period of breastfeeding;

— lactose intolerance, lactase deficiency, glucose-galactose malabsorption (includes lactose monohydrate);

— hypersensitivity to any component of the drug Leia.

With caution

If the patient has any of the conditions / risk factors listed below, the potential risk and expected benefit of using COCs, including Leia, should be carefully weighed.

— risk factors for the development of thrombosis and thromboembolism: Smoking, thrombosis (including in history), myocardial infarction or cerebrovascular accident at a young age in any of the next of kin; obesity with a BMI less than 30 kg/m 2; dislipoproteinemia; controlled hypertension; migraine without focal neurologic symptoms; diseases of the heart valves without complications; irregular heartbeat;

— other diseases in which can be observed peripheral circulatory disorders: diabetes mellitus, systemic lupus erythematosus; hemolytic uremic syndrome; Crohn’s disease and ulcerative colitis; sickle-cell anemia; and phlebitis of superficial veins;

hereditary angioedema;

hypertriglyceridemia;

— liver disease;

— disorders for the first time incurred or aggravated during pregnancy or in the background of previous use of sex hormones (eg, jaundice, cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes pregnant, Sydenham’s chorea);

— postpartum period.

Side effects

Data from clinical trials

, the Frequency of adverse reactions is presented in accordance with the classification of the Medical dictionary for regulatory activities (MedDRA): very often (>10%), often (≥1% <10%), infrequently (≥0.1% <1%), rarely (≥0.01% <0.1%), very rare (<0.01%), frequency unknown (to determine the frequency of the available data is not possible).

Infectious and parasitic diseases: infrequently-candidiasis of the oral mucosa, vaginal candidiasis, herpes simplex.

From the immune system:  infrequently-allergic reactions, rarely-bronchial asthma; frequency unknown-hypersensitivity reactions.

Blood and lymphatic system disorders: rarely-anemia, thrombocytopenia.

Mental disorders:  often-emotional lability; infrequently-depression, nervousness, sleep disorder; rarely-anorgasmia.

Nervous system disorders: often – headache; infrequently-paresthesia, dizziness, migraine; rarely-tremor.

From the side of the visual organ: infrequently – conjunctivitis, dry eye syndrome, visual disturbances.

Hearing disorders and labyrinth disorders: rarely-hearing loss.

From the side of the heart: infrequently – extrasystoles, tachycardia.

From the side of blood vessels: infrequently – pulmonary embolism, increased blood pressure, decreased blood pressure, varicose veins; rarely-arterial and venous thromboembolism, syncope.

Respiratory, thoracic and mediastinal disorders: pharyngitis.

From the gastrointestinal tract: often – nausea; infrequently-vomiting, gastroenteritis, diarrhea; rarely-constipation, abdominal pain, bloating.

Liver and biliary tract disorders: rarely-cholecystitis.

Skin and subcutaneous tissue disorders: infrequently-pruritus, rash, seborrhea, acne; rarely-alopecia, dry skin, eczema, photodermatitis, acneform dermatosis, hypertrichosis, striae, erythema nodosum, erythema multiforme.

Musculoskeletal and connective tissue disorders: infrequently – pain in the neck, limbs, lumbar region; muscle cramps.

From the side of the kidneys and urinary tract: infrequently – cystitis.

From the genitals and breast:  often, breast pain, engorgement, metrorrhagia, no menstrualnopodobnoe bleeding; rarely, tumors of the mammary glands, galactorrhea, ovarian cyst, “tides”, leukorrhea, dryness of the vaginal mucosa, pain in the pelvic area, changes on Papanicolaou smear, decreased libido, breast enlargement, painful menstrualnopodobnoe bleeding, poor menstrualnopodobnoe bleeding; rarely – fibrocystic breast disease, vaginitis, cervical polyps, neoplasia of the cervix, endometrial atrophy, abundant menstrualnopodobnoe bleeding, dyspareunia, postcoital bleeding, the bleeding of “cancel”, the increase in size of the uterus.

From the endocrine system:  very rarely-changes in glucose tolerance or effects on insulin resistance.

General disorders and disorders at the injection site: often-weight gain; infrequently-increased appetite, weight loss, anorexia, edema, asthenia, excessive thirst, sweating.

Laboratory and instrumental data: infrequently-hyperkalemia, hyponatremia.

Post-marketing application data

The following severe adverse reactions with unknown frequency have been reported in women taking COCs: venous thromboembolic complications, arterial thromboembolic complications, increased blood pressure, and liver neoplasms.

The association with the use of COCs is not convincing when the following diseases appear or worsen: Crohn’s disease, ulcerative colitis, epilepsy, uterine fibroids, porphyria, systemic lupus erythematosus, herpes of pregnant women, Sydenham’s chorea, hemolytic-uremic syndrome, cholestatic jaundice, chloasma.

Acute and chronic hepatic impairment may require discontinuation of COCs until markers of hepatic function return to normal.

In women with hereditary angioedema, exogenous estrogens can cause the disease to manifest or worsen.

The rate of breast cancer diagnosis among women taking COCs is slightly increased, although a causal relationship with COCs has not been established.

Interaction

The interaction of oral contraceptives with other medications can lead to” breakthrough ” bleeding and/or a decrease in contraceptive reliability.Women taking these medications should temporarily use barrier methods of contraception in addition to taking Leia, or choose a different method of contraception.

The use of drugs that induce microsomal liver enzymes can lead to an increase in the clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John’s wort.

HIV proteases (e. g. ritonavir) and non-nucleoside reverse transcriptase inhibitors (e. g. nevirapine) and their combinations also have the potential to affect hepatic metabolism.

According to some studies, some antibiotics (such as penicillins and tetracycline) can reduce the intestinal-hepatic recycling of estrogens, thereby lowering the concentration of ethinyl estradiol.

When taking medications that affect microsomal enzymes, and for 28 days after their withdrawal, you should additionally use a barrier method of contraception.

When taking antibiotics (such as ampicillins and tetracyclines) and for 7 days after their withdrawal, you should additionally use a barrier method of contraception. If you run out of active (pink) tablets during these 7 days of using the barrier method of contraception, then you should skip taking placebo tablets (white) from the current package and start taking tablets from the next package of Leia. The main metabolites of drospirenone are formed in plasma without the participation of cytochrome P450 isoenzymes. Therefore, the effect of inhibitors of cytochrome P450 isoenzymes on drospirenone metabolism is unlikely. COCs can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their concentration in plasma and tissues.

Based on in vitro interaction studies, as well as in vivo studies in female volunteers taking omeprazole, simvastatin and midazolam as markers, it can be concluded that the effect of drospirenone at a dose of 3 mg on the metabolism of other drugs is unlikely.

There is a theoretical possibility of increasing the concentration of potassium in the blood plasma in women receiving Leu simultaneously with other drugs that can increase the concentration of potassium in the blood plasma. These drugs include ACE inhibitors, angiotensin II receptor antagonists, some nonsteroidal anti-inflammatory drugs, potassium-sparing diuretics, and aldosterone antagonists. However, in studies evaluating the interaction of drospirenone with ACE inhibitors or Indometacin, there was no significant difference between the plasma potassium concentration compared to placebo. However, in women taking medications that may increase the concentration of potassium in the blood plasma, it is recommended to determine the concentration of potassium in the blood plasma during the first cycle of taking Leia.

To determine possible interactions with medications taken simultaneously with Leia, you should read the instructions for use of these medications.

How to take, course of use and dosage

The drug Leia is intended for oral use daily for 28 days without interruptions, at approximately the same time, with a small amount of water, in the order indicated on the package of the blister. Taking tablets from a new package begins the day after taking the last tablet from the previous package.

How to take Leia

If you did not take any hormonal contraceptives in the previous month.

Taking Leia begins on the first day of the menstrual cycle (i. e., on the first day of menstrual bleeding). It is allowed to start taking on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking tablets from a new package.

Withdrawal bleeding usually begins 2-3 days after the start of taking inactive tablets and may not end before the start of taking tablets from a new package.

When switching from other combined oral contraceptives (COCs, a vaginal ring, or a transdermal patch).

It is preferable to start taking Leia the day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 active tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package). Leia should be started on the day of removal of the vaginal ring or contraceptive patch, but not later than the day when a new ring is inserted or a new patch is applied.

When switching from progestogen-only contraceptives (mini-pills, injectable forms, implants, or intrauterine contraceptives).

A woman can switch from a mini-pill to Leia on any day (without a break), from an implant or intrauterine therapeutic system that releases progestogen – on the day of its removal, from an injectable contraceptive – on the day when the next injection should be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

, a woman can start taking Leia from the first day after the abortion. If this condition is met, the woman does not need additional contraceptive measures.

After childbirth or abortion in the second trimester of pregnancy

It is recommended to start taking the drug Leia on 21-28 days after delivery, in the absence of breastfeeding, or abortion in the second trimester of pregnancy. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if the woman has already had sexual activity, pregnancy should be excluded before taking Leu.

Taking missed pills

Skipping inactive pills can be ignored. However, they should be discarded, so as not to accidentally extend the period of taking inactive pills. The following recommendations apply only to skipping active tablets:

– if the delay in taking the drug is less than 24 hours, the contraceptive protection is not reduced. A woman should take the missed pill as soon as possible, and take the next one at the usual time.

— if the delay in taking pills is more than 24 hours, the contraceptive protection may be reduced. The more pills you skip, and the closer you get to the inactive pill phase, the more likely you are to get pregnant.

In this case, you can follow the following basic rules::

— the drug should never be interrupted for more than 7 days (the recommended interval for taking inactive tablets is 4 days);

— to achieve adequate suppression of the hypothalamic-pituitary-ovarian system,7 days of continuous tablet intake are required.

Thus, if the delay in taking active tablets was more than 24 hours, we can recommend the following::

From day 1 to day 7:

A woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. She continues to take the next pills at the usual time. In addition, during the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual contact took place within 7 days before skipping the pill, the possibility of pregnancy should be considered.

From day 8 to day 14:

A woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. The following tablets should be taken at the usual time. Provided that the woman has taken the pills correctly for 7 days prior to the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

From day 15 to day 24:

The risk of reduced reliability is unavoidable due to the approaching phase of taking inactive tablets. A woman should strictly adhere to one of the following two options. However, if all the pills were taken correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods. Otherwise, she needs to use the first of the following schemes and additionally use a barrier method of contraception (for example, a condom) for 7 days.

1 option:

A woman should take the last missed pill as soon as she remembers (even if it means taking two pills at the same time). The following tablets are taken at the usual time, until the active tablets in the package run out. Four inactive tablets should be discarded and immediately start taking tablets from the next package. Withdrawal bleeding is unlikely until the active tablets in the second pack run out, but there may be “spotting” discharge and “breakthrough” bleeding while taking the tablets.

Option 2:

A woman may also stop taking pills from the current package. Then she should take a break of no more than 4 days, including the days of skipping pills, and then start taking pills from a new package.If a woman skipped active pills, and while taking inactive pills, “withdrawal” bleeding did not occur, pregnancy should be excluded.

Recommendations for gastrointestinal disorders

In severe gastrointestinal disorders, the absorption of the drug may be incomplete, so additional contraceptive measures should be taken.

If vomiting occurs within 4 hours after taking the active tablet, you should follow the recommendations when skipping tablets. If a woman does not want to change her usual intake schedule and postpone the onset of menstruation to another day of the week, an additional active tablet should be taken from a different package.

Changing the day of onset of menstrual-like bleeding

In order to delay the onset of menstrual-like bleeding, a woman should continue taking pills from the next package, skipping inactive pills from the current package. Thus, the cycle can be extended, if desired, for any period of time, until the active tablets from the second package run out. Against the background of taking tablets from the second package, a woman may have “smearing” discharge or “breakthrough” uterine bleeding. Regular use of the drug Leia is resumed after the end of the phase of taking inactive tablets.

In order to move the day of the onset of menstrual-like bleeding to another day of the week, a woman should reduce the next phase of taking inactive pills for the desired number of days. The shorter the interval, the higher the risk that she will not have “withdrawal” bleeding and will continue to have “spotting” spotting and “breakthrough” bleeding while taking the second package (just as in the case when she would like to delay the onset of menstrual-like bleeding).

How to delay withdrawal bleeding

To delay the onset of menstruation, a woman should switch to taking pills from the new Leia package, skipping taking placebo pills. This cycle extension can be continued until the active tablets of the second package run out. During this extension, the woman may experience “breakthrough” bleeding or spotting. In the future, you should resume regular use of the drug Leia after the usual interval without taking tablets, which is 7 days.

To postpone the onset of menstruation to another day that is more suitable for a woman’s usual schedule, you can reduce the second phase of taking placebo pills for as many days as necessary. The shorter this phase is, the higher the risk that withdrawal bleeding will not develop, and that breakthrough bleeding or spotting will occur during the second pack of pills (as well as when menstruation is delayed).

Special patient groups

Children and teenagers

The drug Leia is indicated only after the onset of menarche. The available data do not suggest dose adjustment in this group of patients.

Elderly patients

Not applicable. Leia is not indicated after menopause.

Patients with liver disorders

The drug Leia is contraindicated in women with severe liver diseases until liver function indicators return to normal. (see the sections “Contraindications” and “Pharmacological action”).

Patients with renal impairment

The drug Leia is contraindicated in women with severe renal insufficiency or acute renal failure. (see the sections “Contraindications” and “Pharmacological action”).

Overdose

To date, there have not been any cases of overdose of the drug Leia.

Given the clinical experience of using COCs, in case of overdose of the drug, the following symptoms may occur: nausea, vomiting, “smearing” spotting or metrorrhagia.

There is no antidote, and the treatment is symptomatic.

Special instructions

If any of the conditions / risk factors listed below are currently present, the potential risk and expected benefit of using COCs should be carefully weighed on a case-by-case basis and discussed with the patient before starting the drug. If any of these conditions or risk factors become more severe, worsen, or first appear, a woman should consult with her doctor, who may decide whether to discontinue the medication.

Diseases of the cardiovascular system

The results of epidemiological studies indicate a relationship between the use of COCs and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, and cerebrovascular disorders) when taking COCs. These diseases are rare.

The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these medications. An increased risk is present after the initial use of COCs or the resumption of use of the same or different COCs (after a break between drug doses of 4 weeks or more), mainly during the first 3 months.

Overall risk of VTE in patients taking low-dose COCs ( VTE can be life-threatening or fatal (in 1-2% of cases). Venous thromboembolism, which manifests itself as deep vein thrombosis, or pulmonary embolism, can occur with the use of any COCs.

Very rarely, when using COCs, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. Symptoms of deep vein thrombosis (DVT) include: unilateral swelling of the lower limb or along a vein in the lower limb, pain or discomfort only when standing upright or walking, local fever, redness or discoloration of the skin on the lower limb.

Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden coughing, including with hemoptysis; acute chest pain, which can increase with deep breathing; anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are non-specific and may be misinterpreted as signs of other more or less severe conditions (for example, respiratory tract infection).

Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction.

Symptoms of a stroke include: sudden weakness or loss of sensation in the face, arm, or leg, especially on one side of the body; sudden confusion, problems with speech and understanding; sudden one – or two-way loss of vision; sudden gait disturbance, dizziness, loss of balance or coordination; sudden, severe, or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blueness of the extremities, symptoms of “acute abdomen”.

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

The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases:

— with age;

– in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years of age);

in the presence of:

— obesity (BMI greater than 30 kg / m%^%2);

– dyslipoproteinemia

— – arterial hypertension—

– migraines

— – heart valve diseases;

— atrial fibrillation—

– family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide whether to take COCs;

– prolonged immobilization, serious surgical intervention, any surgical intervention on the lower extremities, pelvic area, neurosurgical operations or extensive trauma. In these cases, the use of COCs should be stopped (in the case of planned surgery, at least four weeks before it) and not resumed for two weeks after the end of immobilization. Keep in mind that temporary immobilization (for example, air travel lasting more than 4 hours) It is also a risk factor for venous thromboembolism.

The risk of developing thrombosis and thromboembolism in a combination of several high-risk factors is mutually reinforcing.

The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial. The increased risk of developing thromboembolism in the postpartum period should be taken into account.

Peripheral circulatory disorders can also occur with diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency and severity of migraines during the use of COCs (which may precede cerebrovascular disorders) is a reason for the immediate withdrawal of these drugs. Biochemical parameters that indicate a hereditary or acquired predisposition to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anti-cardiolipin antibodies, lupus anticoagulant).

When assessing the risk-benefit ratio, consider that adequate treatment of the condition may reduce the associated risk of thrombosis. It should also be taken into account that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (

According to some reports, drugs containing drospirenone have a higher risk of developing thromboembolic complications compared to drugs containing levonorgestrel, norgestimate or norethindrone.

Tumors

The most significant risk factor for developing cervical cancer is persistent papillomavirus infection. There are reports of a slight increase in the risk of developing cervical cancer with prolonged use of COCs. The association with the use of COCs has not been proven. There are still contradictions about the extent to which these findings are related to screening for cervical pathology or sexual behavior (more rarely, the use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of developing breast cancer diagnosed in women currently taking COCs (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these medications. Due to the fact that breast cancer is rare in women under 40, the increase in breast cancer diagnoses among women who are currently or have recently taken COCs is insignificant relative to the overall risk of this disease. The observed increased risk may be due to an earlier diagnosis of breast cancer in women using COCs, the biological effect of oral contraceptives, or a combination of both. Women who have used COCs are more likely to develop early-stage breast cancer than women who have never used them. In rare cases, the development of benign, and in extremely rare cases, malignant liver tumors was observed against the background of the use of COCs, which in some cases led to life-threatening intra-abdominal bleeding. This should be taken into account when making a differential diagnosis in case of severe abdominal pain, enlarged liver, or signs of intra-abdominal bleeding. Tumors can be life-threatening or fatal.

Other states

Clinical studies have shown no effect of drospirenone on the concentration of potassium in blood plasma in patients with mild to moderate renal insufficiency. There is a theoretical risk of developing hyperkalemia in patients with impaired renal function with an initial potassium concentration at the upper limit of normal, while taking medications that lead to potassium retention in the body. However, in women with an increased risk of developing hyperkalemia, it is recommended to determine the concentration of potassium in the blood plasma during the first cycle of taking Leia.

Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking COCs.

Although a small increase in blood pressure has been reported in many women taking COCs, clinically significant increases have rarely been observed. However, if a persistent, clinically significant increase in blood pressure develops while taking COCs, these medications should be discontinued and treatment for hypertension should be initiated. The use of COCs can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.

The following conditions have been reported to develop or worsen both during pregnancy and with COCs, but their association with COCs has not been proven: jaundice and/or pruritus associated with cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham’s chorea; herpes of pregnancy; hearing loss associated with otosclerosis. Cases of Crohn’s disease and ulcerative colitis associated with the use of COCs are also described.

In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema.

Acute or chronic hepatic impairment may require discontinuation of COCs until liver function returns to normal. Relapse of cholestatic jaundice that first developed during a previous pregnancy or previous sex hormone use requires discontinuation of COCs. Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to adjust the dose of hypoglycemic drugs in diabetic patients using low-dose COCs ( However, women with diabetes should be closely monitored by an endocrinologist while taking COCs. Sometimes chloasma can develop, especially in women with a history of chloasma in pregnant women. Women with a tendency to chloasma should avoid prolonged sun exposure and exposure to ultraviolet radiation while taking COCs.

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

Laboratory tests

Taking COCs may affect the results of certain laboratory tests, including liver, kidney, thyroid, and adrenal function, plasma transport protein levels, carbohydrate metabolism, and coagulation and fibrinolysis parameters. Changes usually do not exceed the limits of normal values. Drospirenone increases the activity of plasma renin and aldosterone, which is associated with its antimineralocorticoid effect.

Medical examinations

Before starting or resuming the use of Leia, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough medical (including blood pressure measurement, heart rate, BMI determination) and gynecological examination (including breast examination and cytological examination of cervical mucus), and exclude pregnancy. The frequency and nature of follow-up examinations should be determined individually for each woman, but at least once every 6 months.

Women should be warned that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of Leia may be reduced in the following cases:: when skipping active tablets (pink), vomiting, diarrhea, or as a result of drug interaction.

Insufficient menstrual cycle control

Against the background of taking Leia, irregular bleeding (“smearing” spotting or “breakthrough” bleeding) may occur, especially during the first months of use. Therefore, any irregular bleeding should only be evaluated after an adjustment period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be performed to rule out malignancies or pregnancy. Some women may not develop “withdrawal” bleeding during a break from taking active pills (pink ones). If the drug Leia was taken as directed, it is unlikely that the woman is pregnant. If the drug Leia was taken irregularly or if there are no consecutive “withdrawal” bleeding, then pregnancy should be excluded in order to continue taking the drug.

Influence on the ability to drive vehicles and mechanisms

The effect of Leia on the ability to drive vehicles and mechanisms has not been established.

Active ingredient

Drospirenone, Ethinyl Estradiol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For women, For women of childbearing age, For Adults as prescribed by a doctor

Indications

For contraception