Leia pills 3mg + 0.02mg №84

Indications

- contraception;

- contraception and treatment of moderate acne (acne vulgaris);

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

Dosage and administration

Leia's drug is intended for daily use for 28 days without interruption, at about the same time, with a small amount of water, in the order indicated on the blister package. Taking the pills from the new package starts the day after taking the last pill from the previous package.

How to take the drug Leia

If you have not taken any hormonal contraceptives in the previous month.

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

Bleeding "cancellation", as a rule, begins on the 2-3rd day after the start of taking inactive pills and may not end before the start of taking the pills from a new package.

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

It is preferable to start taking the drug Leia the next day after taking the last active pill from the previous package,but in no case no later than the next day after the usual 7-day break (for preparations containing 21 active tablets) or after taking the last inactive pill (for preparations containing 28 pills per pack). Leia should be taken on the day of removal of the vaginal ring or contraceptive patch, but no later than the day when a new patch is to be inserted or a new patch is stuck.

When switching from contraceptives containing only gestagens (“mini-pilli”, injection forms, an implant or an intrauterine contraceptive).

A woman can switch from “mini-pili” to taking Leia on any day (without a break), from an implant or an intrauterine therapeutic system that releases a gestagen — on the day of its removal, from an injection contraceptive — on the day when the next injection should be given. In all cases, you must use an additional barrier method of contraception during the first 7 days of taking pills.

After abortion in the first trimester of pregnancy

A woman can start taking the drug Leia from the first day after the abortion. Subject to this condition, the woman does not need additional contraceptive measures.

After childbirth or abortion in the II trimester of pregnancy

It is recommended to start taking the drug Leia at 21-28 days after birth, in the absence of breastfeeding, or abortion in the second trimester of pregnancy. If reception is started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. However, if a woman has already lived sexually, before pregnancy begins, Leia should be excluded from pregnancy.

Acceptance of missed pills

Skipping inactive pills can be ignored. However, they should be thrown away in order not to accidentally extend the intake of inactive tablets. The following recommendations apply only to skipping active tablets:

- If the delay in taking the drug was less than 24 hours, 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 the pills was more than 24 hours, contraceptive protection may be reduced. The more pills are missed, and the closer the pill passes to the inactive pill intake phase, the higher the chance of pregnancy.

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 pills is 4 days);

- to achieve adequate suppression of the hypothalamic-pituitary-ovarian system requires 7 days of continuous administration of tablets.

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

From 1st to 7th day:

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

From the 8th to the 14th day:

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 pills should be taken at the usual time. Provided that the woman took the pill correctly for the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

From the 15th to the 24th day:

The risk of loss of reliability is inevitable due to the approaching phase of taking inactive tablets. A woman should strictly adhere to one of the following two options. However, if in the 7 days preceding the first missed pill, all the pills were taken correctly, 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) within 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 pills are taken at the usual time until the active pills in the package run out. Four inactive pills should be thrown away and immediately start taking the pills from the next package.Bleeding "cancellation" is unlikely until the active pills in the second pack run out, but there may be "spotting" discharge and "breakthrough" bleeding while taking the pills.

Option 2:

A woman can also stop taking pills from the current pack. Then she should take a break of no more than 4 days, including the days of skipping the pills, and then start taking pills from a new pack. If a woman missed active pills, and while taking inactive pills, the "cancellation" bleeding did not occur, it is necessary to exclude pregnancy.

Recommendations for gastrointestinal disorders

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

If vomiting occurs within 4 hours after taking the active pill, refer to the recommendations for skipping pills. If a woman does not want to change her usual regimen and postpone the onset of menstruation to another day of the week, an additional active pill should be taken from another package.

Change the day of the onset of menstrual bleeding

In order to delay the onset of menstrual bleeding, a woman should continue taking the pills from the next pack, skipping the inactive pills from the current pack. Thus, the cycle can be extended, if desired, for any period until the active pills from the second package run out.While taking the pills from the second package, a woman may experience "spotting" discharge or "breakthrough" uterine bleeding. Regular intake of the drug Leia is resumed after the end of the phase of taking inactive tablets.

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

How to delay bleeding "cancellation"

To delay the onset of menstruation, a woman should switch to taking pills from a new package of Leia, skipping placebo pills. Such a prolongation of the cycle can be continued until the active pills of the second package run out. During this extension, a 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 the pills, which is 7 days.

To postpone the onset of menstruation to another day, more suitable for a woman’s usual schedule, it is possible to reduce the second phase of taking placebo pills for as many days as necessary.The shorter this phase, the higher the risk that the "withdrawal" bleeding does not develop, and that there will be "breakthrough" bleeding or bleeding during the taking of pills from the second package (as well as a postpone menstruation).

Special patient groups

Kids and teens

Ley's drug is shown only after the onset of menarche. The available data do not suggest dose adjustment in this group of patients.

Elderly patients

Not applicable. Leia's drug is not indicated after menopause.

Patients with hepatic impairment

Leia's drug is contraindicated in women with severe liver disease until liver function rates return to normal. (see sections "Contraindications" and "Pharmacological action").

Patients with kidney impairment

Leia is contraindicated in women with severe renal insufficiency or acute renal failure . (see sections "Contraindications" and "Pharmacological action").

Side effect

Clinical research data

The frequency of adverse reactions is presented in accordance with the classification of the Medical Dictionary of Regulatory Activities (MedDRA): very often (> 10%), often (≥1% <10%), infrequently (≥0.1% <1%), rarely ≥0.01% <0.1%), very rarely (<0.01%), the frequency is unknown (it is not possible to determine the frequency of occurrence from the available data).

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

On the part of the immune system: infrequently - allergic reactions, rarely - asthma; frequency is unknown - hypersensitivity reactions.

From the blood and lymphatic system: rarely - anemia, thrombocytopenia.

Mental Disorders: often - emotional lability; infrequently - depression, nervousness, sleep disorder; rarely-orgasm.

From the nervous system: often - headache; infrequently - paresthesia, dizziness, migraine; rarely - tremor.

On the part of the organ of vision: infrequently - conjunctivitis, dry eye syndrome, visual disturbances.

On the part of the organ of hearing and labyrinth disorders: rarely - hearing loss.

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

From the side of the vessels: infrequently - pulmonary thromboembolism, increase in blood pressure, decrease in blood pressure, varicose veins; rarely - arterial and venous thromboembolism, syncope.

On the part of the respiratory system, organs of the chest and mediastinum: pharyngitis.

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

Liver and biliary tract: rarely - cholecystitis.

Skin and Subcutaneous Tissues: infrequently - pruritus, rash, seborrhea, acne; rarely - alopecia, dry skin, eczema, photodermatitis, acneform dermatosis, hypertrichosis, stretch marks, erythema nodosum, erythema multiforme.

Musculoskeletal and connective tissue: infrequently - pain in the neck, extremities, lumbar region; muscle cramps.

From the kidneys and urinary tract: infrequently - cystitis.

From the genital and breast organs: often - pain in the mammary glands, engorgement of the mammary glands, metrorrhagia, absence of menstrual-like bleeding; infrequently - mammary neoplasms, galactorrhea, ovarian cyst, "hot flashes", leucorrhea, vaginal mucosa dryness, pain in the pelvic region, changes in Pap smear results, decreased libido, breast enlargement, painful menstrual bleeding, poor menstrual-like bleeding; rarely - fibrocystic mastopathy, vaginitis, cervical polyp, cervical neoplasia, endometrial atrophy, heavy menstrual-like bleeding, dyspareunia, postcoital bleeding, "withdrawal" bleeding, an increase in the size of the uterus.

On the part of the endocrine system: very rarely, changes in glucose tolerance or the effect on insulin resistance.

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

Laboratory and instrumental data: infrequently - hyperkalemia, hyponatremia.

Post-marketing data

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

The connection with taking COCs is not convincing when the following diseases appear or worsen: Crohn's disease, ulcerative colitis, epilepsy, uterine myoma, porphyria, systemic lupus erythematosus, pregnant herpes, Sydengham's chorea, hemolytic uremic syndrome, cholestatic jaundice, chloasma.

Acute and chronic liver dysfunction may require discontinuation of COC until liver function markers return to normal.

In women with hereditary angioedema, exogenous estrogens can cause the manifestation of the disease or its exacerbation.

The frequency of breast cancer diagnostics among women taking COCs is slightly increased, although a causal relationship with COC use has not been established.

Contraindications

Leia is contraindicated in the presence of any of the conditions listed below; If any of these conditions arise for the first time during the treatment of COCs, they should be stopped immediately.

- thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis, thromboembolism of the pulmonary artery, myocardial infarction), cerebrovascular disorders (including in history);

- conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) now or in history;

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

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

- multiple or pronounced risk factors of venous or arterial thrombosis, including complicated lesions of the valvular apparatus of the heart, atrial fibrillation; diseases of cerebral vessels or coronary arteries; uncontrolled arterial hypertension; severe dyslipoproteinemia, diabetes mellitus with vascular complications, serious surgical intervention with prolonged immobilization; smoking over the age of 35; obesity with a BMI over 30 kg / m²; extensive injury;

- liver failure, severe liver disease (until normalization of liver function indicators);

- liver tumors (benign or malignant), incl. in the anamnesis;

- severe renal failure, acute renal failure;

- adrenal insufficiency;

- pancreatitis, incl. in history if associated with the presence of severe triglyceridemia;

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

- bleeding from the vagina of unspecified etiology;

- pregnancy or suspicion of it;

- breastfeeding period;

- lactose intolerance , lactase deficiency, glucose-galactose malabsorption (lactose monohydrate is included);

- Hypersensitivity to any component of the drug Leia.

Carefully

If the patient has any of the conditions / risk factors listed below, carefully consider the potential risk and the expected benefits of using COC, including Leia.

- risk factors for thrombosis and thromboembolism: smoking, thrombosis (including history), myocardial infarction, or cerebral circulation at a young age in one of the closest relatives; obesity with a BMI less than 30 kg / m²; dyslipoproteinemia; controlled arterial hypertension; migraine without focal neurological symptoms; valvular disease without complications; heart rhythm disorder;

- other diseases in which there may be violations of the peripheral circulation: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; Crohn's disease and ulcerative colitis; sickle cell anemia; as well as phlebitis of the superficial veins;

- hereditary angioedema;

- hypertriglyceridemia;

- liver disease;

- Diseases that first arose or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, jaundice, cholestasis , cholelithiasis, otosclerosis with impairment of hearing, porphyria, herpes of pregnant women, Sydengam's chorea);

- postpartum period.

Use during pregnancy and lactation

Pregnancy

Leia is contraindicated for use during pregnancy. If pregnancy occurs while taking the drug Leia, you must immediately stop taking it. Conducted epidemiological studies did not reveal an increase in the risk of birth defects in children born to mothers who took COCs before pregnancy, nor a teratogenic effect when COCs were taken carelessly in early pregnancy.

Available data on the use of the drug Leia during pregnancy are too limited and do not allow to conclude that it has a negative effect on pregnancy or on the health of the fetus or newborn.

Breast-feeding

Leia is contraindicated during breastfeeding. COCs can reduce the amount of breast milk and change its quality. A small amount of sex hormones and / or their metabolites can penetrate into breast milk and, possibly, can have an effect on the baby.

Application for violations of the liver

Leia's drug is contraindicated in women with severe liver disease until liver function rates return to normal.

Application for violations of kidney function

Leia is contraindicated in women with severe renal insufficiency or acute renal failure.

Use in children

Ley's drug is shown only after the onset of menarche.The available data do not suggest dose adjustment in this group of patients.

Use in elderly patients

Not applicable. Leia's drug is not indicated after menopause.

special instructions

If any of the conditions / risk factors listed below are present, then the potential risk and the expected benefits of using COCs in each individual case should be carefully weighed and discussed with the patient before taking the drug. In the event of a worsening, aggravation, or first manifestation of any of these conditions or risk factors, the woman should consult with her physician, who may decide to discontinue the drug.

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, cerebrovascular disorders) when taking COCs. These diseases are rare.

The risk of venous thromboembolism (VTE) is maximum in the first year of taking such drugs. Increased risk is present after the initial use of the COC or the resumption of use of the same or different COCs (after a break between taking the drug in 4 weeks or more), mostly during the first 3 months.

The overall risk of VTE in patients taking low-dose COCs (<50 μg of ethinyl estradiol) is 2-3 times higher than in non-pregnant patients who do not take COC, however, this risk remains lower compared to the risk of VTE during pregnancy and childbirth . VTE can be life threatening or fatal (1-2% of cases). Venous thromboembolism, manifested as deep vein thrombosis, or pulmonary embolism, can occur with the use of any COCs.

Thrombosis of other blood vessels, such as the hepatic, mesenteric, renal, cerebral veins and retinal arteries or vessels, is extremely rare with COCs. Symptoms of deep vein thrombosis (DVT) include the following: one-sided swelling of the lower limb or along the vein on the lower limb, pain or discomfort only in a vertical position or when walking, a local increase in temperature, redness or discoloration of the skin on the lower limb.

The symptoms of pulmonary thromboembolism (pulmonary embolism) are as follows: difficulty breathing or rapid breathing; sudden cough, incl. with hemoptysis; acute pain in the chest, which may increase with a deep breath; sense of anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are nonspecific and can be interpreted incorrectly as signs of other more or less severe conditions (for example, an infection of the respiratory tract).

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

The symptoms of a stroke include the following: a sudden weakness or loss of sensation of the face, arm, or leg, especially on one side of the body, sudden confusion, problems with speech and understanding; sudden one or two-sided vision loss; sudden gait disturbance, dizziness, loss of balance or coordination of movements; sudden, severe or prolonged headache for no apparent reason; loss of consciousness or fainting with or without epileptic seizures. Other signs of vascular occlusion are: sudden pain, swelling and weak blueing of the extremities, symptoms of "acute abdomen".

Symptoms of myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of constriction or distention in the chest or behind the sternum; discomfort radiating to the back, jaw, left upper limb, epigastric area; 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 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 old);

in the presence of:

- obesity (BMI over 30 kg / m²);

- dyslipoproteinemia;

- arterial hypertension;

- migraine;

- valvular heart disease;

- Atrial fibrillation;

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

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

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

The question of 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 considered.

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

The increase in the frequency and severity of migraine during the use of COCs (which may precede cerebrovascular disorders) is the reason for the immediate cancellation of these drugs. The biochemical indices indicating hereditary or acquired susceptibility to venous or arterial thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, anti-phospholipid antibodies (anti-thrombolipid antibodies, anti-thrombin III deficiency, anti-phospholipid antibodies (anti-thrombin lipid antibodies, anti-thrombin III deficiency)

When assessing the risk / benefit ratio, it should be borne in mind that adequate treatment of the corresponding condition can reduce the associated risk of thrombosis. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than when taking low-dose oral contraceptives (<0.05 mg of ethinyl estradiol).

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

Tumors

The most significant risk factor for cervical cancer is persistent human papillomavirus infection. There are reports of some increase in the risk of developing cervical cancer with prolonged use of COCs. Connection with taking COC is not proven. There are contradictions regarding the extent to which these findings are associated with screening for cervical pathology or with the characteristics of sexual behavior (more rare use of barrier methods of contraception).

A meta-analysis of 54 epidemiological studies has shown that there is a slightly increased relative risk of developing breast cancer diagnosed in women taking COCs at the present time (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these drugs. Due to the fact that breast cancer is rarely observed in women under 40 years old, an increase in the number of breast cancer diagnoses in women who are taking COCs now or who have recently taken it is insignificant relative to the overall risk of this disease. The observed increase in risk may be due to an earlier diagnosis of breast cancer in women using COCs, the biological effects of oral contraceptives, or a combination of both factors. In women who have used COCs, earlier stages of breast cancer are detected than in women who have never used them. In rare cases, the development of benign, and in extremely rare cases, malignant tumors of the liver, which in some cases led to life-threatening intra-abdominal bleeding, were observed against the background of COCs. This should be considered when carrying out a differential diagnosis in the event of severe pain in the abdomen, 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 plasma potassium concentration in patients with mild to moderate renal insufficiency. There is a theoretical risk of developing hyperkalemia in patients with impaired renal function with initial potassium concentrations at the upper limit of the norm, while taking drugs at the same time, leading to a delay in potassium in the body. However, in women with an increased risk of hyperkalemia, it is recommended to determine the concentration of potassium in the blood plasma during the first cycle of taking the drug Leia.

Women with hypertriglyceridemia (or the presence of this condition in the family history) may increase the risk of developing pancreatitis while taking COCs.

Although a small increase in blood pressure has been described in many women taking COCs, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking a COC,