Qlaira pill №28 * 3

Indications

- oral contraception.

Dosage and administration

Inside, regardless of the meal.

Tablets should be taken in the order indicated on the package every day at approximately the same time, if necessary with a glass of water or other liquid. Pills are taken continuously. It should be taken on 1 tab. / Day consistently for 28 days. Each new package begins after taking the last pill from the previous calendar package. Menstrual-like bleeding usually begins while taking the last pills of a calendar package and may not finish before the next calendar package begins. In some women, menstrual bleeding begins after taking the first pills from a new calendar package.

If hormonal contraception has not been used previously (in the previous month)

The pills start taking on the 1st day of the woman’s natural menstrual cycle (that is, on the 1st day of menstrual bleeding).

Transfer from another combined hormonal contraceptive (another PDA, vaginal ring or transdermal patch)

A woman should start taking Qlaira.^® the day after the last active pill (tablet containing the active substances) was taken from the package of the previous PDA.When using a vaginal ring or transdermal patch, a woman should start taking Qlaira.^® on the day of their removal.

If previously only progestogen contraceptive method was used (mini-pili, injection, implant) or intrauterine system with progestogen release (IUD)

A woman can switch to taking Clyira^® with a mini-drink on any day (from the implant or IUD - on the day they were removed; from the injection method - on the day on which the next injection was scheduled), but in all cases it is recommended to use a barrier method of contraception during the first 9 days of taking the pills.

After abortion in the first trimester of pregnancy

A woman can start taking pills immediately. In this case, additional measures of contraception are not necessary.

After childbirth or abortion in the II trimester of pregnancy

A woman should be advised to start taking pills on the 21-28th day after birth or abortion in the second trimester of pregnancy. If a woman starts taking pills later, then it is recommended that she additionally use a barrier method of contraception during the first 9 days of taking pills. However, if sexual contact has already taken place, before the actual start of taking the drug Qlaira^® it is necessary to exclude pregnancy, or the woman should wait for the onset of the first menstruation.

Acceptance of missed pills

Missing (white) inactive pills can be neglected.However, they should be thrown away in order to avoid inadvertently extending the interval between taking the active pills.

Pass active tablets

If the delay in taking any of the pills is less than 12 hours contraceptive protection is not reduced. A woman should drink the missed pill as soon as she remembers, and take the rest of the pills at the usual time.

If the delay in taking any of the pills is more than 12 hours contraceptive protection may be reduced. A woman should take the last missed pill as soon as she remembers it, even if it means that she will have to drink 2 tabs. at the same time. Then you must continue taking the pills at the usual time.

Depending on the day of the menstrual cycle, on which the pill was missed (for details see table 1), additional contraceptive measures (for example, a barrier method, in particular condoms) are required in accordance with the following principles:

Table 1. Rules for handling missed pills

Allowed to take no more than 2 tab. one day.

If a woman forgot to start a new calendar package or missed one or more pills from the 3rd to the 9th day of the calendar package, she may already be pregnant (if she had sexual intercourse within 7 days before skipping the pill). The more pills (especially with the combination of the two active ingredients on days 3 through 24) are missed and the closer they are to the inactive tablets, the higher the probability of pregnancy.

If a woman misses taking pills, and then there was no menstrual bleeding at the end of the calendar packaging / at the beginning of the new calendar packaging, the probability of pregnancy should be considered.

Recommendations for gastrointestinal disorders

In severe gastrointestinal disorders, absorption may be incomplete, therefore additional contraceptive measures should be taken (for example, a barrier method, in particular condoms).

If 3-4 hours after taking an active pill, vomiting occurs, then in this case there are recommendations regarding the missed pills, which are given in the section “Missed pills”. If a woman does not want to change her usual pill regimen, she needs to drink an extra pill (or pills) from a new pack.

Qlaira^® not shown after menopause.

Clyrah's Drug^® contraindicated in patients with severe liver disease until the liver function returns to normal.

Clyrah's Drug^® not specifically studied patients with impaired renal function. The available data do not imply correction of the dosage regimen in such patients.

Adverse effects

By frequency, unwanted effects are divided into frequent (≥1 / 100 and <1/10), infrequent (≥1 / 1000 and <1/100) and rare (≥1 / 10 000 and <1/1000).

Contraindications

Clyrah's Drug^® Should not be applied in the presence of any of the conditions listed below. The drug should be immediately canceled if any of these conditions develop for the first time against the background of its administration:

- thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), stroke currently or in history;

- conditions preceding thrombosis (includingtransient ischemic attacks, angina) currently or in history;

- the presence of severe or multiple risk factors for venous or arterial thrombosis (including extensive surgical intervention with prolonged immobilization, complicated valvular heart disease, uncontrolled arterial hypertension);

- migraine with focal neurological symptoms, incl. in the anamnesis;

- diabetes with vascular complications;

- pancreatitis with severe hypertriglyceridemia now or in history;

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

- liver tumors (benign and malignant) now or in history;

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

- bleeding from the vagina of unknown origin;

- pregnancy or suspicion of it;

- Hypersensitivity to the active substances or any of the auxiliary substances.

WITH caution

If any of the diseases / conditions / risk factors listed below are presently present, then the potential risk should be carefully correlated with the expected benefits of using Qlaira.^® in each individual case:

- risk factors for thrombosis and thromboembolism (smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, valvular heart disease, heart rhythm disturbances, prolonged immobilization, extensive surgical interventions, extensive trauma);

- other diseases in which there may be violations of the peripheral circulation (diabetes, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia);

- hereditary angioedema;

- hypertriglyceridemia;

- diseases that have first occurred or worsened during pregnancy or against the background of previous intake of sex hormones (for example, cholestatic jaundice, cholestatic itching, cholelithiasis, otosclerosis with impaired hearing, porphyria, pregnant herpes, Sydenhem chorea);

- postpartum period.

Use during pregnancy and lactation

Taking the drug Qlaira^® contraindicated during pregnancy. If the pregnancy occurred on the background of the use of the drug Qlaira^®, further reception must stop. However, large-scale epidemiological studies have not revealed an increase in the risk of birth defects in children born to women who used the CCP before pregnancy, as well as the teratogenic effects of the CCP when they are accidentally taken at the beginning of pregnancy.

PDAs can affect lactation, as they can reduce the amount of breast milk produced, as well as change its composition. Consequently, PDAs are usually not recommended for use until the end of the lactation period. A small amount of contraceptive hormones and / or their metabolites can be excreted in breast milk.

Application for violations of the liver

Clayra's drug is contraindicated in women with severe liver disease until liver function rates return to normal (see also Contraindications).

Application for violations of kidney function

Klayra's drug was not specifically studied in patients with impaired renal function. The available data do not imply correction of the dosage regimen in such patients.

Use in children

The drug Qlaira is shown only after the onset of menarche.

Use in elderly patients

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

special instructions

If any of the diseases / conditions / risk factors listed below are presently present, then the potential risk should be carefully correlated with the expected benefits of using Qlaira.^® in each individual case and discuss it with a woman before she decides to start taking the drug. In the event of weighting, enhancing, or the 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 PDA and an increase in the incidence of venous and arterial thrombosis and thromboembolism (such as DVT, PEH, MI and cerebrovascular disorders). The risk of venous thromboembolism (VTE) is maximum in the first year of taking such drugs, mainly during the first 3 months.Increased risk is present after the initial use of PDA or the resumption of use of the same or different PDAs (after a break between taking the drug in 4 weeks or more).

The overall risk of VTE in patients taking low-dose PDA (ethinyl estradiol content is less than 50 µg) is 2–3 times higher than in patients who do not take PDA, however, this risk remains lower compared to the risk of VTE during pregnancy and childbirth.

VTE can be fatal (1-2% of cases).

VTE, manifested as DVT or PEH, can occur when using any PDA.

Thrombosis of other blood vessels, for example, hepatic, mesenteric, renal, cerebral arteries and veins or retinal vessels, is extremely rare with CPK. There is no consensus regarding the relationship between the occurrence of these events and the use of PDAs. Arterial thromboembolism can be fatal.

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

- with age;

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

in the presence of:

- family history (for example, venous or arterial thromboembolism ever with 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 on the possibility of taking the drug Qlaira.^®;

- obesity (BMI over 30 kg / m²);

- dyslipoproteinemia;

- arterial hypertension;

- migraine;

- valvular heart disease;

- Atrial fibrillation;

- long immobilization; extensive surgery, any operation on the lower limbs or extensive trauma. In such situations, it is advisable to stop taking the drug Qlaira^® (during a planned operation - at least 4 weeks before it) and not to resume reception within 2 weeks after the end of immobilization.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.

You should consider the increased risk of thromboembolism in the postpartum period. 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. Increase in the frequency and severity of migraine during the use of the drug Qlaira^® (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of this drug.

By biochemical factors indicating hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein deficit S, antiphospholipid antibodies (antikardiolipidnye antibodies, lupus anticoagulant).

When assessing the risk / benefit ratio, it should be borne in mind that treating the corresponding condition may reduce the risk of thrombosis associated with it. It should also be borne in mind that the risk of thrombosis and thromboembolism during pregnancy is higher than with low-dose oral contraceptives (the content of ethinyl estradiol is less than 50 μg).

Tumors

The most significant risk factor associated with the development of cervical cancer is persistent human papillomavirus infection (PVI). There are reports of some increased risk of cervical cancer with prolonged use of PDA. Communication with the reception of the CCP is not proven. The possibility of the relationship of these data with screening for diseases of the cervix uteri and the characteristics of sexual behavior (more rare use of barrier methods of contraception) is discussed.

A meta-analysis of 54 epidemiological studies revealed a slight increase in the relative risk (RR = 1.24) of breast cancer development in women taking CPC at the present time. 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 younger than 40 years old, a slight increase in the number of diagnosed breast cancers in women who are currently taking or have recently received PDA is insignificant relative to the overall risk of this disease. His connection with the reception of the CCP is not proven. The observed increase in risk may also be due to an earlier diagnosis of breast cancer in women using PDA.Women who have ever used CCP, are detected earlier stages of breast cancer than women who have never used them.

In rare cases, against the background of the use of PDA, 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, was observed. With the appearance of severe pain in the upper abdomen, an increase in the size of the liver or signs of intra-abdominal bleeding in women taking PDA, with differential diagnosis it is necessary to exclude liver tumors.

Other states

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

Although a small increase in blood pressure has been described in many women taking PDA, a clinically significant increase was rarely observed. However, if against the background of the drug Qlaira^® a persistent, clinically significant increase in blood pressure is developing, the drug should be discontinued and treatment of hypertension should begin. Taking the drug Qlaira^® if necessary, it can be resumed if, through antihypertensive therapy, it is possible to achieve normal blood pressure indicators.

The following conditions develop or worsen both during pregnancy and when taking PDA, but their connection with taking PDA has not been proven: jaundice and / or cholestatic itching, cholelithiasis, porphyria, systemic lupus erythematosus, hemolytico-uremic syndrome, Sydenhem chorea, herpes of pregnant women Otosclerosis due to hearing loss.

In women with hereditary forms of angioedema, exogenous estrogens can induce or worsen the symptoms of angioedema.

Acute or chronic abnormal liver function may require discontinuation of the drug Qlaira.^® until the liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or a previous intake of sex hormones, requires discontinuation of the drug Qlaira^®.

Although KPC may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetics who use Qlaira^®. However, women suffering from diabetes while taking the drug Qlaira^® need careful observation.

Also described are cases of Crohn's disease and ulcerative colitis with PDA use.

Chloasma can sometimes develop, especially in women with a history of chloasma in pregnant women.

Women who are prone to developing chloasma while taking Kleir^® exposure to the sun or UV radiation should be avoided.

Impact on laboratory tests

Taking the drug Qlaira^® may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal glands and kidneys, plasma concentration of transport proteins, such as CSG and lipid / lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis. These changes usually remain within the laboratory limits.

Medical examinations

Before starting the use of the drug Qlaira^® It is necessary to carefully evaluate the contraindications for prescribing the drug on the basis of the history of life, the family history of the woman, and general medical and gynecological examinations. The frequency and nature of these examinations should be based on the existing norms of medical practice with the necessary consideration of the individual characteristics of each patient. As a rule, blood pressure is measured, the state of the mammary glands, abdominal cavity and pelvic organs, including cervical cytology, is checked.

It is necessary to explain to women that the drug Qlaira^® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug Qlaira^® may be reduced by skipping pills with active ingredients, gastrointestinal disorders while taking pills with active ingredients or against the background of concomitant medication.

Insufficient control of the menstrual cycle

Against the background of the use of the drug Qlaira^®, especially in the first months of administration, irregular menstrual-like bleeding may occur (spotting or breakthrough uterine bleeding). Therefore, any irregular menstrual-like bleeding should be evaluated only after a period of adaptation, which is approximately 3 menstrual-like cycles.

If irregular menstrual bleeding recurs or first occurs after previous regular cycles,the likelihood of non-hormonal causes should also be considered and a thorough examination should be conducted to rule out malignant tumors or pregnancy. Such events may include diagnostic curettage.

Some women may not develop menstrual bleeding while taking white inactive tablets. If taking the drug Qlaira^® was carried out in accordance with the rules specified in the section "dosing regimen", pregnancy is unlikely. However, if before the first menstrual-like bleeding that was absent, pills were taken irregularly or there were no 2 menstrual-like bleeding in a row, you should not continue using Qlaira^® until pregnancy is excluded.

Influence on ability to drive motor transport and control mechanisms

No negative effects of the drug Qlaira^® on the ability to drive and work with mechanisms, however, patients who have episodes of dizziness and impaired concentration during the adaptation period (the first 3 months of taking the drug) should be careful.

Overdose

Symptoms: about serious violations in overdose drug Qlaira^® not reported. Based on the cumulative experience with PDA, the symptoms that can occur with an overdose of active pills: nausea, vomiting,spotting or metrorrhagia.

Treatment: symptomatic.

Drug interaction

The effect of other drugs on the active components of the drug Qlaira^®

The interaction of PDA with other drugs can lead to breakthrough uterine bleeding and / or lack of contraceptive effect.

The following types of interactions have been described in the KPC literature as a whole or have been studied during clinical trials of the drug Qlaira.^®.

Inductors or inhibitors of individual enzymes (CYP3A4 isoenzyme)

Isozyme inductors. There may be interaction with drugs that induce microsomal enzymes (for example, cytochrome P450 systems), as a result of which the clearance of sex hormones may increase (phenytoin, barbiturates, primidone, Carbamazepine, rifampicin and, possibly, also oxcarbazepine, topiramate, felbamate, riethampicin, rhymes, rhymes, rhymes, and topromat, felbamates, riethampicin, and perhaps, oxarabazepine, topiramat, felbamate, riethampicin, rhymes, rhymes, and, possibly, oxcarbazepine, topiramat, felbamate, riethampicin, and perhaps, oxcarbazepine, topiramat, felbamate, riethampicin, and perhaps also oxcarbazepine, topiramat, felbamate, riethampicin, and also, and Griseofulvin, as well as preparations containing St. John's wort). It has been reported that inhibitors of HIV protease (for example, ritonavir), non-nucleoside reverse transcriptase inhibitors (for example, nevirapine), and combinations of these can also have an effect on hepatic metabolism.

Effect on enterohepatic circulation. While taking certain groups of antibiotics (for example, the penicillin and Tetracycline groups), the enterohepatic circulation of estrogens may decrease, which may lead to a decrease in the estradiol concentration.

Women who receive treatment with microsomal enzyme inducing agents or antibiotics, in addition to Qlaira^® It is recommended to temporarily use a barrier method of contraception or choose another