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Combined contraceptive (estrogen + progestogen)
The contraceptive effect of combined oral contraceptives (COCs) is based on the interaction of various factors, the most important of which are suppression of ovulation and changes in the properties of cervical mucus. Along with the prevention of unwanted pregnancy, COCs have a number of positive properties that, when taking into account negative properties as well (see “Special Instructions”, “Side Effects”), can help in choosing the most appropriate method of contraception. In women taking COCs, the pain and intensity of menstrual bleeding is reduced, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence of a reduction in the risk of endometrial cancer and ovarian cancer.
Estrogen in the preparation of Qlaira is estradiol valerate, the precursor of natural human 17β-estradiol (1 mg of estradiol valerate corresponds to 0.76 mg of 17β-estradiol). Ethinyl estradiol estrogens or its precursor mestranol, both containing an ethynyl group at position 17α. This group causes a higher metabolic stability, but also a more pronounced effect on the liver.
Admission Qlaira leads to a less pronounced effect on the liver compared with three-phase CEC containing ethinyl estradiol and levonorgestrel. It was shown that the effect on the concentration of the globulin that binds sex steroids (GSM) and hemostasis parameters is less pronounced. In combination with estradiol dienogest, valerate shows an increase in high-density lipoprotein (HDL), while the concentration of low-density lipoprotein cholesterol (LDL) is slightly reduced.
Dienogest is a progestogen, acting by oral administration, which is characterized by additional partial antiandrogenic effects. Its estrogenic, antiestrogenic and androgenic properties are negligible. Due to its special chemical structure, a spectrum of pharmacological action is provided, combining the most important benefits of 19-nor-progestogens and progesterone derivatives.
One pink film-coated tablet: Active ingredients: Estradiol valerate, micro 20 - 2,000 mg Dienogest, micro - 2,000 mg, Auxiliary components: lactose monohydrate, corn starch, pregelatinized corn starch, povidone-25, magnesium stearate Shell: hypromellose, macrogol-6000, talc, titanium dioxide, iron dye red oxide. On one pale yellow film-coated tablet: Active ingredients: estradiol valerate, micro 20 - 2,000 mg Dienogest, micro - 3,000 mg Auxiliary components: lactose monohydrate, corn starch, pregelatinized corn starch, povidone-25, magnesium stearate Shell: hypromellose, macrogol-6000, talc, titanium dioxide, iron dye yellow oxide. One red film-coated tablet: Active ingredient: estradiol valerate, micro 20 - 1,000 mg Auxiliary components: lactose monohydrate, corn starch, pregelatinized corn starch, povidone-25, magnesium stearate Shell: hypromellose, macrogol-6000, talc, titanium dioxide, iron dye red oxide.
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Dosage and Administration
How and when to take Qlaira
Take the pills daily in the order indicated on the package, regardless of the meal, at about the same time, drinking water if necessary. The pill is carried out continuously. It should be taken one tablet per day consistently for 28 days. Receiving pills from each new package begins after taking the last tablet 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, bleeding begins after taking the first pills from a new calendar package.
If used correctly, the Pearl Index (an indicator reflecting the frequency of pregnancy in 100 women during the year of using a contraceptive) is less than 1. If you skip pills or misuse, the Pearl Index may increase.
Preparing a Packing Book
In order to help you keep track of your pills, 7 stickers with the names of 7 days of the week are attached to the package.
Choose a sticker that starts on the day of the week on which you start taking the pills. For example, if you start a reception on Wednesday, use a sticker that starts with the word "Wed."
Place this sticker on top of Klaira's folding package, where the inscription "Place a sticker with days of the week" is located, so that the name of the first day is above the tablet with the number "1".
Now, over each tablet is the name of the corresponding day of the week, and you can see whether the tablet was already drunk on a particular day or not. Follow the direction of the arrow on the package until you have drunk all 28 pills.
Usually, the so-called menstrual bleeding begins during the period of taking the second dark red pill or white pill and may not end before you start the next pack. In some women, bleeding is still continuing after taking the first pills from a new pack.
Begin the next packaging without interruption, i.e. the day after you have finished the current packaging, even if the bleeding has not stopped. This means that the next pack should be started on the same day of the week as the current one, and that menstrual bleeding should occur every month on the same days of the week.
If you use the drug Qlaira as indicated in the instructions, you are protected from unwanted pregnancy, even during those 2 days when you take inactive pills.
How to start taking pills from the first pack?
If hormonal contraceptives were not used last month.
Start taking Qlaira on the first day of the cycle, i.e. on the first day of menstruation.
If you are switching to taking Qlaira from another COC, a combined contraceptive vaginal ring or a patch.
Start taking Qlaira the next day after drinking the last active pill (the last pill with active ingredients) from the current package of hormonal contraceptives. If the packaging of your previous contraceptives contains inactive pills, throw them away and continue taking the first package of Clayr's preparation, without taking a break. If you have previously used a combined contraceptive vaginal ring or patch, start taking Qlaira on the day you remove the ring / patch or follow the advice of a doctor.
When switching from a purely progestogenic method of contraception (mini-pili, injection, implant, or intrauterine system with progestogen release (IUD))
You can switch to taking Qlaira from a purely progestogenic method on any day (from an implant or IUD - on the day of their removal; from an injection method - on the day on which the next injection is scheduled), but in all cases during the first 9 days of taking the drug Klaira You must use additional contraceptive measures (for example, condoms).
Consult a doctor.
If you have just suffered childbirth, then the doctor may advise you to wait until you have gone through the first normal periods before you start using Qlaira. Sometimes it is possible to start earlier. The doctor will advise you what to do.
If you have had sexual contact after giving birth, before you start taking Qlaira, make sure you are not pregnant or wait until the next menstruation begins.
If you are breastfeeding and want to take Qlaira, first discuss this with your doctor.
If you have any doubts about when to start taking Qlaira, seek advice from your doctor.
If too many Qlaira pills were drunk
No serious adverse effects of an overdose of Kleir have been reported.
If you take several active pills at once, you may develop nausea or vomiting. Young girls may have bleeding from the vagina.
If you take too many Qlaira pills, or you find that a child drank a certain number of pills, seek advice from your doctor.
Necessary actions in case of missing pills
pills without active ingredients (placebo): If you miss one of the white pills (2 white pills at the end of the package), you do not need to take it later because it does not contain any active substances, and you are still protected from unwanted pregnancy.
However, it is important that you roll out the missed white pill (or pills) and continue with the next pill at the usual time. Otherwise, protection against unwanted pregnancy may be reduced (as a result of an unintended prolongation of the period during which active pills are not taken).
If you forget to take the last white pill from the current package, it is important that you take the first pill from the next package at the appropriate time.
The following recommendations relate to the omission of active pills (pills 1-26 in the package-book):
Active pills: Depending on the day of the menstrual cycle, in which one active pill was missed, you may need to take additional contraceptive measures, such as the barrier method, in particular condoms.
Take the pills according to the following principles. See also the Missed pills chart for more details.
If the delay in taking any pill is less than 12 hours, then the contraceptive effect of the drug is preserved. Drink a pill as soon as you think about it, and take the rest of the pills at the usual time.
If the delay in taking the pill is more than 12 hours, then the contraceptive reliability of the drug may decrease. Depending on the day of the menstrual cycle, in which one pill was missed, use additional contraceptive measures, for example, a barrier method, in particular condoms. See also the Missed pills chart for more details.
More than one tablet missed from the package.
Seek advice from your health care provider.
Do not take more than 2 active pills on the same day to replenish the missed pills.
If you forgot to start a new package, or you missed one or more pills from the 3rd to the 9th day of administration, there is a risk that you are already pregnant (if you had sexual intercourse within 7 days before the pill was missed). In this case, contact your doctor.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 intake pill phase, the higher the probability of pregnancy. See also the Missed pills chart for more details.
If you forget to take any of the active pills in the package, and then at the end of the package you did not have any bleeding, you may be pregnant. Before starting a new packaging, consult with your doctor.
What to do in case of vomiting or severe diarrhea
If you take vomiting or severe diarrhea after taking any of the 26 active pills of Kleir, your absorption of active substances may be incomplete. If vomiting occurred 3-4 hours after taking the pill, this is equivalent to skipping the pill. Therefore, follow the recommendations described in the section Required actions in case of missing pills. If you have severe diarrhea, consult a doctor. Vomiting or diarrhea on the days of the last 2 inactive pills do not have any effect on the contraceptive effectiveness.
You want to stop taking Qlaira
You can stop taking Qlaira at any time. If you are not planning a pregnancy, ask your doctor about other methods of contraception. If you want to get pregnant, stop taking Qlaira and wait for natural menstrual bleeding before trying to get pregnant. This will help you calculate the expected date of birth of the child.
If you have additional questions about using this drug, talk to your doctor.
The following serious adverse events have been reported in women using PDAs (which include Qlaira®): arterial and venous thrombosis and thromboembolic complications; worsening of the course or provoking symptoms of angioedema; liver tumors; acute pancreatitis
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:
- hypersensitivity to the active substances or any of the auxiliary substances;
- thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), current or current stroke);
- the conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history;
- revealed acquired or hereditary susceptibility to venous or arterial thrombosis, including resistance to activated protein C, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, hyperhomocysteinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant);
- high risk of venous or arterial thrombosis (see. "Special instructions");
- 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;
- breastfeeding period;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
- 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 disease; cardiac arrhythmia; extensive surgical interventions without prolonged immobilization);
- other diseases in which disorders of the peripheral blood circulation can be observed (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia);
- hereditary angioedema;
- diseases first arisen or aggravated during pregnancy or against the background of previous intake of sex hormones (for example, cholestatic jaundice, cholestatic pruritus, cholelithiasis, otosclerosis with impaired hearing, porphyria, herpes of pregnant women, Sydengham's chorea);
- postpartum period.
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 of isoenzymes (CYP3A4 isoenzyme). 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 (such drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbats, ritonavir, griseofulvin, and also 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 affect hepatic metabolism.
Effect on enterohepatic recirculation. While taking certain groups of antibiotics (for example, the penicillin and tetracycline groups), the enterohepatic circulation of estrogens can decrease, which can lead to a decrease in the concentration of estradiol.
Women who are treated 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 method of contraception. The barrier method of protection should be used during the entire period of taking concomitant drugs and for another 28 days after their withdrawal.
Inhibitors of isoenzymes (СYP3А4 isoenzyme). Taking rifampicin together with pills containing estradiol valerate and dienogest resulted in a significant decrease in Css and systemic exposure of dienogest and estradiol. Systemic exposure of dienogest and estradiol at Cssmeasured based on AUC0–24decreased by 83% and 44% respectively.
Known inhibitors of CYP3A4, such as azole antifungal drugs, cimetidine, verapamil, macrolides, diltiazem, antidepressants and grapefruit juice, can increase the concentration of dienogest in the blood plasma. When taken simultaneously with a potent inhibitor ketoconazole, AUC0–24 in equilibrium, in dienogest increased by 186%, and in estradiol - by 57%. With simultaneous use with a moderate inhibitor erythromycin AUC value0–24 in dienogest and estradiol in equilibrium, increased by 62 and 33%, respectively.
Effects of the drug Qlaira® for other drugs: CCP can affect the metabolism of a number of other drugs (for example, lamotrigine), which can lead either to an increase or to a decrease in the concentration of these substances in blood plasma and tissues. However, based on data from in vitro studies, inhibition of CYP enzymes when using the drug Kleir® at the therapeutic dose is unlikely.
Note: to identify possible interactions, you should familiarize yourself with the instructions of related drugs.
Pregnancy and Lactation
Taking the drug Qlaira is contraindicated during pregnancy and during breastfeeding.If pregnancy is detected or suspected while taking Qlaira, the drug should be canceled immediately and consult a doctor. However, extensive epidemiological studies have not revealed any increased risk of developmental defects in children born to women who received sex hormones (including COCs) before pregnancy or the teratogenic effect, when sex hormones were taken by negligence in the early stages of pregnancy.
If you are pregnant or breastfeeding, consult your doctor before taking any medicine.
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 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 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 (body mass index more than 30 kg / m2);
- arterial hypertension;
- 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.
The biochemical factors that indicate hereditary or acquired susceptibility to arterial or venous thrombosis include: the resistance to activated protein C, hyperhomocysteinemia, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, antiphospholipid antibodies (anti-thyroid antibodies, deficiency of protein C, deficiency of protein S, anti-phospholipid antibodies (anti-thrombiolipid antibodies C, deficiency of protein S, anti-phospholipid antibodies (anti-thrombiolipid antibodies C, deficiency of protein S, anti-phospholipid antibodies, anti-thrombin lipid antibodies, deficiency of protein S, anti-phospholipid antibodies, anti-thrombin lipid antibodies, deficiency of protein S, anti-phospholipid antibodies)
When assessing the risk / benefit ratio, it should be borne in mind that treating 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 with low-dose oral contraceptives (the content of ethinyl estradiol is less than 50 μg).
The most significant risk factor associated with the development of cervical cancer is persistent human papillomavirus infection (PVI). There are reports of some increase in the risk of developed cervical cancer with prolonged use of CPC. 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 are taking CCP 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.
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, Sydenhamma 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 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.
Effect on laboratory tests. Taking the drug Qlaira® may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal glands and kidney function, plasma concentration of transport proteins, such as CSG and lipid / lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis parameters These changes usually remain within the laboratory limits.
Medical examinations. Before starting to use 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 existing norms of medical practice, with the necessary consideration of the individual characteristics of each patient. Blood pressure is usually measured, and the condition 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.
Decreased effectiveness. The effectiveness of the drug Qlaira® can be reduced by skipping pills with active ingredients (see recommendations for taking the missed pills in the section “Dosage and administration”), gastrointestinal disorders while taking pills with active ingredients (see recommendations for gastrointestinal disorders in the “ Dosage and administration ") or against the background of concomitant drug treatment (see" Interaction ").
Insufficient control of the menstrual cycle. On 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 occurs for the first time after previous regular cycles, you should also consider the likelihood of non-hormonal causes and conduct a thorough examination to rule out malignant tumors or pregnancy. Such events may include diagnostic curettage.
Some women may not develop menstrual bleeding while taking white inactive pills. If taking the drug Qlaira® was carried out in accordance with the rules specified in the section "Dosage and administration", 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 the ability to drive a car or perform work that requires increased speed of physical and mental reactions. 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.
Symptoms: about serious violations in case of overdose of the drug Qlaira® not reported. Based on the cumulative experience with PDA, the symptoms that can occur during an overdose of active pills are nausea, vomiting, spotting or metrorrhagia.
- Brand name: Qlaira®
- Active ingredient: Dienogest, Estradiol
- Dosage form: coated pills
- Manufacturer: Bayer Pharma AG
- Country of Origin: Germany