Indications
Oral contraception.
$95.00
Active ingredient: | |
---|---|
Dosage form: | |
Indications for use: |
Oral contraception.
Qlaira® should not be used in the presence of any of the conditions listed below. The drug should be discontinued immediately if any of these conditions develop for the first time while taking it. :
WITH CAUTION
Per one dark yellow film-coated tablet:
Active ingredient:
Estradiol valerate micro 20-3,000 mg
Auxiliary components:
lactose monohydrate,
corn starch
, pre-gelatinized corn starch,
povidone-25,
magnesium stearate
Shell:
hypromellose,
macrogol-6000,
talc,
titanium dioxide,
iron oxide yellow dye.
For 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
, pre-gelatinized corn starch,
povidone-25,
magnesium stearate
Shell:
hypromellose,
macrogol-6000,
talc,
titanium dioxide,
iron oxide red dye.
Per 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
, pre-gelatinized corn starch,
povidone-25,
magnesium stearate
Shell:
hypromellose,
macrogol-6000,
talc,
titanium dioxide,
iron oxide yellow dye.
Per one red film-coated tablet:
Active ingredient:
Estradiol valerate micro 20-1,000 mg
Auxiliary components:
lactose monohydrate,
corn starch
, pre-gelatinized corn starch,
povidone-25,
magnesium stearate
Shell:
hypromellose,
macrogol-6000,
talc,
titanium dioxide,
iron oxide red dye.
Per one white film-coated tablet (placebo):
Auxiliary components:
lactose monohydrate,
corn starch,
povidone-25,
magnesium stearate
Shell:
hypromellose,
talc,
titanium dioxide.
Per one dark yellow film-coated tablet:
Active ingredient:
Estradiol valerate micro 20-3,000 mg
Auxiliary components:
lactose monohydrate,
corn starch, pregelatinized corn starch,
povidone-25,
magnesium stearate
Shell:
hypromellose,
macrogol-6000,
talc,
titanium dioxide,
iron oxide yellow dye.
For 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, pre-gelatinized corn starch,
povidone-25,
magnesium stearatobolochka:
hypromellose,
macrogol-6000,
talc,
titanium dioxide,
iron oxide red dye.
Per 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 oxide yellow dye.
Per 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 oxide red dye.
Per one white film-coated tablet (placebo):
Auxiliary components:
lactose monohydrate,
corn starch,
povidone-25,
magnesium stearate
Shell:
hypromellose,
talc,
titanium dioxide.
The contraceptive effect of combined oral contraceptives (COCs) is based on the interaction of various factors, the most important of which are ovulation suppression and changes in the properties of cervical mucus. Along with preventing unwanted pregnancies, COCs have a number of positive properties, which, if taken into account also negative properties, can help in choosing the most appropriate method of contraception.
In women taking COCs, the soreness and intensity of menstrual-like bleeding decreases, resulting in a reduced risk of iron-deficiency anemia. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer.
The estrogen in Qlaira is estradiol valerate, a precursor of natural human 17b-estradiol (1 mg of estradiol valerate corresponds to 0.76 mg of 17b-estradiol) The estrogenic component used in this COC is thus different from the estrogens commonly used in COC, which are the synthetic estrogens ethinyl estradiol or its precursor mestranol, both containing an ethinyl group at position 17α. This group causes higher metabolic stability, but also a more pronounced effect on the liver.
Taking Qlaira leads to a less pronounced effect on the liver compared to three-phase COCs containing ethinyl estradiol and levonorgestrel. It was shown that the effect on the concentration of sex steroid binding globulin (SHBG) and hemostasis parameters is less pronounced.
In combination with dienogest, estradiol valerate shows an increase in high-density lipoproteins (HDL), while the concentration of low-density lipoprotein cholesterol (LDL) decreases slightly.
Dienogest is an oral progestogen that is characterized by additional partial antiandrogenic effects. Its estrogenic, anti-estrogenic and androgenic properties are insignificant. Thanks to its special chemical structure, it provides a spectrum of pharmacological action that combines the most important benefits of 19-nor-progestogens and progesterone derivatives.
Oral contraception.
Taking Qlaira is contraindicated during pregnancy and lactation.
If pregnancy is detected or suspected while taking Qlaira, the drug should be discontinued immediately and a doctor should be consulted.
However, extensive epidemiological studies have not found any increased risk of developmental defects in children born to women who received sex hormones (including COCs) before pregnancy or teratogenic effects when sex hormones were taken carelessly in early pregnancy.
If you are pregnant or breastfeeding, consult your healthcare provider before taking any medication.
Qlaira® should not be used in the presence of any of the conditions listed below. The drug should be discontinued immediately if any of these conditions develop for the first time while taking it. :
WITH CAUTION
System-organ class Often Infrequently Rarely
Infections and infestations Fungal infection, vaginal candidiasis, vaginal infection, unspecified Candidiasis, herpes simplex, suspected eye histoplasmosis syndrome, multicolored lichen, urinary tract infection, bacterial vaginosis, candidal vulvovaginitis
Metabolism and alimentary disorders
Increased appetite, Fluid retention, hypertriglyceridemia
The nervous system
Headache (including tension headache), Depression/decreased mood, decreased libido, mental disorder, mood changes, dizziness, Affective lability, aggressiveness, anxiety, dysphoria, increased libido, nervousness, anxiety, sleep disturbance, stress, attention disorders, paresthesia, vertigo
Visual organ
Contact lens intolerance, dryness of the eye mucosa, edema of the eyelids
Cardiovascular system
Increased blood pressure, migraines (including with and without aura), Bleeding from varicose veins, hot flushes to the face, decreased blood pressure, pain along the veins
From the gastrointestinal tract
Abdominal pain(including bloating), Diarrhea, nausea, vomiting Constipation, dyspepsia, gastroesophageal reflux
Liver and biliary tract disorders
Increased ALT activity, focal nodular hyperplasia of the liver
Skin and subcutaneous tissue disorders
Acnealopecia, pruritus (including generalized pruritus and itchy rash), rash (including spotty rash), hyperhidrosis
Allergic skin reaction, including allergic dermatitis and urticaria, chloasma, dermatitis, hirsutism, hypertrichosis, neurodermatitis, pigmentation disorder, seborrhea, unspecified skin damage
Musculoskeletal and connective tissue disorders
Back pain, muscle spasms, heaviness
From the genitals and breast
Absence of menstrual-like bleeding, discomfort in the mammary glands, pain in the mammary glands, soreness of the nipples, pain in the nipples, painful menstrual-like bleeding, irregular menstrual-like bleeding (metrorrhagia)Breast enlargement, diffuse breast compaction, cervical epithelial dysplasia, dysfunctional uterine bleeding, dyspareunia, fibrocystic mastopathy, menorrhagia, ovarian cysts, pelvic pain, premenstrual syndrome, uterine leiomyoma, uterine spasms, vaginal discharge, vulvovaginal dryness, Benign neoplasm in the breast, breast cyst, bleeding during pregnancy sexual intercourse, galactorrhea, vaginal bleeding, hypomenorrhea, delayed menstrual-like bleeding, ruptured ovarian cyst, burning sensation in the vagina, uterine/vaginal bleeding (including spotting, vaginal odor, vulvovaginal discomfort)
From the blood and lymphatic system Lymphadenopathy
Common symptoms
Weight gain Irritability, edema, weight loss Pain behind the sternum, fatigue, malaise
The following serious adverse events have been reported in women using COCs (which include Qlaira®)::
arterial and venous thrombosis and thromboembolic complications; worsening of the course or provoking symptoms of angioedema; liver tumors; acute pancreatitis
Effect of other drugs on the active components of Qlaira®
The interaction of COCs 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 CPC literature in general or have been studied in clinical trials of Qlaira®:
Inducers of isoenzymes (CYP3A4 isoenzyme). Interaction with drugs that induce microsomal enzymes (for example, cytochrome P450 systems) may occur, 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, felbamate, ritonavir, griseofulvin, as well as drugs containing St. John’s wort). Hepatic metabolism has also been reported to be affected by HIV protease inhibitors (e. g. ritonavir), non-nucleoside reverse transcriptase inhibitors (e. g. nevirapine), and combinations thereof.
Effect on intestinal-hepatic recirculation. When taking certain groups of antibiotics (for example, penicillin and tetracycline groups), the enterohepatic circulation of estrogens may decrease, which may lead to a decrease in the concentration of estradiol.
Women who are receiving treatment with microsomal enzyme-inducing drugs or antibiotics are advised to temporarily use a barrier method of contraception in addition to Qlaira® or choose a different method of contraception. The barrier method of protection should be used for the entire period of taking concomitant medications and for another 28 days after their withdrawal.
Inhibitors of isoenzymes (CYP3A4 isoenzyme). Concomitant use of rifampicin with tablets containing estradiol valerate and dienogest resulted in a significant reduction in Css and systemic exposure to dienogest and estradiol. Systemic exposure to dienogest and estradiol in Css, measured on the basis of AUC0-24, decreased by 83 and 44%, respectively.
Known CYP3A4 inhibitors, such as azole antifungal drugs, cimetidine, verapamil, macrolides, diltiazem, antidepressants, and grapefruit juice, may increase the concentration of dienogest in blood plasma. When administered concomitantly with the potent inhibitor ketoconazole, the steady–state AUC0 — 24 value in dienogest increased by 186%, and in estradiol-by 57%. When co–administered with the moderate inhibitor erythromycin, the AUC0-24 values of dienogest and estradiol at steady state increased by 62 and 33%, respectively.
Effects of Qlaira® on other drugs: COCs can affect the metabolism of a number of other drugs (for example, lamotrigine), which can lead to either an increase or decrease in the concentration of these substances in blood plasma and tissues. However, based on data from in vitro studies, inhibition of CYP enzymes with the use of Qlaira® at a therapeutic dose is unlikely.
Note: to identify possible interactions, you should read the instructions for accompanying drugs.
Incompatibility. Absent.
How and when to take Qlaira
Take the tablets daily in the order indicated on the package, regardless of food intake, at approximately the same time, if necessary, with water. Tablets are taken continuously. You should take one tablet a day consecutively for 28 days. Taking tablets from each new package begins after taking the last tablet from the previous calendar package. Menstrual-like bleeding usually begins while taking the last tablets of the calendar package and may not be completed until the next calendar package begins. In some women, bleeding begins after taking the first tablets from the new calendar package. When used correctly, the Pearl index (an indicator that reflects the frequency of pregnancy in 100 women during a year of contraceptive use) is less than 1. If you skip pills or use them incorrectly, the Pearl index may increase.
Preparation of book packaging
In order to help you keep track of your pill intake, there are 7 stickers attached to the package with the names of 7 days of the week affixed to them. Choose a sticker that starts on the day of the week when you start taking your pills. For example, if you start an appointment on a Wednesday, use a sticker that starts with the word “WED”.
Place this sticker at the top of the Clayra fold-out package, where it says “Put a sticker with days of the week here”, so that the name of the first day is located above the tablet with the number “1”.
Now, above each pill is the name of the corresponding day of the week, and you can see whether the pill has already been consumed on a particular day or not. Follow the direction of the arrow on the book packaging until you have consumed all 28 tablets.
Usually, the so-called menstrual-like bleeding begins during the period of taking the second dark red pill or white pills and may not end yet before you start the next pack. In some women, the bleeding still continues after taking the first pills from the new package.
Start the next pack without a break, i. e. the day after you have finished the current pack, 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-like bleeding should occur every month on the same days of the week.
If you use Qlaira as indicated in the instructions, you are protected from unwanted pregnancy even during the 2 days when you take inactive tablets.
How do I start taking pills from the first package?
If you have taken too many Clyra tablets
No serious adverse effects of Qlaira overdose have been reported.
If you have taken several active pills at one time, you may develop nausea or vomiting. Young girls may have vaginal bleeding.
If you take too many Clayra tablets, or find that a child has taken a certain number of tablets, ask your doctor for advice.
Necessary actions in case of missing pills
Tablets without active ingredients (placebo): If you miss one of the white tablets (2 white tablets 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 discard 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 unintentional prolongation of the period during which active pills are not taken).
If you forget to take the last white tablet from the current package, it is important that you still take the first tablet from the next package at the appropriate time.
The following recommendations apply to skipping active tablets (tablets 1-26 in the package-book):
Active Tablets: Depending on the day of your menstrual cycle when you missed one active pill, you may need to use additional contraceptive measures, such as a barrier method, such as condoms.
Take the pills according to the following guidelines. For more information, see also the Missed Pills chart.
Do not take more than 2 active tablets in one day to make up for missed pills.
If you forget to start a new pack, or skip one or more pills from day 3 to day 9, there is a risk that you are already pregnant (if you had sexual contact within 7 days before skipping the pill). In this case, contact your doctor. The more pills (especially those with a combination of two active ingredients on days 3 to 24) that are missed, and the closer they are to the inactive pill phase, the higher the chance of pregnancy. For more information, see also the Missed Pills chart.
If you forgot 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. Please consult your healthcare provider before starting a new package.
What to do in case of vomiting or severe diarrhea
If you experience vomiting or severe diarrhea after taking any of the 26 active tablets of Clayra, the absorption of the active substances may not be complete. If vomiting occurs 3-4 hours after taking the pill, this is equivalent to skipping the pill. Therefore, follow the recommendations described in the section Necessary actions in case of missing pills. If you have severe diarrhea, contact your doctor. Vomiting or diarrhea on the days of taking the last 2 inactive tablets does not have any effect on the effectiveness of contraception.
Do you want to stop taking Qlaira
You can stop taking Qlaira at any time. If you are not planning to become pregnant, ask your doctor about other methods of contraception. If you want to get pregnant, stop taking Clayra and wait for natural menstrual bleeding before trying to get pregnant. This will help you calculate your child’s expected date of birth.
If you have any further questions about the use of this medicine, please contact your doctor.
Symptoms: No serious abnormalities have been reported with Qlaira overdose.
Based on the combined experience of using COCs, symptoms that may occur with an overdose of active tablets: nausea, vomiting, spotting or metrorrhagia.
Treatment: symptomatic.
If any of the diseases/If the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of using Qlaira® should be carefully correlated in each individual case and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors become more severe, severe, or present for the first time, a woman should consult with her doctor, who may decide whether 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 DVT, PE, MI and cerebrovascular disorders). The risk of developing venous thromboembolism (VTE) is maximal in the first year of taking such drugs, mainly during the first 3 months. An increased risk is present after the initial use of a PDA or the resumption of use of the same or different PDA (after a break between drug doses of 4 weeks or more). The overall risk of VTE in patients taking low-dose COCs (ethinyl estradiol content — less than 50 mcg) is 2-3 times higher than in patients who do not take COCs, but this risk remains lower compared to the risk of VTE during pregnancy and childbirth. VTE can be fatal (in 1-2% of cases).
VTE, which manifests as DVT or PE, can occur when using any PDA. Very rarely, when using PDA, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral arteries and veins, or retinal vessels. There is no consensus on the link between the occurrence of these events and the use of the CPC. Arterial thromboembolism can be 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 smoked or an increase in age, the risk increases, especially in women over 35 years of age);
in the presence of:
– family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of hereditary or acquired predisposition woman should be assessed appropriately skilled to address the question of the possibility of drug Claire®;
– obesity (body mass index more than 30 kg/m 2);
– dyslipoproteinemia;
– arterial hypertension;
– migraine;
– diseases of heart valves;
– atrial fibrillation;
– prolonged immobilization; extensive surgical intervention, any surgery on the lower limbs or major trauma. In such situations, it is advisable to stop taking Qlaira® (for elective surgery — at least 4 weeks before it) and not resume taking it for 2 weeks after the end of immobilization.
The possible role of varicose veins and superficial thrombophlebitis in the development of VTE 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 Qlaira® (which may precede cerebrovascular disorders) may be a reason for immediate discontinuation of this drug.
Biochemical factors that indicate a hereditary or acquired predisposition to arterial or venous thrombosis include the following: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anti-cardiolipid antibodies, lupus anticoagulant).
When assessing the risk-benefit ratio, consider that treating 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 (ethinyl estradiol content is less than 50 mcg).
Tumors
The most significant risk factor associated with the development of cervical cancer is persistent papillomavirus infection (PVI). There are reports of a slight increase in the risk of developing cervical cancer with prolonged use of COCs. The association with PDA use has not been proven. The possibility of correlation of these data with screening of cervical diseases and sexual behavior features (more rare use of barrier methods of contraception) is discussed.
A meta-analysis of 54 epidemiological studies found a small increase in the relative risk (RR = 1.24) of developing breast cancer in women currently taking COCs. The increased risk gradually disappears within 10 years after discontinuation of these medications.Due to the fact that breast cancer is rare in women younger than 40 years of age, a slight increase in the number of breast cancer diagnoses among women who are currently or have recently taken COCs is insignificant in relation to the overall risk of this disease. Its association with PDA use has not been proven. The observed increased risk may also be a consequence of earlier breast cancer diagnosis in women using COCs. Women who have ever used PDAs 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. If severe upper abdominal pain, enlarged liver, or signs of intra-abdominal bleeding occur in women taking COCs, differential diagnosis should exclude liver tumors.
Other states
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 Qlaira®, the drug should be discontinued and treatment for arterial hypertension should be initiated. If necessary, Qlaira® can be resumed if normal blood pressure values can be achieved through antihypertensive therapy.
The following conditions develop or worsen both during pregnancy and when taking COCs, but their association with COCs is not proven: jaundice and/or cholestatic pruritus, cholelithiasis, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham’s chorea, herpes of pregnancy, otosclerosis-related hearing loss.
In women with hereditary forms of angioedema, exogenous estrogens may induce or worsen the symptoms of angioedema.
Acute or chronic hepatic impairment may require discontinuation of Qlaira® until liver function returns to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of Qlaira®.
Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients who use Qlaira®. However, women with diabetes should be closely monitored while taking Qlaira®.
Cases of Crohn’s disease and ulcerative colitis associated with the use of COCs are also described.
Chloasma can sometimes develop, especially in women with a history of pregnancy chloasma.
Women who are prone to developing chloasma should avoid exposure to the sun or UV radiation while taking Qlaira®.
Impact on laboratory tests. The use of Qlaira® may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma transport protein concentrations, such as CSG and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, clotting and fibrinolysis. These changes usually remain within the limits of laboratory standards.
Medical examinations. Before starting the use of Qlaira®, it is necessary to carefully evaluate contraindications to the appointment of the drug based on the life history, family history of the woman, as well as general medical and gynecological examination. The frequency and nature of these examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each patient. As a rule, blood pressure is measured, the condition of the mammary glands, abdominal cavity and pelvic organs is checked, including cervical cytology.
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 Qlaira® may be reduced if you skip tablets with active components (see recommendations for taking missed tablets in the section “Method of use and dosage”), gastrointestinal disorders while taking tablets with active components (see recommendations for gastrointestinal disorders in the section “Method of use and dosage”) or on the background of concomitant drug treatment (see “Interaction”).
Insufficient control of the menstrual cycle. Irregular menstrual-like bleeding (spotting discharge or breakthrough uterine bleeding) may occur during the use of Qlaira, especially in the first months of use. Therefore, any irregular menstrual-like bleeding should only be evaluated after an adjustment period of approximately 3 menstrual-like cycles.
If irregular menstrual-like bleeding recurs or occurs for the first time after previous regular cycles, the possibility of non-hormonal causes should also be considered and a thorough examination should be performed to exclude malignancies or pregnancy. Such activities may include diagnostic curettage.
Some women may not develop menstrual-like bleeding while taking inactive white pills. Pregnancy is unlikely if Qlaira® has been administered in accordance with the guidelines described in the section “Dosage and use”. However, if the tablets were taken irregularly before the first absent menstrual-like bleeding or there are no consecutive 2 menstrual-like bleeding, do not continue using Qlaira® until pregnancy is ruled out.
Influence on the ability to drive a car or perform work that requires an increased rate of physical and mental reactions. There was no negative effect of Qlaira® on the ability to drive a car and work with mechanisms, but patients who experience episodes of dizziness and impaired concentration during the adaptation period (the first 3 months of taking the drug) should exercise caution.
Film-coated tablets
Store at a temperature not exceeding 30 C.
life is 4 years.
Dienogest, Estradiol Valerate and Estradiol valerate [set]
By prescription
Tablets
For women of childbearing age, Adults as prescribed by a doctor
For contraception
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