Claira - instructions for use, analogs, reviews and release forms (birth control pills) of the drug for contraception in women, including during pregnancy and lactation. Adverse effects of admission

In this article, you can read the instructions for using the contraceptive drug Claira. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Claira in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Clayre in the presence of existing structural analogues. Use for contraception in women, including during pregnancy and lactation. Side effects of taking the drug.

Claira - 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 a change in the properties of cervical mucus. Along with the prevention of unwanted pregnancy, COCs have a number of positive properties that, while taking into account also negative properties, can help in choosing the most suitable method of contraception. In women taking COC, the soreness and intensity of menstrual bleeding decreases, which reduces the risk of iron deficiency anemia. In addition, there is evidence of a reduced risk of developing endometrial cancer and ovarian cancer.

Estrogen in Claira's preparation is estradiol valerate, the precursor of natural 17β-estradiol (1 mg of estradiol valerate corresponds to 0.76 mg of 17β-estradiol). The estrogen component used in this COC is thus different from the commonly used in COC estrogens, which are synthetic estrogens - ethinyl estradiol or its precursor mestranol, both containing an ethynyl group at position 17alpha.This group causes a higher metabolic stability, but also a more pronounced effect on the liver.

The administration of Claira's drug 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 SHBG and the parameters of hemostasis is less pronounced. In combination with dienogest of estradiol valerate shows an increase in HDL, while the concentration of LDL cholesterol is somewhat reduced.

Dienogest is a progestogen that works by oral administration, which is characterized by additional partial anti-androgenic effects. Its estrogenic, anti-estrogenic and androgenic properties are insignificant. Thanks to a special chemical structure, a spectrum of pharmacological action is provided that combines the most important advantages of 19-nor-progestogens and Progesterone derivatives.

Preclinical data obtained from routine toxicity studies with repeated doses, genotoxicity, carcinogenic potential, and toxicity to the reproductive system do not indicate a specific risk to humans.However, it should be borne in mind that sex hormones can stimulate the growth of a number of hormone-dependent tissues and tumors.

When used correctly, the Perl index (an indicator that reflects the frequency of pregnancy in 100 women during the year of use of the contraceptive) is less than 1. When missing tablets or improperly used, the Pearl index may increase.

Composition

Estradiol valerate, micro 20 + Dienogest, micro + auxiliary substances.

Pharmacokinetics

Dienogest

After oral administration, dienogest is quickly and almost completely absorbed. Simultaneous food intake does not have a clinically significant effect on the speed and degree of absorption of dienogest. Dienogest is almost completely metabolized, in accordance with the known ways of steroid hormone metabolism (hydroxylation, conjugation), with the formation of mainly hormoneally inactive metabolites. Metabolites are excreted very quickly, so the predominant fraction in the blood plasma is unchanged dienogest. After oral administration at a dose of 0.1 mg / kg, dienogest is excreted as metabolites, which are excreted by the kidneys and through the intestine in a ratio of approximately 3: 1.

Estradiol valerate

After ingestion of estradiol valerate is quickly and completely absorbed. Splitting into estradiol and valeric acid occurs during absorption in the gastrointestinal mucosa or during the first passage through the liver, resulting in the formation of estradiol and its metabolites - estrone and estriol. Estradiol and its metabolites are excreted mainly by the kidneys, with about 10% being excreted through the intestine.

Indications

• oral contraception.

Forms of release

The tablets covered with a film cover of yellow and red color, plus white (placebo).

Instructions for use and reception scheme

Inside, regardless of food intake.

Tablets should be taken in the order given on the packaging every day at approximately the same time, if necessary, washed down with water or another liquid. The tablets are taken continuously. You should take 1 tablet a day consecutively for 28 days. Each new packaging is started after receiving the last tablet from the previous calendar package. Menstruation-like bleeding usually begins during the reception of the last tablets of the calendar pack and may not be completed before the next calendar packing begins.In some women, menstrual bleeding begins after taking the first tablets from a new calendar package.

If hormonal contraception was not used before (the previous month)

Tablets begin to take on the 1st day of the natural menstrual cycle of a woman (ie, on the 1st day of menstrual bleeding).

Transition from another combined hormonal contraceptive (another COC, vaginal ring or transdermal patch)

The woman should start taking Claira's drug the day after the last active tablet (the tablet containing the active substances) was drained from the packaging of the previous COC. When using a vaginal ring or transdermal patch, a woman should start taking Clayra on the day of removal.

If only a progestogenic method of contraception (mini-pil, injection, implant) or intrauterine system with the release of progestogen (IUD) was used previously,

A woman can switch to taking Clayra's drug from a mini-drip on any day (from the implant or the IUD on the day of removal, from the injection method on the day the next injection is scheduled)but in all cases during the first 9 days of taking the tablets it is recommended to use the barrier method of contraception in addition.

After abortion in 1 trimester of pregnancy

A woman can start taking pills immediately. In this case, there is no need for additional contraceptive measures.

After childbirth or abortion in the 2nd trimester of pregnancy

It should be recommended to the woman to start taking pills on the 21-28th day after childbirth or abortion in the 2nd trimester of pregnancy. If a woman starts taking pills later, she is recommended to use the barrier method of contraception during the first 9 days of taking the pills. However, if sexual intercourse has already taken place, before the actual start of the drug, Clire should be excluded from pregnancy, or the woman should wait for the onset of the first menstrual period.

Acceptance of missed tablets in placebo

Missed (white) inactive tablets can be neglected. However, they should be discarded to avoid inadvertently prolonging the interval between taking active tablets.

Skipping active tablets

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

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

Depending on the day of the menstrual cycle, in which the tablet was missed (see Table 2 for details), additional contraceptive measures (for example, barrier method of protection, in particular condoms) are required in accordance with the following principles:

It is allowed to take no more than 2 tablets in one day.

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

If the woman missed taking the tablets, and then at the end of the calendar packing / at the beginning of the new calendar package menstrual bleeding was absent, 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 (eg, barrier method of prevention, in particular condoms).

If vomiting occurs after 3-4 hours after taking an active pill and the woman does not want to change her usual pill regimen, she needs to drink an additional tablet (or tablets) from the new package.

Older patients: Claira is not indicated after menopause.

Side effect

• fungal infection;
• candidiasis of the vagina;
• herpes;
• syndrome;
• colored lichen;
• urinary tract infection;
• bacterial vaginosis;
• increased appetite;
• fluid retention;
• headache (including tension headache);
• depression;
• decreased mood;
• decreased libido;
• mental disorder;
• mood changes;
• dizziness;
• aggressiveness;
• anxiety;
• increased libido;
• nervousness;
• anxiety;
• sleep disturbance;
• stress;
• violation of attention;
• intolerance to contact lenses;
• increased blood pressure;
• migraine (including with aura and without aura);
• bleeding from varicose veins;
• hot flushes to face;
• a decrease in blood pressure;
• pain along the veins;
• pain in the abdomen (including bloating);
• diarrhea;
• nausea, vomiting;
• acne (blackheads);
• alopecia;
• itching (including generalized itching and itching rash);
• rash (including spotted rash);
• allergic dermatitis;
• hives;
• Chloasma;
• hypertrichosis;
• neurodermatitis;
• back pain;
• muscle spasms;
• amenorrhea;
• discomfort in the mammary glands;
• pain in the mammary glands;
• pain in the nipples;
• dysmenorrhea;
• irregular menstrual bleeding (metrorrhagia);
• increased mammary glands;
• diffuse mammary gland thickening;
• dysplasia of the cervical epithelium;
• dysfunctional uterine bleeding;
• fibrocystic mastopathy;
• menorrhagia;
• cysts in the ovaries;
• pelvic pain;
• premenstrual syndrome;
• spasms of the uterus;
• vaginal discharge;
• benign neoplasm in the mammary gland;
• a cyst of a mammary gland;
• bleeding during intercourse;
• delay in menstrual bleeding;
• burning sensation in the vagina;
• uterine / vaginal bleeding (including smearing discharge, vaginal odor, vulvovaginal discomfort);
• weight gain;
• weight loss.

Contraindications

The Clayra drug should not be used 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 now or in the anamnesis (including deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), stroke now or in the anamnesis);
• conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in the anamnesis;
• presence of expressed or multiple risk factors for venous or arterial thrombosis (including extensive surgical intervention with prolonged immobilization, complicated heart valve disease, uncontrolled hypertension);
• Migraine with focal neurological symptoms, incl. in the anamnesis;
• diabetes mellitus with vascular complications;
• Pancreatitis with severe hypertriglyceridemia at present or in the anamnesis;
• hepatic failure and severe liver disease (before the normalization of liver function);
• liver tumors (benign and malignant) at present or in the anamnesis;
• identified hormone-dependent malignant tumors (including genitals or mammary glands) or suspected of them;
• bleeding from the vagina of unknown origin;
• pregnancy or suspected of it;
• hypersensitivity to active substances or any of the excipients.

Carefully

If any of the diseases / conditions / risk factors indicated below are currently available, the potential risk and the expected benefit of using the Clire drug should be carefully correlated in each individual case:

• risk factors for thrombosis and thromboembolism (smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, heart valve disease, heart rhythm disturbance, prolonged immobilization, extensive surgery, extensive trauma);
• other diseases in which peripheral circulation disorders may be noted (diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease and ulcerative colitis, sickle-cell anemia);
• hereditary angioedema;
• hypertriglyceridemia;
• diseases that first appeared or worsened during pregnancy or against the background of previous reception of sex hormones (for example, cholestatic jaundice, cholestatic itching, cholelithiasis, otosclerosis with hearing impairment, porphyria, pregnant herpes, Sydenham's chorea);
• the postpartum period.

Application in pregnancy and lactation

The use of the drug Clayra is contraindicated during pregnancy. If the pregnancy occurred against the background of the drug Clyde, further reception should be discontinued. However, large-scale epidemiological studies did not reveal an increased risk of birth defects in children born to women who used COCs prior to pregnancy, as well as teratogenic effects of COCs when they were randomly admitted at the beginning of pregnancy.

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

Use in children under 12 years of age

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

special instructions

If any of the diseases / conditions / risk factors outlined below are present, then the potential risk and the expected benefit of using Clare in each individual case should be carefully correlated and discussed with the woman before she decides to start taking the drug . In case of weighting, strengthening or the first manifestation of any of these conditions or risk factors, a woman should consult with her doctor who can decide whether to cancel the drug.

Diseases of the cardiovascular system

The results of epidemiological studies indicate the existence of a relationship between the use of COCs and an increase in the 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 COCs or the resumption of the use of the same or different COCs (after a break between doses of 4 weeks or more).

The overall risk of VTE in patients taking low-dose COCs (ethinylestradiol content is less than 50 μg) is 2-3 times higher than in patients who do not take COC, however, this risk remains lower in comparison with the risk of VTE in pregnancy and childbirth.

VTE can lead to death (in 1-2% of cases).

VTE, manifested as DVT or PE, can occur when using any COCs.

It is extremely rare when using COCs, thrombosis of other blood vessels occurs, for example, liver, mesenteric, renal, cerebral arteries and veins or retinal vessels. A common opinion regarding the relationship between the occurrence of these events and the use of COC is absent. Arterial thromboembolism can be fatal.

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

• with age;
• among smokers (with the increase in the number of cigarettes smoked or the increase in age, the risk increases, especially in women over 35)

in the presence of:

• family history (for example, venous or arterial thromboembolism ever at close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, a woman should be examined by an appropriate specialist to decide on the possibility of taking Clayra's drug;
• Obesity (body mass index more than 30 kg / m2);
• dyslipoproteinemia;
• arterial hypertension;
• migraine;
• heart valve diseases;
• atrial fibrillation;
• prolonged immobilization; extensive surgical intervention, any operation on the lower limbs or extensive trauma. In such situations, it is advisable to stop taking Claira's medication (at the planned operation - at least 4 weeks before it) and not to resume the 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.

An increased risk of thromboembolism in the postpartum period should be considered.Violations of peripheral circulation 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. An increase in the frequency and severity of migraine during the use of the Clayra drug (which may precede cerebrovascular disorders) may be the reason for the immediate discontinuation of this drug.

Biochemical factors that indicate hereditary or acquired predisposition to arterial or venous thrombosis include: resistance to activated protein C, hyperhomocysteinemia, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, antiphospholipid antibodies (anticardiolipid antibodies, lupus anticoagulant).

In assessing the relationship between risk and benefit, it should be borne in mind that treatment of an appropriate condition can reduce the risk of thrombosis associated with it. It should also be taken into account that the risk of thrombosis and thromboembolism in pregnancy is higher than when taking low-dose oral contraceptives (ethinylestradiol content is less than 50 μg).

Tumors

The most significant risk factor associated with the development of cervical cancer is persistent papillomavirus infection (PID). There are reports of a certain increase in the risk of advanced cervical cancer with prolonged use of COCs. The connection with the reception of the COC has not been proved. The possibility of interrelation of these data with screening of cervical diseases and peculiarities of sexual behavior (a more rare application 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 in women currently taking COCs. The increased risk gradually disappears within 10 years after discontinuation of these medications. Because breast cancer is rare in women younger than 40 years, a slight increase in the number of diagnosed breast cancers in women who are currently taking COCs or who have recently taken COC is insignificant in relation to the overall risk of this disease. His connection with the use of COC has not been proven. The observed increase in risk may also be a consequence of an earlier diagnosis of breast cancer in women using COCs.Women who have ever used COC have earlier stages of breast cancer than women who have never used them.

In rare cases, with the use of COC, benign, and in very rare cases, malignant liver tumors, which in some cases led to life-threatening intraabdominal hemorrhage, was observed. If there are severe pain in the upper abdomen, increased liver size, or signs of intra-abdominal bleeding in women taking COC, differential diagnosis should exclude liver tumors.

Other states

In women with hypertriglyceridemia (or in the presence of this condition in a family history), an increased risk of developing pancreatitis during COC administration is possible.

Although a small increase in BP was reported in many women taking COC, a clinically significant increase was noted rarely. However, if a persistent, clinically significant increase in blood pressure develops with the use of the Claira drug, it is necessary to cancel the drug and begin treatment of arterial hypertension. The administration of Claira's drug can be renewed if necessary, if it is possible to achieve normal blood pressure by means of antihypertensive therapy.

The following conditions develop or worsen both during pregnancy and when taking COC, but their relationship with COC is not proven: jaundice and / or cholestatic itching, cholelithiasis, porphyria, systemic lupus erythematosus, haemolytic-uremic syndrome, Sydenham's chorea, herpes of pregnant women , due to otosclerosis, hearing loss.

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

Acute or chronic liver dysfunction may require the withdrawal of Clyde's drug until the liver function test results return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous reception of sex hormones, requires the discontinuation of the Clayra drug.

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 Claira. Nevertheless, women suffering from diabetes mellitus need careful monitoring when taking the drug.

Cases of Crohn's disease and ulcerative colitis are also described against the background of COC use.

Sometimes chloasma can develop, especially in women with a history of chloasma.

Women who are prone to develop chloasma, during the period of taking Clayra should avoid exposure to the sun or UV radiation.

Impact on laboratory tests

The administration of Clayra's drug may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney functions, the concentration of transport proteins in the plasma, for example, KCG and lipid / lipoprotein fractions, parameters of carbohydrate metabolism, clotting and fibrinolysis. These changes usually remain within the limits of laboratory norms.

Medical examinations

Before starting the use of the drug, Clayra should carefully evaluate the contraindications to the prescription of the drug based on anamnesis of life, a family history of a woman, as well as general medical and gynecological examination. The frequency and nature of these surveys should be based on existing norms of medical practice, with the necessary consideration of the individual characteristics of each patient.As a rule, BP is measured, the condition of mammary glands, abdominal cavity and pelvic organs is checked, including cervical cytology.

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

Decreased efficiency

The efficacy of Clayr's preparation can be reduced by skipping tablets with active ingredients, gastrointestinal disorders during the administration of tablets with active ingredients, or against the background of concomitant medication.

Insufficient control of the menstrual cycle

Against the background of the use of Clayra's drug, especially in the first months of admission, irregular menstrual bleeding (spotting or breakthrough uterine bleeding) can occur. Therefore, any irregular menstrual bleeding should be evaluated only after a period of adaptation, which is approximately 3 menstrual cycle-like.

If irregular menstrual bleeding is repeated or first occurs after previous regular cycles,should also consider the probability of non-hormonal causes and conduct a thorough examination to exclude malignant neoplasms or pregnancy. Such activities may include diagnostic scraping.

In some women, while receiving inactive white tablets, menstrual bleeding may not develop. If the Claira drug was administered in accordance with the rules specified in the "Dosage regimen" section, pregnancy is unlikely. However, if before the first menstrual-like bleeding, tablets were taken irregularly or there are no contractions of menstrual bleeding, do not continue using Clayr's drug until pregnancy is excluded.

Influence on ability to drive a car and machinery

There was no adverse effect on the ability to drive and work with machines, but patients who have had periods of dizziness and impaired attention during the adaptation period (the first 3 months of taking the drug) should be careful.

Drug Interactions

Interaction of combined oral contraceptives with other drugs may lead to breakthrough uterine bleeding and / or absence of the contraceptive effect.

The following types of interaction have been described in the literature on COCs in general or have been studied in the clinical trials of the Clayra drug.

Inductors or inhibitors of individual enzymes (isoenzyme CYP3A4)

Inductors of isoenzymes. May be interaction with drugs that induce microsomal enzymes (e.g., systems cytochrome P450), whereby the clearance of hormones may increase (phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, as well as preparations containing St. John's wort pitted). It has been reported that the effect on hepatic metabolism may also provide HIV protease inhibitors (such as Ritonavir), non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and combinations thereof.

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

Women who are treated with drugs that induce microsomal enzymes, or antibiotics, in addition to the Claira drug, are advised to temporarily use the 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 medications and for another 28 days after their withdrawal.

Inhibitors of isoenzymes. Simultaneous reception of rifampicin together with tablets 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 equilibrium concentration, measured on the basis of AUC0-24 h, decreased by 83% and 44%, respectively.

Known CYP3A4 inhibitors, such as azole antifungals, cimetidine, verapamil, macrolides, diltiazem, antidepressants and grapefruit juice, can increase the concentration of dienogest in the blood plasma.When administered simultaneously with a potent inhibitor of ketoconazole, the AUC0-24 hour value in the equilibrium state in dienogest increased by 186%, and in estradiol - by 57%. When used simultaneously with a moderate Erythromycin inhibitor, the AUC0-24 hour value of dienogest and estradiol in the equilibrium state increased by 62 and 33%, respectively.

The effects of Claira's drug on other drugs: COCs can affect the metabolism of a number of other drugs (eg, lamotrigine), which can lead to either an increase or a decrease in the concentration of these substances in blood plasma and tissues. However, based on in vitro studies, the inhibition of CYP enzymes with the use of Clayra in a therapeutic dose is unlikely.

Analogues of the drug Clayra

Clayra has no structural analogs for the active substance.

Analogues for the pharmacological group (estrogens, gestagens and their combinations):

• Angelique;
• Antotevin;
• Belara;
• Gynodian Depot;
• Gynoflor E;
• Daillah;
• Demulen;
• Jess;
• Jess Plus;
• Diane-35;
• Divina;
• Divertrain;
• Dicycylene;
• Dimia;
• Evra;
• Janine;
• Genetten;
• Zoeli;
• The individual;
• Klimen;
• Klimodien;
• Clinonorm;
• Cliogest;
• Lindineth 20;
• Lyndyneth 30;
• Logest;
• Marvelon;
• Mersilon;
• Midian;
• Microinon;
• Miniziston 20 fems;
• NovaRing;
• Novinet;
• Non-Ovlon;
• Ovidon;
• Oralcon;
• Pausogest;
• Regulon;
• Rigevidone;
• Silestus;
• Silhouettes;
• Three-Mercy;
• Three-regol;
• Triaclim;
• Trigestrel;
• Trikwilar;
• Trisequence;
• Femaflor;
• Femoden;
• Femoston;
• Cyclo-Proginova;
• Evian;
• Egestenol;
• Yarina.

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