Claira, 2 mg+2 mg, 3 mg+2 mg and 1 mg, 3 mg 28 pcs

The contraceptive effect of combined oral contraceptives (OCs) is based on the interaction of different factors, the most important of which are the suppression of ovulation and changes in the properties of cervical mucus. In addition to preventing unwanted pregnancy, OCs have a number of positive qualities, which, when taken together with the negative qualities, can help to choose the most appropriate method of contraception.

In women taking OCs the pain and intensity of menstrual bleeding is reduced, and as a result the risk of iron deficiency anemia is reduced. In addition, there is evidence of a reduced risk of endometrial and ovarian cancer.

. The estrogen in Klyra is estradiol valerate, a precursor of natural human 17β-estradiol (1 mg of estradiol valerate corresponds to 0.76 mg of 17β-estradiol) The estrogen component used in this OC, thus, differs from estrogens usually used in OCs which are synthetic estrogens ethinyl estradiol or its precursor mestranol, both containing an ethynyl group in position 17α. This group is more metabolically stable, but also has a more pronounced effect on the liver.

The Claira regimen has less liver damage than triphasic OCs containing ethinylestradiol and levonorgestrel. It has been shown that the effect on the concentration of globulin binding sex steroids (GSSB) and hemostasis parameters is less pronounced.

In combination with dienogestrel, estradiol valerate shows an increase in high-density lipoproteins (HDL), while the concentration of low-density lipoprotein cholesterol (LDL) is slightly reduced.

Dienogest is an oral progestagen characterized by additional partial antiandrogenic effects. Its estrogenic, anti-estrogenic and androgenic properties are insignificant. Its special chemical structure provides a spectrum of pharmacological action that combines the most important advantages of 19-nor-progestagens and progesterone derivatives.

Indications

Oral contraception.

Composition

On one dark yellow film-coated tablet:

Active ingredient:

estradiol valerate micro 20 – 3,000 mg

Associate 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,

Pregelatinized corn starch,

Povidone-25,

Magnesium stearate

Shell:

hypromellose,

macrogol-6000,

talc,

How to take, the dosage

How and when to take Claira

Take the tablets daily in the order shown on the package, regardless of meals, at about the same time, with water if necessary. The tablets should be taken continuously. One tablet per day should be taken consecutively for 28 days. Each new pack of pills is started after the last tablet from the previous calendar pack has been taken. Menstrual bleeding usually begins when the last pills of the calendar pack are taken and may not end until the beginning of the next calendar pack. Some women start bleeding after taking the first pills of a new calendar pack.
If used correctly, the Perl Index (an indicator that shows the frequency of pregnancy per 100 women during a year of contraceptive use) is less than 1. If the pill is missed or used incorrectly, the Perl Index may increase.

Preparing your pill box

To help you keep track of your pills, the box includes 7 stickers with the names of the 7 days of the week on them.
Choose the sticker that starts with the day of the week that you start taking the pills. For example, if you start on Wednesday, use the label that starts with the word “Wednesday.

Place this sticker at the top of the fold-out pack of Claira where it says “Put the days of the week sticker here,” so that the name of the first day is above the number “1” pill.

Now each pill has the name of the day of the week above it, so you can see if you already took it on that day or not. Follow the direction of the arrow on the pill box until you have taken all 28 pills.

Usually, so-called menstrual-like bleeding begins while you are taking the second dark red or white pill and may not be over before you start the next package. For some women, bleeding still continues after taking the first pills of the new pack.

Start the next package without a break, that is, the day after you finish the current package, 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 pack, and that menstrual bleeding should fall on the same days of the week each month.

If you use Clyra as directed, you are protected from unwanted pregnancy even during those 2 days when you take the inactive pill.

How do I start taking pills from the first package?

If you have taken too many tablets of Claira

Severe adverse effects of an overdose of Claira have not been reported.

If you have taken several active pills at one time, you may develop nausea or vomiting. Vaginal bleeding may occur in young girls.

If you take too many pills of Claira, or if you find that a child has taken any number of pills, ask your doctor for advice.

Pills without active ingredients (placebos) are necessary if you miss pills

Pills without active ingredients (placebos): If you miss one of the white pills (the 2 white pills at the end of the package), you do not need to take it later because it contains no active ingredients and you are still protected from an 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, your protection against an unwanted pregnancy may be reduced (as a result of inadvertently extending the period during which no active pills are taken).

If you forget to take the last white pill of your current package, it is important that you take the first pill of the next package at the correct time.

The following recommendations apply to skipping active pills (pills 1-26 in the book pack):

The active pills: Depending on the day of the menstrual cycle on which one active pill was missed, you may need to use additional contraceptive measures, such as a barrier method, such as condoms.

Take the pill according to the following principles. Also see the “missed pills” chart for more information.

Do not take more than 2 active pills in one day to make up for missed pills.

If you forget to start a new pack, or if you miss one or more pills from day 3 to day 9, there is a risk that you are already pregnant (if you had intercourse within 7 days before missing the pill). If this is the case, talk to your doctor. The more pills (especially those with a combination of the two active ingredients on days 3 to 24) you miss, and the closer they are to the inactive pill phase, the more likely you are to be pregnant. See also the Missed Pills chart for more details.

If you forget to take any of the active pills in a package and then you don’t bleed at the end of the package, you may be pregnant. Check with your doctor before starting a new pack.

What to do if you vomit or have severe diarrhea

If you vomit or have severe diarrhea after taking any of the 26 active tablets of Claira, the absorption of the active ingredients may not be complete. If vomiting occurs 3-4 hours after taking the pill, it is tantamount to missing the pill. Therefore follow the recommendations described in the section What to do if you miss a pill. If you have severe diarrhea, see your doctor. Vomiting or diarrhea on the days of the last 2 inactive pills has no effect on the effectiveness of contraception.

You want to stop taking Clyra

You can stop taking Clyra at any time. If you are not planning a pregnancy, ask your doctor about other contraceptive methods. If you want to get pregnant, stop taking Clara and wait for your natural menstrual bleeding before trying to get pregnant. This will help you calculate your expected due date.

If you have further questions about the use of this medication, talk to your doctor.

Interaction

The effect of other drugs on the active ingredients of Claira®

The interaction of CRPS with other drugs may lead to breakthrough uterine bleeding and/or lack of contraceptive effect. The following types of interactions have been described in the CRP literature in general or have been studied in clinical trials of Claira®:

Isozyme inducers (CYP3A4 isoenzyme). There may be interaction with drugs that induce microsomal enzymes (e.g. of cytochrome P450 system), which may increase clearance of sex hormones (these drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, as well as preparations containing St John’s wort). HIV protease inhibitors (e.g. ritonavir), non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and their combinations have also been reported to affect hepatic metabolism.

The effect on intestinal-hepatic recirculation. Against the background of taking certain groups of antibiotics (e.g., penicillin and tetracycline groups), enterohepatic circulation of estrogens may be reduced, which may lead to lower concentrations of estradiol.

Women who are treated with drugs that induce microsomal enzymes or antibiotics are recommended to use a temporary barrier method of contraception in addition to Claira® or choose another method of contraception. The barrier method of contraception should be used for the entire period of taking concomitant drugs and for 28 days after their withdrawal.

Isoenzyme inhibitors (CYP3A4 isoenzyme). Concomitant administration of rifampicin together with tablets containing estradiol valerate and dienogest resulted in a significant decrease in Css and systemic exposure to dienogest and estradiol. Systemic exposure to dienogest and estradiol at Css, as measured by AUC0-24, decreased by 83% and 44%, respectively.

Known CYP3A4 inhibitors, such as azole antifungals, cimetidine, verapamil, macrolides, diltiazem, antidepressants and grapefruit juice, may increase plasma concentrations of dienogest. When concomitantly administered with the potent inhibitor ketoconazole, the AUC0-24 at equilibrium was increased by 186% for dienogestr, and by 57% for estradiol. When used concomitantly with the moderate inhibitor erythromycin, the AUC0-24 values of dienogest and estradiol in equilibrium increased by 62% and 33%, respectively.

The effects of Claira® in relation to other drugs: PDA may affect metabolism of several other drugs (e.g. lamotrigine) that may lead to either higher or lower concentrations of these substances in plasma and tissues. However, based on the data of in vitro studies, inhibition of CYP enzymes when using Klaira® in a therapeutic dose is unlikely.

Note: For possible interactions, read the instructions for the concomitant medications.

Incompatibilities. None.

Special Instructions

If any of the diseases/conditions/risk factors listed below are currently present, the potential risks and expected benefits of Claira® should be carefully balanced on a case-by-case basis and discussed with the woman before she decides to start taking the drug. If any of these conditions or risk factors worsen, intensify, or first appear, the woman should consult her doctor, who may decide if the drug should be discontinued.

Cardiovascular disease

Epidemiologic studies suggest a relationship between CPT use and increased rates of venous and arterial thrombosis and thromboembolism (such as DVT, TELA, MI, and cerebrovascular events). The risk of venous thromboembolism (VTE) is maximal in the first year of taking these drugs, mostly during the first 3 months. An increased risk is present after initial use of a PDA or renewed use of the same or different PDAs (after a gap of 4 weeks or more between doses). The overall risk of VTE in patients taking low-dose CRPs (less than 50 mcg ethinylestradiol) is 2-3 times higher than in patients not taking CRPs, but the risk remains lower compared to the risk of VTE in pregnancy and childbirth. VTE can be fatal (1-2% of cases).

VTE, manifesting as DVT or TELA, can occur with any PDA. It is extremely rare for thrombosis of other blood vessels, such as hepatic, mesenteric, renal, cerebral arteries and veins, or retinal vessels, to occur with PDA use. There is no consensus on the relationship between the occurrence of these events and the use of CPT. Arterial thromboembolism can be fatal.

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

– with age;

– in smokers (the risk increases with more cigarettes smoked or increased age, especially in women over 35);

In the presence of:

– a family history (e.g., venous or arterial thromboembolism ever in a close relative or parent at a relatively young age). If there is an inherited or acquired predisposition, the woman should be examined by an appropriate specialist to decide whether she should take Claira®;

– obesity (body mass index greater than 30 kg/m2);

– dyslipoproteinemia;

– arterial hypertension;

– migraine;

– heart valve disease;

– atrial fibrillation;

– prolonged immobilization; extensive surgery, any lower extremity surgery, or extensive trauma. In these situations, it is advisable to stop taking Clyra® (at least 4 weeks before surgery if planned) and not to resume for 2 weeks after the end of immobilization.

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

The increased risk of thromboembolism in the postpartum period should be considered. Peripheral circulatory disorders can also be noted 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 Claira® (which may precede cerebrovascular disorders) may be the reason for immediate discontinuation of the drug.

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

When evaluating the risk-benefit ratio, consider that treatment of the condition may reduce the associated risk of thrombosis. It should also be considered that the risk of thrombosis and thromboembolism in pregnancy is higher than with low-dose oral contraceptives (ethinyl estradiol less than 50 mcg).

Tumors

The most significant risk factor associated with the development of cervical cancer is persistent papillomavirus infection (PVI). Some increased risk of cervical cancer has been reported with long-term use of CRPS. The association with PDA intake has not been proven. The possibility of a correlation with cervical disease screening and sexual behavior patterns (less frequent use of barrier methods of contraception) is being discussed.

A meta-analysis of 54 epidemiological studies found a small increase in the relative risk (OR = 1.24) of developing breast cancer in women currently taking CRC. The increased risk gradually disappears within 10 years of stopping these drugs. Because breast cancer is rare in women younger than 40 years of age, some increase in the number of breast cancers diagnosed in women currently or recently taking CRPs is small relative to their overall risk of the disease. It has not been shown to be associated with taking CRPS. The increased risk observed may also be a consequence of earlier diagnosis of breast cancer in women taking CRPS. Women who have ever used PDAs are found to have earlier stages of breast cancer than women who have never used them.

In rare cases, PDA use has resulted in benign, and in extremely rare cases, malignant liver tumors, which in some cases have led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain, increased liver size, or signs of intra-abdominal bleeding occur in women taking CRP, liver tumors should be excluded in the differential diagnosis.

Other conditions

Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of pancreatitis while taking CRP.

While small increases in BP have been described in many women taking CRP, clinically significant increases have rarely been reported. However, if a persistent, clinically significant increase in BP develops while taking Claira® , the drug should be stopped and treatment for arterial hypertension should be initiated. The use of Claira® may be resumed if necessary, if normal blood pressure values can be achieved by hypotensive therapy.

The following conditions develop or worsen during pregnancy as well as while taking CRP, but their association with taking CRP has not been proven: jaundice and/or cholestatic pruritus, cholelithiasis, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydingham chorea, herpes of pregnancy, otosclerosis-related hearing loss.

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

Acute or chronic liver dysfunction may require withdrawal of Claira® until liver function parameters return to normal. Recurrent cholestatic jaundice that develops for the first time during pregnancy or previous use of sex hormones requires discontinuation of Claira®.

While PDAs may affect insulin resistance and glucose tolerance, it is not necessary to change the therapeutic regimen in diabetic patients who use Claira®. However, women with diabetes need careful monitoring while taking Claira®.

Cases of Crohn’s disease and ulcerative colitis have also been described when taking Clara®.

Chloasma may sometimes develop, especially in women with a history of pregnancy chloasma.

Women who are prone to developing chloasma should avoid sun or UV exposure while taking Klaira®.

Impact on laboratory tests. Administration of Claira® may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma concentrations of transport proteins such as CRP and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, coagulation and fibrinolysis. These changes usually remain within laboratory norms.

Medical examinations. Before starting treatment with Claira® it is necessary to carefully evaluate contraindications for prescribing the drug on the basis of a woman’s life history, family history, and general medical and gynecological examinations. 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, breast, abdominal and pelvic exams are checked, including cervical cytology.

Women should be advised that Claira® does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Decreased efficacy. The efficacy of Claira® may be reduced if pills with active ingredients are missed (see recommendations for missed pills under “Dosage and administration”), gastrointestinal disturbances while taking pills with active ingredients (see recommendations for gastrointestinal disturbances under “Dosage and administration”) or with concomitant drug treatment (see “Interactions”).

Inadequate control of the menstrual cycle. During use of Klaira®, especially during the first months of use, irregular menstrual bleeding (menses or breakthrough uterine bleeding) may occur. Therefore, any irregular menstrual-like bleeding should be evaluated only after an adjustment period of approximately 3 menstrual 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 exam should be performed to rule out malignancy or pregnancy. This might include a diagnostic curettage.

Some women may not experience menstrual bleeding while taking the inactive white pill. If you took Claira® in accordance with the rules specified in the section “Dosage and administration”, pregnancy is unlikely. However, if pills were taken irregularly before the first absent menstrual bleeding, or 2 consecutive menstrual bleedings are absent, it is not necessary to continue using Klaira® until pregnancy can be excluded.

Impact on the ability to drive a car or perform work requiring increased speed of physical and mental reactions. No adverse effect of Claira® preparation on the ability to drive a vehicle or operate mechanisms has been noted, however, patients who have had episodes of dizziness and attention deficit during adaptation period (the first 3 months of taking the drug) should be careful.

Contraindications

The drug Claira® should not be used if any of the conditions listed below are present. The drug must be stopped immediately if any of these conditions develop for the first time while taking it:

Side effects

System-organ class Frequent Infrequent infrequent

Infections and invasions Fungal infection, vaginal candidiasis, vaginal infection, unspecified Candida, herpes, suspected eye histoplasmosis syndrome, variegated shingles, urinary tract infection, bacterial vaginosis, candidal vulvovaginitis

Metabolism and nutritional disorders

Increased appetite,Fluid retention,hypertriglyceridemia

Nervous system

Headache (including.ч. tension headache),Depression/depressed mood, decreased libido, mental disturbance, mood changes,dizziness,Affective lability, aggressiveness,anxiety, dysphoria,increased libido, nervousness,restlessness, sleep disturbance, stress, attention disturbance,paresthesias, vertigo

Eye organ

Intolerance of contact lenses, dry mucous membrane of eyes, edema of eyelids

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Cardiovascular system

Heightened BP, migraine (including aura and without aura).with or without aura,Variceal bleeding, hot flashes to the face, decreased BP, pain along the veins

Gastrointestinal

Pain in the abdomen (including Bloating),Diarrhea,nausea,vomiting Constipation,dyspepsia,gastroesophageal reflux

Hepatic and biliary tract disorders

Increased ALT activity, focal liver nodular hyperplasia

Skin and subcutaneous tissue

AcneAlopecia, pruritus (including generalized pruritus.

AcneaAlopecia (including generalized itching and itchy rash), rash (including

Allergic skin reaction, including allergic dermatitis and urticaria, chloasma, dermatitis, hirsutism, hypertrichosis, neurodermitis, pigmentation disorders, seborrhea, unspecified skin lesions

Skeletal, muscular and connective tissue

Back pain, muscle cramps, feeling of heaviness

From the genital and mammary gland

Absence of menstrual-like bleeding, breast discomfort, breast pain, sore nipples, sore nipples, painful menstrual-like bleeding, Irregular menstrual bleeding (metrorrhagia)Enlargement of the breasts, diffuse thickening of the breasts, cervical epithelial dysplasia, dysfunctional uterine bleeding, dyspareunia, cystic fibroids mastopathy, menorrhagia, ovarian cysts, Pelvic pains, menstrual syndrome, uterine leiomyoma, uterine cramps, vaginal discharge, vulvovaginal dryness, breast cancer, breast cysts, Bleeding during intercourse, galactorrhea, vaginal bleeding, hypomenorrhea, delayed menstrual bleeding, ruptured ovarian cysts, burning sensation in the vagina, uterine/vaginal bleeding (incl.including oozing, vaginal odor, vulvovaginal discomfort)

Overdose

Symptoms: No serious disturbances have been reported with an overdose of Clyra®.

Based on cumulative experience with PDAs, symptoms that may be noted with an overdose of active pills include nausea, vomiting, mastic bloody discharge, or metrorrhagia.

Treatment: symptomatic.

Pregnancy use

The use of Klaira is contraindicated during pregnancy and lactation.

If pregnancy is detected or suspected while taking Clyra, you should stop the drug immediately and see your doctor.

However, extensive epidemiological studies have found no increased risk of developmental defects in children born to women who received sex hormones (including OCs) before pregnancy or teratogenic effects when sex hormones were inadvertently taken early in pregnancy.

If you are pregnant or breastfeeding, consult your doctor before taking any medicine.