dienogest, estradiol | Clayra tablets, 28 pcs.

Latin name

Qlaira

Release form

coated tablets

Packing

2 dark yellow tablets, 5 pink tablets, 17 pale yellow tablets, 2 red tablets and 2 white tablets (total 28 tablets) in one blister of PVC / aluminum foil.

1 blister is glued into a cardboard folding bed. 1 folding book together with a self-adhesive reception calendar and instructions for use are sealed in a transparent film.

Pharmacological action

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, which, when taken into account as well as negative properties, can help in choosing the most suitable method of contraception. In women taking COCs, the pain and intensity of menstrual bleeding decreases, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence of a reduced risk of developing endometrial cancer and ovarian cancer.

The estrogen in the drug Klayra is estradiol valerate, human natural 17 -estradiol precursor (1 mg of estradiol valerate corresponds to 0.76 mg of 17 -estradiol) The estrogen component used in this COC is therefore different from the estrogen commonly used in COCs, which are the synthetic estrogens ethinyl estradiol or its precursor mestranol both containing an ethynyl group at position 17 . This group leads to higher metabolic stability, but also a more pronounced effect on the liver.

Taking Klaira leads to a less pronounced effect on the liver compared with three-phase COCs containing ethinyl estradiol and levonorgestrel. It was shown that the effect on the concentration of sex steroid-binding globulin (SHGS) and the parameters of hemostasis are less pronounced. In combination with estradiol dienogest, 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 progestogen that is characterized by additional partial antiandrogenic effects. Its estrogenic, antiestrogenic and androgenic properties are negligible. Due to the special chemical structure, a pharmacological action spectrum is provided that combines the most important advantages of 19-nor-progestogens and progesterone derivatives.

Indications

Oral contraception.

Contraindications

Klaira® should not be used if any of the conditions listed below is present. The drug should be immediately discontinued if any of these conditions develop for the first time against the background of its intake: hypersensitivity to active substances or any of the excipients

thrombosis (venous and arterial) and thromboembolism at present or in the anamnesis (including deep vein thrombosis (DVT), pulmonary embolism (pulmonary embolism), myocardial infarction (MI) current or past stroke)

conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) currently or in the history of

revealed acquired or hereditary predisposition to venous or arterial thrombosis s, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein S deficiency, hyperhomocystsinemia, antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant)

the presence of a high risk of venous or arterial thrombosis (see "Special instructions")

migraine with focal neurological symptoms, including a history of

diabetes mellitus with vascular complications

pancreatitis with severe hypertriglyceridemia at present or a history of

liver failure and severe liver disease (before normalization of liver function indicators)

liver tumors (benign and malignant) are presently diagnosed or malignant tumors (including genitals or mammary glands) or suspected

vaginal bleeding of unknown origin

pregnancy or suspected her

period of breastfeeding

lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

WITH CAUTION

If any of the diseases / conditions / risk factors listed below are currently present, the potential risk and expected benefits of using Klayra® should be carefully considered in each individual case: risk factors for thrombosis and thromboembolism (smoking) obesity dyslipoproteinemia arterial hypertension migraine heart valve disease heart rhythm disorder extensive surgery without prolonged immobilization)

other diseases in which tmechatsya peripheral circulatory disorders (diabetes, systemic lupus erythematosis, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia)

hereditary angioedema

hypertriglyceridemia

disease, first appeared or worsened during pregnancy or against the background of previous use of sex hormones (e.g. cholestatic jaundice, itching, cholelithiasis, hearing impaired otosclerosis, porphyria, herpes simplex, pregnancy, Sydenham chorea) postpartum

.

Use during pregnancy and lactation

Taking Klaira is contraindicated during pregnancy and lactation. If pregnancy is detected or suspected while taking Klayra, the drug should be immediately withdrawn 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 teratogenicity, when sex hormones were taken by negligence in the early stages of pregnancy.

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

Composition

On one dark yellow film-coated tablet:

Active ingredient: estradiol valerate, micro 20 - 3,000 mg

Auxiliary components: lactose monohydrate, corn starch, corn starch, hypergelatinized, gelatin gelatin , macrogol-6000, talc, titanium dioxide, dye of iron oxide yellow.

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 s magnesium hypromellose, macrogol-6000, talc, titanium dioxide, dye iron oxide red.

For 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 maize starch, soybean oil 25 : hypromellose, macrogol-6000, talc, titanium dioxide, yellow iron dye.

For one red film-coated tablet: Active component: estradiol valerate, micro 20 - 1,000 mg

Auxiliary components: lactose monohydrate, corn starch, pregelatinized corn starch, povidone-25, magnesium stearate srdlkol shell, 6000 gromol shell talc, titanium dioxide, dye, iron oxide red.

For one white film-coated tablet (placebo): Auxiliary components: lactose monohydrate, corn starch, povidone-25, magnesium stearate

Shell: hypromellose, talc, titanium dioxide.

How to take it and take it on a daily basis, take it on a tablet, take it daily, take it, take

the same time, if necessary, washed down with water. Pills are taken continuously. One tablet per day should be taken sequentially for 28 days. Reception of tablets from each new package begins after taking the last tablet from the previous calendar package. Menstrual bleeding usually begins with the last pill in the calendar pack and may not end before the next calendar pack begins. In some women, bleeding begins after taking the first pills from a new calendar package.

When used correctly, the Pearl index (an indicator that reflects the pregnancy rate in 100 women during the year of contraceptive use) is less than 1. If the pill is missed or used incorrectly, the Pearl index may increase.

Preparation of a

package booklet In order to help you keep track of pills, 7 stickers are attached to the package with the names on them for 7 days of the week.

Choose a sticker that starts on the day of the week you start taking the pills. For instance, If you start on Wednesday, use a sticker that begins with the word CP.

Place this sticker at the top of Klaira’s expandable packaging where the inscription is located. Place a sticker with the days of the week here so that the name of the first day is above pill number 1.

Now, above each tablet is the name of the corresponding day of the week, and you can see whether the tablet has already been drunk on a given day or not. Follow the direction of the arrow on the packaging until you have drunk all 28 tablets.

Usually, the so-called menstrual bleeding begins with the second dark red pill or white pill and may not end before you start the next pack. In some women, bleeding still continues after taking the first pills from a new package.

Start the next packaging without a break, i.e. the day after you have finished the current package, even if the bleeding has not stopped. This means that the next pack should begin 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 Klayra as indicated in the instructions, you are protected from unwanted pregnancy even for those 2 days when you take inactive pills.

How to start taking pills from the first package?

If hormonal contraceptives were not used last month.

Start taking Klayra on the first day of the cycle, i.e. on the first day of menstrual bleeding.

If you are switching to Klaira with other COCs, a combined contraceptive vaginal ring or patch.

Start taking Klaira the day after you drink the last active pill (the last pill with the active ingredients) from the current package of hormonal contraceptives. If your previous contraceptives contain inactive pills, discard them and continue with the first pack of Klaira without taking a break. If you previously used a combined contraceptive vaginal ring or patch, start taking Klaira on the day the ring / patch is removed or follow your doctor’s advice.

When switching from a purely progestogen method of contraception (mini-pill, injection, implant or intrauterine system with the release of progestogen (IUD)

You can switch to the Claira drug from the purely progestogen method any day (from the implant or IUD - on the day they are removed from the injection method - on the day for which the next injection is prescribed), but in all cases, during the first 9 days of taking Klaira, you must take additional contraceptive measures (such as condoms).

After a miscarriage

Consult a physician.

After giving birth

If you just had a delivery, then before using Klaira, your doctor may advise you to wait until you have your first normal period. It is sometimes possible to start earlier. The doctor will advise you what to do.

If you have had sexual intercourse after giving birth, before taking Klaira, make sure that you are not pregnant or wait until the next menstruation begins.

If you are breast-feeding and want to take Klaira, first discuss this with your doctor.

If in doubt about when to start taking Klaira, contact your healthcare provider for advice.

If too many tablets of Claira have been drunk

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

If you take several active tablets at a time, you may develop nausea or vomiting. Young girls may have vaginal bleeding.

If you take too many tablets of Klaira, or find that a child has taken a number of tablets, consult your healthcare provider for advice.

Necessary steps for skipping 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 all still protected from unwanted pregnancy.

However, it is important that you throw away 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 extension of the period during which active tablets are not taken).

If you forget to take the last white pill from the current package, it is important that you, nevertheless, take the first tablet from the next package at the right time.

The following recommendations are for skipping active tablets (1-26 tablets in a package):

Active tablets: Depending on the day of your menstrual cycle, in which one active tablet was missed, you may need to take additional contraceptive measures, such as the barrier method in particular condoms.

Take the pill according to the following guidelines. See also the Missed Pill chart.

If the delay in taking any pill is less than 12 hours, then the contraceptive effect of the drug persists. Drink the 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 tablet was missed, use additional contraceptive measures, for example, the barrier method, in particular condoms. See also the Missed Pill chart.

More than one sldlkp tablet has been missing from the package. Contact your health care provider for advice.

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

If you forget to start a new package, or missed one or more tablets from the 3rd to the 9th day of taking, there is a risk that you are already pregnant (if you had sexual intercourse within 7 days before skipping the pill). In this case, contact your doctor. The more tablets (especially with the combination of two active ingredients on days 3 through 24) are missed, and the closer they are to the phase of taking inactive tablets, the higher the chance of pregnancy. See also the Missed Pill chart.

If you forget to take any of the active tablets in the package, and then you had no bleeding at the end of the package, you may be pregnant. Before starting a new package, consult your healthcare provider.

What to do in case of vomiting or severe diarrhea

If you take vomiting or severe diarrhea after taking any of the 26 active tablets of Klaira, 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 tablets. If you have severe diarrhea, consult your doctor. Vomiting or diarrhea on the days of the last 2 inactive tablets does not have any effect on the effectiveness of contraception.

You want to stop taking Klaira

You can stop taking Klaira anytime. If you are not planning a pregnancy, ask your doctor about other methods of contraception. If you want to become pregnant, stop taking Claira and wait for the natural menstrual bleeding before trying to get pregnant. This will help you calculate your expected birth date.

If you have further questions about the use of this drug, contact your doctor.

Side effects of

System organ class Often Infrequently Rarely

Infections and infestations Fungal infection, vaginal candidiasis, vaginal infection, unspecified Candidiasis, herpes, suspected histoplasmosis syndrome, colorful lichen, urinary infection and urinary infection , hypertriglyceridemia

Nervous system Headache (including tension headache) Depression / mood decline, decreased libido, mental disturbance, mood changes, dizziness Effective lability, aggressiveness, anxiety, dysphoria, increased libido, nervousness, anxiety, sleep disturbance, stress, impaired attention, paresthesia, vertigo

Organ of vision Intolerance to contact lenses, dry eyes, swelling of the eyelids

Cardiovascular system Increased blood pressure, migraine (including with aura and without aura) Blood course of varicose veins, hot flashes 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

From the liver and bile ducts ALT activity focal nodular liver hyperplasia

From the skin and subcutaneous tissues Acne Alopecia, pruritus (including generalized pruritus and pruritus rash), rash (including spotted rash), hyperhidrosis Allergic skin reaction, including allergic dermatitis and urticaria, chloasma , hirsutism, hypertrichosis, neurodermatitis, pigmentation disorder, seborrhea, unspecified skin lesion

From the side of musculoskeletal and connective tissue Back pain, muscle cramps, heaviness

From the genitals and mammary gland Lack of menstrual like bleeding, discomfort in the mammary glands, pain in the mammary glands, soreness of the nipples, pain in the nipples, painful menstrual bleeding, irregular menstrual bleeding (metrorrhagia) Breast enlargement, diffuse densification of the mammary glands, cervical epithelium dysplasia, dysfunctional uterine bleeding, dyspareunia, fibrocystic mastopathy, menorrhagia, cysts in the ovaries, pelvic pain, premenstrual syndrome, uterine leiomyoma, uterine cramps, vaginal discharge, dryness in the vulvovaginal region, benign neoplasm breast, bleeding during intercourse, galactorrhea, vaginal bleeding, hypomenorrhea, delayed menstrual bleeding, rupture of an ovarian cyst, burning sensation I'm in the vagina, uterine / vaginal bleeding (including spotting, the smell from the vagina, vulvovaginal discomfort)

From the blood and lymphatic system lymphadenopathy

General simptomyPovyshenie telaRazdrazhitelnost weight, edema, decreased vesaBol in the chest, fatigue,

malaise The following serious adverse events were reported in women using CPC (which include Klaira®): arterial and venous thrombosis and thromboembolic complications, worsening of the course or provoking symptoms of angioedema of the tumor of the liver, acute pancreatitis

Drug Interaction

Effect of Other Drugs on the Active Components of the Clyra®

Drug Interaction with other PDs may lead to breakthrough uterine bleeding and / or lack of contraceptive effects. The following types of interaction have been described in the literature on the PDA as a whole or studied in the course of clinical studies of the drug Claire®:

Inductors of isoenzymes (CYP3A4 isoenzyme). Interactions with drugs that induce microsomal enzymes (eg cytochrome P450 systems) may occur, resulting in increased sex hormone clearance (such as phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly oxcarbazmatepine, possibly ritonavir, griseofulvin, and preparations containing St. John's wort). It has been reported that HIV protease inhibitors (eg ritonavir), non-nucleoside reverse transcriptase inhibitors (eg nevirapine), and combinations thereof, may also have an effect on hepatic metabolism.

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

Women receiving treatment with microsomal enzyme-inducing drugs or antibiotics are advised to temporarily use the barrier method of contraception or choose another method of contraception in addition to the Claira® drug. The barrier method of protection should be used throughout the period of administration of concomitant drugs and for a further 28 days after their withdrawal.

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

Known inhibitors of CYP3A4, such as azole antifungal agents, cimetidine, verapamil, macrolides, diltiazem, antidepressants and grapefruit juice, may increase the concentration of dienogest in blood plasma. When administered concurrently with the potent ketoconazole inhibitor, the AUC0-24 value in the steady state increased by 186% for dienogest and 57% for estradiol. When co-administered with a moderate erythromycin inhibitor, the AUC0-24 value of dienogest and estradiol in the steady state increased by 62 and 33%, respectively.

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

Note: To identify possible interactions, refer to the instructions of the accompanying drugs.

Incompatibility. None.

overdose

Symptoms: No serious overdose has been reported with Claira® overdose. Based on the total experience with the use of PDAs - symptoms that can be observed with overdose of active tablets: nausea, vomiting, spotting or metrorrhagia.

Treatment: symptomatic.

Storage conditions

Store at a temperature not exceeding 30 РC.

Expiration

4 years.

Deystvuyuschee substances

dienogest, estradiol

Pharmacy terms

Pharmacy

Dosage form

dosage form

tablets

Bayer Pharma AG, Germany