Yaz pills 3mg + 0.02mg, 28pcs

Composition

Each active film coated tablet contains: Pill Core: Active ingredient Ethinyl Estradiol (in the form of betadex clathrate) 0.02 Mgdrospirenone 3.00 mgsupportsalactose monohydrate, corn starch, magnesium stearatoball tablets: hypromellose, talc, titanium dioxide, iron oxide red dye. Each placebo film coated tablet contains: Pill Core: Active ingredients: No auxiliary substances available: Lactose monohydrate, Corn starch, Povidone, Magnesium Stearate pill: hypromellose, talc, titanium dioxide.

Pharmacological action

Pharmacotherapeutic groupcontraceptive agent combined (estrogen + progestogen)ATX code G03AA12 Pharmacological PROPERTIESPHARMACODYNAMICAGES is a hormonal contraceptive with antimineralcorticoid and antiandrogenic effects. The contraceptive effect of combined oral contraceptives is based on the interaction of various factors, the most important of which are ovulation suppression and changes in the properties of vertical secretions, as a result of which it becomes poorly permeable to spermatozoa. When used correctly, the Pearl index (number of pregnancies per 100 women per year) is less than 1. If you skip pills or use them incorrectly, the Pearl index may increase. In women taking combined oral contraceptives, the menstrual cycle becomes more regular, painful menstruation is less frequent, and the intensity of bleeding decreases, which reduces the risk of anemia. In addition, according to epidemiological studies, the use of combined oral contraceptives reduces the risk of endometrial cancer and ovarian cancer. Drospirenone, contained in the preparation Jes, has an antimineralocorticoid effect. Prevents weight gain and the appearance of edema associated with estrogen-induced fluid retention, which ensures very good tolerability of the drug. Drospirenone has a positive effect on premenstrual syndrome (PMS). Jesa has been shown to be clinically effective in alleviating the symptoms of severe PMS, such as severe psychoemotional disorders, breast engorgement, headache, muscle and joint pain, weight gain, and other symptoms associated with the menstrual cycle. In the United States, severe PMS is referred to as premenstrual dysphoric syndrome. Drospirenone also has antiandrogenic activity and helps to reduce the symptoms of acne( blackheads), oily skin and hair. This effect of drospirenone is similar to that of natural progesterone produced by the body. Drospirenone has no androgenic, estrogenic, glucocorticoid or anti-glucocorticoid activity. All this, combined with antimineralocorticoid and antiandrogenic effects, provides drospirenone with a biochemical and pharmacological profile similar to natural progesterone. In combination with ethinyl estradiol, drospirenone shows a favorable effect on the lipid profile, characterized by an increase in HDL. Pharmacokinetics of Drospirenone adsorption When taken orally, drospirenone is rapidly and almost completely absorbed. After a single oral dose, the maximum concentration of drospirenone in serum, equal to about 35 ng/ml, is reached in about 1-2 hours. Bioavailability ranges from 76 to 85%. Compared to taking the substance on an empty stomach, food intake does not affect the bioavailability of drospirenone. Distribution After oral use, a two-phase decrease in serum levels of the drug is observed, with half-lives of 1.6±0.7 hours and 27.0±7.5 hours, respectively. Drospirenone binds to serum albumin and does not bind to sex steroid-binding globulin (SHBG) or corticosteroid-binding globulin (CSG). Only 3-5% of the total serum concentration of the substance is present as a free steroid. Ethinylestradiol-induced increase in SHBPS does not affect the binding of drospirenone to serum proteins. The average apparent volume of distribution is 3.7±1.2 l / kg. Metabolism Drospirenone is extensively metabolized after oral use. Most plasma metabolites are acidic forms of drospirenone. Elimination The rate of metabolic clearance of drospirenone in serum is 1.5±0.2 ml / min / kg. In unchanged form, drospirenone is excreted only in trace amounts. Drospirenone metabolites are excreted in the faeces and urine in a ratio of approximately 1.2: 1.4. The elimination half-life of metabolites in the urine and faeces is approximately 40 hours. Steady-state concentration During cyclic treatment, the maximum steady-state serum concentration of drospirenone is reached between day 7 and day 14 of treatment and is approximately 60 ng / ml. There was an increase in the concentration of drospirenone in serum by about 2-3 times (due to accumulation), which was due to the ratio of the half-life in the terminal phase and the dosage interval. A further increase in the serum concentration of drospirenone is observed between 1 and 6 cycles of use, after which no increase in the concentration is observed. Special patient populations Effects of renal insufficiency: The equilibrium serum concentrations of drospirenone in women with mild renal insufficiency (creatinine clearance = 50-80 ml / min) were comparable to those in women with normal renal function (Cr > 80 ml/min). In women with moderate renal insufficiency (Clr = 30-50 ml/min), the serum level of drospirenone was on average 37% higher than in women with normal renal function. Drospirenone treatment was well tolerated in all groups. Drospirenone use did not have a clinically significant effect on serum potassium concentrations. Pharmacokinetics in severe renal insufficiency have not been studied. Effects of hepatic insufficiency Drospirenone is well tolerated in patients with mild to moderate hepatic insufficiency (Child-Pugh class B). Pharmacokinetics in severe hepatic insufficiency have not been studied. Ethinylestradiolabsorption After oral use, ethinylestradiol is rapidly and completely absorbed. The peak serum concentration after a single oral dose is reached in 1-2 hours and is about 88-100 pg / ml. Absolute bioavailability as a result of presystemic conjugation and first passage metabolism is approximately 60%. Concomitant food intake reduces the bioavailability of ethinyl estradiol in approximately 25% of the subjects examined, while no similar changes were observed in other subjects. Distribution The concentration of ethinyl estradiol in serum decreases in two phases, the terminal phase is characterized by a half-life of approximately 24 hours. Ethinyl Estradiol is very significantly, but not specifically, bound to serum albumin (approximately 98.5%) and causes an increase in serum SHBP concentrations. The apparent volume of distribution is about 5 l / kg. Metabolism Ethinyl estradiol undergoes presystemic conjugation in the mucosa of the small intestine and in the liver. Ethinyl estradiol is primarily metabolized by aromatic hydroxylation, and a variety of hydroxylated and methylated metabolites are formed, both in the form of free metabolites and in the form of conjugates with glucuronic and sulfuric acids. Ethinyl Estradiol is completely metabolized. The rate of metabolic clearance of ethinyl estradiol is about 5 ml / min / kg. Elimination Ethinyl estradiol is practically not excreted unchanged. The metabolites of ethinyl estradiol are excreted in the urine and bile in a ratio of. 4: 6. The elimination half-life for the excretion of metabolites is approximately 1 day. Steady-state concentration The steady-state concentration is reached during the second half of the treatment cycle, and the serum level of ethinyl estradiol increases approximately 1.4-2.1 times. Preclinical safety data The preclinical data obtained in standard studies for the detection of toxicity with multiple doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate the presence of a particular risk to humans. However, it should be remembered that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.

Indications

• Contraception
• Contraception and treatment of moderate acne (acne vulgaris)
• Contraception and treatment of severe premenstrual syndrome (PMS)

Contraindications

Thrombosis and thromboembolism, as well as pre-thrombosis conditions, currently or in the anamnesis, cerebrovascular disorders; migraine with focal neurological symptoms currently or in the anamnesis; diabetes mellitus with vascular complications; multiple or pronounced risk factors for venous or arterial thrombosis, including complicated lesions of the valvular heart apparatus; atrial fibrillation; diseases of the brain or coronary arteries; uncontrolled arterial hypertension; serious surgery with prolonged immobilization; smoking over the age of 35; pancreatitis with severe hypertriglyceridemia at present or in the anamnesis; liver failure and severe liver diseases (until liver tests return to normal); liver tumors (benign or malignant) at present or in the anamnesis; severe renal failure, acute renal failure; adrenal gland infection insufficiency; identified or suspected hormone-dependent malignancies (including those of the genitals or mammary glands); vaginal bleeding of unknown origin; pregnancy or suspected pregnancy; breast-feeding period; hypersensitivity to any of the components of Jes. Use with caution.If any of the conditions/risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed in each individual case: risk factors for thrombosis and thromboembolism; diseases that may have peripheral circulatory disorders; hereditary angioedema; hypertriglyceridemia, liver diseases; diseases that first occurred or worsened during pregnancy or against the background of previous use of sex hormones (for example, jaundice, cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes of pregnant women, Sydenham’s chorea); postpartum period.

Side effects

The following most common adverse reactions have been reported in women using Yaz in the “24+4” mode according to the indications “Contraception” and ” Contraception and treatment of moderate acne (acne vulgaris)”: nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified origin. These adverse reactions occurred in more than 3% of women. The following most common adverse reactions (more than 10% of women) were reported in patients using Yaz for the indication “Contraception and treatment of severe premenstrual syndrome”: nausea, breast pain, irregular uterine bleeding. Serious side effects are arterial and venous thromboembolism, and for a” flexible ” regimen of taking the drug, breast cancer and focal nodular hyperplasia of the liver are additionally noted. Below is the frequency of adverse reactions reported in clinical trials of Yaz for the 24+4 regimen according to the indications “Contraception” and “Contraception and treatment of moderate acne (acne vulgaris)” (n=3565), according to the indication “Contraception and treatment of severe premenstrual syndrome” (n=289), as well as the “flexible” regimen of Yaz (n=2738). Within each group, selected according to the frequency of occurrence of an adverse reaction, adverse reactions are presented in order of decreasing severity. By frequency, they are divided as follows: often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), and rarely (≥1/10,000 and For additional adverse reactions identified only in the course of post-marketing observations, and for which it was not possible to estimate the frequency of occurrence, “frequency unknown”is indicated. Frequency of adverse reactions in clinical trials of Yaz (“24+4” and “flexible” mode of use*)Infectious and parasitic diseases: rarely-candidiasis. From the blood and lymphatic system: rarely-anemia, thrombocytopenia. Immune system disorders: rarely-allergic reactions; frequency unknown-hypersensitivity. From the side of metabolism and nutrition: rarely-increased appetite, anorexia, hyperkalemia, hyponatremia. From the side of the psyche: often-emotional lability, depression, decreased libido; infrequently-nervousness, drowsiness; rarely – anorgasmia, insomnia. From the nervous system: often-headache; infrequently-dizziness, paresthesia; rarely-vertigo, tremor. From the side of the organ of vision: rarely-conjunctivitis, dryness of the mucous membrane of the eyes. From the cardiovascular system: often-migraine; infrequently-varicose veins, increased blood pressure; rarely tachycardia, phlebitis, nosebleeds, syncope, venous thromboembolism, arterial thromboembolism. From the gastrointestinal tract: often-nausea; infrequently-abdominal pain, vomiting, dyspepsia, flatulence, gastritis, diarrhea; rarely-bloating, heaviness in the abdomen, hiatal hernia, oral candidiasis, constipation, dry mouth. From the liver and biliary tract: rarely-biliary dyskinesia, cholecystitis. Skin and subcutaneous tissue disorders: infrequently-acne, pruritus, rash; rarely-chloasma, eczema, alopecia, acne dermatitis, dry skin, erythema nodosum, hypertrichosis, striae, contact dermatitis, photodermatitis, skin nodules; frequency unknown-erythema multiforme. From the musculoskeletal system: infrequently-back pain, pain in the extremities, muscle cramps. From the genitals and breast: often – pain in the mammary glands, metrorrhagia**, absence of menstrual – like bleeding; infrequently-vaginal candidiasis, pelvic pain, breast enlargement, fibrocystic formations in the mammary gland, spotting/bleeding from the genital tract**, discharge from the genital tract, “hot flashes” with a feeling of heat, vaginitis, painful menstrual – like bleeding, scanty menstrual-like bleeding, heavy menstrual-like bleeding, dryness of the vaginal mucosa, abnormal Pap test results; rarely-dyspareunia, vulvovaginitis, postcoital bleeding, withdrawal bleeding, breast hyperplasia, breast neoplasm, cervical polyp, endometrial atrophy, ovarian cyst, uterine enlargement. Laboratory and instrumental data: infrequently-weight gain; rarely-weight loss. Other: infrequently-asthenia, increased sweating, edema (generalized edema, peripheral edema, facial edema); rarely-malaise. * in cases where adverse reactions occurred with different frequency against the background of the use of the “24+4” and “flexible” mode, the highest frequency is indicated. ** The frequency of irregular bleeding decreases as the duration of taking Yaz increases. Additional Information The following lists adverse reactions with very rare frequency or delayed symptoms that are believed to be associated with taking medications from the combined oral contraceptive group. Tumors – the frequency of breast cancer diagnosis in women taking combined oral contraceptives is slightly increased. Because breast cancer is rare in women under the age of 40, the increase in breast cancer diagnoses among women taking combined oral contraceptives is insignificant relative to the overall risk of this disease. ;- liver tumors (benign and malignant). Other conditions – erythema nodosum, erythema multiforme (only for the “flexible” mode of taking the drug);- women with hypertriglyceridemia (increased risk of pancreatitis while taking combined oral contraceptives);- increased blood pressure; – conditions that develop or worsen while taking combined oral contraceptives, but their relationship is not proven (jaundice and / or pruritus associated with cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; Sydenham’s chorea; herpes during pregnancy; hearing loss associated with otosclerosis);- in women with hereditary angioedema, taking oestrogens may cause or worsen its symptoms. ;- impaired liver function; – changes in glucose tolerance or effects on insulin resistance;- Crohn’s disease, ulcerative colitis;- chloasma; – hypersensitivity (including symptoms such as rash, urticaria).

Interaction

The effect of other drugs on the drug Yaz may interact with drugs that induce microsomal enzymes, as a result of which the clearance of sex hormones may increase, which, in turn, may lead to breakthrough uterine bleeding and/or a decrease in the contraceptive effect. Women who receive treatment with such drugs in addition to Yaz are advised to use a barrier method of contraception or choose a different non-hormonal method of contraception. The barrier method of contraception should be used for the entire period of taking concomitant medications, as well as for 28 days after their cancellation. If the period of using the barrier method of contraception ends later than the active tablets in the package of Jes, you should start taking Yaz tablets from the new package without interrupting the use of active tablets. Agents that increase the clearance of the drug Yaz (weaken the effectiveness by inducing enzymes): phenytoin, barbiturates, primidone, carbamazepine, rifampicin and, possibly, also oxcarbazepine, topiramate, felbamate, griseofulvin, as well as drugs containing St. John’s wort. Agents with different effects on the clearance of Jes: when co-administered with Jes, many HIV or hepatitis C protease inhibitors and non-nucleoside reverse transcriptase inhibitors can both increase or decrease the concentration of estrogens or progestins in blood plasma. In some cases, this effect may be clinically significant. Drugs that reduce the clearance of combined oral contraceptives (enzyme inhibitors): strong to moderate CYP3A4 inhibitors, such as azole antifungal drugs (e. g., itraconazole, voriconazole, fluconazole), verapamil, macrolide antibiotics (e. g., clarithromycin, erythromycin), diltiazem, and grapefruit juice may increase plasma concentrations of estrogen or progestin, or both. It was shown that etoricoxib at doses of 60 and 120 mg / day, when co-administered with combined oral contraceptives containing 0.035 mg of ethinyl estradiol, increases the concentration of ethinyl estradiol in blood plasma by 1.4 and 1.6 times, respectively. Effect of Yaz on other medicationscombined oral contraceptives can affect the metabolism of other drugs, which leads to an increase (for example, cyclosporine) or a decrease (for example, lamotrigine) in their concentration in blood plasma and tissues.In vitro, drospirenone is able to slightly or moderately inhibit the cytochrome P450 enzymes CYP1A1, CYP2C9, CYP2C19, and CYP3A4. Based on in vivo interaction studies in female volunteers treated with omeprazole, simvastatin, or midazolam as marker substrates, it can be concluded that a clinically significant effect of 3 mg of drospirenone on drug metabolism mediated by cytochrome P450 enzymes is unlikely. In vitro, ethinyl estradiol is a reversible inhibitor of CYP2C19, CYP1A1, and CYP1A2, as well as an irreversible inhibitor of CYP3A4 / 5, CYP2C8, and CYP2J2. In clinical studies, the use of a hormonal contraceptive containing ethinyl estradiol did not lead to any increase or only led to a slight increase in plasma concentrations of CYP3A4 substrates (for example, midazolam), while plasma concentrations of CYP1A2 substrates may increase slightly (for example, theophylline) or moderately (for example, melatonin and tizanidine). Other forms of interaction In patients with undisturbed renal function, the combined use of drospirenone and ACE inhibitors or NSAIDs does not have a significant effect on the concentration of potassium in blood plasma. However, the concomitant use of Yaz with aldosterone antagonists or potassium-sparing diuretics has not been studied. In such cases, the concentration of potassium in the blood plasma should be monitored during the first cycle of taking the drug.

How to take, course of use and dosage

Reception mode “24+4”

Tablets should be taken in the order indicated on the package, every day at approximately the same time, with a small amount of water. Tablets are taken without interruption in reception. It should be taken 1 tab. /day sequentially for 28 days. Each subsequent package should be started the day after taking the last tablet from the previous package. Withdrawal bleeding usually begins 2-3 days after the start of taking inactive (white) tablets and may not be completed until the next pack begins. Taking pills from a new package should always start on the same day of the week, and withdrawal bleeding will occur on approximately the same days of each month.

“Flexible” mode of use

The” flexible ” mode of taking Yaz can only be used if you have a Clyk dispenser and flex cartridges. The drug should be taken 1 tablet daily at the same time, washed down with a small amount of liquid. Tablets should be taken continuously, for at least 24 days. Between 25 and 120 days of use of the drug Jes, a 4-day break in taking tablets can be made by the patient’s decision.

A break in taking pills should not exceed 4 days. A 4-day break in taking tablets should be made no later than 120 days of continuous tablet use. After each 4-day break in taking pills, a new cycle begins with a minimum duration of 24 days and a maximum duration of 120 days. Typically, withdrawal bleeding develops during the 4-day pill break, but may not be completed until the next pill needs to be taken. If spotting/bleeding from the vagina occurs during the period from day 25 to day 120 for 3 consecutive days, it is recommended to take a 4-day break from taking pills. This will reduce the total number of days of bleeding.

Instructions for handling the packaging of the drug Yaz for the “24+4″reception mode

A blister pack containing 24 active hormone-containing light pink tablets and 4 inactive white hormone-free tablets (the last row) is pasted into the package of Jes. The package also includes a reception calendar consisting of 7 self-adhesive strips with the names of the days of the week marked on them. You should select the bar where the first day of the week is indicated, on which you plan to start taking pills. For example, if a woman starts taking pills on a Wednesday, you should use a strip that starts with ” Wed. “

The strip should be pasted along the top of the package so that the designation of the first day is located above the tablet on which the arrow with the inscription “Start” is directed. This way, you will see on which day of the week you should take each pill.

Operating instructions for the Clyk dispenser

Before starting and during operation, you should carefully read the detailed operating instructions of the dispenser.

General description of the Clyk dispenser:

– side keys – the area of depression for receiving the tablets;

– eject button Flex cartridge – by clicking this button retrieves the Flex cartridge;

– delivery zone pills – part of the dispenser, in which there are issued tablets;

– indicator of the time of taking the pill – shows the time of taking the pill;

display – displays the main screen and the menu option and

press “OK” button confirms the action, for example, the beginning of a 4-day break from the pill and sound reminders.

Most important features

Activating a new dispenser: Remove the flex cartridge (containing 30 tablets) from the packaging and insert it immediately into the dispenser. Insert the narrow end of the flex cartridge into the dispenser so that the dispenser window (as well as the tablets in the flex cartridge) is clearly visible. The flex cartridge must be fully inserted.

The dispenser will automatically record the time when the first tablet is dispensed, setting this time as “Take Time”. Thus, a woman needs to:

– be sure that she unpacks and inserts the flex cartridge on the day when she plans to start taking pills;

– be sure that the time of delivery of the first pill will be convenient for daily pill intake.

Every 24 hours, the display of the dispenser will indicate when the next tablet is due.

Extracting the tablet

Press both side keys simultaneously with one hand to extract the tablet, which is received with the other hand.

Replacing the flex cartridge

In normal use, the flex cartridge can only be removed if it is empty, otherwise follow the instructions in the detailed instructions for use of the Clyk dispenser. An empty flex cartridge is removed by pressing the flex cartridge eject button. The dispenser stores all information about the current cycle, and a new filled flex cartridge should be inserted according to the instructions given above.

Before starting and during the application process, you should carefully read the detailed instructions for using the Clyk dispenser enclosed in the package with the drug.

Start of taking the drug

In the absence of taking any hormonal contraceptives in the previous month

Taking the drug Yaz begins on the 1st day of the menstrual cycle (i. e., on the 1st day of menstrual bleeding), in this case, additional contraceptive measures are not required. It is allowed to start taking on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use a barrier method of contraception during the first 7 days of taking tablets from the first package. Then the tablets should be taken in the order indicated for the “24+4” or “flexible” mode of use.

When switching from other combined oral contraceptives, a vaginal ring, or a contraceptive patch

It is preferable to start taking Yaz the next day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 tablets) or after taking the last inactive tablet (for drugs containing 28 tablets in a package). Yaz should be started on the day of removal of the vaginal ring or patch, but not later than the day when a new ring is inserted or a new patch is applied.

In the transition from contraceptives containing only progestins (“mini-pill”, the injectable form, the implant), or progestogen releasing intrauterine contraceptive

Woman can go from taking “mini-pill” on Jess drug any day (without a break), with implant or intrauterine device with progestogen – on the day of its removal, from an injectable contraceptive in the day should be made following the injection. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

, a woman can start taking the drug immediately after a spontaneous or medical abortion in the first trimester of pregnancy. If this condition is met, the woman does not need additional contraceptive measures.

After childbirth or abortion in the second trimester of pregnancy

Taking the drug can be started on 21-28 days after a spontaneous or medical abortion or after childbirth, in the absence of breastfeeding. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if sexual contact has already taken place, pregnancy should be excluded before taking Yaz or you should wait for the first menstruation.

Discontinuation of the drug Jes

You can stop taking the drug at any time. If a woman is not planning a pregnancy or a woman is contraindicated because she is taking potentially dangerous medications for the fetus, you should discuss other methods of contraception with your doctor. If a woman is planning pregnancy, it is recommended to stop taking the drug and wait for natural menstrual bleeding, and then try to get pregnant. This will help you more accurately calculate the duration of pregnancy and the time of delivery.

Taking missed pills

Skipping inactive tablets on the background of the “24+4” mode can be ignored.However, they should be discarded, so as not to accidentally extend the period of taking inactive pills. The following recommendations apply only to skipping active (light pink) tablets.

If the delay in taking the drug is less than 24 hours, the contraceptive protection is not reduced. A woman should take the missed pill as soon as possible, and take the next one at the usual time.

If the delay in taking pills is more than 24 hours, the contraceptive protection may be reduced. The more tablets missed and the closer the skipping of tablets is to the phase of taking inactive white tablets when using the “24+4″ mode or to the period free from taking tablets against the background of a” flexible ” mode of use, the higher the probability of pregnancy.

In this case, you can follow the following two basic rules::

— the drug should never be interrupted for more than 7 days (please note that the recommended interval of taking the inactive pills is 4 days to receive mode “24+4” and for the “flexible” receive mode interval without taking pills should not exceed 4 days);

— to achieve adequate suppression of the hypothalamic-pituitary-ovarian system required 7 days of taking the pills.

The Clyk dispenser allows you to control the intake of pills and warns a woman about the need to use an additional method of contraception. The warning symbol “exclamation mark” appears on the display if you skip pills or if you take pills on an irregular basis for more than 7 consecutive days. The “exclamation mark” disappears after 7 days of continuous dispensing of tablets by the dispenser. If you missed taking more than one tablet, it is recommended to consult a doctor.

In the case of the “24+4” reception mode, as well as in the “flexible” mode, if information from the Clyk dispenser is not available or there are doubts about its reliability, you should follow the following recommendations::

If you miss a pill between day 1 and day 7

, the woman should take the last missed pill as soon as she remembers it, even if it means taking two pills at the same time. She continues to take the next pills at the usual time. In addition, during the next 7 days, you must additionally use a barrier method of contraception (for example, a condom). If sexual contact took place within 7 days before skipping the pill, the possibility of pregnancy should be considered.

When skipping over the 8th to the 14th day of taking the pills when you receive mode “24+4” or when skipping from the 8th to the 24th day of taking the pills in flexible mode of admission,

the woman should take the last missed tablet as soon as you remember about it, even if this means taking two tablets at the same time. She continues to take the next pills at the usual time.

Provided that the woman has taken the pills correctly for 7 days prior to the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more tablets, it is necessary to additionally use barrier methods of contraception (for example, a condom) for 7 days, and with a “flexible” mode of use, barrier methods of contraception should be used until the continuous period of taking tablets reaches 7 days.

When you pass from the 15th to the 24th day of taking the pills when you receive mode “24+4”, or if you pass over with 25th to the 120th day of taking the pills in flexible mode of admission,

the Risk of reduced reliability is imminent because of the approaching phase of the white taking the inactive pills in the case of receive mode “24+4” or free from tablets of the period, with “agile” mode of reception. You must strictly adhere to one of the following two options. However, if all pills were taken correctly during the 7 days preceding the first missed pill, there is no need to use additional contraceptive methods. Otherwise, it is necessary to use the first of the following schemes and additionally use a barrier method of contraception (for example, a condom) for 7 days.

1. A woman should take the last missed pill as soon as she remembers (even if it means taking two pills at the same time). For the “24+4” mode: the following tablets are taken at the usual time, until the active light pink tablets in the package run out,4 inactive white tablets should be discarded and immediately start taking tablets from the next package. Withdrawal bleeding is unlikely until the active light pink tablets in the second pack run out, but there may be spotting and / or breakthrough bleeding while taking the tablets. In the case of using the “flexible” mode, at least 7 tablets should be taken without interruption (one tablet daily).

2. For the “24+4” mode: a woman can also stop taking active light pink tablets from the current package. Then you should take a break of no more than 4 days, including days of skipping pills, and then start taking the drug from a new package. If a woman skipped taking active light pink pills and no withdrawal bleeding occurred while taking inactive white pills, pregnancy should be excluded. For a “flexible” regimen: a woman can also take a 4-day pill break, including a day of skipping the pill, to cause withdrawal bleeding, and then start a new cycle of taking the drug. If a woman skipped taking pills and there was no withdrawal bleeding during the next pill break period, the possibility of pregnancy should be considered.

Recommendations for gastrointestinal disorders

In severe gastrointestinal disorders, absorption may be incomplete, so additional contraceptive measures should be taken.

If there was vomiting or diarrhea within 3-4 hours after taking the active light pink tablet, you should follow the recommendations when skipping tablets. If a woman does not want to change her usual regimen and postpone the onset of menstruation to another day of the week, you should take an additional active light pink tablet.

How to change the time of withdrawal bleeding or how to delay the onset of withdrawal bleeding while taking the “24+4” regimen

To delay the onset of withdrawal bleeding, a woman should continue taking pills from the next pack of Jes, skipping inactive pills from the current pack. Thus, the cycle can be extended, if desired, for any period until the active light pink tablets from the second package run out, i. e. approximately 3 weeks later than usual. If you plan to start the next cycle earlier, you should stop taking active light pink tablets from the second package at any time, discard the remaining active light pink tablets and start taking white inactive tablets (for a maximum of 4 days), and then start taking tablets from the new package. In this case, withdrawal bleeding should begin approximately 2-3 days after taking the last light pink pill from the previous package. Against the background of taking the drug from the second package, a woman may have spotting discharge and/or breakthrough uterine bleeding. Regular use of the drug Yaz is then resumed after the end of the period of taking inactive white tablets.

To postpone the onset of withdrawal bleeding to another day of the week, a woman should shorten the next period of taking inactive white pills by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and will continue to have spotting and / or breakthrough bleeding while taking tablets from the second package.

Overdose

No serious overdose violations were reported. Based on the combined experience of using combined oral contraceptives, symptoms that may occur with an overdose of active tablets: nausea, vomiting, spotting or metrorrhagia. Treatment: There is no specific antidote, and symptomatic treatment should be performed.

Special instructions

If any of the conditions / risk factors listed below are currently present, then the potential risk and expected benefit of using combined oral contraceptives should be carefully weighed 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 become more severe, worsen, or first appear, a woman should consult with her doctor, who may decide whether to discontinue the medication. Diseases of the cardiovascular systemthe results of epidemiological studies indicate a relationship between the use of combined oral contraceptives and an increased incidence of venous and arterial thrombosis and thromboembolism (such as deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular diseases). These diseases are rare. The risk of developing venous thromboembolism (VTE) is highest in the first year of taking these medications. An increased risk is present after the initial use of oral contraceptives or the resumption of the use of the same or different combined oral contraceptives (after a break between taking the drug for 4 weeks or more). Data from a prospective study involving 3 groups of patients show that this increased risk is present mainly during the first 3 months.Overall risk of VTE in patients taking low-dose combined oral contraceptives ( VTE can be life-threatening or fatal (in 1-2% of cases). VTE, which manifests as deep vein thrombosis, or pulmonary embolism, can occur with any combination of oral contraceptives. Very rarely, when using combined oral contraceptives, thrombosis of other blood vessels occurs, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels. There is no consensus on the association between the occurrence of these events and the use of combined oral contraceptives. Symptoms of deep vein thrombosis (DVT) include: unilateral swelling of the lower limb or along a vein in the lower limb, pain or discomfort in the leg only when standing upright or walking, local fever in the affected lower limb, redness or discoloration of the skin on the lower limb. Symptoms of pulmonary embolism (PE) are as follows: difficulty or rapid breathing; sudden coughing, including with hemoptysis; acute chest pain, which can increase with deep breathing; anxiety; severe dizziness; rapid or irregular heartbeat. Some of these symptoms (for example, shortness of breath, cough) are non-specific and may be misinterpreted as symptoms of other more or less severe events (for example, respiratory tract infection). Arterial thromboembolism can lead to stroke, vascular occlusion, or myocardial infarction. Stroke symptoms: sudden weakness or loss of sensation in the face, arm, or leg, especially on one side of the body; sudden confusion, speech and comprehension problems; sudden one – or two-way vision loss; sudden gait disturbance, dizziness, loss of balance or coordination; sudden, severe, or prolonged headache for no apparent reason; loss of consciousness or fainting with or without an epileptic seizure. Other signs of vascular occlusion: sudden pain, swelling and slight blueness of the extremities, a symptom complex “acute abdomen”. Symptoms of a myocardial infarction include: pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest, arm, or behind the sternum; discomfort radiating to the back, cheekbone, larynx, arm, stomach; cold sweat, nausea, vomiting, or dizziness; severe weakness, anxiety, or shortness of breath; rapid or irregular heartbeat. Arterial thromboembolism can be life-threatening or fatal. In women with a combination of several risk factors or a high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increased risk may be higher than with a simple summation of factors. In this case, taking the drug Yaz is contraindicated. The risk of developing thrombosis (venous and/or arterial) and thromboembolism increases:— with age;- in smokers (with an increase in the number of cigarettes or an increase in age, the risk increases, especially in women over 35 years of age);— if you are obese (BMI greater than 30 kg / m2)— – if you have a family history (for example, venous or arterial thromboembolism ever in close relatives or parents at a relatively young age). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide whether to take combined oral contraceptives. ;— in case of prolonged immobilization, major surgery, any foot surgery, or extensive trauma. In these situations, it is advisable to stop using combined oral contraceptives (in the case of planned surgery, at least 4 weeks before it) and not resume taking them for 2 weeks after the end of immobilization. Temporary immobilization (for example, air travel lasting more than 4 hours) may also be a risk factor for venous thromboembolism, especially in the presence of other risk factors— – dyslipoproteinemia;— with arterial hypertension;- for migraines;— diseases of the heart valves— – atrial fibrillation. The use of any combined hormonal contraceptives increases the risk of developing VTE. The use of drugs containing levonorgestrel, norgestimate or norethisterone is associated with the lowest risk of developing VTE. The use of other medications, such as Jes, can lead to a twofold increase in the risk. The decision to use a drug other than the one with the lowest risk of developing VTE should be made only after discussion with the woman to make sure that she understands that the use of Yaz is associated with the likelihood of developing VTE, understands how her risk factors affect the likelihood of developing VTE, and understands that in each first year of using the drug, she There is evidence that the risk of developing VTE increases with the resumption of combined hormonal contraceptives after a 4-week or more break in use. The possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism 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 combined oral contraceptives (which may precede cerebrovascular disorders) is a reason for immediate discontinuation of these drugs. Biochemical parameters that indicate a hereditary or acquired predisposition to venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant). When assessing the risk-benefit ratio, it should be taken into account that adequate treatment of the relevant condition can 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 (Tumors The most significant risk factor for cervical cancer is persistent papillomavirus infection. There are reports of a slight increase in the risk of cervical cancer with long-term use of combined oral contraceptives, but the association with the use of combined oral contraceptives has not been proven. There are still contradictions about the extent to which these findings are related to screening for cervical pathology or sexual behavior (more rarely, the use of barrier methods of contraception). A meta-analysis of 54 epidemiological studies showed that there is a slightly increased relative risk of breast cancer diagnosed in women currently taking combined oral contraceptives (relative risk 1.24). The increased risk gradually disappears within 10 years after discontinuation of these medications. Because breast cancer is rare in women under the age of 40, the increase in breast cancer diagnoses among women who are currently or have recently taken combined oral contraceptives is insignificant relative to the overall risk of this disease. The observed increased risk may be due to an earlier diagnosis of breast cancer in women using combined oral contraceptives, the biological effect of oral contraceptives, or a combination of both factors. Women who have used combined oral contraceptives are more likely to develop early-stage breast cancer than women who have never used them. In rare cases, against the background of the use of combined oral contraceptives, the development of benign, and in extremely rare cases, malignant liver tumors was observed, which in some cases led to life-threatening intra-abdominal bleeding. If there is severe abdominal pain, enlarged liver, or signs of intra-abdominal bleeding, this should be taken into account when making a differential diagnosis. Tumors can be life-threatening or fatal. Other statesclinical studies have shown no effect of drospirenone on serum potassium concentrations in patients with mild to moderate renal insufficiency. There is a theoretical risk of developing hyperkalemia in patients with impaired renal function at the initial concentration of potassium on the ULN, while taking medications that lead to potassium retention in the body. In women with an increased risk of developing hyperkalemia, it is recommended to determine the concentration of potassium in plasma during the first cycle of taking Jes. Women with hypertriglyceridemia (or a family history of this condition) may have an increased risk of developing pancreatitis while taking combined oral contraceptives. Although a small increase in blood pressure has been reported in many women taking combined oral contraceptives, clinically significant increases have rarely been observed.However, if a persistent, clinically significant increase in blood pressure develops while taking combined oral contraceptives, these drugs should be discontinued and treatment for arterial hypertension should be initiated. The use of combined oral contraceptives can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy. The following conditions have been reported to develop or worsen both during pregnancy and with combined oral contraceptives, but their association with combined oral contraceptives has not been proven: jaundice and/or pruritus associated with cholestasis; cholelithiasis; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; Sydenham’s chorea; herpes of pregnancy; hearing loss associated with otosclerosis. Cases of worsening of the course of endogenous depression, epilepsy, Crohn’s disease and ulcerative colitis with the use of combined oral contraceptives are also described. In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen the symptoms of angioedema. Acute or chronic liver function disorders may require discontinuation of combined oral contraceptives until liver function indicators return to normal. Recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, requires discontinuation of combined oral contraceptives. Although combined oral contraceptives may have an effect on insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives ( However, women with diabetes should be carefully monitored while taking combined oral contraceptives. Sometimes chloasma can develop, especially in women with a history of chloasma in pregnant women. Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation while taking combined oral contraceptives. Laboratory TESTSTHE use of combined oral contraceptives may affect the results of certain laboratory tests, including liver, kidney, thyroid, and adrenal function, plasma transport protein concentrations, carbohydrate metabolism, coagulation, and fibrinolysis parameters. Changes usually do not exceed the limits of normal values. Drospirenone increases the activity of plasma renin and aldosterone, which is associated with its antimineralocorticoid effect. Medical examinationsbefore starting or resuming the use of Jes, it is necessary to familiarize yourself with the woman’s life history, family history, conduct a thorough general medical (including blood pressure measurement, heart rate, BMI determination) and gynecological examination (including breast examination and cytological examination of cervical mucus), and exclude pregnancy. The scope of additional examinations and the frequency of follow-up examinations are determined individually. Usually, follow-up examinations should be performed at least once every 6 months. A woman should be warned that combined oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases. Reduced efficacy The effectiveness of combined oral contraceptives may be reduced in the following cases: when skipping active light pink tablets (when using the “24+4” mode or light pink tablets in the case of using the “flexible” mode), with vomiting and diarrhea, or as a result of drug interaction. Insufficient control of the menstrual cycle Against the background of taking combined oral contraceptives, irregular bleeding (spotting spotting or breakthrough bleeding) may occur, especially during the first months of use for both regimens. With the “flexible” mode, irregular bleeding can develop during a fixed period of admission from 1 to 24 days). Therefore, evaluation of any irregular bleeding should only be performed after an adjustment period of approximately three cycles (or 3 months with a “flexible” regimen). If irregular bleeding recurs or develops after previous regular cycles, a thorough diagnostic examination should be performed to rule out malignancies or pregnancy. Some women may not develop withdrawal bleeding during a break from taking active light pink tablets (24+4 mode). If the drug was taken as directed, it is unlikely that the woman is pregnant. However, if the drug has been taken infrequently before, or if there are no consecutive withdrawal bleeds, pregnancy should be ruled out before continuing the drug. Against the background of a” flexible ” regimen of taking the drug, withdrawal bleeding is not regular. Therefore, the absence of withdrawal bleeding cannot be used as a sign of an unexpected pregnancy. In such cases, there are difficulties with the timely diagnosis of pregnancy. This fact is of particular importance for women taking concomitant medications with teratogenic effects. Although pregnancy is unlikely to occur with regular use of Jes, a pregnancy test should be performed at the slightest suspicion of pregnancy. Preclinical safety data The preclinical data obtained in standard studies for the detection of toxicity with multiple doses of the drug, as well as genotoxicity, carcinogenic potential and toxicity to the reproductive system, do not indicate the presence of a particular risk to humans. However, it should be remembered that sex hormones can promote the growth of certain hormone-dependent tissues and tumors. The effect on the ability to drive motor vehicles and manage mechanisms was not revealed.

Storage conditions

The drug should be stored in a dry, inaccessible place for children at a temperature not exceeding 30°C.

Shelf

life is 5 years (blister with 28 tablets),3 years (flex cartridge with 30 tablets).

Active ingredient

Drospirenone, Ethinyl Estradiol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For women of childbearing age, For adults as prescribed by a doctor

Indications

Contraception