Jess plus film coated pills N28
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Active ingredients
Drospirenone + Ethinyl Estradiol + [Calcium levomepholinate]
Release form
Pills
Composition
1 tablet (active) contains: Active substances: ethinylestradiol (micronized, in the form of betadex clathrate) - 20 mcg, drospirenone (micronized) - 3 mg, calcium levomefolat (micronized) - 451 mcg. Auxiliary substances: anhydrous citric acid - 558.5 mg, sodium bicarbonate - 200 mg, sodium carbonate anhydrous - 100 mg, mannitol - 60 mg, anhydrous lactose - 70 mg, ascorbic acid - 25 mg, sodium saccharinate - 6 mg, sodium citrate - 0.5 mg, blackberry flavoring B - 20 mg. tablet (auxiliary vitamin): Active substances: calcium left folate (micronized) - 451 mcg. Adjuvants: lactose monohydrate - 48.349 mg, microcrystalline cellulose - 24.8 mg, croscarmellose sodium - 3.2 mg, hyprolosis (5 cP) - 1.6 mg, magnesium stearate - 1.6 mg. Coat composition: light varnish orange - 2 mg or (alternatively): hypromellose (5 cP) - 1.0112 mg, macrogol 6000 - 202.4 mcg, talc - 202.4 mcg, titanium dioxide - 572.3 mcg, iron dye yellow oxide - 8.9 mcg, iron dye red oxide - 2.8 mcg .
Pharmacological effect
Jess; Plus - a low-dose monophasic oral combined estrogen-gestagenic contraceptive drug, including active pills and auxiliary pills containing calcium levomefolat. The contraceptive effect of the drug Jes; Plus, mainly due to the suppression of ovulation and increasing the viscosity of the cervical secretions. In women taking combined oral contraceptives, the cycle becomes more regular, pain, intensity and duration of menstrual bleeding decrease, resulting in a reduced risk of iron deficiency anemia. There is also evidence of a reduction in the risk of endometrial and ovarian cancer. Drospirenone, which is part of the drug Jess; Plus, it has anti-mineralocorticoid activity and helps prevent hormone-dependent fluid retention, which can manifest itself in weight loss and a reduced likelihood of peripheral edema. Drospirenone also has antiandrogenic activity and helps reduce acne (acne), oily skin and hair (seborrhea). These features of drospirenone should be considered when choosing a contraceptive for women with hormone-dependent fluid retention, as well as women with acne and seborrhea. According to its characteristics, drospirenone is similar to the natural progesterone produced by the female body.When properly used, the Pearl index (an indicator reflecting the number of pregnancies in 100 women using a contraceptive during the year) is less than 1. If you skip the pills or misuse, the Pearl index may increase. methyltetrahydrofolate (L-5-methyl-THF), the main folate form found in food. The average concentration of L-5-methyltetrahydrofolate in the blood plasma of people who do not use food enriched with folic acid is about 15 nmol / l. Levomefolat, unlike folic acid, is a biologically active form of folate. Because of this, it is absorbed better than folic acid. Levomefolat is indicated for women during pregnancy and during breastfeeding to meet the increased need for folate. Introduction of calcium levomefolata to the oral contraceptive reduces the risk of developing a fetal neural tube defect if a woman unexpectedly becomes pregnant immediately after discontinuation of the use of contraception (or, in very rare cases, when using oral contraception).
Pharmacokinetics
Drospirenone AbsorptionAfter ingestion, drospirenone is rapidly and almost completely absorbed. After a single oral administration, Cmax of drospirenone in plasma of 38 ng / ml is achieved in 1-2 hours. Eating does not affect the bioavailability, which ranges from 76% to 85%. DistributionAfter oral administration, a two-phase decrease in the level of the drug is observed serum, with T1 / 2, respectively, 1.6 ± 0.7 h and 27 ± 7.5 h. Drospirenone binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG), or corticosteroid-binding globulin (KSG). Only 3-5% of the total concentration of the substance in the serum is present as a free hormone. An ethinyl estradiol-induced increase in SHBG does not affect the binding of drospirenone to plasma proteins. The average apparent Vd is 3.7 ± 1.2 l / kg. The equilibrium concentration of drospirenone during the first course of the drug with a plasma concentration of about 70 ng / ml is reached 8 days after the start of the drug. There was an increase in plasma concentration of drospirenone approximately 2-3 times (due to cumulation), which was determined by the T1 / 2 ratio in the terminal phase and the dosing interval.A further increase in the concentration of drospirenone in the blood plasma is noted after 1-6 courses of use of the drug, after which there is no increase in the concentration. Metabolism After ingestion, drospirenone is extensively metabolized. Most plasma metabolites are represented by the acidic forms of drospirenone. Drospirenone is also a substrate for oxidative metabolism catalyzed by the CYP3A4 isoenzyme. Injection The plasma metabolic rate of drospirenone is 1.5 ± 0.2 ml / min / kg. In unchanged form, drospirenone is excreted only in trace amounts. The metabolites of drospirenone are excreted through the gastrointestinal tract and kidneys in a ratio of approximately 1.2: 1.4. T1 / 2 metabolites - about 40 hours. Pharmacokinetics in special clinical situations. Studies have shown that the concentration of drospirenone in the blood plasma of women with mild renal impairment (CC 50-80 ml / min) when reaching equilibrium and in women with good kidney function (CC more than 80 ml / min) are comparable. However, in women with moderate renal dysfunction (CC 30-50 ml / min), the average concentration of drospirenone in the blood plasma was 37% higher than in patients with preserved renal function. There was no change in the concentration of potassium in the blood plasma when using drospirenone. In women with moderate liver dysfunction (class B on the Child-Pugh scale), AUC is comparable to the corresponding figure in healthy women with similar Cmax values in the absorption and distribution phases. T1 / 2 of drospirenone in patients with moderately impaired liver function was 1.8 times higher than in healthy volunteers with intact liver function. In patients with moderately impaired liver function, the clearance of drospirenone was reduced by about 50% compared with women with preserved liver function, This is not marked differences in the concentration of potassium in the blood plasma in the studied groups. Changes in the concentration of potassium are not observed even in the case of a combination of factors predisposing to its increase (concomitant diabetes mellitus or treatment with spironolactone). Etinyl estradiol Absorption After ingestion, ethinyl estradiol is rapidly and completely absorbed. Cmax - about 33 pg / ml, achieved within 1-2 hours after a single ingestion. Absolute bioavailability as a result of presystemic conjugation and metabolism during the first passage through the liver is approximately 60%.Concomitant food intake reduces the bioavailability of ethinyl estradiol in about 25% of the examined, while other subjects did not show similar changes. Distribution The concentration of ethinyl estradiol in blood plasma decreases in two phases, T1 / 2 of ethinyl estradiol in the second phase is about 24 hours. blood plasma (about 98.5%) and induces an increase in plasma concentration of SHBG. Estimated Vd is about 5 l / kg. Equilibrium concentration (Сss) is reached in the second half of the drug intake cycle, the concentration of ethinyl estradiol in the blood plasma increases approximately 1.4-2.1 times. Metabolism Ethinyl estradiol undergoes significant primary metabolism in the intestine and liver. Ethinyl estradiol and its oxidative metabolites are primarily conjugated to glucuronides or sulfate. The rate of metabolic clearance of ethinyl estradiol is about 5 ml / min / kg. Injection of ethynyl estradiol is practically not excreted unchanged. Ethinyl estradiol metabolites are excreted by the kidneys and through the intestine at a ratio of 4: 6. T1 / 2 metabolites is approximately 24 hours. Pharmacokinetics in special clinical situations. The effects of ethnicity were not established (a study was conducted on cohorts of European and Japanese women pharmacokinetics. Levomefolat AbsorptionAfter calcium ingestion, levofomolat is rapidly absorbed and included in the body folate pool. After a single dose of 451 μg of calcium levomefolata after 0.5–1.5 h, Cmax becomes 50 nmol / l higher than the initial concentration. Distribution The pharmacokinetics of folates has a two-phase character: a folate pool with fast and slow metabolism is determined. A pool with a fast metabolism is likely to represent folates in the body, which is consistent with T1 / 2 of calcium levomefolat, which is about 4-5 hours after it is taken orally at a dose of 451 μg. The slow metabolism pool reflects the conversion of polyglutamate folate, T1 / 2 of which is about 100 days. Inward-entering folates and folates going through the hepato-hepatic cycle maintain the constant concentration of L-5-methyl-THF in the body. L-5-methyl-THF represents the main form of folate in the body,in which they are delivered to peripheral tissues for participation in cellular folate metabolism. Equilibrium concentration (Css) of L-5-methyl-THF in blood plasma after ingestion of 451 mcg of calcium levomefolata is reached after 8-16 weeks and depends on its initial concentration. In erythrocytes, Css is achieved at a later date due to the erythrocyte life expectancy, which is about 120 days. Metabolism L-5-methyl-THF represents the main folate transported form in blood plasma. When comparing 451 μg of calcium levomefolata and 400 μg of folic acid, similar mechanisms of metabolism were established for other significant folates. Folate coenzymes are involved in 3 major conjugated metabolic cycles in the cytoplasm of cells. These cycles are necessary for the synthesis of thymidine and purines, precursors of DNA and RNA acids, as well as for the synthesis of methionine from homocysteine and the conversion of serine to glycine. Excretion of L-5-methyl-THF is excreted by the kidneys unchanged and in the form of metabolites, as well as through the digestive tract.
Indications
- contraception, intended primarily for women with symptoms of hormone-dependent fluid retention in the body; - contraception and treatment of moderate acne (acne vulgaris); - contraception in women with folate deficiency; - contraception and treatment of severe premenstrual syndrome.
Contraindications
Drug jess; Plus is contraindicated in the presence of any of the conditions / diseases listed below. If any of these conditions / diseases develop for the first time while receiving, the drug should be immediately discontinued.- thrombosis (venous and arterial) and thromboembolism currently or in history (including deep vein thrombosis, pulmonary thromboembolism, heart attack) myocardium, stroke), cerebrovascular disorders; - conditions that precede thrombosis (including transient ischemic attacks, angina pectoris) currently or in history; - revealed acquired or hereditary predisposition to venous or arterial thrombosis, including resistance to activated protein C, antithrombin III deficiency, protein C deficiency, protein deficit S, hyperhomocysteinemia, antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant) - the presence of high risk of venous or arterial thrombosis; - migraine with focalneurological symptoms now or in history; pancreatitis with severe hypertriglyceridemia now or in history; diabetes mellitus with vascular complications; liver failure and severe liver disease (before normalization of liver samples); liver tumors (benign or malignant) currently or in history; severe and / or acute renal failure; identified hormone-dependent malignant neoplasms (including the genitals or mammary glands) or suspected not on them; - bleeding from the vagina of unknown origin; - pregnancy or suspicion of it; - breastfeeding period; - rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption (due to lactose content); - hypersensitivity or intolerance to any from the components of the drug Jess; Plus. With caution It is necessary to assess the potential risk and the expected benefit of using the drug Jess; Plus in each individual case with the following diseases / conditions and risk factors: - risk factors for thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated valvular heart disease, hereditary predisposition to thrombus. , myocardial infarction or impaired cerebral circulation at a young age in any of the closest relatives); - other diseases in which they may be noted Peripheral circulatory disorders: diabetes mellitus without vascular complications, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins; - hereditary angioedema; contraindications; - diseases that first arose or worsened during pregnancy or against the background of previous intake of sex hormones (for example, jaundice and / or itching associated with cholestasis, cold Elitiasis, otosclerosis with impairment of hearing, porphyria, herpes of pregnancy, Chorea Sydenhem); - postpartum period (not earlier than 21-28 days after birth, in the absence of breastfeeding).
Use during pregnancy and lactation
The drug is contraindicated in pregnancy. If pregnancy is detected during the use of the drug Jess; Plus, the drug should be immediately lifted. Data on the results of the use of the drug Jes; Plus, pregnancy is limited, and do not allow to draw any conclusions about the negative impact of the drug on pregnancy, the health of the fetus and the newborn child. At the same time, extensive epidemiological studies have not revealed an increased risk of developmental defects in children born to women taking combined oral contraceptives before pregnancy, or a teratogenic effect in cases of taking combined oral contraceptives because of negligence in the early stages of pregnancy. Specific epidemiological studies on the drug Jes; Plus was not carried out. The drug is contraindicated in the period of breastfeeding. Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, therefore the use of the drug Jess; Plus is contraindicated until the termination of breastfeeding. A small amount of sex hormones and / or their metabolites can penetrate into breast milk and affect the health of the baby.
Dosage and administration
Tablets should be taken orally in the order indicated on the package, every day at the same time, without chewing, with a small amount of water. Take 1 tab. / Day continuously for 28 days. Taking the pills from the next pack starts immediately after taking the previous one. Blood withdrawal, as a rule, begins 2-3 days after the start of taking the inactive pills and may not finish before taking the pills from the next pack. The handling instructions for the packaging of the drug Jess; PlusV unfolding packaging drug Jess; Plus, a blister is glued in containing 24 active (pink) pills and 4 auxiliary (light orange) pills (bottom row). The package also contains a block of stickers consisting of 7 self-adhesive strips with the names of the days of the week marked on them, which are necessary for setting up the reception calendar. You need to choose a strip with the day of the week where the pill begins. For example, if the start of taking pills falls on Wednesday, you should use a strip that starts with Wed.The strip is glued along the upper part of the package so that the designation of the first day is above the tablet on which the arrow with the inscription Start is directed. Thus, it becomes clear on which day of the week each pill should be taken. Start taking the drug If you did not take any hormonal contraceptives in the previous month, take the drug Jess; Plus, they start on the 1st day of the menstrual cycle (i.e., on the 1st day of menstrual bleeding). On this day, you must take one pink (active) pill, which is labeled with the corresponding day of the week. Then you should take the pills in order. Drug jess; Plus begins to act immediately, so there is no need to use additional barrier methods of contraception. It is allowed to start taking the drug on the 2-5th day of the menstrual cycle, but in this case, you must additionally use a barrier method of contraception (for example, a condom) during the first 7 days taking pink (active) pills from the first package. When switching from other combined oral contraceptives, a vaginal ring or a contraceptive patch, it is preferable to start taking the drug D the EU; Plus 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 pills) or after taking the last inactive tablet (for drugs containing 28 pills in packaging). Taking the drug Jess; Plus, you should start on the day of removal of the vaginal ring or patch, but not later than the day when a new patch should be introduced or a new patch should be pasted. progestogen release systems; Transfer from mini-drank to Jess; Plus, it is possible on any day (without a break), from an implant or IUD with a gestagen - on the day of their removal, from an injection contraceptive - on the day when the next injection should be given. In all cases during the first 7 days of taking the drug Jess; Plus, you must additionally use a barrier method of contraception (for example, a condom). After an abortion (includingspontaneous) in the first trimester of pregnancy. You can start taking the drug immediately. If this condition is observed, additional contraceptive measures are not required. After delivery (in the absence of breastfeeding) or abortion (including spontaneous) in the second trimester of pregnancy, it is recommended to start taking the drug on the 21-28th day after birth or abortion (including h spontaneous) in the II trimester of pregnancy. If taking the drug started later, you must use an additional barrier method of contraception during the first 7 days of taking the pills. However, if sexual intercourse took place, prior to taking the drug, Jess; Plus, pregnancy should be avoided. Missed pills can be skipped. Skip auxiliary light orange pills can be ignored. However, the missed pills should be thrown away in order not to accidentally extend the period of taking the auxiliary pills. The following recommendations apply only to skipping active pink pills (pills 1-24 per pack). If the delay in taking any pink (active) pill was less than 24 hours, contraceptive protection does not decrease. A woman should take the missed pill as soon as possible, and then take the next pill at the usual time. If the delay in taking any pink (active) pill is more than 24 hours, the contraceptive protection can be reduced. The more pills are missed and the closer the pass of pills to the phase of taking light orange (auxiliary) pills, the higher the probability of pregnancy. At the same time remember: - The drug should never be interrupted for more than 7 days (you should pay attention to that the recommended interval for taking light orange (auxiliary) pills is 4 days); - 7 days of continuous administration of active (pink) pills are required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system. Accordingly , if the delay in taking active (pink) pills was more than 24 hours, we can recommend the following: From the 1st to the 7th day, a woman should take the last missed pill as soon as she remembers, even if it means taking two pills at the same time. The following pills must be taken at the usual time. In addition, over the next 7 days, you must additionally use a barrier method of contraception (for example, a condom).If sexual intercourse took place within 7 days before the missed pill, consider the possibility of pregnancy. From the 8th to the 14th day, a woman should take the last missed pill as soon as she remembers, even if it means taking two pills at the same time. She continues to take the following pills at the usual time. Subject to the pill regimen for 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as skipping two or more pills, it is necessary to additionally use barrier methods of contraception (for example, a condom) for the next 7 days. From the 15th to the 24th day, the risk of a decrease in contraceptive reliability is inevitable due to the upcoming reception phase - orange (auxiliary) pills. In this case, it is necessary to adhere to the following algorithms: - if during the 7 days preceding the first missed pill, all the pills were taken correctly, there is no need to use additional contraceptive methods. When taking missed pills, you should be guided by points 1 or 2. - if during the 7 days preceding the first missed pill, the pills were taken incorrectly, then over the next 7 days you must additionally use a barrier method of contraception (for example, a condom) and in this case you should be guided clause 1 for taking missed pills.1. Take the missed pill as soon as possible as soon as the woman remembers it (even if it means taking two pills at the same time). The following pills are taken at the usual time until the pink (active) pills in the package run out. Four light orange (auxiliary) pills should be discarded and the pink (active) pills should be taken from the new package immediately. Until the pink (active) pills from the second package run out, withdrawal bleeding is unlikely, but there may be spotting and / or breakthrough bleeding. Stop taking pink (active) pills from the current package, then take a break of 4 days or less (including the days of missing pills),then start taking the drug from a new package. If a woman misses taking pink (active) pills and while taking light orange (auxiliary) pills, no withdrawal bleeding has occurred, you need to make sure that you are not pregnant. You are allowed to take no more than two pills on the same day. Recommendations for gastrointestinal disorders. In severe gastrointestinal disorders, the absorption of the drug may be incomplete, therefore, additional contraceptive measures should be taken. If within 3-4 hours after taking a pink (active) pill will cause vomiting or diarrhea, should be guided by the recommendations when skipping pills. If a woman does not want to change her usual regimen and transfer the onset of menstruation to another day of the week, an additional pink (active) pill should be taken from another package. Discontinuation of the drug Jess; Plus, taking the drug Jess; Plus you can stop at any time. If the woman is not planning a pregnancy, you should take care of other methods of contraception. If pregnancy is planned, you should simply stop taking the drug Jess; Plus, wait for the natural menstrual bleeding, and only then try to get pregnant. This will help to more accurately calculate the duration of pregnancy and the time of delivery. Delaying the onset of menstrual bleeding To delay the onset of withdrawal bleeding, skip taking 4 light orange (auxiliary) pills from the current package and start taking pink (active) pills from the following package of Jess; A plus. If all 24 pink pills from the second package have been taken, in this case 4 light orange pills should also be taken. Only then can you start taking pills from a new package. Thus, the cycle can be extended, if desired, for any period, up to 3 weeks, incl. until all pink pills from the second pack are taken. If a woman wants menstrual bleeding to start earlier, you should stop taking the pink pills from the second pack, throw it away and take a break in taking all the pills for no more than 4 days, and then start taking the pills from the new pack. In this case, menstrual bleeding will begin about 2-3 days after taking the last pink pill from the second pack.While taking the drug jess; Plus from the second package, there may be spotting and / or breakthrough bleeding on the days of taking the pills. Changing the day of the onset of menstrual bleeding If the pills are taken in accordance with the recommendations, menstrual bleeding will occur about the same day every 4 weeks. If a woman wants to change the day of the onset of menstrual bleeding, you should stop taking light orange pills for as many days as the woman wants to change the onset of menstrual bleeding. For example, if the cycle usually begins on Friday, and in the future a woman wants it to start on Tuesday (3 days earlier), taking the pills from the next package should be started 3 days earlier than usual, that is, do not use the last 3 light orange pills from the current package and start taking the pills from the next package. The less light-orange pills a woman takes, the higher the likelihood that menstrual-like bleeding does not occur. While taking the drug jess; Plus, the following packaging may be spotting and / or breakthrough bleeding. Efficacy and safety of the drug Jess; Plus as a contraceptive studied in women of reproductive age. The use of the drug in children and adolescents is contraindicated until regular menstrual cycles are established. Preparations Jess; Plus does not apply after menopause. The drug is contraindicated for use in women with severely impaired liver function. The drug is contraindicated for use in women with severely impaired renal function and in acute renal failure.
Side effects
The most common adverse reactions reported in connection with the use of the drug are nausea, pain in the mammary glands, irregular uterine bleeding, bleeding from the genital tract of unspecified genesis (more than 3% of women using the drug for Contraception and Contraception and treatment moderate acne (acne vulgaris)); nausea, pain in the mammary glands, irregular uterine bleeding (more than 10% of women using the drug as indicated Contraception and treatment of severe premenstrual syndrome (PMS)). Serious adverse reactions are arterial and venous thromboembolism. The incidence of adverse reactions, which have been reported during clinical trials of Jess drugs; and jess; Plus, as indicated by contraception,as well as indications. Contraception and treatment of the moderate form of acne (acne vulgaris) (n = 3565) and Contraception and treatment of the severe form of premenstrual syndrome (PMS) (n = 289) for the drug Jess; Within each group, selected depending on the frequency of occurrence, adverse reactions are presented in order of decreasing severity. In terms of frequency, they are separated as follows: often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100) and rarely (≥1 / 10 000 and <1/1000). For additional adverse reactions identified only in the process of post-marketing observations, and for which it was not possible to estimate the frequency of occurrence, the frequency is unknown. Infectious and parasitic diseases: rarely - candidiasis. On the side of metabolism and nutrition: not often - an increase in body weight; rarely - weight loss, increased appetite, anorexia, hyperkalemia, hyponatremia. On the mental side: often - mood swings; infrequently - decrease or loss of libido2, drowsiness, depression / depressed mood; rarely - anorgasmia, insomnia. From the nervous system: often - headache; infrequently - dizziness, paresthesia. From the cardiovascular system: infrequently - increase in blood pressure, migraine; rarely - tachycardia, venous and arterial thromboembolism *, fainting, nasal bleeding. On the part of the organ of vision: rarely - conjunctivitis, dryness of the mucous membrane of the eyes, visual impairment. On the side of the gastrointestinal tract: often - nausea1; infrequently - abdominal pain, vomiting, gastritis, diarrhea, dyspepsia, flatulence; rarely - bloating, constipation, dry mouth. From the liver and biliary tract: rarely - pain in the right hypochondrium. From the immune system: rarely - allergic reactions; frequency is unknown - hypersensitivity. On the side of the skin and subcutaneous tissues: infrequently - acne, itching, rash; rarely - alopecia, hypertrichosis, eczema, dry skin, contact dermatitis, acneformal dermatosis; frequency is 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 glands1, tenderness of the mammary glands, acyclic bleeding / bleeding from the vagina1, bleeding from the genital tract of unspecified genesis, absence of menstrual-like bleeding; infrequently - pain in the pelvic area,hot flushes, fibrocystic mastopathy, vulvovaginal candidiasis, vaginal discharge, copious menstrual-like bleeding, scanty menstrual-like bleeding, rare menstrual-like bleeding, painful menstrual-like bleeding, dry vaginal mucosa, bleeding, painful menstrual bleeding, dryness of the vaginal mucosa, bleeding, painful menstrual bleeding, dryness of the vaginal mucosa, bleeding, painful menstrual bleeding rarely, breast hyperplasia, cervical polyp, ovarian cyst, endometrial atrophy. From the hematopoietic system: rarely anemia, thrombocythemia. Others: infrequently, asthenia, increased sweating, generalized or peripheral edema; rarely - malaise. Adverse events were classified using the MedDRA dictionary. Different MedDRA terms reflecting the same symptom were grouped together and presented as the only adverse reaction in order to avoid weakening or blurring the true effect. * Approximate frequency of epidemiological studies covering the group of combined oral contraceptives. The frequency bordered on a very rare. - Venous or arterial thromboembolism includes the following nosol