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Active ingredients
Nomegastrol + Estradiol
Release form
Pills
Composition
1 tablet contains: Active substance: estradiol hemihydrate 1.55 mg, estradiol 1.5 mg, nomegestrol acetate 2.5 mg Auxiliary substances: microcrystalline cellulose - 14 mg, crospovidone - 2.4 mg, talc - 0.7 mg, magnesium stearate - 0.7 mg, colloidal silicon dioxide - 0.44 mg, lactose monohydrate - 57.71 mg. The composition of the shell: opadry II white - 1.6 mg (polyvinyl alcohol - 0.64 mg, titanium dioxide - 0.4 mg, macrogol 3350 - 0.32 mg, talc - 0.24 mg).
Pharmacological effect
Combined hormonal contraceptive drug containing estrogen 17 & # 946.-Estradiol and progestogen nomegastrol acetate. Estradiol (17 & # 946.-Estradiol) is a natural estrogen identical to the endogenous human 17 & # 946.-Estradiol (E2). Unlike ethinyl estradiol, which is a part of other combined oral contraceptives, E2 does not have an ethynyl group in the 17th and # 945 position. When using the drug Zoely. average concentrations of E2 are comparable with those in the initial follicular phase and the late phase of the yellow body of the menstrual cycle. Nomegastrol acetate is a highly selective progestogen that is derived from natural steroid hormone progesterone and is structurally similar to it. Nomegastrol acetate has a pronounced affinity for the human progesterone receptor, has high antigonadotropic activity, moderate anti-androgenic activity and does not possess estrogenic, androgenic, glucocorticoid and mineralocorticoid activity. Contraceptive effect of the drug Soely. due to a combination of various factors, the most important of which are in suppressing ovulation and changing the secretion of cervical mucus. When taking Zoely. Nomegestrol acetate mainly suppresses ovulation, and E2 enhances the effects of progestogen. After the cancellation of Zoely. most women ovulate quickly restored. During administration, the concentration of folic acid in the serum does not change and remains at a basic level for 6 consecutive months of taking the drug Zoely .. In clinical studies it was found that the Pearl index for women aged 18 to 50 years was 0.66 (upper limit 95% confidence interval 1.07), and for women aged 18 to 35 years, the Pearl index was 0.75 (the upper limit of the 95% confidence interval 1.23).In clinical studies, it was found that when taking Zoely. glucose tolerance and insulin sensitivity did not change, there were no clinically significant effects on lipid metabolism and hemostasis. Reception Zoely. increased the content of protein carriers of thyroxin-binding globulin and corticosteroid-binding globulin (CSG), but to a lesser extent than the combination of levonorgestrel with ethinyl estradiol. When taking the drug Zoely. the content of sex hormone-binding globulin (SHBG) slightly increased, androstenedione, dehydroepiandrosterone, total and free testosterone significantly decreased. After 13 cycles of the drug was not observed pathological changes in the histological study of the endometrium.
Indications
- contraception.
Contraindications
There are no epidemiological data on the use of combined oral contraceptives containing 17 # .46-estradiol, however, contraindications to the use of the drug Zoely correspond to contraindications to the use of contraceptives containing ethinyl estradiol. If any of these conditions occur during the period of Zoeli's application, the drug should be immediately discontinued: - deep vein thrombosis or pulmonary embolism, incl. in the anamnesis. - arterial thrombosis (myocardial infarction, impaired cerebral circulation) or prodromal states (transient ischemic attack, angina), including in the anamnesis. - migraine with focal neurological symptoms, incl. in the anamnesis. - severe or multiple risk factors for venous or arterial thrombosis, such as: diabetes mellitus with vascular symptoms, severe arterial hypertension, severe dyslipoproteinemia. - hereditary or acquired susceptibility to the development of venous or arterial thrombosis, for example, resistance of activated protein C, deficiency of antithrombin III, deficiency of proteins C and S, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant). - pancreatitis with severe hypertriglyceridemia, incl. in the anamnesis. - severe liver disease, incl. history, to normalize the performance of the liver. - liver tumors (malignant or benign), incl.in the anamnesis. - known or suspected hormone-dependent malignant tumors (for example, of the genital organs or the mammary gland). - Vaginal bleeding of unknown etiology. - postmenopause. - established or suspected pregnancy. - lactation period (breastfeeding). - Lactase deficiency, lactose intolerance, glucose-galactose malabsorption. - hypersensitivity to the drug. With care If you have any of the conditions / diseases listed below, you should evaluate the benefits of using Zoely and the possible risks for each woman. This should be discussed with the woman before she starts taking the drug Zoely .. In cases of worsening, exacerbation of the disease or the occurrence of any of these conditions, for the first time a woman should consult a doctor to decide on the possibility of further use of Zoely vessels. - severe depression or the presence of this disease in history. - Systemic lupus erythematosus. - Crohn's disease . - ulcerative colitis . - abnormal liver function. - hypertriglyceridemia, including in the family history. - risk factors for coronary heart disease (obesity, smoking at age 35 and older, arterial hypertension). - long-term immobilization or extensive surgery. - the presence in the family history of venous thrombosis, arterial embolism in brothers, sisters or parents at a relatively young age.
Use during pregnancy and lactation
The use of the drug Zoely during pregnancy is contraindicated. In the case of pregnancy with the use of Zoely should stop taking the drug. Most epidemiological studies have not revealed an increase in the risk of congenital malformations in children of women who took ethinyl estradiol-containing combined oral contraceptives before pregnancy. In case of accidental use of combined oral contraceptives containing ethinyl estradiol at the beginning of pregnancy, no teratogenic effects were noted. Limited experience with Zoely in pregnant women indicates the absence of undesirable effects of the drug on the condition of the fetus or newborn. Combined oral contraceptives can affect lactation, because they cause a change in the amount and composition of breast milk.Therefore, the use of combined oral contraceptives is not recommended until complete cessation of breastfeeding. Small amounts of contraceptive steroids and / or their metabolites can be eliminated with breast milk, but there is no evidence of their undesirable effect on the health of the newborn.
Dosage and administration
The drug is intended for oral administration. Recommendations for taking pills are the same for all women. The pills are taken daily at the same time of the day, regardless of the meal, in the order indicated on the package, if necessary with a small amount of water. It should be taken on 1 tab. / Day for 28 consecutive days. Reception should begin with white pills containing the active ingredients, within the first 24 days, and over the next 4 days - yellow pills that do not contain the active ingredients (placebo). Taking pills from each subsequent package should be started the next day after taking the last tablet from the previous package, regardless of the presence or absence of withdrawal bleeding. Withdrawal bleeding usually begins 2-3 days after taking the last white pill and may not stop by the start of taking the pills from the next pack. Start taking the drug Zoely. In the absence of previous use of hormonal contraceptives. Taking pills should be started on the 1st day of the menstrual cycle (on the first day of menstrual bleeding). In this case, the use of additional contraceptives is not required. You can start taking pills from the 2nd to 5th day of the cycle, but then during the first 7 days of taking the pills, it is recommended to additionally use a barrier method of contraception. Transition from a combined hormonal contraceptive (combined oral contraceptive, vaginal ring or transdermal patch) It is recommended to start the day after taking the last pill containing the active ingredients, but no later than the next day after completing the usual interval between cycles or taking placebo pills. If a woman used a vaginal ring or transdermal patch, then start taking the drug Zoely. preferably on the day of their removal, but no later than on the day when you should insert a new ring or stick another patch. If a woman constantly and correctly used the previous method of contraception, and there is no doubt that she is not pregnant, then go to the drug Zoely. can also be any day.In no case should not exceed the recommended hormone interval of the previous method. Switching from drugs containing progestogen only (pills, implants, injectable forms or hormone-containing intrauterine systems - IUD) A woman can stop taking pills containing only progestogen on any given day, and start taking the drug Zoely on the next day. any day, taking the drug Zoely. should start on the day of their removal. If a woman received an injection, then take Zoely. begin on the day when you had to make another injection. In all these cases, the woman is recommended to additionally use a barrier method of contraception during the first 7 days of taking pills containing active ingredients. After an abortion made in the first trimester of pregnancy, a woman can start taking the drug right away. in this case, there is no need for an additional method of contraception. After childbirth or abortion in the second trimester of pregnancy. A woman should start taking the drug between the 21st and 28th day after delivery or abortion in the second trimester. At a later start of the drug is recommended to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if after childbirth or abortion there was already sexual intercourse, before taking the drug Zoely. it is necessary to exclude pregnancy or wait for the first menstruation. In the case of the omission of pills. The recommendations given below concern only the omission of the intake of white pills containing active substances. If a woman takes another pill with a delay of less than 12 hours, the contraceptive effect does not decrease. A woman should take a pill as soon as possible as soon as she remembers. Subsequent pills must be taken at the usual time. If a woman takes an active pill more than 12 hours late, then the contraceptive effect may be reduced. When skipping pills, it is advisable to follow two rules: - in order to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, white pills containing active substances must be taken for at least 7 consecutive days. - the more missed white pills containing active ingredients, and the closer the time of taking 4 yellow placebo pills, the higher the risk of pregnancy. If one white pill containing the active ingredients is missed, the contraceptive effect is not reduced.A woman should take the last white pill she missed as soon as she remembers, even if she has to take two pills at the same time. Then the pills should be taken as usual. Additional contraceptive measures are not required. If two white pills or more are missed If after skipping two or more white pills containing the active ingredients, there was no withdrawal bleeding while taking the yellow placebo pills, then pregnancy should be excluded. Days 1-7 A woman should take the last white pill she missed as soon as she remembers, even if she has to take two pills at the same time. Then the pills should be taken as usual. At the same time during the first week of continuous use of white pills, you must use the barrier method of contraception. If during the previous 7 days there was sexual intercourse, then you should consider the possibility of pregnancy. Days 8-17 A woman should take the last white pill she missed as soon as she remembers, even if she has to take two pills at the same time. Then the pills should be taken as usual. However, over the next 7 days of taking white pills, you must use a barrier method of contraception. Days 18-24 The risk of a reduction in the contraceptive effect increases with the onset of taking the yellow placebo pills. However, a change in the pill regimen avoids a reduction in contraceptive action. A woman should take the last white pill she missed as soon as she remembers, even if she has to take two pills at the same time. You can not simultaneously take more than two white pills containing active ingredients. Over the next 7 days of taking the white pills, you must use a barrier method of contraception, and the next pack should be started immediately after the end of the white pills from the previous pack, i.e. women should not take yellow placebo pills. In this case, withdrawal bleeding usually occurs while taking the yellow pills from the next pack, but while taking the white pills, breakthrough bleeding or spotting may occur. If a woman is not sure about the number of missed pills or their color and, accordingly, does not know what recommendations she should follow, then it is necessary to use a barrier method of contraception until the woman takes white pills for 7 consecutive days.If the yellow placebo pill is missed, the contraceptive effect is not reduced. A woman may not take yellow pills from the last (fourth) row of blisters. However, missed pills should be discarded to avoid an unintended increase in the duration of the placebo phase. Recommendations for gastrointestinal disorders In the case of gastrointestinal disorders (for example, vomiting or diarrhea), the absorption of the drug may be incomplete, so additional contraceptive measures should be resorted to. If vomiting occurs within 3-4 hours after taking the pill, then its reception should be considered missed. If you miss one white pill, the contraceptive effect is not reduced. If vomiting develops again the next day or days, it is necessary to follow the recommendations for skipping two or more pills. If a woman does not want to change the usual pill regimen, then she should take an extra white pill or pills from another package. How to shift or delay the onset of menstrual bleeding To delay the onset of menstrual bleeding, a woman should continue taking white pills from another package without taking yellow pills. White pills from the second package can be continued until they run out. After you finish taking the yellow pills from the second pack, you must resume taking the drug Zoely. in the usual way. With an extended regimen, breakthrough bleeding or spotting may occur. In order to shift the day of the onset of menstrual bleeding to another day, you can shorten the phase of taking placebo pills (maximum 4 days). The shorter the break, the higher the risk of the absence of menstrual-like withdrawal bleeding and the occurrence of breakthrough bleeding or spotting bleeding while taking the pills from the second package.
Side effects
The tolerability of the drug Zoely is good, and the safety profile is similar to that of other combined oral contraceptives. Side effects that occurred when taking combined oral contraceptives containing ethinyl estradiol: venous and arterial thromboembolism, increased blood pressure, hormone-dependent tumors (eg, liver tumors, breast cancer), chloasma. The incidence of breast cancer is slightly higher in women taking combined oral contraceptives.Breast cancer is rarely observed in women under 40 years of age and the number of additional cases when taking combined oral contraceptives is small compared with the overall risk of breast cancer. The relationship with the reception of combined oral contraceptives has not been established. In patients with impaired renal or liver function, no studies have been conducted. In women with impaired liver function, the metabolism of steroid hormones may worsen.
special instructions
The tolerability of the drug Zoely is good, and the safety profile is similar to that of other combined oral contraceptives. Side effects that occurred when taking combined oral contraceptives containing ethinyl estradiol: venous and arterial thromboembolism, increased blood pressure, hormone-dependent tumors (eg, liver tumors, breast cancer), chloasma. The incidence of breast cancer is slightly higher in women taking combined oral contraceptives. Breast cancer is rarely observed in women under 40 years of age and the number of additional cases when taking combined oral contraceptives is small compared with the overall risk of breast cancer. The relationship with the reception of combined oral contraceptives has not been established. In patients with impaired renal or liver function, no studies have been conducted. In women with impaired liver function, the metabolism of steroid hormones may worsen.