Zoely contraceptive pills: reviews from doctors, price, instructions for use, analogues

Compound

1 tablet - 2.5 mg of nomegestrol acetate and 1.55 mg of estradiol hemihydrate (respectively 1.5 mg of estradiol ) - active substances.
Auxiliary ingredients:

0.7 mg - talc;
14 mg - microcrystalline cellulose;
0.7 mg - magnesium stearate;
2.4 mg - crospovidone;
57.71 mg - lactose monohydrate;
0.44 mg - colloidal silicon dioxide.

Shell:

1.6 mg - opadry II white.

Placebo tablets :

0.7 mg - talc;
14 mg - microcrystalline cellulose;
0.7 mg - magnesium stearate;
2.4 mg - crospovidone;
61.76 mg - lactose monohydrate;
0.44 mg - colloidal silicon dioxide.

Shell:

2.4 mg - opadry II yellow.

Pharmacodynamics and pharmacokinetics

Zoely is a hormonal combined contraceptive drug consisting, in addition to additional substances, of the active components: estradiol (17β) and nomegestrol.

Estradiol is a naturally occurring estrogen identical to human endogenous 17β-estradiol (E2) . The main difference from ethinyl estradiol , which is part of the structure of other COCs (combined oral contraceptives), is the absence of an ethynyl group in the 17α-position. Taking Zoely's medication causes average concentrations of E2 , which correspond to those in the initial follicular phase and the final luteal phase of the menstrual cycle.

A derivative of natural progesterone, nomegestrol , is similar to it in structure and is a highly selective progestogen . Having a pronounced affinity for the progesterone (human), it exhibits high antigonadotropic and moderate antiandrogenic activity, without having androgenic, glucocorticoid, estrogenic and mineralocorticoid effects.

The contraceptive effect of Zoely is a combination of several effects, the most significant of which are changes in the secretion of the cervical and suppression of ovulation . E2 increases the effects of progestogen , and nomegestrol is involved in the process of suppressing ovulation. After stopping taking Zoely, normal ovulation , in most women, is restored quite quickly.

The serum folic acid content does not change while taking Zoely and remains at the baseline level for six months of sequential use.

Clinical studies have established a Pearl index of 0.66 for the age category of women 18-50 years old and 0.75 for women 18-35 years old, with a corresponding upper limit of the 95% confidence interval of 1.07/1.23.

Studies have shown that taking Zoely does not lead to significant changes in lipid metabolism and does not affect insulin glucose tolerance and hemostasis . The drug increased the amount of proteins that transport CSG (corticosteroid-binding) and TSH (thyroxine-binding) globulins , but to a much lesser extent than the combination of ethinyl estradiol and levonorgestrel . Also, the content of free and total testosterone, dehydroepiandrosterone, and androstenedione globulin increased slightly . When conducting a histological examination of the endometrium , after using Zoely for 13 cycles, no pathological changes were observed.

Nomegestrol, when taken internally, is rapidly absorbed and detects Cmax (7 ng/ml) in plasma after 2 hours. When taken once, the absolute bioavailability, regardless of food intake, is 63%.

97-98% binds to albumin , without binding to CSG or SHBG. Vss - 1.645±576 l.

Metabolized by cytochrome P450 to several hydroxylated inactive metabolites, which in turn, together with nomegestrol , form sulfate and glucuronide conjugates. At steady state, the clearance is 26 l/h.

At steady state, T1/2 is on average 46 hours (from 28 to 83 hours). Nomegestrol is excreted through the kidneys to a lesser extent and through the intestines to a greater extent. Approximately 80% is eliminated within 4 days and almost completely within 10 days.

The linearity of the pharmacokinetics of nomegestrol depends on the dose taken (in the range of 0.625–5 mg).

the pharmacokinetics of nomegestrol . The equilibrium state is observed after 5 days. Average Css is 4 ng/ml. Cmax in plasma is approximately 12 ng/ml and appears 90 minutes after administration.

Nomegestrol does not interact with glycoprotein P and does not have a significant inhibitory or inducing effect on cytochrome P450.

Estradiol , when taken orally, is subject to significant first-pass metabolism. Absolute bioavailability, regardless of food intake, is about 5%.

Actively spreads throughout the body. The highest content is shown in target organs of PG ( sex hormones ). In the blood it binds 37% to SHBG, 61% to albumin . Only 1–2% of estradiol is found in unbound form.

When taken orally, exogenous estradiol is actively biotransformed and, due to its similarity with endogenous estradiol , is quickly converted in the liver and intestines into several metabolites (mainly estrone ). The latter are conjugated, undergoing hepatic-intestinal circulation. Oxidation occurs due to cytochrome P450 isoenzymes.

Cmax in serum is observed after 6 hours and is equal to 90 pg/ml. The average serum concentration is 50 pg/ml.

It is cleared from the blood quickly, T1/2 fluctuates over a wide range and after intravenous administration is 8.4 ± 6.4 hours.

Pharmacodynamics

Nomegestrol acetate is a highly selective progestogen that is a derivative of the natural steroid hormone progesterone. Nomegestrol acetate has a strong affinity for the human progesterone receptor, has antigonadotropic activity, progesterone receptor-mediated antiestrogenic activity, moderate antiandrogenic activity, and no estrogenic, androgenic, glucocorticoid or mineralocorticoid activity. Zoely® contains 17β-estradiol, a natural estrogen identical to endogenous human 17β-estradiol. Unlike ethinyl estradiol, which is included in other COCs, E2 does not have an ethynyl group at the 17α position. When using the drug Zoely®, the average concentrations of E2 are comparable to those in the initial follicular phase and the late phase of the corpus luteum of the menstrual cycle (see “Pharmacokinetics”). The contraceptive effect of Zoely® is due to a combination of various factors, the most important of which are suppression of ovulation and changes in the viscosity of cervical secretions.

In two randomized, open-label comparative studies of efficacy and safety, more than 3,200 women aged 18–50 years took Zoely® for 13 consecutive cycles and more than 1,000 women took the combination of drospirenone (3 mg)/ethinyl estradiol (30 mcg) in a dosing regimen of 21 /7. In the group taking Zoely®, weight gain was reported in 8.6% of women (in the comparison group - 5.7%), irregular withdrawal bleeding (mainly the absence of such) was reported in 10.5% of women (in the group comparison - 0.5%), acne was reported in 15.4% of women (in the comparison group - 7.9%) (see "Side effects"). An assessment of the development of acne while taking Zoely® showed that the majority of women (73.1%) did not experience a change in condition compared to the condition before treatment, 16.8% of women experienced an improvement in condition and 10.1% of women experienced appearance or worsening of acne. In a clinical study of the drug Zoely®, conducted in the EU, Asia and Australia, the following Pearl index indicators were calculated for the age group 18–35 years: ineffectiveness of the method - 0.4 (upper limit of the 95% confidence interval 1.03); ineffectiveness of the method and patient error - 0.38 (upper limit of 95% confidence interval 0.97).

In a clinical study of Zoely® conducted in the USA, Canada and Latin America, the following Pearl index values were calculated for the age group 18–35 years: method ineffectiveness - 1.22 (upper limit of 95% confidence interval 2.18); method ineffectiveness and patient error - 1.16 (upper limit of 95% confidence interval 2.08).

In a randomized, open-label study, 32 women received Zoely® for 6 cycles. After stopping Zoely®, ovulation was restored on average 20.8 days after the last pill, with the earliest date of ovulation recorded on the 16th day.

Folic acid is an important vitamin in early pregnancy. While taking Zoely®, the concentration of folic acid in the blood plasma does not change and remains at the baseline level for 6 consecutive months of taking the drug. In a randomized, open-label comparative study of 2 years duration, Zoely® was administered to women aged 21–35 years and there was no clinically significant effect of Zoely® on bone mineral density.

A randomized, open-label, comparative multicenter study was conducted to evaluate the effect of Zoely® on blood coagulation parameters, lipid profile, carbohydrate metabolism, the functional state of the adrenal glands and thyroid gland, as well as androgen concentrations. 60 women aged 18–50 years took Zoely® for 6 consecutive cycles. In clinical studies, it was found that when taking Zoely®, insulin resistance and glucose tolerance did not change, and clinically significant effects on lipid metabolism and hemostasis were not detected. Taking Zoely® increased the concentrations of the transport proteins thyroxine-binding globulin and corticosteroid-binding globulin (CBG). When taking Zoely®, the concentration of sex hormone binding globulin (SHBG) slightly increased and the concentrations of androstenedione, dehydroepiandrosterone, total and free testosterone significantly decreased. In a clinical study in a group of women (n=32), after 13 cycles of taking Zoely®, no pathological changes were observed in histological examination of the endometrium.

Contraindications

exact data on contraindications for oral contraceptives containing 17β-estradiol . However, it can be assumed that they correspond to those when taking ethinyl estradiol-containing drugs. While taking Zoely, if any of the following conditions occur, you should stop taking it immediately.

hypersensitivity to any of the components of the tablet;
pulmonary embolism thrombosis , both current and past;
arterial thrombosis (pathologies of cerebral circulation, myocardial infarction );
migraine with focal neurological symptoms, including a history;
prodromal conditions ( angina pectoris, transient ischemic attack ), including a history of;
multiple and/or pronounced factors for the occurrence of arterial or venous thrombosis ( severe hypertension, diabetes mellitus with vascular symptoms, severe dyslipoproteinemia );
pancreatitis with severe hypertriglyceridemia, both currently and in the past;
acquired or hereditary predisposition of the patient to arterial or venous thrombosis , for example: deficiency of antithrombin III and proteins C and S, protein C resistance, hyperhomocysteinemia and the presence of antiphospholipid antibodies (lupus anticoagulant, antibodies to cardiolipin);
tumors and severe pathologies of the liver, including a history of it;
suspected or diagnosed malignant hormone-dependent neoplasms ( tumors of the breast or genital organs );
breastfeeding period;
suspected or diagnosed pregnancy ;
vaginal bleeding of unknown etiology;
lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
postmenopause.

With extreme caution:

severe depression , also in history;
diabetes mellitus , passing without vascular pathologies;
systemic lupus erythematosus;
ulcerative colitis;
Crohn's disease;
pathologies of liver function;
hypertriglyceridemia , currently present or traced in a family history;
risk factors for ischemic heart disease ( smoking, obesity, arterial hypertension );
presence in the family history of arterial embolism and venous thrombosis ;
major surgery and prolonged immobilization.

Zoely, 28 pcs., 2.5 mg+1.5 mg, film-coated tablets

If any of the following conditions, diseases, or risk factors are present, the benefits of using Zoely® and the possible risks for each individual woman should be assessed. This should be discussed with the woman before she starts taking Zoely®. In cases of deterioration, exacerbation, or the first occurrence of any of these conditions, diseases, or risk factors, a woman should consult a doctor to decide on the possibility of further use of the drug Zoely®.

The following data were obtained from epidemiological studies with the use of COCs containing ethinyl estradiol. Zoely® contains 17β-estradiol, however, the special instructions regarding the use of COCs containing ethinyl estradiol are considered to apply to Zoely®.

Vascular disorders

The use of any COC is accompanied by an increased risk of developing venous thrombosis and embolism, which is highest during the first year after starting COC use.

Epidemiological studies demonstrate that the incidence of VTE in patients without known risk factors taking low-dose (<50 mcg ethinyl estradiol) COCs ranges from 20 to 40 cases per 10,000 person-years. For comparison, the same parameter in patients who do not take COCs is 5–10 cases per 10,000 person-years or 60 cases per 100,000 pregnancies. VTE can be fatal in 1–2% of cases.

There is no data on the effect of Zoely® on the risk of venous thrombosis and embolism compared to other COCs.

Epidemiological studies have established a connection between the use of COCs and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic attacks).

In patients taking COCs, thrombosis of other vessels, incl. hepatic, mesenteric, renal, cerebral arteries and veins or retinal vessels. There is insufficient information about the relationship between the occurrence of these complications and the use of COCs.

Symptoms of venous and arterial thrombosis or acute cerebrovascular accident may include the following: sudden pain and/or swelling of the lower extremity, sudden intense chest pain, radiating or not radiating to the left arm, sudden shortness of breath, sudden cough, unusual severe and prolonged headache, sudden partial or complete loss of vision, diplopia, speech impairment or aphasia, dizziness, collapse with or without focal convulsions, weakness or severe numbness that suddenly appears on one side of the body, movement disorders, acute abdomen.

Risk factors for the development of venous thrombosis and embolism:

- age;

- presence of diseases in the family history (venous thrombosis and embolism in brothers, sisters or parents at a young age). If there is a hereditary predisposition, then before starting any hormonal contraceptives you should consult a specialist;

- prolonged immobilization, extensive surgery, any surgery on the lower extremities or serious injury. In these cases, it is recommended to stop taking hormonal contraceptives (at least 4 weeks before planned surgery) and resume it only 2 weeks after complete restoration of motor activity. If the use of COCs has not been stopped in advance, the need for antithrombotic agents should be considered;

— obesity (body mass index >30 kg/m2).

There is no sufficient information about the role of superficial vein thrombophlebitis and varicose veins in the etiology of venous thrombosis.

Risk factors for arterial thrombosis or acute cerebrovascular accident:

- age;

- smoking (the risk increases even more with heavy smoking, especially in women over 35 years of age). Women over 35 years of age should be strongly advised to quit smoking if they wish to take COCs;

- dislipoproteinemia;

— obesity (body mass index >30 kg/m2);

- arterial hypertension;

- migraine;

- heart valve disease;

- atrial fibrillation;

- presence of diseases in the family history (arterial thrombosis in brothers, sisters or parents at a young age). If a hereditary predisposition is suspected, then before starting any hormonal contraceptives, you should consult a specialist.

Other conditions that have been associated with adverse vascular events include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, inflammatory bowel disease (Crohn's disease and ulcerative colitis), and sickle cell disease.

It is necessary to take into account the increased risk of thromboembolic complications in the postpartum period.

An increase in the frequency or severity of migraine when using COCs (which may precede the development of a cerebrovascular complication) is grounds for immediate discontinuation of Zoely®.

Women taking COCs should consult a doctor if possible symptoms of thrombosis appear. In cases of suspected or confirmed thrombosis, COC use should be discontinued. In this case, adequate contraception should be started, given the teratogenicity of anticoagulant therapy (coumarins).

Tumors

The most significant risk factor for cervical cancer is persistent infection with human papillomavirus (HPV).

. Epidemiological studies have shown that long-term use of COCs containing ethinyl estradiol increases this risk, but it is unclear to what extent this effect is due to other factors, such as more frequent cervical examination or sexual behavior, including the use of barrier contraceptives. or with a combination of these factors. A cause-and-effect relationship with COC use has not been proven.

When using COCs in higher doses (50 mcg ethinyl estradiol), the risk of developing endometrial and ovarian cancer is reduced. It remains unclear whether this applies to COCs containing 17β-estradiol.

A meta-analysis of 54 epidemiological studies in women receiving COCs containing ethinyl estradiol found a small increase in the relative risk (RR) of developing breast cancer (RR = 1.24). The increased risk gradually disappears within 10 years after stopping COC use. Breast cancer rarely develops in women under 40 years of age, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Women who use COCs are diagnosed with earlier stages of breast cancer than women who have never used them. During the use of COCs, the risk of developing breast cancer increases slightly, which may be due to earlier diagnosis, the effect of the drug, or a combination of these two factors.

In rare cases, women taking COCs have developed benign liver tumors and, even more rarely, malignant ones. In some cases, these tumors have led to life-threatening intra-abdominal bleeding. If intense pain in the upper abdomen, liver enlargement, or symptoms of intra-abdominal bleeding occur in women taking COCs, it is necessary to exclude a liver tumor.

Other states

Women with hypertriglyceridemia or a corresponding family history have an increased risk of developing pancreatitis when taking COCs.

Many women receiving COCs experienced a slight increase in blood pressure, although clinically significant increases were rare. The connection between taking COCs and arterial hypertension has not been established. However, if persistent arterial hypertension develops while taking COCs, then it is advisable to stop taking COCs and prescribe antihypertensive therapy. With adequate blood pressure control using antihypertensive drugs, it is possible to resume taking COCs. In clinical studies lasting up to two years, no clinically significant changes in blood pressure were detected when using Zoely®.

During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their connection with the use of contraceptives has not been definitively established: jaundice and/or itching associated with cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (minor chorea), herpes during pregnancy, hearing loss associated with otosclerosis.

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

In acute and chronic liver dysfunction, it may be necessary to discontinue COCs until liver function tests return to normal. If cholestatic jaundice recurs, first observed during pregnancy or during previous use of sex hormones, it is necessary to stop taking COCs.

Although COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the dosage regimen of hypoglycemic drugs in patients with diabetes mellitus taking COCs containing less than 0.05 mg ethinyl estradiol. However, it is necessary to carefully conduct periodic examinations of women with diabetes taking COCs, especially during the first months. The drug Zoely® does not affect the insulin resistance of peripheral tissues and glucose tolerance in healthy women (see “Pharmacodynamics”).

Worsening of depression, Crohn's disease and ulcerative colitis was associated with COC use.

Chloasma sometimes developed, especially in women with a history of this disease. Women who are predisposed to developing chloasma should avoid sun exposure or exposure to UV light while taking COCs.

Medical examinations/consultations

Before prescribing Zoely®, you should carefully review the woman’s medical history (including family history) and exclude pregnancy. It is necessary to measure blood pressure and, if indicated, conduct a physical examination, taking into account contraindications and precautions. The interval between control medical examinations is determined in each individual case, but not less than once every 6 months.

Women should be informed that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of COCs may be reduced in case of missed tablets (see "Dosage and Administration"), gastrointestinal disorders while taking active tablets (see "Dosage and Administration") or in the case of concomitant therapy (see "Interactions") .

Changes in the nature of menstruation

Breakthrough bleeding or spotting may occur when taking any COC, especially in the first few months. Therefore, examination for irregular bleeding is justified only after an adaptation period (approximately 3 cycles). In 15–20% of women using Zoely®, acyclic bleeding was observed after this adaptation period. If irregular bleeding persists or occurs after previous regular cycles, it is necessary to assume non-hormonal causes and conduct diagnostic tests to exclude a malignant tumor or pregnancy. A diagnostic curettage may be required. In women taking Zoely®, the duration of withdrawal bleeding averaged 3–4 days.

Some women taking Zoely® reported no withdrawal bleeding while taking the yellow placebo tablets, even though they were not pregnant. In clinical studies, the absence of withdrawal bleeding was observed in 18–32% of cases (during cycles 1 to 12). In such cases, the absence of withdrawal bleeding was not associated with a higher incidence of breakthrough bleeding/spotting in subsequent cycles. In 4.6% of women, there was no withdrawal bleeding in each of the first three cycles of drug use. In this subgroup there was a high percentage of women with no withdrawal bleeding in subsequent cycles (76–87%). Of the 28% of women who experienced no withdrawal bleeding in at least one cycle (during cycles 2, 3, or 4), 51–62% of patients also experienced no withdrawal bleeding in subsequent cycles.

If there is no withdrawal bleeding when taking Zoely® in accordance with the recommendations described in the section “Dosage and Administration”, then the likelihood of pregnancy is low. However, if a woman did not take the drug in accordance with the recommendations or there are no 2 withdrawal bleedings in a row, then pregnancy must be excluded.

Impact on the ability to drive vehicles and operate machinery.

Zoely® does not affect the ability to drive vehicles or operate machinery.

Side effects

As practice has shown, the Zoely contraceptive is generally well-tolerated, and the safety of use is at the level of other combination drugs with similar effects. Below are possible negative effects that have been observed while taking Zoely.

Metabolism:

weight gain;
fluid retention;
increase or decrease in appetite.

CNS:

decreased or increased libido ;
depression;
migraine;
attention disorder;
headache.

Organs of vision:

dry eyeballs;
intolerance to wearing contact lenses.

Vascular system:

tides.

Digestive system:

bloating;
nausea;
increased activity of liver enzymes;
dry mouth.

Skin and subcutaneous tissues:

acne;
alopecia;
hyperhidrosis;
itching;
seborrhea;
dry skin;
hypertrichosis;
chloasma.

Musculoskeletal system:

feeling of heaviness.

Genital organs and mammary glands:

withdrawal bleeding;
menorrhagia;
pain in the pelvic area;
hypomenorrhea;
engorgement of the mammary glands;
metrorrhagia;
galactorrhea;
premenstrual syndrome;
uterine spasm;
lumps in the mammary glands;
dryness of the vagina and vulva;
dyspareunia;
discomfort in the vaginal area;
unpleasant odor from the vagina.

Are common:

edema;
irritability;
hunger.

Side effects observed with the use of COCs (combined oral contraceptives) that contain ethinyl estradiol:

increase in blood pressure;
arterial and venous thromboembolism ;
chloasma;
hormone-dependent tumors ( breast cancer, liver tumors ).

The incidence of breast cancer diagnosis in women using COCs is slightly higher than that in women using other methods and means of contraception.

The connection between breast cancer and COC use has not been established.

Instructions for use of Zoely (Method and dosage)

The instructions for Zoely recommend taking the tablets orally at the same time every day, without taking into account food intake. The tablets are taken in the sequence indicated on the blister and washed down with water.

For all women, recommendations for using Zoely are the same. For 28 days you need to take 1 tablet every day in a row. In the first 24 days, take white tablets containing active ingredients, after which, over the next 4 days, take yellow tablets ( placebo ), which do not contain active ingredients.

The initial tablet from each subsequent blister (or package) must be taken the next day after the final tablet from the previous blister. The drug is taken regardless of the absence or presence of withdrawal bleeding , which is usually observed 24-36 hours after consuming the last white tablet and can continue until the next blister is used.

Start of use

For women who have not previously taken hormonal contraceptives, it is best to start taking Zoely on the first day of the menstrual cycle . In this case, additional contraception will not be needed. It is allowed to start using it from the 2nd to 5th day of the cycle, but during the week, it is necessary to use additional contraceptive barrier methods.

When switching from other contraceptives with combined hormonal action (other COCs, patches , vaginal rings ), in the case of using other COCs, it is recommended to start taking Zoely on the next day after the last active tablet ( not placebo ) and no later than the next day after the end of the usual range between cycles or taking placebo . If you have previously used a transdermal patch or vaginal ring , it is advisable to start switching to Zoely tablets on the day of their removal (removal), but no later than during the next recommended application of the patch or insertion of the ring.

With correct and constant use of previous contraceptive methods and guaranteeing the absence of pregnancy, it is possible to switch to Zoely any day. Under no circumstances should you exceed the recommended hormone-free period of the previous contraceptive method.

In case of switching from contraceptives containing one progestogen ( implants , tablets, injections or IUD - intrauterine system ) with previous use of other tablets, you can switch to Zoely on any day, the next day after stopping taking tablets with progestogen. When switching from injection forms, taking Zoely tablets is replaced by the next recommended injection. The IUD or implant is removed on any convenient day, on which Zoely is started. In all of the above cases, it is recommended to use additional barrier contraceptives for a week.

After an abortion in the first trimester , you can begin using Zoely immediately after the end of the procedure, and no additional contraceptive measures are required.

After an abortion in the second trimester or childbirth, you should start using the drug between 21 and 28 days. barrier contraceptives for a week . In case of previous sexual intercourse, it is necessary to exclude possible pregnancy before using it.

If you miss taking pills

If you miss another active (white) tablet, the following recommendations are given.

If the next dose is less than 12 hours late, take the required tablet without adjusting the order and time of taking subsequent tablets.

If you are more than 12 hours late, two rules are followed:

Active tablets should be taken for at least 7 days in a row;
The greater the number of active tablets missed and the closer the time of placebo , the higher the possibility of pregnancy.

If you miss the first tablet, take it as soon as possible, even if you take the next 2 tablets at the same time. In the future, continue with the usual regimen of use, without additional measures.

If you miss 2 or more tablets and there is no withdrawal bleeding during the placebo , pregnancy .

If you miss a cycle during the 1st – 7th day, you should take the last missed tablet as soon as possible, even if you take 2 subsequent tablets at the same time. In the future, continue the usual regimen of use, using barrier contraception , during the first week. If you have sexual intercourse at this time, pregnancy .

If you miss during the 8th - 17th day of the cycle, you should take the last missed tablet as soon as possible, even if you take 2 subsequent tablets at the same time. In the future, continue the usual regimen of use, using barrier contraception , during the first week.

If you miss during the 18th - 24th day of the cycle, you should take the last missed tablet as soon as possible, even if you take 2 subsequent tablets at the same time. You cannot take more than 2 active tablets at the same time. During the first week barrier contraception , and the first active tablet from the next blister should be taken after the last active tablet from the previous one, that is, the last phase of taking placebo . With this regimen, withdrawal bleeding most often occurs during the next placebo spotting or breakthrough bleeding may occur during the current cycle

If you are unsure about the number of missed pills, you need to use barrier contraceptives for at least a week of continuous use of the current pills.

placebo pills does not reduce the contraceptive effect.

In case of gastrointestinal painful conditions, such as diarrhea or vomiting, the absorption process of Zoely may be affected, and therefore it is necessary to resort to auxiliary contraceptive measures.

If vomiting within 3–4 hours after swallowing the tablet, this dose is considered to be a missed dose. If this painful condition continues for several days, you should use the recommendations described above. If you do not want to change the typical regimen of use, you can take an additional active tablet or a tablet from another blister.

To delay the moment of menstrual-like bleeding, you need to start taking white tablets from the next blister, immediately after finishing them from the previous blister, that is, exclude taking placebo . The white tablets from the second blister can be taken in full. After taking the placebo from the second blister, resume the usual regimen of taking Zoely. , spotting and/or breakthrough bleeding may occur . To shift the day of onset of menstrual-like bleeding , you can reduce the placebo (by a maximum of 4 days). A shorter break increases the risk of no withdrawal bleeding and the development of spotting and breakthrough bleeding.

Pharmacokinetics

Nomegestrol acetate

Suction. Nomegestrol acetate is rapidly absorbed after oral administration. After a single dose, Cmax in plasma is about 7 ng/ml and is achieved after 2 hours. Absolute bioavailability after a single dose is 63%. Food does not have a clinically significant effect on the bioavailability of nomegestrol acetate.

Distribution. Nomegestrol acetate binds actively to albumin (97–98%), but does not bind to SHBG or DSG. The apparent Vss of nomegestrol acetate is (1645±576) l.

Metabolism. Nomegestrol acetate is metabolized to several inactive hydroxylated metabolites under the influence of liver cytochrome P450 isoenzymes, mainly CYP2C8, CYP2C19, CYP3A4 and CYP3A5, with possible participation in the metabolism of CYP2C8 and CYP2C19 isoenzymes. Nomegestrol acetate and its hydroxylated derivatives undergo pronounced phase 2 metabolism with the formation of glucuronide and sulfate conjugates. Clearance at steady state is 26 l/h.

Excretion. T1/2 at steady state is 46 hours (from 28 to 83 hours). T1/2 of metabolites has not been established. Nomegestrol acetate is excreted by the kidneys and intestines (approximately 80% of the dose is excreted within 4 days). Nomegestrol acetate is almost completely eliminated within 10 days. Excretion through the intestines exceeds excretion by the kidneys.

Linearity. Linearity of pharmacokinetics depending on the dose was observed in the range of 0.625–5 mg (assessed in women of reproductive and postmenopausal age).

Equilibrium state. SHBG does not affect the pharmacokinetics of nomegestrol acetate. The equilibrium state is achieved after 5 days. The average Css is 4 ng/ml. Cmax of nomegestrol acetate in plasma is about 12 ng/ml and is achieved 1.5 hours after taking the drug.

Interactions. In vitro, nomegestrol acetate does not have a significant inducing or inhibitory effect on cytochrome P450 isoenzymes and does not interact with glycoprotein P.

Estradiol (E2)

Suction. 17β-estradiol undergoes extensive first-pass metabolism after oral administration. Absolute bioavailability is approximately 1%. Food intake does not have a clinically significant effect on the bioavailability of E2.

Distribution. The distribution of exogenous and endogenous E2 is similar. Estrogens are actively distributed throughout the body. Their concentrations are usually higher in the target organs of sex hormones. In the blood, estradiol binds to SHBG (37%) and albumin (61%), and only 1–2% of estradiol circulates in unbound form.

Metabolism. Exogenous E2 is actively biotransformed after oral administration. The metabolism of exogenous and endogenous E2 is similar. E2 is rapidly converted to several metabolites in the intestine and liver (mainly estrone), which are subsequently conjugated and undergo enterohepatic circulation. There is a dynamic equilibrium between E2, estrone and estrone sulfate due to the activity of various enzymes, including estradiol dehydrogenases, sulfotransferases and arylsulfatases. Oxidation of estrone and E2 occurs under the influence of cytochrome P450 isoenzymes, mainly CYP1A2, CYP1A2 (outside the liver), CYP3A4, CYP3A5, CYP1B1 and CYP2C9.

Excretion. E2 is quickly eliminated from the blood. Due to metabolism and enterohepatic circulation, there is a large pool of circulating estrogen sulfates and glucuronides. As a result, T1/2 E2, adjusted to the initial value, varies widely and amounts to (3.6 ± 1.5) hours after i.v. administration.

Equilibrium state. Cmax E2 in serum is about 90 pg/ml and is achieved 6 hours after administration. The average serum concentration is 50 pg/ml. This E2 concentration corresponds to that in the initial and late phases of the menstrual cycle.

Special patient groups

Children. The pharmacokinetics of nomegestrol acetate (primary target) following a single oral dose of Zoely® were comparable in healthy postmenarchean adolescent girls and adult women. Concentrations of E2 (secondary target) in adolescent girls compared with adult women were comparable during the first 24 hours and lower than in adult women after 24 hours. The clinical significance of this finding is unknown.

Renal dysfunction. The effect of renal disease on the pharmacokinetics of Zoely® has not been studied.

Liver dysfunction. The effect of liver disease on the pharmacokinetics of Zoely® has not been studied. However, in patients with impaired liver function, the metabolism of sex hormones may deteriorate.

Ethnic groups. The pharmacokinetics of the drug in representatives of ethnic groups has not been specifically studied.

Interaction

In order to completely exclude possible interactions, you should carefully read the instructions for them in the instructions for use of drugs used in parallel.

Interaction of COCs, including Zoely, with other drugs may cause bleeding and/or a decrease in contraceptive effectiveness. Below are generalized interactions of other drugs with COCs.

Hepatic metabolism

Interaction with inducers of microsomal liver enzymes is possible, which can cause an increase in the clearance of PG ( sex hormones). There is definitely an interaction with barbiturates, Phenytoin, Primidone, Rifampicin, Carbamazepine . Interaction with Griseofulvin, Topiramate, Oxcarbazepine, Felbamate and St. John's wort preparations is possible. Also, agents that inhibit HIV proteases ( Ritonavir , etc.) and non-nucleoside reverse transcriptase inhibitors ( Nevirapine , etc.), as well as their combinations, have an effect on hepatic metabolism.

When taking microsomal enzyme inducers , as well as for 28 days after their discontinuation, it is necessary to use barrier contraception. In case of long-term therapy with these drugs, the issue of prescribing another contraceptive method should be considered.

Inhibitors of microsomal enzymes , such as ketoconazole , can lead to increased plasma concentrations of PG.

Antibiotics

When used together with antibiotics such as tetracyclines and ampicillin , a decrease in the effectiveness of COCs containing ethinyl estradiol . The mechanism of this interaction is not fully understood. reliable data on the interaction of COCs containing 17β-estradiol and antibiotics. Women who are undergoing antibiotic therapy (except for the use of Griseofulvin and Rifampicin ) should use additional barrier contraceptives throughout the entire period of treatment, as well as 7 days after. If the period of additional barrier contraception covers the end of taking the active pills, it is recommended to skip the placebo and immediately proceed to taking the active pills from another blister.

Other drugs

COCs can affect the metabolism of other drugs, increasing their plasma and tissue concentrations, as in the case of Cyclosporine , or decreasing, as in the case of Lamotrigine .

Use during pregnancy and breastfeeding

The use of Zoely® is contraindicated during pregnancy. If pregnancy occurs while using Zoely®, you should stop taking the drug.

Most epidemiological studies have not found an increased risk of birth defects in children whose mothers took COCs containing ethinyl estradiol before pregnancy. No teratogenic effects were observed with the occasional use of COCs containing ethinyl estradiol at the beginning of pregnancy.

There is limited experience with the use of Zoely® in pregnant women, which indicates the absence of undesirable effects of the drug on the condition of the fetus or newborn.

Reproductive toxicity has been reported in laboratory animal studies of the nomegestrol acetate/estradiol combination.

Zoely® is intended to prevent unwanted pregnancy. If a woman wants to stop taking Zoely® in order to become pregnant, it should be taken into account that ovulation is restored on average 20.8 days after the last dose of Zoely® tablet (see Pharmacodynamics).

COCs may affect lactation because they cause changes in the quantity and composition of breast milk. Therefore, the use of COCs is not recommended until breastfeeding has completely stopped (an alternative method of contraception should be selected). Small amounts of contraceptive sex hormones and/or their metabolites can be excreted in breast milk, but there is no data on their undesirable effects on the health of the newborn.

special instructions

The data below were obtained during epidemiological studies of COCs containing ethinyl estradiol . The drug Zoely includes 17β-estradiol , however, the special instructions described apply to it as well.

Vascular disorders

An association has been observed between taking COCs and the risk of thromboembolism , as well as venous and arterial thrombosis ( myocardial infarction, deep vein thrombosis, stroke, pulmonary embolism). Against the general background, these conditions rarely develop, but during the first year of taking COCs, the risk of developing these complications is highest. You should know that 1-2% of cases of embolism and venous thrombosis .

With the development of thrombosis, the following may occur:

pain and/or swelling of the legs;
sudden shortness of breath ;
sharp pain in the chest, with or without rebound, in the left arm;
unexpected cough ;
sudden loss of vision (partial or complete), uncharacteristic severe prolonged headaches;
diplopia;
dizziness;
speech disorder;
collapse (possibly with convulsions);
weakness;
movement disorders;
sudden severe numbness on one side of the body;
acute abdomen syndrome.

Risk factors for embolism and venous thrombosis :

advanced age;
hereditary predisposition (family history of these diseases);
obesity;
thrombophlebitis;
phlebeurysm;
serious injury;
major surgery;
long-term immobilization.

Risk factors for arterial thrombosis :

smoking;
advanced age;
dyslipoproteinemia;
arterial hypertension;
obesity;
migraine;
atrial fibrillation;
heart valve disease;
hereditary predisposition.

It is worth remembering the increased risk of thromboembolic exacerbations in the postpartum period.

For any of these disorders, you should consult your doctor before taking Zoely tablets. In cases of suspected thrombosis or its diagnosis, while using COCs, the tablets should be discontinued. For conditions requiring hospitalization (serious trauma, major surgery, prolonged immobilization), it is better to stop using COCs (one month before a planned operation), with resumption of use 14 days after normal resumption of motor functions.

Also, consultation with a doctor will be required for such diseases as:

diabetes;
uremic hemolytic syndrome;
systemic lupus erythematosus;
ulcerative colitis;
Crohn's disease;
sickle cell anemia.

Increased migraine is an indication for immediate discontinuation of Zoely.

Tumors

Long-term use of ethinyl estradiol-containing COCs , according to research results, increases the risk of developing cervical cancer , however, the question of other exposure factors remains open. It is not fully understood whether COC use, more frequent cervical testing, sexual intercourse (including barrier contraception), or a combination of these leads to an increased risk.

reliable information about the effect of Zoely on the development of ovarian and endometrial .

A slight increase in the relative risk (RR) of breast cancer (RR = 1.24). This risk decreases over 10 years after discontinuation of COCs. This increase is possibly due to earlier detection, the effects of COCs, or a combination of both.

Sometimes, when taking COCs, the development of liver tumors (benign) was detected, and even less often - malignant. In rare cases, these tumors, due to intra-abdominal bleeding, became a threat to the patient’s life. If an enlarged liver, intense abdominal pain, or symptoms of intra-abdominal bleeding are detected, a possible liver tumor should be excluded.

Other states

Taking COCs with hypertriglyceridemia or a family history of it slightly increases the risk of pancreatitis .

increase in blood pressure was often observed , which was rarely clinically significant. The connection between COC use and the formation of arterial hypertension . However, if it develops, it is worth stopping the use of COCs and considering prescribing adequate antihypertensive therapy. When blood pressure is stabilized with the use of antihypertensive drugs, it is possible to resume the use of COCs. According to the results of clinical studies, taking Zoely for up to 12 months did not lead to clinically significant blood pressure disorders.

During the use of COCs and during pregnancy, complications or development were noted: itching and/or jaundice , cholelithiasis, gestational herpes, porphyria, hemolytic uremic syndrome, systemic lupus erythematosus, Sydenham's chorea, angioedema , as well as hearing loss.

Liver pathologies may require discontinuation of COCs until the liver condition is completely normalized.

In case of recurrence of cholestatic jaundice, which was first diagnosed during pregnancy or previous steroids

glucose tolerance and insulin resistance . However, while taking them, it is necessary to conduct careful periodic examinations, especially for women with diabetes .

ulcerative colitis, Crohn's disease and was observed .

chloasma developed , especially when this disease was mentioned in the anamnesis. In this case, it is better to avoid prolonged exposure to the sun, solarium and other exposure to ultraviolet radiation.

Conducting consultations and examinations

Before prescribing a COC, it is necessary to obtain an understanding of the woman’s personal and family history, and also to exclude possible pregnancy. Measure blood pressure and, if indicated, prescribe a physical examination , taking into account all contraindications. The frequency of control examinations in each case is determined separately, but at least twice a year.

Women should receive full information about the action and side effects of COCs, and also be informed that this method of contraception does not prevent HIV infection and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of COCs may be reduced if active tablets are missed, as well as gastrointestinal disorders.

Menses

The use of COCs, especially in the first months, may be accompanied by spotting or breakthrough bleeding . In this regard, it is advisable to conduct a study of these manifestations after the adaptation period (3 months). If these symptoms persist after three cycles of taking COCs, their non-hormonal nature should be assumed and diagnostics should be prescribed to exclude possible tumors or pregnancy . may be performed .

When studying the drug Zoely, bleeding developed rarely and was short-lived, mild and slightly painful. In some cases, the absence of proper withdrawal bleeding was observed when taking placebo, without diagnosing pregnancy, which indicates its low probability even in the absence of withdrawal bleeding. If two bleedings are missed, when taking the drug in accordance with the instructions, a possible pregnancy must be excluded.

Zoely®

In cases of deterioration, exacerbation, or the first occurrence of any of these conditions, diseases, or risk factors, a woman should consult a doctor to decide on the possibility of further use of the drug Zoely®.

The data below were obtained from epidemiological studies with the use of CHCs containing ethyttestradiol. Zoely® contains 17β-estradiol, however, the special instructions regarding the use of combined contraceptives containing ethinipestradiol are considered applicable to Zoely®.

Vascular disorders

— The use of COCs is accompanied by an increased risk of developing VTE compared to the risk of developing VTE in patients not using COCs. The greatest additional risk of VTE is observed in the first year of COC use. The risk also increases when starting to use a COC or when restarting the same or a different COC after a break of 4 weeks or more. Epidemiological studies demonstrate that the incidence of VTE in patients without known risk factors taking low-dose (<50 mcg ethinyl estradiol) COCs ranges from 3 to 12 cases per 10,000 woman-years (WY). For comparison, the same parameter in non-pregnant patients who do not take CHCs is from 1 to 5 cases per 10,000 YL, and in pregnant women - from 5 to 20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in standard studies; Based on the assumption that pregnancy lasts 9 months, the risk ranges from 7 to 27 cases per 10,000 YL). In postpartum women, the risk of developing VTE ranges from 40 to 65 cases per 10,000 women. VTE can be fatal in 1-2% of cases. There is no data on the effect of Zoely® on the risk of venous thrombosis and embolism compared to other CHCs.

— Epidemiological studies have established a connection between the use of CGCs and an increased risk of arterial thromboembolism (myocardial infarction, transient ischemic attacks).

- Thrombosis of other vessels, including hepatic, mesenteric, renal, cerebral arteries and veins, or retinal vessels, was extremely rare in patients taking CHCs.

— Symptoms of venous and arterial thrombosis or acute cerebrovascular accident may include the following conditions: sudden pain and/or swelling of the lower limb; sudden intense chest pain, radiating or not radiating to the left arm; sudden shortness of breath; sudden cough; unusual severe or prolonged headache; sudden partial or complete loss of vision; diplopia; speech impairment or aphasia; dizziness; collapse, with or without focal convulsions; weakness or severe numbness that suddenly appears on one side of the body; movement disorders; "acute belly"

— The risk of developing venous thromboembolism increases with the presence of the following risk factors:

Age.
Family history of disease (venous thrombosis and embolism in siblings or parents aged <50 years). If a hereditary predisposition is suspected, then before starting any hormonal contraceptives, you should consult a specialist.
Prolonged immobilization, major surgery, any surgery on the lower extremities or serious trauma. In these cases, you should stop taking the drug (at least 4 weeks before planned surgery) and resume it only 2 weeks after complete restoration of motor activity. If the use of COCs has not been discontinued in advance, the need to use antithrombotic agents should be considered (see also section "Contraindications").
Obesity (body mass index more than 30 kg/m2).
Air travel longer than 4 hours may temporarily increase the risk of developing a blood clot, especially in women with other risk factors.

— There is no sufficient information about the role of thrombophlebitis of superficial veins and varicose veins in the etiology of venous thrombosis.

— The risk of developing complications of arterial thromboembolism or acute cerebrovascular accident increases in the presence of the following risk factors:

Age.
Smoking (the risk increases even more with heavy smoking, especially in women over 35 years of age). Women over 35 years of age should be strongly advised to stop smoking if they wish to take COCs.
Dyslipoproteinemia.
Obesity (body mass index more than 30 kg/m2).
Arterial hypertension.
Migraine.
Heart valve disease.
Atrial fibrillation.
Family history of disease (arterial thrombosis in siblings or parents aged <50 years). If a hereditary predisposition is suspected, then before starting any hormonal contraceptives, you should consult a specialist.

— Other conditions that have been associated with adverse vascular events include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, inflammatory bowel disease (Crohn's disease and ulcerative colitis), and sickle cell disease.

— It is necessary to take into account the increased risk of thromboembolic complications in the postpartum period.

— An increase in the frequency or severity of migraine when using COCs (which may precede the development of a cerebrovascular complication) is grounds for immediate discontinuation of Zoely®.

Tumors

— The most significant risk factor for developing cervical cancer is persistent infection with human papillomavirus (HPV). Epidemiological studies have shown that long-term use of ethinyl estradiol-containing combination contraceptives increases this risk, but it is unclear to what extent this effect is due to other factors, such as more frequent cervical examination or sexual behavior patterns, including the use of barrier contraceptives. , or a combination of these factors. A cause-and-effect relationship with COC use has not been proven.

- When using COCs in higher doses (50 mcg ethinyl estradiol), the risk of developing endometrial and ovarian cancer is reduced. It remains unclear whether this applies to COCs containing 17β-estradiol.

— A meta-analysis of 54 epidemiological studies in women receiving COCs containing ethinyl estradiol found a small increase in the relative risk (RR) of developing breast cancer (RR = 1.24). The increased risk gradually disappears within 10 years after stopping COC use. Breast cancer rarely develops in women under 40 years of age, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Women who use COCs are diagnosed with earlier stages of breast cancer than women who have never used them.

— Another epidemiological study conducted in Denmark involving 1.8 million women, with a follow-up of an average of 10.9 years, found an increased RR of breast cancer in women who took long-term COCs compared with women who never used COCs (overall RR = 1.19; RR ranged from 1.17 [for 1 year to less than 5 years of use] to 1.46 [for more than 10 years of use]). The observed difference in absolute risk (number of breast cancer cases among women who had never used COCs compared with women who were taking or had recently taken COCs) was small: 13 cases per 100,000 woman-years.

— Epidemiological studies do not provide evidence of a connection. The observed increased risk may be due to earlier diagnosis of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both.

- In rare cases, women taking COCs have developed benign liver tumors and, even more rarely, malignant ones. In some cases, these tumors have led to life-threatening intra-abdominal bleeding. If intense pain in the upper abdomen, liver enlargement, or symptoms of intra-abdominal bleeding occur in women taking COCs, it is necessary to exclude a liver tumor.

Hepatitis C

In clinical trials of the drug combination for the treatment of hepatitis C virus ombitasvir/paritaprevir/ritonavir with or without dasabuvir, increases in ALT levels greater than 5 times the upper limit of normal were observed significantly more often in women using drugs containing ethinyl estradiol, such as KGC. In women using drugs containing estrogens other than ethinyl estradiol, such as estradiol, the rate of increase in ALT activity was similar to that in women not using any estrogens. However, due to the limited number of women taking estrogens other than ethinyl estradiol, caution should be exercised when co-administering the drug with the ombitasvir/paritaprevir/ritonavir drug combination with or without dasabuvir (see Interactions with Other Drugs section). ).

Other states

- Women with hypertriglyceridemia or a corresponding family history have an increased risk of developing pancreatitis when taking COCs.

- Many women receiving COCs experienced a slight increase in blood pressure, but clinically significant increases in blood pressure were rare. The connection between taking COCs and arterial hypertension has not been established. However, if persistent arterial hypertension develops while taking COCs, then it is advisable to stop taking COCs and prescribe antihypertensive therapy. If blood pressure is adequately controlled with antihypertensive drugs, it is possible to resume taking COCs. In clinical studies lasting up to two years, no clinically significant changes in blood pressure were detected when using Zoely®.

— During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their connection with the use of contraceptives has not been definitively established: jaundice and/or itching associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; Sydenham's chorea (minor chorea); herpes during pregnancy; hearing loss associated with otosclerosis.

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

- In acute and chronic liver dysfunction, it may be necessary to discontinue COCs until liver function tests normalize. If cholestatic jaundice recurs, first observed during pregnancy or during previous use of sex hormones, it is necessary to stop taking COCs.

— Despite the fact that COCs may have an effect on insulin resistance and glucose tolerance, there is no need to change the dosage regimen of hypoglycemic drugs in patients with diabetes mellitus taking COCs containing less than 0.05 mg of ethinyl estradiol. However, it is necessary to carefully conduct periodic examinations of women with diabetes mellitus taking COCs, especially during the first months. Zoely® has no effect on insulin resistance of peripheral tissues and glucose tolerance in healthy women (see section “Pharmacological properties”, subsection “Pharmacodynamics”).

- Crohn's disease, ulcerative colitis and worsening depression were associated with COC use.

- Sometimes chloasma developed, especially in women with a history of this disease. Women who are predisposed to developing chloasma should avoid sun exposure or exposure to ultraviolet light while taking COCs.

Medical examinations/consultations

Before prescribing or resuming taking Zoely®, you should carefully review the woman’s medical history (including family history) and exclude pregnancy.

It is necessary to measure blood pressure and, if indicated, conduct a physical examination, taking into account contraindications and precautions. The interval between control medical examinations is determined in each individual case, but not less than once every 6 months.

Women should be informed that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of COCs may be reduced in case of missed tablets (see section "Method of administration and dosage"), gastrointestinal disorders while taking tablets containing active ingredients (see section "Method of administration and dosage") or in case of concomitant therapy, which reduces the concentration of nomegestrol acetate in the blood plasma (see section “Interaction with other drugs”).

Changes in the nature of menstruation

When taking any COC, you may experience breakthrough bleeding or spotting, especially in the first few months. Therefore, examination for irregular bleeding is justified only after an adaptation period (approximately 3 cycles). In 15-20% of women using Zoely®, acyclic bleeding was observed after this adaptation period.

If irregular bleeding persists or occurs after previous regular cycles, it is necessary to assume non-hormonal causes and conduct diagnostic tests to exclude a malignant tumor or pregnancy. A diagnostic curettage may be required.

Women taking Zoely® experienced breakthrough bleeding/spotting in subsequent cycles. In 4.6% of women, there was no bleeding “oooo Method of administration and dose”, there was no “withdrawal” bleeding in a row, then it is necessary to exclude pregnancy.

Zoely's analogs

Level 4 ATC code matches:
Ovidon

Rigevidon

Non-Ovlon

Mercilon

Yarina Plus

Yarina

Miniziston 20 fem

Novinet

Microgynon

Janine

Lindineth

Cyclo-Proginova

Regulon

Logest

Midiana

Belara

Femoden

Jess Plus

Jess

Analogues of Zoely are represented by the following contraceptive drugs:

Claira;
Trisiston;
Trigestrel;
Tri-regol;
Triquilar.

Zoely or Klaira - which is better?

Despite some differences in the composition of the active ingredients, nomegestrol + estradiol in Zoely and dienogest + estradiol valerate in Qlaira , the mechanism of action of both drugs is almost the same. Both drugs are microdosed, however, Klaira , in each group of tablets (different in color), contains a different mass fraction of active substances, while in Zoely the dosage in each active tablet is the same. These contraceptives practically repeat each other, both in contraindications and side effects. In this regard, it is not possible to give a definite answer which of these drugs is better.

Oral contraceptives of hormonal action are selected individually and the best suitable drug can be prescribed only after undergoing many tests and undergoing some research. We should not forget about chronic diseases, a history of painful conditions (both personal and family) and many other factors that can also affect the choice of contraceptive.

Whenever you choose between Zoely and Claira , you should remember that these drugs, if you strictly follow the recommendations for their use, are highly effective and cause fewer side effects compared to other contraceptives. But the choice of COCs should be purely individual.

Reviews about Zoely

The pharmaceutical industry produces many hormonal contraceptives for oral use. Considering Zoely's birth control pills, reviews from gynecologists, subject to all the rules for taking the pills, are mostly positive. Naturally, any doctor in his practice has encountered many side effects of medications, and Zoely cannot do without them. Although, compared to many other COCs, Zoely tablets exhibit fewer side effects, and those that are detected are less pronounced.

Reviews of Zoely among women using this drug are purely positive, and this suggests that the active and auxiliary composition of the tablets is completely suitable for their body. Negative reviews are found among women who tried this contraceptive and eventually abandoned its use due to various side effects.

Each organism is individual and has its own set of characteristics, therefore, when choosing a contraceptive, you need to rely on the experience of a gynecologist, as well as undergo all the tests recommended by him. In this case, you have a much better chance of choosing exactly “your” contraceptive, which will not only protect you from unwanted pregnancy, discomfort into your life .

Zoely price, where to buy

The price of Zoely on the Russian pharmaceutical market ranges from 800 to 1100 rubles.

You can buy Zoely birth control pills in Moscow at an average cost of 850 rubles.

Online pharmacies in RussiaRussia

ZdravCity

Zoely tablets p.p.o.
2.5 mg + 1.5 mg placebo 28 pcs. Delpharm Lille S.A.S./Merck Sharp and Dome B.V./N.V.Organon RUB 1,160 order