Zoely

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Product Description

Composition
For tablets containing active ingredients

Active ingredients: nomegestrol acetate 2.50 mg, estradiol hemihydrate 1.55 mg (equivalent to 1.50 mg estradiol).

Excipients: microcrystalline cellulose 14.00 mg, crospovidone 2.40 mg, talc 0.70 mg, magnesium stearate 0.70 mg, colloidal silicon dioxide 0.44 mg, lactose monohydrate 57.71 mg;

Shell of the tablet: Opadry II white (1.6 mg) contains 0.64 mg of polyvinyl alcohol, 0.40 mg of titanium dioxide, 0.32 mg of macrogol-3350, 0.24 mg of talc.

For tablets not containing active ingredients (placebo)

Excipients: microcrystalline cellulose 14.00 mg, crospovidone 2.40 mg, talc 0.70 mg, magnesium stearate 0.70 mg, colloidal silicon dioxide 0.44 mg, lactose monohydrate 61.76 mg;

Shell of the tablet: Opadry II yellow (2.4 mg) contains 0.96 mg polyvinyl alcohol, 0.58 mg titanium dioxide, macrogol-3350 0.48 mg, talc 0.36 mg, iron dye yellow oxide 0.016 mg, iron dye black oxide 0,00024 mg.

Pharmachologic effect
Estradiol is a natural estrogen identical to human endogenous 17β-estradiol (E2). E2 does not have an ethynyl group in the 17α position, which is different from ethinyl estradiol, a substance contained in other combined oral contraceptives.

Nomegestrol acetate is a highly selective progestogen derived from the steroid natural hormone, which has a structure similar to it. It has high antigonadotropic activity, moderate antiandrogenic activity, in addition, nomegestrol acetate does not have glucocorticoid, estrogenic, mineralocorticoid, androgenic activity. The contraceptive effect of Zoely's tablets is due to a combination of various factors, the main of which are: suppressing ovulation and changing the secretion of cervical mucus. After stopping taking Zoely tablets, most women notice a fairly rapid recovery in ovulation.

Indications
Contraception.

Pregnancy and lactation
Pregnancy

The use of Zoely® is contraindicated during pregnancy. In case of pregnancy when using Zoely®, you should stop taking the drug.

Most epidemiological studies have not revealed an increased risk of congenital malformations in children whose mothers took COCs containing ethinyl estradiol before pregnancy. In case of accidental administration of COCs containing ethinyl estradiol at the beginning of pregnancy, no teratogenic effects were observed. There is limited experience with the use of Zoely® in pregnant women, which indicates the absence of an undesirable effect of the drug on the condition of the fetus or newborn.

In studies of the combination of nomegestrol acetate / estradiol in laboratory animals, reproductive toxicity was recorded.

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® tablets (see the section “Pharmacological properties”, subsection “Pharmacodynamics”).

Breastfeeding period

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

Contraindications
COCs should not be used in the presence of any of the following conditions / diseases. There is no epidemiological data on the use of COCs containing 17β-estradiol, however, contraindications to the use of Zoely® drug correspond to contraindications to the use of contraceptives containing ethinyl estradiol. If any of these conditions / diseases occurs during the period of use of the Zoely® preparation, you should immediately stop taking the drug.

Deep vein thrombosis or pulmonary thromboembolism, including a history of.
Arterial thrombosis (myocardial infarction) or prodromal conditions (transient ischemic attack, angina pectoris), including a history of.
Acute cerebrovascular accident, including a medical history.
Migraine with focal neurological symptoms, including a history.
Severe or multiple risk factors for venous or arterial thrombosis (see the "Special Instructions" section), such as: diabetes mellitus with vascular symptoms; uncontrolled arterial hypertension; severe dyslipoproteinemia; obesity (body mass index more than 30 kg / m2); prolonged immobilization; extensive surgery, any surgery on the lower extremities or serious injury; complicated heart defects; atrial fibrillation; smoking over the age of 35 years.
An inherited or acquired predisposition to the development of venous or arterial thrombosis, for example, resistance of activated protein C, antithrombin III deficiency, protein C and S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant).
Pancreatitis with severe hypertriglyceridemia, including a history of.
Severe liver disease, including a history, to normalize liver function indices.
Tumors of the liver (malignant or benign), including a history of.
Known or suspected hormone-dependent malignant tumors (e.g., genitals or mammary glands).
Established or suspected pregnancy, period of breastfeeding.
Hypersensitivity to any active or auxiliary substance.
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Vaginal bleeding of unknown etiology.

Postmenopause.
There is no data on the effectiveness and safety of the use of Zoely® in
teenage girls under the age of 18. Available information on pharmacokinetics is presented in the Pharmacokinetics section.

With caution: in the presence of any of the following conditions, diseases, risk factors, 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®. See the “Special Instructions” section for more information. In cases of deterioration, aggravation or the first occurrence of any of these conditions, diseases, risk factors, a woman should consult a doctor to decide on the possibility of further use of the Zoely® preparation. Diabetes mellitus without vascular damage; history of severe depression or the presence of this disease; systemic lupus erythematosus; Crohn's disease; ulcerative colitis; impaired liver function; hypertriglyceridemia, including a family history; risk factors for coronary heart disease (obesity, arterial hypertension); the presence in the family history of venous thrombosis, arterial embolism in siblings or in parents at a young age (see section "Special instructions").

Side effects
The safety of using Zoely® was evaluated in seven multicenter clinical trials lasting up to two years. The research data included 3490 women aged 18-50 years (a total of 35028 cycles).

Tolerance of the drug Zoely® is good, the safety profile is similar to that of other COCs. The table lists the possible adverse effects that have been reported with the use of the drug.

The frequency of adverse events is indicated in terms of:

“Very often” (≥ 1/10),
“Often” (<1/10, ≥ 1/100),
Infrequently (<1/100, ≥ 1/1000),
“Rarely” (<1/1000),
according to MedDRA (synonyms or related conditions are not listed, but should also be taken into account).

Disorders from the side of metabolism and nutrition: infrequently - increased appetite, fluid retention; rarely - loss of appetite.

Mental disorders: often - decreased libido, depression, mood swings; rarely - increased libido.

Disorders from the nervous system: often - migraine, headache; rarely - impaired attention.

Disorders of the organ of vision: rarely - intolerance to contact lenses, dry eyes

Violations of the blood vessels: infrequently - "tides".

Violations of the gastrointestinal tract: often - nausea; infrequently - bloating; rarely - dry mouth.

Disorders from the skin and subcutaneous tissues: very often - acne1; infrequently - hyperhidrosis, alopecia, itching, dry skin, seborrhea; rarely - chloasma, hypertrichosis.

Disorders from the musculoskeletal system and connective tissue: infrequently - a feeling of heaviness.

Violations of the genitals and mammary gland: very often - irregular bleeding "cancellation"; often - heavy acyclic bleeding, heavy menstrual bleeding, tenderness of the mammary glands, pain in the pelvic area; infrequently - scanty menstrual bleeding, breast engorgement, galactorrhea, uterine muscle spasm,

premenstrual-like syndrome, compaction in the mammary glands, dyspareunia, dryness of the mucosa of the vulva and vagina; rarely - an unpleasant odor from the vagina, discomfort in the vagina.

General disorders and disorders at the injection site: infrequently - irritability, edema; rarely - hunger.

Laboratory and instrumental data: often - weight gain; infrequently - increased activity of liver enzymes.

1 - Acne is not a spontaneously reported, but a requested phenomenon, since the assessment was carried out at each visit during the study.

In addition to the above adverse events, when using the Zoely® preparation, hypersensitivity reactions were reported (frequency of occurrence not established).

Side effects that occurred when taking COCs containing ethinyl estradiol are described in detail in the Special Instructions section: venous and arterial thromboembolism, increased blood pressure, hormone-dependent tumors (eg, liver tumors, breast cancer), chloasma.

Interaction
To exclude possible interaction, you must read the instructions for the use of concomitant drugs.

The effect of other drugs on Zoely®

The interaction of oral contraceptives with other drugs that induce enzymes can lead to “breakthrough” bleeding and / or reduce the effectiveness of contraception.

Drugs that induce liver enzymes (and therefore increase the clearance of sex hormones) include drugs containing phenytoin, phenobarbital, primidone, bosentan, carbamazepine, rifampicin, drugs or herbal products containing perforated hypericum (Hypericum perforatum), and degree medications containing oxcarbazepine, topiramate, felbamate and griseofulvin. HIV protease inhibitors with inducing activity (e.g. ritonavir and nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine and efavirenz) can also affect hepatic metabolism.

During the concomitant use of drugs inducing microsomal enzymes, and within 28 days after their withdrawal, the barrier method of contraception should be used. If necessary, for long-term treatment with drugs that induce microsomal enzymes, it is necessary to consider the use of another method of contraception.

No studies of drug interactions have been conducted for Zoely®, however, two studies have been conducted on the use of a combination of higher doses of nomegestrol acetate and estradiol (nomegestrol acetate 3.75 mg + estradiol 1.5 mg) in combination with rifampicin and in combination with ketoconazole in the population postmenopausal women. Concomitant use of rifampicin reduces AUC0-∞ of nomegestrol acetate by 95% and increases AUC0-t (last) of estradiol by 25%. Concomitant administration of ketoconazole (a single dose of 200 mg) does not affect the metabolism of estradiol, but increases the maximum concentration (85%) and AUC0-∞ (115%) of nomegestrol acetate, however, these changes are not clinically significant. It is assumed that similar changes can occur in the case of the use of these drugs in women of reproductive age.

Effect of Zoely® on other drugs

Oral contraceptives may affect the metabolism of other drugs.
With caution, Zoely® in combination with lamotrigine should be prescribed.

The effect of Zoely® on laboratory tests

COC intake may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma (transport) protein concentration (e.g., CSH and fractions
lipids / lipoproteins), indicators of carbohydrate metabolism, indicators of blood coagulation and fibrinolysis. These indicators usually do not go beyond the normal range.

How to take, course of administration and dosage
The drug is intended for oral administration.

Tablets 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. One tablet per day should be taken for 28 consecutive days. Reception should begin with white tablets containing active ingredients. White tablets containing active ingredients are taken within the first 24 days. Over the next 4 days, yellow tablets are taken that do not contain active substances (placebo). Reception of tablets from each subsequent package should begin the next day after taking the last tablet from the previous package, regardless of the presence or absence of bleeding "cancellation". “Cancellation” bleeding usually begins 2–3 days after taking the last white pill and may not stop by the start of taking the pill from the next pack. For more information, see the “Special Instructions” section of the “Changing the Nature of Menstruation” section.

Special patient groups

Impaired renal function

There are no data on the use in patients with renal insufficiency, however, the effect of renal failure on the excretion of nomegestrol acetate and estradiol is unlikely.

Impaired liver function

The effect of liver diseases on the pharmacokinetics of Zoely® has not been studied. However, since in patients with impaired liver function, the metabolism of sex hormones may be impaired, the use of Zoely® in this group of patients is not recommended until the normalization of liver function indicators (see section "Contraindications").

How to start taking Zoely®

In the previous cycle, hormonal contraceptives were not used

Pills should be started on the first day of a woman’s 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-5th day of the cycle. In this case, during the first 7 days of taking the tablets, it is recommended to additionally use the barrier method of contraception.

Transition from a combined hormonal contraceptive (COC, vaginal ring or transdermal patch)

It is advisable for a woman to start taking Zoely® the next day after taking the last tablet containing the active substances, but no later than the next day after completing the usual interval between cycles or taking placebo tablets. If a woman used a vaginal ring or transdermal patch, then it is advisable to start taking Zoely® on the day they are removed, but later than on the day when a new ring should be inserted or another patch should be glued.

Switching from drugs containing only progestogen (tablets, implants, injectable forms, or hormone-containing intrauterine systems (IUDs))

A woman can stop taking pills containing only a progestogen any day and start taking Zoely® the next day. An implant or IUD can be removed any day. In this case, taking Zoely® should start on the day they are removed. If a woman received an injection, then Zoely® is started on the day when the next injection should be made. In all these cases, a woman is recommended to additionally use the barrier method of contraception during the first 7 days of taking tablets containing active substances.

After an abortion in the first trimester

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

For breast-feeding women, see the section "Use during Pregnancy and during Breastfeeding."

A woman should start taking the drug between the 21st and 28th day after childbirth or abortion in the second trimester. At a later start of the drug, it is recommended to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if there has already been sexual intercourse after childbirth or abortion, pregnancy should be excluded before the first menstruation begins before taking Zoely®.

What to do if you miss a pill

The following recommendations apply only to skipping white tablets containing active ingredients.

If a woman takes another pill with a delay of less than 12 hours, then the contraceptive effect does not decrease. A woman should take the pill as soon as possible, as soon as she remembers this. Subsequent tablets should be taken at the usual time.

If a woman takes an active pill with a delay of more than 12 hours, then the contraceptive effect may decrease. When skipping pills, it is advisable to follow two rules:

in order to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, white tablets containing active substances must be taken for at least 7 consecutive days;
the more missed white tablets containing active ingredients, and the closer the time of taking 4 yellow placebo tablets, the higher the risk of pregnancy.

Advice for skipping pills

If you missed taking one white tablet containing the active substances

The contraceptive effect is not reduced. A woman should take the last missed white pill as soon as she remembers this, even if she has to take two tablets at the same time. Then the tablets should be taken as usual. Additional contraceptive measures are not required.

If you missed taking two white tablets or more

If after skipping the intake of two or more white tablets containing the active substances, there was no “withdrawal” bleeding while taking the yellow placebo tablets, pregnancy should be excluded (see also the section “Special Instructions”, subsection “Changes in the nature of menstruation”).

Days 1-7

A woman should take the last missed white pill as soon as she remembers this, even if she has to take two tablets at the same time. Then the tablets should be taken as usual. Moreover, during the first week of continuous use of white tablets, it is necessary to use the barrier method of contraception. If during the previous 7 days there was sexual intercourse, then the possibility of pregnancy should be considered.

Days 8-17

A woman should take the last missed white pill as soon as she remembers this, even if she has to take two tablets at the same time. Then the tablets should be taken as usual. In this case, during the next 7 days of taking white tablets, it is necessary to use the barrier method of contraception.

Days 18-24

The risk of a decrease in the contraceptive effect increases with approaching the start of taking placebo yellow tablets. However, a change in the pill regimen avoids a decrease in the contraceptive effect. A woman should take the last missed white pill as soon as she remembers this, even if she has to take two tablets at the same time. You can not take more than two white tablets containing active substances at the same time. Over the next 7 days of taking white tablets, it is necessary to use the barrier method of contraception, and start the next package immediately after the white tablets have finished from the previous package, that is, a woman should not take yellow placebo tablets. In this case, “withdrawal” bleeding usually occurs during the administration of yellow tablets from the next package, however, “breakthrough” bleeding or “spotting” discharge may occur during the administration of white tablets.

If a woman is not sure about the number of missed tablets or their color and, accordingly, does not know what recommendations she should follow, then it is necessary to use the barrier method of contraception until the woman takes white tablets for 7 consecutive days.

If you missed taking yellow placebo tablets

The contraceptive effect is not reduced. A woman may not take yellow pills from the last (fourth) row of the blister. However, missed tablets should be discarded to avoid inadvertently increasing the duration of the placebo phase.

Gastrointestinal Disorders

In case of gastrointestinal upsets (for example, vomiting or diarrhea), the absorption of the drug may be incomplete, so you should resort to additional contraceptive measures.

If vomiting occurs within 3-4 hours after taking the pill, then its reception should be considered missed. If you missed taking one white pill, then the contraceptive effect is not reduced. If vomiting develops again the next day or days, then it is necessary to follow the recommendations for skipping two or more tablets (see "Recommendations for Skipping Pills"). If a woman does not want to change the usual pill regimen, then she must take an additional white pill or tablets from another package.

How to move or delay the onset of menstrual bleeding

To delay the onset of menstrual bleeding, a woman should continue to take white tablets from another package without taking yellow tablets. White tablets from the second package can continue to be taken until they run out. After completing the administration of yellow tablets from the second package, it is necessary to resume taking Zoely® as usual. With an elongated regimen, “breakthrough” bleeding or “spotting” discharge may occur.

In order to shift the start day of menstrual bleeding to another day, you can reduce the phase of taking yellow placebo tablets (the maximum duration of taking yellow placebo tablets is 4 days). The shorter the break, the higher the risk of the absence of menstrual bleeding “cancellation” and the occurrence of “breakthrough” bleeding or “spotting” spotting while taking tablets from the second package (as in the case of a delayed onset of menstrual bleeding).

Overdose
Repeated use of Zoely® in doses that are 5 times higher than recommended, and a single dose of nomegestrol acetate in doses that are 40 times higher than recommended, were not accompanied by undesirable effects.

Symptoms that may occur with an overdose: nausea, vomiting, spotting from the vagina.

Treatment: antidotes do not exist. Further treatment should be symptomatic.

Special instructions
In the presence of any of the following conditions, diseases, risk factors, 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, aggravation or the first occurrence of any of these conditions, diseases, risk factors, a woman should consult a doctor to decide on the possibility of further use of the Zoely® preparation.

The following data were obtained from epidemiological studies using COCs containing ethinyl estradiol. Zoely® contains 17β-estradiol, however, special instructions regarding the use of combined contraceptives containing ethinyl estradiol are also considered to be applicable to Zoely®.

Vascular disorders

The use of any COCs is accompanied by an increased risk of venous thrombosis and embolism, which is the highest during the first year after starting COC.
The results of epidemiological studies demonstrate that the incidence of venous thromboembolism (VTE) in patients without known risk factors taking low-dose (<50 μg ethinyl estradiol) COCs is 20 to 40 cases per 10,000 person-years. For comparison, a similar 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 with other COCs.
In epidemiological studies, a relationship has been established between the use of COCs and an increased risk of developing arterial thromboembolism (myocardial infarction, transient ischemic attacks).
Patients taking COCs exceptionally rarely developed thrombosis of other vessels, including the hepatic, mesenteric, renal, cerebral arteries, and veins or vessels of the retina. There is insufficient information on 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 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 and prolonged headache, sudden partial or complete loss of vision, diplopia, speech impairment or aphasia, dizziness, collapse, accompanied or not accompanied by focal seizures, weakness or severe numbness, which suddenly appear on one side of the body, motor disorders, "acute abdomen."
Risk factors for the development of venous thrombosis and embolism: age; the presence of diseases in the family history (venous thrombosis and embolism in brothers, sisters or parents at a young age). If a hereditary predisposition is expected, 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 the planned surgical intervention) and resume it only 2 weeks after the complete restoration of motor activity. If the use of COCs has not been discontinued in advance, the need for the use of antithrombotic agents should be considered; obesity (body mass index more than 30 kg / m2).
There is insufficient information on the role of thrombophlebitis of superficial veins and varicose veins in the etiology of venous thrombosis.
Risk factors for arterial thrombosis or acute cerebrovascular accident: age; smoking (the risk is even greater with intensive smoking, especially in women over 35 years old). Women over 35 years old should be strongly advised to stop smoking if they want to take COCs; dyslipoproteinemia; obesity (body mass index more than 30 kg / m2); arterial hypertension; migraine; heart valve disease; atrial fibrillation; the presence of diseases in the family history (arterial thrombosis in siblings or in parents at a young age). If a hereditary predisposition is expected, then before starting any hormonal contraceptives, you should consult a specialist.
Other conditions accompanied by unwanted vascular disorders, including diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, inflammatory bowel disease (Crohn's disease and ulcerative colitis) and sickle cell anemia.
It is necessary to take into account the increased risk of developing thromboembolic complications in the postpartum period.
An increase in the frequency or severity of migraine with the use of COCs (which may precede the development of cerebrovascular complications) is the reason for the immediate withdrawal of Zoely®.
Women taking COCs need to see a doctor if possible symptoms of thrombosis appear. In cases of suspected or confirmed thrombosis, COCs 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 human papillomavirus (HPV) infection. Epidemiological studies have shown that prolonged use of combined contraceptives containing ethinyl estradiol increases this risk, but it remains unclear to what extent this effect is associated with other factors, such as a more frequent study of the cervix or features of sexual behavior, including the use of barrier contraceptives , or with a combination of these factors. A causal relationship with COC administration has not been proven.
When using COCs in higher doses (50 μg 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 who received COCs containing ethinyl estradiol revealed a slight increase in the relative risk (RR) of developing breast cancer (RR = 1.24). The increased risk gradually disappears within 10 years after stopping COC. Breast cancer rarely develops in women under the age of 40, so the additional number of cases of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Women using COCs have 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 action of the drug, or a combination of these two factors.
In rare cases, women taking COCs have developed benign liver tumors and, even less often, malignant ones. In some cases, these tumors led to life-threatening intra-abdominal bleeding. If there is intense pain in the upper abdomen, liver enlargement, or symptoms of intra-abdominal bleeding in women taking COCs, it is necessary to exclude a liver tumor.

Other conditions

Women with hypertriglyceridemia or a related family history have an increased risk of developing pancreatitis when taking COCs.
Many women receiving COCs showed a slight increase in blood pressure, although a clinically significant increase in blood pressure was rare. The relationship between taking COCs and hypertension has not been established. However, if persistent arterial hypertension develops while taking COCs, then it is advisable to cancel COCs and prescribe antihypertensive therapy. With adequate control of blood pressure 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 with the use of Zoely®.
During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted, although their relationship with the use of contraceptives has not been conclusively established: jaundice and / or itching associated with cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham chorea (small chorea), herpes during pregnancy, hearing loss associated with otosclerosis.
In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.
In acute and chronic impaired liver function, it may be necessary to cancel COCs until liver function indices are normalized. With a relapse of cholestatic jaundice, first observed during pregnancy or with previous use of sex hormones, it is necessary to stop taking COCs.
Although COCs may affect 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 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 the section "Pharmacological properties", subsection "Pharmacodynamics").
Deterioration in the course of depression, Crohn's disease, and ulcerative colitis was associated with COC.
Sometimes chloasma developed, especially in women with a history of the disease. Women prone to developing chloasma should avoid exposure to the sun or UV light while taking COCs.

Changes in the nature of menstruation

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

In women who took Zoely®, the duration of “withdrawal” bleeding was an average of 3-4 days.

Some women who took Zoely® noted a lack of “withdrawal” bleeding while taking yellow placebo tablets, although they were not pregnant. During clinical trials, the absence of “withdrawal” bleeding was noted in 18-32% of cases (during cycles 1 to 12). In such cases, the absence of “withdrawal” bleeding was not associated with a higher frequency of “breakthrough” bleeding / “spotting” discharge in subsequent cycles. In 4.6% of women there was a lack of “withdrawal” bleeding in each of the first three cycles of the drug. In this subgroup there was a high percentage of women with no “withdrawal” bleeding in subsequent cycles (76-87%). Of 28% of women who had “withdrawal” bleeding in at least one cycle (during cycles 2, 3, or 4), 51-62% of patients also showed a lack of “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 probability of pregnancy is low. However, if the woman did not take the drug in accordance with the recommendations or if there are no two “withdrawal” bleeding consecutively, then pregnancy must be excluded.

Influence on the ability to drive vehicles and other mechanisms requiring increased concentration of attention

Zoely® does not affect the ability to drive vehicles and work with mechanisms.

Release form
Film-coated tablets.

Storage conditions
Store at a temperature of 2 to 30 ° C. Keep out of the reach of children.

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