Zoely®

The drug is intended for oral administration.

Recommendations for taking pills are the same for all women.

The pills are taken daily at the same time of the day, regardless of the meal, in the order indicated on the package, with a little water if necessary. It should be taken on 1 tab. / Day for 28 consecutive days. Reception should begin with white pills containing the active ingredients, within the first 24 days, and over the next 4 days - yellow pills that do not contain the active ingredients (placebo). Taking pills from each subsequent package should be started the next day after taking the last tablet from the previous package, regardless of the presence or absence of withdrawal bleeding. Withdrawal bleeding usually starts 2-3 days after taking the last white pill and may not stop by the start of taking the pills from the next pack.

Start taking the drug Zoely^®

In the absence of previous use of hormonal contraceptives

Taking the pills should begin on the 1st day of the menstrual cycle (on the first day of the menstrual bleeding). In this case, the use of additional contraceptives is not required. You can start taking pills from the 2-5th day of the cycle, but then during the first 7 days of taking the pills, it is recommended to use a barrier method of contraception.

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

Taking the drug Zoely^® It is recommended to start the day after taking the last pill containing the active ingredients, but no later than the next day after completing the usual interval between cycles or taking placebo pills. If a woman used a vaginal ring or transdermal patch, then start taking the drug Zoely^® preferably on the day of their removal, but no later than on the day when a new ring should be inserted or another patch should be glued.

If a woman constantly and correctly used the previous method of contraception, and there is no doubt that she is not pregnant, then go to the drug Zoely^® can also be any day. In no case should not exceed the recommended hormone interval of the previous method.

Transition from drugs containing only progestogen (pills, implants, injectable forms or hormone-containing intrauterine systems - IUD)

A woman can stop taking progestogen-only pills any day and start taking the drug Zoely the next day.^®. The implant or IUD can be removed on any given day, taking Zoely^® should start on the day of their removal.

If a woman received an injection, then take Zoely^® begin on the day when the next injection should have been made. In all these cases, the woman is recommended to additionally use a barrier method of contraception during the first 7 days of taking pills containing active ingredients.

After an abortion in the first trimester of pregnancy

A woman can start taking the drug right away; in this case, there is no need for an additional method of contraception.

After childbirth or abortion in the II trimester of pregnancy

A woman should start taking the drug between the 21st and 28th day after childbirth or abortion in the second trimester. With a later start of the drug is recommended to use an additional barrier method of contraception during the first 7 days of taking the pills. However, if after childbirth or abortion you have already had sex, before you start taking the drug Zoely^® it is necessary to exclude pregnancy or wait for the first menstruation.

In case of missing pills

The recommendations given below concern only the skipping of reception of the white pills containing active ingredients.

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

If a woman takes an active pill more than 12 hours late, then the contraceptive effect may be reduced. When you skip taking pills, it is advisable to follow two rules:

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

If you miss one white pill containing the active ingredients

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

If you miss two or more white pills

If, after skipping the intake of two or more white pills containing the active ingredients, there was no withdrawal bleeding while taking the yellow placebo pills, then pregnancy should be excluded.

Days 1-7

A woman should take the last missed white pill as soon as she remembers, even if she has to take two pills at the same time. Then the pills should be taken as usual. At the same time during the first week of continuous use of white pills, you must use the barrier method of contraception. If during the previous 7 days there was sexual intercourse, then you should consider the possibility of pregnancy.

Days 8-17

A woman should take the last missed white pill as soon as she remembers, even if she has to take two pills at the same time. Then the pills should be taken as usual. However, over the next 7 days of taking white pills, you must use a barrier method of contraception.

Days 18-24

The risk of reducing the contraceptive effect increases with the onset of the start of the yellow placebo pills. However, a change in the pill regimen avoids a reduction in contraceptive action. A woman should take the last missed white pill as soon as she remembers, even if she has to take two pills at the same time. You can not simultaneously take more than two white pills containing active ingredients. Over the next 7 days of taking the white pills, you must use a barrier method of contraception, and the next pack should be started immediately after the end of the white pills from the previous pack, i.e. women should not take yellow placebo pills. In this case, withdrawal bleeding usually occurs while taking the yellow pills from the next pack, but while taking the white pills, breakthrough bleeding or spotting may occur.

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

If you miss the yellow placebo pill

Contraceptive effect is not reduced. A woman may not take yellow pills from the last (fourth) row of blisters. However, missed pills should be discarded to avoid an unintended increase in the duration of the placebo phase.

Recommendations for gastrointestinal disorders

In the case of gastrointestinal disorders (for example, vomiting or diarrhea), the absorption of the drug may be incomplete, therefore, additional contraceptive measures should be used.

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

How to move or delay the onset of menstrual bleeding

To delay the onset of menstrual bleeding, a woman should continue taking white pills from another package without taking yellow pills. White pills from the second package can be continued until they run out. After you finish taking the yellow pills from the second pack, you must resume taking the drug Zoely^® in the usual way. With an extended regimen, breakthrough bleeding or spotting may occur.

In order to shift the day of the onset of menstrual bleeding to another day, you can shorten the phase of taking placebo pills (maximum 4 days). The shorter the break, the higher the risk of the absence of menstrual-like withdrawal bleeding and the occurrence of breakthrough bleeding or spotting bleeding while taking pills from the second package.

Use of the drug Zoely^® during pregnancy is contraindicated. In case of pregnancy with the use of Zoely^® should stop taking the drug.

Most epidemiological studies have not revealed an increase in the risk of congenital malformations in children of women who took ethinyl estradiol-containing combined oral contraceptives before pregnancy. In case of accidental use of combined oral contraceptives containing ethinyl estradiol at the beginning of pregnancy, no teratogenic effects were noted.

Limited Zoely Experience^® in pregnant women indicates the absence of undesirable effects of the drug on the condition of the fetus or newborn.

Combined oral contraceptives can affect lactation, because they cause a change in the amount and composition of breast milk. Therefore, the use of combined oral contraceptives is not recommended until complete cessation of breastfeeding. Small amounts of contraceptive steroids and / or their metabolites may be excreted in breast milk, but there is no evidence of their undesirable effect on the health of the newborn.

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

The following data was obtained during epidemiological studies with COC use containing ethinyl estradiol. The drug Zoeli® contains 17β-estradiol, however, specific instructions regarding the use of combined contraceptives containing ethinyl estradiol, are also applicable to the drug Zoeli®.

Vascular Disorders

• The use of any COC is accompanied by an increased risk of venous thrombosis and embolism, which is the highest during the first year after the start of COC administration.
• The results of epidemiological studies demonstrate that the incidence of venous thromboembolism (VTE) in patients without known risk factors that take low-dose (<50 g="" ethinyl="" estradiol="" cocs="" ranges="" from="" 20="" to="" 40="" cases="" per="" 10="" 000="" person-years="" for="" comparison="" a="" similar="" parameter="" in="" patients="" who="" do="" not="" take="" is="" 5-10="" or="" 60="" 100="" pregnancies="" vte="" can="" be="" fatal="" 1-2="" of="" there="" are="" no="" data="" on="" the="" effect="" zoeli="" risk="" venous="" thrombosis="" and="" embolism="" compared="" with="" other="" li="">
• Epidemiological studies have established a link between the use of COCs 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 exceptionally rare in patients taking COCs. There is insufficient information about the relationship between the occurrence of these complications and the use of COC.
• 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 dyspnea, sudden cough, unusual severe and prolonged headache, sudden partial or complete loss of vision, diplopia, impaired speech or aphasia, dizziness, collapse, accompanied or not accompanied by focal convulsions, weakness or marked numbness that suddenly appears on one side of the body, movement disorders, "acute stomach".
• Risk factors for venous thrombosis and embolism: age; the presence of diseases in the family history (venous thrombosis and emboli in brothers, sisters or parents at a young age). If a genetic predisposition is assumed, then before starting any hormonal contraceptives, you should consult with a specialist; prolonged immobilization, extensive surgery, any operation on the lower limbs or a serious injury. In these cases, it is recommended to stop taking hormonal contraceptives (at least 4 weeks before the planned surgery) and resume it only 2 weeks after the full recovery of motor activity. If the use of COCs has not been stopped in advance, the need to use antithrombotic agents should be considered; obesity (body mass index more than 30 kg / m²).
• There is insufficient information on the role of thrombophlebitis of the 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 more increased with intensive smoking, especially in women over 35). Women over 35 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; valvular disease; atrial fibrillation; the presence of diseases in the family history (arterial thrombosis in brothers, sisters or parents at a young age). If a genetic predisposition is assumed, then before starting any hormonal contraceptives you should consult with a specialist.
• Other conditions that were accompanied by unwanted vascular disorders include 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 thromboembolic complications in the postpartum period.
• An increase in the frequency or severity of migraine when using COCs (which may precede the development of cerebrovascular complications) is a reason for the immediate discontinuation of Zoeli®.
• Women taking COCs should see a doctor if they have any possible symptoms of thrombosis. In cases of suspected or confirmed thrombosis, COCs should be discontinued. At the same time, adequate contraception should be initiated, taking into account the teratogenicity of anticoagulant therapy (coumarins).

Tumors

• The most significant risk factor for cervical cancer is persistent infection caused by the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of combined contraceptives containing ethinyl estradiol increases this risk, but it is unclear to what extent this effect is related to other factors, such as more frequent cervical studies or sexual behavior, including the use of barrier contraceptives. , or with a combination of these factors. The causal relationship with the admission of COC is not proven.
• With higher doses of COC (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 ethinyl estradiol-containing COCs revealed a slight increase in the relative risk (RR) of breast cancer (RR = 1.24). The increased risk gradually disappears within 10 years after discontinuing COC. Breast cancer rarely develops in women under the age of 40 years, so the additional number of breast cancer cases in women who take or have taken COCs is small compared with the overall risk of developing breast cancer. Women who use COCs detect earlier stages of breast cancer than women who have never used them. During the application of COCs, the risk of developing breast cancer slightly increases, which may be due to an earlier diagnosis, drug action, or a combination of these two factors.
• In rare cases, women who took COCs have experienced the development of benign liver tumors and, more rarely, malignant tumors. In some cases, these tumors led to life-threatening intra-abdominal bleeding. If intense pain in the upper abdomen, liver enlargement or symptoms of intra-abdominal bleeding occurs in women taking COCs, it is necessary to exclude a liver tumor.

Other states

• Women with hypertriglyceridemia or an appropriate family history have an increased risk of pancreatitis when taking COCs.
• In many women receiving COCs, a slight increase in blood pressure was noted, although a clinically significant increase in blood pressure was rarely observed. The relationship between COK and arterial hypertension has not been established. However, if persistent arterial hypertension develops in patients with COC, it is advisable to stop taking COCs and prescribe anti-hypertensive therapy. With adequate blood pressure control with antihypertensive drugs, it is possible to resume taking COCs. In clinical studies with a duration of up to two years, there were no clinically significant changes in blood pressure when using the drug Zoeli®.
• Against the background of pregnancy and during the use of COCs, the development or deterioration of the following conditions was noted, although their relationship with the use of contraceptives has not been definitively established: jaundice and / or itching associated with cholestasis, gallbladder stones, porphyria, systemic lupus erythematosus uremic syndrome, Sydengham's chorea (small chorea), herpes during pregnancy, hearing loss associated with otosclerosis.
• In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen the symptoms of angioedema.
• In case of acute and chronic abnormal liver function, it may be necessary to abolish COC until the liver function normalizes. When recurrent cholestatic jaundice, first observed during pregnancy or the previous use of sex hormones, you must stop taking COCs.
• Despite the fact that COCs may affect insulin resistance and glucose tolerance, there is no need to change the dosage regimen of hypoglycemic drugs in diabetic patients taking COCs containing less than 0.05 mg of ethinyl estradiol. However, it is necessary to carefully conduct periodic examinations of women with diabetes who take COCs, especially during the first months. Zoeli® drug does not affect the insulin resistance of peripheral tissues and glucose tolerance in healthy women (see the Pharmacological Properties section, Pharmacodynamics subsection).
• Worsening of the course of depression, Crohn's disease and ulcerative colitis was associated with taking COCs.
• Chloasma sometimes developed, especially in women with the disease in history. Women prone to developing chloasma should avoid sun exposure or exposure to ultraviolet light while taking COCs.

Medical examinations / consultations

Before prescribing Zoeli®, you should carefully review the medical history (including family) of women and exclude pregnancy.

Blood pressure should be measured and, if indicated, a physical examination should be carried out taking into account contraindications and cautions. The interval between the control medical examinations is determined in each individual case, but not less than 1 time in 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 decrease if pills are missed (see section “Dosage and administration”), gastrointestinal disorders while taking active pills (see “Administration and dosage”) or in case of concomitant therapy (see “ Interaction with other drugs ").

Changes in the nature of menstruation

When taking any COCs, "breakthrough" bleeding or "spotting" discharge may occur, especially in the first few months. Therefore, a survey with irregular bleeding is justified only after a period of adaptation (approximately 3 cycles). At 15-20% of women at use of the drug Zoeli® acyclic spotting after this period of adaptation was observed. If irregular bleeding persists or occurs after previous regular cycles, it is necessary to assume non-hormonal causes and conduct diagnostic studies to rule out a malignant tumor or pregnancy. May require diagnostic curettage.

In women who took the drug Zoeli®, the duration of the "cancellation" bleeding averaged 3-4 days.

Some women who took the drug Zoeli®, noted the absence of "withdrawal" bleeding while taking the yellow placebo pills, although they were not pregnant.In clinical studies, the absence of "withdrawal" bleeding was noted in 18-32% of cases (for cycles 1 through 12). In such cases, the absence of "withdrawal" bleeding was not associated with a higher frequency of "breakthrough" bleeding / "bloody" discharge in subsequent cycles. In 4.6% of women, there was no “withdrawal” bleeding in each of the ne