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Zoeli - instructions for use, reviews, analogs and forms of release (birth control pills 2.5 mg + 1.5 mg) of the drug for preventing pregnancy and contraception in women. Composition and side effects

Zoeli - instructions for use, reviews, analogs and forms of release (birth control pills 2.5 mg + 1.5 mg) of the drug for preventing pregnancy and contraception in women. Composition and side effects

In this article, you can read the instructions for using the drug Zoeli. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of physicians specialists on the use of Zoeli in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Zoeli in the presence of existing structural analogs. Use to prevent pregnancy and contraception in women. Composition of the contraceptive.

 

Zoeli - a combined hormonal contraceptive containing estrogen 17 beta-estradiol and progestagen nomegastrol acetate.

 

Estradiol (17 beta-estradiol) is a natural estrogen identical to endogenous human 17 beta-estradiol (E2). Unlike ethinyl estradiol, which is part of other combined oral contraceptives, E2 does not have an ethynyl group in the 17 alpha position. When using Zoeli, the average E2 concentrations are comparable to those in the initial follicular phase and the late phase of the yellow body of the menstrual cycle.

 

Nomegastrol acetate is a highly selective progestogen that is a derivative of the natural steroid hormone Progesterone and structurally similar to it. Nomegastrol acetate has a pronounced affinity for the human receptor of progesterone, has high antigonadotropic activity, moderate antiandrogenic activity and does not possess estrogenic, androgenic, glucocorticoid and mineralocorticoid activity.

 

The contraceptive effect of Zoeli's preparation is due to a combination of various factors, the most important of which are suppression of ovulation and a change in the secretion of cervical mucus.When Zoeli is taken Nomegastrol acetate basically suppresses ovulation, and E2 enhances the effects of progestogen. After the abolition of Zoeli in most women, ovulation is quickly restored.

 

At the time of administration, the serum folate concentration does not change and remains at the baseline level for 6 consecutive months of Zoeli's drug intake.

 

In clinical studies, it was found that the Perl index for women aged 18 to 50 years was 0.66 (the upper limit is 95% confidence interval 1.07), and for women aged 18 to 35, the Perl index was 0.75 (the upper limit of 95% of the interval 1.23).

 

In clinical studies it was found that when Zoeli was taken, glucose tolerance and insulin sensitivity did not change, no clinically significant effects on lipid metabolism and hemostasis were found. Zoeli's intake increased the protein content of the carriers of thyroxine-binding globulin and corticosteroid-binding globulin (COG), but to a lesser extent than the combination of levonorgestrel and ethinylestradiol. When taking Zoeli's drug, the content of globulin, which binds sex hormones (SHBG), slightly increased, the content of androstenedione, dehydroepiandrosterone, total and free testosterone decreased significantly.After 13 cycles of taking the drug, no pathological changes were observed in the histological examination of the endometrium.

 

Composition

 

Estradiol hemihydrate + Estradiol + Nomegastrol acetate + excipients.

 

Pharmacokinetics

 

Estradiol (E2)

 

17 beta-estradiol (E2) undergoes a pronounced metabolism at the "first passage" after ingestion. Absolute bioavailability is approximately 5%. Eating does not have a clinically significant effect on the bioavailability of E2. The distribution of exogenous and endogenous E2 is similar. Estrogens are actively distributed throughout the body. Their concentrations are usually higher in the organs-targets of sex hormones. Exogenous E2 is actively biotransformed after oral administration. Metabolism of exogenous and endogenous E2 is similar. E2 rapidly turns into several metabolites in the intestine and liver, mainly in estrone (E1), which are subsequently conjugated and subjected to intestinal-hepatic circulation. E2 is quickly excreted from the blood. Due to metabolism and intestinal-hepatic circulation, there is a large pool of circulating sulfates and estrogen glucuronides.

 

Nomegestrol acetate

 

Nomegastrol acetate is rapidly absorbed after oral administration. Absolute bioavailability after a single dose is 63%. Food has no clinically significant effect on the bioavailability of nomegestrol acetate. Nomegastrol acetate actively binds to albumin (97-98%), but does not bind to GSH or CSG. Nomegastrol acetate is metabolized to several inactive hydroxylated metabolites under the action of cytochrome P450 isoenzymes of the liver, mainly CYP2C8, CYP2C19, CYP3A4 and CYP3A5. Has no significant inducing or inhibitory effect on cytochrome P450 isoenzymes and does not interact with P-glycoprotein. Nomegastrol acetate is excreted by the kidneys and through the intestine. Approximately 80% of the dose is excreted by the kidneys and through the intestine for 4 days. Nomegastrol acetate is almost completely eliminated within 10 days. Excretion through the intestine exceeds excretion by the kidneys.

 

Pharmacokinetic modeling did not reveal differences in the pharmacokinetics of nomegestrol acetate in girls aged 12-17 years after the onset of menarche and in adult women.

 

Indications

  • contraception.

 

Forms of release

 

Tablets, coated with a coating of 2.5 mg + 1.5 mg.

 

Instructions for use and reception scheme

 

The drug is intended for oral administration.

 

Recommendations for the reception of tablets are the same for all women.

 

Tablets are taken daily at the same time of the day, regardless of food intake in the order indicated on the package, if necessary, with a small amount of water. Take 1 tablet a day for 28 consecutive days. Admission should begin with white tablets containing active ingredients for the first 24 days, and for the next 4 days - yellow tablets that do not contain active ingredients (placebo). The taking of tablets from each subsequent package should begin the day after the last tablet from the previous package, regardless of the presence or absence of bleeding cancellation. Bleeding cancellation usually begins 2-3 days after the last white pill and may not stop at the beginning of taking the tablets from the next package.

 

Initiation of Zoeli

 

In the absence of prior application of hormonal contraceptives

 

Tablets should be taken on the first day of the menstrual cycle (the first day of menstrual bleeding).In this case, the use of additional contraceptives is not required. You can begin taking pills and from the 2-5th day of the cycle, but then during the first 7 days of taking the tablets it is recommended to use the barrier method of contraception in addition.

 

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

 

It is recommended that Zoeli should be taken on the next day after the last tablet containing the active substances, but no later than the day after the end of the usual interval between cycles, or the taking of the placebo tablets. If a woman used a vaginal ring or a transdermal patch, Zoeli should be taken on the day of removal, but no later than on the day when a new ring should be inserted or another patch applied.

 

If a woman regularly and correctly used the previous method of contraception, and there is no doubt that she is not pregnant, then you can go to taking Zoeli's drug any day. In no case should the recommended non-hormonal interval of the previous method be exceeded.

 

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

 

A woman can stop taking pills containing progestogen only on any day and start taking Zoeli's drug the next day. The implant or IUD can be removed on any day, Zoeli should be taken on the day of removal.

 

If a woman received injections, Zoeli's reception starts on the day when the next injection should be made. In all these cases, the woman is recommended to use the barrier method of contraception in the first 7 days of taking the tablets containing the active substances.

 

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 2nd trimester of pregnancy

 

A woman should start taking the drug between the 21st and 28th day after childbirth or abortion in the 2nd trimester. At a later start of the drug, an additional barrier method of contraception is recommended during the first 7 days of taking the tablets.However, if there have been sexual intercourse after childbirth or abortion, you must exclude pregnancy or wait for the first menstrual period before starting Zoeli.

 

In case of missing tablets

 

The recommendations below concern only the admission of white tablets containing active ingredients.

 

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

 

If a woman takes an active tablet with a delay of more than 12 hours, the contraceptive effect may decrease. If you miss taking pills, it is advisable to follow two rules:

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

 

If a single white tablet containing active ingredients is missed

 

The contraceptive effect is not reduced. A woman should take the last missed white pill as soon as she remembers it, even if she has to take two tablets at the same time. Then the tablets should be taken as usual. No additional contraceptive measures are required.

 

If you missed taking two white tablets or more

 

If after missing two or more white tablets containing active ingredients, there was no withdrawal bleeding during taking yellow tablets, then pregnancy should be excluded.

 

Days 1-7

 

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

 

Days 8-17

 

A woman should take the last missed white pill as soon as she remembers it, 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, a barrier method of contraception should be used.

 

Days 18-24

 

The risk of a decrease in the contraceptive effect increases with the approach of the start of the yellow tablets taking placebo. However, changing the regimen of taking tablets helps to avoid a decrease in contraceptive activity. A woman should take the last missed white pill as soon as she remembers it, even if she has to take two tablets at the same time. You can not simultaneously take more than two white tablets containing active ingredients. During the next 7 days of taking white tablets, a barrier method of contraception should be used, and the next package should begin immediately after the end of the white tablets from the previous package, i.e. a woman should not take a yellow placebo pill. In this case, withdrawal bleeding usually occurs during the administration of yellow tablets from the following package, however, during the reception of white tablets, breakthrough bleeding or spotting can occur.

 

If a woman is not sure of 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 the yellow tablets of placebo are missed

 

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

 

Recommendations in case of gastrointestinal disorders

 

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

 

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 the next day or days again develops vomiting, then it is necessary to follow the recommendations for missing two or more tablets. If a woman does not want to change the usual scheme for taking tablets, she should take an additional white tablet 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 taking white tablets from another package without taking yellow tablets. White tablets from the second package can be taken until they run out. After the completion of taking yellow tablets from the second package, it is necessary to resume taking Zoeli's drug according to the usual scheme. With an extended admission scheme, breakthrough bleeding or spotting can occur.

 

In order to shift the day of onset of menstrual bleeding the next day, you can reduce the phase of taking placebo tablets (maximum 4 days). The shorter the break, the higher the risk of no menstrual like bleeding cancellation and the occurrence of breakthrough bleeding or spotting spotting during the taking of tablets from the second package.

 

Side effect

  • increase in body weight;
  • increased appetite;
  • fluid retention;
  • decreased appetite;
  • decreased libido;
  • depression;
  • mood swings;
  • increased libido;
  • migraine;
  • headache;
  • violation of attention;
  • intolerance to contact lenses;
  • dry eyes;
  • tides;
  • nausea;
  • bloating;
  • dry mouth;
  • acne;
  • hyperhidrosis;
  • alopecia;
  • itching;
  • dry skin;
  • seborrhea;
  • Chloasma;
  • hypertrichosis;
  • irregular bleeding cancellations;
  • metrorrhagia;
  • menorrhagia;
  • tenderness of the mammary glands;
  • pain in the pelvic region;
  • hypomenorrhoea;
  • engorgement of mammary glands;
  • galactorrhea;
  • spasm of the uterus;
  • premenstrual syndrome;
  • seals in the mammary glands;
  • dyspareunia;
  • dryness of the vulva and vagina;
  • unpleasant odor from the vagina;
  • discomfort in the vagina;
  • irritability;
  • edema;
  • hunger.

 

Side effects that occurred when taking combined oral contraceptives containing ethinylestradiol: venous and arterial thromboembolism, increased blood pressure, hormone-dependent tumors (eg, liver tumors, breast cancer), chloasma.

 

The frequency of detection of breast cancer is slightly higher in women taking combined oral contraceptives. Breast cancer is rare in women under 40 years of age and the number of additional cases with combined oral contraceptives is small compared to the generalrisk of breast cancer. Communication with the use of combined oral contraceptives is not established.

 

Studies in patients with impaired renal or hepatic function were not conducted. In women with impaired liver function, a deterioration in the metabolism of steroid hormones is possible.

 

Contraindications

 

There are no epidemiological data on the use of combined oral contraceptives containing 17 beta-estradiol, but contraindications to the use of Zoeli's preparation correspond to contraindications to the use of contraceptives containing ethinylestradiol. If any of these conditions occur during the period of Zoeli's application, stop taking the drug immediately:

  • deep vein thrombosis or thromboembolism of the pulmonary artery, incl. in the anamnesis;
  • arterial thrombosis (myocardial infarction, cerebral circulation disorder) or prodromal conditions (transient ischemic attack, angina pectoris), incl. in the anamnesis;
  • Migraine with focal neurological symptoms, incl. in the anamnesis;
  • expressed or multiple risk factors for venous or arterial thrombosis, such as: diabetes mellitus with vascular symptoms, severe arterial hypertension, severe dyslipoproteinemia;
  • hereditary or acquired predisposition to the development of venous or arterial thrombosis, for example, resistance of activated protein C, deficiency of antithrombin III, deficiency of proteins C and S, hyperhomocysteinemia and antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);
  • Pancreatitis with severe hypertriglyceridemia, incl. in the anamnesis;
  • severe liver disease, incl. in the anamnesis, before normalization of indicators of liver function;
  • liver tumors (malignant or benign), incl. in the anamnesis;
  • known or suspected hormone-dependent malignant tumors (eg genitals or breast cancer);
  • vaginal bleeding of unclear etiology;
  • postmenopause;
  • established or suspected pregnancy;
  • lactation period (breastfeeding);
  • deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;
  • hypersensitivity to the components of the drug.

 

Carefully

 

In the presence of any of the following conditions / diseases, the benefits of using Zoeli and the possible risk for each woman should be assessed.This should be discussed with the woman even before she starts taking Zoeli's drug. In cases of worsening, exacerbation of the disease or the onset of any of these conditions, a woman should first consult a doctor to decide whether Zoeli can continue to be used:

  • diabetes mellitus without vascular disease;
  • severe depression or history of the disease;
  • systemic lupus erythematosus;
  • Crohn's disease;
  • ulcerative colitis;
  • impaired liver function;
  • hypertriglyceridemia, incl. in a family history;
  • risk factors for IHD (obesity, smoking in 35 years and older, hypertension);
  • prolonged immobilization or extensive surgical operation;
  • the presence in the family history of venous thrombosis, arterial embolism in the brothers, sisters or parents at a relatively young age.

 

Application in pregnancy and lactation

 

The use of Zoeli during pregnancy is contraindicated. In the case of pregnancy when using Zoeli should stop taking the drug.

 

Most epidemiological studies have not shown an increased risk of congenital malformations in children of women taking ethinylestradiol-containing combined oral contraceptives prior to pregnancy.In case of accidental intake of combined oral contraceptives containing ethinylestradiol at the beginning of pregnancy, there were no teratogenic effects.

 

The limited experience of using Zoeli in pregnant women indicates that there is no undesirable effect of the drug on the condition of the fetus or newborn.

 

Combined oral contraceptives can influence 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 the complete cessation of breastfeeding. Small amounts of contraceptive steroids and / or their metabolites can be excreted in breast milk, but there is no evidence of their undesirable effects on the health of the newborn.

 

Use in children

 

Data on the efficacy and safety of the drug in children under the age of 18 years are absent.

 

special instructions

 

The following data were obtained in epidemiological studies using combined oral contraceptives containing ethinylestradiol.Zoeli contains 17 beta-estradiol, however, special instructions regarding the administration of combined contraceptives containing estradiol are considered applicable for Zoeli.

 

Vascular disorders

 

Epidemiological studies have established a link between the use of combined oral contraceptives containing ethinyl estradiol and an increased risk of arterial and venous thrombosis and thromboembolism, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. These complications are rare.

 

The use of any combined oral contraceptives containing ethinylestradiol is associated with an increased risk of venous thrombosis and embolism, which is the highest in the first year after the onset of combined oral contraceptive. This increased risk is lower than the risk of developing venous thrombosis and embolism associated with pregnancy (60 per 100,000 person-years). In women who do not take oral contraceptives, the risk of venous thrombosis and embolism is 5-10 per 100,000 person-years. Venous thrombosis and embolism result in death in 1-2% of cases.

 

Data on the effect of Zoeli on the risk of venous thrombosis and embolism compared to other combined oral contraceptives are not available.

 

In patients who took combined oral contraceptives, extremely rarely developed thrombosis of other vessels, including. hepatic, mesenteric, renal, cerebral arteries and veins or retinal vessels. There is insufficient information on the relationship between the onset of these complications and the use of combined oral contraceptives.

 

Symptoms of venous and arterial thrombosis can include the following conditions: pain and / or swelling of the foot, sudden intense chest pain, irradiating 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 disturbance or aphasia, dizziness, collapse accompanied or not accompanied by focal cramps, weakness or severe numbness that suddenly appear on one side of the body, motor e disorder syndrome "acute abdomen".

 

Risk factors for venous thrombosis and embolism:

  • age;
  • the presence of diseases in the family history (venous thrombosis and embolism in the brothers, sisters or parents at a relatively early age). If hereditary predisposition is assumed, then before starting any hormonal contraceptives, you should consult a specialist;
  • prolonged immobilization, extensive surgical intervention, 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 surgical intervention) and resume it only 2 weeks after the complete restoration of the motor activity;
  • Obesity (body mass index (BMI) more than 30 kg / m2);
  • possibly, thrombophlebitis of superficial veins and varicose veins.

 

There is insufficient information on the role of these conditions in the etiology of venous thrombosis.

 

Risk factors for arterial thrombosis:

  • age;
  • smoking (the risk is even more likely to increase with intensive smoking, especially in women older than 35 years);
  • dyslipoproteinemia;
  • Obesity (BMI more than 30 kg / m2);
  • arterial hypertension;
  • migraine;
  • valvular heart disease;
  • atrial fibrillation;
  • the presence of diseases in the family history (arterial thrombosis in the brothers, sisters or parents at a relatively early age). If hereditary predisposition is assumed, then before starting any hormonal contraceptives should consult with a specialist.

 

Other conditions that were accompanied by undesirable vascular disorders: 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 (which may precede the development of cerebrovascular complications) is the basis for the immediate withdrawal of Zoeli's drug.

 

Women who take combined oral contraceptives should consult a doctor if symptoms of thrombosis appear. In cases of suspected or confirmed thrombosis, the use of a combined oral contraceptive should be discontinued.In this case, adequate contraception should be started, taking into account the teratogenicity of therapy with anticoagulants (coumarins).

 

Tumors

 

The most significant risk factor for developing cervical cancer is a persistent infection caused by the human papillomavirus (HPV). In epidemiological studies, long-term use of combined contraceptives containing ethinylestradiol has been shown to increase this risk, but it remains unclear to what extent this effect is related to other factors, such as more frequent cervical examination or sexual behavior, including the use of barrier contraceptives , or is a combination of these factors.

 

When combined oral contraceptives are used at higher doses (50 μg ethinyl estradiol), the risk of developing endometrial and ovarian cancer is reduced. It remains unclear whether this applies to combined oral contraceptives containing 17 beta-estradiol.

 

In a meta-analysis of 54 epidemiological studies, women who received ethinylestradiol-containing combined oral contraceptives had a slight increase in the relative risk of developing breast cancer (relative risk = 1.24).The increased risk gradually disappears within 10 years after discontinuation of combined oral contraceptives. Breast cancer rarely develops in women under the age of 40, so the additional number of breast cancers in women who take or take combined oral contraceptives is small compared to the overall risk of breast cancer. Breast cancer diagnosed in women using combined oral contraceptives is clinically less pronounced than the detected cancer in women who never used these drugs. During the use of combined oral contraceptives, the risk of breast cancer is slightly increased, which may be due to earlier diagnosis, the effect of the drug, or a combination of these two factors.

 

In rare cases, women who took combined oral contraceptives, observed the development of benign liver tumors and even less often - malignant. In some cases, these tumors led to life-threatening intra-abdominal bleeding. When there is intense pain in the upper abdomen,liver enlargement or symptoms of intra-abdominal bleeding in women taking combined oral contraceptives, it is necessary to exclude liver tumor.

 

Other states

 

In women with hypertriglyceridemia or a corresponding family history, the risk of developing pancreatitis when taking combined oral contraceptives is increased.

 

In many women receiving combined oral contraceptives, a small increase in blood pressure was noted, although clinically significant BP increase was rare. The relationship between the administration of combined oral contraceptives and the development of hypertension has not been established. However, if persistent arterial hypertension develops on the background of taking a combined oral contraceptive, it is advisable to cancel combined oral contraceptives and prescribe antihypertensive therapy. With adequate control of blood pressure with the help of antihypertensive drugs, it is possible to resume taking a combined oral contraceptive. In clinical studies of up to 1 year, there were no clinically significant changes in blood pressure when Zoeli was used.

 

Against the background of pregnancy and during the use of combined oral contraceptives was observed the development or worsening of these conditions, although their relationship with oral contraceptives not been definitively established: jaundice and / or pruritus related to cholestasis, the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham chorea, gestational herpes, hearing loss associated with otosclerosis, (hereditary) angioedema.

 

In acute and chronic disturbances of liver function may need to cancel COCs until until normalized liver function. When relapse cholestatic jaundice, first observed during pregnancy or previous use of sex steroids, you must stop taking combined oral contraceptives.

 

The need for changing circuit receiving low-dose combined oral contraceptives (containing less than 0.05 mg ethinyl estradiol) in women with no diabetes. However, periodic screening of women with diabetes taking combined oral contraceptives should be carefully conducted, especially during the first months.Zoeli has no effect on insulin resistance of peripheral tissues and glucose tolerance in healthy women.

 

The worsening of the course of depression, Crohn's disease and ulcerative colitis was associated with the use of combined oral contraceptives.

 

Sometimes chloasma developed, especially in women with this disease in history. Women who are prone to develop chloasma should avoid sun exposure or exposure to ultraviolet light while taking combined oral contraceptives.

 

Medical examinations / consultations

 

Before prescribing the drug, you should carefully read the medical history (including family) of a woman and exclude pregnancy.

 

It is necessary to measure blood pressure and, in the presence of indications, conduct a physical examination taking into account contraindications and cautions. The interval between the control medical examinations is determined in each case separately, but not less than once in 6 months.

 

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

 

Decreased efficiency

 

The effectiveness of combined oral contraceptives may be reduced in the case of missing tablets, gastrointestinal disorders during active tablets or concomitant therapy.

 

Changes in the nature of menstruation

 

As with any combined oral contraceptive, breakthrough bleeding or spotting can occur, especially in the first few months. Therefore, the examination with irregular bleeding is justified after a period of adaptation (approximately 3 cycles). If irregular bleeding persists or occurs after previous regular cycles, it is necessary to assume non-hormonal causes and conduct diagnostic studies to exclude a malignant tumor or pregnancy. Diagnostic curettage may be required.

 

In clinical studies in women taking Zoeli, the incidence of side effects associated with bleeding was low. Bleeding cancellations were mild, short-term (on average 3-4 days) and often less painful.

 

Some women who took Zoeli's drug noted that there was no withdrawal bleeding during taking yellow tablets, although they were not pregnant.In such cases, the absence of bleeding cancellation was not associated with a higher incidence of irregular bleeding in the following cycles. The nature of menstrual bleeding at the start of Zoeli's preparation (cycles 2-4) allows us to predict the nature of menstrual bleeding in subsequent cycles.

 

If Zoeli does not have withdrawal bleeding in accordance with the recommended dosing regimen, then the probability of pregnancy is low. However, if a woman does not take the drug in accordance with these recommendations or there are no two consecutive bleeding abortions, then pregnancy should be excluded.

 

Lab tests

 

Data for combined oral contraceptives have shown that the use of these drugs may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney functions, plasma protein transport concentrations, for example, corticosteroid hormones, lipid / lipoprotein fractions, carbohydrate metabolism, blood coagulation and fibrinolysis. Usually these changes remain within the normal range.

 

Impact on the ability to drive vehicles and manage mechanisms

 

The drug Zoeli does not affect the ability to drive vehicles and work with mechanisms.

 

Drug Interactions

 

To avoid possible interactions, it is necessary to read the instructions for the use of concomitant medications.

 

The effect of other drugs on Zoeli

 

The interaction of oral contraceptives with other drugs can lead to breakthrough bleeding and / or a decrease in the effectiveness of contraception. The literature describes the drug interaction with combined oral contraceptives in general.

 

Hepatic metabolism: it is possible to interact with inducers of microsomal liver enzymes, which can lead to an increase in the clearance of sex hormones. An interaction was established, for example, with phenytoin, barbiturates, primidon, carbamazepine, rifampicin, and possibly with oxcarbazepine, topiramate, felbamate, griseofulvin, and preparations containing Hypericum perforatum. HIV protease inhibitors (eg, ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg,nevirapine) and their combination also had an effect on hepatic metabolism.

 

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

 

Drugs that inhibit microsomal enzymes (eg, ketoconazole) can cause an increase in the concentration of sex hormones in the plasma.

 

Antibiotics: a decrease in the effectiveness of oral contraceptives containing ethinyl estradiol was noted with the concomitant administration of antibiotics such as ampicillin and tetracyclines. The mechanism of this effect has not been studied. There is no information on the interaction of antibiotics with contraceptives containing 17 beta-estradiol. Women taking antibiotics (with the exception of rifampicin and griseofulvin) should additionally use the barrier method of contraception during the entire period of antibiotic therapy and within 7 days after their withdrawal.If the period during which the barrier method of contraception is applied continues after the end of the reception of white tablets from the Zoeli package, you should skip the yellow tablets from the current package and immediately start taking the white tablets from the next package.

 

Effect of Zoeli on other drugs

 

Oral contraceptives can affect the metabolism of other medicines. Accordingly, their concentrations in plasma and tissues may increase (eg, cyclosporine) or decrease (eg, lamotrigine).

 

Analogues of the drug Zoeli

 

Zoeli does not have structural analogs for the active substance. The drug is unique in the combination of active ingredients that make up the composition.

 

Analogues for the pharmacological group (estrogens and gestagens):

  • Activel;
  • Angelique;
  • Belara;
  • Gynodian Depot;
  • Gynoflor E;
  • Jess;
  • Jess Plus;
  • Diane 35;
  • Divina;
  • Dimia;
  • Evra;
  • Janine;
  • The individual;
  • Clira;
  • Klimodien;
  • Clinonorm;
  • Cliogest;
  • Lindineth;
  • Logest;
  • Marvelon;
  • Mersilon;
  • Midian;
  • NovaRing;
  • Novinet;
  • Ovidon;
  • Revmelid;
  • Regulon;
  • Rigevidone;
  • Silestus;
  • Silhouettes;
  • Three Mercy;
  • Three regol;
  • Triogynal;
  • Femaflor;
  • Femoston;
  • Cyclo Proginova;
  • Evian;
  • Erica 35;
  • Yarina;
  • Yarina Plus.

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Reviews (3):
Guests
Margo
The question arose about the choice of protection against unwanted pregnancy (a permanent MCH appeared). I decided to try hormonal pills after the advice of a gynecologist. She appointed me Zoeli, detailing the scheme of the reception. The first month was a nightmare. I felt pregnant with a toxicosis. I felt sick, my head was spinning, but on the advice of a doctor finished the first month. She could not take more, returned to the barrier means of contraception.
Visitors
Gapon Marina
Hello. How old can you take this drug? I am now 46, I endure it well. Thank you.
Administrators
admin
Gapon Marina, Modern oral contraceptives can be taken before menopause or menopause, then on the recommendation of a doctor to switch to hormone replacement therapy (HRT).

Rules for publishing reviews and visitor questions