Zoely tabs 2.5mg + 1.5mg #84

User manual for Zoely

Reed more and buy Zoely contraceptive tablets on this page

Composition

1 tablet - 2.5 mg of nomegastrol acetate and 1.55 mg of estradiol hemihydrate (1.5 mg of estradiol, respectively) are the active substances.
Auxiliary Ingredients:
    0.7 mg - talc;
    14 mg of microcrystalline cellulose;
    0,7 mg - magnesium stearate;
    2,4 mg of crospovidone;
    57.71 mg - lactose monohydrate;
    0.44 mg of colloidal silicon dioxide.
Sheath:
    1.6 mg - opadrai II white.
Placebo tablets:
    0.7 mg - talc;
    14 mg of microcrystalline cellulose;
    0,7 mg - magnesium stearate;
    2,4 mg of crospovidone;
    61.76 mg of lactose monohydrate;
    0.44 mg of colloidal silicon dioxide.
Sheath:
    2,4 mg - opadrai II yellow.

Form of issue

The drug Zoely is available in the form of tablets in a film shell of 28 or 84 tablets in one package. The blister containing the tablets is numbered by the days of the week.

pharmachologic effect

Contraceptive.

Pharmacodynamics and pharmacokinetics

Zoely - hormonal combined contraceptive drug, consisting, in addition to additional substances, from the active components: estradiol (17β) and nomegastrol.
Estradiol is a natural estrogen identical to human endogenous 17β-estradiol (E2). The main difference from ethinylestradiol, 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 E2 concentrations that correspond to those in the initial follicular phase and the final luteal phase of the menstrual cycle.
The natural progesterone derivative is nomegestrol, similar in structure and is a highly selective progestogen. Possessing a pronounced affinity for the progesterone receptor (human), it exhibits a high antigonadotropic and moderate antiandrogenic activity, without having an androgenic, glucocorticoid, estrogenic and mineralocorticoid action.
The contraceptive effect of Zoely's drug is a combination of several effects, the most significant of which is a change in the secretion of the mucous membrane of the cervix and suppression of ovulation. E2 increases the effects of progestogen, and nomegestrol is involved in the process of suppressing ovulation. After the end of Zoely's drug intake, normal ovulation, in most women, is restored fairly quickly.
Content in the serum of folic acid during the reception of Zoely does not change and during the half-year of consecutive admission is maintained at a basic level.
Clinical studies established the Perl index of 0.66 for the age group of women 18-50 years and 0.75 for 18-35 years, with a corresponding upper limit of 95% confidence interval of 1.07 / 1.23.
In the conducted studies it was proved that taking Zoely's drug does not lead to significant changes in lipid metabolism, does not affect insulin sensitivity, glucose tolerance and hemostasis. The drug increased the amount of proteins that transport CSG (corticosteroid-binding) and TSH (thyroxine-binding) globulins, but much less than ethinyl estradiol with levonorgestrel. Also, the content of free and total testosterone, dehydroepiandrosterone, androstenedione decreased significantly and the concentration of sex hormone binding globulin (SHBG) increased insignificantly. In carrying out a histological study of the endometrium, after Zoely's application for 13 cycles, no pathological changes were observed.
Nomegastrol with internal reception is rapidly absorbed and detects Cmax (7 ng / ml) in plasma after 2 hours. When taken once, absolute bioavailability, regardless of food intake, is 63%.
At 97-98% binds to albumin, while not binding to CSG or SHBG. Vss - 1,645 ± 576 liters.
It is metabolized by cytochrome P450 to several hydroxylated inactive metabolites, which in turn, together with nomegestrol, form sulfate and glucuronide conjugates. In the equilibrium state, the clearance is 26 l / h.
In the equilibrium state, T1 / 2, an average of 46 hours (from 28 to 83 hours). Nomegastrol is excreted by the means of the kidneys in less, and the intestines to a greater extent. Approximately 80% is displayed for 4 days and almost completely for 10 days.
The linearity of the pharmacokinetics of nomegestrol is dependent on the dose taken (in the range of 0.625-5 mg).
The pharmacokinetics of nomegestrol is not affected by SHBG. The equilibrium state is observed after 5 days. The average Css is 4 ng / ml. Cmax in plasma is about 12 ng / ml and manifests itself 90 minutes after administration.
Nomegastrol does not interact with the glycoprotein P and does not have a significant inhibitory or inducing action on cytochrome P450.
Estradiol, when taken orally, lends itself to a pronounced metabolism at its first passage. Absolute bioavailability, regardless of food intake, is about 5%.
Active throughout the body. The greatest content shows in the target organs of PG (sex hormones). In the blood, it binds to 37% with SHBG, 61% with albumin. Only 1-2% of estradiol is found in unbound form.
When administered orally, the exogenous estradiol is actively biotransformed and due to its similarity with endogenous estradiol, it is rapidly converted in the liver and intestine into several metabolites (mainly estrone). The latter are conjugated, undergoing hepatic-intestinal circulation. Oxidation occurs due to cytochrome P450 isoenzymes.
C max in the serum is observed after a lapse of 6 hours and is equal to 90 pg / ml. The average serum concentration is 50 pg / ml.
The blood is removed quickly, T1 / 2 fluctuates in a wide range and after IV introduction is 8.4 ± 6.4 hours.

Indications for use

Zoely's contraceptive pills are prescribed for contraception.

Contraindications

There are no precise data on the contraindications of oral contraceptives containing 17β-estradiol. However, it can be assumed that they correspond to those with ethinylestradiol-containing agents. When taking Zoely, if any of the following conditions occur, you should immediately stop receiving it.
    hypersensitivity to any of the pill components;
    thromboembolism of the pulmonary artery and thrombosis of deep veins, both in the present time and in the past;
    arterial thrombosis (pathology of the cerebral circulation, myocardial infarction);
    Migraine with focal neurologic symptoms, including in history;
    prodromal conditions (angina pectoris, transient ischemic attack), including in the anamnesis;
    multiple and / or expressed factors of arterial or venous thrombosis (severe hypertension, diabetes mellitus with vascular symptoms, severe dyslipoproteinemia);
    Pancreatitis in severe hypertriglyceridemia, both in the present 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, resistance of protein C, hyperhomocysteinemia and the presence of antiphospholipid antibodies (lupus anticoagulant, antibodies to cardiolipin);
    tumors and severe liver pathologies, including in the anamnesis;
    presumed or diagnosed malignant hormone-dependent neoplasms (tumors of the mammary gland or genital organs);
    period of breastfeeding;
    anticipated or diagnosed pregnancy;
    vaginal bleeding of unexplained etiology;
    lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
    postmenopause.
With extreme caution:
    a serious condition of depression, also in the anamnesis;
    diabetes mellitus, which passes without pathology of blood vessels;
    systemic lupus erythematosus;
    ulcerative colitis;
    Crohn's disease;
    pathology of liver function;
    hypertriglyceridemia present or traced in a family history;
    risk factors for ischemic heart disease (smoking, obesity, hypertension);
    presence in the family history of arterial embolism and venous thrombosis;
    Serious surgical operation and prolonged immobilization.

Side effects

As practice has shown, the tolerability of the contraceptive Zoely is basically good, and the safety of use is at the level of other combined drugs with a similar effect. Below are the possible negative effects that were observed when taking Zoely.
Metabolism:
    weight gain;
    fluid retention;
    increase or decrease in appetite.
CNS:
    decreased or increased libido;
    depression;
    migraine;
    violation of attention;
    headache.
Organs of vision:
    dry eyeballs;
    intolerance of wearing contact lenses.
Vascular system:
    tides.
Digestive system:
    bloating;
    nausea;
    increased activity of liver enzymes;
    dryness in the oral cavity.
Skin and subcutaneous tissues:
    acne;
    alopecia;
    hyperhidrosis;
    itching;
    seborrhea;
    dry skin;
    hypertrichosis;
    chloasma.
Musculoskeletal system:
    feeling of heaviness.
Genital organs and mammary glands:
    bleeding cancellation;
    menorrhagia;
    pain in the pelvic region;
    hypomenorrhoea;
    engorgement of mammary glands;
    metrorrhagia;
    galactorrhea;
    premenstrual syndrome;
    spasm of the uterus;
    seals in the mammary glands;
    dryness of the vagina and vulva;
    dyspareunia;
    discomfort in the vagina;
    unpleasant odor from the vagina.
Are common:
    edema;
    irritability;
    hunger.
Side effects observed with the use of COCs (combined oral contraceptives) that contain ethinylestradiol:
    increased blood pressure;
    arterial and venous thromboembolism;
    Chloasma;
    hormone-dependent tumors (breast cancer, liver tumors).
The frequency of diagnosing breast cancer in women using COC is slightly higher than that of women using other methods and contraceptives.
The relationship between breast cancer and COC intake is not established.

Instructions for use Zoely (Method and dosage)

Instructions on Zoely recommend that you take your daily pills inside at one time, without taking food intake into account. The tablets are taken in the sequence indicated on the blister and washed down with water.
For all women, the recommendations for the use of Zoely are the same. For 28 days, one tablet should be taken in a row every day. In the first 24 days, white tablets are taken, including active substances, after which, during the next 4 tablets of yellow color (placebo), which do not contain any active ingredients.
The initial tablet from each next blister (or package) should be taken the next day after the final tablet from the past blister. The drug is taken regardless of the absence or presence of withdrawal bleeding, which is usually observed 24-36 hours after the last white tablet is consumed and can continue until the next blister is used.

Start application

For women who did not previously take hormonal contraceptives, it is best to start taking Zoely on the first day of the menstrual cycle. In this case, additional contraceptives will not be needed. It is allowed to start from the 2nd-5th day of the cycle, but during the week, additional contraceptive barrier methods should be used.
When switching from other contraceptives of combined hormonal action (other COCs, transdermal patches, vaginal rings), in 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 tablets. With the previous use of the transdermal patch or vaginal ring, it is advisable to switch to Zoely tablets on the day they are removed (removed), but not later than during the next recommended patch or ring insertion.
With the correct and consistent use of previous contraceptive methods and with the guarantee of a lack of pregnancy, you can go to Zoely any day. To exceed the recommended non-hormonal period of the previous contraceptive method, it is impossible in any case.
In the case of switching from contraceptives containing one progestogen (implants, tablets, injections or IUDs - the intrauterine system) with the previous use of other tablets, you can go to Zoely on any given day, the day after stopping taking progestogen tablets. When switching from injection forms, Zoely tablets are replaced with the next recommended injection. The IUD or implant is removed on any convenient day, which Zoely begins to take. In all the cases described above, it is recommended to use additional barrier contraceptives for a week.
After an abortion in the first trimester, you can start using Zoely immediately after the procedure, with additional contraceptive measures are not required.
After abortion in the second trimester or birth, you should start using the drug between 21 and 28 days. In case of later application, it is better, during the week, to additionally use barrier contraceptives. At previous sexual contacts, it is necessary to exclude a possible pregnancy, before its application.

In case of missing the tablet

In the case of missing the next active (white) tablets, the following recommendations are given.
If the next reception is delayed by less than 12 hours, take the desired tablet without correction of the follow-up and time of taking the subsequent tablets.
At more than 12-hour delay, two rules are followed:
    active tablets should be taken for at least 7 consecutive days;
    The greater the number of missed active tablets and the closer the time of placebo use, the higher the possibility of pregnancy.
If you miss the 1st pill, take it as soon as possible, even if you take 2 subsequent tablets at the same time. Continue to continue the usual scheme of application, without additional measures.
If you miss 2 or more tablets, if there is no withdrawal bleeding during the placebo period, you should exclude pregnancy.
If you skip during the 1 st - 7 th days of the cycle, you should take the last missed tablet as early as possible, even if you take two subsequent tablets at the same time. Continue to continue the usual scheme of use, using barrier contraception, during the first week. In the case of sexual intercourse at this time, pregnancy is possible.
If you skip during the 8th - 17th day of the cycle, you should take the last missed tablet as early as possible, even if you take two subsequent tablets at the same time. Continue to continue the usual scheme of use, using barrier contraception, during the first week.
If you skip during the 18th - 24th day of the cycle, you should take the last missed tablet as early as possible, even if you take two subsequent tablets at the same time. You can not simultaneously take more than 2 active tablets. During the first week, barrier contraception should be used, and the first active pill from the next blister should be taken after the last active tablet from the previous one, that is, the mine phase of taking placebo. In this scheme, withdrawal bleeding most often occurs in the next phase of taking a placebo, however, during the current cycle, there may be spotting or breakthrough bleeding.
If you are unsure of the number of missed tablets, you need to use barrier contraceptives for at least a week of continuous intake of active tablets.
Passing the placebo tablets does not lead to a decrease in the contraceptive effect.
In gastrointestinal disease states, such as diarrhea or vomiting, the absorption process of Zoely's preparation may suffer, and therefore, it is necessary to resort to supplementary measures of contraception.
If there is vomiting for 3 to 4 hours after swallowing the pill, then this method is equated with the missed one. If this painful condition continues for several days, the above recommendations should be followed. If you do not want to change the typical application scheme, you can take an additional active tablet or tablet from another blister.
To delay the moment of menstrual bleeding, it is necessary to start taking white tablets from the next blister, immediately ending them from the previous blister, that is, excluding the placebo. Tablets of white color from the second blister can be taken completely. After taking a placebo from the second blister, resume the usual scheme of taking Zoely. In case of prolonged use, mucus discharge and / or breakthrough bleeding may occur. To shift the day of the onset of menstrual bleeding, it is possible to reduce the phase of taking placebo (maximum for 4 days). A smaller break increases the risk of bleeding from withdrawal and development of spotting blood and breakthrough bleeding.

Overdose

Serious side effects, with an overdose of the drug Zoely was not observed. 5-fold repeated doses and a single dose exceeding 40 times the dose did not reveal any negative effects.
You can allow the occurrence of nausea, vomiting, bloody discharge from the vagina.
Symptomatic therapy is indicated.

Interaction

In order to completely eliminate the possible interaction, you should carefully read the instructions for them, the instructions for the use of concurrently used drugs.
The interaction of COCs, including Zoely, with other drugs can cause bleeding and / or a decrease in contraceptive effectiveness. Below are the generalized interactions of other drugs with COCs.
Hepatic metabolism
Possible interaction with inducers of microsomal hepatic enzymes, which can cause increased clearance of PG (sex hormones). Definitely interaction with barbiturates, phenytoin, primidon, rifampicin, carbamazepine. Perhaps the interaction with Griseofulvin, Topiramate, Oxcarbazepine, Felbamate and preparations of St. John's wort perfumed. Also, influences on hepatic metabolism are possessed by agents that inhibit HIV proteases (ritonavir, etc.) and non-nucleoside reverse transcriptase inhibitors (Nevirapine, etc.), as well as their combinations.
With parallel reception of inducers of microsomal enzymes, and also during 28 days after their cancellation, it is necessary to use barrier contraception. In the case of long-term therapy with these drugs, consideration should be given to the appointment of another contraceptive method.
Inhibitors of microsomal enzymes, such as ketoconazole, can lead to an increase in plasma PG concentration.
Antibiotics
When combined with antibiotics, such as tetracyclines and ampicillin, there was a decrease in the effectiveness of COCs involving ethinylestradiol. The mechanism of this interaction is not fully understood. There are no reliable data on the interaction of COCs, which contain 17β-estradiol and antibiotics. Women who undergo antibiotic therapy (except for the use of Griseofulvin and Rifampicin) should use additional barrier contraceptives throughout the treatment period, as well as 7 days after. If the period of additional barrier contraception covers the time of the end of the intake of active pills, it is recommended to skip the placebo and immediately proceed to receive the active tablets 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 lowering, as in the case of Lamotrigine.

Terms of sale

You can buy Zoely without prescription.

Storage conditions

At a temperature of 2-30 ° C.
Shelf life - 36 months.

special instructions

The following data were obtained during epidemiological studies of COCs, which include ethinyl estradiol. Zoely's preparation includes 17β-estradiol, but the specific instructions described apply to it.

Vascular disorders

There was a correlation between the administration of COC and the risk of thromboembolism, as well as venous and arterial thrombosis (myocardial infarction, deep vein thrombosis, stroke, pulmonary embolism). On the general background, these conditions develop rarely, but during the first year of COC use, the risk of these complications is highest. One should know that 1-2% of cases of embolism and venous thrombosis end with death.
With the development of thrombosis may manifest:
    pain and / or swelling of the legs;
    sudden shortness of breath;
    severe pain in the chest, with or without, in the left arm;
    an unexpected cough;
    sudden loss of vision (partial or complete), uncharacteristic pronounced prolonged headaches;
    diplopia;
    dizziness;
    speech impairment;
    collapse (possibly with convulsions);
    weakness;
    motor disorders;
    sudden numbness of one side of the body;
    acute stomach syndrome.
Risk factors for embolism and venous thrombosis:
    advanced age;
    hereditary predisposition (data of the disease in a family history);
    obesity;
    thrombophlebitis;
    phlebeurysm;
    serious injury;
    serious surgical intervention;
    prolonged immobilization.
Risk factors for arterial thrombosis:
    smoking;
    advanced age;
    dyslipoproteinemia;
    arterial hypertension;
    obesity;
    migraine;
    atrial fibrillation;
    valvular heart 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 suspicion of thrombosis or its diagnosis, during the use of COC, the taking of tablets is canceled. For conditions requiring hospitalization (serious trauma, serious surgery, prolonged immobilization), it is better to stop using COC (one month before the scheduled operation), with the resumption of admission 14 days after the normal resumption of motor functions.
Also, the doctor's consultations will require such diseases as:
    diabetes;
    uremic hemolytic syndrome;
    systemic lupus erythematosus;
    ulcerative colitis;
    Crohn's disease;
    sickle-cell anemia.
Migraine enhancement is an indication for the immediate abolition of Zoely.

Tumors

Long-term use of ethinylestradiol-containing COCs, as a result of the research, increases the risk of developing cervical cancer, while the question of other factors of exposure remains open. Until the end, it is not clear what leads to an increased risk, COC, more frequent testing of the cervix, features of sexual intercourse (including barrier contraception) or their general combination.
There is no reliable information about the influence of Zoely on the development of ovarian and endometrial cancer.
A slight increase in the relative risk (RR) of breast cancer has been identified (RR = 1.24). This risk is reduced for 10 years after the cancellation of the COC. This increase may be due to earlier detection, COC effects, or a combination thereof.
Sometimes, when taking COC, the development of liver tumors (benign), even less often - malignant. In rare cases, these tumors, due to intra-abdominal bleeding, became a threat to the life of the patient. If liver enlargement, intense pain in the abdomen, symptomatology of intra-abdominal hemorrhage are detected, a possible tumor of the liver should be excluded.

Other states

Taking COC with hypertriglyceridemia or mentioning it in a family history, slightly increases the risk of pancreatitis.
Often observed a slight increase in blood pressure, which is rarely clinically significant. There is no established connection between COC administration and the formation of hypertension. However, in the case of its development, it is worth repealing the use of COCs and considering the appointment of adequate antihypertensive therapy. With the stabilization of blood pressure using 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 violations of blood pressure.
During the use of COCs and during pregnancy, complications or development were noted: pruritus and / or jaundice, cholelithiasis, gestational herpes, porphyria, hemolytic uremic syndrome, systemic lupus erythematosus, Sydenham's chorea, angioedema, and hearing loss.
The pathology of the liver may require the cancellation of the COC until the liver is completely normal.
In the case of recurrence of cholestatic jaundice, which was first diagnosed during pregnancy or taking sex steroids in the past, it is necessary to interrupt the use of COCs.
Zoely tablets, in healthy women, did not affect glucose tolerance and insulin resistance. However, during their admission, it is necessary to conduct thorough periodic examinations, especially for women suffering from diabetes.
Progression of ulcerative colitis, Crohn's disease and the course of depression were observed.
Occasionally, the development of chloasma, especially when mentioning this disease in history. In this case, it is better to avoid long exposure to the sun, solarium and other effects of ultraviolet radiation.

Consultations and surveys

Before the appointment of the COC it is necessary to get an idea of ​​the personal and family history of the woman, and also to exclude a possible pregnancy. Conduct blood pressure measurement and, if there are indications, 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 effects and side effects of COCs, and be informed that this method of contraception does not prevent the entry of HIV and other sexually transmitted diseases.

Efficiency reduction

The effectiveness of COCs can be reduced by missing active tablets, as well as gastrointestinal disorders.

Menses

The use of COC, especially in the first months, may be accompanied by smearing discharge or breakthrough bleeding. In this regard, the study of these manifestations should be appointed after the adaptation period (3 months). If these symptoms persist after three cycles of COC administration, they should be assumed to be nonhormonal in nature and prescribe a diagnosis to exclude possible tumors or pregnancy. It is possible to perform diagnostic curettage.
When studying the drug Zoely, bleeding developed rarely and was short-term, mild and poorly painful. In some cases, there was a lack of proper withdrawal bleeding when taking a placebo, without diagnosing pregnancy, which indicates its low probability even in the absence of bleeding cancellation. In the case of missing two bleeding, when taking the drug in accordance with the instructions, you need to exclude a possible pregnancy.

Zoely or Qlaira - which is better?

Despite some difference in the composition of active ingredients, nomegestrol + estradiol in Zoely and dienogest + estradiol valerate in Qlaira, the mechanism of action of both drugs is almost identical. Both preparations are microdosed, but Clayra, in each group of tablets (different in color), contains a different mass part of the active substances, whereas in Zoely the dosage in each active tablet is the same. These contraceptives practically repeat each other, both in contraindications and in side effects. In this regard, to give an unambiguous answer, which of these drugs is better, is not possible.
Oral contraceptives of hormonal action are selected individually and the best suitable drug can be prescribed only after the delivery of many tests and the passage of some studies. Do not forget about chronic diseases, medical conditions in the anamnesis (both in own and in family) and many other factors that can also affect the choice of a contraceptive.
With any of your choices between Zoely and Qlaira, it should be remembered that these drugs, with strict adherence to recommendations for their admission, are highly effective and cause fewer side effects than other contraceptives. But the choice of COC should be purely individual.

Children

There is no data on the safety of the use and efficacy of Zoely in children and adolescents (female) under 18 years of age.

With alcohol

Accepting alcohol within reasonable limits does not affect the effectiveness of Zoely.

In pregnancy and lactation

The use of the contraceptive drug Zoely in the case of pregnancy diagnosis is contraindicated.
When breastfeeding, taking Zoely tablets is not recommended. If it is necessary to use COC during lactation, it is necessary to stop feeding.

Reviews of Zoely

The pharmaceutical industry produces many hormonal contraceptives for oral administration. Considering the contraceptive pills Zoely reviews of doctors and gynecologists, while respecting all the rules for taking tablets, are mostly positive. Naturally, any doctor in his practice encountered many side effects of medicines, Zoely does not do without them. Although, compared to many other COCs, Zoely tablets show fewer side effects, and those that reveal are less pronounced.
Reviews about Zoely among women using this drug are very positive and this indicates that the active and auxiliary composition of the tablets has completely approached their body. Negative responses are found among women who have tried this contraceptive and eventually refused to use it due to various side effects.
Each organism is individual and has its own set of features, therefore, when choosing a contraceptive, one must rely on the experience of a gynecologist and pass all the tests recommended by him. In this case, you have much better chances to choose exactly "your" contraceptive, which not only protects from unwanted pregnancy, but also does not bring discomfort to your life.