Yaz (Jess) tabs #28

User manual for Yaz

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Yaz is a monophasic oral contraceptive drug with antiandrogenic properties.

Release form and composition

Yaz's dosage form - film-coated tablets: biconvex, round, the core at a break from almost white to white: active - light pink, on one side there is an engraving in the correct hexagon in the form of letters "DS"; placebo - white, engraved on one side in the correct hexagon in the form of letters "DP" (28 pcs., including 24 active and 4 placebos, in blisters, in a folding book 1 or 3 blisters; 30 pcs. each. (active tablets) in blisters, 1 blister each in flex-cartridges, in a cardboard box 1 or 3 flex-cartridges, possibly complete with a Clyk dispenser).
Active ingredients in 1 active tablet:
    ethinylestradiol (in the form of betadex clathrate) - 0.02 mg;
    drospirenone - 3 mg.
Auxiliary components in 1 tablet (active / placebo):
    core: lactose monohydrate - 48.18 / 23.205 mg, microcrystalline cellulose - 0 / 54.21 mg, corn starch - 28/0 mg, magnesium stearate - 0.8 / 0.585 mg;
    shell: talc - 0.3036 / 0.2024 mg, hypromellose - 1.5168 / 1.0112 mg, titanium dioxide - 1.1748 / 0.7864 mg, red dye iron oxide - 0.0048 / 0 mg.

Pharmacodynamics

Yaz is one of the combined hormonal contraceptives that have antimineralocorticoid and antiandrogenic effects.
The contraceptive effect is based on the interaction of various factors, the most important of which are changes in the properties of cervical secretions and suppression of ovulation.
The Pearl index, when used correctly, is less than 1 (it can increase if the recommended intake regimen is not followed).
During therapy, the menstrual cycle becomes more regular, painful periods develop less often, the intensity of bleeding decreases, which reduces the likelihood of anemia. In addition, according to the results of epidemiological studies, the use of combined oral contraceptives helps to reduce the likelihood of developing ovarian and endometrial cancer.
One of Yaz's active ingredients - drospirenone - has an anti-mineralocorticoid effect. Prevents an increase in body weight and the appearance of edema, which are associated with estrogen-induced fluid retention, as a result of which the drug is well tolerated. Drospirenone has a positive effect on premenstrual syndrome (PMS).
Also drospirenone has antiandrogenic activity and helps to reduce acne, oily hair and skin. This effect is similar to that of natural progesterone, which is produced by the body.
Drospirenone has no estrogenic, androgenic, antiglucocorticoid and glucocorticoid activity. All this, in combination with antiandrogenic and antimineralocorticoid action, provides drospirenone with a pharmacological and biochemical profile similar to natural progesterone.
Drospirenone, when used with ethinylestradiol, has a beneficial effect on the lipid profile, characterized by an increase in HDL.
Yaz can be taken in the usual ("24 + 4") or "flexible" (extended) mode, which consists in continuous intake of active pills for 120 days. Thus, the continuous period of taking can be from 24 to 120 days, and the break in taking the tablets should not be longer than 4 days. This therapy mode is only possible with the Clyk dispenser and flex cartridges. It allows you to achieve the maximum duration of periods without bleeding (up to 120 days) and reduce the total number of days of menstruation per year to 41 days.

Pharmacokinetics

Drospirenone

Absorption: the substance is rapidly and almost completely absorbed; bioavailability - 76–85% (food intake has no effect); Cmax (maximum concentration of the substance) in the serum is reached in about 1–2 hours and is about 38 ng / ml.
Distribution: after oral administration, there is a biphasic decrease in serum drospirenone with a T1 / 2 (half-life) of 1.6 ± 0.7 hours and 27 ± 7.5 hours, respectively. Does not bind to globulin, binding occurs with serum albumin. Cssmax (steady-state concentration during cyclic administration) of a substance in serum is reached between 7 and 14 days of therapy and is approximately 70 ng / ml.
Metabolism: The substance is extensively metabolized. Plasma metabolites are mainly represented by acidic forms of drospirenone. Also drospirenone is a substrate for oxidative metabolism, which is catalyzed by the cytochrome P450 isoenzyme CYP3A4.
Excretion: the rate of metabolic clearance of the substance in the serum is 1.5 ± 0.2 ml / min / kg. T1 / 2 - about 40 hours. It is displayed unchanged only in trace amounts. Excretion of metabolites occurs by the kidneys and through the intestines in a ratio of approximately 1.4: 1.2.

Ethinylestradiol

Absorption: completely and quickly absorbed; after a single oral administration Cmax is achieved in 1-2 hours and is approximately 88-100 pg / ml. The absolute bioavailability in the "first pass" through the liver is about 60%. The bioavailability of ethinyl estradiol may decrease concomitant food intake.
Distribution: the serum concentration of ethinyl estradiol decreases in two phases, the T1 / 2 of the terminal phase is 24 hours. The apparent Vd is about 5 l / kg. The substance is significantly, but not specifically, associated with serum albumin (approximately 98.5%) and causes an increase in serum SHBG concentrations.
Metabolism: The substance undergoes significant primary metabolism in the liver and intestines. The metabolic clearance rate is approximately 5 ml / min / kg.
Withdrawal: practically not displayed unchanged. Ethinyl estradiol metabolites are excreted through the intestines and kidneys in a ratio of 6: 4. T1 / 2 metabolites - 24 hours.

Indications for use

Yaz is prescribed for contraception, including for the concomitant treatment of moderate acne (acne vulgaris) and severe premenstrual syndrome.

Contraindications

Absolute:
    the presence of an increased risk of arterial / venous thrombosis;
    thrombosis (arterial and venous) and thromboembolism (including pulmonary thromboembolism, deep vein thrombosis, myocardial infarction), including a burdened history of these diseases, cerebrovascular disorders;
    the presence of a predisposition (hereditary or acquired identified) to arterial / venous thrombosis (including resistance to activated protein C, deficiency of antithrombin III, protein C and S), hyperhomocysteinemia, antibodies to phospholipids;
    adrenal insufficiency;
    malignant / benign liver tumors, including a burdened history;
    hormone-dependent malignant diseases, including the mammary glands or genitals, including diagnosed or suspected;
    severe / acute renal failure;
    vaginal bleeding with an unclear etiology;
    angina pectoris, transient ischemic attacks and other conditions preceding thrombosis, including a burdened history;
    migraine, accompanied by focal neurological symptoms, including a burdened history;
    liver failure and severe liver disease (before normalization of indicators);
    diabetes mellitus with vascular complications;
    glucose-galactose malabsorption, lactase deficiency, lactose intolerance;
    pregnancy (confirmed or suspected) and the period of breastfeeding;
    individual intolerance to the components of the drug.
Relative (diseases / conditions, in the presence of which the appointment of Yaz requires an assessment of the balance of benefits with risks):
    the presence of risk factors for the development of thrombosis and thromboembolism, including smoking, thrombosis, a burdened family history at a young age of myocardial infarction or cerebrovascular accident, migraine, extensive trauma, serious surgery, heart valve disease, heart rhythm disturbances, prolonged immobilization, dyslipoproteinemia, obesity , arterial hypertension;
    hereditary angioedema;
    other diseases in which peripheral circulation disorders may occur, including diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, phlebitis of superficial veins, sickle cell anemia, ulcerative colitis and Crohn's disease;
    liver disease;
    hypertriglyceridemia;
    postpartum period;
    diseases that first appeared or worsened during pregnancy or against the background of previous use of sex hormones, for example, cholestasis, jaundice, porphyria, cholelithiasis, otosclerosis with hearing impairment, herpes of pregnant women, Sydenham's chorea.

Instructions for the use of Yaz: method and dosage

Reception mode "24 + 4"

Yaz tablets must be taken daily (without interruption), at about the same time, 1 pc. a day with a little water. After 28 days (after the end of the tablets from the previous package), the intake is continued from the new package. Typically, withdrawal bleeding begins 2–3 days after the start of the placebo tablets (inactive, white) and may continue until the next pack begins.

"Flexible" reception mode

Tablets must be taken daily, at about the same time, 1 pc. a day with a little water. This mode can only be used with flex cartridges and a Clyk dispenser. Yaz is taken continuously for at least 24 days. At the decision of the patient, a break of 4 days (maximum) can be made between 25 and 120 days of therapy. The interval in therapy should be made no later than 120 days of continuous pill intake. Taking pills after each break should have a minimum duration of 24 days, a maximum of 120 days. Withdrawal bleeding usually develops during a break in taking the drug. If spotting spotting / bleeding from the vagina appears for 3 consecutive days in the period from 25 to 120 days, it is recommended to take a break of 4 days, which will reduce the total number of bleeding days.

Start taking the drug

    the lack of taking any hormonal contraceptives in the previous month: therapy begins on the 1st day of the menstrual cycle (i.e., on the 1st day of menstrual bleeding), additional contraceptive measures are not required. If the reception is started on the 2-5th day - the first 7 days it is recommended to use barrier methods of contraception;
    switching from other combined oral contraceptives, vaginal ring or contraceptive patch: it is preferable to start therapy the next day after taking the last active pill, but no later than the next day after the usual seven-day break (21 tablets in a package) or taking the last inactive tablet (in a package of 28 tablets ); vaginal ring or patch - therapy begins on the day of removal, but no later than the day when a new patch should be glued or a new ring inserted;
    transition from contraceptives containing only progestogens, or from a progestogen-releasing intrauterine contraceptive (the first 7 days it is recommended to use barrier methods of contraception): transition from "mini-pili" - you can start therapy any day (without interruption); transition from an implant or intrauterine contraceptive with gestagen - therapy begins on the day of their removal; switching from an injectable contraceptive - therapy begins on the day when the next injection is to be made;
    use after abortion (spontaneous / medical) and childbirth: abortion in the first trimester of pregnancy - you can start taking Yaz immediately after an abortion without additional protective measures; abortion in the second trimester and childbirth (in cases of absence of breastfeeding) - therapy can be started after 21-28 days (if therapy begins later, additional barrier methods of contraception are required for 7 days). In cases where sexual intercourse has already taken place, you need to wait for the first menstruation or first exclude pregnancy.

Termination of therapy

You can refuse to take Yaz at any time. In cases of planning pregnancy, it is recommended to wait for natural menstrual bleeding after the end of therapy.

Taking missed pills

If the placebo pills were missed during the “24 + 4” regimen, it is recommended to throw them away so that the period of taking them is not accidentally extended. No additional measures are required.
All further recommendations apply to taking active pills.
If the delay is less than 24 hours, the Yaz effect is not reduced. The missed single dose should be taken as soon as possible, without further changing the dosage regimen.
For longer periods, contraceptive protection may decrease. The more pills were missed and the closer the break is to the phase of taking inactive pills (“24 + 4” regimen) or to the pill-free period (“flexible” regimen), the higher the likelihood of pregnancy. In such cases, you need to adhere to the following recommendations:
    the break in taking Yaz should not be more than 7 days (for the "flexible" regimen and the "24 + 4" regimen, the recommended interval for taking active pills is 4 days);
    adequate suppression of the hypothalamic-pituitary-ovarian system is achieved after 7 days of continuous therapy.
Using the Clyk dispenser, you can control the pill intake. Also, the dispenser warns a woman in cases of the need to use an additional method of contraception (with an "exclamation mark" symbol on the display when you miss taking pills or if you take pills irregularly for more than 7 days in a row). In cases where more than one tablet is missed, it is recommended to consult a doctor.
If information is not available from the Clyk dispenser, or if you have doubts about its reliability, you should adhere to the recommendations below.
1–7 days, subject to any of the dosage regimens: you need to take the missed pill as soon as possible, even if it means taking 2 pills at once. Over the next 7 days, the woman should use additional protective measures. If sexual intercourse took place within 7 days before the date of the pass, the likelihood of pregnancy should be taken into account.
8-14 days with the "24 + 4" mode and 8-24 days with the "flexible" mode: you need to take the missed pill as soon as possible, even if it means taking 2 pills at once. Further, the dosage regimen should not be adjusted. If in the previous period the Yaz regimen was not violated, additional protective methods should not be used. Otherwise, or if ≥ 2 tablets are missed for 7 days, the recommendations for additional protective measures should be followed.
15-24 days with the "24 + 4" mode and 25-120 days with the "flexible" mode: during this period there is a possibility of a decrease in the effectiveness of the drug. One of the following two rules must be strictly observed. Moreover, if during the 7 days preceding the first missed pill, the drug use regimen was not violated, there is no need to use additional protective measures. Otherwise, you should use the first of the following schemes and additionally use a barrier method of contraception for 7 days.
    You need to take the missed dose as soon as possible, even if you have to drink 2 tablets at once. Mode "24 + 4" - subsequent pills are taken at the usual time, until the active pills in the package run out, after which you need to start taking active pills from the new package, skipping the placebo. Until the end of the intake from the new package, the appearance of withdrawal bleeding is unlikely, however, spotting / breakthrough bleeding is possible. "Flexible" regimen - the tablets must be taken daily for at least 7 days.
    Mode "24 + 4" - taking active pills can be interrupted, and after 4 days of interruption, start taking from a new package in the usual way. In cases where withdrawal bleeding did not occur while taking the placebo, it is necessary to confirm the absence of pregnancy. "Flexible" mode - it is permissible to take a four-day break (including the day of admission), and then start a new cycle. If the withdrawal bleeding does not occur in the next period of the break, pregnancy can be assumed.
Against the background of severe gastrointestinal disorders, the absorption of Yaz may be incomplete, and therefore additional protective measures must be taken.
If in the period 3-4 hours after taking the active tablet there was diarrhea or vomiting, you must adhere to the recommendations for skipping the tablets, or take an additional single dose.
To delay the onset of withdrawal bleeding, inactive pills should be skipped. Thus, this period can be extended for any period until the end of the tablets from the package. You can stop taking the active pills at any time you want by taking a break of 4 days.

Side effects

Possible adverse reactions when observing two modes of administration (> 10% - very often;> 1% and <10% - often;> 0.1% and <1% - infrequently;> 0.01% and <0.1% - rarely; <0.01% - very rarely; with an unspecified frequency - in cases where it is not possible to determine the frequency of occurrence of the violation from the available information):
    nervous system: often - headache; infrequently - paresthesia, dizziness; rarely - tremor, vertigo;
    immune system: rarely - allergic reactions; with an unknown frequency - hypersensitivity;
    cardiovascular system: often - migraine; infrequently - varicose veins, increased blood pressure; rarely - arterial thromboembolism, venous thromboembolism, tachycardia, epistaxis, phlebitis, fainting;
    digestive system: often - nausea; infrequently - vomiting, abdominal pain, diarrhea, dyspepsia, gastritis, flatulence; rarely - a feeling of heaviness in the abdomen, bloating, oral candidiasis, hiatal hernia, dry mouth, constipation;
    lymphatic system / blood: rarely - thrombocytopenia, anemia;
    biliary tract / liver: rarely - cholecystitis, biliary dyskinesia;
    parasitic / infectious diseases: rarely - candidiasis;
    musculoskeletal system: infrequently - muscle cramps, pain in the back and limbs;
    nutrition / metabolism: rarely - anorexia, hyperkalemia, increased appetite, hyponatremia;
    organ of vision: rarely - dryness of the mucous membrane of the eyes, conjunctivitis;
    mammary gland / genitals: often - metrorrhagia, pain in the mammary glands, absence of menstrual bleeding; infrequently - vaginal candidiasis, enlargement of the mammary glands, pain in the pelvic area, spotting / bleeding from the genital tract, fibrocystic formations in the mammary gland, painful menstrual bleeding, discharge from the genital tract, hot flashes (proceeding with a feeling of heat), vaginitis, scanty / heavy menstrual bleeding, abnormal Pap tests, dry vaginal mucosa; rarely - withdrawal bleeding, dyspareunia, vulvovaginitis, postcoital bleeding, cervical polyp, breast hyperplasia, uterine enlargement, neoplasm in the mammary gland, ovarian cyst, endometrial atrophy;
    subcutaneous tissue / skin: infrequently - acne, rash, itching; rarely - chloasma, alopecia, eczema, acne dermatitis, photodermatitis, striae, dry skin, hypertrichosis, erythema nodosum, contact dermatitis, skin nodules; with an unknown frequency - erythema multiforme;
    instrumental / laboratory data: infrequently - weight gain; rarely - weight loss;
    psyche: often - emotional depression, lability, decreased libido; infrequently - drowsiness, nervousness; rarely - insomnia, anorgasmia;
    others: infrequently - asthenia, increased sweating, edema (peripheral edema, generalized edema, facial edema); rarely - malaise.
It is also possible to develop disorders characterized by a very rare development, or having delayed symptoms (presumably there is a connection with Yaz's reception):
    pancreatitis against the background of hypertriglyceridemia;
    liver tumors (benign and malignant);
    tumors;
    erythema nodosum, erythema multiforme (only when using a "flexible" regimen);
    chloasma;
    appearance / aggravation of symptoms of hereditary angioedema;
    increased blood pressure;
    conditions that appear / worsen during therapy (link not proven), including jaundice and / or pruritus associated with cholestasis, porphyria, cholelithiasis, systemic lupus erythematosus, Sydenham's chorea, hemolytic uremic syndrome, herpes during pregnancy, otosclerosis-related decrease hearing;
    influence on insulin resistance / change in glucose tolerance;
    impaired hepatic function;
    Crohn's disease, ulcerative colitis;
    hypersensitivity reactions (including rash, urticaria).
It should be taken into account that when combined with other drugs (enzyme inducers), breakthrough bleeding / reduced contraceptive efficacy may develop.

Overdose

The main symptoms: vomiting, nausea, metrorrhagia, spotting spotting; there are no data on cases of serious overdose.
Therapy: symptomatic; there is no specific antidote.

Special instructions

When prescribing / conducting therapy, it is necessary to take into account the presence of conditions / risk factors (in cases of the appearance / aggravation of symptoms, Yaz is canceled):
    diseases of the cardiovascular system: with a combination of several risk factors or a high severity of one of them, the likelihood of mutual reinforcement should be taken into account; the risk of thrombosis and thromboembolism increases with smoking, obesity, a burdened family history, prolonged immobilization, extensive trauma and serious surgical interventions, against the background of migraine (in cases of increased severity / frequency of migraine, the drug is canceled), atrial fibrillation, dyslipoproteinemia, arterial valvular disease, hypertension, as well as with age;
    tumors: persistent human papillomavirus infection is one of the most significant risk factors for cervical cancer; the development of benign tumors during the period of therapy is observed only in rare cases, in extremely rare cases the occurrence of malignant liver tumors is noted; when carrying out a differential diagnosis for severe pain in the abdomen, signs of intra-abdominal bleeding or enlargement of the liver, these factors should be taken into account;
    hyperkalemia in the presence of an increased risk of its development: the first cycle of therapy should be carried out under the control of serum potassium concentration;
    pancreatitis against the background of hypertriglyceridemia or a burdened family history of this disease;
    clinically significant, persistent increase in blood pressure: Yaz should be canceled, therapy can be continued after reaching normal blood pressure with antihypertensive therapy;
    angioedema: onset / worsening of symptoms.
A physical examination and personal / family history should be performed prior to prescribing Yaz tablets. It is also necessary to exclude pregnancy. The volume of additional studies and the frequency of control examinations are determined individually. Control examinations, as a rule, are carried out at least once every 6 months.
Yaz does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
A decrease in the effectiveness of the drug can be observed when you skip taking active tablets, in cases of vomiting and diarrhea, as well as due to drug interactions.
Any irregular bleeding should only be assessed after an adaptation period of approximately 3 cycles (or 3 months for a “flexible” dosing regimen). In cases where irregular bleeding recurs or develops after previous regular cycles, in order to exclude pregnancy or malignant neoplasms, a thorough diagnostic examination should be carried out.
It must be taken into account that Yaz can promote the growth of some tumors and hormone-dependent tissues.

Application during pregnancy and lactation

According to the instructions, Yaz is contraindicated for use during pregnancy and lactation.
When planning a pregnancy, taking the drug can be interrupted at any time.
When pregnancy is diagnosed, therapy is immediately canceled, there is no information about the effect of therapy on the health of the mother and fetus.
Taking Yaz during lactation can lead to a decrease in the amount of breast milk and a change in its composition.

Childhood use

Yaz can only be prescribed after the onset of menarche. There is no need for dose adjustment.

With impaired renal function

Acute / severe renal failure is a contraindication to taking Yaz.

For violations of liver function

The use of the drug is contraindicated in the following cases:
    liver failure and severe liver disease (before normalization of indicators);
    malignant / benign liver tumors, including a burdened history.

Use in the elderly

For women after menopause, Yaz is not prescribed.

Drug interactions

Possible interactions:
    drugs that induce microsomal enzymes: an increase in the clearance of sex hormones, as a result of which there may be a decrease in the contraceptive effect / the appearance of breakthrough uterine bleeding (it is recommended to choose another non-hormonal method of contraception or use a barrier method of contraception, including a period of 28 days after discontinuation of such drugs);
    barbiturates, phenytoin, carbamazepine, primidone, rifampicin and probably felbamate, oxcarbazepine, griseofulvin, topiramate, as well as preparations containing St. John's wort: an increase in Yaz's clearance and a decrease in its effects;
    non-nucleoside reverse transcriptase inhibitors and many inhibitors of HIV protease or hepatitis C virus: increase / decrease in plasma concentration of active substances in the blood (sometimes significant);
    grapefruit juice, diltiazem, azole antifungals, verapamil, macrolide antibiotics and other moderate / strong CYP3A4 inhibitors: increased plasma concentration of Yaz's active substances;
    aldosterone antagonists or potassium-sparing diuretics: therapy should be carried out under the control of plasma potassium concentration in the blood (interaction has not been studied).

Terms and conditions of storage

Store at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life:
    flex cartridge of 30 tablets - 3 years;
    blister of 28 tablets - 5 years.

Reviews about Yaz

According to reviews, Yaz is an effective drug that, even with prolonged use, leads to the development of side effects only in rare cases. It is noted that it is important to take the drug at the same time. Also, in some cases, the use of vitamin complexes may be required to reduce the severity of adverse reactions. Most of the reviews indicate a normalization of menstruation, no weight gain and an improvement in skin condition.

Terms of sell

You don't need a prescription from a doctor to buy Yaz.