Evra® (Evra)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceNorelgestromine + EthinylestradiolNorelgestromine + Ethinylestradiol
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  • Evra®
    patch cutaneous 
    Johnson & Johnson, LLC     Russia
    • Dosage form: & nbsptransdermal patch
    Composition:

    Each transdermal patch contains 6 mg of noregestromine (HE) and 600 μg of ethinylestradiol (EE).

    Each patch within 24 hours gives 203 μg HE and 33.9 μg EE.

    Transdermal patch consists of the following layers:

    Excipients: an adhesive mixture of polyisobutylene and polybutylene - 221.4 mg, lauryllactate - 12 mg, crospovidone - 60 mg.

    Non-woven material of polyester - 34 mg, supporting film - 110.70 mg, protective film - 208.95 mg.

    Description:

    Square transdermal patch with beige matte backing, rounded corners, perforation along the tear line, colorless glue (adhesive) layer and transparent protective film. The inscription is stamped on the substrate "EVRA". The size of the patch of transdermal Eur® along the length and width (along with the protective film) is (51.0 + 1.0) mm x (51.0 + 1.0) mm.

    Pharmacotherapeutic group:contraceptive combination (estrogen + progestogen)
    ATX: & nbsp

    G.03.A.A.13   Norelgestromine and ethinylestradiol

    Pharmacodynamics:

    Oppresses the gonadotropic function of the pituitary gland, suppresses the development of the follicle and prevents the process of ovulation.The contraceptive effect is also enhanced by increasing the viscosity of the secretion of the cervix and reducing the susceptibility of the endometrium to the blastocyst. The Perl index (0.90) reflects the incidence of pregnancy in 100 women within 12 months of the application of the selected method of contraception.

    The frequency of pregnancy does not depend on age, race, but increases in women with a body weight of more than 90 kg.

    Pharmacokinetics:

    Absorption

    The concentrations of noregestromine and ethinylestradiol in the blood plasma reach steady values ​​48 hours after the application of the transdermal patch Eura® and are 0.8 ng / ml and 50 pg / ml, respectively.

    With the long-term use of the transdermal patch Eura®, the equilibrium concentration (Css) and the area under the "concentration-time" curve (AUC) slightly increase.

    At various temperature regimes and physical activity, there are no significant changes Css and AUC noregestromine, a AUC Ethinylestradiol slightly increases with physical activity, whereas Css remains unchanged.

    Target Values Css noreglestromine and ethinyl estradiol are maintained for 10 days using the transdermal patch Evra®, i.e.the clinical efficacy of the transdermal patch may persist even if the woman carries out its next replacement 2 full days after the scheduled seven-day period.

    Distribution

    Norelgestromine and norgestrel (serum noreglestromine metabolite) have a high degree (> 97%) of binding to plasma proteins. Norelgestromine binds to albumin, norgestrel binds primarily to sex hormone binding globulins. Ethinylestradiol has a high degree of binding to plasma albumin.

    Biotransformation

    Norelgestromine is metabolized in the liver, with the formation of the metabolite norgestrel, as well as various hydroxylated and conjugated metabolites. Ethinylestradiol is metabolized to various hydroxylated compounds and their glucuronide and sulfate conjugates.

    Progestogens and estrogens inhibit many enzymes of the cytochrome P-450 system (including CYP AP4, CYP 2C19) in microsomes of human liver.

    Elimination

    The average half-life of noregestromine and ethinylestradiol is about 28 and 17 hours, respectively. Metabolites of noregestromine and ethinylestradiol are eliminated by the kidneys and through the intestine.

    The influence of age, body weight and body surface area

    Values Css and AUC norelgestromine and ethinylestradiol slightly decrease with increasing age, body weight or body surface area.

    Indications:

    Contraception in women.

    Contraindications:

    Transdermal patch Euras ® is contraindicated in women under the following conditions:

    - thrombosis (arterial and venous) and thromboembolism at present or in the anamnesis (including thrombosis, deep vein thrombophlebitis, pulmonary embolism, myocardial infarction, stroke, cerebrovascular disorders);

    - conditions preceding thrombosis (including, transient ischemic attacks, angina pectoris) at present or in the anamnesis;

    - hereditary predisposition to venous, or arterial thrombosis, incl. resistance of activated protein C, deficiency of antithrombin III, deficiency of protein C, deficiency of protein S, hyperhomocysteinemia, the presence of antibodies to phospholipids (antibodies to cardiolipin, lupus anticoagulant), etc .;

    - multiple or severe risk factors for venous or arterial thrombosis, including complicated cardiac valve disease, subacute bacterial endocarditis, atrial fibrillation,cerebrovascular or coronary artery disease, uncontrolled arterial hypertension, smoking over the age of 35, hereditary dyslipoproteinemia, volumetric surgical intervention with prolonged immobilization, obesity (body mass index more 30 kg / m2 calculated as the ratio of body weight in kilograms to the square of rohundred in meters);

    - diabetes mellitus with vascular lesions;

    - migraine with focal neurological symptoms;

    - confirmed or suspected breast cancer;

    - diagnosed (including, in the anamnesis) estrogen-dependent malignant tumors (for example, endometrial cancer) or suspicion of them;

    - bleeding from the vagina of an unexplained etiology;

    - Cholestatic jaundice during pregnancy or jaundice when using hormonal contraceptives previously;

    - acute or chronic liver disease with impaired liver function;

    - benign or malignant liver tumors;

    - postpartum period (4 weeks);

    - known or suspected pregnancy;

    - lactation period;

    - hypersensitivity to the components of the drug;

    - age to 18 years.

    Carefully:

    - Venous or arterial thromboembolism in brothers, sisters or parents at a relatively young age;

    - Thrombophlebitis of superficial veins and varicose veins;

    - controlled arterial hypertension;

    - severe migraine without focal neurological symptoms;

    - Diabetes mellitus without vascular complications;

    - an existing (or in the anamnesis) severe depression;

    - existing (or in the anamnesis) cholelithiasis;

    - Chronic idiopathic jaundice;

    - Cholestatic jaundice in a family history (eg, Rotor syndrome, Dubi-on-Johnson syndrome);

    - acute impairment of liver function during previous pregnancy or previous use of sex hormones;

    - systemic lupus erythematosus;

    - ulcerative colitis;

    - Crohn's disease;

    - hypertriglycerelemia;

    - hemolytic-uremic syndrome;

    - Sydenham's chorea;

    - porphyria;

    - herpes during pregnancy;

    otosclerosis;

    - multiple sclerosis;

    - Chloasma;

    uterine myoma and endometriosis;

    - the presence of relatives of the first line of kinship with breast cancer.

    Pregnancy and lactation:Transdermal patch Euras ® is contraindicated during pregnancy and during breastfeeding.
    Dosing and Administration:

    Dose

    Nakozhpo

    To achieve the maximum contraceptive effect, women should apply the transdermal patch Evra® in strict accordance with the directions.

    Instructions regarding the beginning of the use of the transdermal patch of Eura® are given below in the section "How to start using the transdermal patch Eura®". At the same time, only one transdermal patch Eura® can be used.

    Each used transdermal patch Evra® is removed and immediately replaced with a new one on the same day of the week (the "day of replacement") on the 8th and 15th days of the drug cycle (weeks 2 and 3). Transdermal patch Evra® can be changed at any time of day of replacement. During the 4th week, from the 22nd to the 28th day of the cycle, the transdermal patch Eura® is not used.

    The new contraceptive cycle begins the day after the end of the 4th week; the next transdermal patch of Eura® should be glued, even if the menstrual bleeding "cancellation" was not or it did not end.

    Under no circumstances should a break in wearing a transdermal patch of Evra® be more than 7 days, otherwise the risk of pregnancy increases.In such situations, the barrier method of contraception must be used simultaneously for 7 days, since the risk of ovulation increases every day exceeding the recommended duration of the period free from the use of the transdermal patch Eura®. In the case of sexual contact during such an increased period, the probability of conception is very high.

    Mode of application

    Transdermal patch Evra® should be applied to clean, dry, intact and healthy skin of the buttocks, abdomen, outer surface of the upper part of the upper arm or the upper part of the trunk with minimal hair, in areas where it does not come into contact with closely fitting clothing.

    To avoid possible irritation, each subsequent transdermal patch of Eura® should be glued to another area of ​​the skin, this can be done within the same anatomical area. It is inadmissible to use a transdermal patch on the area of ​​the mammary glands.

    Transdermal patch Evra® should be pressed tightly, so that its edges are in good contact with the skin. To prevent a decrease in the adhesive properties of the transdermal Euras® patch, makeup should not be applied,creams, lotions, powders and other local remedies on those areas of the skin where it is glued or glued.

    A woman should examine the transdermal patch Eura® daily in order to be sure of its firm attachment.

    The used transdermal patch should be disposed of carefully in accordance with the recommendations.

    Disposal considerations

    Since the transdermal patch used contains significant amounts of active ingredients, it should be disposed of carefully. To do this, separate the special adhesive film from the outside of the sachet. Place the used transdermal patch in the sachet so that its sticky side is facing the colored area on the sachet, and lightly pressed to seal. The sealed sachet is discarded. The used transdermal patch should not be thrown into the toilet or sewer.

    How to start using the transdermal patch Evra®

    If during the previous menstrual cycle the woman did not use the hormonal contraceptive

    Contraception with a transdermal patch of Eura® begins on the first day of menstruation.Glue one skin transdermal Euras ® to the skin and use it all week (7 days). The day of gluing the first patch of transdermal Evra® (1st day / day of the beginning) determines the subsequent days of replacement. Day replacement will occur on the same day each week (8th and 15th days of the cycle). On the 22nd day of the cycle, the transdermal patch is removed, and from the 22nd to the 28th day of the cycle the woman does not use the transdermal patch Evra®. The next day is considered the first day of a new contraceptive cycle.

    If a woman starts using a patch of transdermal Evra® not on the first day of menstruation, then barrier methods of contraception should be used simultaneously during the first 7 days of the first contraceptive cycle.

    If a woman changes from a combined oral contraceptive to a transdermal patch Eura®

    Transdermal patch Evra® should be glued on the skin on the first day of menstrual bleeding "cancellation", which began after discontinuation of the combined oral contraceptive. If menstrual bleeding does not begin within 5 days after taking the contraceptive pill, then pregnancy should be excluded before using the transdermal patch Eura®

    If the application of Evra® begins after the first day of menstrual bleeding, then for 7 days it is necessary to use barrier methods of contraception at the same time.

    If, after taking the last contraceptive pill, more than 7 days have passed, the woman may experience ovulation, and therefore she should consult a doctor before starting to use the transdermal patch Eura®. Sexual contact during this extended period, free from taking contraceptive pills, can lead to the onset of pregnancy.

    If a woman switches from contraceptive medications containing only progestogen to a transdermal patch Eura®

    A woman can switch from using a progestogen only (on the day of removal of the implant, on the day the next injection is to be made), but within the first 7 days of using the transdermal patch Eura®, a barrier method should be used to enhance the contraceptive effect.

    After an abortion or miscarriage

    After an abortion or miscarriage before the 20th week of pregnancy, you can immediately begin using a transdermal patch Eura®.If a woman starts using a transdermal patch Eura® immediately after an abortion or a miscarriage, it is not necessary to resort to an additional method of contraception. A woman should know that ovulation can occur within 10 days after an abortion or a miscarriage.

    After an abortion or miscarriage at the 20th week of pregnancy, or later, a transdermal patch of Euras® can be started on the 21st day after the abortion or miscarriage, or on the first day of the first menstrual period (whichever comes first).

    After childbirth

    Women who do not breastfeed can begin using the transdermal patch Eura® not earlier than 4 weeks after giving birth. If a woman starts using a transdermal patch Evra® later, then within the first 7 days sheshould additionally use the barrier method of contraception. If there was sexual contact, then you must exclude pregnancy before starting the application of a patch of transdermal Evra®, or the woman should wait for the first menstruation.

    With full or partial peeling off the transdermal patch Evra®

    If the transdermal patch Evra® completely or partially peeled off, then an insufficient amount of its active ingredients enters the blood.

    Even with a partial peeling off of the transdermal patch Eura®

    - less than a day (up to 24 h): reattach the transdermal patch Eura® to the same place, or immediately replace it with a new transdermal patch Eura®. No additional contraceptives are required. The next transdermal patch of Eura® must be glued to the usual "replacement day".

    - more than 24 hours and longer, and if the woman does not know exactly when the transdermal patch Evra® has partially or completely peeled off: pregnancy may occur. A woman should immediately start a new cycle, pasting a new transdermal patch Eura® and counting this day as the first day of the contraceptive cycle. Barrier methods of contraception should be applied simultaneously only in the first 7 days of a new cycle.

    Do not try to paste the transdermal patch of Eura® again if it has lost its adhesive properties; instead, you need to immediately attach a new transdermal patch of Eura®.Do not use additional adhesive tapes or bandages to hold the transdermal patch Eura® in place.

    If you missed the regular days of replacement of the transdermal patch of Eur®

    At the beginning of any contraceptive cycle (1st week / 1st day):

    At an increased risk of pregnancy, a woman should glue the first transdermal patch of Evra® a new cycle as soon as she remembers it. This day is considered a new "1st day" and a new "day of replacement" is counted. Barrier methods of contraception should be applied simultaneously during the first 7 days of a new cycle. In the case of sexual contact during an extended period without the use of contraception, conception may occur.

    In the middle of the cycle (2nd week / 8th day or 3rd week / 15th day):

    - from the day of replacement, one or two days (up to 48 hours) passed: a woman should immediately glue a new transdermal patch of Eura®. The next transdermal patch of Eura® must be glued to the usual "replacement day". If, within 7 days preceding the first missed attachment day of the transdermal patch of Euras®, the woman correctly applied the transdermal patch Evra®, then additional contraception is not required;

    - from the date of replacement more than two days (48 hours or more) have passed: there is an increased risk of pregnancy. The woman should stop the current contraceptive cycle and immediately begin a new 4-week cycle, pasting a new transdermal patch of Eura®. This day is considered a new "1st day" and a new "day of replacement" is counted. Barrier contraception should be applied simultaneously during the first 7 days of the new cycle;

    - at the end of the cycle (week 4 / day 22): if the transdermal patch Evra® was not deleted at the beginning of the 4th week (22nd day), then it should be deleted as soon as possible. The next contraceptive cycle should begin on the usual "replacement day", which is the next day after the 28th day. Additional contraception is not required.

    Change day of replacement

    If a woman considers it necessary to postpone the replacement day, the current cycle should beis complete. Removal of the third patch of transdermal Evra® should be performed on a normal day of replacement. During a week free from the use, a woman can choose a new day of replacement by gluing the first transdermal patch of Evra® the next cycle on the selected day.The period free from the use of the transdermal patch of Eura® should in no case be more than 7 days. The shorter this period, the higher the likelihood that a woman will not have another menstrual bleeding, and during the next contraceptive cycle acyclic copious or scanty bleeding may occur.

    Side effects:

    The most common side effects observed in clinical trials were unpleasant sensations in the mammary glands, headache, reactions at the site of application and nausea. The most frequent side effects that led to the withdrawal of the transdermal patch of Eura were reactions at the site of application, discomfort in the mammary glands (including discomfort and pain in the mammary glands, swelling of the mammary glands), nausea, headache and emotional instability. Also in the course of clinical trials, the following side effects were detected, less than one percent of patients: galactorrhea, symptom complex similar to premenstrual syndrome, changes in vaginal secretion, insomnia, change in libido.

    The frequency of undesirable effects was classified as follows:

    Very often ≥ 1/10

    Often ≥ 1/100 and <1/10

    Infrequently ≥ 1/1000 and <1/100

    Rarely ≥1/10000 and <1/1000

    Very rarely <1/10000, including individual messages

    The following undesirable effects were noted:

    General disorders and reactions at the site of application:

    Often: skin reactions at the site of application (burning, dryness, scars, bruises, photosensitivity, peeling, swelling, crusting, paresthesia, bleeding, inflammation, densification, atrophy, excoriation, loss of sensitivity, infection, ulcer, eczema, nodule formation, pustules, discharge, abscess, tumor-like growth, erosion, unpleasant odor), fatigue, malaise.

    Infrequently: irritation, peripheral edema, hypersensitivity;

    Disorders from the central and peripheral nervous system:

    Often: headache;

    Often: dizziness, migraine;

    Rarely: disorders of cerebral circulation (including transient disorders cerebral circulation; ischemic and hemorrhagic strokes, occlusions and stenoses of cerebral vessels), migraine with focal neurological symptoms, subarachnoid hemorrhage, dysgeusia.

    Hcardiovascular system disorders:

    Infrequently: arterial hypertension;

    Rarely: venous thrombosis; thrombophlebitis of the veins of the extremities;

    Rarely: infarction myocardium, arterial thrombosis and thromboembolism, hypertensioncrisis.

    Disorders from the gastrointestinal tract:

    Often: nausea;

    Often: pain at belly, vomiting, diarrhea, swelling abdomen;

    Rarely: colitis

    Disorders from the reproductive system and mammary glands:

    Often: a feeling of discomfort in the mammary glands, an increase in milkswelling, swelling, pain, swelling, increased sensitivity, fibrocystic breast changes;

    Often: painful bleeding "cancellation", spasm of the uterus, vaginal dischargetion;

    Infrequently: breast tumor, galactorrhea, dry mucosacaries and vulva, discharge from the genital tract;

    Rarely: absence of menstrual bleeding, rare menstrualsimilar bleeding;

    Rarely: cervical dysplasia, meager / copious menstrual crouphemorrhage, acyclic bleeding, suppression of lactation.

    Disturbances from the skin and subcutaneous tissues:

    Often: itching, skin reactions, acne;

    Infrequently: alopecia, allergic dermatitis, erythema, chloasma, eczema, reaction photosensitivity, hives;

    Rarely: generalized itching, erythematous rashes, itching rash;

    Rarely: angioedema, polyforma, erythema nodosum, exfoliationrash, seborrheic dermatitis.

    Disorders from the metabolism and nutrition:

    Often: weight gain

    Rarely: hyperglycemia, increased appetite, insulin resistance.

    Hepatobiliary disorders:

    Infrequently: cholelithiasis, cholecystitis;

    Rarely: cholestasis, defeat liver, cholestatic jaundice.

    Disorders from the organs of vision:

    Rarely: intolerance to contact lenses.

    Mental disorders:

    Often: emotional instability, anxiety, affect, aggression, depress, tearfulness;

    Infrequently: insomnia, changes in libido;

    Rarely: anger, frustration.

    Neoplasms of benign, malignant and indeterminate etiology (including cysts and polyps):

    Rarely: leiomyoma the uterus;

    Rarely: cancer dairy glands, cancer neck " the uterus, fibroadenoma dairy jellythyroid, adenoma of the liver, neoplasm of the liver.

    From the musculoskeletal system:

    Often: muscular convulsions.

    Infections and infestations:

    Often: fungal infections the vagina;

    Rarely: pustular rashes.

    Change in laboratory indicators

    Rarely: change in the concentration of cholesterol in the blood, change in concentration glucose in the blood, an increase in the concentration of low-density lipoproteins.

    Overdose:

    Symptoms: nausea, vomiting, bleeding from the vagina.

    Treatment: there is no specific antidote. Remove the transdermal patch and perform symptomatic therapy.

    Interaction:

    Changes in contraceptive efficacy associated with the joint use of transdermal patch Eura® with other drugs

    In the event that a woman using the transdermal patch Evra® takes a medicinal product or herbal medicinal product that induces microsomal liver enzymes (with the exception of rifampicin), including CYP3A4, metabolizing contraceptive hormones,it should be warned about the need to use additional contraception or another method of contraception during the whole reception of such medications, and also within 7 days after its termination. Women taking rifampicin, should use the barrier method of contraception in addition to the transdermal patch Eura® throughout the time of rifampicin intake, and also within 28 days after discontinuation. Women taking antibiotics (with the exception of rifampicin) should use the barrier method of contraception until the 7th day after their withdrawal. With long-term therapy with these drugs for more than 3 weeks, the new contraceptive cycle begins immediately, without the usual period, free from the use. Drugs or herbal remedies that induce microsomal liver enzymes reduce the concentration of contraceptive hormones in the blood plasma and can reduce the effectiveness of transdermal patch Eura® or cause acyclic bleeding. Some drugs or herbal medicines that may decrease the effectiveness of hormonal contraceptives include:

    - some antiepileptic drugs (for example, carbamazepine, eslcarbazepine acetate, felbamate, oxcarbazepine, phenytoin, Rufinamide, topiramate)

    - (phosphate) aprepitant

    - barbiturates

    - bosentan

    - griseofulvin

    - Some of the HIV protease inhibitors or combinations thereof (eg, nelfinavir, ritonavir, ritonavir-boosted protease inhibitors)

    - modafinil

    - some non-nucleoside reverse transcriptase inhibitors (eg, nevirapine)

    - rifampicin and rifabutin

    - preparations of St. John's wort perfumed

    The induction effect can persist for 4 weeks after the cancellation of the herbal preparation containing St. John's Wort.

    HIV protease inhibitors and nucleoside HIV reverse transcriptase inhibitors: in some cases, when combined with HIV protease inhibitors and nucleoside HIV reverse transcriptase inhibitors, significant changes (increase or decrease) in plasma levels of estrogen and progestin have been observed.

    Antibiotics: there are reports of pregnancy hormonal contraceptives and antibiotics, but during the pharmacokinetic clinical studies, no significant effect of antibiotics on the concentration of synthetic steroids in blood plasma was detected.During the study of the pharmacokinetic interaction of drugs, oral administration of 500 mg of tetracycline hydrochloride 4 times a day 3 days before the application of the transdermal patch Eura® and for 7 days after its administration had no significant effect on the pharmacokinetics of noregstromine or ethinylestradiol.

    Increase in the level of hormones in the plasma kroen, associated with the joint use of drugs

    Some drugs and grapefruit juice can increase the level of ethinyl estradiol in blood plasma, provided they are co-administered. These include:

    - paracetamol

    - ascorbic acid

    - inhibitors CYP3A4 (including itraconazole, ketoconazole, voriconazole, fluconazole and grapefruit juice)

    - etorikoksib

    - some HIV protease inhibitors (for example, atazanavir, indanavir)

    - inhibitors HMG-CoA-reductase (including atorvastatin and rosuvastatin)

    - some non-nucleoside reverse transcriptase inhibitors (eg, etravirine)

    Changes in the levels of drugs administered in conjunction with contraceptives in blood plasma

    Data obtained from the use of oral hormonal contraceptives,also indicate the possibility of their effect on the pharmacokinetics of some other drugs, provided they are used together. To drugs, the levels of which in the blood plasma can be increased (in connection with inhibition CYP), relate:

    - ciclosporin

    - omeprazole

    - prednisolone

    - selegiline

    - theophylline

    - tizanidine

    - voriconazole

    Drugs, the levels of which in the blood plasma can be reduced (due to the induction of glucuronidation), include:

    - paracetamol

    - clofibrate

    - lamotrigine (see below)

    - morphine

    - salicylic acid

    - temazepam

    Lamotrigine: it was found that, probably due to the induction of lamotrigine glucuronin, the combined hormonal contraceptives significantly reduced the lamotrigine plasma concentrations when administered together. This can provoke an attack of seizures; it is possible to correct doses of lamotrigine.

    It is recommended to advise doctors about labeling of co-administered medications in order to obtain further information about their interaction with hormonal contraceptives or the potential for alteration of enzymes with the possible need for dose adjustment.
    Special instructions:

    Before starting the transdermal patch, you need to collect a detailed medical history of the next of kin, including data on heredity, and exclude pregnancy. It is necessary to conduct a general (including measurement of blood pressure, breast examination, mammography) and gynecological examination. If you suspect a hereditary predisposition to venous thromboembolism (in the presence of venous thromboembolism in a brother, sister or parents), a woman should be referred for advice to a specialist.

    When appointing a patch of transdermal Evra®, it is necessary to take into account the likelihood of thromboembolic complications (thrombophlebitis, venous thromboembolism, including pulmonary embolism, cerebrovascular diseases and thrombosis of the retina vessels). At the slightest manifestation of the symptoms of any of these diseases, the use of the transdermal patch Eura® should be immediately discontinued.

    There have been several epidemiological studies assessing the risk of venous thromboembolism (VTE) among women,using a patch transdermal Evra ®, in comparison with women taking various oral contraceptive drugs. The likely index of occurrence of VTE among women using the transdermal patch of Eura® ranged from 0.9 (the risk does not increase) to 2.4 (the risk increases by 2.4 times).

    The risk of vascular complications is increased in women with thrombophlebitis of superficial veins and with varicose veins, and also with obesity (body mass index more than 30 kg / m2).

    The states of prolonged immobilization or surgical interventions on the lower limbs, obesity or the presence of a family history of thromboembolic complications can increase the risk of venous thromboembolic complications. In this regard, it is recommended to stop the use of hormonal contraceptives 4 weeks before surgery (during a planned operation) and within two weeks after an emergency surgery, as well as during and after prolonged immobilization.

    Some epidemiological studies have revealed an increased risk of developing breast cancer with long-term use of combined hormonal contraceptives especially at a young age, before the onset of the first pregnancy.Some studies have shown that taking hormonal contraceptives is associated with an increased risk of developing cervical tumors, including cancer.

    In women who use combined contraceptives, benign liver adenomas may occur, which can cause life-threatening intra-abdominal bleeding. The risk of their appearance increases after 4 or more years of use. In case of severe pain in the upper abdomen, enlargement of the liver or symptoms of intra-abdominal bleeding, differential diagnosis should be performed to exclude a liver tumor.

    If there is pharmacologically uncontrolled arterial hypertension in women during the application of combined hormonal contraceptives, the drug should be canceled, the use of a transdermal patch can be resumed after the normalization of blood pressure.

    Hormonal contraceptives can affect certain indicators of functional tests of endocrine glands, liver function markers and blood components:

    - increase the concentration of prothrombin and coagulation factors VII, VIII, IX and X; the levels of antithrombin III decrease; protein levels decrease S; aggregation of platelets increases;

    - increases the content of thyroxine-binding globulin, which causes an increase in the concentration of the total thyroid hormone. The binding of free triiodothyronine (T3) with an ion-exchange resin decreases, as evidenced by the increase the concentration of thyroxin-binding globulin, the concentration of free thyroxine (T4) does not change;

    - levels of other binding proteins may be increased in plasma;

    - increases the concentration of globulins, binding sex hormones, which leads to an increase in the concentrations of common circulating endogenous sex hormones. At the same time, the concentrations of free or biologically active sex hormones decrease or remain unchanged;

    - high cholesterol concentrations of high-density lipoproteins (X-HDL), total cholesterol, low-density lipoprotein (LDL-C) cholesterol and triglycerides, while the ratio of LDL-C / HDL-C may remain unchanged;

    - glucose tolerance decreases;

    - the serum folate concentrations decrease, which can have potentially clinically significant consequences in the case of pregnancy soon after hormonal contraceptive withdrawal.Currently, all women who are aware of their current deficiency of folic acid, it is recommended to take it at an early pregnancy.

    Combined hormonal contraceptives can affect the resistance of peripheral tissues to insulin and glucose tolerance, but there is no evidence of a need to change the regimen of diabetes therapy during the application of combined hormonal contraceptives. However, it is necessary to closely monitor the health status of women with diabetes mellitus, especially at an early stage of using the transdermal patch Eura®.

    There are clinical observations of cases of retinal vascular thrombosis associated with the use of hormonal contraceptives. The intake of oral contraceptives should be discontinued in the event of an unexpected transient, partial or complete loss of vision; seizures of vision or diplopia; edema of the papilla or disruption of the integrity of the vessels of the retina. Appropriate diagnostic and therapeutic measures should be taken immediately.

    Chloasma: women who have hyperpigmentation of the facial skin during pregnancy should avoid exposure to sunlight or artificial ultraviolet light during the application of the transdermal patch of Evra®, since such hyperpigmentation is not completely reversible.

    Women should be informed that the transdermal patch Euras ® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

    When using combined hormonal contraceptives, the appearance of smearing bleeding may occur, especially in the first 3 months of contraception.

    If, in the case of a long-term use of the transdermal Eurasian patch, acyclic spotting for a long time is observed, or if there are such discharges after previous regular cycles, other reasons should be taken into account, in addition to using a transdermal patch. It is necessary to remember the non-hormonal causes of the violation of the cycle of the drug and to more carefully examine a woman to eliminate organic diseases and pregnancy.

    There may be no menstrual bleeding of "cancellation" in some women during the period free from the use of the transdermal patch of Eura®. If a woman violated the instructions for use during the period preceding the first non-compliant menstrual bleeding "cancellation" or if she did not have two menstrual bleeding "cancellations" after interruptions of transdermal patch application, then pregnancy should be excluded before continuing the use of the transdermal patch Eura ®.

    In some women, the abolition of hormonal contraceptives can provoke a lack of menstrual bleeding "cancellation" or rare menstrual like bleeding, especially if they are present before the onset of hormonal contraception.

    If the use of the transdermal patch of Eura® causes skin irritation, it is possible to glue a new transdermal patch of Eura® onto another area of ​​the skin and carry it until the next day of replacement. Simultaneously, only one transdermal patch can be used.

    Transdermal patch Eura® can not be damaged or cut.If the transdermal patch Evra® is damaged (the shape is changed, the transdermal patch is cut off or there are other visible lesions), then the effectiveness of the contraceptive effect may decrease.

    In women with a body weight of 90 kg or more, the effectiveness of contraception can be reduced.

    Smoking during the use of a transdermal patch of Eura® increases the risk of cardiovascular side effects (see "Side Effects" section). Women who use a transdermal patch Evra® it is strongly recommended to refrain from smoking.

    The safety and efficacy of the transdermal patch of Euras ® are only for women 18 years before the onset of menopause.

    During the application of the transdermal patch Eura®, women should undergo regular preventive medical examinations. The frequency and volume of these examinations should be based on appropriate instructions, and should be individually selected for each woman on the basis of the clinical picture, but at least 1 time in six months.

    Effect on the ability to drive transp. cf. and fur:

    Transdermal patch Evra® does not influence or slightly affects the ability to drive and other mechanisms.

    Form release / dosage:

    Transdermal patch, 6 mg of noregestromine (HE) and 600 μg of ethinylestradiol (EE).

    Packaging:

    One patch transdermal into a package of laminated paper and aluminum foil, 3 packages are stacked together in a transparent plastic film bag.

    For 3 or 9 transdermal patches (1 or 3 packs) in a cardboard pack, along with instructions for use and special labels on the calendar to mark the period of use of the transdermal patch.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep in original packaging.

    Keep out of the reach of children.

    Shelf life:

    2 years. Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N016120 / 01
    Date of registration:26.01.2010
    The owner of the registration certificate:Johnson & Johnson, LLC Johnson & Johnson, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspJohnson & Johnson LLC Johnson & Johnson LLC Russia
    Information update date: & nbsp06.08.2015
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