Active substanceLevonorgestrel + EthinylestradiolLevonorgestrel + Ethinylestradiol
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  • Dosage form: & nbsp

    coated tablets

    Composition:

    Composition for 1 tablet, coated:

    Tablets I:

    Active substances:

    Levonorgestrel 0.150 mg

    Ethinylestradiol 0.030 mg

    Excipients:

    - in the core of the tablet: silicon dioxide colloid - 0.275 mg, magnesium stearate - 0.550 mg, talc - 1,100 mg, corn starch - 19,895 mg, lactose monohydrate - 33,000 mg;

    - in the tablet shell: sucrose - 22,459 mg, talc - 6,826 mg, calcium carbonate - 3,006 mg, titanium dioxide - 1,706 mg, kopovidone - 0,592 mg, macrogol 6000 - 0,148 mg, silicon dioxide colloid - 0,146 mg, povidone - 0,088 mg, carmellose sodium - 0.029 mg .

    Tablets II:

    Core:

    iron fumarate 76.05 mg, silicon dioxide colloid - 0.50 mg, croscarmellose sodium - 0.60 mg, magnesium stearate - 1.20 mg, povidone - 2.40 mg, talc - 2.40 mg, potato starch - 2 , 10 mg, corn starch - 10.20 mg, lactose monohydrate - 24.55 mg.

    Sheath: sucrose 38.295 mg, talc 11.752 mg, calcium carbonate 5.103 mg, titanium dioxide 2.226 mg, copovidone 1.124 mg, silicon dioxide colloid 0.240 mg, iron oxide red oxide 77491 / E172 0.787 mg , povidone - 0.144 mg, macrogol 6000 - 0.281 mg, carmellose sodium - 0.048 mg.

    Description:

    Pills

    White, round biconvex tablets covered with a sheath, the surface on the fracture is white.

    Tablets-Placebo

    Russet, glossy, round biconvex tablets, coated. At the break of a light brown color.

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

    G.03.A.B   Progestogens and estrogens (combinations for sequential administration)

    G.03.A.B.03   Levonorgestrel and ethinyl estradiol

    Pharmacodynamics:

    Oral monophasic combined estrogen-gestagen contraceptive drug. When ingested, depresses the pituitary secretion of gonadotropic hormones.The contraceptive effect is associated with several mechanisms. As a progestogen component (progestin) contains a derivative of 19-nortestosterone - levonorgestrel, surpassing the activity of the hormone of the yellow body progesterone (and synthetic analogue of the latter - pregnin), acts at the level of receptors without preliminary metabolic transformations. The estrogen component is ethinyl estradiol. Under the influence of levonorgestrel comes the blockade of releasing the releasing factors (luteinizing and follicle-stimulating hormones) of the hypothalamus, suppressing the secretion of the gonadotrophic hormones by the pituitary gland, which leads to inhibition of maturation and the release of the ovum ready for fertilization (ovulation). The contraceptive effect is enhanced by ethinyl estradiol. Preserves high viscosity of the cervical mucus (making it difficult for sperm to enter the uterine cavity). Along with the contraceptive effect with regular intake normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including. tumor nature.

    Pharmacokinetics:

    Levonorgestrel

    Levonorgestrel is rapidly absorbed (the time of full absorption is less than 4 hours). There is no effect of the first passage through the liver.

    Biological availability is almost 100%. Most of the levonorgestrel binds to blood plasma proteins, mainly with albumins and with globulins that bind sex steroids (GSPC).

    The time to reach the maximum concentration of levonorgestrel in plasma (TCmah) is 2 hours. The half-life of levonorgestrel (T1 / 2) varies from 8 to 30 hours (an average of 16 hours). Levonorgestrel is released through the kidneys - 60% and the intestine - 40% in the form of metabolites (sulfate and glucuronide conjugates).

    Ethinylestradiol

    Ethinyl estradiol is absorbed rapidly and almost completely. Ethinyl estradiol inherent effect of primary passage through the liver, TCmah is 1.5 hours. After oral administration, the bioavailability is about 38-48%. Ethinylestradiol almost completely binds to blood plasma proteins, mainly with albumins.

    Ethinyl estradiol undergoes presystemic metabolism in the wall of the intestine and liver. Active substances are metabolized in the liver. how ethinyl estradiol, and metabolites (2-OH-ethynyl-estradiol and 2-methoxy-ethynylestradiol) are isolated as conjugates (sulfates and glucuronides) in bile and are subjected to intestinal hepatic recirculation. The elimination half-life is 26 ± 6.8 hours. About 40% is released through the kidneys and about 60% through the intestines.

    Both components (levonorgestrel and ethinyl estradiol) are excreted in breast milk.

    Indications:

    - Contraception;

    - Hormone-dependent functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, menorrhagia without an organic cause, premenstrual syndrome).

    Contraindications:

    Increased individual sensitivity to the components of the drug, pregnancy; period of breastfeeding, hepatic insufficiency, liver tumors; congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson and Rotor); cholelithiasis; cholecystitis; chronic colitis; presence or indication in the history of severe cardiovascular and cerebrovascular changes, thromboembolism and predisposition to them, decompensated heart defects; hormone-dependent malignant neoplasms of genital organs and mammary glands (incl.suspicion of them), especially breast cancer or endometrium; violation of the metabolism of fats; congenital hyperlipidemia; uncontrolled arterial hypertension of medium and severe degree with arterial pressure 160/100 mm Hg. and higher; diabetes mellitus of severe course (accompanied by retinopathy and microangiopathy); sickle-cell anemia; chronic hemolytic anemia; bleeding from the vagina of an unclear etiology; migraine; otosclerosis (which worsened during the previous pregnancy); idiopathic jaundice, severe itching, herpes of pregnant women in anamnesis; pancreatitis (including in the anamnesis), accompanied by severe hyperlipidemia; jaundice due to the use of drugs containing steroids; smoking over the age of 35; age over 40 years.

    Carefully:

    Diseases of the liver, epilepsy, depression, ulcerative colitis, uterine fibroids, mastopathy, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles), diabetes mellitus, cardiovascular diseases, hypertension, renal dysfunction, varicose veins, phlebitis , otosclerosis, multiple sclerosis, minor chorea, intermittent porphyria, latent tetany, bronchial asthma.

    Dosing and Administration:

    One tablet a day, preferably at the same time of day.

    If the woman in the previous cycle did not take the contraceptive, and the doctor did not appoint otherwise, the first tablet should be taken on the first day of menstruation and taking the tablets continue for 21 days. Then, the drug is recommended to continue with reddish-brown tablets for 7 days, during which menstrual bleeding occurs. After this, continue to receive the next package containing 21 tablets of white color, and then 7 tablets of reddish-brown color without interruption.

    Thus, each reception cycle starts on the same day of the week.

    In that case, if a woman took a contraceptive in the previous cycle, and in the previous package there were 21 tablets, the drug should be taken after a 7-day break, on the eighth day.

    The composition of tablets of different colors is not the same. Therefore, the beginning and the correct sequence of reception - first 21 white tablets, then 7 reddish-brown tablets - are indicated on the package with numbers and arrows.

    When switching to Rhevidone® 21 + 7 from another contraceptive, the above scheme should be used.

    Reception of the drug after childbirth or after an abortion You can start no earlier than the first day of menstruation of the first two-phase cycle. The first two-phase cycle is usually shortened because of premature ovulation. If the drug is taken with the first spontaneous bleeding, the drug can not successfully prevent premature ovulation, so in the first two weeks of the cycle, contraception may not be reliable.

    If the tablet was missed within the prescribed time, then the missed tablet should be taken within the next 12 hours. In this case, there is no need for additional methods of contraception. The remaining tablets are recommended at the usual time. If more than 12 hours have passed, the last missed tablet should be taken (bypassing the remaining unacceptable tablets) and continue taking the drug in normal mode. In this case, additional methods of contraception (barrier methods, spermicides) should be used in the next 7 days.

    This does not apply to tablets of a reddish brown color. they do not contain hormones. For medicinal purposes The dose of the drug and the scheme of application are selected by the doctor for each patient individually.

    Side effects:

    Nausea, vomiting, headache, breast engorgement, weight gain and libido, depressed mood, intermenstrual bleeding, in some cases - eyelid edema, conjunctivitis, visual impairment, discomfort when wearing contact lenses (these phenomena are temporary and disappear after withdrawal without prescribing any therapy). With prolonged admission, chloasma, hearing loss, generalized pruritus, jaundice, calf muscle cramps, and increased frequency of epileptic seizures can very rarely occur.

    Rarely: increased triglycerides, glucose in the blood, decreased glucose tolerance, increased blood pressure, pulmonary embolism, thromboembolism, myocardial infarction, cardiovascular disorders, for example: cerebral vascular embolism, stroke, retinal thrombosis, mesenteric thrombosis, organ vascular thrombosis small pelvis, lower extremities, deep vein thrombophlebitis of the lower extremities, hepatitis, jaundice, skin rashes, hair loss, increased vaginal discharge, vaginal candidiasis, fatigue, diarrhea.

    Iron fumarate, which is part of the reddish-brown tablets, coated with sugar,can cause irritation of the mucous membrane of the gastrointestinal tract, nausea, vomiting, diarrhea, constipation and stain the stools in black.

    Overdose:

    Taking large doses of oral contraceptives is not accompanied by the development of serious symptoms. Signs of an overdose: nausea, in young girls - nevilnye vaginal bleeding.

    The drug does not have a specific antidote, the treatment is symptomatic.

    Interaction:

    The drug should be used with caution at the same time as:

    - barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), derivatives of pyrazolone (possible enhancement of the metabolism of the constituents of the drug steroids).

    - ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines, dihydroergotamine, tranquilizers, phenylbutazone (the contraceptive effect may be reduced, so another nonhormonal contraceptive method should be used additionally),

    - anticoagulants, coumarin derivatives or indanedione (it is necessary to re-determine prothrombin time and, if necessary, change the dose of anticoagulant),

    - tricyclic antidepressants, maprotiline, beta-blockers (their bioavailability and toxicity may increase),

    - oral antidiabetics, insulin (a dose change of these drugs may be required),

    - bromocriptine (decreased bromocriptine efficacy),

    - hepatotoxic drugs, especially with dantrolene (the risk of hepatotoxicity increases, especially in women over 35 years of age).

    Special instructions:

    Before the beginning of the course of taking the drug and, subsequently, every 6 months, a general medical and gynecological examination is recommended to exclude diseases that are contraindicated to the use of oral contraceptives, as well as pregnancy, including a cytological analysis of the vaginal smear, assessment of the condition of the mammary glands, determination of blood glucose , cholesterol, control of liver function indicators, blood pressure, urinalysis.

    The use of any combination oral contraceptive increases the risk of venous thromboembolic disease. The risk of these diseases reaches a maximum in the first year of taking medications.

    The appointment of Rigevidone® 21 + 7 to women with thromboembolic disease at a young age and increased blood coagulability in a family history is not recommended.

    The use of oral contraception is allowed no earlier than 6 months after the transferred viral hepatitis in the normalization of liver function.

    After long-term use hormonal contraceptives, in rare cases, benign, in very rare cases, a malignant liver tumor, which in some cases can lead to life-threatening bleeding in the abdominal cavity. When there are sharp pains in the upper abdominal areas, hepatomegaly and signs of intra-abdominal bleeding, there may be a suspicion of a liver tumor. If necessary, the drug should be discontinued.

    If there is a violation of the liver, it is necessary to undergo medical supervision every 2-3 months.

    If the liver function indicators worsen during the reception of Rigevidone® 21 +7 a consultation of the therapist is necessary.

    When mild acyclic (intermenstrual) bleeding occurs, the drug should be taken, as in most cases these bleedings spontaneously cease.If acyclic (intermenstrual) bleeding does not disappear or recur, a medical examination should be performed to exclude the organic pathology of the reproductive system.

    In the case of vomiting or diarrhea, taking the drug should be continued, additionally applying another, non-hormonal method of contraception.

    Smokers who take hormonal contraceptives have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women older than 35 years).

    A large number of epidemiological studies have investigated the incidence of ovarian, endometrial, cervical and breast cancer in women taking combined oral contraceptives. Studies have shown that these drugs protect women from ovarian and endometrial cancer.

    Some studies have found an increase in the incidence of cervical cancer among women who have been taking combined oral contraceptives for a long time, but the results are mixed.In the formation of cervical cancer, there is sexual behavior, the presence of human papilloma virus and other factors, so the relationship between cervical cancer and the use of combined oral contraceptives is not proven.

    The relative risk of developing breast cancer is slightly higher among women taking combined oral contraceptives. In the next 10 years after discontinuation of combined oral contraceptives, the risk level is gradually reduced. Since breast cancer is rare in women younger than 40, the increase in the number of diagnosed cases of breast cancer in women currently taking or taking previously combined oral contraceptives is low compared to the risk of breast cancer throughout life.

    In the absence of bleeding cancellation, pregnancy should be excluded.

    After discontinuation of the drug fertility is restored quickly enough, during 1-3 menstrual cycles.

    The drug should be discontinued immediately in the following cases:

    - when a migraine headache occurs for the first time or if it is worse (if it was not previously), or if there is an unusually severe headache;

    - when there are early signs of phlebitis or phlebothrombosis (unusual pain or bloating of the veins on the legs);

    - if there is jaundice or hepatitis without jaundice;

    - with acute deterioration of visual acuity;

    - with cerebrovascular disorders;

    - with the appearance of stitching pains of unclear etiology during breathing or coughing, pain and tightness in the chest, with a sharp increase in blood pressure;

    - at suspicion of a thrombosis or a heart attack;

    - when generalized itching occurs;

    - with increased epileptic seizures;

    - for 3 months. before the planned pregnancy;

    - before the planned operation (for 6 weeks before the operation);

    - during prolonged immobilization (for example, after injuries);

    - in the presence of pregnancy.

    Effect on the ability to drive transp. cf. and fur:Does not affect the ability to drive and work with machinery.
    Form release / dosage:

    The tablets covered with a cover, 0,15 mg + 0,03 mg.

    Packaging:

    Pills I white color - 21 pcs.

    Tablets II reddish brown - 7 pcs.

    28 tablets (I, II) in the blister A1 / PVC.

    1 or 3 blisters in a cardboard box with instructions for use.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N015250 / 01
    Date of registration:25.11.2009 / 20.10.2015
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp31.05.2016
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