Active substanceNorgestrel + EstradiolNorgestrel + Estradiol
Similar drugsTo uncover
  • Cyclo-Proginova®
    pills inwards 
    Bayer Pharma AG     Germany
  • Dosage form: & nbsppills
    Composition:Active components:
    - 1 white pellet contains 2.0 mg estradiol valerate
    - 1 light brown pellet contains 2.0 mg of estradiol valerate and 0.5 mg of norgestrel.
    Auxiliary substances for white pills: lactose monohydrate 46.25 mg, corn starch 26.2 mg, povidone 25,000 3 mg, talc 2.4 mg, magnesium stearate 0.15 mg, sucrose crystalline 33.54 mg macrogol 6000 3.767 mg , povidone 700,000 - 0.296 mg, calcium carbonate - 14.7 mg, talc - 7.171 mg, wax montaglycol 0.075 mg.
    Auxiliary substances for light brown pellets: lactose monohydrate 46.75 mg, corn starch 26.2 mg, povidone 25,000 3 mg, talc 2.4 mg magnesium stearate 0.15 mg, sucrose crystalline 33.433 mg, povidone 700,000 0.323 mg, macrogol 6,000 - 3,707 mg, calcium carbonate precipitated - 14,538 mg, talc - 7,088 mg, glycerol 85% - 0,204 mg, titanium dioxide - 0,408 mg, iron oxide yellow - 0,102 mg, iron oxide red - 0,123 mg, wax montaglycol 0.075 mg.
    Description:Round dragees of white color (11 dragees) and light-brown color (10 dragees).
    Pharmacotherapeutic group:Anti-climacteric (estrogen + progestogen)
    ATX: & nbsp

    G.03.A.A.06   Norgestrel and ethinylestradiol

    Pharmacodynamics:

    Cyclo-Proginova contains estrogen - estradiol valerate, which in the human body turns into a natural 17ß-estradiol. Also in the composition of the drug Cyclo-Proginova is the progesterone derivative - norgestrel. Addition of norgestrel within 10 days of each cycle prevents the development of hyperplasia and endometrial cancer.

    Due to the composition and the cyclic scheme of Cyclobo-Proginov (taking only estrogen for 11 days, then - the combination of estrogen and progestogen for 10 days, and, finally, a 7-day break) in women with an unrefined uterus with a regular intake of the drug, the menstrual cycle is established.

    Against the background of taking CyclO-Proginova, there is no suppression of ovulation, and the production of hormones in the body practically does not change. Cyclo-Proginova can be used by women of reproductive age to regulate the menstrual cycle, as well as by women in perimenopause for the treatment of irregular uterine bleeding.

    Estradiol replenishes the estrogen deficiency in the female body after the onset of menopause and provides effective treatment of psycho-emotional and vegetative climacteric symptoms (such as "hot flashes", increased sweating,increased nervous excitability, irritability, palpitation, cardialgia, dizziness, headache, decreased libido, muscle and joint pain); involution of the skin and mucous membranes, especially the mucosal genitourinary system (urinary incontinence, dryness and irritation of the vaginal mucosa, tenderness in sexual intercourse).

    Estradiol prevents bone loss caused by estrogen deficiency. This is mainly due to the suppression of osteoclast function and the shift of the bone remodeling process towards bone formation. It has been proven that prolonged use of hormone replacement therapy (HRT) can reduce the risk of fractures of peripheral bones in women after menopause. With the abolition of HRT, the rate of bone mass reduction is comparable to that characteristic for the period immediately after menopause. It is not proven that using HRT, it is possible to achieve bone mass recovery to the pre-menopausal level.

    HRT also has a beneficial effect on the content of collagen in the skin, as well as on its density, and can also slow the process of wrinkle formation.

    HRT leads to lower total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol, as well as increased triglyceride levels. The gestagen contained in Cyclo-Proginova to a certain extent prevents the effect of estradiol on lipid metabolism.

    Observational studies suggest that among women in postmenopausal women, the use of HRT reduces the incidence of colon cancer. The mechanism of action is still unclear.

    Pharmacokinetics:

    After ingestion estradiol valerate quickly and completely absorbed from the gastrointestinal tract (GIT). After entering the body, it quickly metabolizes with the formation of 17ß-estradiol and estrone, which are subsequently subjected to standard metabolic transformations. After oral administration, the bioavailability of estradiol is about 3%. Eating does not affect the bioavailability of estradiol. The maximum concentration of estradiol in the serum, about 30 pg / ml, is usually achieved 4-9 hours after taking the pills. Estradiol is excreted in the form of metabolites, mainly with urine in the form of sulfates and glucuronides.

    After ingestion, norgestrel is rapidly and almost completely absorbed from the digestive tract. The maximum concentration of levonorgestrel in the serum, about 7-8 pg / ml, is usually achieved 1-1.5 hours after taking the pills. Levonorgestrel binds to albumin and globulin, binding sex hormones (SHGG). About 1-1.5% of the total concentration of levonorgestrel in the serum is not associated with protein. With a half-life of approximately 1 day, metabolites Norgestrel is excreted in urine and bile.

    Indications:

    - Hormone replacement therapy (HRT) for climacteric disorders, involutional changes of the skin and the urogenital tract, depressive states in climacteric and symptoms of estrogen deficiency due to natural menopause or hypogonadism, sterilization or primary ovarian dysfunction in women with a uterus unremoved.

    - Prevention of postmenopausal osteoporosis.

    - Normalization of irregular menstrual cycles.

    - Treatment of primary or secondary amenorrhea.

    Contraindications:

    It is not recommended to start taking the drug CyclO-Proginova in the presence of any of the following conditions / diseases. If any of these states occurrednot at the time of taking the drug Cyclo-Proginova, it should immediately discontinue use of the drug.

    - Pregnancy and lactemia

    - Bleeding from the vagina of an unclear etiology

    - Proven or suspected diagnosis of breast cancer.

    - Confirmed or suspected diagnosis of hormone-dependent precancerous disease or hormone-dependent malignant tumors (eg, cancer endometrium)

    - Liver tumors now or in the anamnesis (benign or malignant)

    - Severe liver disease

    - Acute arterial thromboembolism (eg, myocardial infarction, stroke)

    - Deep vein thrombosis in the acute stage, thromboembolism currently or anamnesis

    - Presence of high risk of development venous and arterial thrombosis

    - Severe hypertriglyceridemia

    - Hypersensitivity to components of the drug CyclO-Proginova

    - Deficiency of lactase, sucrose / isomaltase, glucose-galactose malabsorption

    - Children and adolescence under 18

    Carefully:

    Cyclo-Proginova should be administered with caution in the following conditions: hypertension, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome and Rotor syndrome), cholestatic jaundice or cholestatic itching during pregnancy, endometriosis, uterine myoma, diabetes mellitus (see "Special instructions" ).

    Pregnancy and lactation:Application, the drug during pregnancy and breastfeeding is contraindicated. If pregnancy develops during reception of the drug CyclO-Proginova, then the the drug should be immediately discontinued. A small amount of sex hormones can be excreted with human milk.
    Dosing and Administration:

    If the patient still has menstruation, the treatment should begin on the 5th day of the menstrual cycle (the 1st day of menstrual bleeding corresponds to the 1st day day of the menstrual cycle).

    Patients with amenorrhea or very rare menstruation, as well as postmenopausal women, can start taking the drug at any time, provided that pregnancy is excluded (see section "Pregnancy and lactation").

    Each package is designed for a 21-day reception.

    Daily for the first 11 days take one white pellet, and then for 10 days - every day, one light brown pellet. After 21 days of taking the drug, a 7-day break in taking the drug follows, during which menstrual bleeding occurs, caused by cancellation of the drug (usually 2-3 days after taking the last pills).

    After a 7-day break in taking the drug, they begin a new package of CyclO-Proginova, taking the first pills on the same day of the week as the first pills from the previous package.

    Dragee swallowed whole, squeezed a small amount of liquid. The time of day when a woman takes the drug does not matter, however, if she starts taking the pills at any particular time, she should stick to this time and on. If the woman forgot to take the pills, she can take it within the next 12 - 24 hours. If treatment is interrupted for a longer time, vaginal bleeding may occur.

    Side effects:

    When taking the drug CyclO-Proginova, undesirable effects can be noted, the relationship of which with the administration of this drug can not be either confirmed or disproved.

    System bodies

    Often (≥1/100)

    Infrequently (≥1 / 1000 and <1/100)

    Rarely (<1/1000)

    Organ view

    Visual disturbances

    Intolerance to contact lenses (unpleasant sensations when wearing them)

    Gastrointestinal tract

    Nausea, pain in abdomen

    Dyspeptic disorders, jaundice

    Vomiting, swelling belly

    Immune system

    Reactions hypersensitivity

    Metabolism

    Weight gain or weight loss

    Skeleton and musculature

    Muscular convulsions

    Nervous system

    Headache

    Dizziness

    Migraine

    Mental

    disorders

    Decrease moods

    Anxiety, decline libido or increased libido

    Cardiovascular system

    Feeling palpitation

    Reproductive system and mammary glands

    Uterine / vaginal bleeding (frequency non-regular bleeding usually decreases in flow long treatment)

    Pain in dairy glands, sensitivity dairy glands, roughing dairy glands

    Dysmenorrhea, vaginal allocation,

    enlargement dairy glands, symptoms premenstrual syndrome (PMS)

    Skin and subcutaneous tissue

    Rash, pruritus

    Knotty erythema, hives

    Hirsutism, acne

    General symptoms

    Edema

    Increased fatigue

    When taking the drug in rare cases, it is possible to develop thromboses and thromboembolism (see also "Special instructions"), there were cases of increased blood pressure (from the cardiovascular system).

    In very rare cases, there is chloasma, especially in women with a history of pregnant chloasma.

    In women with hereditary forms of angioedema, exogenous estrogens can cause or worsen symptoms of angioedema.

    Overdose:There was no risk of serious side effects with the occasional use of Cyclobulin Progestin in an amount many times greater than the daily therapeutic dose. Symptoms that may occur during an overdose: nausea, vomiting, vaginal bleeding. There is no specific antidote, treatment is symptomatic.
    Interaction:

    At the beginning of HRT, it is necessary to stop the use of hormonal contraceptives. If necessary, the patient should recommend non-hormonal contraceptives.

    Long-term treatment with drugs that induce liver enzymes (for example, some anticonvulsant and antimicrobial drugs) can increase the clearance of sex hormones and reduce their clinical effectiveness.A similar property of inducing liver enzymes was found in hydantoids, barbiturates, primidon, carbamazepine and rifampicin, the presence of this feature is also assumed in oxcarbazepine, topiramate, felbamate and griseofulvin. The maximum induction of enzymes is usually observed not earlier than 2-3 weeks, but then it can persist for at least 4 weeks after discontinuation of the drug.

    In rare cases, along with the concomitant use of certain antibiotics (for example, penicillin and tetracycline groups), a decrease in the level of estradiol was observed.

    Substances that are highly conjugated (for example, paracetamol), can increase the bioavailability of estradiol due to competitive inhibition of the conjugation system in the absorption process.

    Due to the effect of HRT on glucose tolerance, in some cases, the need for oral antidiabetics or insulin may change.

    - Interaction with alcohol

    Excessive consumption of alcohol during HRT may lead to an increase in the level of circulating estradiol.

    Special instructions:

    In the presence of several risk factors for the development of thrombosis or a high degree of severity of one of the risk factors, CyclO-Proginova is contraindicated for use (due to an increase in the likelihood of thrombosis).

    Medical examinations

    Before the use of the drug, and then at certain intervals during treatment (at least 1 time in 6 months) should be spend gynecological and general medical examinations, including examination of the mammary glands, measurement of blood pressure and other necessary studies.

    Medical examination (including periodic determination of prolactin concentration) is necessary if the patient has an anterior pituitary adenoma.

    If hormone replacement therapy is performed with one of the diseases or conditions listed below, you may need to have careful medical supervision. Therefore, if you have one of these conditions, tell your doctor before you start taking CyclO-Proginov.

    -fibromyoma of the uterus;

    -endometriosis at present or in the past;

    - liver or gallbladder disease.After the transferred hepatitis, the administration of the drug is possible not earlier than in 6 months (before the normalization of the liver function);

    -hickness in previous pregnancy or previous reception of sex hormones;

    -diabetes;

    - arterial hypertension (high blood pressure);

    -chloasis (areas of discolored skin) now or in the past. If they are available, avoid prolonged exposure to the sun or ultraviolet radiation;

    -epilepsy;

    -proven diseases of mammary glands (mastopathy);

    -bronchial asthma;

    -migraine;

    -porphyria;

    -osclerosis;

    - Systemic lupus erythematosus;

    -chorea;

    -increased risk of vein thrombosis. The risk rises with age. It can also increase in the case of past thrombosis in you or your relatives, with varicose veins; excess body weight.

    The risk of deep vein thrombosis is temporarily increased as a result of surgery, serious injuries or prolonged immobility. If you are using Cyclobulin Proinova, tell your doctor about any planned hospitalization or surgery (4-6 weeks).

    Do not use hormone replacement therapy to prevent heart attack or stroke.

    The following warnings regarding the use of HRT should be considered when using the CyclO-Proginov preparation.

    HRT and tumors

    -Endometrial cancer

    With prolonged use of estrogens in monotherapy, the probability of cancer of the uterine mucosa (endometrial cancer) increases. If you have a uterus preserved. You will need an additional method of progestogens. The addition of gestagens reduces the risk of endometrial cancer.

    Inform your attending physician if you often have cycle irregularities or breakthrough bleeding when taking Cyclo- Proginova.

    - Mammary cancer

    Several studies have shown that in women who have used hormone replacement therapy (HRT) for several years, breast cancer is observed somewhat more frequently than their peers who have never used HRT. Ifnschinbut discontinues HRT, this elevated indicator is reduced in such a way that, 5 years after the abolition of HRT, the likelihood of finding breast cancer in her is the same as in women who have never used HRT.If breast cancer is detected in women using HRT, the probability of spreading the tumor to other organs is less than that of women who have never used HRT. It is not known whether this difference is explained by the use of HRT. Perhaps it is caused by the fact that women who use hormone replacement drugs are more likely to be examined, and therefore the presence of breast cancer is detected at earlier stages.

    The likelihood of detecting breast cancer increases with duration of treatment, but these the rates are comparable to the increased risk of breast cancer that occur with the later onset of natural menopause. Preparations for HRT, to which Cyclo-Proginova belongs, increase the mammographic density of the milkчнglands, which in some cases may have a negative effect on X-ray detection of breast cancer. Therefore, other methods should be used to detect breast cancer.

    - Liver tumors

    In rare cases, with the use of sex hormones, development benign, and even less often - malignant liver tumors. In separate cases such tumors led to the development of life-threatening bleeding into the abdominal cavity.

    Communication with HRT is not proven. Although such cases are extremely unlikely, you should inform your doctor if you experience unusual sensations in the upper abdomen that do not go away for a short time.

    The reasons for the immediate cessation of CyclO-Proginov

    You should immediately stop treatment and consult a doctor if you experience any of the following conditions:

    - the first occurrence of a migraine attack (characterized by a throbbing headache and nausea, which is preceded by a visual impairment);

    - exacerbation of existing migraines; any unusually frequent or unusually severe headaches;

    - sudden visual or hearing impairment;

    - inflammation of the veins (phlebitis).

    If you have a thrombosis in the presence of Cyclo-Proginov or if you suspect that this could happen, you should immediately stop taking the drug and consult a doctor. The warning signs of a possible thrombosis are:

    - coughing up blood;

    - unusual pain in the hands or feet or their swelling;

    - a sudden sense of lack of air;

    - loss of consciousness.

    Admission of Cyclo-Proginova should also be discontinued immediately in case of pregnancy or development of jaundice.

    Influence on the results of laboratory studies

    Reception of sex steroids can affect the results of some laboratory tests. Always inform your doctor if you are taking CyclO-Proginov.

    Cyclo-Proginova does not apply with purpose of contraception.

    If it is necessary to use contraception, non-hormonal methods should be used (with the exception of calendar and temperature methods). If you suspect a pregnancy, you should stop taking the drug until pregnancy is not ruled out.

    Additional information on some groups of patients.

    There is no data on the need for dose adjustment at women depending on age. Inform Doctors if you start taking the drug Cyclo-Proginova at the age of over 65 years.

    The use of Cyclo-Proginova in women with impaired liver function has not been studied.

    The use of Cyclo-Proginova in women with impaired renal function was studied. The available data indicate that there is no need for dose adjustment in such patients.

    Effect on the ability to drive transp. cf. and fur:Not found.
    Form release / dosage:

    pills

    Packaging:10 drops of light brown color and 11 white dragees are placed in a blister made of polyvinyl chloride film and aluminum foil. Each blister with a self-adhesive appointment calendar and instructions for use is placed in a cardboard box.
    Storage conditions:

    Keep out of the reach of children! Store under normal conditions.

    Shelf life:5 years. Do not use until the expiry date printed on the package!
    Terms of leave from pharmacies:On prescription
    Registration number:П N016035 / 01
    Date of registration:24.03.2010
    The owner of the registration certificate:Bayer Pharma AGBayer Pharma AG Germany
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp09.08.2015
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