Cyclo-proginova

Active substances:

estradiol valerate,

norgestrel;

Auxiliary facilities:

lactose monohydrate;

corn starch;

povidon 25000;

talc;

magnesium stearate;

crystalline sucrose;

povidon 700000,

macrogol 6000;

calcium carbonate;

wax.

CYCLO-PROGINOVA - estrogenic, estrogen-gestagenic.

It compensates for the insufficient production of endogenous estrogens, reduces the level of LDL cholesterol in the blood.

Stops somatic, mental and other menopausal symptoms in the pre- and postmenopause periods; prevents bone mass reduction and osteoporosis.

Hormone replacement therapy reduces the risk of cardiovascular diseases; in combination with gestagen, it prevents the development of proliferative processes in the endometrium.

• hormone replacement therapy (HRT) for climacteric disorders, involutional changes in the skin and genitourinary tract, depressive states in the menopausal period, as well as symptoms of estrogen deficiency due to natural menopause or hypogonadism, sterilization or primary ovarian dysfunction in women with an unremoted uterus;
• prevention of postmenopausal osteoporosis;
• normalization of irregular menstrual cycles;
• treatment of primary or secondary amenorrhea.

It is not recommended to start hormone replacement therapy (HRT) if you have any of the following conditions. If any of these conditions occurs during the HRT, the use of the drug should be stopped immediately.

• pregnancy and lactation;
• vaginal bleeding of unclear origin;
• confirmed or suspected diagnosis of breast cancer;
• confirmed or suspected diagnosis of hormone-dependent precancerous disease or hormone-dependent malignant tumors;
• liver tumors now or in history (benign or malignant);
• severe liver diseases;
• acute arterial thrombosis or thromboembolism (such as myocardial infarction, stroke);
• deep vein thrombosis in the acute stage, thromboembolism at present or in history;
• pronounced hypertriglyceridemia;
• hypersensitivity to the components of the drug Cyclo-Proginov.

In rare cases - headaches, nausea, stomach dysfunction, breast roughness, change in body weight, uterine bleeding, chloasma.

At the beginning of HRT, it is necessary to stop using hormonal contraceptives. If necessary, the patient should be recommended non-hormonal contraceptives.

Long-term treatment with drugs that induce liver enzymes (for example, some anticonvulsants and antimicrobials) can increase the clearance of sex hormones and reduce their clinical effectiveness. A similar property to induce liver enzymes was found in hydantoins, barbiturates, primidone, carbamazepine and rifampicin, the presence of this feature is also assumed in oxcarbazepine, topiramate, felbamate and griseofulvin. Maximum induction of enzymes is usually observed no earlier than 2-3 weeks, but then it can continue for at least 4 weeks after discontinuation of the drug.

In rare cases, against the background of concomitant use of some antibiotics (for example, penicillin and tetracycline groups), a decrease in estradiol levels was observed.

Substances that are largely subject to conjugation (e.g. paracetamol) can increase the bioavailability of estradiol due to competitive inhibition of the conjugation system during the absorption process.

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

Interaction with alcohol:

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

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

One white dragee is taken daily for the first 11 days, and then one light brown dragee is taken daily for 10 days. After a 21-day intake of the drug, there is a 7-day break in taking the drug, during which menstrual-like bleeding occurs caused by the cancellation of the drug (usually 2-3 days after taking the last dragee).

After a 7-day break in taking the drug, a new package of Cyclo-Proginov begins, taking the first dragee on the same day of the week as the first dragee from the previous package.

The dragee is swallowed as a whole, washed down with a small amount of liquid. The time of day when a woman takes the drug does not matter, however, if she started taking dragees at a particular time, she should stick to this time further. If a woman forgot to take a dragee, she can take it within the next 12-24 hours. If the treatment is interrupted for a longer time, vaginal bleeding may occur.

Cyclo-Proginova is not used for contraception.

If contraception is necessary, non-hormonal methods should be used (except for calendar and temperature methods). If pregnancy is suspected, the intake of dragees should be suspended until the pregnancy is excluded (see section "Pregnancy and lactation").

If any of the following conditions or risk factors are in the presence or worsened, the ratio of individual risk to benefit of treatment should be assessed before starting or continuing HRT.

Venous thromboembolism

A number of controlled randomized as well as epidemiological studies revealed an increased relative risk of developing venous thromboembolism (VTE) against the background of HRT, i.e. deep vein thrombosis or pulmonary embolism. Therefore, when prescribing HRT to women with risk factors for VTE, the risk-benefit ratio of treatment should be carefully weighed and discussed with the patient.

Risk factors for the development of VTE include an individual and family history (the presence of VTE in close relatives at a relatively young age may indicate a genetic predisposition) and severe obesity. The risk of VTE also increases with age. The question of the possible role of varicose veins in the development of VTE remains controversial.

The risk of VTE can temporarily increase with prolonged immobilization, "large" planned and traumatological operations or massive injury. Depending on the reason or duration of immobilization, the feasibility of temporary termination of HRT should be resolved.

Treatment should be stopped immediately if symptoms of thrombotic disorders appear or if they occur.

Arterial thromboembolism

In randomized controlled trials with long-term use of combined conjugated estrogens and medroxyprogesterone acetate, there was no evidence of a positive effect on the cardiovascular system. Large-scale clinical trials of this compound revealed a possible increase in the risk of coronary disease in the first year of use. An increased risk of stroke was also found. To date, no long-term randomized controlled trials have been conducted with other HRT drugs to identify a positive effect on cardiovascular morbidity and mortality. Therefore, it is not known whether this increased risk applies to HRT drugs containing other types of estrogens and progestogens.

Endometrial cancer

With long-term monotherapy with estrogens, the risk of developing endometrial hyperplasia or carcinoma increases. Studies have confirmed that the addition of gestagens reduces the risk of hyperplasia and endometrial cancer.

Breast cancer

According to clinical trials and the results of observational studies, an increase in the relative risk of developing breast cancer in women using HRT for several years was found. This may be due to earlier diagnosis, the biological effect of HRT or a combination of both factors. The relative risk increases with the duration of treatment and perhaps further increases when estrogens are combined with progestogens. This increase is comparable to the increase in the risk of breast cancer in women every year of delay in the onset of natural menopause, as well as in obesity and alcohol abuse. The increased risk gradually decreases to normal levels within the first few years after the termination of HRT.

According to studies, breast cancer detected in women taking HRT is usually more differentiated than in women who do not take it.

HRT increases the mammographic density of the mammary glands, which in some cases can have a negative impact on the radiological detection of breast cancer.

Liver tumor

Against the background of the use of sexual steroids, which include HRT products, in rare cases, benign, and even less often malignant liver tumors were observed. In some cases, these tumors led to life-threatening intra-abdominal bleeding. In case of pain in the upper abdomen, enlarged liver or signs of intra-abdominal bleeding, differential diagnosis should take into account the likelihood of a liver tumor.

Gallstone disease

Estrogens are known to increase the lithogenicity of bile. Some women are predisposed to developing cholelithiasis in treatment with estrogens.

Other conditions

Treatment should be stopped immediately when migraine-like or frequent and unusually severe headaches appear for the first time, as well as when other symptoms appear - possible precursors of thrombotic brain stroke.

The relationship between HRT and the development of clinically pronounced arterial hypertension has not been established. Women taking HRT have a slight increase in blood pressure, and a clinically significant increase is rare. However, in some cases, with the development of persistent clinically significant arterial hypertension against the background of HRT, the abolition of HRT can be considered,

In case of mild liver dysfunction, including various forms of hyperbilirubinemia, such as Dubin-Johnson syndrome or Rotor syndrome, medical supervision is necessary, as well as periodic studies of liver function. If liver function deteriorates, HRT should be canceled.

In case of a recurrence of cholestatic jaundice or cholestatic itching, observed for the first time during pregnancy or previous treatment with sex steroid hormones, it is necessary to stop HRT immediately.

Special monitoring of women with moderately elevated triglyceride levels is necessary. In such cases, the use of HRT can cause a further increase in the level of triglycerides in the blood, which increases the risk of acute pancreatitis.

Although HRT can affect peripheral insulin resistance and glucose tolerance, there is usually no need to change the treatment regimen for diabetes mellitus during HRT. Nevertheless, women with diabetes should be monitored during HRT.

Some patients under the influence of HRT may develop undesirable manifestations of estrogen stimulation, such as pathological uterine bleeding. Frequent or persistent pathological uterine bleeding against the background of treatment is an indication for endometrial examination.

If the treatment of irregular menstrual cycles does not yield results, an examination should be carried out to exclude an organic disease.

Under the influence of estrogens, uterine fibroids can increase in size. In this case, the treatment should be stopped.

It is recommended to stop treatment in case of recurrence of endometriosis against the background of HRT.

If prolactinoma is suspected before treatment, this disease should be excluded.

In some cases, chloasma may occur, especially in women with a history of chloasma in pregnant women. During the HRT, women with a tendency to chloasma should avoid prolonged exposure to the sun or ultraviolet radiation.

The following conditions can occur or worsen against the background of HRT. Although their relationship with HRT has not been proven, women with these conditions should be under the supervision of a doctor during HRT: epilepsy; benign breast tumor; bronchial asthma; migraine; porphyria; otosclerosis; systemic lupus erythematosus, minor chorea.

Medical examination and counseling

Before starting or resuming HRT, a woman is recommended to undergo a thorough general medical and gynecological examination (including breast examination and cytological examination of cervical mucus), to exclude pregnancy. In addition, disorders of the blood clotting system should be excluded. Control surveys should be carried out periodically.

Impact on laboratory results

Taking sex steroids can affect the biochemical performance of the liver, thyroid, adrenal and kidney function, the plasma content of transport proteins such as corticosteroid-binding globulin and lipid/lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis.

Impact on the ability to drive vehicles and control mechanisms

Doesn't affect.

Dragee