Cyclo-Progynova® [Norgestrel, Estradiol]

For oral useswallowing whole with a little liquid. If the patient continues to have menstruation, treatment should begin on the 5th day of the menstrual cycle (the 1st day of menstrual bleeding corresponds to the 1st day of the menstrual cycle).

Patients with amenorrhea or very rare menstrual periods, as well as postmenopausal women, can begin taking the drug at any time, provided that pregnancy is ruled out.

Each package is designed for a 21-day reception.

Every day, for the first 11 days, take one white dragee, and then, for 10 days, take one light brown dragee each day. After a 21-day drug intake, there is a 7-day break, during which menstrual-like bleeding occurs, caused by drug withdrawal (usually 2-3 days after taking the last bean). After a 7-day break, begin a new packaging Cyclo-progynova^®, taking the first dragee on the same day of the week as the first dragee from the previous package.

The time of day when a woman takes the drug does not matter, however, if the dragee is started at any particular time, you should continue to follow it. If the dragee is not taken on time, it should be taken within the next 12-24 hours. If treatment is interrupted for a longer time, vaginal bleeding may occur.

Contraindicated in pregnancy.

Cyclo-progynova is not used for contraception.

If contraception is necessary, non-hormonal methods should be used (except for the calendar and temperature methods). If pregnancy is suspected, pills should be stopped until pregnancy is excluded (seesection "Pregnancy and lactation").

If any of the following conditions or risk factors are present or worsening, before starting or continuing HRT, the ratio of the individual risk to the benefit of treatment should be evaluated.

Venous thromboembolism

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

Risk factors for VTE include an individual and family history (the presence of VTE in immediate 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 may temporarily increase with prolonged immobilization, “large” planned and traumatic operations or massive injury. Depending on the cause or duration of immobilization, the question of whether to temporarily stop HRT should be decided.

Treatment should be discontinued immediately if symptoms of thrombotic disorders appear or if they are suspected.

Arterial thromboembolism

In the course of randomized controlled trials with long-term use of combined conjugated estrogens and medroxyprogesterone acetate, no evidence of a positive effect on the cardiovascular system was obtained. In large-scale clinical trials of this compound, a possible increase in the risk of coronary disease in the first year of use was identified. An increased risk of stroke was also detected. So far, no other long-term randomized controlled trials have been conducted with other drugs for HRT in order to detect a positive effect on morbidity and mortality related to the cardiovascular system. Therefore, it is not known whether this increased risk extends to drugs for HRT containing other types of estrogen and progestogen.

Endometrial cancer

Long-term estrogen monotherapy increases the risk of endometrial hyperplasia or carcinoma. Studies have confirmed that adding progestogens reduces the risk of endometrial hyperplasia and cancer.

Mammary cancer

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

According to research data, breast cancer detected in women taking HRT is usually more differentiated than women not taking it.

HRT increases the mammographic density of the mammary glands, which in some cases may have a negative effect on the x-ray detection of breast cancer.

Liver tumor

Against the background of the use of sex steroids, which include drugs for hormone replacement therapy, benign and, even more rarely, malignant tumors of the liver have been observed in rare cases. In some cases, these tumors led to life threatening intra-abdominal bleeding. For pain in the upper abdomen, an enlarged liver, or signs of intra-abdominal bleeding, a differential diagnosis should take into account the likelihood of a liver tumor.

Cholelithiasis

It is known that estrogen increases the lithogenicity of bile. Some women are predisposed to the development of cholelithiasis with estrogen therapy.

Other states

Treatment should be stopped immediately, with the first appearance of migraine-like or frequent and unusually severe headaches, as well as with the appearance of other symptoms - possible harbingers of a cerebral thrombotic stroke.

The relationship between HRT and the development of clinically severe arterial hypertension has not been established. In women taking HRT, a slight increase in blood pressure has been described, a clinically significant increase is rare. However, in some cases, with the development of HRT with persistent, clinically significant arterial hypertension, the withdrawal of HRT may be considered.

In cases of mild abnormalities in liver function, including various forms of hyperbilirubinemia, such as Dubin-Johnson syndrome or Rotor syndrome, physician observation is required, as well as periodic liver function tests. With a deterioration in liver function, HRT should be abolished.

When recurrent cholestatic jaundice or cholestatic pruritus, observed for the first time during pregnancy or prior treatment with sex steroid hormones, it is necessary to immediately stop HRT.

Special attention should be paid to women with moderately elevated triglyceride levels. In such cases, the use of HRT may cause a further increase in the level of triglycerides in the blood, which increases the risk of acute pancreatitis.

Although HRT may affect peripheral insulin resistance and glucose tolerance, it is usually not necessary to change the treatment regimen for diabetics when performing HRT. However, women with diabetes mellitus should be monitored during HRT.

In some patients, unwanted manifestations of estrogen stimulation, such as abnormal uterine bleeding, may develop under the influence of HRT. Frequent or persistent abnormal uterine bleeding during treatment is an indication for endometrial examination.

If the treatment of irregular menstrual cycles does not give results, an examination should be conducted to exclude diseases of an organic nature.

Under the influence of estrogen, uterine fibroids may increase in size. In this case, treatment should be discontinued.

It is recommended to stop treatment in case of endometriosis recurrence with HRT.

If you suspect the presence of prolactinomas before the start of treatment, this disease should be excluded.

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

The following conditions may occur or be aggravated against the background of HRT. Although their relationship with HRT has not been proven, women with these conditions should be monitored by a physician during an HRT: epilepsy; benign breast tumor; bronchial asthma; migraine; porphyria; otosclerosis; systemic lupus erythematosus, small 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, violations of the blood coagulation system should be excluded. Periodic control tests should be carried out.

Impact on laboratory results

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

Influence on ability to drive motor transport and control mechanisms

Does not affect.