Cyclo-Progynova, tablet set 0.5 mg+2 mg and 2 mg 21 pcs

CYCLO-Progynova is estrogenic, estrogen-gestagenic.

Makes up for insufficient production of endogenous estrogens, reduces the level of LDL cholesterol in the blood.

Cures somatic, mental and other menopausal symptoms during pre- and postmenopause; prevents the reduction of bone mass 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.

Indications

Menopause, Osteoporosis, Menstrual Disorders

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

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Composition

Active substances:

estradiol valerate,

norgestrel;

Associates:

Lactose monohydrate;

Corn starch;

povidone 25000;

talk;

Magnesium stearate;

saccharose crystalline;

povidone 700000,

macrogol 6000;

calcium carbonate;

wax.

How to take, the dosage

If the patient is still menstruating, treatment should be started on day 5 of the menstrual cycle (day 1 of menstrual bleeding corresponds to day 1 of the menstrual cycle).

Patients with amenorrhea or very infrequent menstruation, as well as postmenopausal women, may start the drug at any time, provided that pregnancy is excluded (see “Pregnancy and lactation” section). Each pack is designed for 21 days of use.

Daily for the first 11 days, take one white dragee and then one light brown dragee daily for 10 days. After 21 days of taking the drug, a 7-day break in taking the drug follows, during which menstrual-like bleeding occurs, caused by withdrawal of the drug (usually on the 2nd or 3rd day after taking the last dragee).

After a 7-day break in taking the drug, a new package of Ciclo-Proginova is started, taking the first dragee on the same day of the week as the first dragee from the previous package.

The tablets are swallowed whole with a small amount of liquid. The time of day the woman takes the pills is irrelevant, but if she starts taking the pills at a particular time, she must keep to that time. If the woman forgets to take the pills, she can take them within the next 12 to 24 hours. If treatment is interrupted for a longer time, vaginal bleeding may occur.

Interaction

The use of hormonal contraceptives should be discontinued at the start of MHT. Non-hormonal contraceptives should be recommended to the patient, if necessary.

Long-term treatment with drugs that induce liver enzymes (for example, some anticonvulsants and antimicrobials) may increase clearance of sex hormones and reduce their clinical effectiveness. A similar property of inducing liver enzymes has been found in the hydantoins, barbiturates, primidone, carbamazepine, and rifampicin; this feature has also been suggested for oxcarbazepine, topiramate, felbamate, and griseofulvin. Maximum enzyme induction is not usually seen before 2-3 weeks, but then it may persist for at least another 4 weeks after discontinuation of the drug.

In rare cases, a decrease in estradiol levels has been observed with concomitant administration of certain antibiotics (e.g., penicillin and tetracycline groups).

Substances that are highly conjugated (e.g., paracetamol) may increase bioavailability of estradiol through competitive inhibition of the conjugation system during absorption.

The effect of MHT on glucose tolerance may in some cases alter the need for oral antidiabetic medications or insulin.

Interaction with alcohol:

Excessive consumption of alcohol during MHT may increase circulating estradiol levels.

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Special Instructions

Cyclo-Proginova is not used for the purpose of contraception.

If contraception is necessary, non-hormonal methods should be used (with the exception of calendar and temperature methods). If pregnancy is suspected, the administration of the dragee should be suspended until pregnancy can be excluded (see section “Pregnancy and lactation”).

If any of the following conditions or risk factors are present or worsen, the individual risk-benefit ratio of the treatment should be evaluated before starting or continuing with ZGT.

Venous thromboembolism

A number of controlled randomized as well as epidemiologic studies have found an increased relative risk of venous thromboembolism (VTE) with ZGT, i.e., deep vein thrombosis or pulmonary embolism. Therefore, when prescribing MHT to women with risk factors for VTE, the risk-benefit ratio of treatment must be carefully weighed and discussed with the patient.

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

The risk of VTE may temporarily increase with prolonged immobilization, “major” elective and trauma surgeries, or massive trauma. Depending on the cause or duration of immobilization, the question of whether or not temporary discontinuation of VTE should be considered

Stop treatment immediately if symptoms of thrombotic disorders appear or are suspected.

Arterial thromboembolism

In randomized controlled trials, there has been no evidence of cardiovascular benefit with long-term use of combined conjugated estrogens and medroxyprogesterone acetate. In large-scale clinical trials of this compound, a possible increased risk of coronary disease in the first year of use was found. An increased risk of stroke has also been found. To date, no long-term randomized controlled trials have been conducted with other MHT drugs to find a beneficial effect on cardiovascular morbidity and mortality. Therefore, it is not known whether this increased risk extends to MHT drugs containing other types of estrogens and progestagens.

Endometrial cancer

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

Breast cancer

In clinical trials and observational studies, an increase in the relative risk of breast cancer has been found in women who have used ZHT for several years. This may be due to earlier diagnosis, the biological effects of MHT, or a combination of both. The relative risk increases with duration of treatment and possibly increases even more when estrogen is combined with progestogens. This increase is comparable to the increased risk of breast cancer in women with each year of delay in natural menopause, as well as with obesity and alcohol abuse. The increased risk gradually decreases to normal levels during the first few years after cessation of MHT.

The breast cancer found in women taking MHT is usually more differentiated than in women not taking it, according to studies.

MST increases mammographic breast density, which in some cases may have a negative impact on radiological detection of breast cancer.

Hepatic tumors

In the background of using sex steroids, which include MHT, benign and even rarer malignant liver tumors have been observed in rare cases. In some cases these tumors have resulted in life-threatening intra-abdominal bleeding. If there is upper abdominal pain, an enlarged liver, or signs of intra-abdominal bleeding, the possibility of a liver tumor should be considered in the differential diagnosis.

Biliary stone disease

Oestrogens are known to increase the lithogenicity of bile. Some women are predisposed to develop gallstone disease when treated with estrogen.

Other conditions

The treatment should be stopped immediately if migraine-like or frequent and unusually severe headaches occur for the first time, or if other symptoms – possible precursors of a thrombotic cerebral stroke – occur.

The relationship between MHT and the development of clinically significant arterial hypertension has not been established. Small increases in blood pressure have been described in women taking MHT, and clinically significant increases are rare. However, in individual cases, if persistent clinically significant arterial hypertension develops on ZGT, discontinuation of ZGT may be considered.”

In mild liver function disorders, including various forms of hyperbilirubinemia such as Dubin-Johnson syndrome or Rotor syndrome, monitoring of the liver is necessary, as well as periodic liver function tests. If liver function worsens, ZHT should be discontinued.

If there is a recurrence of cholestatic jaundice or cholestatic pruritus observed for the first time during pregnancy or prior treatment with sex steroid hormones, ZGT should be stopped immediately.

Women with moderately elevated triglyceride levels require special monitoring. In such cases, use of MHT may cause triglyceride blood levels to rise further, increasing the risk of acute pancreatitis.

While MHT may affect peripheral insulin resistance and glucose tolerance, there is usually no need to change a diabetic’s treatment regimen while on MHT. Nevertheless, women with diabetes should be monitored while on MHT.

Some patients may develop adverse effects of estrogen stimulation, such as abnormal uterine bleeding, under the influence of ZGT. Frequent or persistent abnormal uterine bleeding after treatment is an indication for endometrial study.

If treatment of irregular menstrual cycles fails, it may be necessary to screen for organic disease.

In response to estrogen, uterine myomas may increase in size. In this case the treatment should be stopped.

To discontinue treatment, discontinuation is recommended if endometriosis relapses on ZHT.

If prolactinoma is suspected, this disease should be ruled out before starting treatment.

In some cases, chloasma may occur, especially in women with a history of pregnancy chloasma. Women with a history of chloasma should avoid prolonged sun exposure or ultraviolet radiation while on MHT.

The following conditions can occur or be exacerbated on MHT. Although there is no proven relationship to MHT, women with these conditions should be monitored by a physician during MHT: epilepsy; benign breast cancer; bronchial asthma; migraine; porphyria; otosclerosis; systemic lupus erythematosus; minor chorea.

Medical examination and counseling

Before starting or resuming ZGT, a woman should undergo a thorough general medical and gynecologic exam (including breast examinations and cervical mucus cytology) and pregnancy should be ruled out. In addition, clotting disorders should be excluded. Periodic follow-up examinations should be performed.

Impact on the results of laboratory tests

. Taking sex steroids may affect biochemical measures of liver, thyroid, adrenal, and renal function, plasma levels of transport proteins such as corticosteroid-binding globulin and lipid/lipoprotein fractions, carbohydrate metabolism, coagulation, and fibrinolysis.

Influence on the ability to drive and operate machinery

No effect.

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Contraindications

It is not recommended that hormone replacement therapy (HRT) be started if any of the following conditions are present. If any of these conditions occur during MHT, the use of the drug should be stopped immediately.

• pregnancy and lactation;
• vaginal bleeding of unclear origin;
• confirmed or suspected diagnosis of breast cancer;
• present or history of liver tumors (benign or malignant);
• severe liver disease;
• acute arterial thrombosis or thromboembolism (such as myocardial infarction, stroke);
• expressed hypertriglyceridemia;
• high sensitivity to components of Cyclo-Proginova.

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Side effects

In rare cases, headaches, nausea, abnormal stomach function, breast engorgement, weight changes, uterine bleeding, and chloasma.

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