Climen, 21 pcs.

Climen is a combined product containing estrogen (female sex hormones) – estradiol valerate and antiandrogen (a substance that has the opposite effect to that of male sex hormones) – cyproterone acetate, which has gestagenic (similar to the action of ovarian corpus luteum hormones) properties.

It is a means of hormone replacement therapy to compensate for the lack of sex hormones in women. It reduces or eliminates symptoms of menopausal disorders and has a preventive effect against the development of osteoporosis (bone nutrition disorders accompanied by increased bone fragility associated with changes in hormonal background) and cardiovascular diseases.

Estradiol valerate eliminates or reduces symptoms associated with a decrease in estrogen levels during premenopause, such as hot flashes, sweating, sleep disturbances, irritability, depression (depressed), memory impairment, vascular crises (rapid rise in blood pressure), Atrophic degenerative changes in the skin and mucous membranes (high nail fragility, thinning of the skin and the formation of wrinkles, dry mucous membranes of the urogenital tract), osteoporosis and high bone fragility, changes in lipid metabolism, manifested by increased levels of LDL (low-density lipoproteins), which cause atherosclerotic changes in blood vessels.

In contrast to synthetic estrogens of nonsteroidal structure, estradiol valerate has less effect on protein synthesis function of the liver and weakly stimulates renin formation.

Cyproterone acetate is an anti-androgenic product; due to its gestagenic properties it promotes secretory changes in the proliferating epithelium of the uterus and other target organs, which stops further proliferative processes leading to hyperplasia (overgrowth), in particular the growth of progesterone-deficient hormonal tumors (associated with low progesterone in the body).

As an active anti-androgen, cyproterone acetate reduces androgenization phenomena (appearance of male features in women – coarsening of the voice, male hairiness, etc.). etc.) in patients receiving estrogen replacement therapy in connection with estrogen deficiency, including against the background of ovariectromia (surgical removal of ovaries). It has almost no effect on lipid metabolism, which contributes to a fuller realization of the preventive action of estradiol in relation to cardiovascular disease in the postmenopausal period.

Indications

Active ingredient

Composition

1 white colored tablet contains:

The active ingredient:

estradiol valerate 2 mg;

Associates:

lactose monohydrate;

corn starch;

povidone 25000;

talk;

magnesium stearate;

sucrose;

povidone 700000 (K700);

macrogol 6000;

calcium carbonate;

wax.

1 pink colored dragee contains:

Active substances:

estradiol valerate2 mg;

ciproterone acetate1 mg;

Associates:

Lactose monohydrate,

corn starch,

povidone 25000 (K25),

talc,

magnesium stearate,

sucrose,

povidone 700000 (K700),

macrogol 6000,

calcium carbonate,

glycerol 85%,

titanium dioxide,

iron oxide red,

iron oxide yellow,

wax.

How to take, the dosage

Overly, without chewing, drinking a small amount of liquid, approximately at the same time, 1 tablet a day, starting on the 5th day of the cycle.

After the end of taking the drug from 1 calendar pack, take a 7-day break, during which menstrual-like bleeding begins on days 2-4 after taking the last dragee.

If the doctor does not prescribe other therapy, after a 7-day break begin taking the drug from the next calendar pack. If there is no bleeding during the 7-day break, treatment continues only after ruling out pregnancy.

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 to induce 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.

Special Instructions

Clemen is not used for the purpose of contraception.

If contraception is necessary, non-hormonal methods should be used (except calendar and temperature methods). If pregnancy is suspected, the administration of the pills should be suspended until pregnancy can be excluded.

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

Venous thromboembolism

A number of controlled, randomized, and 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 medroxyprogestrone 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 and with obesity and alcohol abuse. The increased risk gradually decreases to normal levels during the first few years after cessation of MHT.

Breast cancer detected in women taking MHT tends to be more differentiated than in women not taking it, according to most studies.

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

Hepatic tumors

Hepatic tumors have rarely been observed with the use of sex steroids, which include MHT, and even less commonly with malignant liver tumors. 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 against the background of ZGT, discontinuation of ZGT may be considered.

In non-serious liver function disorders, including various forms of hyperbilirubinemia such as Dubin-Johnson syndrome or Rotor syndrome, monitoring by a physician and periodic liver function tests are necessary. 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 exploration.

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 when on MHT: epilepsy; benign breast cancer; bronchial asthma; migraine; porphyria; otosclerosis; systemic lupus erythematosus; minor chorea.

Medical examinations and counseling

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

Impact on laboratory results

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

Impact on the ability to drive and operate machinery

No effect.

Contraindications

Side effects

Reproductive system and mammary glands: changes in the frequency and intensity of uterine bleeding, breakthrough bleeding, intermenstrual bleeding (usually subsiding during therapy), dysmenorrhea, changes in vaginal discharge, premenstrual-like condition; soreness, tension and/or enlargement of the breasts.

Gastrointestinal tract: dyspepsia, abdominal bloating, nausea, vomiting, abdominal pain, recurrence of cholestatic jaundice

Skin and subcutaneous tissue: skin rash, skin itching, chloasma, erythema nodosum

CNS side: Headache, migraine, dizziness, anxiety or depressive symptoms, increased fatigue

Others: palpitations, edema, increased blood pressure, venous thrombosis and thromboembolism, muscle cramps, weight changes, changes in libido, visual disturbances, contact lens intolerance, allergic reactions

Overdose

Symptoms that may occur in case of overdose: nausea, vomiting, vaginal bleeding.

Treatment: there is no specific antidote, treatment is symptomatic.