Universal reference book for medicines
Name of the preparation: CYCLO-PROGINOVA (CYCLO-PROGINOVA)

Active substance: estradiol valerate, norgestrel

Type: Anti-climacteric drug

Manufacturer: BAYER PHARMA (Germany) manufactured by BAYER WEIMAR (Germany)
Composition, form of production and packaging
There are
two types of pills .

White dragees (11 pcs in a blister).

1 dragee

Estradiol valerate 2 mg

Excipients: corn starch - 26.2 mg, lactose monohydrate - 46.25 mg, magnesium stearate - 0.15 mg, povidone 25,000 - 3 mg, talc - 2.4 mg.

The composition of the shell: wax - 0.075 mg, calcium carbonate - 14.711 mg, macrogol 6000 - 3.767 mg, povidone 700000 - 0.296 mg, saccharose crystalline - 33.54 mg, talc - 7.171 mg.

Dragee light brown color (10 pcs in the blister).

1 dragee

Estradiol valerate 2 mg

norgestrel 500 μg

Excipients: lactose monohydrate - 46.75 mg, corn starch - 26.2 mg, povidone 25,000 - 3 mg, talc - 2.4 mg, magnesium stearate - 0.15 mg.

The composition of the shell: microcrystalline sucrose - 33.433 mg, glycerol 85% - 0.204 mg, calcium carbonate - 14.538 mg, iron oxide oxide yellow (E172) - 0.102 mg, iron dye red oxide (E172) 0.123 mg, macrogol 6000 - 3.707 mg, povidone 700,000 - 0.323 mg, talc - 7.088 mg, titanium dioxide (E171) - 0.408 mg, wax monoglycolic - 0.075 mg.

21 pcs.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2010.

PHARMACHOLOGIC EFFECT

Cyclo-Proginova contains estrogen - estradiol valerate, which in the human body is converted to natural 17? -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 cyclic scheme of Cyclobulin-Proginov administration (taking only estrogen for 11 days, then - combining estrogen and progestogen for 10 days, and finally 7-day break) in women with an unsuccessful uterus with 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, sleep disturbances, increased nervous excitability, irritability, palpitations, cardialgia, dizziness, headache, 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 the function of osteoclasts and a shift in the process of bone remodeling toward the formation of bone. 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 with HRT decreases the incidence of colon cancer.
The mechanism of action is still unclear.
PHARMACOKINETICS

After ingestion of estradiol valerate is quickly and completely absorbed from the digestive tract.
After entering the body, it quickly metabolizes with the formation of 17? -estradiol and estrone, which are further 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 h after taking the pills. Levonorgestrel binds with albumin and globulin, binding sex hormones (SHGG). About 1-1.5% of the total serum levonorgestrel concentration is not associated with the protein. With a half-life of approximately 1 day, the metabolites of norgestrel are excreted in the urine and bile.
INDICATIONS

- hormone replacement therapy (HRT) for menopausal disorders, involutional changes in the skin and genitourinary tract, depressive conditions in the climacteric period, as well as symptoms of estrogen deficiency due to natural menopause or hypogonadism, sterilization or primary ovarian dysfunction in women with an unrefined uterus;

- prevention of postmenopausal osteoporosis;

- normalization of irregular menstrual cycles;

- treatment of primary or secondary amenorrhea.

DOSING MODE

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 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 the 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 start 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 the treatment is interrupted for a longer time, vaginal bleeding may occur.
SIDE EFFECT

On the part of the reproductive system and mammary glands: changes in the frequency and intensity of uterine bleeding, breakthrough bleeding, intermenstrual bloody discharge (usually weakened during therapy), dysmenorrhea, changes in vaginal discharge.
a condition similar to premenstrual syndrome; tenderness, tension and / or enlargement of the mammary glands.
From the gastrointestinal tract: dyspepsia, bloating, nausea, vomiting, abdominal pain, relapse of cholestatic jaundice.

From the skin and subcutaneous tissue: skin rash, skin itch, chloasma, erythema nodosum.

From the side of the central nervous system: headache, migraine, dizziness, anxiety or depressive symptoms, increased fatigue.

Other: heart palpitations, swelling, increased blood pressure, venous thrombosis and thromboembolism, muscle cramps, weight changes, changes in libido, visual impairment, contact lens intolerance, allergic reactions.

CONTRAINDICATIONS

It is not recommended to start hormone replacement therapy (HRT), in the presence of any of the conditions listed below.
If any of these conditions occurs during HRT, the drug should be discontinued immediately.
- Pregnancy and lactation;

vaginal bleeding of unknown origin;

- confirmed or suspected diagnosis of breast cancer;

- confirmed or suspected diagnosis of hormone-dependent precancerous disease or hormone-dependent malignant tumors;

- Liver tumors presently or in the anamnesis (benign or malignant);

- severe liver disease;

- Acute arterial thrombosis or thromboembolism (such as myocardial infarction, stroke);

- deep vein thrombosis in the acute stage, thromboembolism now or in the anamnesis;

- severe hypertriglyceridemia;

- Hypersensitivity to the components of the drug Cyclo-Proginova.

Carefully:

Cyclo-Proginova should be administered with caution in the following diseases:

- arterial hypertension;

- congenital hyperbilirubinemia (syndromes Gilbert, Dubin-Johnson and Rotor);

- cholestatic jaundice or cholestatic itching during pregnancy;

- endometriosis;

- myoma of the uterus;

- Diabetes mellitus (see "Special instructions").

PREGNANCY AND LACTATION

HRT is not prescribed during pregnancy or lactation.

Large-scale epidemiological studies of steroid hormones used for contraception or HRT did not reveal an increased risk of developing birth defects in children born in women who took such hormones before pregnancy, as well as teratogenic effects of hormones when they were accidentally taken in the early stages of pregnancy.

A small amount of sex hormones can be excreted in the mother's milk.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in a liver tumor at present or in an anamnesis (benign or malignant);
with severe liver disease.
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 you suspect a pregnancy, you should stop taking the pills until the pregnancy is excluded (see the section "Pregnancy and lactation").
In the presence or deterioration of any of the following conditions or risk factors, the relationship between individual risk and benefit of treatment should be evaluated before starting or continuing HRT.

Venous thromboembolism

In a number of controlled randomized, as well as epidemiological studies, an increased relative risk of venous thromboembolism (VTE) in the background of HRT, i.e.
deep vein thrombosis or pulmonary embolism. Therefore, when HRT is prescribed for women with risk factors for VTE, the risk-benefit ratio should be carefully weighed and discussed with the patient.
Risk factors for VTE development include 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 may temporarily increase with prolonged immobilization, "large" planned and traumatological operations or massive trauma.
Depending on the cause or duration of immobilization, it should be decided whether to temporarily discontinue HRT
It should immediately stop treatment if symptoms of thrombotic disorders occur or if they are suspected.

Arterial thromboembolism

In randomized controlled trials with prolonged 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. To date, long-term, randomized, controlled trials have not been conducted with other HRT medications 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 preparations for HRT containing other types of estrogens and progestogens.
Endometrial cancer

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

According to clinical trials and observational studies, an increase in the relative risk of breast cancer in women using HRT for several years has been found.
This may be due to earlier diagnosis, the biological effect of HRT, or a combination of both. The relative risk increases with the duration of treatment and possibly further increases with the combination of estrogens with progestogens. This increase is comparable to the increase in the risk of breast cancer in women every year, the delay in the onset of natural menopause, as well as with obesity and alcohol abuse. The increased risk gradually decreases to the usual level during the first few years after discontinuation of HRT.
According to studies, breast cancer detected in women taking HRT is usually more differentiated than that of women who do not take it.

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

Tumor of the liver

Against the background of the use of sex steroids, which include and means for HRT, in rare cases, there were benign, and even less often, malignant liver tumors.
In some cases, these tumors led to a life-threatening intra-abdominal bleeding. With pain in the upper abdomen, enlarged liver, or signs of intra-abdominal bleeding in differential diagnosis, the probability of a liver tumor should be taken into account.
Cholelithiasis

It is known that estrogens increase the lithogenicity of bile.
Some women are predisposed to the development of cholelithiasis in treatment with estrogen.
Other states

Immediately discontinue treatment, with the appearance of migraine-like or frequent and unusually severe headaches for the first time, as well as with the appearance of other symptoms-possible precursors of thrombotic cerebral stroke.

The relationship between HRT and the development of clinically significant arterial hypertension has not been established.
Women taking HRT, described a small increase in blood pressure, a clinically significant increase is noted rarely. However, in some cases, with the development of HRT in the presence of persistent clinically significant hypertension, cancellation of HRT can be considered,
In case of mild violations of the liver function, including various forms of hyperbilirubinemia, such as Dubin-Johnson syndrome or Rotor syndrome, a doctor's supervision is necessary, as well as periodic studies of liver function.
With worsening of liver function parameters HRT should be abolished.
In case of recurrence of cholestatic jaundice or cholestatic pruritus observed for the first time during pregnancy or previous treatment with sex steroid hormones, HRT should be discontinued immediately.

Special care is required for women with moderately elevated triglycerides.
In such cases, the use of HRT may cause a further increase in triglyceride levels in the blood, which increases the risk of acute pancreatitis.
Although HRT may affect peripheral insulin resistance and glucose tolerance, there is usually no need to change the regimen for treating diabetic patients with HRT.Nevertheless, women suffering from diabetes mellitus should be monitored during HRT.

In some patients, HRT may cause unwanted estrogen stimulation, such as abnormal uterine bleeding.
Frequent or persistent abnormal uterine bleeding against the background of treatment is an indication for endometrial research.
If treatment of irregular menstrual cycles does not give results, a survey should be conducted to eliminate the organic disease.

Under the influence of estrogen, uterine fibroids may increase in size.
In this case, treatment should be discontinued.
It is recommended to stop treatment with the development of recurrence of endometriosis in the background of HRT.

If you suspect a prolactinoma before starting treatment, you should exclude this disease.

In some cases, there may be a chloasma, especially in women with a history of pregnant women with chloasma.
During the HRT women with a tendency to the appearance of chloasma should avoid prolonged exposure to the sun or ultraviolet radiation.
The following conditions may occur or be exacerbated by HRT. Although their relationship with HRT has not been proven, women with these conditions during HRT should be under a doctor's supervision: epilepsy; benign breast tumor; bronchial asthma; migraine; porphyria; otosclerosis; systemic lupus erythematosus, chorea.
Medical examinations and counseling
Before starting or resuming HRT woman should undergo a thorough general medical and gynecological examination (including breast examination and cytological examination of cervical mucus), exclude pregnancy. Furthermore, it should eliminate blood coagulation disorders. Periodic follow-up examinations should be carried out.
Effect on laboratory results
Receiving sex steroids can affect liver function, thyroid, adrenals and kidneys, to the content in the plasma transport proteins such as globulin kortikosteroidsvyazyvayuschy and lipid / lipoprotein fractions, carbohydrate metabolism, coagulation and fibrinolysis.
Impact on the ability to drive vehicles and manage mechanisms

Does not affect.

OVERDOSE

Not revealed the risk of serious side effects if accidentally taking the drug Cyclo-Proginova in an amount several times greater than the daily therapeutic dose. Symptoms that may occur with overdose include nausea, vomiting, vaginal bleeding. No specific antidote, symptomatic treatment.
DRUG INTERACTION

At the beginning of HRT need to halt the use of hormonal contraceptives. The patient should be advised that hormonal contraceptives if necessary.
Prolonged treatment with drugs that induce liver enzymes (e.g., some anticonvulsants and antimicrobials) can increase the clearance of hormones and reduce their clinical efficacy. This property of inducing liver enzymes was found in hydantoins, barbiturates, primidone, carbamazepine and rifampicin, the presence of this feature is also contemplated at oxcarbazepine, topiramate, felbamate and griseofulvin. Maximal enzyme induction is generally observed not earlier than 2-3 weeks, but then it may persist for at least 4 weeks after stopping treatment.
In rare cases, the background concomitant ingestion of certain antibiotics (e.g., penicillin and tetracycline groups) there was a decrease in estradiol levels.
Substances largely exposed conjugation (e.g., paracetamol) may increase the bioavailability of estradiol due to competitive inhibition of conjugation in the process of absorption.
Due to the influence of hormone therapy on glucose tolerance in some cases may change the need for oral antidiabetic agents or insulin.
Interactions with Alcohol:
Excessive alcohol consumption during HRT may lead to an increase in circulating levels of estradiol.
TERMS AND CONDITIONS OF STORAGE

Keep out of reach of children! Store at ambient conditions.
Shelf life - 5 years.
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